cyrilzakka/clinical-trials huggingface dataset:
European Postgraduate Training in Geriatric Medicine

The objective of the study is to give a structured update on geriatric postgraduate education throughout Europe. The study will be performed as a cross-sectional structured quantitative online survey with qualitative comments. The survey content covers structural items, content and educational aspects of geriatric specialty training in European countries.

The study is performed as a cross-sectional structured quantitative survey leaving space for qualitative comments. The survey content covers structural items, content and educational aspects of geriatric specialty training in European countries. To prove feasibility in the questionnaire setting and time management the survey will be piloted in five international experts in geriatric medicine. Questions in the survey are closed with the possibility to give a free comment.Validity of individual data collection will be controlled by repeated hidden content within different questions.

Experts in the field of geriatric medicine and members of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS) and a strong personal focus of interest in postgraduate training are contacted by the survey coordinator and invited to participate in the survey personally and via E-mail. The survey will be performed online using the following software (http://www.surveyxact.com/) . To reassure data quality, the survey will be sent for double checks within nations.

Eligibility Criteria:
Inclusion Criteria:

Experts in geriatric medicine and member of one of the organizations European Union of Medical Specialists (UEMS), European Academy for the Medicine of Ageing (EAMA) or European Union Geriatric Medicine Society (EUGMS).

Exclusion Criteria:

none
Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT

In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* lymphoid malignancies
* donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
* patients with ECOG \<3

Exclusion Criteria:

* inform consent not provided
* ECOG \>=3
* poor liver function (enzyme \>2N or bilirubin \>2N)
* poor renal function (Scr \>2N)
* poor cardiac function (EF \<45%)
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
* Infants who are entering their first RSV season at the time of screening

Key Exclusion Criteria:

* Gestational age \< 32 weeks 0 days and \>34 weeks 6 days
* Meets AAP or other local criteria to receive commercial palivizumab
* Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization
* Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
* Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
* Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
Yoga, Aerobic and Stretching Exercise Effects on Neurocognition

The investigators propose to conduct a 6-month 3-arm randomized controlled exercise trial among older adults to compare the efficacy of yoga with aerobic exercise and stretching-toning exercises on cognitive function, brain structure and function, cardiorespiratory fitness, functional fitness, and inflammatory and molecular markers. Using a single-blind, three arm randomized control trial, 168 older adults ages 55-79 will be assigned to either: a Hatha yoga group, an aerobic exercise group or an active stretching and toning control group. The groups will engage in hour-long group exercise sessions 3x/week. A comprehensive neurocognitive test battery, brain imaging, cardiovascular fitness test, and a blood draw will take place at baseline; end of the 6-month intervention, and at 12-month follow-up.

The proposed work will examine the relationship between yoga training and improved cognitive functioning as well as identify neurobiological correlates as potential mechanisms of action through which yoga training exerts its effect on cognitive function.

COVID-19 Precautions: Due to COVID-19, all exercise sessions will be conducted live via Zoom video-conferencing such that 1/3rd of the participants in each group will exercise in person with the research staff at UIUC campus once a week while the remaining 2/3rd will tune in via Zoom


Eligibility Criteria:
Inclusion Criteria:

* 55-79 years of age at study enrollment
* TICS-M score of 32 or higher
* No current or past diagnosis of mild cognitive impairment or dementias
* Low-active (≤ 2 days of 30 minutes of structured exercise/week)
* Physician's consent to participate in VO2max testing and the exercise program
* Ambulatory
* Absence of health conditions that may be exacerbated by exercise
* Good or corrected vision and hearing
* No MRI contraindications (e.g. metal or implanted devices in the body)
* Right-handed
* Intention to remain in the Champaign-Urbana area over the study duration

Exclusion Criteria:

* Below 55 or above 79 years of age at study enrollment
* TICS-M score of 31 or lower
* Current or past diagnosis of mild cognitive impairment or dementias
* High-active (3 or more days of 30 minutes of structured exercise/week)
* Physician's non-consent to participate in VO2max testing and the exercise program
* Non-ambulatory (use of wheelchairs or walkers)
* Presence of health conditions that may be exacerbated by exercise
* Poor vision and hearing
* MRI contraindications (e.g. metal or implanted devices in the body)
* Left-handed
* Plans to travel outside of Champaign-Urbana area during the study
R230C and C230C Variants of ABCA1 and Glyburide Response

The objective of the study is to know if the R230C and C230C variants of the ATP-binding cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect compared to the wild type allele (R230R) in patients with type 2 diabetes.

