cyrilzakka/clinical-trials huggingface dataset:
Implementing and Evaluating the Genie Tool in COPD

The Generating Engagement in Network Involvement (GENIE) Tool is designed to support people to find and join social activities in their own neighbourhoods.

Evidence has shown that people with more social support have increased ability to manage long term conditions and ill health.

Patients with Chronic Obstructive Lung Disease (COPD) have difficulty breathing every day; this is both tiring and makes its difficult to socialise as they did prior to having their condition. COPD can be managed with medicines, and exercise, but will never be cured, so it is considered a 'long term condition.'

This study plans to use a social mapping tool (GENIE) with COPD patients that are already part of the community service. The aim of the study is to increase opportunities to socialise and get day to day support outside of the health service.

Patients will be offered either the tool, or usual care.

If the study is successful then use of health care may reduce in the COPD patients already using the COPD service.

The main aim here is to increase long term health care management options in Solent NHS ( National Health Service) Trust by building social capacity to support self-management. The GENIE tool will be introduced into the COPD service to improve options for social groups and exercise when leaving a pulmonary rehabilitation group, or when clinically unable to participate in exercise. The implementation of the GENIE tool aims;

* to build social networking awareness and the importance of utilising existing social resources in the professional and voluntary members of the COPD service
* to use social network mapping techniques and preference elicitation to engage COPD patients in reflecting on their support preferences and needs, help them access further resources and knowledge
* Evaluate the success of the social mapping techniques (GENIE) in the COPD patient population
* Evaluate the cost benefit to the health service of the GENIE in the COPD patient population

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 with a predominant diagnosis of COPD
* Ability to understand spoken English
* Attending PR assessment/ enrolled in Pulmonary Rehabilitation (PR) or maintenance therapy
* Ability and capacity to make their own decision and consent freely

Exclusion Criteria:

* No clear COPD diagnosis
* Inability to consent
Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.

A randomized, cross-over study design will be used to evaluate immune effects of consumption of 25 mg ergothioneine. On the first clinic day, participants will take a placebo with a one week wash out. Following the wash out week, participants will take 25 mg ergothioneine for 7 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements
* Willing to maintain a consistent diet and lifestyle routine throughout the study
* Willing to avoid consumption of meals where the predominant ingredients include mushrooms, seafood, and organ meat (liver, heart).\*
* Willing to abstaining from exercising on the morning of a study visit
* Willing to abstain from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit
* Willing to abstain from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

* Previous major gastrointestinal surgery
* Active chronic immunological disease
* Currently taking daily OTC medications, prescription pain medications, antipsychotic medications, anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects if the test product, nutritional supplements containing medicinal mushroom extracts
* Diagnose with Type I diabetes, autoimmune disorders
* Getting regular joint injections
* Active severe chronic disease (such as HIV, chronic hepatitis)
* Currently experiencing intense stressful events/ life changes
* Currently in intensive athletic training
* Experiencing an unusual sleep routine
* Unwilling to maintain a constant intake of supplements over the duration of the study
* Anxiety about having blood drawn
* Women who are pregnant, nursing, or trying to become pregnant
* Known food allergies to ingredients in test product
Theta-Burst-Stimulation in Recurrent Stroke Recovery

The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.

By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.

The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Eligibility Criteria:
Inclusion Criteria:

* written consent
* age: 40-90 years
* recurrent stroke
* hemiparesis with impaired hand motor function

Exclusion Criteria:

* Subjects who are legally detained in an official institute (§20 MPG)
* Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
* Medication pump (e.g. insulin pump)
* Metal splinters in eye or head
* Pregnancy / breastfeeding
* Severe Neurodegenerative disease
* Severe Neuroinflammatory disease
* History of seizures / epilepsy
* Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
* Insufficient compliance
* Present or past malignant tumor involving the central nervous system
* Severe Psychiatric disease
* Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

35 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG Schafer 1 to 4
* Medicated IOP ≥ 21
* naive of any prior glaucoma surgery

Exclusion Criteria:

* Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study

HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.

At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use in Control arm.

Primary endpoint is recanalization within 1 year after embolization, and secondary endpoint are:

1. aneurysmal rupture within 1 year after embolization
2. any event within 30 days after embolization
3. recanalization within 6 months after embolization
4. aneurysmal retreatment within 1 year after embolization
5. aneurysmal rupture and any death within 1 year after embolization
6. any stroke within 1 year after embolization
7. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
8. change in aneurysmal occlusion
9. any comlicaion within 1 year after embolization
10. %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.

