cyrilzakka/clinical-trials huggingface dataset:
Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index

Chemotherapy and radiation used in patients undergoing bone marrow transplant (BMT) disrupts the endothelial lining (a thin layer of cells inside the blood vessels) which is found all throughout the body including the kidney, heart, lungs, and intestines. Disruption of this endothelial lining can lead to complications such as graft-vs-host disease (GVHD), thrombotic microangiopathy (TMA) and veno-occlusive disease (VOD). The purpose of this research study is to help investigators see if pravastatin is safe and well tolerated in patients undergoing BMT to see if it will reduce endothelial injury after BMT.

The investigator hypothesizes that prophylactic pravastatin in pediatric allogeneic hematopoietic stem cell transplant recipients with elevated BMI is safe and feasible.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for allogeneic stem cell transplant
* Ages ≥ 2 - ≤ 25 years old
* Elevated BMI defined by the Center for Disease Control and Prevention definitions. Both overweight (BMI between 85th-94th percentile) and obese (BMI \>95th percentile) patients are eligible
* All diagnoses are eligible

Exclusion Criteria:

* Patients with documented anaphylaxis to pravastatin
* Patients will be ineligible if they are unable to take medication orally or enterally (i.e. intestinal failure)
* Patients with elevations in ALT/AST levels 3x ULN at time of enrollment
* Patients with renal impairment as clinically measured (GFR \<50 ml/min/1.73m2) at time of enrollment
* Patients with known neuromuscular and metabolic disorders associated with an increased risk of rhabdomyolysis (ie metabolic muscle disorders, mitochondrial disorders, and muscular dystrophies)
* Patients taking any drugs that are known substrates for OATP1B1 and OATP1B3 transporters
Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis

In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size. Patients are randomized to receive either mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20 session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6 months are planned.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia, schizophreniform or schizoaffective disorder (DSM IV 295.1- .9), delusional disorder (DSM IV 297.1)
* Score of 4 or more on one of the PANSS-items P1, P3, G9
* Positive psychotic symptoms for 3 months or more
* Age between 14 and 18
* Fluently German speaking

Exclusion Criteria:

* Diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system
* Alcohol- or drug dependence according to DSM IV
* Verbal IQ \< 80
* Travel time to the study centre of more than 1 hour
Analysis of Treatment Outcome and Toxicity in Non-small Cell Lung Cancer Patients Wither-irradiated to a High Dose for Recurrent Disease

As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again using high doses of radiation.

Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and toxicity for patients treated in MAASTRO are unknown at present. This study will provide knowledge on benefit and risks of such a therapeutic approach.

MAASTRO clinic is a leader in the (individual) management of patients with lung cancer. This has resulted in major publications in the past on individualized (chemo)radiotherapy for (NSCLC) \[van Baardwijk 2006 and 2010\]. As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation is also given in curative intent, thus again using high doses of radiation.

Publications on this topic are rare. Most reports address the results of palliative re-irradiation of NSCLC \[Ebara 2007, Jackson 1987, Montebello 1993, Tada 2005\]. The ones available on re-irradiation with curative intent used outdated techniques \[Okamoto 2002, Wu 2003\]. Only one recent publication has analyzed the results of 37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy \[Kruser in press\].

The results of radical re-irradiation applying highly conformal radiation techniques within MAASTRO are unknown. This study will provide knowledge on benefit and risks of such a therapeutic approach. Furthermore, it may provide enough evidence to initiate a Phase II/III clinical trial for re-irradiation of NSCLC patients with curative intent.

Eligibility Criteria:
Patients with advanced stage non-small cell lung cancer treated to higher doses of irradiation (i.e. EQD2\>50Gy) twice: in the primary and recurrent setting.
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers

It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine. This testing is free of hypothesis, because these markers are still unknown. There is no intervention, and it is not possible to establish primary and secondary outcomes.

