cyrilzakka/clinical-trials huggingface dataset:
The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes

There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation.

Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* HbA1C \>6%

Exclusion Criteria:

* Insulin therapy (except: BOT=basal supported oral therapy)
* Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery
* Known intolerance against niacins
* Known contra-indications against magnetic resonance (MR-) examinations
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.

Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant.

Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants at least 1 week of age
* no active disease or treatment (like respiratory support)
* place in incubator

Exclusion Criteria:

* active disease or treatment
Guided Meditation During Radiotherapy.

The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment.

This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
* Willing to attend MBI sessions weekly during RT
* Able to transport themselves to scheduled MBI sessions in the DAHLC
* Able to complete questionnaire(s) by themselves
* Native English speaker (MBI sessions, videos, and QOL questionnaires are only available in English)
* ECOG Performance Status 0-2

Exclusion Criteria:

* Prescribed a course of RT with fewer than 15 consecutive, daily fractions
* Unable or unwilling to attend required MBI sessions
Study of Danggui Buxue Decoction in Preventing Neutropenia

To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Women aged ≥18 years and \< 70 years; Histologically confirmed invasive breast cancer by core needle biopsy, suggested to receive EC/TC regiments for adjuvant chemotherapy by MDT; Leukocyte ≥ 3\*109/L; Neutrophil ≥ 1.5\*109/L; PLT ≥ 100\*109/L; Serum AST/SGOT or ALT/AGPT ≤ 2.5 times of upper limit of normal (UNL) range Serum creatinine/BUN ≤ upper limit of normal (UNL) range; No dysphagia, be able to take the Danggui Buxue Decoction(DBD) Written informed consent according to the local ethics committee requirements. Has ECOG Performance Score 0-1;

Exclusion Criteria:

Metastatic breast cancer; Family history of endometrial cancer or any other kind of gynecologic cancer; Patients with severe co-morbidity that indicate intolerant to adjuvant chemotherapy; patients with psychiatric disorder or other diseases leading to incompliance to the therapy; Known severe hypersensitivity to any drugs in this study; Prior adjuvant chemotherapy of any kind cancer; Hematologic disorders relative to aplasia
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.

Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be male and have a pathological diagnosis of prostate cancer
* Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
* No treatment (surgery, radiation, or hormones) prior to study entry.
* PSA between 2.0 and 10.0 ng/ml.
* If PSA is \>10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
* No known allergy to soy or soy products.
* The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
* Participant has not been on any previous GCP clinical trial.
* Normal Chemistry values prior to study entry.

Exclusion Criteria:

* No pathological documentation of prostate cancer.
* Prior treatment for prostate cancer.
* PSA \>10.0 ng/ml but not on Active Surveillance for 12 months.
* Allergy to soy or soy products.
* Abnormal chemistry values.
FeNO After Hypoxia in Asthma Patients

Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic chamber simulating 2800m above sea level. Study participants will be blinded to the treatment given and divided into a hypoxic and a sham group (about 360m above sea level).

Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before and after the study. Secondary endpoints include blood parameters, lung function testing and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* stable Asthma (GINA 1-2)

Exclusion Criteria:

* autoimmune disease
* unstable Asthma (GINA 3-4)
* history of pneumonia/fever within 3 months
* place of residence \>1000m above sea level
* trip/vacation above \>2500m within 4 weeks
* cystic fibrosis
* diabetes mellitus
* immunodeficiency
* atopic dermatitis
* ciliary dyskinesia
* pregnancy
* chronic obstructive pulmonary disease
* history of smoking (\>1py)
* immunosuppression / systemic corticosteroids within 3 months
* cardiovascular diseases
* interstitial lung disease
* bronchopulmonary dysplasia
Mechanochemical Ablation vs Thermal Ablation

Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.

During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study.

Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.

The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.

During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.

At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* clinical classification of venous disease C2-C4
* ultrasound-verified reflux in the GSV
* mean GSV diameter in the thigh between 5 and 12 millimetres
* informed consent.

Exclusion Criteria:

* body mass index (BMI) of over 40
* peripheral arterial disease
* lymphoedema
* pregnancy
* allergy to either the sclerosant or lidocaine
* severe general illness
* malignancy
* previous deep venous thrombosis
* previous varicose vein intervention in the same leg
* coagulation disorders
Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis

Infliximab is a chimeric monoclonal antibody directed towards Tumor Necrosis Factor -alpha that is largely used in inflammatory diseases such as rheumatoid arthritis (RA).

A relationship between dose and clinical outcomes was shown in populations of RA patients but there is an interindividual variability of this relationship. At an individual level, this dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or PK) and the concentration-effet (pharmacokinetic-pharmacodynamic or PK-PD) relationships.

