cyrilzakka/clinical-trials huggingface dataset:
Intraoral 30% Glucose Effect In Newborns

Newborn often sedated during MRI but sedation itself creates adverse events and management is more challenging in the MR environment. The investigators describe the investigators initial experience with oral 30% glucose administration through a pacifier during MRI for imaging of newborns. Using this technique, majority of newborns can complete MRI examination without the need for sedation and also offers the availability of administering sedatives to unsuccessful patients.

19 consecutive newborns over 10 months period were assessed retrospectively. 0.5-1 mL 30% glucose solution was administered orally and after suckling, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added. After 2 consecutive oral glucose administration the newborns who did not keep motionless or sleep and had motion artefacts sedated with midazolam. The outcome measure was the success of the procedure which was determined by providing qualitative images appropriate for interpretation following 30% glucose administration. The routine blood glucose level measurement of the newborns after imaging procedures in the ICU was also performed for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Newborns admitted from newborn intensive care unit for MR imaging

Exclusion Criteria:

* Intubated newborns
Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir in Healthy Subjects

To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS


Eligibility Criteria:
Inclusion Criteria:

1. Males or females who meet the inclusion/exclusion criteria; females must not be pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
2. Age ≥18 and \<60 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2
4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Exclusion Criteria:

1. Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
6. Intake of drugs with a long half-life (\>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
7. Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
8. Participation in another trial with an investigational drug within one month prior to administration or during the trial
9. Current smoker
10. Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
11. Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
12. Excessive physical activities (within 1 week prior to study drug administration or during the trial)
13. Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
14. Inability to comply with dietary regimen required by the protocol
15. Chronic or relevant acute infections
16. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
17. HIV-1 infected as defined by a positive HIV ELISA test
Evaluation of Diabetes and WELLbeing Programme

This study evaluates the impact of 'DWELL' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. Up to 600 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes

The DWELL (Diabetes and WELLbeing) 12-week programme has been designed to incorporate specific elements of diabetes education and is underpinned by motivational interviewing to ensure it is tailored to individuals. Each of the four elements of the programme - education, nutrition, physical activity and wellbeing - have been carefully selected based on previous research into diabetes education. The Canterbury Christ Church University (CCCU) DWELL Team are responsible for the evaluation of DWELL, which will explore whether the combination of the programme elements is effective in improving self-management. Additionally, a process evaluation and cost effectiveness analysis will be conducted alongside participant outcomes

The programme will be delivered at five sites (two in the UK, one in Belgium, one in France, one in the Netherlands). The CCCU DWELL research team will be responsible for quality assurance, management and analysis of data, sample size assessment and reporting of adverse events. Each delivery site is responsible for adhering to their own Standard Operating Procedures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Over the age of 18

Exclusion Criteria:

* Under the age of 18
* Pregnant women
* Individuals who do not have the mental capacity to participate
Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women

The purpose of the research is to determine if eating sweetened, dried cranberries or strawberry fruit pieces will increase the types of different E. coli bacteria in the intestines which may reduce the likelihood of a major, or highly harmful urinary type of bacteria which cause urinary tract infections in susceptible women.

This is a research study about the number and types of bacteria that cause urinary tract infections (E. coli strains) that are present in the intestine. The bacteria will be collected and analyzed before and after eating either sweetened, dried cranberries or strawberry fruit pieces. This study will help us learn more about whether or not the components of consumed sweetened, dried cranberries or strawberry fruit pieces reduce the numbers of harmful E. coli bacteria in the vaginal and intestinal tracts, thereby reducing the number of urinary tract infections among women.

Eligibility Criteria:
Inclusion Criteria:

* Women, ages 18-65
* History of recurrent urinary tract infections defined as three in the past year, or two in the last six months
* Subjects must be willing to follow the study protocol that includes consuming the mandatory daily dose of cranberries or strawberry fruit pieces and traveling to the UWHC Urology clinic for scheduled rectal and vaginal swab procedures.

The non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.

Exclusion Criteria:

Women who:

* Are pregnant
* Have an immune compromising disease
* Have diabetes
* Have kidney stones
* Have chronic bowel inflammatory disease
* Have known allergies to cranberries, strawberries, elderberries, or wheat fiber

Non-UTI-susceptible group will include women ages 18-65 with no history of recurrent UTI's as defined above.
EHealth Based Self-management Intervention for Chronic Kidney Disease Care in China

The purpose of this study is to develop an evidence-based tailored eHealth self-management intervention for patients with chronic kidney disease in China, and test the impact on implementation and effectiveness of interventions.

