cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

The subjects will be randomized (1:1) in the 2 treatment groups to explore responses to vaccination in a sub-group analysis based on age (6 to 17 months, 18 to 35 months).

Eligibility Criteria:
Inclusion Criteria:

* Subject's parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Subjects in stable health as determined by the investigator's clinical examination and assessment of subject's medical history.
* Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
* Child in care.
* Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed.
* 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.
* History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Acute disease and/or fever at the time of enrolment.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male / Female outpatients 7 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised \[CDRS-R\] with a total score greater than or equal to 40 at Visit 1, Visit 2, and Visit 3 and a Clinical Global Impressions of Severity \[CGI-Severity\] rating of greater than or equal to 4 at Visit 1, Visit 2, and Visit 3.)
* Female patients must test negative on a pregnancy at visit 1.

Exclusion Criteria:

* Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or electrocardiogram (ECG) result, hypersensitivity to duloxetine, or to its inactive ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C) that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
* Have a significant suicide attempt within 1 year of Visit 1 or have a score of 5 or greater on Item 13 (Suicidal Ideation) on the CDRS-R at Visit 1, Visit 2, or Visit 3, or are currently at risk of suicide in the opinion of the investigator.
* Have a weight less than 20 kg at any Screening Phase visit.
* Have previous exposure to duloxetine
* Female patients who are either pregnant, nursing or have recently given birth.
Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
3. Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
4. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
5. Have not experienced peritonitis episodes in the last 3 months
6. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
7. Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
8. Have Kt/V urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
9. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
10. Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
11. Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
12. Be treated by the participating clinical Investigator for a period of at least three months
13. Have understood and signed the Informed Consent Form.

Exclusion Criteria:

1. Have a history of drug or alcohol abuse in the six months prior to entering the protocol
2. Be in treatment with androgens
3. Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
4. Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT \> 2 times the upper normal limit)
5. Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
6. Have a history of congestive heart failure and clinically significant arrhythmia
7. Have an history of epilepsy or any NCS disease
8. Have malignancy within the past 5 years, including lymphoproliferative disorders
9. Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year
10. Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
11. Have used any investigational drug in the 3 months prior to entering the protocol
12. Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)

The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.

Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated BCR-ABL-negative ALL
* Age between 25 and 64 years
* Performance status between 0 and 3 (ECOG criteria)
* Adequate functioning of the liver (serum bilirubin level \< 2.0 mg/dL); kidneys (serum creatinine level \< 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
* Written informed consent to participate in the trial

Exclusion Criteria:

* Uncontrolled active infection
* Another severe and/or life-threatening disease
* Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
* Another primary malignancy which is clinically active and/or requires medical interventions
* Pregnant and/or lactating women
* Past history of renal failure
Toward Self-management in ILD

Treating and caring for people with long term conditions accounts for a substantial proportion of health care resources. Self-management is advocated as a mechanism that can empower service users with long term conditions to choose healthier options and also transform the relationship between service user and caregivers from one in which the former is a passive recipient of care to one in which they are an active partner in decision-making.

Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often express concern about the lack of information on possible rehabilitation programmes and other services that could potentially improve self-management of the disease. In addition, there is a general perception about a lack of co-ordination between health care professionals especially in relation to referral to services for comprehensive management of the disease. Therefore, the needs of patients with ILD and their carers, and possible gaps in service provision need to be explored further.

In this study, the investigators propose to explore the needs of ILD patients from all types of ILD and all stages of severity and to also involve carers and clinicians. The investigators will conduct three focus groups for patients and carers and six one-to-one interviews with clinicians to explore perceptions about service gaps and needs in two ILD centres in South and North London, UK.

This study will provide valuable information to develop the building blocks of a self-management resource and will enable the investigators to make it specific to the different types of ILD.


