cyrilzakka/clinical-trials huggingface dataset:
Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation

The human body responds to inflammation, such as psoriatic skin lesions, by activating the cholinergic anti-inflammatory pathway. In patients with plaque psoriasis, this pathway is not sufficient to clear the skin lesions. Importantly, the vagus nerve, that is part of the anti-inflammatory pathway, also innervates the ear where it can be activated through non-invasive transcutaneous auricular vagus nerve stimulation (taVNS). This raises the research question if taVNS - added to standard of care - improves the symptoms of plaque psoriasis by augmenting the function of the cholinergic anti-inflammatory pathway. Thus, the aim of this project is to test the hypothesis that daily taVNS applied for 3 months results in anti-inflammatory actions and improvements in the Psoriasis Area and Severity Index (PASI). Potential anti-inflammatory actions of taVNS compared to a sham-taVNS control group will be assessed by plasma cytokine levels, flow cytometry, and cell culture experiments. This project is potentially significant, because it may demonstrate that taVNS lessens the symptoms of plaque psoriasis and, therefore, improves the quality of life of millions of patients.

An estimated 20% of psoriasis patients experience treatment failure. Afferent vagal nerve fibers that are part of the anti-inflammatory reflex sense inflammation, such as psoriatic skin lesions. The investigators' pilot data show that transcutaneous auricular vagus nerve stimulation (taVNS) activates afferent nerve fibers within the auricular branch of the vagus nerve to trigger anti-inflammatory reflex responses in healthy individuals. However, it is unknown if taVNS improves plaque psoriasis through the anti-inflammatory reflex. The lack of studies on taVNS in plaque psoriasis constitutes a missed opportunity to reduce treatment failures.

The long-term goal of this research is to establish a neuromodulatory approach to activate the anti-inflammatory reflex in patients with plaque psoriasis to lessen treatment failures. The objective of this study is to test the hypothesis that taVNS elicits anti-inflammatory reflex responses and reduces the severity of plaque psoriasis.

In a single-blinded randomized controlled clinical trial, participants will self-administer taVNS or sham-taVNS (control) daily for a duration of 3 months, while continuing their standard-of-care treatment. At baseline, 7 days, and 1, 2, and 3 months, clinical , autonomic, and inflammatory responses will be assessed.

At the conclusion of this study, the investigators expect to demonstrate anti-inflammatory reflex responses to taVNS and reduced severity of plaque psoriasis. These outcomes are expected to have important positive impact, because they are anticipated to reduce treatment failures in patients with plaque psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Plaque psoriasis diagnosed by a dermatologist

Exclusion Criteria:

* pregnancy
* vestibulocochlear neuronitis or nerve damage
* cardiac arrhythmia
* epilepsy
* anticipated change in medication during the 3-month study period
Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With RA

The aim of this study is to investigate the relationship between grip endurance, disability of upper extremity and quality of life in patients with rheumatoid arthritis.

Upper extremity functions affect the quality of life at different levels in patients with rheumatoid arthritis (RA). In the current literature; it has been shown that grip endurance is associated with upper limb functions. However, there is no study investigating the relationship between grip endurance and quality of life in patients with RA. The purpose of this study is to investigate the relationship between grip endurance, disability of upper extremity, and quality of life in patients with RA.

Eligibility Criteria:
Inclusion Criteria:

* RA patients were classified according to the ACR 2010 criteria.
* taking regular medication.

Exclusion Criteria:

* having a history of trauma or surgery in the upper limb.
* having neurological, cognitive, or psychiatric diseases.
The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

The investigators aimed to study the effect of supplementation with species of Lactobacillus on anthropometric measurements, body composition, appetite and serum lipid profile in overweight and obese adults

The Objective of This Study was Evaluating the Effect of supplementation with Species of Lactobacillus on anthropometric measurements include weight, waist and hip circumference , body composition include body fat and muscle percent, appetite measured by visual analogues scale and serum lipid profile in overweight and obese adults.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* BMI more than 25 Kg/m2

Exclusion Criteria:

* taking drugs that could affect weight change, including anti-diabetic drugs, lipid lowering drugs
* endocrine,cardiovascular, thyroid, or chronic liver disease.
* had received surgery to reduce weight
* taking probiotics or antibiotics within one month
* Pregnancy or lactation or menopause
* A history of cancer
* Heart disease - cardiovascular, pulmonary, renal and diabetes
* A history of autoimmune disease
* Taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers
* weight change over five percent within three months
* change in activity or diet habit
Study of Brain Response to Emotional Pictures Using a Magnetic Resonance Imaging (fMRI) While on Escitalopram

The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain

This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called Escitalopram(trade name: Lexapro).

