cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.

Brief Summary:

The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection.

This study looks at data records from a database in the United States.

This study includes patient's data from the database who:

* Are 15-30 years old.
* Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.

This data has already been collected in the past and is being studied between April and June of 2023.

This study is a retrospective cohort study including individuals registered and available in the PharMetrics Plus database from 01 Jan 2016 to 31 Dec 2022 In order to estimate the effect of Trumenba vaccination, the cumulative incidence rate over time of the defined disease of interest among Trumenba + MenACWY vaccines will be compared to that among MenACWY vaccinees. Stratified analysis will be made by age groups, gender and state of residence

Eligibility Criteria:
Inclusion Criteria:

1. Individuals of 15-30 years old registered in the PharMetrics Plus system
2. Individuals having the index vaccination event at the age of 15-30 in 2016-2021

Exclusion Criteria:

1. Individuals having any dose of Bexsero at any time during the study period and prior to the study
2. Individuals with incomplete information on variables to be collected.
Turkish Translation of SportsConcussion Assesment Tool 6

Concussions, a significant type of sports injury caused by head, face, or neck trauma, are common in contact sports and require serious attention due to potential fatal consequences of mismanagement. The Sport Concussion Assessment Tool (SCAT), developed by the Concussion in Sport Group (CISG) and updated in 2023, provides a standardized approach to assess head injuries and manage athletes' return-to-sport process. While SCAT has been adapted into various languages, no Turkish version exists. This study aims to translate and culturally adapt SCAT 6 into Turkish, contributing to the accurate evaluation and management of concussion injuries among Turkish-speaking athletes.

Concussions constitute an important part of sports injuries. Concussion is a head trauma caused by blows to the head, face and neck. Head injuries are common in contact sports. They are usually minor injuries. However, injuries should be taken seriously. Because mismanagement can be fatal in cases of misdiagnosis. Therefore, it is among medical emergencies .

A sports concussions group has been established for the correct management of concussions seen in sports. In 2022, the group met in Amsterdam, renewed the existing consensus and published it in the British Journal of Sports Medicine in 2023 . The Sport Concussion Assessment Tool (SCAT), developed by the sports concussion group (CISG), is a valid and reliable approach to assessing sports-related head injuries ('Sport Concussion Assessment Tool 6 (SCAT6),' 2023). The main purpose of SCAT is to assess head injuries with a standardised method and to manage the return to sport process of athletes. SCAT is an assessment tool that evaluates adult athletes over the age of 13 in terms of physical, mental and cognitive aspects and includes different sections.

In the literature, there are adaptations of previous and current versions of SCAT in different languages (Korean, Chinese, Persian, Arabic). However, no Turkish translation and adaptation study of any version has been conducted before. Turkishisation of this assessment tool is an important step in terms of accurately evaluating concussion injuries in Turkish-speaking athletes and managing the return to sport process correctly. The aim of this study is to translate the SCAT 6 into Turkish and to provide intercultural adaptation of the SCAT 6 to the literature.

Eligibility Criteria:
Inclusion Criteria:

To be 13 years old

* Talking in Turkish
* Being a Professional Athlete

Exclusion Criteria:

* Athletes who experience any injury during the test, retest process will be excluded from the study.
Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19

This is a randomized, placebo-controlled, double-blind phase I clinical study of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and antiviral efficacy for the treatment of adult patients with mild COVID-19 and low risk of disease progression.


Eligibility Criteria:
Key Inclusion criteria

* Outpatient with a RT-qPCR confirmation of SARS-CoV-2 infection
* Body Mass Index (BMI) at screening of 18.0 - 34.9 kg/m\^2
* Presence of at least one symptom consistent with COVID-19
* Mild illness as defined by no requirement of supplementary oxygen or hospitalization criteria are met

Key Exclusion criteria

* Presence of a risk factor for disease progression documented for COVID-19 such as: uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary disease, COPD, asthma, active cancer, immunosuppression, hypercoagulable states, CKD currently under dialysis
* Documented allergy to equine serum proteins
* Previous hospitalization due to COVID-19
* Supplementary oxygen, invasive ventilation, or mechanical circulatory support requirements
* Having received convalescent plasma or intravenous immunoglobulins for the treatment of COVID-19
* Previous vaccination or plans to get vaccinated for COVID-19
* In the opinion of investigator, other health conditions that suppose an increased risk of progression of disease

NOTE: Other inclusion/exclusion criteria apply
Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of GERD

