cyrilzakka/clinical-trials huggingface dataset:
AvoCog - the Effect of Daily Avocado Intake on Cognitive Function in Older Adults

The goal of this clinical trial is to determine if adding avocados to the diet of impacts cognition in 70 older adults, age 65-85, without dementia. We will test for change in functional MRI, cognitive performance, and brain blood flow. Intervention group participants will be asked to consume 1 avocado per day for 12 weeks. Participants in the control group will be asked to continue their normal intake for 12 weeks. Throughout the study, participants will be asked to perform cognitive tests, MRI, blood tests, and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 65-85 years
* Good general health with no concomitant disease
* BMI 18.5 - 35 kg/m2
* Mini Mental State Exam ≥26
* Reports consuming ≤2 medium avocados per month
* Reports consuming ≤3 servings of carotenoid-rich foods per week and ≤3 servings of fruits and vegetables per day
* Skin carotenoid content \<400

Exclusion Criteria:

* Unwilling or unable to consume avocado
* Latex allergy
* Consistently taking lutein + zeaxanthin supplements
* Skin carotenoid content ≥400
* Central neurological disease such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, brain tumor, etc.
* Serious medical risk: cancer requiring chemotherapy or radiation within the past 5 years, recent cardiac event (i.e. heart attack, etc.)
* Diabetes mellitus or uncontrolled hypertension
* Use of psychoactive or investigational medications
* Consumption of ≥3 alcoholic drinks per day or substance abuse
* Unable to undergo MRI
An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health

An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health. This is a dual centre (UCD and University of Ulster) 2-year randomised, placebo controlled, double blind intervention.

Osteoporosis is a major public health issue, especially among older adults. The condition is widespread, with an estimated 1 in 2 women and 1 in 5 men over the age of 50 years expected to have an osteoporotic fracture. The associated health care costs are considerable and growing as the population of older adults increases. Furthermore, osteoporotic fractures are associated with loss of independence and risk of further fractures and health problems for the individual. Given these negative impacts, new approaches to help maintain better bone health in older age are urgently needed.

Vitamin D and calcium have well established protective roles, however, other evidence links certain B vitamins with bone health. This study will investigate the effect of B-vitamin supplementation over a two year period at two centres (UCD and University of Ulster)

Eligibility Criteria:
Inclusion Criteria:

* 50 years and over
* Generally healthy, free living in the community
* Males and females (post menopausal and not taking HRT)

Exclusion Criteria:

* Currently taking a supplement containing B vitamins
* Currently consuming \>4 portions of foods fortified with B vitamins per week
* Currently taking drugs known to interfere with folate/ B-vitamin metabolism
* Have a condition of the gastrointestinal system (such as coeliac disease/ chron's disease, ulcerative colitis) or liver disease (hepatitis and NAFLD)
* Be unable to consent to participate
* Be currently involved in another research study
Effects of Low Calorie Sweeteners on Dietary Intakes, Hunger, Appetite and Satiety

Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals.

The study will be a monocentric randomized controlled open trial including two parallel groups to examine effects of LCS beverages as compared to water on daily intakes of energy and macronutrients. The effects of LCS beverages on hunger, satiety, desire to eat and on the selection of sweet or savory foods eating occasions will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: Lower limit 18 kg/m²; Upper limit 28 kg/m²; weight stable within ± 3 kg in the last 6 months
* Habitual energy intake within the 95% confident interval of the reference energy intake for the French population (as provided by the INCA 2 survey
* Must not be a regular drinker of LCS beverages (less than once a week no more than every 15 days) and be willing to use LCS according to protocol
* For female participants: not pregnant, not breast feeding, planning to become pregnant during the study or on contraception since at least 3 months (regular 28-day cycle)
* Subject registered with the French Social Security.

Exclusion Criteria:

* Currently diagnosed somatic pathology
* On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months
* Major psychiatric disorder, particularly eating disorders as defined by the Diagnostic and Statistical Manual od Mental Disorders-IV
* Rejection of sweet foods or drinks as revealed by the diet history
* Smoking subject planning to stop smoking in the next 3 months
* Subjects suffering from food allergies or intolerance
* Subject not capable of understanding the constraints of the study and who not agree to abide
Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain

The purpose of this study is to determine whether transforaminal dexamethasone injections are effective in the treatment of chronic Hemiplegic Shoulder Pain.

Shoulder pain is the most common complication in hemiplegia after Stroke (CVA). Almost three quarters of all patients with hemiplegia will suffer from shoulder pain in the first twelve months after stroke. Because of the lack of effective treatment today, the optimal management of hemiplegic shoulder pain is prevention. Although widely studied, all clinical trials for shoulder pain in stroke fail to show efficacy. TF was never investigated to treat Hemiplegic Shoulder Pain (HSP). The investigators hypothesize that injecting the epidural space at the C6 level via transforaminal would desensitize both central medullary components of pain as peripheral sensitized structures such as the suprascapular nerve of the affected shoulder.

