cyrilzakka/clinical-trials huggingface dataset:
Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)

To determine associations between dietary factors and risk of major chronic diseases and their risk factors

STUDY POPULATION The Kuopio Ischaemic Heart Disease Risk Factor Study (KIHD) is an on-going prospective, population-based cohort study of risk factors for cardiovascular diseases, other chronic diseases and metabolic conditions in a sample of men from eastern Finland. The baseline examinations were carried out between 1984 and 1989, when 2,682 men (82.9% of those eligible) who were 42, 48, 54 or 60 years old were recruited. The first cohort consisted of 1166 men who were 54 years old, enrolled in 1984-1986, and the second cohort included 1516 men who were 42, 48, 54 or 60 years old, enrolled in 1986-1989. The baseline examinations were followed by the 4-year examinations (1991-1993), in which 1038 men from the second cohort (88% of the eligible) participated. At the 11-year examinations (1998-2001), all men from the second cohort were invited and 854 men (95% of the eligible) participated. These examinations were also the baseline for 920 postmenopausal women (78.4% of the 1173 eligible women) from the same area, aged 53-73 years. During the 20-year examination round, all men from the first and second baseline cohorts and all women were invited to the study site, and a total of 1241 men (80% of the eligible) and 634 women (81.0%) participated.

ASSESSMENT OF DIETARY INTAKES Food consumption has been assessed with an instructed food recording of four days, one of which was a weekend day, by household measures. A picture book of common foods and dishes was used to help in estimation of portion sizes. For each food item the participant could choose from 3-5 commonly used portion sizes or describe the portion size in relation to those in the book. In order to further improve accuracy, instructions were given and completed food records were checked by a nutritionist together with a participant. Nutrient intakes were estimated using the NUTRICA® 2.5 software (Social Insurance Institution, Turku, Finland). The databank of the software is mainly based on Finnish values of nutrient composition of foods.

OUTCOME ASSESSMENT Registration of the incidence of major chronic diseases and deaths during the follow up is based on the national registries (Hospital discharge registry, Cause of death register, Social Insurance Institution of Finland register for reimbursement of medicine expenses) by use of the Finnish personal identification code (social security number), and/or on findings at the re-examination rounds (such as fasting plasma glucose or 2-h oral glucose tolerance test to define type 2 diabetes in addition to data from the national registries).

Eligibility Criteria:
Inclusion Criteria:

* Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)
* Aged 53 to 73 years (women at their baseline in 1998-2001)
* Living in the city of Kuopio or neighboring rural areas

Exclusion Criteria:

* Condition that prevented visit at study clinic
MindMate: A Study of a Reminder System for People With Dementia

A study to investigate the effectiveness of a reminder tool application at increasing performance on memory tasks in people with mild dementia

Background

Memory difficulties are a core feature of dementia. These include difficulties remembering to do something at a specific time and place in the future (Prospective Memory). Although a range of electronic prospective memory aids currently exist (e.g. "Neuropage"), the evidence supporting their use among the dementia population remains limited. "Mindmate" is a recently developed mobile application that aims to support individuals with a diagnosis of dementia, improving self-management skills and quality of life.

Aims

This study will explore the effectiveness of "MindMate" reminder alerts delivered to a smart phone or tablet computer as a memory aid for people with a diagnosis of Mild Dementia.

Method

Three participants with a diagnosis of dementia, who are considered to be in the early stages and who report everyday prospective memory difficulties, will be recruited from Older People Community Mental Health teams within Greater Glasgow and Clyde. The participants will own a smart phone or tablet and will be living with a partner or family member who will also participate in the study. During the initial baseline phase, the partner or family member will monitor the number of pre defined tasks the participant remembered and forgot. The partner or family member will record this information on a weekly monitoring form and this phase will last between five to seven weeks. This will be followed by a five-week intervention phase where "MindMate" reminder alerts will be sent to the participant's phone or tablet. Again, tasks that require remembering will be identified prior to the intervention phase, and family members or carers will monitor their success on a form. Results will be analysed using visual inspection and Tau-U analysis.