Eligibility Criteria:
PATIENTS

Inclusion Criteria:

* Diagnosed with Interstitial Lung disease (all types apart from sarcoidosis)
* Age \>18 years
* At least one consultation with a health care professional

Exclusion Criteria:

* Diagnosed with sarcoidosis
* Unable to communicate in English
* Severity of condition and commodities preventing participation

CAREGIVERS

Inclusion Criteria:

- Currently caring for a participant with ILD

Exclusion Criteria:

- Unable to communicate in English

CLINICIANS:

Inclusion Criteria:

- Involved in the clinical management and treatment of ILD patients

Exclusion Criteria:

- Health care professionals not directly involved in management or treatment of ILD patients
Measurement of Gastric Emptying During and After COLOKIT® Intake

Ultra-sound study to assess changes in intragastric volume after bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* Subject who signed an informed consent to participate in the trial.
* Subject affiliated with Social Security
* Men and women aged 18 to 75 years.
* Subject with an indication of scheduled outpatient colonoscopy.
* colonoscopy performed within six hours after the second sequence COLOKIT®.
* Subject able to swallow tablets.

Exclusion Criteria:

1. Women pregnant or likely to be (without contraception) or nursing.
2. Subject having any of the following diseases or conditions:

   * allergy or hypersensitivity to the product tested or any of its excipients,
   * nausea, vomiting or abdominal pain,
   * clinically significant renal failure,
   * primary hyperparathyroidism associated with hypercalcemia,
   * congestive heart failure,
   * ascites,
   * a known or suspected bowel obstruction,
   * megacolon (congenital or acquired)
   * intestinal perforation,
   * ileus,
   * an inflammatory disease or suspected inflammatory bowel disease,
   * swallowing disorders,
   * known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus),
   * diabetes mellitus (insulin or non insulin-dependent)
   * a history of gastric surgery (partial or total)
   * a contraindication to the anesthesia required for the completion of the colonoscopy,
   * Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.
Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis

Low-intensity pulsed ultrasound (LIPUS) is effective in accelerating the healing of fractures, reduction in costs to the state, reduction in the numbers of those patients who progress from out-patient care to long term care who, in the process lose their ability to perform activities of daily living and consequently their independence.

Aim of this study was to determine the effects of low-intensity pulsed ultrasound on pain and functional disability in patients with lumbar spondylolysis. Thirty four (29 males \& 5 females) diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months aged between twenty to forty years were recruited. This randomized controlled trial was a part of PhD Physical Therapy project conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore, Pakistan, from June 2020 to March 2021 by using non probability purposive sampling technique. Subjects were divided randomly into two equal groups (Group-A and Group-B). Lottery method was used to randomly assign patients into two groups. Numeric Pain Rating Scale (NPRS) was utilized to measure pain intensity and Oswestry Disability Index (ODI) to measure functional disability. Data was analyzed by using SPSS 21.

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* Diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months
* Age: 20-40 years

Exclusion Criteria:

* Subjects with the history of neurological or autonomic deficits,
* Other fracture or bony abnormalities
* Rheumatic disease
* Other spinal problems
* Post-menopausal female
* Osteoporosis
* Osteopenia
Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients

90 saliva samples will be isolated from patient who possess different ages and caries activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then the determination of the best selective media for mutans streptococcus isolated from saliva and authenticate the MS via PCR technique.


Eligibility Criteria:
Inclusion Criteria:

* healthy participant

Exclusion Criteria:

* participant received antimicrobial therapy in previous month.
* participant who taking xylitol chewing gum or undergo fluoride therapy.
OHRQoL and Parental Perception in a Group of Children and Adolescents With Down Syndrome: A Cross

The aim of the study is to evaluate Oral Health related quality of life of children and adolescents with down syndrome and Parental Perception, knowledge and Attitude on oral health conditions of children and adolescents with down syndrome

Oral disease and conditions can undermine self-image and self-esteem , dis-courage normal social interaction, and cause other health problems and lead to chronic stress and depression , They may also interfere with vital-functions such as breathing , food selection eating, swallowing and speaking, and with activities of daily living such as work, school, and family interactions .

Oral Health Related Quality of Life captures the aim of new prospective and defined as a multidimensional construct that reflects people's comfort when eating, sleeping and engaging in social inter-action, their self-esteem and their satisfaction with respect to their oral health .

Down syndrome (DS) is the most common neuro-developmental disorder of known genetic origin, arising from an extra copy of chromosome 21.

Children and adolescents with down syndrome present particular characteristics that may have a negative impact on their oral health and function. Protruding large tongue and facial muscle hypotonicity impairing speaking and chewing abilities. Bruxism, respiratory problems and mouth breathing are common among them.