To test this hypothesis, the investigators developed a treatment protocol consisting of two C6 transforaminal epidural steroid injection with dexamethasone (TF with 0.5mL of lidocaine 1% and 1.5mL of Dexamethasone 10mg/ml). This procedure was compared to a sham intervention.

Eligibility Criteria:
Inclusion Criteria:

* 3 months of shoulder pain following a stroke
* hemiplegia or paresis after a cerebral stroke for at least 6 months
* Shoulder pain greater than 4 in a visual analogue scale
* 50 to 65 years old

Exclusion Criteria:

* inability to understand or answer the tools in the study
* local inflammation or infection
* History of malignancy
* use of cardiac pacemaker
* allergy to lidocaine or dexamethasone
* disorders of coagulation
The Effect of Consuming on Body Composition and Blood Biochemistry Index

To assess the effect of consuming on body composition and blood biochemistry index


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 20 and 60 years old
* Body mass index (BMI) ≥ 24 (kg/m\^2) or body fat mass: male \> 25%, female \> 30%
* Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
* Abidance by the similar diet and exercise habits over the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Menopausal woman
* Diabetes mellitus
* Implementation in weight loss programs before a half year of this study
* Metabolic disorders
* Kidney diseases
* Liver diseases
* Cardiovascular diseases
* Nervous system diseases
* Gastrointestinal diseases
* Heavy drinking or constant drug use.
RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who give a written informed consent obtained according to local guidelines
2. Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:

   1. Histolocial analysis of newly diagnosed disease must not be older than 8 weeks from signed consent
   2. Relapse must be confirmed by histology
   3. Neuroendocrine differentiation
3. World Health organisation (WHO) performance status grade ≤ 1
4. measurable disease
5. Adequate bone marrow function
6. Adequate liver function
7. Adequate renal function

Exclusion Criteria:

1. History or clinical evidence of central nervous system (CNS) metastases.
2. Presence of SCLC cells
3. Patients who have a history of another primary malignancy ≤ 3 years, with the exception of inactive basal or squamous cell carcinoma of the skin or cervical cancer in situ, early stages of breast cancer (LCIS and DCIS) and prostate cancer (stage T1a)
4. prior chemotherapy for the treatment of advanced lung cancer and/or not having recovered from the side effects of any other therapy (adjuvant treatment for earlier stages I-III is allowed if finished at least one year before study entry)
5. Patients who have received any investigational drug ≤ 28 days before starting study treatment or who have not recovered from side effects of such therapy
6. Patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
7. Patients who have received prior therapy with RAD001 or other mTOR inhibitors
8. Having any severe and/or uncontrolled medical conditions
9. Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply
Improving Work Outcomes for Veterans With Traumatic Brain Injury

The 12-month study will investigate a cognitive training augmentation of supported employment to improve cognitive performance and work outcomes, which are expected to result in improved quality of life and community integration for veterans with mild to moderate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who receive supported employment plus cognitive training will work more weeks during the 12 months.


Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF veteran
* History of mild-to-moderate TBI (loss of consciousness \<6 hours; post-traumatic amnesia \<7 days)
* Documented impairment in at least one neuropsychological domain
* Unemployed, but stating a goal of work
* Written informed consent to participate in the study

Exclusion Criteria:

* Current alcohol/substance abuse or dependence
* Participation in other intervention studies
Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability

The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially solid (i.e. crystalline) states.

A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend four study visits, separated by at least one week. On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order. All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature. The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers. This will isolate the impacts of physical state and acid stability, and their interactions. Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage. The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying. It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of gastric emptying. Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the four visits.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18 - 26 kg/m2
* generally healthy
* non-smoking
* non to moderate alcohol drinkers
* fasting plasma cholesterol level \<5.2 mmol/L
* plasma triacylglycerol level \<1.7 mmol/L
* plasma glucose level \<5.6 mmol/L
* no history of gastric surgeries

Exclusion Criteria:

* History of major medical conditions
* taking prescription medications/ over the counter medications
* taking natural health products/ dietary supplements (other than a multivitamin)
* oral antibiotic use in the previous 3 months
* planning to take oral antibiotics in the next 3 months
* food allergy/anaphylactic/life-threatening allergy
* smokers/ regular users of recreational drugs
* elite/ training athletes
* significant weight loss/ gain during the past 3 months
* previous reaction/ sensitivity to acetaminophen
* inability to avoid taking acetaminophen for 48 hours
* sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
* not willing to consume Sugar Twin® Sucralose or Artificial vanilla.
A Phase I Study of GZR18 Injection in Healthy Subjects

This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects sign informed consent voluntarily.
* 2. Chinese adult subjects, male or female.
* 3. Age 18-55 at screening (both included).
* 4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
* 5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.

Exclusion Criteria:

* 1. History of dizziness with blood and needles.
* 2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
* 3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
* 4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
* 5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
* 6. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.
Pulmonary Rehabilitation for Long COVID (Post COVID-19 Condition)

In the PuRe COVID study (a randomized, controlled, multicenter, pragmatic trial) the investigators aim to assess the effect of a pulmonary rehabilitation program in primary care on exercise capacity (6MWT) and daily life physical activity in patients with long COVID.

