cyrilzakka/clinical-trials huggingface dataset:
Mixed Nuts and Brain Vascular Function

Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. The Mediterranean diet, which is rich in nuts, may protect against the development of impaired cognitive performance. The hypothesis is that long-term mixed nut consumption increases brain insulin-sensitivity thereby improving brain vascular function and cognitive performance. The primary objective is to evaluate in elderly men and women the effect of 16-week mixed nut consumption on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to investigate effects on the cerebral blood flow response to intranasal insulin delivery - a marker of insulin-sensitivity in the human brain - as quantified by ASL, and cognitive functioning as assessed with a neuropsychological test battery.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 60-70 years
* BMI between 25-35 kg/m2
* Fasting plasma glucose \< 7.0 mmol/L
* Fasting serum total cholesterol \< 8.0 mmol/L
* Fasting serum triacylglycerol \< 4.5 mmol/L
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria:

* Allergy or intolerance to nuts
* Left-handedness
* Current smoker, or smoking cessation \< 12 months
* Diabetic patients
* Familial hypercholesterolemia
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
* Use medication to treat blood pressure, lipid or glucose metabolism
* Use of an investigational product within another biomedical intervention trial within the previous 1-month
* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
* Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
Lithium in Multiple System Atrophy

The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.

Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable MSA (Gilman, et al. 2008)
* Age ≥18, \<80

Exclusion Criteria:

* Heart failure
* Liver disease
* Kidney failure
* Thyroid disease
* Sick sinus syndrome and/or significant ECG alterations
* Hyposodemia
* Treatment with diuretics
* Treatment with haloperidol and/or other antipsychotics
* Treatment with NSAIDs or corticosteroids
* Treatment with ACE inhibitors
* Treatment with aminophyllines
* Treatment with mannitol
* Pregnancy and/or breastfeeding
* Acute diseases that might interfere with the trial
Psychiatric Inpatient Discharge Data - Rwanda

The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

For a one-year period, descriptive data on all inpatients with age \> 18 years, discharged from Ndera Hospital the only inpatient psychiatric hospital in Rwanda, will be collected from files. The descriptive data includes diagnosis, duration of hospitalization, medication, addiction, insurance, Somatic- and psychiatric comorbidity, referral pathways, employment status, number of previous hospitalizations. To the investigators' knowledge, there is no descriptive data on psychiatric inpatients in the country of Rwanda. Therefore, this. Information will be crucial for understanding the service provision at the referral hospitals and the accessibility to intensive mental health care in Rwanda. The data will be anonymized and recorded - this ensures the data cannot be linked to anyone subject which supplied it.

Eligibility Criteria:
Inclusion Criteria:

* All patients discharged from the inpatient psychiatric unit at Ndera Hospital, Rwanda

Exclusion Criteria:

* none
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate

This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.


Eligibility Criteria:
1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
4. Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
5. Have a high probability for compliance with and completion of the study.
Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis

Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).


Eligibility Criteria:
Key Inclusion Criteria:

* Must be 18 years of age and provide written informed consent and sign the HIPAA form
* Must have history of allergic rhinitis
* Must have positive response to Allergen BioCube

Key Exclusion Criteria:

* Must not have a significant illness such as moderate to severe allergic asthmatic reactions
* Must not have compromised lung function
* Must not use any disallowed medications
* Must not have been in an investigational study in the last 30 days
Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis

The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with Cystic Fibrosis.

Cystic fibrosis (CF) is an autosomal recessive, multisystem involvement disease. The most important cause of mortality in CF is pulmonary complications. Prevention of pulmonary complications is only possible with pulmonary rehabilitation. Pulmonary rehabilitation methods used in CF are called airway cleaning techniques that include postural drainage, breathing techniques and use of devices. These techniques have not been proven to be superior to each other. Active cycle of breathing techniques (ACBT) is one of the breathing techniques used to remove secretions from the lungs.

Pulmonary disease progression in CF causes postural impairment and decrease of exercise tolerance, which can reduce effectiveness of pulmonary rehabilitation. The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with CF.

Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed with KF
2. Be able to understand commands

Exclusion Criteria:

1. FEV1 below than %30
2. Cor pulmonale
3. Advanced gastroesophageal reflux
4. Current hospital admission due to lung infection
5. Be diagnosed with neuromuscular disease
Training in a Local Community Aimed Upon Musculoskeletal Health Promotion for Postmenopausal Women

To minimize fracture risk, diverse and varied training of high intensity (multimodal training) is recommended to increase bone strength. However, the effectiveness of different training programmes performed in community settings remain uncertain. The present study aimed to evaluate the feasibility and the effectiveness of 19-week of multimodal training in a local community center in Copenhagen, Denmark. The health promotion initiative had special emphasis on musculoskeletal health in postmenopausal women.