Interventions that support disease self-management (further referred to as 'self-management interventions') can have a significant impact on the health and quality of life of patients suffering from chronic conditions in general and chronic kidney disease (CKD) patients in specific. In the last decade, the use of electronic health (eHealth) technology in self-management interventions has become more and more popular. EHealth-based self-management interventions have been shown to improve health-related outcomes, such as blood pressure (BP) control and medication adherence, and found to be feasible and acceptable for CKD patients and care professionals. Hence, the use of eHealth self-management interventions for CKD patients has become increasingly popular. Knowledge of the implementation and effectivity of such interventions in China and other developing countries is, however, still lacking. Researchers from the Leiden University Medical Center (LUMC) developed 'Medical Dashboard', an eHealth intervention to help support and involve CKD patients in their disease self-management. We aim to tailor the evidence-based Dutch intervention 'Medical Dashboard' to the Chinese context and evaluate its implementation process and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients: (1) aged over 18 years old; (2) diagnosis of chronic kidney disease; (3) Chinese speaking.
* Health care providers who work in the Department of Nephrology

Exclusion Criteria:

* Individuals unable to participate due to physical or mental disabilities.
* Individuals unable to write or read.
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer.

AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if Oligomeric Procyanidin Complex (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

Eligibility Criteria:
Inclusion Criteria

1. Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer.
2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be \<50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain \<50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.
3. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
4. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:

   * Hematology parameters: ANC \>1000/mcL, platelets \> 100,000/mcL, Hgb \>8.0gm/dL
   * Renal Function: eGFR of \> 45mls/min using Cockgroft and Gault formula (see appendix C).
   * Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5xULN
5. Able to swallow and retain oral medication
6. ECOG performance status of 0 - 2
7. Ability to sign written informed consent
8. Testosterone level \<50ng/dL

Exclusion Criteria

1. Known allergy to grapes or grape seed
2. History of receiving more than 2 classes of ADT.
3. Current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine. See section 4.7 for more details.
Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk

The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study and willingness to participate as evidenced by participants' parents and/or legal guardian's voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
* Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
* Good general and mental health with, in the opinion of the investigator or medically qualified designee
* Child residing in the peri-urban areas of Bangalore city
* Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.

Exclusion Criteria:

* Children in Care (CiC)
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
* Participants with severe anaemia (Haemoglobin \< 8g %) as determined by laboratory results
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
* Recent history (3 months) of serious infections, injuries and/ or surgeries
* Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week) in last 6 months prior to screening visit
* Use of any prescription medications within 15 days prior to screening and throughout the entire duration of the study
* Recent history (within the last 1 year) of alcohol or other substance abuse.
Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality

This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.

Sleep quality impairment has long been identified as a risk factor to develop cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep, characterized by slow oscillations, has a major role on memory and hormones releasing. Here, we aim to assess a miniaturized sleep device that would automatically detect and stimulate sleep slow oscillations with sounds to enhance deep sleep quality.

The subjects realize 3 conditions :

* Up condition : Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.
* Random condition : Auditory stimulations are randomly delivered during N3 sleep stage.
* Placebo condition: The device is worn without any auditory stimulations delivered.

The subjects are equipped with a reference polysomnography and the auditory stimulation device during 3 nights and one habituation night prior to them. A wash out period of 6 days between each night will be respected.

Eligibility Criteria:
Inclusion Criteria:

* healthy subject
* moderate morningness, intermediate or moderate eveningness chronotype (Horne \& Östberg questionnaire)

Exclusion Criteria:

* sleep disorder according to the ICSD-3 or DSM-5
* travelling away from more than a time zone in the previous month
* acute or chronic disorders (cardio-vascular, respiratory, neurologic, psychiatric)
* night shifts work
* smoking more than 5 cigarettes per day
* drinking more than 5 glass of alcohol per week
* consuming excessive drinks with xanthics (coffee, tea, coke more than 6 cups per day).
* having a body mass index \>30kg.m -2
* being pregnant
Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure

This study has two primary objectives:

