cyrilzakka/clinical-trials huggingface dataset:
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older

A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.


Eligibility Criteria:
Inclusion Criteria:

Individuals eligible for enrolment in this study are those:

1. who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent.
2. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol.
3. who are in good health as determined by clinical judgment of the investigator.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

1. who are unwilling or unable to give written informed consent or assent to participate in the study.
2. who are perceived to be unreliable or unavailable for the duration of the study period.
3. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
4. who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
5. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine.

   (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
6. who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study.
8. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
10. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. who are included in study personnel or close family members of personnel conducting this study.
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

The purpose of this study is to assess the performance and safety of using the investigational catheter.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
* Signed participants Informed Consent Form (ICF)
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* Structural heart defect which can only be repaired by cardiac surgery
* Pericarditis within 6 months
* Left ventricular ejection fraction (LVEF) less than or equal to (\<=) 25 percent (%) for ventricular tachycardia (VT) participants
* LVEF \<= 40% for participants with atrial arrhythmia
* History of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux
* History of abnormal bleeding and/or clotting disorder
* Clinically significant infection or sepsis
* History of stroke or transient ischemic attack (TIA) within the past 6 months of enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
* Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
* Implanted with a mechanical valve
* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention
* Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or significant coagulation disorder)
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
* Concurrent enrollment in an investigational study evaluating another device or drug
Non-Invasive Electrical Stimulation of the Human Brain

This study is designed to allow researchers to use transelectrical stimulation to explore the function of the human nervous system and improve diagnosis of neurological disorders.

Transcranial electrical stimulation is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. Electrical stimulation involves placing electrodes on the scalp or skin and passing an electrical current between them. When this is done, an electrical field is created that activates areas of the brain that control muscles. Muscle activity as a result of the stimulation can be recorded and analyzed.

This protocol application is written to permit us to use transcranial electrical stimulation, a safe and noninvasive method for activating the brain, spinal cord, or proximal nerves through the skin, in appropriate subjects. We will use this technique to explore the function of the human central and peripheral nervous system and to aid in the diagnosis of neurological disorders.

Eligibility Criteria:
Males and females, ages 18 and over.

Diverse racial groups.

Amputees and others with whom we will have no patient-care relationship may also be considered to be volunteers.

Patients will be recruited from those referred to the Human Motor Control Section, NINDS who have neurological syndromes that are of interest.

On rare occasions we may attempt to study children as young as 10 years with TES.

Individuals without indwelling cardiac lines and pacemakers.

Patients recruited for study would come from those referred to the EMG laboratory and to the Human Motor Control Clinic who would have distinct neurologic syndromes from well defined peripheral and central nervous system lesions including hemiplegia from stroke, trauma, tumor or focal demyelination (most commonly patients would have hemiplegia from stroke), peripheral nerve lesions, amputations, spinal cord injury.

Normal volunteers, including NIH employees, would be healthy adults without history of physical examination evidence of neurologic disease and individuals with different types of amputations involving upper and lower extremities.

Volunteers may also be participants in the electrophysiological protocol (84-N-0196).

No history of epilepsy.
The Change of Pulmonary Blood Flow During One Lung Ventilation

To investigate the changes of regional pulmonary blood flow in nondependent lung by transesophageal echocardiography during one lung ventilation


Eligibility Criteria:
Inclusion Criteria:

* adult patients (ASA physical status I-III) requiring OLV for selective thoracic surgery.

Exclusion Criteria:

* chronic obstructive pulmonary disease
* hypertension
* cardiovascular
* esophageal disease
Connecticut Child STEPs

Connecticut Child STEPS is a randomized controlled trail investigating the effectiveness of MATCH-ADTC in treating anxiety, depression, trauma, and/or behavioral problems in children seeking services at four Department of Children and Families (DCF) funded clinics in the state of Connecticut. The study will evaluate child outcomes following two forms of therapist training in the MATCH model.

This randomized controlled trial (RCT) will investigate the effectiveness of a modular, transdiagnostic treatment protocol for youth with anxiety, depression, trauma, and/or behavioral problems (MATCH-ADTC) in four DCF funded clinics in the state of Connecticut. MATCH synthesizes common elements found across dozens of evidence-based treatments into one model that is flexible and responsive to the complex needs of children and families. The RCT will evaluate child outcomes following two forms of therapist training in the MATCH model: (1) the 6-day MATCH training only; (2) the 6-day MATCH training plus weekly ongoing case consultation with a MATCH consultant. Participating children are between the ages of 7 and 15.