The rational for the immunological study by LATIM is the observation made by the group that individuals vaccinated with the 17DD yellow fever vaccine show significant alterations on the levels of expression of genes such as CLEC5A, IFNG, IL6, RNASEL, IRF7, IRF9, STAT2 e OAS1 (8). The study which will be conducted by the Rockefeller University will be focused in the qualitative analysis of the genome and exome of volunteers. The study in LATIM will be focused in the quantitative analysis of mRNA, which, together with the results of sequencing, may help in the search for biomarkers. As the expression of mRNA is restricted to the acute phase of the adverse event, it will be done only during the first 30 days after the beginning of the adverse event.

Eligibility Criteria:
Inclusion criteria:

* Evidence of a systemic reaction in two or more organs within one month of vaccination with yellow fever vaccine;
* Laboratory evidence of yellow fever vaccine virus (at least one):

Positive culture for more than 7 days after vaccination; RT-PCR ≥ 3 log10 PFU/mL at any day after vaccination; Positive RT-PCR more than 14 days after vaccination; Presence of vaccine virus in tissue by culture, RT-PCR or immunohistochemistry.

* Laboratory exclusion of relevant differential diagnosis such as leptospirosis, viral hepatitis and arboviruses.
* Cases not obeying these strict criteria but that could be plausibly YEL-AVD or YEL-AND may be included, if approved by the investigator or co-investigators.

Exclusion Criteria:

* Cases with adverse event after yellow fever vaccine not severe.
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
* HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
* Body mass index (BMI) between 27-40 kg/m\^2 (both inclusive)
* Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
* Euthyroid subjects
* Subjects should be unrestrained eaters

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Known or suspected allergy to trial products or related products
* Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* Known or suspected abuse of alcohol or narcotics
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator
11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism

Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of secondary hypertension. The diagnosis and targeted treatment of PA is essential because of high vascular morbidity associated with PA as compared to essential hypertension with comparable blood pressure levels. PA is usually caused by either a unilateral aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction between APA and BAH is critical since the former may be cured by adrenalectomy, and the latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA). Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s) producing the most of aldosterone excess. The distinction between unilateral and bilateral PA can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008 guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning which does not distinguish between aldosterone-producing and common non-functioning adrenal nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive, dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).

Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy, use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1 and 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Biochemically proven PA
* Good general health enabling possible adrenalectomy
* BMI less than 35

Exclusion Criteria:

* Any contraindication for AVS, MTO-PET or CT
* Subjects not willing to consider adrenal surgery
* Pregnancy
* Familial PA
* Suspicion of other tumor than adenoma or hyperplasia in adrenal CT scan
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Saudi Arabia, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
2. Diagnosed with type 2 diabetes mellitus
3. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
4. Male or female, age above or equal to 18 years at the time of signing informed consent
5. Available HbA1c value below or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice
6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of below 14 days

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Treatment with any investigational drug within 30 days prior to enrolment into the study
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects and in Patients With Ischemic Heart Disease

Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects.

This effect might be attributed to caffeine, given that decaffeinated coffee (\<2 mg of caffeine) was not associated with any change in endothelial performance.

In the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects \& in patients with proven ischemic heart disease.

Background:

Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects.

This effect might be attributed to caffeine, given that decaffeinated coffee (\<2 mg of caffeine) was not associated with any change in endothelial performance.

In the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects \& in patients with proven ischemic heart disease.

Aim:

To evaluate the impact of 200 mg caffeine tablet intake (equivalent to 2 cups of coffee), compared to placebo on brachial endothelial function in healthy subjects \& in patients with proven ischemic heart disease.

