cyrilzakka/clinical-trials huggingface dataset:
Noradrenergic Activity and Attention

Older adults demonstrate increased distractibility by task-irrelevant information which contributes to general cognitive impairment. However, it is yet unclear how changes in noradrenergic activity during aging influences attentional control. In the current study, tonic noradrenergic activity will be increased or decreased to investigate its behavioral and neural effects on attentional control.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Aged between 18-35 or 50-80
* Have normal or corrected-to-normal vision and hearing, and normal color vision
* Have a mobile phone and email address

Exclusion Criteria:

* Non-English speakers
* Currently practicing any relaxation, meditation, or breathing technique for more than an hour per week
* Have participated in studies measuring attentional capture in the past year
* Experiencing symptoms of dementia
MIRAGE: Multi-Institutional Research in Alzheimer's Genetic Epidemiology

The goal of MIRAGE is to evaluate the association of genetic and non-genetic risk factors for Alzheimer's Disease.

For the past 13 years the MIRAGE project has demonstrated that genetic factors play a major role in the development of Alzheimer's Disease (AD) among patients ascertained in clinical settings. This research has also shown that the E4 variant of apolipoprotein E (APOE), is the strongest AD risk factor identified thus far.

The researchers are turning their attention to the growing body of evidence from pathological, epidemiological and genetic studies that risk factors for vascular disease also enhance the risk of AD. However, since most epidemiological studies lack neuroimaging data, it is unclear whether the apparent association between vascular risk factors and AD is brought about by ischemic injury to the brain, acceleration of the primary Alzheimer neurodegenerative process, or some other process.

Some vascular risk factors are more prevalent in African American and Japanese American populations than in Caucasians. This study will build upon earlier work by evaluating the association between APOE, genes involved in vascular function, and other indictors of cerebrovascular health including blood pressure and structural brain imaging (MRI), and susceptibility to AD in these ethnic groups.

In order to carry out this project successfully, a sample of 1000 patients (500 Caucasians, 300 African Americans, 200 Japanese Americans) who meet NINCDS/ADRDA criteria for probable or definite AD from 11 centers in the U.S., Canada and Germany will be recruited. Many patients will be identified from the existing family registries. Family history, medical history, and epidemiological information will be obtained from the AD patient and their first-degree relatives using standardized questionnaire instruments and established protocols. A cognitive screening test will be administered to and blood samples will be collected from the patient's living siblings, spouses and children over the age of 50 years. DNA, plasma and MRI of the brain will be evaluated in patients and siblings.

Eligibility Criteria:
Inclusion Criteria:

NOTE: This trial accepts patients with Probable AD, and their cognitively normal brothers or sisters

* Probable or definite AD by NINCDS-ADRDA criteria
* Living siblings who are cognitively normal as measured by a brief standardized cognitive assessment
* Ages 60 and over for Alzheimer's disease patients
* Ages 50 and over for cognitively normal siblings

Exclusion Criteria:

* Early onset Alzheimer's disease attributed to APP, PS1 or PS2 gene mutations
* History of clinical stroke
* Siblings whose cognitive assessment does not meet study criteria
* Pacemaker or other contraindication to MRI
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 18 years of age
* Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
* Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
* Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria:

* Presence of tumor cells in the brain or spinal cord that have not been treated
* Active known or suspected autoimmune disease
* Any serious or uncontrolled medical disorder or active infection
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Any positive test result for hepatitis B or C indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply
The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.

Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.

Eligibility Criteria:
Inclusion Criteria:

* 145 mmHg ≤ msSBP ≤ 190 mmHg
* Triglycerides \< 500 mg/dL
* LDL-C ≤ 250 mg/dL

Exclusion Criteria:

* sSBP ≥ 20mmHg and sDBP ≥ 10mmHg
* symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia
* history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV)
* hypersensitivity to telmisartan or rosuvastatin
* history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal
* estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal
* potassium levels \>5.5 mmol/L; or any diseases that could affect the results of the study.
Set Point Acupuncture for Migraines Using a Digital Assistant

The object of this research study is to test a standardized set of acupuncture points on migraine patients to reduce frequency and intensity of headaches. Acupuncture has been studied in prior research but the treatment points have varied between subjects, making it difficult to replicate studies.

