cyrilzakka/clinical-trials huggingface dataset:
Influenza Burden Assessment in the United Kingdom, 1996-2008

The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.

This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. The data collection will be a query of existing electronic healthcare databases.

Eligibility Criteria:
Inclusion Criteria:

• Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.

Exclusion Criteria:

-
Angiotensin-Converting Enzyme Gene Polymorphism and the Risk of Chronic Allograft Nephropathy

This study is intended to help doctors learn about the relationships between specific genetic makeup (gene markers) and the development of chronic rejection. This study is being done to see if there is a relationship between genetic patterns and the development of Chronic Allograft Nephropathy (CAN). Medical scientists also hope to learn more about how genetic differences between people determine their response to a drug or a disease by storing a small blood sample in a special "bank". This sample may be tested at some point in the future in an attempt to better understand the factors that may influence rejection, transplantation outcomes and transplant success rates.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be recipients of a renal allograft.
* Study subjects must have evidence of biopsy-proven Chronic Allograft Nephropathy (CAN).
* Control subjects must not have evidence of CAN.
3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst

Lack of depth perception and spatial orientation are drawbacks of laparoscopic surgery. The advent of the three-dimensional (3D) camera system enables surgeons to regain binocular vision. The aim of this study was to gain subjective and objective data to determine whether 3D systems are superior to two-dimensional (2D) systems in terms of surgical outcomes.

Elective laparoscopic ovarian cystectomy is established as the treatment of choice for benign ovarian cysts. The advantages of laparoscopic surgery over conventional open surgery are less pain, shorter recovery time, shorter hospital stay, and consequently faster return to normal activity as well as better cosmetic effects. However, laparoscopic surgery is more challenging compared with open surgery, partly because surgeons must operate in a three-dimensional (3D) space through a two-dimensional (2D) projection on a monitor, which results in loss of depth perception and consequently more cognitive workload on the surgeon. In traditional 2D laparoscopic procedures, the surgeon has to mentally transform and process the 2D image into a 3D image using motion parallax through movement of the laparoscope, relative position of instruments, and shading of light and dark. During the past 3 decades, 3D imaging systems have been introduced in and attempt to improve in-depth perception and spatial orientation during minimally invasive surgery. The anticipated advantages for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, a reduced learning curve, and enhanced safety.

Nevertheless, studies, to date, examining the potential advantages and disadvantages of 3D versus 2D imaging systems have produced contradictory results. Moreover, there have been no studies exploring the advantage of 3D imaging system in patients undergoing laparoscopic ovarian cystectomy. The aim of this study was to gain subjective and objective data to determine whether 3D imaging systems in the treatment of ovarian cyst are superior to 2D systems in terms of surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* age between 19 and 48 years
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* absence of pregnancy at the time of surgery.

Exclusion Criteria:

* any suspicious finding of malignant ovarian diseases
* any concomitant diseases requiring uterine or upper abdominal surgery
* unavailability of the surgical recording equipment for laparoscopic procedure
* post-menopausal status
The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial

Delirium is highly associated with adverse clinical outcomes of intensive care unit (ICU) patients, including increased cognitive impairment, duration of intubation, ICU length of stay, mortality, physical dependence, and health care costs. This randomised controlled study will firstly develop a family-supported sensory stimulation package based on the literature review as well as the findings of the cross-sectional survey and the in-depth interview. The intervention effects than will be evaluated using outcomes including delirium incidence, delirium duration, delirium severity, ICU patients' consciousness and cognitive function as well as family members' satisfaction and anxiety. This study is expected to provide evidence of the effectiveness of family-supported sensory stimulation on preventing delirium among ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* the first time admitted to ICU
* a Richmond Agitation-Sedation Scale (RASS) score ≥-3

Exclusion Criteria:

* diagnosed with stroke, dementia, delirium or acute psychiatric illness at admission
* diagnosed with end-stage of cancer
* severe hearing impairment and cannot be corrected by hearing aids
* admitted to ICU with radiative material.
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit

The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention - to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP).