Serum trough concentrations of infliximab have been shown to be variable between patients receiving the same treatment regimen. This PK variability may be explained by several factors (e.g. genetic and immunological factors). The concentration-effect relationship may also be variable and the sources of this variability need to be studied as well. To date no detailed infliximab PK analysis has been published. The sources of variability of the dose-effect relationship need to be characterized to optimize infliximab dosing regimen in patients.

The FAKIR study is a multicenter prospective observational study that will focus on patients treated with infliximab. Its aims are:

1. to characterize the PK and PK-PD variability of infliximab in RA, using clinical criteria and biomarkers, assessed over time ;
2. to study the influence of the polymorphism of FCGRT (the gene encoding FcRn) on the PK variability of infliximab; to study the influence of the polymorphism of FCGR3A (the gene encoding Fc gamma RIIIa) on the PK-PD variability of infliximab; and to study the influence of antibodies toward infliximab on the PK and PK-PD variabilities of infliximab.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis according to ACR criteria
* Patient already receiving infliximab for more than 14 weeks
* No modification of the dose regimen of infliximab since the last infusion
* No modification of disease modifying anti rheumatic drugs since the last 4 weeks

Exclusion Criteria:

* Surgery scheduled during the duration of the study
* Pregnancy
* infection, malignancy, immune reaction to infliximab or demyelinating diseases
Diagnostic Performance of a New Method for the Echocardiographic Assessment of Coronary Arteries Abnormalities

Coronary artery anomalies (CAA) are a rare congenital condition, accounting abnormalities of origin, course, destination, size, and number of the coronary vessels. In normal hearts, the coronary arteries, the left and right coronary arteries (LCA and RCA, respectively) originate from the two facing aortic sinuses of Valsalva, so-called left and right. To overcome the echocardiographic limitations, the investigators designed, studied and implemented in our Institute a specific echocardiographic-based two-dimensional non-Doppler 4-views approach for the diagnosis of CAA.

The method consisted of 4-CAA-focused specific views, routinely available from any echocardiographic exam: parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 4/5-chambers views. PSAX, the traditional approach, along with the PLAX, and the apical 4/5-chambers views.

A hallmark of CAA was considered the absence of a proper visualization of the origin of the coronary arteries from the aortic root. In addition, the presence of the ring sign, visualized from the PLAX was considered as abnormal. This sign is of interest when an aberrant left or right CAA is suspected. A coronary artery originating from the contralateral aortic sinus, along its intramural course, crosses the mid-anterior line of the circular aorta to reach the sinus of Valsalva of its intended origin. Consequently, its cross-section should be visible in an orthogonal view traversing the mid-long axis of the aorta, namely the parasternal long-axis view.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing their first echocardiographic examination

Exclusion Criteria:

* already known congenital heart disease and cardiomyopathies
Geriatric Education and Its Effect on Certain Aspects of Hospital Care of the Nursing Home Patients - 12 Month Retrospective Study

Nursing home patients admitted to the hospital poses significant challenge for health care providers. Geriatric teaching pays particular attention to these admissions and related problems. However, it yet to be proven, that geriatric training helps to overcome any of them in better way then non-geriatric education. The study aims to prove that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital.

Context Nursing home patients admitted to the hospital poses significant challenge for health care providers. Geriatric age, frailty, multiple readmissions, prolonged length of stay, and high mortality are just few attributes of nursing home patients in the hospital. Geriatric teaching pays particular attention to these challenging problems. However, it yet to be proven, that geriatric training helps to overcome any of them in better way then non-geriatric education.

Objective To test the hypothesis that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital in regards to length of stay, rate of expirations and rate of readmissions. The secondary objective is to compare expirations and readmissions among patients cared for by geriatricians and non-geriatricians.

Design, Setting, and Participants Retrospective cohort study of patients admitted from Metropolitan Jewish Geriatric Nursing Home (MJGNH) to Maimonides Medical Center (MMC) over 12 month period and under the care of geriatricians, non-geriatric internists, and surgeons. Comparison of the three study groups by age, sex, expiration rate, length of hospital stay (LOS) and readmission rate. Comparison of expired patients by age, sex and average LOS. Comparison of readmissions expiration rate, by preservation of continuity of care, by emergency room visits without admission.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to Maimonides Medical Center (MMC) from affiliated Metropolitan Jewish Geriatric Nursing Home (MJGNH)for '12 month period.

Exclusion Criteria:

* none
Safety and Tolerability Study of N6022 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.

This is a single dose escalation, first-time-in-human study with three ascending cohorts. Eligible subjects will receive a single dose of investigational medicinal product or placebo on Day 1 and will be followed for safety, PK, and PD for 72 hours post dose. Follow-up visits on Day 4 and Day 7 for the end-of-study safety. Participation of an individual subject may last up to 36 days from the time of screening until the end-of-study follow-up visit. Each cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These subjects will be followed for 48 hours postdose and safety data reviewed before the remaining subjects in the cohort receive IMP. A Safety Monitoring Committee will review the seven-day safety data in each cohort before proceeding to the next ascending dose cohort, according to the stopping rules outlined in the protocol.