Applications

This study will provide information on the effectiveness of a form of assistive technology at supporting people with a dementia, which could improve quality of life of those with a diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* has a diagnosis of Mild Dementia, according to International Classification of Diseases (ICD) 10 Criteria
* has received the diagnosis from a psychiatrist
* owns a smart phone or tablet
* has a family member/partner/carer who is willing to monitor memory aid use
* has capacity to consent to being involved in the research
* is reporting memory difficulties that are affecting them in daily life

Exclusion Criteria:

* visual or auditory difficulties which cannot be corrected through the use of appropriate aids
* has a pre-existing neurological or severe psychiatric problem (e.g. bipolar disorder, psychosis)
* has a diagnosis of dementia that is considered to be in the moderate to severe stages
* those whose first language is not English
* those with a diagnosed or suspected developmental learning disability
* those who are currently using online or electronic memory aids
Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome

Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.

Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome (ST elevation and non ST elevation)
* Early invasive strategy

Exclusion Criteria:

* contraindication to statin therapy
* refusal of consent
A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions

This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial. Patients will be randomized to N-acetylcysteine (NAC) or ambroxol or placebo in a 1:1:1 ratio. A total of approximately 333 patients in China will be randomized. The total study duration will be approximately 8 months including the enrolment period of approximately 7 months and the patient participation duration of 1 month or 4 weeks. Each patient will undergo a screening period of up to 1 week, a 1-week treatment period and a 2-week follow-up period. This study will be conducted in approximately 15-25 sites in China.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult (≥18 years old) hospitalized patients with respiratory tract diseases and abnormal mucus secretions such as: acute bronchitis, chronic bronchitis and exacerbations, emphysema, mucoviscidosis and bronchiectasis.
2. Chinese ethnicity and/or Chinese
3. Signed the informed consent form before any study-related procedure
4. Sputum viscosity score ≥ 2 at randomization visit
5. Expectoration difficulty score ≥ 2 at randomization visit
6. Willingness and ability to comply with study procedures

Exclusion Criteria:

1. Intolerance or contra-indication to treatment with NAC or ambroxol or allergy to any component of the study treatments
2. (For female patients) ongoing pregnancy or lactation, or childbearing potential but unwillingness to adopt abstinence or contraception measures during the study
3. Intake of an investigational drug within 1 month before the screening visit
4. Use of expectorants or drugs with expectorant effect within 2 days before randomization visit
5. Diagnosis of active tuberculosis, lung cancer, pulmonary fibrosis, acute pulmonary thromboembolism or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the patient or affect the interpretation of the results
6. Medical history of and/or illness (including laboratory abnormality) and/or treatment that in the investigator's opinion may interfere with the patient's safety, compliance, or study evaluations
7. Serum alanine aminotransferase and/or aspartate transaminase more than 3 times above the upper limit of normal at screening visit
8. Serum creatinine more than 3 times above the upper limit of normal at screening visit
9. Addiction to alcohol or drugs
10. Mental illness, or other reasons for non-cooperation in the investigator's opinion
Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age

With the use of molecular methods new viruses have been detected in respiratory and gastrointestinal tracts of both patients and asymptomatic subjects in recent years. The clinical importance of these viruses has not been adequately studied.

The aim of this study is to use molecular methods to detect viruses in upper respiratory tract and gastrointestinal tract of children with acute bronchiolitis, acute gastroenteritis and febrile convulsions and to try to correlate the severity of clinical picture with the amount of viruses present in clinical samples. The investigators will also try to detect the increase in specific antibodies in paired sera.


Eligibility Criteria:
Inclusion Criteria:

presence of

* acute bronchiolitis
* acute gastroenteritis
* febrile convulsion requiring hospital admission

Exclusion Criteria:

* none
Unloading Induced Effects on Local Glucose Uptake Into m. Soleus

The present study aimed to investigate whether a daily intake of lupin protein and a neuromuscular electrical stimulation training twice a day can improve local glucose uptake into m. soleus during a 60 day unloading phase with a special unloading device, the HEPHAISTOS orthosis (HEP).