The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention - to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP). The intervention arm receiving health services in the mobile unit will be supported by peer navigation. An active control arm will receive peer navigation to health services available at community-based agencies. Impact (cost-effectiveness, mathematical modeling) and implementation factors (mixed methods to identify barriers and facilitators of the interventions) will contextualize findings from the efficacy analysis. The impact of the COVID-19 epidemic in the study population will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Urine test positive for recent opioid use and with evidence of recent injection drug use ("track marks")
* Diagnosed with OUD per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
* Able and willing to give informed consent
* Willing to start MOUD treatment
* Able to successfully complete an Assessment of Understanding
* Self-reported sharing injection equipment and/or condomless sex in the last three months with partners of HIV-positive or unknown status
* Able to provide adequate locator information
* Confirmed HIV status, as defined in the HPTN 094 Study Specific Procedures Manual

Exclusion Criteria:

* Urine testing that is not negative for methadone within 30 days prior to Enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.
* Received MOUD in the 30 days prior to enrollment by self-report
* Co-enrollment in any other interventional study unless approved by the Clinical Management Committee (CMC)
Drug Interaction Study of Clopidogrel and Rosuvastatin

The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals, male or female, age 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam and laboratory evaluations
* Subjects that take no other medications 2 weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications (except acetaminophen), dietary supplements, or drugs of abuse
* Subjects with a SLCO1B1\*1A genotype
* Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
* Subjects able to abstain from grapefruit, grapefruit juice, orange juice, caffeinated beverages and/or alcoholic beverages from 3 pm the day before the study to completion of that study day.
* Participants determined to have normal liver and kidney function as measured at baseline
* BMI between 18.5 - 30 kg/m2
* Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing
* Be able to read, speak, and understand English

Exclusion Criteria:

* Subjects with active medical problems
* Subjects on chronic prescription or OTC medications that cannot be stopped 2 weeks prior to and during the study.
* Subjects incapable of multiple blood draws (HCT \<30 mg/dL)
* Subjects with a history of rhabdomyolysis
* Subjects with a history of drug-related myalgias
* Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias
* Subjects with a history of GI bleed or peptic ulcer disease
* Subjects with a recent history of trauma
* Subjects with a recent history of or upcoming plan of surgery
* Subjects that smoke tobacco or have ongoing alcohol or illegal drug use
* Subjects who are pregnant, lactating, or trying to conceive during the study period
* Subjects allergic to rosuvastatin or clopidogrel or any known component of the medications
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell response, due to continuous pressure of high viral load. Treatment of chronic HCV patients with ASV and DCV will result in a significant drop in HCV viral load. At present, no information is available on the immunological effects of treatment with ASV and DCV, nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects. This information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound or relapses during, at the end of treatment or during the follow up period.

Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.

Study design: This is an investigator-initiated single center open label study with one arm of 12 patients.

Study population: Adult chronic HCV patients with genotype 1b, who are previous non-responders to the treatment.

Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks.

Main study parameters/endpoints:

1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T cells, NK cells and monocytes
2. Gene expression levels of leukocyte populations before, during and after treatment
3. Gene expression levels of the type I IFN signaling pathway on whole blood samples
4. Serum cytokines levels using multiplex platforms


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1b infection
* Patients are non-responders to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy
* High viral load (\>400,000 IU/ml)
* Indication for antiviral therapy of hepatitis C according to current clinical guidelines
* Written informed consent

Exclusion Criteria:

* Decompensated cirrhosis (Child-Pugh Grade B or C)
* Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma within the last 3 months.
* Females who are pregnant or breast-feeding
* History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
* Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV)
* Presence of contra-indications for antiviral therapy with ASV and DCV:
* Interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week)
* Any exposure to NS3 protease inhibitors or NS5A polymerase inhibitors
* Treatment with peginterferon/ ribavirin within 6 months before start of therapy
* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study
Remifentanil for Preventing Propofol Injection Pain in Elderly Patients

Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II undergoing general anesthesia

Exclusion Criteria:

* neurologic disorder
* psychologic disorder
* vascular disorder
* patients with chronic pain
* difficulty in vascular access
Neuroplastic Alterations of the Motor Cortex by Caffeine

Caffeine is a psychostimulant drug. It acts as a competitive antagonist at adenosine receptors, which modulate cortical excitability as well. In deep brain stimulation (DBS), the production of adenosine following the release of adenosine triphosphate (ATP) explains the reduction of tremor. Binding of adenosine to adenosine A1 receptors suppresses excitatory transmission in the thalamus and hereby reduces both tremor-and DBS-induced side effects. Also, the effect of adenosine was attenuated following the administration of the 8-Cyclopentyl-1,3-dipropylxanthine (DPCPX) adenosine A1 receptor antagonist. Therefore, the presence of a receptor antagonist such as caffeine was suggested to reduce the effectiveness of deep brain stimulation (DBS) in treating tremor and other movement disorders.