Eligibility Criteria:
Inclusion:

* Subject is healthy

Exclusion:

* Subject is a current alcohol abuser and/or has a history of illicit drug abuse within six months of entry.
* Subject has donated blood (\> 500 mL) or blood products within 56 days prior to Day -1
PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease

To evaluate PK and PD responses to L-citrulline given orally for four weeks to patients with sickle cell disease who are otherwise healthy.

Phase 1, single center, open label, multiple-dose study consisting of a screening period followed by four weeks of treatment. At least 12 male and female patients, 10 years of age or older, with sickle cell disease but otherwise healthy, will be enrolled in the study.

PK measurements include plasma concentrations of L-citrulline, L-arginine, L-ornithine, and L-proline following the first dose of orally administered L-citrulline and after four weeks of twice daily administration of the drug.

PD measurements include intercellular and vascular adhesion molecules (ICAM, VCAM, and E-selectin), surrogate markers of sickle cell disease activity, and PAT, a measurement of vascular function.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 10 years of age or older on the day of dosing, and generally healthy as determined by medical history, physical examination, and laboratory test values
2. Diagnosis of sickle cell anemia (Hb SS)
3. For female of child-bearing potential, a negative serum pregnancy test and using an adequate method of contraception
4. Has signed and received a copy of the written informed consent form approved by the investigator's Institutional Review Board (IRB), understands the purposes and risks of the study and agrees to follow the restrictions and schedule of procedures as defined by this protocol

Exclusion Criteria:

1. History of sickle-cell-related pain crisis within two weeks of study
2. Pregnant or breast feeding
3. Transfusion within last 90 days
4. Creatinine \>1.5 X upper limit of normal
5. SGPT \> 2 X upper limit of normal
6. History of allergic reaction to arginine or citrulline product
7. Requires chronic medication other than study drug that cannot be discontinued during the study period
8. Unable to take or tolerate oral medications
9. Unreliable venous access
10. Noncompliant with regular care
11. Participation in an investigational drug or medical device study within previous 30 days
12. In the opinion of the investigator is not a good candidate for participation in the study
Precisely Estimation of the Prognostic Value of Lymph Node in ESCC

Data were collected on a large multi-institution dataset consisting of ESCC patients who underwent surgery between January 2003 and December 2013 at ten institutions in the People's Republic of China. The datasets were approved for research by the institutional review board of each participating center. Prior to surgery, all patients received computerised tomography (CT) of the chest and abdomen and EUS as part of their routine staging workup. Patients received whole body FDG-PET to eliminate the possibility of distant metastases if the attending physician considered it was necessary. All patients in the dataset received a surgical R0 resection; patients who received an R1 or R2 resection were excluded. Notably, there is nothing approaching a consensus on the extent of lymph node dissection for ESCC patients. Patients who received neoadjuvant therapy were excluded due to the influence of neoadjuvant therapy on lymph node status and pathologic T stage. The primary endpoints were overall survival (OS), which was defined as the time between surgical resection and death from any cause, and cancer-specific survival (CSS), defined as the time from surgical resection to death caused by ESCC. After receiving esophagectomy, patients were followed up by clinical examination every three months for the first year, every three to six months for the second year, and every six to twelve months from then on.


Eligibility Criteria:
Inclusion Criteria:

1. Minimum age: 18 years
2. Patients underwent R0 resection and lymphadenectomy.
3. ECOG PS less than or equal 2
4. Adequate bone marrow function: Leukocytes \> 3,5 x 10\^9/L Absolute neutrophil count \> 1,5 x 10\^9/L Platelet count \> 100 x 10\^9/L Hemoglobin \> 10 g/dl
5. Adequate hepatic function: Total bilirubin \< 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT \< 3 x ULN 7. Serum creatinine \< 1,5 mg/dl, creatinine-clearance \> 50 ml/min
6. Written informed consent before randomization

Exclusion Criteria:

1. R1 or R2 resection
2. Patients underwent neoadjuvant therapy
3. Fertile patients without adequate contraception during therapy
4. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
5. History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:\* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; \* active uncontrolled intercurrent infections or sepsis
6. Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
Complementary Effect of Reflexology on Chemotherapy-Induced Nausea and Vomiting

Reflexology treatment may influence the severity of chemotherapy-induced nausea and vomiting. This study aims to investigate the clinical effect of reflexology on chemotherapy-induced nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy patients

Exclusion Criteria:

* Myocardial Infarction in previous 6 months
* Mechanical colonic obstruction