cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System

The increased incidence of pain syndromes requires the investigation of pathophysiological coherences as well as searching for new therapies. In the recent years neurostimulating techniques have been a promising approach regarding their analgesic effect. Combined with therapeutic standard procedures they can increase these effects and can have a positive impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient analgesic method in animal experiments and open clinical pilot studies amongst humans. Despite the lack of controlled approaches applying the method against defined pain syndromes, the stimulation of the vagus nerve has shown up as an effective method treating other psychiatric diseases like depression. The processing of stress, which is involved directly and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation. Compared with invasive methods the transcutaneous stimulation offers obvious advantages concerning appliance and occurrence of side effects. There are no studies so far dealing with the neuromodulatory effect on the handling of pain or the clinical therapy of defined (chronic) pain related diseases using the t-VNS system. The study hypothesis implies a change of experiencing pain when applying the t-VNS in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age: Minimum: 18 years Maximum: no limit
* Both Gender
* Normal psychiatric medical history
* Normal neurological report

Exclusion Criteria:

* Psychiatric disease incl. pain-related diseases
* Subject is on medication
* Abuse of drugs or alcohol until 12 weeks before enrollment in the study
* Actual wearing conditions
* Pronounced lack of sleep within the last 2 days of enrollment
* Excessive consumption of alcohol in the last 2 days
* Peripheral neuropathy
* Severe neurological diseases (cerebrovascular diseases, traumatic brain injury, epilepsy, Morbus Parkinson, dementia, systemic neurologic diseases etc.)
* migraine
* carpal tunnel syndrome or other entrapment syndromes
* missing Informed Consent
* Pregnancy
* active implant (like cochlea implant, VNS, pacemaker)
* severe internistic diseases (e.g. arterial hypertension, respiratory failure)
* malignant diseases within the last five years
* severe acute infections (e.g. HIV, hepatitis)
* diseases of the ENT bodysystem: Hearing loss of the left ear which is treated with an hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal
* Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
Biological and Clinical Efficacy of Shingrix in Patients With CLL

This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.

This is a multi-centre, prospective study, performed on biological samples only. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study.

According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart.

Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix. All protocol procedures (including clinical assessment and blood draws) will be performed during regular follow-up visits according to clinical practice. No additional invasive/dangerous/painful procedures will be required by the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL or small lymphocytic lymphoma (SLL) or CLL-like MBL according to IWCLL guidelines. Patients must belong to one of the following subgroups:

  * Group A: Patients with MBL or previously untreated early-phase CLL/SLL (Binet stage A or RAI stage 0), with no clear signs of disease progression;
  * Group B: Patients with active or symptomatic disease according to IWCLL guidelines or with advanced Binet or Rai stages receiving both the first and second vaccine doses before treatment initiation;
  * Group C: Patients with CLL/SLL receiving targeted drugs (i.e. ibrutinib/acalabrutinib-based treatment or venetoclax-based treatment) for at least 6 months prior to the administration of the first vaccine dose.
* Age 18 years or older
* Eligible to receive Shingrix according to clinical indication and free of charge through the Italian National Health System
* Life expectancy \>6 months
* No active, symptomatic herpes zoster infection or varicella-zoster virus reactivation within 12 months prior to vaccination
* No prior exposure to Shingrix
* Able and willing to provide written informed consent and to comply with the study protocol procedures

Exclusion Criteria:

* Female patients who are currently in pregnancy or are willing to be pregnant
* Any uncontrolled active systemic infection
* Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination
* Concomitant use of radiotherapy or chemotherapy
* Hereditary or acquired immunodeficiency syndrome unrelated to CLL
* Chronic use of immunosuppressive medications given for indications that are not CLL-related
Absorption of Mango in Healthy Individuals

The objective of this research is to characterize the urinary metabolites produced after the consumption of mango pulp in an effort to begin to characterize the bioavailability of the major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight into their in vivo physiological behavior.