Eligibility Criteria:
Inclusion Criteria:

1. 7 to 15 year old child and their caregivers
2. seeking services at community mental health clinics
3. primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems

Exclusion Criteria:

1. child is outside of 7-15 age range
2. child does not have elevations in the areas of anxiety, depression, conduct, or posttraumatic stress
3. child is experiencing other primary clinical problems outside of MATCH focus such as:

   * ADHD identified as primary reason for seeking treatment
   * Schizophrenic spectrum disorder including Major Depressive Disorder with psychotic features
   * Autism spectrum disorder including Pervasive Developmental Disorder, Asperger's Disorder, Child Disintegrative Disorder, Rett's Disorder
   * Eating disorder including Anorexia Nervosa and Bulimia Nervosa
   * Mental Retardation
4. having been hospitalized for suicidal thoughts or behaviors within the past year
5. if the problem area of focus is beyond the scope of outpatient treatment and MATCH (e.g., severe aggression, psychosis, severe current suicidal ideation)
6. if child does not have a primary caregiver that can be involved in treatment and complete research assessments
Using EEG Operant Conditioning to Improve Trait Self-Control and Promote Healthy Behavior

The field of neuroeconomics has begun to elucidate neural mechanisms underlying self-control; however, researchers have not yet harnessed neuroeconomics findings to develop interventions for improving self-control ability. The investigators are currently developing such an intervention. The investigators' approach involves using a brain-computer interface with audiovisual feedback to show people what is happening in their own brains, in real time. Through this interface, individuals are trained to increase levels of neural activity that may facilitate self-control, which, in turn, may improve the ability to exhibit self-controlled behaviors. This may increase the ability to engage in heath behaviors for which self-control is required (eg, dieting and exercising). The investigators' long-term goal is to create a tool that will help people develop the self-control needed to achieve lasting improvements in health behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Can read and write fluently in English
* At least 18 years of age
* Right-handed
* Overweight or obese (BMI \> 24.9)
* Currently has a University of Rochester meal plan
* Currently in contemplation or action stages of change with respect to weight loss (measured with the Weight Stages of Change Algorithm; Rossi, Rossi, Velicer, \& Prochaska, 1995).

Exclusion Criteria:

* History of diabetes, epilepsy, celiac disease, lactose intolerance, food allergies, veganism, mental illness, or eating disorders
* Currently taking a medication that may have a strong effect on EEG recordings (eg, an antidepressant, stimulant medication, etc.)
* Currently drinks more than 3 cups of coffee per day or roughly equivalent caffeine intake
Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children

The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.


Eligibility Criteria:
Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the designated childcare centers

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who will not be present at the childcare center for all of the scheduled study days
Piloting Pathways With Lung Cancer Patients

The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with advanced stage and metastatic lung cancer.

In this study, investigators will first test the Pathways procedures with 6 patients to identify any improvements that need to be made. Then, investigators will test the feasibility of the Pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. Pathways is designed to help patients set and pursue personal goals during lung cancer treatment. In this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the University of Kentucky Markey Cancer Center to participate in the Pathways intervention.

Eligibility Criteria:
Inclusion Criteria:

* new or recurrent stage IIIB, stage IIIC or stage IV non-small cell lung cancer (NSCLC) or extensive stage SCLC
* 18 years of age or older
* ECOG PS 0-2/Karnofsky 60-100
* 3 to 12 weeks into active cancer treatment

Exclusion Criteria:

* unstable brain metastases
* cognitive or psychiatric condition for which participating would be inappropriate
* unable to speak and read English
A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis

the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.

it is a multicenter phase 2 ,double blind study in patient with active Rheumatoid arthritis ,there are 2 group in the study A and B ,where group A receive Rhustoxicodendron in 30 potency the first dose will administered orally (1/2 ml)after the completion of case taking ,and repeated every 7th day for 5 month and on the other hand group B receive placebo orally in (1/2 ml) at same interval for same period .

Eligibility Criteria:
Inclusion Criteria:

* those who will provide written consent to participate in the study
* patient willing to turn up for 7th day follow up
* patient who are willing and compliance to the study
* those who are between 25 to 60 years .
* patient who are willing and compliance to the study .
* ESR more then 28 mm.