Based on this finding, the investigators hypothesize that the antagonistic effect of caffeine can tentatively block the excitatory effects of transcranial alternating current stimulation (tACS). The plasticity effects might differ among caffeine users and non- caffeine users depending on the availability of receptor binding sites.

Apart from that, a major issue in NIBS studies including those studying motor-evoked potentials is the response variability both within and between individuals. The trial to trial variability of motor evoked potentials (MEPs) may be affected by many factors. Inherent to caffeine is its effect on vigilance. In this study, the investigator shall monitor the participant's vigilance by pupillometry to (1) better understand the factors, which might cause variability in transcranial excitability induction studies and (2) to separate the direct pharmacological effect from the indirect attentional effect of caffeine.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female healthy participants between the ages of 18-45.
2. Right-handed (Oldfield 1971).
3. Free willing participation and written, informed consent of all subjects obtained prior to the start of the study.
4. Participant's weight is above 60 kg

Exclusion Criteria:

1. Age \< 18 or \> 45 years old;
2. Left hand dominant;
3. Evidence of a chronic disease or history with a disorder of the nervous system
4. History of epileptic seizures;
5. Pacemaker or deep brain stimulation;
6. Metal implants in the head region (metal used in the head region, for example, clips after the operation of an intracerebral aneurysm (vessel sacking in the region of the brain vessels), implantation of an artificial auditory canal);
7. Cerebral trauma with loss of consciousness in prehistory;
8. Existence of a serious internal (internal organs) or psychiatric (mental illness)
9. Alcohol, medication or drug addiction;
10. Receptive or global aphasia (disturbance of speech comprehension or additionally of speech);
11. Participation in another scientific or clinical study within the last 4 weeks;
12. Pregnancy
13. Breastfeeding
14. Intolerance to caffeine or coffee products
15. Participant who has abnormal heart activity from an electrocardiography (ECG) finding
16. Weight is less than 60 kg
Study of Osteopathic Manipulation in the Management of Angina

The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Canadian Cardiovascular Society Class II, III for a minimum of 6 months
* documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel.

Exclusion Criteria:

* severe left ventricular dysfunction
* symptomatic heart failure
* symptomatic aortic stenosis or any valvular disease
* significant pulmonary disease
* unstable angina
* major surgery or angioplasty in the past three months
* acute myocardial infarction within past three months
* insulin dependent diabetes mellitus
* uncontrolled hypertension
* acute renal or hepatic failure
* currently being treated with osteopathic manipulation
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia

The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with receiving multiple drugs schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients who receive 1 or more antipsychotic drugs
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
* Age 12 months up to 6 years
* Written informed consent

Exclusion Criteria:

* Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.
* Therapy with prednisolone for prior episodes of nephrotic syndrome
* Persistent estimated glomerular filtration rate (GFR) \<75 ml/min/1.73 m2
* Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
* Patients with initial steroid resistance
* Patients who are allergic to glucocorticoids
* The compliance of patients or their guardians is poor
MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.

In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to validate former results from CSF studies through microRNA profiling investigate the pathophysiological mechanisms that lead to systemic complications such as cardiac dysfunction, acute lung injury (ALI) and systemic inflammatory response syndrome(SIRS).

We will accomplish this through analyzing the profile of microRNA expression in blood and cerebrospinal fluid from SAH patients.

Validation:

As in our earlier study we wish to compare the expression of 20 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus. In addition, some of the patients will have established invasive neuromonitoring including microdialysis in which we will study changes of certain microRNAs.

DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:

"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components \[eye, motor on either side, verbal\]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."

Systemic complications:

Furthermore, we wish to compare the expression of 754 specific microRNA in blood drawn on day 3 after ictus between patients with ALI (as described Kahn et al, Crit Care Med. 2006; 34: 196-202) and patients without ALI. Of at least 36 patients expected to be included 12 should statistically develop ALI according to the referred definition.

Additionally, we wish to compare the expression of 754 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in blood drawn on day 3 after ictus.

Moreover, we wish to compare the expression of 754 specific microRNA in blood between 36 patients (group 1-3) to that of healthy controls. The specific microRNAs of interest in which the expression in blood between patients with systemic complication are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.

Eligibility Criteria:
Inclusion Criteria Group 1-3:

* Uncertainty \< 24 times on time of ictus

Inclusion Criteria Group 1-2:

* Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain.

Inclusion Criteria Group 3:

* Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain.

Exclusion Criteria Group 1-3:

* Transfer to other hospital within 5 days of admission