cyrilzakka/clinical-trials huggingface dataset:
A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine

The investigators hypothesize that people working in an acute care hospital setting will be able to successfully self-administer the intradermal vaccine (Intanza) in less time than nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The investigators also hypothesize that people administering the intradermal vaccine for the second time will take less time to successfully administer than people administering it for the first time.

Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the patients they care for, as well as reducing illness and absenteeism in the healthcare workers themselves, and healthcare worker vaccination programs have been shown to be cost-effective for hospitals because of the reduced absenteeism. Although influenza vaccination programs based on nurse-administered intramuscular vaccination are effective, easy access to vaccination for hospital staff remains a challenge, in part because of large numbers of staff working evening, night and weekend shifts. In addition, in the Canadian setting, increasing the efficiency of all hospital programs is a priority. If regular recipients of seasonal vaccine became accustomed to the practice, self-administration may significantly improve the efficiency of pandemic mass vaccination campaigns.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable men or women 18 to 69 years of age (inclusive)
* Work in any capacity (including physicians and midwives with admitting privileges), volunteer, or student at participating hospital
* Able to read, understand, and respond to questionnaires
* Able to read, understand, and sign an informed consent form
* Available for follow-up for 8 days post-vaccination
* Participants in Part B (repeat administration) of the study must also have participated in the previous randomized control trial of self- versus nurse-administered intradermal influenza vaccine and must have attempted to self-administer the vaccine

Exclusion Criteria:

* Already received 2012-13 influenza vaccine
* History of a severe reaction following influenza vaccination
* Known allergy to components of study vaccines (Intanza® or Vaxigrip®)
* History of Guillain-Barré Syndrome (GBS) within 8 weeks following influenza vaccination
* Acute febrile illness (\>37.9ºC orally) within the past 48 hours (participation may be deferred until recovery for these subjects)
n-Acetylcysteine and Cocaine

This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and n-acetylcysteine.


Eligibility Criteria:
Inclusion Criteria:

* Current cocaine use
* Current cigarette smoker

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine or n-acetylcysteine
* History of schizophrenia in first degree relative
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to 70.
2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
3. Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\].
4. ECOG performance score: 0 to 1.
5. Primary lesions can measurable.
6. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
7. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
8. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Exclusion Criteria:

1. Primary lesions or lymph node have been operated (except of operation for biopsy).
2. Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy.
3. Other malignant tumor.
4. Participation in other interventional clinical trials within 1 month.
5. History of Serious lung or heart disease.
6. Pregnant or breast-feeding women and women who refused to take contraceptive method.
7. Drug abuse or alcohol addiction.
8. History of serious allergic or allergy.
9. Refused or can't signed informed consent form.
10. Other patients who are considered ineligible for the study by the investigator.
Dronabinol for Post-operative Pain After Lumbar Fusion

Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion

This is a randomized double-blind clinical trial comparing 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. The outcome of interest is post-operative opioid consumption defined as cumulative Morphine Milligram Equivalents at 72 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old
* Patients undergoing 1 to 3 level posterolateral fusion
* Opioid naïve or not
* No prior spine fusion
* Willing and able to sign an Informed Consent

Exclusion Criteria:

* Indication for surgery is fracture, tumor or infection
* Comorbid psychiatric diagnosis requiring therapy and/or medication
* Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia)
* Has hepatic disease
* On workers compensation/disability/litigation
* Known adverse reaction to medications to be administered
* History of alcohol and drug abuse
* On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)
Sex- and Context-dependent Effects of Oxytocin on Social Reward Processing

The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences social reward processing and whether the effects are context- and sex-dependent.

In a double-blind, randomized, placebo-controlled, between-subject design healthy volunteers will receive either oxytocin or placebo nasal spray (40IU in 10 puffs).

Subjects will come to the experiment in pairs (two friends of the same sex). 45 min after drug administration, the two subjects will simultaneously undergo a social reward task - during the task, functional magnetic resonance imaging (fMRI) data will be acquired from one of them. During the social reward task subjects will be asked to rate the valence and arousal of emotional pictures in three different conditions: alone, share with a stranger and share with their friend.

Before treatment, subjects will complete a range of validated questionnaires to control for potential confounders, such as level of depression (assessed using the BDI) and to explore associations between relevant personality factors and treatment effects, such as adult attachment style (assessed using the AAS).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorder, right-handed, had normal or corrected-to normal vision.