Eleven healthy volunteers (2 male, 9 female) who had no medical history of digestive disorders or chronic diseases participated in the 10-day mango consumption study. They were aged between 21-38 years and with a weight between 45-95 kg. Participants were asked to stop taking dietary supplements for 1 week prior to the study begin and study duration and asked to avoid excessive exercise and alcohol consumption 3 days prior to the start of the study day 1 and study day 10. Participants were also required to fill out a 72-hour nutritional report at home that detailed their food consumption over the previous 3 days leading up to the first and tenth day and were reviewed for compliance. All participants fasted from fruit and vegetables, coffee and tea one day prior to study day 1 and 10 and were asked to bring in a stool sample collected prior to consumption of mango on the first day of the study. After an overnight fast of at least 12 hours, urine collections were made (baseline) and a baseline blood draw was taken from each participant. Each participant was given 400 grams of mango to consume and urine collections were made at 0-3, 3-6, 6-8, and 8-12 hours. The volume of urine was recorded and an aliquot immediately frozen at -80°C until analysis. Blood samples were also taken at 0.5, 1, 2, 3, 4, 6, 8, and 12hrs, collected in heparinized tubes and centrifuged for 10 mins at 4000 x g, 4°C. Supernatant (plasma) was aliquoted into 2mL samples, acidified with 50 μL 85% formic acid, and immediately frozen at -80° C until analysis. Participants were given 400 grams of mango to consume daily for the next eight days and the study design was repeated again on the 10th day. After completion of the tenth day of study, stool samples were collected and immediately frozen at -20°C for microbial analysis.

Eligibility Criteria:
Inclusion Criteria:

* No medical history of digestive disorders or chronic diseases

Exclusion Criteria:

* Have medical history of digestive disorders or chronic diseases
Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions

This study aims to investigate the effect of EBV reactivation or EBV reactivation added with dexamethasone(DXM) in patients with adverse drug reactions(CDR) , through evaluating the levels on monocyte, macrophage M2/M1 and cytokines. To investigate whether expression of EBV receptors EphA2 could specifically influence on EBV activation in CDRs. We performed a prospective longitudinal study on the frequencies of Monocyte, Macrophage, M2/M1 and cytokines included IL-4,IL-13,TNF-α,IFN-γ,IFN-β, CXCL9 and CXCL10 after onset of MPE ,SJS/TEN and control groups. PBMCs collected from peripheral blood were cocultured with EBV or EBV with DXM. We next examined whether EBV or EBV with DXM could have a strong impact on the MOs, Mac, M2/M1 and cytokines and which cytokines could be crucial for the interaction between M2/M1 and EBV, by in vitro cocultures. Finally, EphA2 were detected to evaluate reactivation of EBV.


Eligibility Criteria:
Inclusion Criteria:

1. Age and Gender: The study includes male and female patients aged 18 years and older.
2. a.Erythema Multiforme (MPE) Patients: Diagnosed based on clinical presentation and medical examination findings.b.Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) Patients: Diagnosed according to the criteria set by the International Dermatology Society for SJS or TEN.c.Control Group: Healthy volunteers, without any history of chronic disease or acute infection, and not currently on any medications.

Exclusion Criteria:

1. Other Chronic Diseases: Patients with active heart, liver, kidney disease, or other systemic conditions.
2. Acute Infection: Patients who have had a viral or bacterial infection within the month prior to enrollment.
3. Immune Status: Patients who are immunocompromised or are receiving immunosuppressive therapy.
4. Allergy History: Patients with a known allergy to any drugs or agents used in the study.
5. Pregnancy or Lactation: Women who are currently pregnant or breastfeeding.
NETTUNIT - Italy-Tunisia Cross-border Environmental network_2

The study involves the development and validation of a questionnaire for risk perception to be administered to residents of areas declared to be at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). The questionnaire will be administered twice, at baseline and after 1 month.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).

Exclusion Criteria:

* Individuals with learning difficulties.
Naltrexone Effects on Alcohol Intake

The purpose of this study is to examine drinking behavior and decision-making while taking Naltrexone and placebo. This is a double-blind, randomized, placebo-controlled crossover study. There are two cycles: one cycle on Naltrexone and one cycle on placebo.

The study proposed is a 22 to 23 day, double-blind, placebo-controlled crossover study in 60 male and female moderate to heavy alcohol users who are Asp40 positive and negative. Subjects will undergo a 6 to 7-day cycle taking the first study drug (naltrexone or placebo) with an alcohol self-administration visit in the laboratory bar on the 6th or 7th day of drug. The first alcohol self-administration visit is followed by an 8 to 9 day washout period. Subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). On the final day (either day 8 or 9) of the first study drug cycle, the subject will undergo functional imaging (fMRI) at the WBIC. There will be at least one day in between the 'lab bar' and the fMRI scan. The first fMRI visit is followed by a 5-6 day washout period. Subjects then cross over to repeat the cycle while taking the other drug (placebo or naltrexone). Subjects will keep daily diaries of alcohol and medication use throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who are 21-40 years of age
* If female, 7-20 alcoholic drinks must be consumed weekly.
* If male, 10-25 alcoholic drinks must be consumed weekly.
* If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or double barrier method \[male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream\]).
* Must have a body mass index (BMI) ≥18 and ≤30.
* Able and willing to provide an informed consent.
* Able to understand and follow the instructions of the investigator, including the delayed discounting tasks.
* Have a breath alcohol concentration of less than 0.02 on visits 1, 2, 3, 5, and 6; and 0.00 on visits 4, 4a, 7 and 7a.

