cyrilzakka/clinical-trials huggingface dataset:
Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices

Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely described. Thus the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

When pharmacological therapy becomes insufficient in advanced end-stage heart failure (HF) transplantation remains the gold standard of therapies. However, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. Mechanical circulatory support in the form of a CF-LVAD is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. Implantation with a CF-LVAD increases survival and improves quality of life, but peak oxygen uptake (peak VO2) remains severely reduced post-implant. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. Furthermore a fixed CF-LVAD pump speed prevents adequate circulatory support during strenuous exercise. The effects of late right ventricular (RV) failure on exercise capacity and quality of life (QOL) is, however, unknown and the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients from Department of Cardiology, Rigshospitalet, Denmark.
* Age ≥ 18 years.
* Ischemic or non-ischemic cardiomyopathy.
* Signed informed consent.

Exclusion Criteria:

* Unstable patients with the need for intravenous inotropic therapy.
* CF-LVAD implantation less than one month ago.
* eGFR \< 45 ml/min.
* Contrast allergy.
Procalcitonin to Shorten Antibiotics Duration in ICU Patients

The trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior outcome as compared to the conventional therapy

The duration of antibiotic therapy in patients with sepsis is largely empirical. An extended treatment course for up to two weeks is a common practice for patients with sepsis in the ICU, despite lack of evidence for this duration of therapy.

Procalcitonin (PCT) is a new biomarker that has high negative predictive value for systemic bacterial infection. The purpose of this trial is to evaluate whether serial PCT measurements can shorten antibiotic treatment duration in patients with sepsis in the ICU.

Specific Aims

1. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients
2. To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

Eligibility Criteria:
Inclusion Criteria:

* All patients with laboratory- or image-confirmed severe infection at admission or during stay in ICU will be eligible for inclusion.

Definition of laboratory- or image-confirmed severe infection:

1. Two or more of four Signs of Inflammation

   * Temperature \> 38.3℃ or \< 36℃
   * Heart rate \> 90 beats/min
   * Respiratory rate \> 20 breaths/min or PaCO2 \< 32 mmHg
   * WBC \> 12,000 cells/mm3, \< 4000 cells/mm3, or \> 10% bands
2. Initial Procalcitonin \> 0.5 ng/mL
3. Presence of either laboratory or image evidence of infection

Laboratory evidence:

Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess

Image evidence:

Compatible findings on Chest X ray、ultrasound、CT、or MR image

Exclusion Criteria:

* Age less than 20 years
* Known pregnancy
* Presence of DNR order
* Expected ICU stay less than 3 days
* Neutropenia (ANC count \< 500/mm3)
* Specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis
EEG Changes During Induction of Propofol Anesthesia

PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol.

PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol. EEG changes are investigated in different levels of anesthesia from awake state to deep anesthesia in which burst suppression pattern (BSP) is seen in the EEG. Furthermore, the relation of EEG changes and clinically evaluated depth of anesthesia is studied.

The study population is comprised of neurologically healthy individuals who come to the hospital for elective surgery requiring general anesthesia. The patients will not receive any pre-medication. They will give a written consent to participate to the study. During induction of anesthesia, the vital signs will be monitored using the standard protocol of the operating room. EEG will be recorded using a wireless measurement device. The EEG is observed during the recording from a laptop or tablet computer. The anesthesia is induced using propofol with a fixed infusion rate of 30 mg/kg/h. The patient is asked to squeeze the anesthetist's hand repeatedly every 10 s. The moment at which the patients does not respond to the command anymore is considered as the loss of consciousness. The infusion is continued until BSP is observed in the EEG. The infusion is then continued for 3 min after which the recording of EEG is stopped. The administration of anesthesia is then continued as required by the operation.

The EEG recording will be carried out using two different devices. The first dataset, including 20 patients, will be collected using Bittium BrainStatus EEG electrode and device. The second dataset, including 30 patients, will be collected using Nihon Kohden CerebAir device.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 (no neurological or cardiovascular diseases)

Exclusion Criteria

* BMI \> 30
Comparison of Auto-Adjusting Positive Airway Pressure Devices

Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.


