cyrilzakka/clinical-trials huggingface dataset:
IONA Longitudinal Cohort Study

Understanding more about how diseases that cause dementia develop is critical as the number of people living with, or affected by, dementia in Scotland continues to grow. The IONA Longitudinal Cohort Study (LCS) has been set up to gather information about people's cognitive health (their memory and thinking abilities), their lifestyle and health risk factors for future dementia (such as hearing loss and obesity), genetics and disease biomarkers, over a number of years. The IONA LCS has three main objectives: Firstly to develop this cohort that is well characterised (also known as being "well-phenotyped") that represent the Scottish population (taking into consideration age, sex, ethnicity and education). The second objective is to use this data to build disease models to better understand trajectories of diseases, and identify any sub-populations who have different (i.e. better, worse) disease trajectories. Finally the third objective for IONA LCS is to offer people an optional consent to hear about future studies they may be interested in taking part in.

IThe IONA Longitudinal Cohort Study (LCS) will provide a well-phenotyped (combining data on risk factors for dementia, cognitive assessment results, disease biomarkers and genetics) population representative of the Scottish population aged 50 and above across the spectrum of risk for, and the earliest disease stages of, AD dementia and other neurodegenerative conditions. Recent therapeutic successes in the treatment of Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD, as well as progressions in diagnostic tools such as blood-based biomarkers, has energised the field to develop more specific diagnostics and therapies following the best principles of precision medicine. Large, 'real world' cohorts are needed to understand whether these, and other future breakthroughs, are valid in real world populations away from highly selective clinical trials. Precision medicine requires identification of disease sub-populations who share similar diagnostic profiles that reflect similar disease mechanisms and hence are likely to respond consistently to specific therapeutic interventions. This will require detailed clinical, genetic and biological phenotyping. IONA LCS will recruit uniquely in Scotland and will ensure that a large, diverse, real-world population will be available to drive developments globally of more accurate diagnostics and accelerate the development of new disease modifying therapies.

Eligibility Criteria:
* Age at least 50 years.
* Living in Scotland.
* Able to read and write and with minimum 7 years of formal education.
* Have a study partner who is aged 18 years or older.
* Have capacity to provide informed consent at baseline.
* Able to speak English to a level where the cognitive assessments can be completed.
Multicenter Worksite Nutrition Study

The purpose of this study is to study the potential benefits of low fat vegan diet in a randomized, controlled and multi-centered workplace setting, the investigators will enroll participants from 10 worksites of Government Employee Insurance Company (GEICO). After randomization, 5 will be the vegan sites and 5 will be the control sites for 10 month study. The vegan sites will receive low fat vegan diet instructions and weekly group sessions starting from year 1. no intervention is done to the control sites until the week 18 when the identical program will be given. At various time points, health measurements will be give to all participants.

The purpose of this study is to study the weight loss and other potential benefits of low fat vegan diet as compared to the standard American diet in a randomized, controlled and multi-centered workplace setting.

The 10 months study involves 5 vegan sites and 5 control sites generated through a random process after recruitment. The vegan sites will receive low fat vegan diet instructions and weekly group sessions starting from the January, 2011. The control sites will also receive identical instructions starting from the 5th month and lasting for 18 weeks.

For each participant at baseline and week 18 a blood test will be conducted, along with blood pressure, weight, hip and waist measurements. A questionnaire will also be administered during these time points to assess dietary intake, work productivity, quality of life, and healthcare utilization. At the end of one year, information about health insurance utilization will be obtained from Health Maintenance Organization(HMO) or Preferred Provider Organization(PPO) for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Paid employee at a participating GEICO worksite for at least 6 months
* Currently a full-time employee at GEICO working for GEICO (at least 38.75 hours/week)
* Age of at least 18 years
* Ability and willingness to participate in all components of the study
* A willingness to be assigned to the vegan diet group or the control group
* Body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes

Exclusion Criteria:

* A history of alcohol abuse or dependency followed by any current use
* Current or unresolved past drug abuse
* Pregnancy or plans to become pregnant in the next 12 months
* Intention to leave GEICO in the next 12 months
* History of severe mental illness
* Unstable medical status
* Already following a low-fat, vegetarian diet
* An inordinate fear of blood draws
* Previously participated in GEICO two site study
A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>/= 18 years of age
* moderate to severe active rheumatoid arthritis
* inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
* DAS \>3.6
* pneumology examination (including chest x-ray and quantiferon)

Exclusion Criteria:

* \< 18 years of age
* active infection
* active tuberculosis
* uncontrolled hyperlipoproteinaemia
* demyelinating disorders
* concomitant anti-TNF drugs
* history of intestinal ulceration and diverticulitis
Use of Hydroxyurea and Magnesium Pidolate for Treatment of Sickle Cell Disease

The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 months.