Specific objectives:

1. In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following continuous variables:

   * Fasting glucose
   * Percentage reduction
   * Hemoglobin A1c,
   * Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol
   * Weight
2. In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following binomial variables:

   * Number of cases that reach fasting plasma glucose lower than 110 mg/dl
   * Number of cases that reach an HbA1c less than 7%

Eligibility Criteria:
Inclusion Criteria:

* Adults 20 to 79 years
* Body mass index \>18 and 39.9 ≤
* Men or women
* Mexicans mestizos.
* Moderate hyperglycemia (126 to 250 mg/dl and HbA1c levels between 7 and 10%) despite being treated with a dietary program in combination or not with metformin (2 g/d).

Exclusion Criteria:

* Patients with chronic complications of diabetes: ischemic heart disease, stroke, proliferative retinopathy or blindness, albuminuria, chronic diarrhea, gastroparesis, non-traumatic amputation of lower limbs.
* Patients with any monogenic syndrome, obesity, diabetes or hypoalphalipoproteinemia
* Patients with acquired diseases that produce secondarily obesity or diabetes.
* Treatment with anorexigenics or accelerate weight loss at the time of the selection.
* Cardiovascular event in the 6 months prior to study entry.
* Steroids, chemotherapy, immunosuppressive or radiotherapy.
* Infections or concurrent acute diseases.
* Catabolic diseases such as cancer or AIDS
* Pregnancy
Glaucoma Screening

* The primary objective of this study is to evaluate the diagnostic accuracy of the TEMPO (iMOvifa) visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test.
* The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.


Eligibility Criteria:
Inclusion Criteria (All subjects):

* Subjects 40 years of age or older on the date of informed consent.
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
* BCVA 20/40 or better in both eyes.

Inclusion Criteria- Normal Population

* IOP ≤ 21 mmHg
* Healthy anterior and posterior segment evaluation on clinical examination.

Inclusion Criteria - Pathology Population

• Diagnosis of glaucoma on clinical examination.

Exclusion Criteria (All subjects):

* Unable to tolerate ophthalmic imaging and/or diagnostic testing.
* History of intraocular surgery (uncomplicated surgeries are accepted).
* Ocular diseases including uveitis, non-glaucomatous optic neuropathy, severe or proliferative diabetic/ hypertensive retinopathy (controlled diabetes and hypertension participants with no or mild to moderate retinopathy \[not involving the macula\] can be included), unresolved trauma.
* Any neurodegenerative diseases including Alzheimer, Parkinson, or dementia, or history of stroke.
* Unreliable VF testing and/or poor-quality OCT scans.
* Poor fixation.
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.

Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

To characterize, in routine practice, non compliant patient to continuous positive airway pressure who can get a benefit of a bilevel positive airway pressure therapy as a second line treatment (Aircurve 10 VAutoTM ) To evaluate the clinical management of obstructive sleep apnea patients treated by Aircurve 10 VAutoTM , especially impact on compliance and residual apnea hypopnea Index.

To evaluate Aircurve 10 VAutoTM benefit on quality of Life and quality of sleep

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy
* Patient naive of bilevel Positive Airway Pressure therapy

Exclusion Criteria:

* Bilevel positive airway pressure Contraindication
* Severe respiratory disease diagnostic
The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers

Double blind, randomized, placebo control, multiple dose, dose escalation study

A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289 in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* 19\~55 years healthy male
* BMI measurement 20kg/m²\~27kg/m²
* 90 ≤ SBP\<140(mmHg) 60 ≤ DBP\<100(mmHg) 45 ≤ Pulse rate\<100(bpm)
* Signed the informed consent form to participate voluntarily and to comply with the trial requirements
* For a follow-up visit and during the study period, blood samples and availability

Exclusion Criteria:

* History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer)
* History of skin disease of graft affecting absorption of the drug
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 60 days of the screening test
* Donated blood within 60 days prior to screening test
Effects of Aleurone-enriched Products on Cardiovascular Risk Factors

Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total antioxidant status or endothelial function, whereas an improvement of C-reactive protein was observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of aleurone-enriched products with higher ferulic acid biodisponibility and longer time of treatment could influence these parameters in individuals with metabolic syndrome. Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which aleurone may act in vivo are still unknown.