The 60 day unloading intervention with the HEPHAISTOS unloading device had the following key objectives:

primary hypothesis:

* Assesment and evaluation of insulin sensitivity and local glucose uptake in the unloaded m. soleus and whether it can be improved by dietary supplementation of lupin seeds and neuromuscular electrical stimulation.

secondary hypotheses:

* Assesment and evaluation of unloading-induced reductions in muscle mass and whether they can be mitigated by dietary supplementation of lupin seed and neuromuscular electrical stimulation.
* Assesment and evaluation of whole-body glycemic effects of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Male volunteers
* Age: between 20 and 45 years
* Body mass index (BMI): 20 -26 kg/m2
* Agreement and signed consent before the study

Exclusion Criteria:

* Smoker
* Competitive Athletes
* Diabetes mellitus
* Rheumatic disease
* Muscle or joint disease
* Bone fractures in the period up to one year before study start
* Herniated disc
* Flatfeet (pes planus)
* Allergy to nuts or legume
* Vascular diseases
* Epilepsy
* Severe hyperlipidemia
* Anemia (\< Hb standard values; standard values healthy men: 13.5 -17.5 g/dl) \*
* Increased thrombosis risk \*
* Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine \< 1.20 mg/dl)\*
* Lesions of the cruciate ligaments, or orthopedic surgery in the past 10 years on the side of the Hephaistos orthosis
* Achilles tendon injury, or rupture in the past 10 years on the side of the orthosis
* hyper-/hypocalcaemia (abnormal levels of calcium in the blood, normal level: 2.15 - 2.64 mmol/l)
* Intake of anti-inflammatory drugs during the study
* Abuse of drugs or alcohol (\> than 20-30g alcohol/day)
* Participation in another clinical study within the last 2 months before the start of this study
* Increased bleeding tendency (hemophilia, regular use of anticoagulants)
* History of intolerance to local anesthetics
* Imprisoned during study
* Any other condition classed as unsuitable for study participation by the medical executive director
* prior convictions (objectionable criminal record)

Additional Exclusion Criteria for MRI

* Metal implants or other osteosynthesis material
* Pacemaker
* Claustrophobia
Pain Neuroscience Education in Chronic Musculoskeletal Pain

Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high socio-economic costs, with many negative effects on quality of life. CMP affects the ability to perform work, social, recreational and domestic tasks by changing the mood and concentration of this population that suffers.

In a study carried out in 2010, 17% of the Spanish population had experienced pain in the last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24% mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck pain and 23% due to shoulder pain.

Pain neuroscience education (PNE) has been shown as an effective treatment strategy in increasing knowledge and understanding of neurobiology, neurophysiology and pain processing, modifying beliefs about it, improving patient skills and encouraging to the accomplishment of physical and social activities in different chronic pathologies.

Study design and setting: The design of the present study will be a quasi-experimental study with 2 follow-ups (one month and four months after intervention) that will be performed between Apr 2018 and Apr 2020 in public health system in Malaga, Spain. The outcomes will be assessed at baseline (t0), one month (t1) and four months after the physiotherapy treatment begins (t2). Written informed consent will be acquired for all participants prior to their participation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years
* Chronic Musculoskeletal Pain according to the ACCTION-APS Pain Taxonomy (AAPT), included chronic axial musculoskeletal low back pain

Exclusion Criteria:

* Chronic postoperative musculoskeletal pain and chronic musculoskeletal pain related to a traumatic injury six months before the beginning of the trial
* Inability to provide written informed consent and/or complete questionnaires in Spanish.
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.


Eligibility Criteria:
Inclusion:

* Male or female adult patients \> 40 and ≤ 85 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
* Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml
* ASA Physical Status II - III
* Signed written informed consent form

Exclusion:

* Hypersensitivity to the active substances or to any of the other excipients of the investigational medicinal products
* Body weight ≥ 140 kg
* Sepsis
* Burns
* Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic renal replacement therapy
* Intracranial or cerebral haemorrhage
* Critically ill patients (typically admitted to the intensive care unit)
* Hyperhydration
* Pulmonary oedema
* Dehydration
* Hyperkalaemia
* Severe hypernatraemia
* Severe hyperchloraemia
* Severely impaired hepatic function
* Congestive heart failure
* Severe coagulopathy
* Organ transplant patients
* Metabolic alkalosis
* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Wet Cupping Therapy in Ankylosing Spondylitis