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-50 years and able to give voluntary informed consent.
* Satisfy criteria for Major Depressive Disorder (MDD) and current depressed episode using the Mini International Neuropsychiatric Interview (M.I.N.I.).
* 17-item Hamilton Depression Rating Scale (HDRS) score \> 18.
* Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
* Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following -
* Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
* No danger to self or others.

Exclusion Criteria:

* Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
* On monoamine oxidase inhibitors in the past 2 weeks.
* History of narrow angle glaucoma.
* Lack of response of the current episode of depression to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
* Use of neuroleptic in the past 2 weeks.
* Use of antidepressants in the past 2 weeks. If on fluoxetine in the past, then should not have been on this medication for 4 weeks.
* Use of mood stabilizers in the past 2 weeks.
* Use of benzodiazepines in the past 2 weeks.
* Acutely suicidal or homicidal or requiring inpatient treatment.
* Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
* Use of alcohol in the past 1 week.
* No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
* Current pregnancy or breast-feeding.
* Metallic implants.
* Previously known positive HIV blood test as reported by the subject.
Caries Management by Risk Assessment in Children

The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be:
2. Patients of record at the Tenderloin community and UCSF pediatric dental clinics
3. 5-9 years old

3. Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian 4. Be unlikely to move from the area during the study period 5. Be willing to participate regardless of group assignment and comply with all study procedures

Exclusion Criteria:

Persons with:

1. Prolonged antibiotic use in the past three months.
2. Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics
Impact of Evolocumab in Cardiac Transplant Patients With CAV

Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary objective of this study is to measure the impact of PCSK9-inhibitors on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline.

Heart transplant remains the treatment of choice for patients with advanced heart failure. Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of the donor heart, and limits long term survival after transplant. The pathophysiology of CAV is complex and involves smooth muscle proliferation, inflammatory infiltrates, and lipid deposition. To date, only statin therapy has reduced CAV-related mortality. PCSK9 inhibitors are a new lipid lowering therapy shown to reduce cardiovascular clinical events in patients with coronary artery disease. We hypothesize that PCSK9 inhibition via evolocumab will significantly lower low density lipoprotein (LDL) and be well-tolerated in transplant patients with CAV. This phase II, open label, single center trial with enroll up to 40 heart transplant patients with CAV for treatment with evolocumab for one year. The primary outcome will be percent change in LDL at 12 weeks. Secondary outcomes will include change in CAV progression, impact of evolocumab on immunosuppression regimens and transplant rejection, and change in serum lipids after 52 weeks. Results of this study are intended to provide safety data in heart transplant patients with CAV and assess secondary outcomes including CAV progression and impact on immunosuppression and transplant rejection.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplant patients 19-80 years of age
* Coronary allograft vasculopathy grade 1 or 2 documented by left heart cardiac catheterization
* Able to provide signed informed consent

Exclusion Criteria:

* Cardiac allograft vasculopathy (CAV) grade 3
* Rejection requiring IV therapy in the prior 3 months
* Infection requiring IV therapy in the prior 3 months
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal
* Current or recent use of a PCSK9 inhibitor within the past 12 weeks
* Organ transplant recipient other than heart
* Renal dysfunction defined as glomerular filtration rate (GFR) \< 20 ml/min
* Known allergy to evolocumab or its components
The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers

The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas) after oral administration will be investigated in Korean healthy male volunteers. All volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period 1). After one week's wash-over period, the volunteers take higher dosages (Period 2).


Eligibility Criteria:
Inclusion Criteria:

* Healthy males subjects, 20-45 years inclusive
* Weight over 55 kg inclusive and Ideal Body Weight (IBW) between -20% and +20% inclusive
* Written informed consent given

Exclusion Criteria:

* Hypersensitivity to drugs(aspirin, antibiotics and so on) including naftopidil
* History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, urinary, hematological, oncological pathology
* Have a history of drug abuse, or show positive for drug abuse at urine screening
* Have participated in another clinical study within 2 months prior to entering inth the study
* Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination

Currently there are no standards for healthcare worker vaccination with the HPV, Gardasil-9 vaccine. For health care workers, the CDC only recommends for vaccination against hepatitis B, influenza virus, Measles, Mumps and Rubella (MMR), Chickenpox (Varicella), Tetanus, Diptheria, and Pertussis (Tdap), and meninogococcal infections6

Initial antibody titers will be measured immediately prior to initial vaccination (month 0). This will entail a blood-draw sample (less than 1 teaspoon) that will be sent to FOCUS labs for evaluation. This will be paid for by funding received from Merck.

