cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19

Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S).

This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years.

Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28 days apart.

* low dose ≥ 1 x 10e7 IU (N=8)
* middle dose ≥ 5 x 10e7 IU (N=8)
* high dose ≥ 1 x 10e8 IU (N=8)

Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single injection.

* low dose ≥ 1 x 10e7 IU (N=12)
* middle dose ≥ 5 x 10e7 IU (N=12)
* high dose ≥ 1 x 10e8 IU (N=12)

All participants will be followed up for safety until D168.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Healthy male and female adults aged 18 - 64 at time of informed consent.
3. Body mass index 18.5 - 32.0 kg/m2 and weight \> 50 kg at screening.
4. Female participants: non-pregnant, non-lactating with negative pregnancy test.
5. Females who agree to comply with the applicable contraceptive requirements of the protocol.
6. ≥ 6 months fully vaccinated with a (conditionally)licensed mRNA vaccine against COVID-19 (Part B only)

Exclusion Criteria:

1. Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
2. Previous rMVA immunization.
3. Previous immunization with investigational vaccine against COVID-19.
4. Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
5. Evidence of active SARS-CoV-2 infection
6. Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
7. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
8. Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
9. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
10. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
11. Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy

Tonsillar disorders are frequent In both pediatric and adult otolaryngological practice, . Numerous disorders that damage tonsillar tissue necessitate tonsillectomy. Tonsillectomy is typically required for recurrent tonsillitis. (Mani et al., 2019).

According to studies, the mucosa-associated lymphoid tissue (MALT) of the stomach and tonsillar tissue in the Waldeyer's ring are both lymphoid tissues (Ma et al., 2018).

One of the most prevalent and frequent conditions in otorhinolaryngology is chronic tonsillitis, which is mostly brought on by bacterial infection. Chronic tonsillitis attacks can affect not only the tonsillar tissue but also can contribute to the emergence and progression of systemic disorders (Alrayah.,2023).

A gram-negative, urease-producing bacterium called Helicobacter pylori colonizes the mucosa of the digestive tract. It has been linked to gastric malignancies, notably mucosa-associated lymphoid tissue (MALT) lymphoma, as well as gastric ulcers and duodenal ulcers (Kusters et al., 2006).


Eligibility Criteria:
Inclusion Criteria:

1. Age: 5 to 50 years.
2. Of both sex.
3. Diagnosed with chronic tonsillitis undergoing elective tonsillectomy

Exclusion Criteria:

1. Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .
2. Immune-compromised patients.
3. Patients with obstructive sleep apnea candidates for adenotonsillectomy
Effect on Bacterial Glycolytic Acid Formation on Plaque

To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.


Eligibility Criteria:
Inclusion Criteria:

* Maxillary dentition is preferentially natural.
* Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
* Natural mandibular front teeth and first premolars (4-4) are retained.
* Second mandibular molars are ideally present to serve as abutment teeth.
* Mandibular restorations and/or reconstructions must be in clinically good condition.
* Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
* Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
* Willingness to give their informed consent and comply with the protocol.
* No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Current participation in other dental clinical trials.
* Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
* Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
* Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
* Subjects taking drugs known to currently affect salivary flow.
* Subjects with un-stimulated salivary flow \<0.3 ml/min and/or stimulated flow \<0.9 ml/min.
* Women who are pregnant or breastfeeding
* History of allergy to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
* Medical condition which requires premedication prior to dental procedures/visits
* History of allergy to amino acids
Enhancing the Vagal Tone in Prediabetes Individuals

This is a 2-year course of study. A randomized control trial will be conducted, in which 90 prediabetes individuals will be recruited and randomly assigned them into the wait-list control group or experimental group to test the effectiveness of 8 once-a-week, individual, 20-min sessions of HRV biofeedback on modulating vagal tone, glycemic control, psychological wellbeing, and inflammatory status in this population. Its longitudinal effects will be evaluated after 3- and 6-month follow-up.

Background. Compared to healthy population, individuals with prediabetes have a higher risk to develop diabetes and other cardiovascular diseases. However, these downward progressions might positively associate with autonomic nervous dysfunction, especially low vagal tone, which can be detected prior to comorbidities confirmed. The significant correlations among low autonomic nervous, high psychological distress, inflammatory status, and poor glycemic regulation, which are regarded as the psychoneuroimmunological integration, have not been well studied in prediabetes individuals. Heart rate variability (HRV) biofeedback is an easy and noninvasive intervention, which has been confirmed to strengthen baroreflex stimulation, facilitate the modulation of vagal tone, and further promote the physiological and psychological wellbeing in various diseases but not in prediabetes.

Objective. To test the effectiveness of HRV biofeedback on the modulating vagal tone and further enhancing the psychoneuroimmunological integration related to glycemic control, anti-inflammatory reaction, and psychological wellbeing.

