cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

The purpose of this study is to determine whether a small electrical current to the vestibular nerve (balance organ) will decrease the time it take for participants to fall asleep.

This 2 arm study will look at the proposed treatment (electrical stimulation of the vestibular nerve) versus a sham or placebo device. The effect of the device will be evaluated in a study that uses normal sleepers and advances them(puts them to bed 5-hours earlier than normal) to see if they fall asleep faster in one group or the other. Stimulation in the treated or sham group is only for the first hour after lights off.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 21- 50 attempts will be made to enroll equal distributions of males and females
* Able and willing to provide written informed consent
* Self reported habitual bedtime between 2100 and 0100 hours, which does not vary by more than 1 hour at least 5 nights per week
* Self reported 7.5-9 hrs. habitual sleep time
* Able to commit to 9 hrs of sleep opportunity throughout the study, but especially for the 3 nights prior to their PSG
* Pass Berlin questionnaire, i.e. low likelihood of sleep disordered breathing
* No history or evidence of RLS(restless leg syndrome) /PLMS (periodic limb movement syndrome) /Narcolepsy, no non-respiratory related sleep disorders.

Exclusion Criteria:

* Regular use of a pack or more per day of tobacco products
* Typically consumes more than 2 (12 oz) caffeinated beverages per day
* Self reported history of motion sickness
* Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
* Clinically significant medical or psychiatric condition as determined by the investigator
* Probable diagnosis of a current sleep disorder including but not limited to insomnia, sleep apnea, restless legs syndrome, or periodic limb movement disorder
* History of current or recent (e.g. within past 5 years) alcohol, narcotic or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV)
* Currently works night shift or rotating shift
* Travel or planned travel across more than 1 time zone within one week prior to randomization
* Use of any medication that, in the opinion of the investigator, may alter sleep or wakefulness. (See Appendix E: Guideline For Medications Commonly Associated With Alterations Of Sleep / Wake Functioning). Subjects will undergo urine drug testing.
* Consumption of more than 14 alcoholic drinks per week, or the recent consumption of more than 4 alcoholic drinks in one night. Subjects will be tested for alcohol, using a saliva test kit.
* Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women's of child bearing age).
* Presence of a pacemaker
* Presence of epilepsy or other uncontrolled medical conditions.
* Prior participation in a VirtuSom protocol
* History of vestibular disorders, (such as vertigo)
Feasibility and Validity of Remote Lung Function Assessment

Comparison of standard spirometry to non invasive remote lung function measures of chest wall movement using depth camera technology.

This study plans to test a new non invasive way of measuring lung function and compare it to the current method of blowing into a spirometer.

Spirometry is an essential investigation for diagnosis and assessment of severity in people with Chronic Obstructive Pulmonary Disease (COPD) and other respiratory conditions, it is used in every respiratory unit and across primary care. It requires subjects to blow into a tube which measures volume and flow of expired air. It involves specialist equipment and training to perform and interpret. Not all patients are capable of performing spirometry, in particular children, frail, cognitively impaired and those experiencing a flare or exacerbation of symptoms. Remote lung function assessment technology has the potential to enable assessment of lung function in these groups of patients. In the future it is also hoped that it could be used to improve respiratory disease monitoring outside the healthcare environment such as in the patients home.

This new method uses the latest infra-red depth detection cameras to measure chest wall movement. (N.B this does not capture identifiable images). We would like to record participants chest wall movements while blowing into the spirometer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients attending outpatient department in respiratory medicine.
2. Scheduled to undergo spirometry -

Exclusion Criteria:

1. Unable to give informed consent
2. Unable to perform spirometry -
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects

The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 2 and 10 years of age at the time of vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
* Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
* Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
* Previous vaccination with tetanus toxoid within the last month.
* History of meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
* History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Efficacy of EA on Depression Related Insomnia: Study Protocol for a Multicenter RCT

The investigators describe a protocol for a multicenter randomized controlled trial to find out the efficacy of electroacupuncture for depression related insomnia.

Sleep difficulties are among the main symptoms presented by depressed patients, and they can profoundly impact course of illness. Acupuncture is a widely recognized therapy to treat depressive disorders and sleep disturbances in clinical practice. This multicenter randomized placebo-controlled trial is aimed to investigate the efficacy and safety of electroacupuncture, sham acupuncture and standard medical care, administrated by professional acupuncturists and psychiatrists, in depression patients with insomnia.