Subjects will be recording daily headache activity on personal digital assistants (PDA's) for 12 weeks before and 12 weeks after 8 weeks of acupuncture intervention. MIDAS, HIT-6 and BDI-II measurements will be done at the beginning of the study (12 weeks pre-intervention), directly before the intervention, directly after, and 12 weeks post-intervention. Measurements will be compared before and after intervention. This is a follow-up to a successful earlier study when these same acupuncture points were used on subjects with chronic daily headache, the majority being migraine.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 21 years and 65 years of age
* Subjects with a history of migraine headaches for at least 12 months
* Subjects who have not received acupuncture for any medical condition in the past 6 months.
* A negative pregnancy test for childbearing females since some acupuncture points may be contraindicated in pregnancy. Pregnancy tests will be conducted at MMC.
* Subjects willing and able to use a PDA daily for data collection

Exclusion Criteria:

* Subjects who plan to receive acupuncture treatment for any other type of medical condition while enrolled in this protocol
* Subjects with the presence of organic pathology (i.e., brain tumor)
* Subjects who have the presence of a systemic disorder or illness, including serious psychiatric illness
* Subjects who began a new headache treatment less than two weeks before proposed enrollment date
* Subjects who are pregnant, lactating, or planning to become pregnant within 6 months
* Subjects that use alcohol on a regular basis
* Subjects that use recreational drugs
* Subjects that have a cardiac pacemaker
* Subjects that use analgesics on more than 10 days per month
* Subjects that exercise prophylactic headache treatment with drugs during the past 4 weeks
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes

The purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS Health Check programme.

The University Hospitals of Leicester and The University of Leicester have developed a self-assessment risk score and a practice data risk score that can be used in a variety of setting to detect undiagnosed diabetes and impaired glucose regulation. This is done to establish a simple and effective 1st stage screen to identify those people at risk of diabetes and engage the public to increase the number of high risk individuals attending screening invitations but reducing the overall number of oral glucose tolerance tests. This study aims to test in a pragmatic way the use of such tools in a primary care setting administered by primary care staff as part of the NHS Health Check programme.

Eligibility Criteria:
Inclusion Criteria:

* 40-75 years old (30 -75 years old if South Asian origin)

Exclusion Criteria:

* Current diagnosis of diabetes
* Terminal illness or mental incapacity
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

This is a multicentric, retrospective, and prospective biomarker study.

This is a multicentric, retrospective, and prospective biomarker study, involving a total of 170 patients with SCC (Squamous Cell Carcinoma) of the mucosa of the anogenital tract and head-neck region, recruited from INT-NA (n=50), UPO (n=40), AOUP (n=40), and ITB (n=40). Specifically, retrospective and prospective samples will be collected and analyzed for the study of molecular and viral biomarkers. Simultaneously, fibroblastic tumor-associated cells (CAFs) will be isolated from prospective samples. Through co-cultivation with immortalized cell lines derived from anogenital and head-neck SCCs, these CAFs will enable the production of 3D organoids for use in experiments assessing the response to telomerase and deacetylase SIRT1 inhibitors, both in vitro and in preclinical models.

Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥ 18 years, candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, and head-neck region (including microinvasive and invasive carcinomas) who are capable of understanding and willing to sign the informed consent form. Prospective patients must provide written informed consent before any procedures.

Exclusion Criteria:

Patients presenting any of the following criteria are not eligible for inclusion in this study. Exclusion criteria include:

1. Metastatic neoplasia
2. Treatment for other oncological pathologies
3. Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)
Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

The prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and virological status) with FibroScan® as gold standard; to evaluate the feasibility of these different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors, alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.

Primary outcome: Screening of clinically significant fibrosis with FibroMeter blood score. Screening for hepatitis B and hepatitis C viruses.

Secondary outcome: Clinically significant fibrosis confirmed with FibroScan®.

The means for this study are a clinical questionnaire, a virological screening, a blood score for liver fibrosis: FibroMeter according to cause of the fibrosis and FibroScan® is referent and independent examination.

The expected results from this study are the knowledge of the prevalence of hepatopathies with hepatic fibrosis will be able to justify, possibly, a screening politic of them. This study will permit to evaluate the feasibility of noninvasive screening of the liver fibrosis in the goal to suppress the liver biopsy in a population having numerous drawbacks.

Eligibility Criteria:
Inclusion Criteria:

* Person over 18,
* All new inmates, for less than one month, in Angers jail,
* To have a written informed consent.

Exclusion Criteria:

* No consent obtained from person,
* Detention inferior to one month,
* Person under 18.
Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.


Eligibility Criteria:
Inclusion Criteria:

* Patients satisfying the Rome II Diagnostic Criteria.
* Patients in whom no organic changes were observed in large intestine.