Research methods. In this 2-year RCT study, the investigators are planning to recruit 90 prediabetes individuals and randomly assigned them into wait-list control group or experimental group by using the random sequence of numbers generated from the Excel Bernoulli Function. Experimental group will receive 8 once-a-week, individual, 30-min sessions of HRV biofeedback and 1 session of healthy lifestyle education. During the biofeedback training period, subjects will be encouraged to self- home practice of resonant frequency breathing for 20 mins, twice-a-day. Control group will receive 1 session of healthy lifestyle education. All subjects will be repeatedly assessed at time of enrollment, post-training (8 weeks after enrollment), 3-month, and 6-month follow-up. Repeated assessments will include physiological measurements of HRV, BDNF, GAS6, HbA1c, CRP, IL- 6, FPG, and salivary cortisol, and psychological measurements of perceived stress, anxiety, and depression.

Eligibility Criteria:
Inclusion Criteria:

* aged 20 or more
* fasting blood glucose level of 100 to 125 mg/dl
* HbA1C value of 5.7% to 6.4%

Exclusion Criteria:

* lack of Chinese literacy
* visual and hearing deficits
* the presence of arrhythmia
* previous diagnosed with diabetes
* any other serious physical illness (e.g. severe neurocognitive disorders or evidence of cor pulmonale) or psychiatric disorders
S-Equol in Alzheimer's Disease 2 Trial

By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.

Enrolled participants with a diagnosis of Alzheimer's Disease (AD) will be randomized to receive either S-equol or placebo first, and then cross over to receive the opposite intervention. The study, therefore, consists of two treatment periods with randomly assigned treatment order. Specifically, subjects are randomized to either: (1) S-equol for one month, then placebo for one month; or (2) placebo for one month, then S-equol for one month.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of Alzheimer's Disease (AD)
* Have a study partner who has a close relationship with the participant and will attend study visits with the participant
* Do not possess an Alkylphenol ethoxylates 4 (APOE4) variant of the APOE gene
* Speak English as their primary language
* Have not had any medication changes within the past 30 days

Exclusion Criteria:

* Reside in a nursing home or dementia special care unit
* Have a potentially confounding, serious medical risk such as insulin-requiring diabetes, any history of cancer that required a chemotherapy or radiation therapy intervention within the past 5 years, or a recent cardiac event
* Have any clinically significant abnormal safety laboratory values at the SEAD2 screening visit
* Have any clinically significant abnormal findings on vital signs measurements, or on physical or neurological examination at the SEAD2 screening visit
* Use any type of systemic estrogen or testosterone replacement therapy
* Has participated in another clinical trial or received any investigational drug or investigational therapy within 30 days before the screening visit
Sensorimotor Maps of Vowel Perception and Production

Speech develops through a co-structuring of auditory and motor representations, especially in the first years of life during language acquisition. In the present study, we will test by means of functional magnetic resonance imaging whether vowel perception and production might depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of this study will lead to a better understanding of whether both vowel perception and production are processed in the human brain and will provide important insight into brain-language relationships. Besides new theoretical perspectives on speech perception and production, this project might raise important questions concerning patients with speech disorders by identifying which aspects of speech perception and production are functionally linked.

The goal of this study is to explore the functional neuroanatomy of vowel processing. To this aim, we will investigate the neural basis of both attentive auditory perception and production of natural French vowels using functional magnetic resonance imaging. More specifically, we will compare vowels that varied along a given phonetic feature dimension while keeping other feature characteristics constant. The phonetic features to be tested are roundedness (rounded/unrounded vowels), place of articulation (front/back vowels) and height (close, close-mid, open-mid vowels). Our study posed three specific questions. First, where exactly in the human brain is the perceptual and motor segregation of different vowel categories accomplished? Second, are these stimulus dimensions implemented topographically in an orthogonal manner, as they vary orthogonally in natural speech? Most specifically, one would expect a topographic segregation between two vowel categories (e.g., front vs back vowels) in both auditory and motor cortices that are characterized by widely distinct acoustic and articulatory values. Third, does these possible sound-related topographic activations in auditory and motor cortices overlap during vowel perception and production? This latter result would support a functional coupling between speech perception and production systems.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 year-olds
* Personal health insurance

Exclusion Criteria:

* Contraindications to IRM (Pacemaker, Aneurysm Clip, Heart/Vascular Clip, Prosthetic Valve, Metal Prosthesis, Claustrophobia, Metal fragments in body).
* Pregnancy / nursing mother
* Participation to another fMRI study in the last month
* Speaking or hearing disorders (past/present)
* Neurological and/or psychiatric disorders (pats/present)
* Left-handed
* Non-native French speaker
Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.


Eligibility Criteria:
Inclusion Criteria:

* healthy, white, male volunteers between 18 and 55 years of age (inclusive)
* BMI between 19 and 28 kg/m² (inclusive)

Exclusion Criteria:

* previous participation in a clinical study with Rotigotine
* history or current condition of epilepsy and/or seizures
* known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
* history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
* history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
* clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations
* positive HIV, hepatitis B or C test or positive alcohol or drug test
* relevant hepatic or renal dysfunction
* intake of medication that might interfere with the test drug within 2 weeks prior to dosing
* thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites
Mental Flexibility

The main purpose of this research is evaluate if HBMT reduces HAB in Soldiers, reduces intra-team conflict, improves trust, and improves unit cohesion. A secondary purpose of this research is to test Soldier acceptability and perception of the training. Volunteers will be randomized to a training or placebo version of a computer task designed to reduce HAB and interpersonal conflict. Soldiers will then complete surveys at multiple time intervals before, during, and following deployment. If successful, this research would demonstrate the ability of a computer based training to improve unit cohesion and Soldier attitudes during pre-deployment training and deployment itself.