134 patients with long COVID, defined by self-reported persistent COVID related symptoms ≥6 weeks after COVID-19 infection and a positive symptom score (CAT score ≥10 or mMRC score ≥2 or CIS-fatigue ≥36 or PCFS score of ≥2), will be recruited and divided into an intervention group or a control group. The intervention group will get twelve weeks of primary care pulmonary rehabilitation (PR) including coaching by primary care physiotherapists. The control group consists of usual care, which does not include a pulmonary rehabilitation program.

This study will help determine whether the type of symptoms or affected body system can impact recovery form long covid during rehabilitation and after follow-up. The investigators will analyze determinants and risk factors that characterize non-responders and non-adherers to better understand which patients with long COVID benefit from rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with status post COVID-19 (positive COVID-19 PCR or an official pharmacy performed antigen test or a self-performed test confirmed by a physician during the acute COVID-19 ≥ 6 weeks ago or positive antibodies before vaccination or positive antibodies before vaccination).
* Persistent COVID related symptoms that were not present pre-COVID-19 or were less severe pre-COVID.
* Symptomatic: quantified by dyspnea on exertion, loss of energy, fatigue or sleep impairment based upon the score of four questionnaires:

  * COPD Assessment Test (CAT) ≥10, and/or
  * modified Medical Research Council dyspnea scale (mMRC) ≥2, and/or
  * CIS-fatigue ≥36, and/or
  * post-COVID-19 Functional Status (PCFS) ≥2.

Exclusion Criteria:

* Patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation.
* Prior physiotherapy for long COVID if:

  * patients who have completed ≥9 sessions of physiotherapy in total for long COVID.
  * patients who completed any physiotherapy session in the previous 12 weeks for long COVID (primary care or hospital based; pulmonary or non-pulmonary).
* Patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study.
* Patients that are not able to give informed consent or not able to complete questionnaires.
* Patients who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list.
* Patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.
Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes

The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety


Eligibility Criteria:
Inclusion Criteria:

* Patients of Senior Attending orthopedic sports medicine surgeons at Mayo Clinic Arizona
* Patients with a proficiency in English in order to participate without need for translator.
* Patients with a diagnosis of a primary ACL injury in need of surgical reconstruction utilizing any surgical technique for ACL reconstruction.

Exclusion Criteria:

* Patients with a diagnosis of ACL injury in need of a surgical revision.
* Patients who have any multi-ligamentous injuries to the knee requiring modified postoperative unloading.
* Patients who have history of previous anterior cruciate ligament reconstructions in either leg.
* Patients who have either auditory or visual impairments.
* Patients who are medical professionals with work-related knowledge of ACL reconstruction.
* Patients with an inability or unwillingness of individual or legal guardian to give written informed consent.
A Self-Help Metacognitive Therapy for Cardiac Rehabilitation Patients (PATHWAY WS3)

Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy.

Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings.

This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a self-help format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to evaluate the effectiveness and cost-effectiveness of Home-MCT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are referred to the CR pathway who meet Department of Health (DoH) and/or British Association for Cardiovascular Prevention and Rehabilitation (BACPR) CR eligibility criteria:

   * Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart
   * Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia
   * Stable heart failure
   * Stable angina is chest pain or discomfort that most often occurs with activity or stress
   * Following implantation of cardioverter defibrillators/cardiac resynchronisation devices
   * Heart valve repair/replacement
   * Heart transplantation and ventricular assist devices
   * Adult congenital heart disease identified in adulthood
   * Other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain)
2. A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
3. Minimum of 18 years old
4. Competent level of English language skills

Exclusion Criteria:

1. Cognitive impairment which precludes informed consent or ability to participate
2. Acute suicidality
3. Active psychotic disorders (i.e., two \[or more\] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
4. Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
5. Concurrent psychological intervention for emotional distress that is not part of usual care
6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks
7. Life expectancy of less than 12 months

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2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen

To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for patients with transitional cell carcinoma of urothelium


Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed TCC
* Received 1st line chemotherapy for locally advanced or metastatic TCC with CDDP regimen
* To have at least one measurable region
* PS: 0-2
* To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

* To have Interstitial pneumonia or pulmonary fibrosis
* Within 4 weeks after the latest chemotherapy or radiotherapy
* To have brain metastasis with symptom
* To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Vitamin D Deficiency Epidemiological Research in Sichuan, China

Vitamin D insufficiency and deficiency is pandemic in the world.Sichuan Basin has a subtropical monsoon climate with China's lowest sunshine totals. Inferably, the prevalence of vitamin D insufficiency/deficiency in Sichuan basin is high, and possibly the highest in China. This study will research the serum 25OHD level to get the prevalence of vitamin D deficiency and insufficiency of urban and rural residents in Sichuan Province, China.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 30 years old living in Sichuan province.