The aim of this study is to investigate whether 8 weeks supplementation with aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese subjects with high cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese subjects of both gender
* Age range between 20 and 70 years
* High cardiovascular and metabolic risk profile will be enrolled in the study
* Waist circumference \> 102 cm for men, and \> 88 cm for women
* At least one of the characteristics of the metabolic syndrome according to the NCEP/ATP III criteria:

  * Fasting triglycerides ≥150 mg/dl
  * High-density lipoprotein cholesterol \<40 mg/dl (men)/\<50 mg/dl (women)
  * Blood pressure ≥ 130/85 mmHg
  * Fasting glucose ≥100 mg/dl

Exclusion Criteria:

* Age \<20 and \>70 years
* Fasting triglycerides ≥400 mg/dl
* Fasting cholesterol \>270 mg/dl
* Cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; established diabetes mellitus or any chronic disease
* Renal and liver failure (creatinine \>1.7 mg/dl and ALT/AST \>2 times than normal values, respectively)
* Anaemia (Hb \<12 g /dl)
* Any chronic disease
* People treated with antihypertensive drugs will have to keep the type and dosage of medication unchanged during the whole study period
Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment

Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. The most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. In clinical examination, both can appear very thin and transparent.

Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age.
* Ophthalmoscopic evidence of RS or RD
* Written informed consent has been obtained.

Exclusion Criteria:

* Progression of retinal detachment or retinoschisis requiring surgical treatment
* Contraindication to pupil dilation, known allergy.
Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients

Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.

Patient will be selected from the ICU, based on the defined inclusion and exclusion criteria. Potential study subjects will be screened by the research fellow or the on-site study co-investigator. Eligible patients will be allocated to receive propofol sedation titrated to 3 different BIS levels in a random order. BIS XP monitors (Aspect Medical Systems, Norwood, MA, USA) will be used which are relatively resistant to EMG artifact; a BIS sensor will be position on forehead of the patient after the skin is degreased and gently abraded. Esophageal pressure monitoring will be performed by a catheter inserted from the nose to the esophagus and left there trough the study period.

If patients are on sedation they will be placed on propofol sedation for a washout period. Each patient will receive propofol sedation by continuous infusion titrated to a different levels of BIS in a randomized fashion according to a computer-generated random-number sequence;

1. BIS levels of 70, will be targeted (Anxiolysis/high-frequency EEG activity, beta-augmentation);
2. BIS levels of 50 will be targeted, (Low frequency EEG activity, theta-delta activity);
3. BIS levels of 35 will be targeted (low frequency EEG activity). A propofol infusion will be titrated by the investigators to the designated BIS target according to randomization. Clinical personnel will not be blinded to the study, and if patient has clinically significant change in hemodynamic parameters study will be interrupted. Each BIS target level will be kept as constant as possible for at least one hour; thereafter, lower esophageal pressures will be recorded for 15 minutes using high resolution esophageal manometry. Studies will be done in supine position \[Most ICU patients are now kept head-up.\], and the manometric assembly will be positioned to record from the hypopharynx to the stomach with 4-6 of the sensors positioned in the stomach.

All patients will otherwise receive routine ICU care and medications without interruption of standard clinical care.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Written informed consent from relatives
* Clinically stable
* Mechanically ventilated \< 2days
* Require sedation and expected to be given propofol

Exclusion Criteria:

* Recent injury or other pathologic condition of the esophagus
* Major bronchopleural fistula
* History of liver failure
* History of renal failure
* History of major neuromuscular disease
* Multiple trauma
* Upper motor nerve injury
* Hypersensitivity to propofol
* Recent gastrointestinal surgery
* Patients with a diagnosed or suspected condition that may give false results in BIS monitoring.
* Tracheostomized patients
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome

Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating tachycardia upon postural changes such as standing that impairs their quality of life. Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120 beats/min within the first ten minutes of a diagnostic tilt table test without postural hypotension. There are currently no effective treatment methods for POTS. However, several studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has been also used for treatment of inappropriate sinus tachycardia with good benefit. The hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve functional status in patients with POTS.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-65.
* Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE\> 600pg/ml))
* Subjects with no structural heart disease
* Subject with no arrhythmias
* Subjects with norepinephrine levels greater than 600 pg/ml
* Subjects with normal CBC, Metabolic, and thyroid levels

Exclusion Criteria:

* Thyroid or adrenal disorders
* Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)
* Presentation of peripheral edema and discolored toes with peripheral autonomic neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color), legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)
* Subjects who have had a history of systemic illnesses (acute or chronic infectious); autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness
* Subjects with resting heart rate\< 60beats/min, atrial fibrillation, advanced AV blocks, sinus disease, and acute decompensated heart failure and severe hepatic impairment.
* Smokers or alcohol abuse
* Pregnant or breastfeeding mothers
* Woman of childbearing potential who are unwilling to use highly effective contraception during treatment and for an additional one month after discontinuing the study drug