cyrilzakka/clinical-trials huggingface dataset:
Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Anxiety and depression are common in patients with severe chronic obstructive pulmonary disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear and indeed this may be the main cause for the for hospital admission. Patients prone to a tendency to experience and communicate somatic distress in response to psychosocial stress and to seek medical help for it are top of the "frequent flyer" league, costing the health care economy dearly. This is a particular problem in Hull with the high levels of smoking and urban deprivation combining to place the city at the bottom of the Department of Health COPD league tables.

Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus allowing the patient time to access the existing community based support services.


Eligibility Criteria:
Inclusion Criteria:

* Male/females aged between 40-80 years.
* Previous diagnosis of COPD confirmed by the GOLD criteria.
* At least two previous admissions to hospital for acute exacerbation of COPD.
* Physician diagnosed anxiety
* At least Mild anxiety score on HADS and GAD-7
* On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
* Known history of cigarette smoking at least 10 pack yrs
* Willing and able to comply with study procedures
* Able to provide written informed consent to participate

Exclusion Criteria:

* Current or past diagnosis of asthma
* Long-term oxygen therapy
* Currently on treatment with anti-depressives
* Serious inter-current illness (eg lung cancer)
* One year survival considered unlikely
* Patients who have evidence of alcohol or drug abuse
* Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit
* Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
* Known or suspected hypersensitivity to escitalopram
Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilitiesdisability

The object of this study is the theory and practice of adaptive physical activity for people with intellectual disability. It focuses on the concepts, paths, and applications of adaptive physical activities for young people with intellectual disability, and systematically studies and discusses the concepts, paths, and application strategies of adaptive physical activities for young people with intellectual disability, so as to provide solutions and support for the scientific exercise of this special population group. The study will focus on the following four aspects: (1) theoretical research on the interventions of young people with intellectual disability (2) analysis of the sports and health needs of young people with intellectual disability (3) empirical research on adaptive physical activities for young people with intellectual disability (4) exploration of strategies for the use of adaptive physical activities.

Based on theoretical and practical research, to understand the current situation of sports participation and influencing factors of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability , to provide a reliable basis for the formulation of adaptive sports activity programmes suitable for the rehabilitation concepts of the Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability; to increase the interest of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability in sports activities, so as to enable them to master the basic sports skills, have the physical abilities required for completing the basic social activities, and be able to participate in sports activities on a regular basis in their future lives; and to promote their physical health and happy lives, with a view to facilitating their integration into regular education and, ultimately, social integration.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Intellectual disability
* Agree and promise to participate in the exercise intervention throughout the study programme
* No other physical activity other than participation in school sports

Exclusion Criteria:

* Have other medical conditions that limit physical activity (e.g. asthma, heart disease, etc.)
* Suffers from complex neurological disorders
* unable to play sports due to abnormal physical development
Reliability of the Smartphone Inclinometer App and Flexicurve

The presedent study evaluates intra-rater and inter-rater reliability of the Smartphone inclinometer app and the flexicurve, on the thoracic kyphosis

Sixty subjects ranging from 17to 24 years of age were evaluated by two independent evaluators using the Flexicurve and the Smartphone inclinometer app to measure thoracic kyphosis

Eligibility Criteria:
Inclusion Criteria:

* over 30 degree toracic kyphosis,
* 18-30 age year old,
* individuals to willing participate in the study

Exclusion Criteria:

* Skolyoz (Cobb angle 10\< ),
* rigid thoracic kyphosis,
* congenital spine disease,
* training with professional sports
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.


Eligibility Criteria:
Inclusion Criteria:

* FEV1 30% to 60%
* FEV1/FVC \<70%
* Prior smoker (at least 10 pack years)
* Quit smoking for at least 6 months

Exclusion Criteria:

* Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
* Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
* Pulmonary nodule requiring surgery
* Presence of implantable electronic devices
* Active respiratory infection within recent weeks
* COPD exacerbation within recent weeks
* Recent Myocardial infarction (MI)
* Recent and unstable or life threatening arrhythmia
* Malignancy treated with radiation or chemotherapy within the last 2 years
* Presence or clinical diagnosis of other respiratory diseases other than COPD
The Correlation Between Genetic Polymorphism, Platelet Activity, Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients

In this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum adipokines level, and Clopidogrel responsiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 y/o
2. Acute coronary syndrome patients
3. Chronic coronary artery disease patients
4. Healthy volunteers

Exclusion Criteria:

1. Patient refusal
2. Allergy to Clopidogrel
3. Receive Gp IIb/IIIa inhibitor simultaneously
4. Cancer history
5. Severe renal and liver function impairment
6. Coagulopathy
Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.

Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patients who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.
The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.

This study will investigating the effects of glucagon on renal blood flow in humans using MRI technology. Glucagon, a hormone produced by the pancreas, plays a key role in regulating blood sugar levels. It has been shown to affect renal function, including electrolyte balance and blood flow, especially in conditions like type 2 diabetes where abnormal glucagon levels are common. The study aims to understand how glucagon affects regional blood flow in the kidneys, specifically the cortex and medulla, and whether these effects are mediated by glucagon receptors.

The study will be conducted on 10 healthy male participants aged 20-60 years. It involves three test days where participants will receive either glucagon, glucagon with a GLP-1 receptor antagonist, or placebo. Blood flow, glomerular filtration rate, and other renal functions will be measured using MRI. The study seeks to clarify whether glucagon's effects on the kidneys are linked to changes in regional blood flow and to determine if these effects are mediated solely by glucagon receptors.


Eligibility Criteria:
Inclusion Criteria:

* Normal health confirmed through; Interview and Medical examination
* Normal values with respect to blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function tests, and electrolytes
* Informed consent

Exclusion Criteria:

* Immunosuppressive treatment in the previous 12 months
* Alcohol abuse
* Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists, which, in the opinion of the principal investigator, may interfere with glucose metabolism
* Use of lithium
* Medical treatment that affects insulin secretion or the renin-angiotensin-aldosterone system
* Liver disease (ALT \> 2x normal value)
* Renal impairment (serum creatinine \> 130 µM and/or albuminuria)
* Individuals with severe claustrophobia
* Individuals with MR-incompatible foreign bodies
* Individuals with hypertension
Metabolism of Patients With Genetically Caused Cardiac Arrhythmia

Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS) due to a prolonged cardiac repolarisation phase. Hypoteses: patients with loss-of-function mutations also exhibit altered hormone release upon glucose ingestion.

Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS) due to a prolonged cardiac repolarisation phase.

Voltage-gated potassium (Kv-) channels are known for their relation to malignant cardiac arrhythmias, but also play a role in pancreatic alpha- and beta cell hormone secretion, and possibly in incretin hormone secretion. We hypothesised that patients with loss-of-function mutations also exhibit altered hormone release upon glucose ingestion.

Eligibility Criteria:
Inclusion Criteria:

LQTS Gain of function Matched healthy controls

Exclusion criteria:

none
Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients

This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped

Study design:This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped.

Study population:Patients with FIGO stage III - IV epithelial ovarian cancer Drug exposure:Not applicable Planned study sites and sample size:The objective number of patients will be 200 from approximately 20 hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
* Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer \[or a combination of these cancers\] after January 1, 2019
* Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019
* Patients who have undergone or are scheduled to undergo BRACAnalysis
* Patients who give their written informed consent to participate in this study (However, the cases of death should be handled in accordance with the instructions of the Ethical Review Board of each site.)

Exclusion Criteria:

* Patients who are not recommended enrolling this study decided by physician
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients

This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

This is a feasibility trial to determine the feasibility of using home monitoring devices (e.g. blood pressure cuffs) to improve outcomes for cirrhosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7

Exclusion Criteria:

* None
APA and PAS Training for Gait Initiation in Parkinson's Disease

Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability.

Research on Brain Excitability and Balance Function Performance in Patients with Parkinson's Disease and Related Physical Therapy Methods

Research indicates that non-motor disorders and cognitive impairments are prevalent in most patients with Parkinson's disease. These include balance issues, postural instability, impaired cognitive functions like working memory and executive functions, and gait instability. Additionally, electrophysiological phenomena in Parkinson's disease patients reveal abnormal central excitatory and inhibitory responses compared to healthy individuals.

This experiment seeks to investigate the link between motor performance and brain excitability in patients with Parkinson's disease. Previous studies suggest that associative electrical stimulation, used to regulate sensorimotor information integration, can enhance brain excitability in both healthy individuals and those with Parkinson's disease. However, the optimal parameters for this stimulation remain uncertain.

Furthermore, balance exercise training can improve motor performance in Parkinson's disease patients. This study aims to determine if various designs of associative electrical stimulation parameters can help these patients achieve optimal brain excitability regulation. The combined approach of this stimulation and balance exercise training aims to maintain and improve the patients' functional performance, thereby enhancing the safety of their daily activities.