Eligibility Criteria:
Inclusion Criteria:

* Males aged ≥ 18 years
* Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
* Naive to CPAP therapy
* Participants willing and able to give written informed consent

Exclusion Criteria:

* Participants requiring Bi-level PAP
* Participants requiring supplemental oxygen
* Participants who are pregnant
* Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
Eye Movements and Reading Disabilities

The mechanism of the eye movement anomalies seen in dyslexic patients is not well defined. Some optometrists use observational eye movement tests as screening devices for dyslexia and advocate eye movement therapy as a treatment option for dyslexia. The reliability of the clinical eye movement tests and the efficacy of the eye movement therapies have not been determined.

Saccades are the fast eye movements that move our eyes from one word to the next when we read. The eye movement recordings from patients diagnosed with reading disorders, extra ocular muscle imbalances and control patients (no learning disability or eye movement disorder) will be analyzed and compared. The sensitivity and specificity of detecting reading disorders will be determined for the Visagraph III and the Readalyzer. Although these clinical tests are frequently used to diagnose saccadic inaccuracies and diagnose dyslexia in school aged children, the validity of these clinical screening tests has not been determined.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 7 to 13 (Must be in at least 2nd grade, but not higher than 8th grade) 2. Complete ophthalmic examination performed by a pediatric ophthalmologist and orthoptist.

  3. All ocular structures must be within normal limits. 4. Best corrected visual acuity must be equal to or better than 20/30 in each eye.

  5. Group 1:
  1. Children with a reading disability must be given the diagnosis by a clinical educational specialist, educational psychologist or neuro-behavioral psychologist.
  2. Children with a reading disability may not have any ophthalmic anomaly determined by testing as described above. This includes but is not limited to amblyopia, strabismus, nystagmus, or any organic disease.

     6. Group 2

  a. Eye movement disorder confirmed by testing by a pediatric ophthalmologist and/or orthoptist b. All other ocular structures must be within normal limits (including visual acuity).

  7. Group 3:
  1. No evidence of reading disability, attention deficit disorder or ocular anomaly, including eye muscle or movement disorder as specified above.

     Exclusion Criteria:
* 1. Myopia more than - 6.00 diopters (spherical equivalent) in either eye. 2. Hyperopia more than + 6.00 diopters (spherical equivalent) in either eye. 3. History of vision therapy or orthoptic treatment 4. Any ocular anomaly with the exception of eye movement disorder for group 2.
SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia

Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.

Combined niacin and a statin treatment has greater potential value than either agent alone for the dyslipidemia of insulin resistance, obesity and the metabolic syndrome. The efficacy of Slo-Niacin and atorvastatin has not been formally examined in this setting.

Methods: Forty-four dyslipidemic men and women (LDL-C \>130mg/dL and below average HDL-C (\<55 in women and \<45 in men) were randomized to a 3 month course of atorvastatin 10 mg or Slo-Niacin increased monthly at doses of 500, 1000 and 1500 mg/day. The alternate drug was added in the second 3-month segment. Lipid profiles and transaminase measurements were obtained monthly and full lipoprotein quantifications, apoproteins, remnant like lipoproteins (RLP), LDL buoyancy, glucose, insulin, and C-reactive protein were measured at the end of each 3-month sequence. Results: Mean entry lipids were (mg/dL) TG 187, LDL-C 171, HDL-C 39. Mean BMI was 32.6 Kg/M2. When Slo-Niacin and atorvastatin were given alone, respective decreases in triglyceride (TG) were 18% and 10%, LDL-C 12% and 36% and non-HDL-C 15% and 36%. HDL-C increased 8% and 6%, respectively. Combined therapy decreased median TG 33% and mean LDL-C 43% and increased mean HDL-C 10%. Mean hs CRP decreased 23% and RLP 44.5% in the combined groups. Conclusions: Slo-Niacin with atorvastatin improves all lipoprotein fractions, RLP and hsCRP in combined hyperlipidemia. The reduction of LDL with the drug combination is equivalent to that obtained with 20-80 mg of atorvastatin alone.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C \> 130 mg/dL
* HDL-C \<= 45 mg/dL in men and \<= 55 mg/dL in women

Exclusion Criteria:

* history of hypersensitivity to any statin, niacin or aspirin
* diagnosis of diabetes or a fasting glucose \> 125 mg/dL
* hyper or hypothyroidism (unless treatment stable)
* meet other health, medication, and logistical criteria
Autoimmunity in the Pathogenesis of AF

This research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.