Eligibility Criteria:
Inclusion Criteria:

* saccular intracranial aneurysm
* endovascular treatment scheduled within 60days after consent
* 20-79 years old
* unruptured, chronic SAH or acurte SAH Grade 1-III
* 7-20mm in size
* 1 year follow up possibel
* independent (mRS 0-2)
* document consent

Exclusion Criteria:

* previous endovascular treated
* additional aneurysm scheduled of endovascular treatment
* pregnant
* ineligible for study
A Cohort Study for Occupational Stress Induced Early Embryonic Death

Occupation stress can be the risk factors of early embryonic death


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women and their spouses in the gynecology clinic patients and wish to create the cards in the hospital;
2. the gestational age is less than 14 weeks;
3. pregnant women and their spouses have jobs before treatment.

Exclusion Criteria:

Do not sign the informed consent.
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer
* Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
* Life expectancy ≥ 3 months
* ECOG performance status ≤ 2

Exclusion Criteria:

* Symptomatic or untreated leptomeningeal disease
* Symptomatic brain metastasis
* Patients with clinically manifested diabetes
* Acute or chronic pancreatitis
* Clinically significant cardiac disease

Other protocol-defined inclusion/exclusion criteria may apply.
Levels of Circulating T Cells Expressing VLA-1 Collagen Receptors

The examination of the percentage of peripheral T cells carrying VLA-1 in ischemic heart disease patients. The hypothesis is that the percentage levels of cells carrying this integrin rise according to the severity of the ischemic heart disease.

Atherosclerosis is considered an inflammatory disease in which lymphocytes have an important role. The study was disigned to find out the changes in T cell levels carrying VLA-1 involvement in this process.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of acute MI for group 1
* clinical diagnosis of ACSl for group 2
* clinical diagnosis of Chronic Heart Disease for groups 3 and 4
* Chest pain but normal heart scan for group 5

Exclusion Criteria:

* none
Multifaceted Physioterapeutic Intervention at Workplace

BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases might need an additional rehabilitation program.

OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs.

METHODS: A Nordic musculoskeletal questionnaire was applied pre and post intervention to determine the efficacy of a multifaceted program, including ergonomics, exercise program and acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a hearing-aid industry. Additionally, a self-perception survey (Likert scale) concerning absenteeism, quality of life and work ability helped to evaluate the program that lasts one year and ten months.

The work-related musculoskeletal disorders (MSDs) have substantially increased worldwide from the 1980s In Brazil, MSDs are the leading cause of occupational diseases. The harm to society is enormous and justifies the study of methods to prevent them and / or reduce them. Many authors have evaluated isolated approaches to manage the problem, but as this is usually multifactorial, a set of interventions could bring better results. Physiotherapy is a specialty that works to improve working conditions through ergonomic interventions, physical therapy treatments and gymnastics and thus contributes to prevention and treatment of these disorders. The objective of this study is: to determine the effect of this set of interventions on the quality of life of workers and the productivity of a company that has been evaluated in a previous study to this. The study population will consist of 185 employees of a multinational company that manufactures and sells hearing aids in Brazil. Of those, 126 made up the experimental group (headquarter) and 59 control group (subsidiaries). Two questionnaires, one on musculoskeletal symptoms and another on risk factors at work are applied. An ergonomic evaluation of activities and tasks will be held, which will assist the diagnosis of situations which may be modified by ergonomic measures. Management of pre-existing complaints by acupuncture and orientation of specific exercises are used. The program's effectiveness analysis will be done by two methods: a questionnaire assessing the perception of workers about the their quality of life at work and the number of musculoskeletal complaints pre and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* must work in the industry for at least one year

Exclusion Criteria:

* workplace of the study is not the main one
Sleep Duration in Women With Previous Gestational Diabetes

Women with a history of gestational diabetes (GDM) are at high risk of developing diabetes in the future. Sleep disturbances are emerging as risk factors for incident diabetes. The purpose of this study is to test the effects of 6-week sleep extension in women with a history of GDM and short sleep on glucose metabolism by randomized controlled study.