This is a Phase I clinical trial evaluating the combination of hydroxyurea and magnesium pidolate for patients with sickle cell disease with either hemoglobin SS disease or hemoglobin S beta thalassemia. Hydroxyurea and magnesium pidolate will be tested in pediatric and adolescent patients with sickle cell disease who already have been treated with hydroxyurea for a minimum of six months. Magnesium pidolate will be given in combination with hydroxyurea for six months. In successive small groups of patients, the dose of magnesium will be increased in order to eventually determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for magnesium when given in combination with hydroxyurea. The maximum tolerated dose is the highest drug dose that can be given safely to participants. The dose limiting toxicity is determined when drug side effects prevent an increase in dose.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 3 years and \< 15 years at the time of study enrollment
2. Diagnosis of Hb SS or Hb S beta thalassemia
3. Hydroxyurea treatment for at least 6 months prior to study entry at dose of 15 - 30 mg/kg/day
4. Compliance with taking HU treatment of at least 70 % for 6 months prior to study entry

Exclusion Criteria:

1. Red blood cell transfusion within the last 3 months resulting in a level of Hb A of 10% or more
2. Pregnancy or unwillingness to use effective birth control in sexually active subjects (females who state that they are sexually active)
3. Renal dysfunction defined by a serum creatinine greater than 1.5 times the upper limit of normal for age
4. Liver dysfunction defined by an ALT greater than twice the upper limit of normal for age
5. Concomitant usage of an "antisickling" agent other than hydroxyurea
6. Current use of Mg containing drugs
7. Iron deficiency, defined by serum ferritin ≤ 10 ng/ml
8. Concomitant chronic illness other than sickle cell anemia
Strength Training for Injury Prevention

The purpose of this study is to explore the effects of a strength \& conditioning (S \& C) program on risk factors for injury (Y-balance and Functional Movement Screen scores), as well as parent reported injury occurrence in 12-16 year old male and female athletes. Forty girls and 40 boys aged 12-16 will be recruited; half will participate in supervised S \& C sessions 2-3x/week while the other half will continue with their regular sports and activities. Risk factors for injury and performance indices (20 m sprint and multiple jump test) will be assessed before and after the 4 month study. Injury occurrence will be recorded via bi-weekly phone calls to the parent and athlete.


Eligibility Criteria:
Inclusion Criteria:

* Athletes between 12 and 16 years of age, actively participating in organized sport

Exclusion Criteria:

* Any condition or injury that will place the athlete at risk during testing or training
A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Outpatients of both sexes, aged \> 12 years
* Moderate to severe symptomatic asthma
* Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values
* Reversibility test
* "Partly controlled" asthma (GINA revised 2006)
* Patients free of long-acting beta2-agonists (LABAs) treatment
* Under inhaled corticosteroids (ICS) treatment
* A minimum inspiratory flow ≥ 40 L/min 10.
* Non-smokers or ex smokers
* Asthma Control Questionnaire ACQ score ≥ 1.5

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
* Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
* History of near fatal asthma
* Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
* Diagnosis COPD
* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
* Diagnosis of restrictive lung disease
* Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
* Allergy to any component of the study treatments
* Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
* Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
* Patients with abnormal QTc
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.

The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.

Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state:

Treatment A: single dose of rosuvastatin tablet alone

Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet

The study will comprise:

1. A Screening Period of maximum 28 days.
2. Two Treatment Periods up to 3 days
3. A follow-up period of 10 to 12 days after the last administration of the study drug.

Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3).

The total duration of the study will be up to 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
* Females must have a negative pregnancy test at screening and must not be lactating
* Participants with BMI between 18 and 30 kg/m\^2, inclusive, and weighing between 50 kg and 100 kg, inclusive

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization and second vaccination within 10 days of screening
* Confirmed Coronavirus disease 2019 (COVID-19) infection at admission, by Polymerase chain reaction (PCR) test
* Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
* History or presence of severe allergy/hypersensitivity
* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening
* Positive screen for drugs of abuse, alcohol, or cotinine at screening
* Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug
* Any clinically significant abnormalities in clinical chemistry, hematology, coagulation, urinalysis results, ECG or vital signs
The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer

This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer.

Women with breast cancer receiving paclitaxel will complete the Brief Pain Inventory(BPI), Neuropathic Pain Syndrome Inventory (NPSI)while a member of the research team will conduct an assessment of their nails. Once complete, cryotherapy will be administered 15 minutes prior to the paclitaxel infusion, continuously during and then 15 minutes after completion of the paclitaxel for a total of 90 minutes. Cyrotherapy will be delivered using Elasto-gel mitts and Rapid relief slippers. These items will be changed 45min after initiation to ensure coldness.

There will be two arms of the study. One arm will include subjects who will wear one slipper/one mitt on their foot/hand while the other foot/hand will serve as a control. The other arm will include subjects who will have cryotherapy to both hands and feet. . This process will be repeated for a total of 12 times in conjunction with 12 doses of paclitaxel. At time point 13, during a routine visit to their oncologist, the subjects nails will be reassessed along with completion of the BPI and NPSIA total of 25 subjects will be enrolled in each arm.