The study sets out to identify an explanation for the pathogenesis of AF, potentially forming the basis for designing novel targeted therapies to prevent or reverse this prevalent human disease. The overall objectives are to determine whether autoimmune diseases are associated with AF development and to identify specific diagnostic and prognostic biomarkers that will improve the ability to accurately predict risk of AF development. The study will prospectively enroll patients with and without AF and determine their serum cytokine levels and assess the functional responses of T cells on the basis of cytokine production after in vitro T-cell specific stimulation, using Luminex bead-based multiplex technology.

Eligibility Criteria:
Inclusion Criteria:

* Cases: AF (Persistent, paroxysmal AF)
* Controls 1: (No prior history of AF or inflammatory or autoimmune diseases)
* Controls 2: (biopsy proven Psoriasis)

Exclusion Criteria:

* Clinically apparent acute infections over the past 4 weeks
* Chronic infections
* Recent malignancies
* Recent Radiation or chemotherapy
* Chronic kidney disease (≥ stage 2)
* Organ transplantation
* History of chronic liver disease
* Major surgery or invasive procedure in the past 6 months
* Internal prosthesis
* Receiving immunosuppressive therapy
* Known rheumatologic diseases (except for the participants with psoriasis)
* Females who are known to be pregnant
Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma

the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.

Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)

Eligibility Criteria:
Inclusion Criteria:

* age between 40 and 75 years;
* diagnosis of primary OAG (POAG) from, at least, 3 years;
* visual acuity \> 0.7 (7/10) decimals;
* refractive error \< 5 D (spheric) and \< 2D (toric);
* transparent diopter means (cornea and lens);
* controlled IOP (\<18 mmHg, morning value) with beta-blockers and prostaglandin analogues as monotherapy or as associative therapy (fixed or unfixed);
* stable IOP\<18 mmHg in the last 2 years;
* stable and unchanged topical therapy in the last 6 months;
* stable disease in the last 2 years (no more than -1 dB/year at MD of visual field);
* at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm -SITA- Standard) per year in the last 2 years;
* early to moderate visual field defect (MD \<12 dB);
* electrophysiological (PERG) parameters alterations similar to glaucomatous pathology;
* written consent to participate to study procedures and data utilization in an anonymous form

Exclusion Criteria:

* ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;
* congenital glaucoma; secondary glaucoma; normal tension glaucoma;
* history of recurrent uveitis/scleritis/herpes infection;
* pregnancy and breastfeeding;
* contraindication to Citicoline and/or Homotaurine
* contraindication to beta-blockers and prostaglandine analogues
* topical therapy with Brimonidine monotherapy or fixed combination (with timolol or brinzolamide)
* topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment
* systemic therapies affecting patients' performance in visual field examination (sedatives);
* glaucomatous scotomas within 10 degree from fixation
* any condition limiting the patient's ability to participate in the study;
* other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy;
* other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders;
* cerebral ischemia in the last 2 years
* any change in topical therapy in the 6 months prior to enrollment or during the study period concomitant participation to another clinical trial
* any previous filtering and/or retinal surgery;
* cataract surgery in the last 6 months;
* any previous laser treatment for glaucoma in the last 5 years
Hemoglobin and Iron Recovery Study

The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (\<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.

The effect of taking iron supplements after blood donation on time to recovery of hemoglobin has been documented but it is not clear whether the benefits of iron supplements vary with age, gender or iron stores. To study this issue, individuals who are eligible to donate blood, based on hemoglobin level, will be randomized to receive daily iron supplements or no supplements. Randomization will be stratified on gender (male or female), age (\<60 years old vs. at least 60 years old) and iron status (serum ferritin \>26 vs serum ferritin no greater than 26). Subjects will be followed for 24 weeks with periodic blood draws to determine time to recovery of hemoglobin and iron stores. A 7 ml (about 1.5 teaspoons) blood sample will be drawn at each of seven study visits over the 24 weeks to track recovery of hemoglobin and iron.