Exclusion Criteria:

* self-reported medication use, substance abuse, and presence of medical or psychiatric disorders
The Effect of Massage on Stress in Premature Babies

The practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. The stress experienced by premature infants affects the baby's behavior and laboratory findings. Massage is an effective application in facilitating the adaptation of premature babies to extrauterine life and ensuring that they are least affected by adverse environmental conditions. Massage in premature babies has an important place in reducing stress and supporting psychological, mental and physiological development as a healthy tactile stimulus.

This study was planned to examine the effects of massage on stress behaviors and salivary cortisol levels in premature infants. The research was planned on a randomized controlled experimental. In the research, the group to which massage will be procedure is the experimental group, and the group to which the swaddling procedure will be the control group will form.

Eligibility Criteria:
Inclusion Criteria:

* Families being voluntary to participate in the study
* Babies being born between 30 and 36 weeks plus 6 days of gestation
* Postnatal 3-5. premature babies between days
* Not taking analgesics or sedatives
* Absence of congenital anomaly
* Absence of skin disease
* The premature babies passing to oral feeding
* Not having a proven sepsis diagnosis
* No need for mechanical ventilator support

Exclusion Criteria:

* Having a congenital anomaly
* Presence of skin disease
* Having intracranial bleeding
* Having sepsis
* Receiving phototherapy
* Taking analgesic / sedative type drugs
Mother-infant Microbiota Transmission and Its Link to the Health of the Baby

The human intestinal tract harbors a diverse and complex microbial community, known as gut microbiota, which is critical in sustaining physiology, metabolism, nutrition and immune function. Dysbiosis of gut microbiota has been linked with obesity, hyperglycemia, hyperlipidemia, inflammatory bowel disease and other chronic inflammatory diseases. Gut microbiota is affected by host genetic markup, diet and life style; and therefore varied by human races and geographical locations.

The development of gut microbiota starts before birth. The infant's microbiome can impact on human health in later life. The microbiome of pregnant women are associated with early-life microbiota of their offspring as well as growth, neurodevelopment and the development of allergic and neurocognitive disorders.

Early childhood, when the microbiota is less mature and more malleable, is a golden age for microbiota manipulation to prevent disease. Studying microbiota at this golden age also allow us to dissect the development of a faulty microbiota and identify therapeutic targets to reverse it and cure diseases that are already developed.


Eligibility Criteria:
Pregnant women

Inclusion Criteria:

1. Being pregnant
2. Plan to give birth in local hospital
3. Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent)
4. Plan to stay in the same local area for at least 7 years post-delivery Exclusion Criteria: No

New Born Baby Inclusion Criteria

1. Be a new born baby of an enrolled pregnant woman
2. One of the parents or legal guardian is competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No

Father of new born baby Inclusion Criteria

1. Biological father of an enrolled new born baby
2. Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) \> 1 year prior to enrollment
* At least 1-year post-transplant
* Able and willing to provide informed consent
* Able and willing to undergo all study activities throughout the duration of the study

Exclusion Criteria:

* Confirmed pregnancy
* Receipt of ATG or carfilzomib within the past 3 months
* Receipt of rituximab within the past 3 months
* Receipt of basiliximab within the past 3 months
* Prednisone dose \>= 20 mg/day at the time of enrollment
* History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)
A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.

This prospective, multicenter study evaluates the performance of the Osseotite Prevail implant when to support a short fixed bridge with immediate occlusal loading, providing the patient with the use of a temporary prosthesis until the final prosthesis is made.

Study (null) hypothesis: This is an observational study in which no concurrent control group will be observed. Results of the study will be compared with the performance of other Osseotite implants from published Osseotite multicenter studies.

This is a prospective, observational study in which all the patients will have implants placed and a provisional prosthesis attached within 24 hours of implant surgery. Each restorative case will consist of a posterior short span fixed bridge of four implants or less. The final prosthesis will be placed within five months or implant placement surgery. Overall success will be determined on the basis of procedural success, prosthesis success, and implant success.