Methods:

1. Patients will be invited for two endothelial function tests 1 week apart.
2. ECG, heart rate \& blood pressure will be recorded at rest prior to each test.
3. Following overnight fasting and discontinuation of all medications for ≥ 12 hours and absence of \> 48 hour caffeine consumption, patients will receive 200 mg of caffeine tablets or placebo, in a double-blind, cross-over study design. An hour later the patient will undergo endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent, nitroglycerin (NTG)-mediated vasodilation will be assessed non-invasively in the brachial artery, using a high resolution (15 MHz) linear array ultrasound.
4. Prior to and after the FMD, blood will be drawn to test caffeine levels, adiponectin, CBC, electrolytes, CRP and lipids.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented ischemic heart disease
* Healthy subjects who are not heavy regular coffee drinkers

Exclusion Criteria:

* Patients with unstable angina pectoris
* Patients with acute or chronic heart failure
* Patients with cardiac arrhythmia
Absorption of Phenolic Acids From Coffee in Humans

Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and are characterised by a phenol ring in their structure. The phenolic compounds we are going to focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates formed between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant activity (2).

HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet (3) and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few studies suggest protective effects for cardiovascular diseases (5), neurodegenerative diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field are obtained from in vitro and/or in animal, and it is difficult and dangerous to extrapolate between these and risk in humans of development or progression of particular health conditions, more human studies are therefore needed.

We aim to compare people that metabolise the best CGAs from coffee to those that metabolise them the least well. This will be achieved by measuring the metabolites in urine. The effect of CGAs on the human body does not only depend on the amount ingested, but also on the quality of the metabolism, we therefore also want to determine which mechanisms are responsible for inter-individual variations in order to identify any link with health biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.

For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers will be recruited at the School of Food Science \& Nutrition. If they meet the selection criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36 hours, participants won't be allowed to drink coffee, they will be asked to follow a diet low in phenolic acids and keep a record of their meals. On the first day of the study, a single dose of coffee rich in antioxidants will be given to the participant and urine will be collected from that time until 36 hours after coffee consumption. Participants will be followed again after 5 to 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Normal Body Mass Index (BMI) 18-29 kg/m2
* Non-smoker, former or weak smoker (max. 5 cigarettes per day)
* No more than 4 alcoholic units as a regular and daily consumption

Exclusion Criteria:

* diagnosed chronic disease (e.g. pancreas, kidneys, liver, heart)
* haemophilia
* long term prescribed medication (contraceptive medication allowed)
* previous GI (gastrointestinal) tract operation
* pregnant or breast feeding
WatchPAT Compared to PSG at 8500'

Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.

The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a "gold standard"

Eligibility Criteria:
Inclusion Criteria:

* Male and females ≥ age 17yrs
* Subject is able to read understand and sign the informed consent form.
* Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.

Exclusion Criteria:

* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).

  * Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.
Hepatic and Cardiac Metabolic Flexibility in Obese With NAFLD.

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence indicates that NAFLD is associated with development of heart failure, abnormal ventricular glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac involvement and the progression from NAFLD to NASH are poorly understood but must include altered cardiac and intrahepatic lipid handling. In collaboration with renowned research groups from Oxford, Mayo Clinic and Copenhagen investigators plan comprehensive kinetic studies of heart and liver FA uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with NAFLD and NASH and the relationship with heart function. In addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. Investigators will address these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. Effects of acute exercise will be assessed. The overarching goals are to define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG) metabolism and to assess the effect of exercise on both hepatic, cardiac and adipose and skeletal muscle lipid and substrate utilisation.


Eligibility Criteria:
Inclusion Criteria:

* 10 obese subject men/women with NAFLD (MR spectroskopi, fibro scanner) (BMI \> 30).
* 10 obese subject men/women without NAFLD (MR spectroskopi, fibro scanner) (BMI \> 30).
* age between 40-70 years
* Written consent before the start of the study

Exclusion Criteria:

* known current disease
* Fixed Medical drug consumption, statins and antihypertensive drugs (non-beta blocker). However, pause 3 weeks before the examination date
* Blood donation within the last 3 months prior to the study
* Participation in experiments involving radioactive isotopes within the last 6 months
* Alcohol abuse (over 21 items per week for men and 14 for women)
* Smoking
* Weight over 130 kg
* Cancer patients
* Large intake of medication