Exclusion Criteria:

* Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
* Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
Self-administered Acupressure for Insomnia Disorder

The study is to evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course. Subjects will be offered either self-administered acupressure training or sleep hygiene education. Their insomnia severity will be compared after 8 weeks.

Objectives: To evaluate the clinical effects of self-administered acupressure for treating insomnia disorder delivered by a training course.

Hypothesis: Subjects in the self-administered acupressure group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at 4 weeks and 8 weeks.

Design and subjects: A randomized controlled trial. 184 subjects with insomnia disorder recruited from the community will be randomized to self-administered acupressure or SHE groups in a 1: 1 ratio.

Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.

Interventions: Subjects in the self-administered acupressure group will attend two training lessons (2-hour each) to learn self-administered acupressure and practice it every night for 4 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the self-administered acupressure group.

Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and compliance of self-administered acupressure will be evaluated.

Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
2. Aged 18-64 years;
3. A current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ)
4. Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
5. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
2. Pregnancy;
3. Cognitive impairment as indicated by a Mini Mental State Examination ≤23;
4. At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3) ;
5. No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy;
6. Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline; and
7. Shift-workers/
Effect of Prebiotics on Hyperuricemia

Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of Hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of Hyperuricemia through several mechanisms. This trial aims to examine its protective effect in humans.

Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.

However, whether administration of prebiotics also has a protective effect in subjects with Hyperuricemia remain unknown.

Eligibility Criteria:
Inclusion Criteria:

* Local residents aged between 18-65 years old;
* Stable weight (\<5% weight change over last 3 months);
* Fasting uric acid was \> 420μmol/L for male and \> 360μmol/L for female on two different days
* Those who have never taken uric acid lowering drugs or have stopped taking uric acid lowering drugs for at least four weeks;
* Absence of any diet or medication that might interfere with Uric acid metabolism and gut microbiota, especially antibiotics and probiotics at least 4 weeks before recruitment.

Exclusion Criteria:

* Acute illness or evidence of any acute or chronic inflammatory of infective diseases;
* Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
* Women of childbearing age who are pregnant, breast-feeding or preparing for pregnancy; Patients who had surgery within the past six months or planned surgery during the trial period
Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials

The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and nonselective COX inhibitors impact on Health related Quality of Life (HrQOL) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(NSAID) response


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet modified New York Classification and/or Assessment of Spondyloarthritis International Society (ASAS) criteria for Classification Criteria for AxSpA
* Ankylosing Spondylitis Disease Activity Score greater than or equal to 2.1.

Exclusion Criteria:

* Changing background biologic/disease modifying-rheumatic medications within less than 3 months.
* Opioid medication use
* Current or expected pregnancy
* History of cardiovascular disease (previous stroke, myocardial infarction, or percutaneous intervention.
* End stage liver disease
* Chronic Kidney Disease greater than Stage IIIb
Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

Nowadays, Percutaneous Nephrolithotomy (PCNL) has been the surgical procedure of choice for renal stones larger than 2cm or staghorn stones. Yet, the associated postoperative pain is a major drawback. The regional anesthetic management of pain in PCNL operation has been of great concern. The introduction of ultrasound guided erector spinae plane block and paravertebral plane block has been under great focus regarding the efficacy of postoperative pain management. Paravertebral plane block (PVB) is a regional nerve block technique that depends on local anesthetic injection adjacent to the vertebra to block spinal nerve roots in a dermatomal distribution. Erector spinae plane block (ESPB) is a newer regional anesthesia technique that depends on injecting local anesthetic (LA) in a plane between the transverse process and erector spinae muscle. The LA diffuses into the paravertebral space and spreads on both rami (dorsal and ventral) of spinal nerves through spaces between adjoining vertebrae.

The aim of this study is to compare the effect of ultrasound guided Paravertebral blockade versus Erector spinae blockade on postoperative opioid use as well as postoperative pain control in patients undergoing unilateral PCNL.


Eligibility Criteria:
Inclusion Criteria:

* ASA I - II.
* Patients undergoing unilateral percutaneous nephrolithotomy (PCNL) surgery under general anesthesia.

Exclusion Criteria:

* Patient refusal.
* Uncooperative patients.
* Allergy to local anesthetics.
* Infection or anatomical abnormality at injection site.
* Coagulopathy.
* Bilateral PCNL.
* Spinal anesthesia or any other regional anesthesia.
* Block failure: the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.