To describe the frequency, type and severity of the symptoms in patients visiting the GI or internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)


Eligibility Criteria:
Inclusion Criteria:

* Patients from both sexes, aged 18 years or older
* Patients complaining of symptoms consistent with reflux disease

Exclusion Criteria:

* Patients with GI cancer and those where the only reason for the visit is renewing the prescription are excluded
Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10

The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of an adrenocorticotropic hormone (ACTH) short fragment. That is free from hormonal effects and has neuromodulatory effects. We investigate the neuroprotective effects of ACTH4-10Pro8-Gly9-Pro10 can lessen neurotoxicity against ketamine in neonatal rats by looking at BDNF expression in the cortex and hippocampus tissue as well as BDNF blood levels.

The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects. The immune-modulating and neurotrophic activity of the drug were shown to balance the state of anti-inflammatory and trophic factors (IL-IO, TNF-a, TGF-Pl, BDNF, NGF) over proinflammatory factors (IL-Ip, IL-8, CRP, LE) to increase the anti-apoptotic defense (Bcl-2 elevation), as well as to reduce the peroxidation process (increased SOD activity).

ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis. Based on research by Gusev and Skvortsova, ischemic stroke patients who were given ACTH4-10Pro8-Gly9-Pro10 showed increased levels of BDNF, decreased mortality, and reduced length of stay. Based on the description above, the researcher was interested in analyzing the effect of the administration of ACTH4-10Pro8-Gly9-Pro10 on ketamine neurotoxicity in neonatal rats by assessing the level of BDNF.

Eligibility Criteria:
Inclusion Criteria:

* Rattus norvegicus rats
* Male, seven days old, weighing 15-20 grams
* Spraque-Dawley strain, obtained from the Experimental Animal Care Unit

Exclusion Criteria:

* Animals that behave aggressively in observation by attacking other groups
The Effects of Hesperidin on Metabolic Syndrome

To study the effects of Hesperidin supplement in patients with metabolic syndrome, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HDL

Exclusion Criteria:

* pregnancy or lactation
* A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* Following program to lose weight in recent 3 mo
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel

The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in QOL from baseline to post-treatment, as measured by the Functional Assessment of Cancer Treatment- lymphoma (FACT-Lym). Secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and communicating these and other concerns across care settings. To support patients and facilitate the collection of key PROs, a digital health coaching solution provided by Pack Health will be provided to each participant over the 6-month study enrollment. The digital coaching program provides an evidence-based curriculum focused on monitoring and managing CAR T-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. The participating site(s) will collect longitudinal PRO data focused on QOL across physiologic and psychosocial domains that coaching personnel will access and review with participants.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Able to read, speak and consent in English
* Diagnosis of diffuse large b-cell lymphoma
* Confirmed treatment with tisagenlecleucel (Kymriah)
* Internet access via smartphone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.

Exclusion Criteria:

* Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
* Individuals for whom there is documentation of inability to provide consent in the medical record
Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.

Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia

Exclusion Criteria:

* Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
* Epilepsy or other EEG abnormality
* Prescription or illicit drugs known to affect the EEG
Short Period Incidence Study of Severe Acute Respiratory Illness

This is a multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with SARI. The study period will occur, in both Northern and Southern hemispheric winters. The study period will comprise a 5 to 7-day cohort study in which patients meeting a SARI case-definition, who are newly admitted to the hospitals / ICUs at participating sites, will be included in the study. The study will be conducted in 20 to 40-hospital/ ICU-based research networks globally. All clinical information and sample data will only be recorded if taken as part of the routine clinical practice at each site and only fully anonymised and de-identified data will be submitted centrally.

The primary aim of this study is to establishing a research response capability for a future epidemic / pandemic through a global SARI observational study. The secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.

Severe acute respiratory infection (SARI) continues to be of major relevance to public health worldwide. In the last 10 years there have been multiple SARI outbreaks around the world. The 2009 H1N1 pandemic was estimated to result in more than 200,000 respiratory deaths globally. The World Health Organization (WHO) defines SARI as an acute respiratory infection of recent onset (within 10 days) requiring hospitalisation, manifested by fever (≥38oC) or a history of fever and cough. There is international consensus that it is important to undertake observational studies of patients with SARI as an essential component of pandemic and epidemic research preparedness.

Eligibility Criteria:
Inclusion Criteria:

* A history of feverishness or measured fever of ≥ 38 deg C;
* Cough;
* Dyspnoea (shortness of breath) OR Tachypnoea.