Eligibility Criteria:
Health subjects:

Exclusion Criteria:

* Musculoskeletal injuries on legs.
* Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

* Musculoskeletal injuries on legs
* Osteoporosis.
* Any peripheral or central nervous system injury or disease patients.
Seroprevalence of MERS-CoV IgG in Healthcare Workers

The investigators aim to do serosurvey of healthcare-personnel who had participated in treatment of confirmed patients of Middle-East respiratory syndrome. The investigators collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and will collect the post-exposure serum from about 25-30 centers in which confirmed MERS patients had been treated.

The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators will subdivided the seroprevalence according to the degree of exposure and preparedness of personal protective equipment.

We aim to deduct the seroprevalence of healthcare-personnel (HCP) who had participated in treatment of confirmed patients of Middle-East respiratory syndrome.

In first step, we collected the base-line (pre-exposure) serum from the HCP who worked in the hospitals in which confirmed MERS patients were treated. Pre-exposure serum was collected in a few centers. If the serum was drawn within 3 weeks from initial exposure, then the serum was considered adequate as pre-exposure. (Because, antibody against the MERS-CoV would be produced after more the 17-21 days of exposure). The serum was frozen.

In second step, we will collect the post-exposure serum from the HCP who worked in the hospitals in which confirmed MERS patients were treated or detected. We plan to include 25-30 centers. The timing of sample collection is 6-8 weeks after last contact with confirmed MERS patients. The serum will also freeze.

In third step, we will assay the presence of antibody in collected sample. We will use MERS-CoV ELISA kit (EUROIMMUNE co.) as screening test and MERS-CoV IFA kit (EUROIMMUNE co.) as confirm test.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare-personnel who are working for hospitals in which confirmed MERS patients were treated or detected
* Close contact with confirmed patient(s).
* Agree to informed consent

Exclusion Criteria:

* disagree to consent
* confirmed MERS patient
Effects of Acute Prucalopride Administration in Healthy Volunteers

This study will investigate whether administration of a single dose of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and non-emotional cognition in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive a single dose of either prucalopride (1mg) or placebo. All participants will come for a Screening Visit to ensure their suitability for the study. If they meet study criteria, they will be invited to a Research Visit, where they will receive the study medication and wait for two hours while the drug reaches peak levels. After two hours they will be asked to complete a series of computer-based tasks measuring emotional, non-emotional cognitive processing, and reward processing. The primary study hypothesis is that acute prucalopride administration will have positive effects on processing facial expressions of emotion. Secondary hypotheses are that acute prucalopride administration will affect other measures of emotional processing, and non-emotional cognition.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-40 years
* Willing and able to give informed consent for participation in the study
* Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

* Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
* Any past or current Axis 1 DSM-IV psychiatric disorder
* Significant medical condition
* Current or past gastro-intestinal disorder or irritable bowel syndrome
* Current pregnancy or breastfeeding
* Known lactate deficiency or any other problem absorbing lactose, galactose or glucose
* Current or past history of drug or alcohol dependency
* Participation in a psychological or medical study involving the use of medication within the last 3 months
* Previous participation in a study using the same, or similar, emotional processing tasks
* Smoker \> 5 cigarettes per day
* Typically drinks \> 6 caffeinated drinks per day
Diamel in the Treatment of Polycystic Ovary Syndrome

The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Two of the following criteria:

  * Oligo or Anovulation
  * Polycystic Ovary diagnosed by ultrasound technique
  * Clinical signs of Hyperandrogenism
* Signed informed consent

Exclusion Criteria:

* Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
* Patients under other experimental treatment
* Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
* Treatment with vitamins within 7 days before treatment
* Treatment with dietary supplements within 60 days before treatment
* Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension
Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

This is a prospective study consisting in testing whether systematic use of aspirin is beneficial for primary prevention of vascular access for hemodialysis attested by doppler ultrasound exam. The investigators will study aspirin resistance in the population of patients undergoing hemodialysis. The investigators will test sensibility of resistant patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to define aspirin resistance.

Three groups of dialysed patients will be included in this study. The first is the placebo group, the second is the aspirin group fixed dose and the last group includes patients receiving a dose of aspirin titrated by the result of PFA-100.

At the end of this study the investigators will be able to identify whether systematic antiaggregation is suitable for a vascular access for hemodialysis. The investigators will also conclude which is better for patients fixed dose or aspirin dose escalation determined by the result of PFA-100. The study will analyse the prevalence of aspirin resistant patients in this particular population of dialysed patients.

Eligibility Criteria:
Inclusion Criteria:

* dialysed patients
* vascular access aged less than one year
* no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis

Exclusion Criteria:

* pregnant and breastfeeding women
* patients receiving at baseline other antiaggregant or anticoagulant
* patient not allowed to be treated by aspirin
* systolic blood pressure\> 200 mmhg
* diastolic blood pressure\>115 mmhg
* liver failure