Eligibility Criteria:
Inclusion Criteria:

* potential blood donors with hemoglobin of at least 12.5 gm/dL
* no blood donation for at least 4 months
* successful donation of a unit of whole blood

Exclusion Criteria:

* individuals who are taking iron supplements including multivitamins containing iron and refuse to stop do so for the 24 weeks of the study.
* baseline ferritin \>300 ug/L (to exclude individuals with hemochromatosis)
Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.

This is a phase III study for evaluation of Nasotestt efficacy compared to Androgel in the treatment of male participants with hypogonadism condition (reduced levels of testosterone) that have clinical indication of hormonal replacement with testosterone.

This efficacy and safety study will evaluate the superiority of Nasotestt (nasal gel) treatment compared to Androgel (topic gel) after 60 days of starting use. The efficacy endpoint will be verified through the percentage of participants which presented at the end of 60 days normalized levels of total testosterone (\<300 ng/dL to \>1050 ng/dL). Secondary efficacy endpoints will be collected throughout the study through: evaluation of symptoms of erectile dysfunction (The International Index of Erectile Function - IIEF), symptoms of prostatic disease (International Prostate Symptom Score - IPSS), measurement of abdominal perimeter and clinical global response to treatment (CGI-I questionnaire). As exploratory investigation, the satisfaction/comfort of Nasotestt use will be assessed by a specific questionnaire that will be applied to participants at the end of study. Safety evaluation data will include report of all adverse events, including type, frequency, intensity, seriousness, severity and action taken related to the investigational product of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male research participant, aged 18 years or older, with BMI between 18.50 and 32.00 kg/m2;
2. To present symptomatic or asymptomatic hypogonadism and serum total morning testosterone levels ≤ 300 ng / dL;
3. Laboratory evaluation of prostate specific antigen (PSA) levels within the normal range established by the laboratory or with non clinically significant changes (NCS) judged by the study Investigator;
4. Rhinoscopy and Glatzel mirror test normal or with changes that do not interfere with nasal absorption of medication Test;
5. Present healthy skin in the region of Comparator product application (skin of the shoulder).

Exclusion Criteria:

1. Diagnostic of prostatic and/or breast neoplasia;
2. PSA levels 4 ng/mL or higher, or 3 ng/mL or higher with elevated risk for prostatic neoplasia development;
3. Treatment with estrogens, gonadotropin releasing hormone (GnRH), growth hormone (GH) in the last 12 months;
4. Treatment with testosterone or any other androgen in the last two weeks (oral, buccal and topic), four weeks (intramuscular) or twelve weeks (implant) that precede randomization in the study;
5. Active rhinitis: allergic, seasonal, medicinal, vasomotor and atrophic;
6. Presence of grade II or III septum deviation (in any region of the nasal septum) and / or presence of nasal polyps or other conditions that determine nasal obstruction;
7. Hypersensibility of testosterone as well as to components present in the formulation of drugs.
Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy babies
* Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
* birth weight between 2500 g- 4500g
* Having obtained the baby's legal representative's informed consent.
* FF groups:

babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed

• BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.

Exclusion Criteria:

* Congenital illness or malformation that may affect growth
* Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
* Minor parent(s)
* Newborn whose parents / caregivers cannot be expected to comply with study procedures
* Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.
Midodrine in Hepatopulmonary Syndrome

This proof-of-concept clinical trial will determine the safety and tolerability of midodrine in patients with hepatopulmonary syndrome (HPS). Exploratory endpoints will assess the effect of midodrine on oxygenation, intrapulmonary shunting and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to very severe hepatopulmonary syndrome, defined as the presence of all of the following:

  1. Liver disease or portal hypertension
  2. Intrapulmonary shunting on contrast-enhanced echocardiogram
  3. Hypoxemia \[A-a gradient ≥15mmHg (or ≥20mmHg if age \>64) and PaO2\<80mmHg on arterial blood gas testing\]
* Ability to provide informed consent
* Ability to comply with study medication use and testing, in the opinion of the principal investigator or co-investigator

Exclusion Criteria:

* Vulnerable study population, including imprisoned individuals, non-English speaking patients
* Participation in other investigational drug studies
* Any of the following conditions:
* Systolic blood pressure\>160mmHg or diastolic blood pressure \>100mmHg
* Heart rate \<50bpm
* Urinary retention at baseline
* Left ventricular ejection fraction \<50%
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Women of child-bearing potential not willing or able to use highly effective methods of birth control