1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus high-dose loop diuretics (standard of care) in patients with acute decompensated heart failure at high risk for diuretic resistance.
2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in addition to loop diuretic therapy in patients with acute decompensated heart failure at high risk for diuretic resistance.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years and able to give informed consent
* Clinical diagnosis of acute decompensated heart failure within the previous 8 h
* At least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)
* Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission
* NT-proBNP \>1000 ng/L
* Left ventricular ejection fraction \<50%
* At least one out of three of the following criteria:

  * Serum sodium \<136 mmol/L
  * Serum urea/creatinine ratio \>50 (comparable to a BUN/creatinine ratio \>25)
  * Admission serum creatinine increased with \>0.3 mg/dL compared to previous value within 3 months before admission

Exclusion Criteria:

* History of cardiac transplantation and/or ventricular assist device
* Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise \>99th percentile
* Mean arterial blood pressure \<65 mmHg, or systolic blood pressure \<90 mmHg at the moment of admission
* Use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study
* A baseline estimated glomerular filtration rate \<15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion
* Use of renal replacement therapy or ultrafiltration before study inclusion
* Treatment with acetazolamide within the previous month
* Treatment with ≥2 mg bumetanide or an equivalent dose during the index hospitalization before randomization
* Use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist not specified by the protocol
* Exposure to nephrotoxic agents (i.e. contrast dye) anticipated within 3 days
Roniciclib Mass Balance Study

The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.


Eligibility Criteria:
Inclusion Criteria:

* - Male or female subjects aged ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
* Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements to be conducted within 14 days prior to the first dose of study drug:

Exclusion Criteria:

* Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
* History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class III or IV, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. Accepted exemptions are bisphosphonates, luteinising hormone releasing hormone (LHRH) agonists for prostate cancer, and mitotane for adrenal carcinoma.
* Radiotherapy within 3 weeks prior to the first dose of study drug. Palliative radiotherapy will be allowed
* Intake of strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil (withdrawn in the US), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin , rifampin and St. John's Wort)
Evaluation of the Improvement of Autonomic Nervous System by a Physical Rehabilitation Program Adapted to Adulthood After Chemotherapy or Radiotherapy in Childhood

Survival rate of childhood cancers is now reaching 80%. However, early or late complications related to surgery, chemotherapy and radiotherapy remain high and greatly increase the risk of late mortality.

Health of individuals is closely correlated to the stability of the autonomic nervous system (ANS), a key system for maintaining homeostasis in any living species. Efficient computer tools allowed the opportunity to assess the intrinsic autonomic regulation of the ANS either directly or at a later time by an analysis of the heart rate variability (HRV). These tools have become very powerful predictors of cardiovascular morbidity and neurological aging. Physical endurance training improves both maximal aerobic capacity and ANS activity.

The main objective of this study is to evaluate improvement of ANS parameters after 6 months of adapted physical activity in adults treated for childhood cancer in Rhône-alpes region in France who have deregulation ANS or autonomic imbalance.

Eligibility Criteria:
Inclusion Criteria:

* Included in the SALTO_SNA study (NCT01574196)
* Alteration of the autonomic nervous system activity or deregulation of the sympatho-vagal balance

Exclusion Criteria:

* Written consent form
* Left ventricular dysfunction
The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Retrospective Study

Sedation and anesthesia for diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea.

The investigators reviewed 3739 charts of pediatric patients sedated for MRI/CT between January and November 2012.

In this study, the investigators will report the nature and frequency of adverse events associated with sedation for MRI/CT between January and November 2012.


Eligibility Criteria:
Inclusion Criteria:

* Requiring sedation for MRI/CT, aged 0- 18 years

Exclusion Criteria:

* None
Pilot Study: Mobile Phone Based Physical Activity in Sedentary Men and Women

The purpose of this pilot study is to estimate the efficacy of a mobile phone based physical activity intervention in sedentary men and women.


Eligibility Criteria:
Inclusion Criteria:

1. Sedentary lifestyle at work and/or during leisure time
2. Male or female, age between 21-69
3. Access to a telephone at home or a mobile phone
4. Speak and read English
5. BMI between 20-43 kg/m2

Exclusion Criteria:

1. Known medical condition or other physical problems that need special attention in an exercise program
2. Planning a trip out of the United States during the study
3. Pregnant/Delivered a baby during the last 6 months
4. HIV positive
5. Known severe hearing or speech problems
6. Currently participating in lifestyle modification programs or research studies (such as physical activity, diet, and/or weight loss programs)