This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics

In addition to the medical treatment, WCT will be applied once a month, 3 times (Day 0, 30, 60) to the intervention group whereas the control group will not receive any intervention. The BASFI, BASDAI, VAS and Schober test will be applied to both groups at 0 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of ankylosing spondylitis 18-65 years of age Consent to participate

Exclusion Criteria:

Any ongoing medical treatment other than NSAIDs Pregnancy At least one contraindication to WCT that was detected in subject's history or in the routine blood examinations prior to enrollment (Hgb \<9.5; INR\> 1.2; history of hemophobia, bleeding disorder, malignant disorder).
Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia

This research trial studies deoxyribonucleic acid (DNA) in blood or bone marrow samples from younger patients with acute myeloid leukemia. Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PRIMARY OBJECTIVES:

l. Perform a genome-wide scan to test for loci associated with acute myeloid leukemia (AML) relapse and infection risk.

II. Validate positive associations seen in the genome-wide scan with a fine mapping approach.

III. Perform simulated clinical trials using germline genetic variation data to test the feasibility of using genetic data to inform the clinical care of pediatric patients with AML.

OUTLINE:

Germline DNA is obtained from previously collected peripheral blood or bone marrow samples for array-based genotyping studies, including genome-wide association studies (single nucleotide polymorphisms) and fine mapping genotyping. Clinical trial simulations are performed to test the clinical applicability of using genetic variation data in the management of infectious complications.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML

  * In remission
* Adequate DNA from peripheral blood or bone marrow samples
* Concurrent enrollment on CCG-2961, COG-AAML03P1, COG-AAML0531, AML-93, AML-97, AML-04,AML-09, or Canada AML Infection clinical trial required
Face of Sleepiness

The purpose of this pilot study is to find out whether successful treatment of obstructive sleep apnea makes people look less sleepy, for example by reducing swelling or dark circles under the eyes. In addition, this study will help determine whether facial photographs may be used to help identify patients who should be tested for sleep apnea and daytime sleepiness.

The main symptom of nocturnal sleep disorders is often excessive daytime sleepiness. Although sleepiness can be a major contributor to decreased quality of life, and even mortality, patients frequently grow habituated to their sleepiness, ignoring it and any underlying disorder. One scarcely explored potential consequence that could motivate patients to address sleep disorders is a sleepy facial appearance. No peer-reviewed literature, to our knowledge, has explored whether inadequate or insufficient sleep actually causes changes facial appearance. No published literature has examined the extent to which treatment for sleep disorders might improve such facial changes, and perhaps motivate patients to treat their sleep disorders.

To address these questions in a preliminary manner, therefore, the investigators propose to use cutting-edge photographic technology to assess subtle changes in facial appearance. The investigators will recruit 20 sleepy adult patients who are diagnosed with obstructive sleep apnea, an ideal disease model in which subjects can be tested before and after alleviation of severe sleepiness by home use of continuous positive airway pressure. Results of this pilot study could show for the first time that successful treatment of a chronic sleep disorder improves facial features commonly perceived as an undesirable sign of sleepiness.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18-65
* Recently diagnosed with obstructive sleep apnea, confirmed by polysomnography (sleep study)
* Experiencing daytime sleepiness, based on Epworth Sleepiness Scale
* Scheduled for a positive airway pressure (PAP) titration study (CPAP or BiPAP)
* Willing to use CPAP or BiPAP at pressures prescribed by the treating physician
* Willing to have facial photographs taken before treatment and 2-4 months after nightly use of CPAP or BiPAP

Exclusion Criteria:

* Diagnosed with other sleep, medical or psychiatric disorders that might limit the effectiveness of PAP treatment (such as morbid obesity, emphysema, and neurodegenerative disorders)
* Conditions that may cause daytime sleepiness (such as narcolepsy, primary insomnia, seizure disorders, or major depression)
* Use of medications or herbal remedies that affect sleep and behavior
* History of facial plastic or reconstructive surgery or Botox injections or plans to undergo these types of treatments prior to completing the second study visit