Exclusion Criteria:

* Participating as a subject in any other clinical research study.
* Children below the age of 25years.
* Female subject who are pregnant or planning for pregnancy within 6 month.
* History of seizures
* Breast feeding women's.
* Patient on treatment for life threatening illness like cancer aids etc.
* Patient should not have any congenital abnormality or patient should not have undergone any operative procedure as consequences of RA.
Bicarbonate v Saline to Prevent Contrast Nephropathy

Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.

A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.

It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise \> 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.

Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.

Eligibility Criteria:
Inclusion Criteria:

* Booked for cardiac or other non-renal arteriography
* Pre-existing reduced kidney function: Serum Creatinine \>= 1.3 \& \<= 4 mg/dl (female gender) or \>= 1.5 \& \<= 5 mg/dl (male gender)
* Age \> 18 years

Exclusion Criteria:

* GFR MDRD estimate \< 15 ml/min/m2
* End-stage renal disease already on dialysis
* Known current Acute Kidney Failure with serum creatinine rise of \> 0.5 mg/dl within 24 hours
* Pulmonary edema - current or within 48 hours
* Clinically relevant ascites, edema or other fluid overload
* Uncontrolled hypertension (\> 165 mmHg systolic, or \> 105 mmHg diastolic)
* Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support
* Emergency (unplanned) angiography
* IV contrast procedure
* Exposure to iodinated radiocontrast within 3 days prior to study
* Prior anaphylactoid reaction to contrast
* Planned administration of N-acetylcysteine
* Planned administration of dopamine, fenoldopam or mannitol
* Current pregnancy
Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia

The objective of this prospective randomised trial was to compare the short- and long-term efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to assess the short-term outcome of each procedure performed either under spinal anaesthesia or local anaesthesia with pudendal block with ropivacaine combined with intravenous sedation.

We think, Ligasure haemorrhoidectomy under local anesthesia can be performed as day-case procedure and with equal results at long-term than conventional diathermy (considered goal standar of haemorrhoidectomy).

Seventy-four consecutive patients with a long-standing history of symptomatic grade III or IV haemorrhoids were assigned randomly by means of a computer-generated list to conventional diathermy haemorrhoidectomy under spinal anaesthesia (group I); conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II); Ligasure™ under spinal anaesthesia (group III) and Ligasure™ with local anaesthesia combined with intravenous sedation (group IV). Allocations were sealed in opaque numbered envelopes. All patients were operated on electively and by the same surgical team (two colorectal surgeons) and variables were collected after operation by an independent observer who was unaware of the operation performed.

The intraoperative time was measured. Intraoperative and early (within the first 48 h) postoperative complications associated with the surgical procedure and complications related to the anaesthetic technique (headache, vomiting, nausea, acute urinary retention, bleeding and hypotension) were recorded. A 100-mm visual analogue scale (VAS) was used to assess the intensity of pain, which was measured at 2, 6 and 24 hours postoperatively and during the first bowel movement. Seven days after surgery, patients were contacted by phone and the following data were recorded: VAS score at rest and during bowel movements, bleeding (categorised as 0 = none, 1 = occasional with defecation, 2 = with each defecation, 3 = with and without defecation) and pruritus (categorised as 0 = none, 1 = occasional, 2 = frequent) and tenesmus (categorised as 0 = none, 1 = occasional, 2 = frequent). These variables were collected at 4 and 12 months after operation by an independent observer who was unaware of the operation performed. Clinical evaluation at 1 year included relapse, continence according to the incontinence score system of Jorge and Wexner19, anal stenosis, presence of skin tags, patient's degree of satisfaction (where 0 corresponded to a unsatisfactory result and 10 an excellent result) and days of sick leave.

Eligibility Criteria:
Inclusion Criteria:

* patients with a long-standing history of symptomatic grade III or IV haemorrhoids

Exclusion Criteria:

* previous anal surgery, concomitant anal disease (fissure, fistula, incontinence and inflammatory bowel disease), use of anticoagulants or analgesics, known hypersensitivity to local anaesthetics and the inability to give written informed consent.
Acitretin Plasma Levels Under Hemodialysis

Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.

Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined.

* Trial with medicinal product

Eligibility Criteria:
Inclusion criteria:

* Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin

Exclusion criteria:

* Hepatopathy
* Pregnancy