The investigators describe a protocol for a multicenter randomized controlled trial. Two hundred seventy eligible patients in 3 different health-care centers in Shanghai will be randomly assigned to one of 3 treatment groups: EA group (electroacupuncture+standard medical care), Control A group (sham acupuncture+standard medical care) and Control B group (standard medical care). Treatment will be given 3 times per week for 8 weeks. The primary outcomes is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD) score and Self-rating Anxiety Scale (SAS) score. Daily dose of patients' antidepressant and sedative-hypnotic medication will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks post-treatment and 8 weeks post-treatment, as well as at 1 month, 3 months and 6 months follow-up.

The findings from this trial will help further about the efficacy and safety of acupuncture for depression related insomnia, as well as determine the differences between electroacupuncture, sham acupuncture and standard medical care for treating insomnia and depression.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants aged 18-70;
2. Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
3. Participants whose HAMD score is 20-35;
4. Participants who have complaint about insomnia at the first visit to the doctor;
5. Participants whose PSQI score is more than 7;
6. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

Exclusion Criteria:

1. Participants with secondary depressive disorders caused by organic diseases, medicine, or psychotic disorders including schizophrenia, etc;
2. Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases;
3. Participants with alcohol abuse or drug dependence;
4. Participants who refuse to wear the Actigraphy during the trial;
5. Pregnant or lactating women.
Study of RNS60 on Pain and Function After Hip Labral Repair

The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.


Eligibility Criteria:
Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation

Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.

A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital

Exclusion Criteria:

* All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
* Patients who did not consent to participate in the study
Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors

Beta-lactams are the most prescribed antibiotics in intensive care units. The lack of linearity between the dose administered and the exposition due to the very high variability of the pharmacokinetics in critically ill patients requires that the treatment be adapted on a case-by-case basis depending on the drug serum concentration. However, maximum concentrations not to be exceeded in order to limit beta-lactams toxicity are generally unknown. The main toxic risk of beta-lactams in intensive care is indeed neurological, but the neurotoxicity is probably underdiagnosed due to the variability of the signs observed, their time to onset, and confounding factors. Apart from recommendations for dose adjustment in the event of renal insufficiency, the procedures for the proper use of beta-lactams in intensive care are poorly established. The study presented here aims to assess the impact of the neurotoxic risk of beta-lactams in intensive care based on therapeutic drug monitoring, and thus to improve beta-lactam safety in critically ill patients.

This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU
* Treatment initiation by an antibiotic of the beta-lactam class
* Beta-lactam therapeutic drug monitoring

Exclusion criteria:

* Any neurological disorder already present at admission
* Patients on mechanical ventilation who presented a neurological disorder before being intubated and sedated
Injectable Diclofenac for the Prevention of Post-operative Dental Pain

This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.


Eligibility Criteria:
Inclusion Criteria:

1. Out-patients of either gender.
2. Patients aged ≥ 18 to ≤ 65 years old.
3. Subjects able and willing to give their written consent prior to inclusion in the study.
4. Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
5. Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
6. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.

Exclusion Criteria:

General

1. Patients refusing to give written informed consent.
2. Patients not able to understand the purposes of the study or not willing to return for the control visits.
3. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
4. Patients enrolled in any clinical trial in the previous 3 months.
5. Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
6. Pregnant or breast-feeding women.
7. Alcohol or drug abuse in the previous 12 months.
8. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
Early Screen and Treatment for Gestational Diabetes

In the current study we aim to determine if early glucose screening and treatment among women at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half of the participant will be assigned to an early glucose screen group (12-18 weeks) and treatment if necessary and the other half to a standard 24-28 weeks glucose screen.


Eligibility Criteria:
Inclusion Criteria:

Pregnant subjects 18-45 y/o and Any of the following:

Obesity defined as having a BMI\>30 kg/m2 History of pregnancy complicated with GDM History of pregnancy complicated with macrosomia First degree relative with diabetes Multiple gestation

Exclusion Criteria:

* Incomplete Data: if any data is missing (i.e Delivery data) , analysis cannot be completed.