Periodontal disease is the most significant oral health problem in people with Down syndrome due immunological deficiency, poor masticatory function and poor oral hygiene .

Another common oral manifestation associated with the syndrome is malocclusion. In this regard, mandibular protrusion, anterior open bite, and posterior crossbite have been reported as prevalent outcomes among DS individuals .

It has been shown that the impact of oral disease on Oral Health Related Quality Of Life of children with disabilities can be used in health service planning and priority setting.

Studies have recommended that people with a negative oral condition should receive treatment first , Hence this vulnerable group of children needs to be prioritized in the planning of health services and oral health care programs

Eligibility Criteria:
Inclusion Criteria:

* Parents of children and adolescents diagnosed with Down syndrome who agree to participate in the study.
* Children and adolescents with Down syndrome aged from 4 to 14 years.
* Both genders.

Exclusion Criteria:

-Children/adolescents with multiple disabilities
Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia

A stratified, parallel-group, double-blind, randomized controlled trial of remotely delivered START treatment to individuals with severe-to-moderate stroke (with recruitment focused on individuals with low SES) will be conducted. Subjects and assessors will be blinded to the condition making the experiment double blind. Specifically, subjects will be told that we are exploring a new therapy that using different sounds to improve therapy. Parallel group design will ensure that subjects in the Control group are unaware that their "sounds" are softer than the START group. Trainers may become aware that a loud sound is present thus a unique Assessor will evaluate clinical performance before and after training making the study double-blind. Fifty-four subjects will undergo baseline testing in the laboratory to establish their capacity for functional and expressive speech as well as their self-reported health-related quality of life (power analysis below). Next, subjects will participate in a high-frequency, word-picture verification/ auditory-repetition treatment, 2 hr/day for 5 consecutive days focusing on expression of words of functional significance (e.g., water, fall). Subjects will either receive training with START or without (Control). Subjects will be re-tested immediately following training as well as one-month post to assess retention. Aim 1 will evaluate capacity of START to enhance SLT outcomes by assessing the % change in clinical assessment of functional and expressive speech. Our preliminary data points to a robust response \[details\]. Aim 2 will focus on the capacity of these changes to 1) be retained and 2) impact subject's reported quality of life. NOTE: While we are planning in-person baseline, end, and retention testing, in response to COVID, we have established remote clinical screening using peer-reviewed validated techniques for WAB and ABA-2 (see Alternative Solutions). All preliminary data collected for this proposal were collected remotely via no-contact protocols.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Native English Speakers
* Capacity to provide informed consent
* Right-handed
* Corrected to normal vision
* Left hemisphere cerebral stroke at least 6 months prior to testing
* Presence of severe-to-moderate, non-fluent aphasia, i.e. Aphasia Quotients of 0-50 on the Western Aphasia Battery-Revised (PsychCorp, 2007)
* Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender41,42 NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. Based on our ongoing aphasia studies, we expect that \~30% of participants will use hearing aids; we will not exclude these individuals but rather include hearing aid use as a covariate in analyses.

Exclusion Criteria:

* Severe concurrent uncontrolled medical problems (e.g. cardiorespiratory impairment).
Ketone Pharmacokinetic Study in HFrEF

The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HFrEF (ejection fraction\<=45%)
* Systolic blood pressure greater \>=90 mmHg

Exclusion Criteria:

* Intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for \>7 days prior to visit)
* Significant liver disease (cirrhosis) or alcohol abuse disorder (\>14 drinks/week).
* Unique cardiomyopathies: infiltrative/hypertrophic cardiomyopathy, pericardial disease, or other cardiomyopathies that in the investigator's opinion have unique treatment options that would be less likely to be affected by ketone therapy.
* Estimated glomerular filtration rate\<25 mL/min/1.73 m2 as the most recent value in the last year.
* Type 1 diabetes mellitus
* Use of ventricular assist device, history of heart transplant, or use of continuous inotropes
* Pregnant women. Due to unknown affects of nutritional ketosis in pregnant women, pregnancy will be an exclusion. Accordingly, women of childbearing age with a menstrual cycle within the past year will be asked to submit a urine specimen for pregnancy testing.