The study will consist of a double blind randomized controlled trial of HBMT (versus placebo) with subsequent pre-, during, and post-deployment surveys to assess the effectiveness of HBMT to influence relevant unit- and Soldier-level outcomes. Soldiers will be Command directed to participate. As such, all data will be used for briefing to unit leadership, however, participants will be asked to consent whether they allow their data to be used for research purposes. Subordinate units within the BN will be randomly assigned to complete either an active training or placebo version of the task. The individual briefing the Soldiers during training sessions will not know which version of the training the Soldiers are completing on the computer. Up to 40 Soldiers will complete HBMT at a time on individual study computers. Brief surveys will follow each training. There will also be a survey shortly before deployment, during deployment and shortly after deployment. See Appendix Q for tentative study timeline. For details on procedure see Section 9.8. Surveys completed during same day as HBMT training sessions will be completed on experimenter provided laptops, whereas surveys completed independent of an HBMT training session will be completed in pencil and paper format. See section 219.8 for details. The current protocol provides details for the first time point (initial HBMT training session). Additional amendments will be used to provide details and obtain approval for subsequent time points as these are coordinated with the unit. However, general information for follow-on time points is provided in this version of the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Soldiers assigned to the 1-128 IN BN / Wisconsin Army National Guard.

Exclusion Criteria:

* Soldiers not assigned to the 1-128 IN BN / Wisconsin Army National Guard.
Effects of Task-Specific Step Training on Reactive Balance

The goal of this study is to investigate the effects of a novel form of balance training called trip training. Trip training typically involves repeatedly exposing an individual to trip-like losses of balance on a specialized treadmill. This repeated exposure can lead to improvements in responses to trips while walking in the future, thereby reducing the risk of falling after a trip. Trip training typically is commonly conducted using a costly specialized treadmill. This study will evaluate the efficacy of a trip training protocol that does not require a treadmill. Adults age 65-80 will be assigned to either 1) non-treadmill trip training, 2) treadmill trip training, or 3) no intervention. The investigators hypothesized that responses to laboratory-induced trips would be better after non-treadmill trip training compared to no intervention, and that there would be no statistical difference between responses to laboratory-induced trips after non-treadmill trip training and treadmill trip training. The results from this work will advance the use of trip training, and may enable its wider use by establishing a protocol that does not require a costly treadmill.


Eligibility Criteria:
Inclusion Criteria:

* 65-80 years old
* willing to use wearable sensors for 2-3 weeks (for a separate study)
* no lower limb amputation
* not weigh over 250 pounds
* pass a telephone interview related to cognitive status

Exclusion Criteria:

* participants must pass a health screening involving a questionnaire that will be reviewed by a health care specialist.
* participants must not have clinical osteoporosis as indicated by a bone mineral density of the lumbar vertebra and proximal femur of t\<-2.0 as obtained from dual energy x-ray absorptiometry (DEXA), or a DEXA scan completed within the last year.
Expanded Access of Pimavanserin for Patients With PD Psychosis

The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.


Eligibility Criteria:
Inclusion Criteria:

1. Patient meets one of the following criteria:

   1. Patient has participated in a previous study of pimavanserin for Parkinson's disease psychosis (PDP)
   2. New ("De novo") patients
2. A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
3. Female patients must be of non-childbearing potential
4. Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
5. Patient that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
6. The patient or Legally Authorized Representative (LAR) is willing and able to provide consent
7. The patient or LAR is willing and able to adequately communicate in English.

Exclusion Criteria:

1. Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
2. Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
3. Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
4. Patient has had a myocardial infarction in last six months
5. Patient has any surgery planned during the screening, treatment, or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
VCRC Longitudinal Protocol for Aortitis

The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA), Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This study will establish a longitudinal cohort for these diseases.

This study will develop a longitudinal cohort of patients with different types of aortitis to systematically study the natural history, optimal treatments, and outcomes in this group of diseases. This will provide a resource for future studies and for identification of new biomarkers of aortitis for purposes of diagnosis, disease activity measurement, disease damage assessment, determination of disease states, and evaluation of treatment response.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be included if they meet one of the following criteria:

1. Previous or current microscopic evidence of aortitis (active or healed) on surgical specimen obtained during aortic resection
2. Previous or current radiographic aortitis that could include circumferential aortic wall thickening of at least 3mm on CT or MRI or increased PET FDG uptake in the aorta at values equal to or greater than the liver, in absence of an alternative explanation for the radiographic findings.

Exclusion

1. Subjects already enrolled in one of the other VCRC longitudinal cohorts: 5502, 5503, 5504, 5505, and 5506.
2. Inability of participants (or their guardians in the case of children) to give informed consent and to sign the consent form.