Pregnancy complicated with fetal malformations or aneuploidy: It affects prenatal care, mode of delivery as well as perinatal outcome.

Pregestational or Overt Diabetes: Patients with Diabetes cannot be diagnosed with GDM.

Chronic medical conditions such as hypertension, renal disease, autoimmune conditions: Those conditions may affect prenatal care, perinatal morbidity.

Early diabetes screen performed prior to enrollment in study: Participant cannot be randomized, and probably have been treated.

Medical contraindication to glucose tolerance test (bariatric surgery): patients with h/o gastric bypass frequently cannot tolerate oral glucose load, therefore cannot be screened for GDM in the traditional way.
Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors

The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ST+ACT) to help people resume social participation after stroke and live in the community.

Investigators will also compare the changes in social participation and psychological flexibility from baseline to follow-up at one-month after rehabilitation to see if participants who receive ST+ACT report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to ST alone.

Participants will:

* complete testing to see if they are eligible for the study. If qualified, complete testing to understand how the stroke has affected their daily life
* be randomized to receive either ST+ACT or ST alone rehabilitation program for 10 sessions at their home
* repeat part of the tests at the end of the intervention and one month after


Eligibility Criteria:
Inclusion Criteria:

1. primary diagnosis of chronic stroke, ≥6 months post onset,
2. ≥18 years old,
3. community-dwelling (i.e., living in a residential setting in the community),
4. restrictions in social participation, indicated by Activity Card Sort (\<80% of pre-stroke activities)
5. experiential avoidance, indicated by Acceptance and Action Questionnaire-II (score ≥24)

Exclusion Criteria:

1. progressive neurological diagnosis (e.g., dementia, Parkinson's disease, multiple sclerosis, or brain tumor) reported by participants or proxy,
2. inability to provide written informed consent,
3. severe aphasia (score 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale),
4. currently undergoing stroke rehabilitation or psychological intervention,
5. major depressive disorder, indicated by PRIME-MD, unless undergoing treatment for at least 4 weeks and are released to participate by their physician or counselor
6. bipolar or psychotic disorder, indicated by PRIME-MD, or
7. substance abuse within 3 months, indicated by Mini-International Neuropsychiatric Interview
Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study

Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomized controlled comparative prospective clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* both sex.
* age from 18 to 60.

Exclusion Criteria:

* patient refusal.
* patients with associated ano-rectal diseases such as fissures, fistulas, ano-proctitis, recurrent or thrombosed hemorrhoids and ano-rectal malignancy.
* patients with liver cell failure. patients unfit for surgery according to American Society of Anesthesiologists.
The Reversal Intervention for Metabolic Syndrome Study

The aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future.

People who have a combination of risk factors termed metabolic syndrome are at increased risk of developing diabetes, heart disease and strokes. Metabolic syndrome is a major public health concern requiring urgent action because 25% of the adult UK population fulfil the criteria, and this will increase as people continue to be less active and levels of overweight and obesity rise.

The aim of our study is to see if people with metabolic syndrome who attend a structured group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes and cardiovascular disease in the future. Overall, we hope to show that this type of education reduces the number of people who have metabolic syndrome.

Subjects recruited with metabolic syndrome will be randomised to intervention or control arms. The intervention arm will receive group education and the control group will receive routine care.

The results will inform primary prevention strategies in people from varied ethnic backgrounds who are at high risk of developing type-2 diabetes and cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40 - 74 years inclusive
* Registered with a general practice in Leicester City or Leicester County Primary Care Trust
* Availability of data to allow diagnosis of MetS (IDF criteria) collected at a screening visit

Exclusion Criteria:

* Previous diagnosis of T2DM, CVD (stroke/cerebrovascular accident, transient ischaemic attack), peripheral arterial disease, or coronary heart disease (angina, myocardial infarction, coronary artery bypass surgery, angioplasty)
* Life-limiting terminal illness
* Pregnancy and/or breast feeding
* Lack of capacity to give informed consent because of serious mental health problems or learning disability.
* People who are housebound
* Patients residing in nursing/care homes
* Individuals who are unable to speak and understand English. (The intervention will be made appropriate for ethnically diverse populations, but individuals who are unable to understand, speak and read English will be excluded at this stage. However, if the self-management programme is found to be successful we would adapt it for non-English speakers.)