Exclusion Criteria:

• No exclusion criteria
Response to Hepatitis B Vaccine in Celiac Disease Patients

Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series via a different route of administration (into the skin rather than the muscle) results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series into the skin or to the muscle. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
* Completion of the IM HBV vaccine series in infancy.
* HBsAb titer of ≤10mIU/mL at the time of enrollment.

Exclusion Criteria:

* Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathiopurine, 6-MP, steroids).
* Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.
Clozapine Therapy Sample Collection - Method Comparison Study

The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Study subjects must meet all the following criteria to be eligible for enrollment into the study:

  1. Female or male subjects 21 years of age or older;
  2. Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment;
  3. Capable of understanding and complying with parameters as outlined in the protocol;
  4. Capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study specific procedures.

Exclusion Criteria:

* 1. Female or male subjects under the 21 years of age; 2. Unwilling or unable to follow protocol requirements or to give written informed consent.
Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space

Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann \& Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to poorer test performance.


Eligibility Criteria:
Inclusion Criteria:

* Younger subjects

  * aged between 18 and 35 years
  * ability to provide written informed consent
  * right-handedness
* Elderly subjects

  * aged between 50 and 85 years
  * ability to provide written informed consent
  * right-handedness

Exclusion Criteria:

- Exclusion criteria for both groups:

* serious psychiatric disorders (including depression, psychosis) in the past
* severe neurological disorders (such as epilepsy, dementia, stroke) in the past
* current severe medical disorder
* drugs, medication or alcohol abuse at the time of the study
* severe traumatic brain injury or tumor in the past
* operations on the brain, trepanations
* metallic implants in the head / neck area (except in the mouth), such as screws, splinter, artificial cochlea, electrodes
* severe skin diseases (like eczema) or very sensitive skin in the head region in the past
* epilepsy in the family
* current use of neuroleptics, antiepileptics, antidepressants, L-dopa, benzo-diazepines
* current pregnancy or lactation
* current claustrophobia
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

The purpose of the RISE study is to examine how the 24-hour rhythm of sleep and social activity relate to mood and suicidal ideation among older adults that recently lost a spouse or life partner.

Experiencing the death of a spouse or life partner is a profoundly distressing event that may cause abrupt changes in one's daily routine, including decreased self-care and withdrawal from social activities. While most individuals adapt over time, a substantial number of older bereaved spouses (20-35%) experience depression, loneliness, suicidal thoughts, and early mortality, including death by suicide.

The objective of this study is to examine the risk for and resilience to late life suicide during the early spousal bereavement period by investigating the extent to which (1) social connectedness influences suicide risk and (2) whether circadian rhythm instability (inconsistent patterns of sleep, activity, meals, and socialization) helps explain this association.

The investigators will enroll 169 adults aged 60+ years who experienced the death of a spouse or life partner within the previous 12 months. All participants will complete repeated assessments of social connectedness, clinical assessments of depression and suicide ideation, and accelerometry recordings of the 24-hour pattern of sleep and activity. Participants will also complete a 3-month behavioral probe, designed to promote self-care behaviors in older bereaved spouses using technology and motivational health coaching. The behavioral probe targets circadian rhythm stability by focusing on regular routine of sleep, meals, and social activities. The behavioral probe will determine whether modifying social connectedness reduces suicide risk and whether circadian rhythm stability explains part of this association.

Eligibility Criteria:
Older adults who recently lost their spouse or life partner and are high risk for suicidal thoughts and/or behavior.

Inclusion Criteria:

1. Bereaved \< or = to 12 months from spousal/partner loss
2. \> or = to 65 years old
3. Verified history of suicide attempt/attempts and/or current or past history of Major Depressive Disorder/Major Depressive Episode (MDD/MDE) (without psychotic features), or history of depression severe enough to trigger treatment, or current subsyndromal depression (\> or = to 9 HDRS)
4. No diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis
5. Does not reside in nursing home
6. Not a current shift worker
7. No major cognitive impairment: TICS score of \> or = to 27

Exclusion Criteria:

1. Bereaved \>12 months from spousal/partner bereavement
2. \< 65 years old
3. Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
4. Prior diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis or medications listed indicate diagnosis of these disorders/MDD or MDE with psychotic features
5. Major cognitive impairment: TICS score of \<27
6. Current shift worker
7. Resides in a nursing home
8. Unstable medical condition (e.g., unstable angina, end stage renal disease)