A local community center was offering supervised multimodal training (MMT) to postmenopausal, healthy women twice weekly, and the aim of the present study was to evaluate the feasibility and the musculoskeletal health promoting effects of the training. The evaluation study lasted for 19 weeks, and the average attendance rate of MMT participants had to be \> 1 hour weekly. The primary outcomes were bone mineral density (BMD) assessed by Dual-Energy X-ray Absorptiometry (DXA) scanning and the fasted plasma concentration of bone turnover markers (BTM): N-terminal propeptide of type I procollagen (P1NP) , C-terminal telopeptide of type I collagen (CTX), Osteocalcin), while secondary outcomes were body composition variables, dynamic postural balance and functional muscle strength. To test within- and between-group differences in the pre and post outcomes the training group (MMT) was compared with a sedentary control group (CON).

Every participant was fully informed before giving her written informed consent to the procedures and potential discomfort associated with the study. The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee of the Capital Region of Denmark, H-18044190.

Eligibility Criteria:
Inclusion Criteria:

* past menopause
* non-smoking
* BMI \<30 kg/m2

Exclusion Criteria:

* T-score \< -3 SD in the lumbar spine or hip
* Z-score \> 1.5 SD)
* use of hormone therapy, medical treatment or supplements that affect bone metabolism
* previous or current medical condition affecting bone health
* engagement in regular and systemic weight-bearing training or strength training during the preceding two years
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.


Eligibility Criteria:
Inclusion Criteria:

* For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
* Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Exclusion Criteria:

* For Chronic Migraine participants:

  * Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
  * Current use or prior exposure to Galcanezumab or other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.
  * Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
  * History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
  * Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).
Insomnia in Patients With Metastatic Lung Cancer

This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.

PRIMARY OBJECTIVE:

I. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.

OUTLINE: This is an observational study.

Patients undergo medical chart review and complete a questionnaire on study.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of metastatic non small cell lung cancer

  * Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy
  * Older than 18 years old at the time of diagnosis

Exclusion Criteria:

* Subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review
Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-based Vaccine for Preventing RSV Hospitalizations in Older Adults

The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in older adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.

The study is a pragmatic, registry-based, open-label, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 130,000 participants. Participants will be individually randomized 1:1 to receive either a bivalent RSV prefusion F vaccine (RSV vaccine) or no RSV vaccine. The trial is designed to assess the vaccine effectiveness of the RSV vaccine vs. no RSV vaccine on RSV-related and all-cause cardio-respiratory outcomes.

Eligibility Criteria:
Inclusion Criteria

* Age 60 years and above
* Informed consent form has been signed and dated

Exclusion Criteria:

* There are no specific exclusion criteria for this study
Nutritional Strategies to Augment the Postprandial Muscle Protein Synthetic Response to the Ingestion of a Low Dose of Protein in Middle-aged Women

Using stable isotope methodology, investigators will determine the postabsorptive and postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: \<30 kg/m2) immediately after an acute bout of resistance exercise. Participants will be divided in to 5 groups of twelve women (n=12). Each group will receive a different protein beverage or placebo to consume following the resistance exercise training. Group 1 will consume a beverage consisting of whey protein; group 2 will consume whey protein supplemented with additional leucine; group 3 will consume whey protein supplemented with additional leucine and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional leucine and citrulline; group 5 will just consume water. During the testing, blood and muscle samples will be collected.


Eligibility Criteria:
Inclusion Criteria:

* BMI \<30 kg/m2
* Healthy, sedentary
* Either 20-30 years old or 50-79 years old

Exclusion Criteria:

* Tobacco use
* Allergies to milk consumption
* Unusually high protein consumption
* Vegan diet
* Allergies to antibiotics or xylocaine
* Phenylketonuria (PKU)
* Diagnosed GI tract diseases
* Arthritic conditions
* A history of neuromuscular problems
* Heart disease
* Metabolic disorders
* -Liver, kidney, or urinary disease
* Musculoskeletal problems
* Autoimmune disease
* Neurological disease
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
* Individuals using thyroid medications or other medications affecting endocrine function
* Pregnancy
* Contraindications for exercise
* BMI ≥30
* supplements that influence protein metabolism (e.g omega 3 fish oils)
Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff

Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks

Antiviral effecacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks this study is a trial for evaluation of adding a proved antiviral material to the mask and to compare between the protective value of this mask and the ordinary one.

Eligibility Criteria:
Inclusion Criteria:

* health care personells and family contact of confirmed COVID-19 cases.