Eligibility Criteria:
Inclusion Criteria:

* Females 18 or older
* Histologically confirmed diagnosis of breast cancer
* Receiving neo-adjuvant or adjuvant dose-dense anthracycline (AC) plus taxane-based chemotherapy or paclitaxel in combination with trastuzumab and pertuzumab

Exclusion Criteria:

* Prior taxane therapy
* Prior oxaliplatin therapy
* Non-English speaking
* History of peripheral neuropathy, i.e., Buerger's disease
* History of diabetes mellitus
* Pre-existing peripheral neuropathy from other conditions, e.g., Raynaud's disease, Guillain-Barre, Miller Fisher Syndrome
* Hand, nail or foot conditions, e.g., hand/foot syndrome, arthritis, hammer toe, carpal tunnel, bunions, deformities
* Alcohol abuse (history/current)
* Current medication usage of opioids, anti-depressants, anti-convulsants, glutamines, vitamin B12
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.

Exclusion criteria:

* ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.
Freshman Sleep and Health Project

Sleep is a clearly necessary neurobiologic process that influences innumerable aspects of basic daily functions, physical health, and mental well-being. Recent literature shows that college students across the country are experiencing high rates of sleep deprivation. Interestingly, some recent studies have implicated this sleep loss in contributing to weight gain that occurs in the first year of college, also known as the "freshman fifteen." Rates of depression and other mental health issues, which are closely connected to sleep disturbances, are also on the rise in college campuses. The majority of the sleep data obtained in this population has been via questionnaires and self report, and the studies usually include college students at all seniority levels (e.g., freshmen, sophomores, seniors). Here, the investigators outline a novel study investigating how sleep time changes in college freshman, and how it relates to multiple different aspects of their health and functioning over the course of one quarter.

As technology has advanced, the ability to easily obtain objective measurements of different health parameters has increased dramatically. The investigators plan to use wireless actigraphy devices to measure sleep over a baseline seven day period in college-bound UCSD students prior to matriculation, and for 2 additional seven day periods during the first quarter of college. To the knowledge of the investigators, this is the first study to directly measure sleep time in college freshman in their normal environment. Effects of sleep time loss will be evaluated through multiple different metrics of physical and mental health. Given the recent link between sleep disturbances and weight gain in college freshman, the investigators will plan to measure weight changes prior to entering college and at two different time points through the first quarter. The investigators will use the PSQ-9 and GAD7 batteries as measures of mental health, obtained at the same time points as the sleep and weight information. As one of the primary consequences of sleep deprivation is on neurocognition in the daytime, the investigators plan to measure vigilant attention using psychomotor vigilance testing (PVT) as well. Screen time use has recently been targeted as a possible contributor to sleep loss in adolescents as well as adults and is something the investigators will attempt to measure as well using a smartphone application. Finally, this project will test the efficacy of a one hour sleep education intervention on improving total sleep time.

To the knowledge of the investigators, no other studies have closely examined how total sleep time changes during the first year of college in freshman in relationship to weight and mental health parameters, nor has PVT been done in this context. Additionally, with the increasing concerns regarding screen time use in adolescents and young adults, this study provides prime opportunity to examine this issue in the context of sleep.


Eligibility Criteria:
Inclusion Criteria:

* Incoming UCSD freshman

Exclusion Criteria:

* Under 18 years of age
* Not living on UCSD campus
Sunphenon in Progressive Forms of Multiple Sclerosis

The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.

The hypotheses of our study are:

Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb.

Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger.

A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary chronic progressive multiple sclerosis (ms)
* EDSS 3-8
* Age 18-65

Exclusion Criteria:

* Relapsing-remitting ms
* Immunodulatoric or immunosuppressive therapy
* pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin \<2 month before screening
* pretreatment with Glairameracetat or beta-Interferons \<4 weeks before screening
* signs of hepatic dysfunction
* active ulcus ventriculi or duodeni
* neoplasias if not cured \>1 year before screening
Korean Cohort Study of AKI & HRS in Cirrhosis

The aim of this study is to investigate i) whether two biomarkers (urine NAG, urinary cystatin C) could be predictive factor in patient with liver cirrhosis, , and ii) whether these biomarkers can predict response of terlipressin.

Acute kidney injury (AKI) in patients with liver cirrhosis is sometimes accompanied by tubular injury which can lead to poor outcome. Current AKI criteria using serum creatinine (Cr) has some limitations to predict reversibility of renal function and discriminate renal parenchymal injury in cirrhotic patients. The aim of this study is to evaluate whether urine biomarkers \[cystatin C, N-acetyl-β-D-Glucosaminidase (NAG)\] can predict survival and response to terlipressin in cirrhotic patients with AKI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
* Patients who voluntarily agreed to the study

Exclusion Criteria:

* Patients with active bleeding (eg, varix bleeding) within 7 days
* Patients with hepatocellular carcinoma
* Patients with hypersensitivity to terlipressin
* Patients with anuria
* Pregnant and lactating patients
* Patients who did not agree with the study