The primary aim of this study is to evaluate the effects of a sleep extension intervention in non-diabetic women with a prior history of GDM and habitual short sleep duration on the outcomes of glucose metabolism. The participants will be randomized to a 6-week sleep extension intervention group, using technology-assisted sleep intervention, or a healthy living information control group. Glucose metabolism parameters will be assessed by an oral glucose tolerant test.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, age 18-45, with a history of GDM who currently do not have diabetes
* At least one year post-partum
* Reported habitual sleep duration \<7h/night during work- or weekdays with a desire to sleep longer
* Reported time spent in bed =\<8 hours
* Own a smartphone compatible with Fitbit.
* No need to provide care at night for her child(ren), defined as \>3 times a week and \>30 minutes at a time
* No history of obstructive sleep apnea, insomnia, or restless leg syndrome

Exclusion Criteria:

* A1C ≥6.5%
* Currently pregnant or planning pregnancy or breast feeding
* Insomnia symptoms defined as severe as assessed by the Insomnia Severity Index (score ≥15)
* Rotating shift or night shift work
* High risk for obstructive sleep apnea screened by STOP BANG questionnaire.
* Significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.
Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Adipose Tissue of Diabetic Patients

The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.

Glucose management in type 1 diabetic patients comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or continuous subcutaneous infusion.

The present study seeks to test an alternative treatment approach that combines glucose measurement and insulin delivery at a single subcutaneous tissue site, thereby circumventing the need for fingerstick blood glucose monitoring. Microperfusion and microdialysis probes are applied in type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site. The feasibility of estimating blood glucose concentrations from the glucose levels measured at the subcutaneous insulin delivery site is then assessed during an overnight fast and an oral glucose tolerance test.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus patients aged 18 - 65
* C-peptide negative (≤ 0.05 nmol/L)
* HbA1c (glycosylated haemoglobin A1c) \< 10%
* Body Mass Index: 21 - 30 kg/m2
* Informed consent obtained before any trial-related activities.

Exclusion Criteria:

* Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
* Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator
* Treatment with drugs that could interfere with glucose metabolism and subcutaneous insulin absorption
* Subject with mental incapacity or language barriers
Barrier Enhancement for Eczema Prevention

The primary objective is to determine whether advising parents to apply emollient (moisturiser) to their child's skin for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only.


Eligibility Criteria:
Inclusion Criteria:

* child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma
* child up to 21 days old
* consenting adult has the ability to understand English

Exclusion Criteria:

* preterm birth (defined as birth prior to 37 weeks gestation)
* sibling (including twin) previously randomized to this trial. If multiple births, the first child will be randomized into the trial.
* child has a severe widespread skin condition that would make the detection and/or assessment or eczema difficult
* child has a serious health issue, which, at parent or investigator discretion, would make it difficult for the family to take part in the trial
* any condition that would make the use of emollient inadvisable or not possible
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 16-19 years old
* Weight within ±30% of ideal body weight
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Preventing Falls and Participation Restrictions in Neurological Diseases

A randomized open clinical trial to assess the added value of a comprehensive rehabilitation program on fall prevention and improve participation and activities of daily living. Baseline assessment, 6-month experimental intervention (experimental group) vs. usual rehabilitation programs and assessment at end of treatment and six months after treatment will be performed.

90 patients will be randomly patients will be stratified by disease type and randomized separately.

The trial will be organized in Baseline assessment (clinical characteristics; fall predictors, chosen among the variables found to predict falls in the observational study), experimental intervention (experimental group) vs. usual rehabilitation programs (control group) and assessment at end of treatment and six months after treatment.

The aim of the treatment will be the prevention of falls.

Eligibility Criteria:
Inclusion Criteria:

Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.

Exclusion Criteria:

1. Cognitive impairment (Minimental State Examination score \<21); 2. Major depression; 3. Severe joint/bone disorder interfering with mobility, 4. Aphasia if interfering with understanding the aims of the study and self-administered tests; 5. relapses in the previous three months (MS); 6. Stroke occurred in least four weeks before study entry.
Use of Beta-agonists in Stable Severe Congestive Heart Failure

The purpose of this study is to determine whether Salbutamol is effective in the treatment of severe heart failure due to ischemic and non- ischemic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory Patients with a diagnosis of ischemic and non-ischemic cardiomyopathy with a measured EF \<35%, class III as defined by the NYHA with ICD and who receive optimal pharmacological therapy.

Exclusion Criteria:

* Heart Failure class I, II, IV
* atrial fibrillation
* any significant valvular disease
* chronic obstructive pulmonary disease who treated with inhaled β2 agonist
* significant kidney disease with eGFR \<30%
* severe uncontrolled electrolyte abnormalities
* prior allergic reaction to Salbutamol
* Pregnancy and nursing women
Primovist Post-marketing Surveillance in Japan

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Primovist for liver MRI

Exclusion Criteria:

* Patients who are contraindicated based on the product label