Exclusion Criteria:

* Positive urine drug screen
* Using Cocaine, stimulants (other than nicotine and caffeine), methamphetamine, and/or amphetamines greater than 30 times in the last 24 months
* Using inhalants, hallucinogens, ecstasy, and/or ketamine greater than 30 times in the last 24 months
* Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer
* Binge drinking more than three times per week (\>5 standard drinks in one session is a binge)
* Currently trying to quit alcohol use
* Current dependence on any other psychoactive drug (except nicotine or caffeine) and/or alcohol as determined by the study physician's assessment .
* Clinically significant medical or psychiatric illness as determined by screening blood tests, medical history, and physical exam performed by the study physician
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 18-78 years inclusive
* Type 2 diabetes diagnosis at least 2 months prior to study entry
* Body mass index in the range of 22-45 kg/m2
* HbA1c in the range of 6.5 to 9% inclusive
* Fasting plasma glucose \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents
* Congestive heart failure requiring pharmacologic treatment
* Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply
High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals

High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good differentiation between nerve and surrounding tissues within foramen und allows to reliably quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery and its relation to neural structures / foramina can be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* \>18 years old
* no cervical back pain

Exclusion Criteria:

* previous surgery
* tumor patients
* pregnancy or breast feeding
* any MRI contra-indications
Direct Measurement of Motor Cortical Responses to tDCS

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with movement deficits, such as Parkinson's disease and chronic stroke. However, the effects of tDCS have so far not been proven on a wider scale due to lack of knowledge regarding exactly how tDCS works. This has limited the adoption of this potentially useful therapy for patients with Parkinson's disease, chronic stroke and other conditions affecting movement. The investigators hypothesize that by studying the effects of tDCS in subjects performing a motor task, the brain signals mediating improvements in motor control will be identified. The investigators will use both noninvasive and invasive methods to explore this hypothesis. The investigators expect this combined approach to broaden understanding of tDCS application in conditions affecting movement and possibly lead to therapeutic advances in these populations.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Previous consent to be contacted regarding potential participation in a research study at Medical University of South Carolina

Exclusion Criteria:

* Subjects unable to actively participate in the consent process physically and/or cognitively
* Pregnancy
* Presence of scalp injury or disease
* Prior history of seizures
* Metal implants in head or neck
* Prior intracranial surgery
* Prior brain radiotherapy
* Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation
A Phase I/II Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

The overall objective of this Phase 1 study is to evaluate the safety, PK,and anti-tumor activity of daily oral dosing with HP518,selecting the RP2D of HP518 based on assessments of patients with progressive mCRPC in dose-escalation phase

This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.

Eligibility Criteria:
Inclusion Criteria:

1. Male, age ≥18
2. Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)
3. Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics.
4. Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study.
5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.
6. Must have recovered from toxicities related to any prior treatments
7. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
8. ECOG performance status score of 0 to 1.

Exclusion Criteria:

1. Combination of research or commercially available drugs targeting AR
2. Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
3. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
4. Has significant cardiovascular disease.
Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization

Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.

The investigators attempt to validate this long-standing statement.


Eligibility Criteria:
Inclusion Criteria:

* adult patients over the age of 18 undergoing general anesthesia

Exclusion Criteria:

* history of neck or breast surgery
* anatomical anomaly of the neck or breast
* neck mass
* breast mass
Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.

To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.

Eligibility Criteria:
Inclusion Criteria:

* Acute or chronic low back pain as chief complaint
* Capacity to understand all relevant risks and potential benefits of the study (informed consent);
* Willingness to communicate information

Exclusion Criteria:

* Radicular pain likely reflecting a surgical or mechanical problem
* BMI greater than 30 (device won't fit)
* Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
* Diabetic neuropathy rendering a patient unable to determine if the device is too hot
* New neurologic deficits
* Skin lesions over the low back area
* Contraindication to any medication for pain management that would impact analgesic use record
* Inability to apply DuoTherm