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and of any race, 18 years of age or older
* patients for whom the decision has already been made to use dental implants for treating partial edentulism in the posterior mandible or maxilla using a short span fixed prosthesis of two to four units
* patients must be physically able to tolerate conventional surgical and restorative procedures
* requirements for implant placement include: at least 1mm bone will be available at the buccal and lingual aspect of the implant and at least 1mm of bone below the apex
* patients must agree to return to the clinic for each study follow-up visit
* requirements for prosthetic fabrication include: bone width at least 6mm and a bone height of at least 11mm

Exclusion Criteria:

* patients with active infection or severe inflammation in the areas intended for implant placement
* patients with a \>10 cigarettes / day smoking habit
* patients with uncontrolled diabetes or metabolic bone disease
* patients with a history of therapeutic radiation to the head
* patients in need of bone grafting at the site of the intended study implant; if at the time of surgery some lateral voids need to be filled this is acceptable and does not exclude the patient from the analysis
* patients who are known to be pregnant
* patients with para-functional habits with evidence of severe bruxing or clenching
* placement of implants into sites with less than sixteen weeks of post-extraction healing; for 3-4 unit cases one implant site may have less than sixteen weeks of healing prior to implant placement
* type III or IV bone characteristics of the intended implant sites
* inter-arch distance of less than 7mm (planned location of implant seating platform to the apposing occlusal landmark)
Prevalence and Characterization of Pain in RASopathies

RASopathies are a group of syndromes caused by variants in genes belonging to the RAS/MAPK pathway. Pain is a neglected topic in RASopathies but it is frequently complained by affected individuals.

To detect prevalence and characteristics of pain in RASopathies by using scales, questionnaires, biochemical analysis and neurophysiological assessment tests.

Eligibility Criteria:
Inclusion Criteria:

* All individuals with clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion Criteria:

* Individuals with a RASopathy con confirmed by genetic analysis
A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China

The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.

The study aims to evaluate the current surgical treatment and its result for Congenital Pseudarthrosis of tibia (CPT)in children in China. A retrospective study will be conducted with around 150 patients at 11 centers in China. This study will use available registry data from a defined time period of Jan 2006-Dec 2014. The treatment method will be recorded. The bone union rate and the refracture rate were calculated to evaluate the final result of several surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.

Exclusion Criteria:

* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
* Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc
* Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc.
* Age between 18 and 80 years.
* Moderate to severe pain (NVS\>4).
* Right proficient oral and written language.

Exclusion Criteria:

* Patients with high intracranial pressure.
* Patients with Multiple Sclerosis.
* Patients with Guillain-Barré syndrome radiculopathy of vascular origin.
* Patients with previous lumbar surgery.
* Patients pregnant or lactating.
* Patients with allergy or intolerance to any of the drugs used.
* Patients with severe cognitive impairment.
* Patients with intrathecal injectio radiculalgia.
* Patients with poorly controlled major psychiatric pathology.
* Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac\>8.5).
* Patients with glaucoma.
* Patients with caudal equine syndrome.
* Patients with pre-treatment with steroid injections/or local anesthetics.
* Patients with central canal stenosis.
* patients with chronic treatment with oral corticosteroids without stabilized pattern.
Iron Long-Term Labelling Study Malawi

Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Have participated in the original absorption study and the two follow-up samplings
* Signed written informed consent from the guardian to participate in the study

Exclusion Criteria:

* Long-term medication
* Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet))
* Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start.
* Residence too far away (\> 2 hours by motorbike) from study location (Zomba)
Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

Respiratory muscle strength, dyspnea perception, physical activity and quality of life measurements will be performed and groups will be compared in two groups consisting of patients with idiopathic pulmonary fibrosis referred to pulmonary rehabilitation clinic and healthy volunteers in similar age range.

The patients who have agreed to participate in the study from patients diagnosed with idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the interstitial lung disease polyclinic will be included in the study. In addition, a healthy adult control group will be established from similar age groups. The two groups will be compared in terms of outcome measures.The study outcome measurements are maximum inspiratory/expiratory muscle strength , international physical activity questionaire, modified Medical Research Council dyspnea scale, Short form 36 quality of lide questionaire, fatigue severity scale, six minute walking test.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-70
* Patients signing informed consent form
* Patients diagnosed with idiopathic pulmonary fibrosis.

Exclusion Criteria:

* Patients who use steroids for less than 1 year
* The patient does not want to participate in the study