The three-dose vaccination schedule will be followed with injections at month 0, 2, and 6. Gardasil 9 dosing will be per the recommended and approved labeled guidelines. Post-vaccination titers would be measured at month 7, which is in alignment with the methods of previous studies. This will entail a blood-draw sample (less than 1 teaspoon) that will be sent to FOCUS labs for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* • Actively practicing attending surgeon in the field of Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology employed by EVMS or credentialed by CHKD and/or SNGH.

or

• Current residents of EVMS Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology programs

Exclusion Criteria:

* • Age 26 or younger

  * Age over 69
  * Hypersensitivity to vaccine component
  * History of severe allergic or hypersensitivity reactions to yeast
  * History of previous HPV vaccination with 9 valent vaccine
  * Pregnant
  * Moderate or severe acute illness
Paracervical Block in Laparoscopic Hysterectomy

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

Postoperative pain management is an important component of patient care and satisfaction after surgery. Although contemporary changes such as a shift to minimally invasive approaches and an introduction of the enhanced recovery after surgery (ERAS) program have resulted in improved outcomes, a large number of patients undergoing surgery have still inadequate pain control. Paracervical block is a single-injection of anesthetic around the cervix at a depth of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing through Frankenhäuser plexus. Moreover, recent randomized trials demonstrated that patients who underwent vaginal hysterectomy and received a paracervical block had lower postoperative pain in the first 3-6 hours compared with placebo.

However, it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* the absence of pregnancy at the time of surgery

Exclusion Criteria:

* history of cervical surgery such as conization or cerclage
* inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix)
* allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection
* any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedures (anterior or posterior colporrhaphy or mid-urethral slings), previously taking opioids for chronic pain
* inability to accurately express their pain
Systemic Lupus Erythematosus and Accelerated Aging

The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a breakdown of tolerance against nuclear antigens. Thanks to improvements during the last decades in diagnosis, therapeutics and medical care, the lifespan of SLE patients has remarkably increased. However, standardized mortality ratio are still high in this population, with an increased mortality and morbidity associated with cardiovascular events and infectious events. Interestingly, these conditions are more commonly found during old age in the general population, raising the question of the presence of an acceleration of the aging process in SLE patients.

It has been demonstrated that the aging of the immune system, i.e. immunosenescence, is a key player in the development of many age-related diseases. The acceleration of immunosenescence, as it is observed during chronic viral infections for example, could favor the premature occurrence of clinical manifestations of accelerated aging. The exact contribution of such phenomenon in the context of SLE has, so far, never been explored.

Here, the investigators propose to perform a comprehensive study of the phenomena of immune system aging in patients with SLE in comparison to age-matched healthy controls.

The study will recruit 50 SLE patients followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to extensively evaluate immune system aging. Fundamental research will be realized on patients' samples. Patients will be included within their usual follow-up. No extra visit will be needed, and blood samples will be drawn at the same time as those drawn for clinical purposes.

Eligibility Criteria:
Inclusion Criteria:

* male or female;
* age between 18 and 60 years;
* Lupus patient : diagnosis of systemic lupus erythematosus according to ACR or SLICC criteria;
* being affiliated to health insurance;
* willing to participate and to sign informed consent.

Exclusion Criteria:

* pregnant or breastfeeding women;
* persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

* a) Smoking history of at least 10 pack-years
* b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
* c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.
Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification

The purpose of this study is to test a new technology for obtaining x-ray images of your treatment fields when you are positioned on the treatment machine, to determine whether this new system is as reliable and easy to use as conventional systems.. These so-called portal images are normally taken on a weekly basis, prior to your radiation treatment. The new portal imaging system to be tested is designed to produce better quality images than are currently achievable, but with no additional dose or added treatment time.

The objective of this proposal is to test the clinical practicality of a new technology; cone beam imaging, for verification of treatment set up accuracy of cancer patients receiving radiation therapy. Currently, treatment accuracy is checked via use of 2-dimensional projection x-rays taken with the megavoltage treatment beam and electronic portal imaging devices (EPID). Typically 2 orthogonal portal images are obtained to confirm patient positioning accuracy. This method of treatment verification, however, usually provides images of poor quality and lacks true 3D information, thus making it difficult for the radiation oncologist to definitively confirm treatment accuracy. New generation EPIDs are capable of obtaining higher quality images at significantly lower imaging doses. Thus, for the same total imaging dose new generation EPIDs permit acquisition of many projection images rather than just 2 or 3. The combination of more images and higher quality images should permit more definitive assessment of treatment accuracy. We propose here to test the clinical practicality and reliability of a new prototype portal imaging system.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologic proof of a malignancy suitable for radiation therapy in order to be eligible for this study

Exclusion Criteria:

* None