Exclusion Criteria:

* refusal of participate to use the masks.
* pregnancy or lactation known hypersensitivity to ivermectin.
Impact of Coronary Anatomy on Angina Relief in Patients Undergoing Coronary Revascularization

We hypothesize that Coronary Artery Disease (CAD) severity assessed by SYNTAX score is an independent predictor of recurrent or persistent angina following coronary revascularization. The SYNTAX score is a score that suggests the severity of coronary artery disease detected by coronary angiography. Coronary revascularization is a procedure that occurs in two ways, a percutaneous coronary intervention (PCI) and a coronary artery bypass graft (CABG) and is done when there is narrowing and blockage or hardening of the arteries (atherosclerosis) surrounding the heart. Narrowing and blockages reduce blood flow to parts of the heart causing chest pain (known as angina) and sometimes myocardial infarction.

PCI and CABG are two well-established revascularization approaches to treatment of chronic angina caused by coronary atherosclerosis. Nevertheless, 35-42% of patients report recurring or persisting anginal symptoms after coronary revascularization. This can be attributed to many structural and functional causes, prominent amongst which is pre-revascularization angina severity, unrevascularized coronary territory, progression of native or bypass graft atherosclerosis, restenosis (re-narrowing of the vessels) and accompanying adjunctive pharmacotherapy.

The SYNTAX score is an angiographic tool for grading the complexity of coronary disease. It is the sum of points assigned to coronary lesions within one of the 16 segments of the coronary tree. The segments are given a 1,2, or 5 based on the disease presence as defined by the American Heart Association classification. The SYNTAX score has been used to help predict the outcomes of patients undergoing PCI with 3-vessel involvement (e.g. a triple bypass or 3-stent placement PCI). Those patients with the highest scores had the highest risk of a poor outcome with PCI revascularization compared to CABG. Despite these observations, the impact of CAD severity on post-revascularization angina, using the SYNTAX has never been systematically addressed in the current era.

Eligibility Criteria:
Inclusion Criteria:

* Any VA patient who has had an PCI from January 1, 2003 and December 31, 2011 and in the database used in protocol 09-018 (VA-CAP Study).
* Any VA patient who has received or will receive a 1-year follow up.

Exclusion Criteria:
Process Evaluation of OptimiseRx and PINCER

This study aims to evaluate two interventions designed to make medication prescribing safer, OptimiseRx and PINCER, which are being used in general practices across England. The findings from the evaluation will be used to generate recommendations as to how these interventions can be used sustainably in the long-term.

This study has been designed to evaluate and gain an understanding of the 'real world' implementation, fidelity and medium and longer-term embedding and sustainability of two prescribing safety interventions: the computerised decision support (CDS) tool - Optimize Rx, and PINCER (pharmacist-led information technology intervention for reducing clinically important errors in medication management). The longitudinal process evaluation will involve observations, interviews, focus groups and questionnaires. The consolidated learning exercise, which aims to inform long-term, sustainable intervention use will involve a documentary analysis, interviews, focus groups, development workshops and a synthesis of the evaluation results.

Eligibility Criteria:
Inclusion Criteria:

Staff and stakeholders

* Able to give written informed consent
* 18 years of age or over (no maximum age limit)
* Staff members working in/for a practice or a CCG or the software developer which has received the intervention/s and have direct contact with it/them
* Staff from relevant AHSNs, NHS England, the University of Nottingham or PRIMIS and other relevant staff who have had involvement in the PINCER rollout
* Staff who have either had direct contact with, have an understanding of and/or are in a position to influence wider adoption of the PINCER and OptimseRx interventions (e.g. contracting, IT systems engineer, commissioner, etc.)

Patients

* Able to give written informed consent
* 18 years of age or over (no maximum age limit)
* Patients registered with a general practice who have attended a consultation (or other related activity) for the PINCER intervention, or selected by their clinical care team, or attached to a patient group within a CCG or practice or those identified via social media who are living with a long-term health condition and/or who require regular blood tests to monitor their medication and have had a medication review within the past six months

Members of the public and patient representatives

* Able to give written informed consent
* 18 years of age or over (no maximum age limit)
* Those who have either had direct contact with the PINCER intervention or have an understanding of the related medicines management issues in primary care

Exclusion Criteria:

Staff and stakeholders

* Unable to give written informed consent
* Under 18 years of age

Patients

* Unable to give written informed consent
* Under 18 years of age
* Those considered by their healthcare professional to be inappropriate to recruit due to psycho-social reasons or significant health reasons, e.g. terminal illness/diagnosis.

Members of the public and patient representatives

* Unable to give written informed consent
* Under 18 years of age
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation

To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Age 21 and older
* Regular corneal astigmatism ≥ 1.5 D
* written informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* High myopia (\> 29 mm AL)
* Irregular corneal astigmatism on corneal topography
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)