cyrilzakka/clinical-trials huggingface dataset:
Stress and Fetal Brain Development

The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

Over the last decades there is growing evidence that increased maternal stress levels lead to an adverse effect on the physiological, metabolic and neuronal development of the fetus during gestation with possible long-lasting effects. Several studies showed that maternal stress also affects fetal endocrine processes during pregnancy and increases the risk for childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute stress related to the action of the artificial glucocorticoid betamethasone on fetal heart and brain activity. The fetal activity will be measured with biomagnetic sensors.

Eligibility Criteria:
Inclusion Criteria:

* German speakers (fluently)
* Gestational age between 28 and 34 weeks
* Treatment with Betamethasone for improvement of fetal lung function -

Exclusion Criteria:

* Smoking (regularly)
* Alcohol and drug consumption during pregnancy
* Congenital fetal disorders
* Women with bed rest
* acute depression or other psychiatric disorder (self report)
Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia

Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.

Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephrine is the most common used in obstetric anesthesia but its cardiac depressant activity, being an only alpha-adrenergic agonistic, is linked to frequent side effects such as bradycardia and decreased cardiac output.

Norepinephrine is a vasopressor characterized by both alpha and minor beta-adrenergic agonistic activity, it has then a minimal cardiac depressant activity. Hence it would provide a better stability of hemodynamic and cardiac output, and appears as a better alternative to phenylephrine.

In this study, the investigators will compare prophylactic continuous variable infusion of both vasopressors. Phenylephrine started at the dose of 0,5mcg/kg/min and Norepinephrine tartrate started at the dose of 0,1mcg/kg/min. The doses will be adjusted according to maternal systolic blood pressure in order to prevent hypotension (defined by a systolic blood pressure under 80% of baseline).

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy higher than 36 weeks of amenorrhea
* Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia

Exclusion Criteria:

* Extreme height (less than 140cm; higher than 180cm)
* Weight less than 50kg
* Weight higher than 120kg
* Cardiovascular disease with use of cardiac medication (including antihypertensive drug)
* Active neurological disease
* Anti-hypertension treatment.
* High blood pressure or severe pre-eclampsia
* American Society of Anesthesiologists physical status class higher than 3
* Placenta accrete/percreta
* Cesarean section scheduled under general anesthesia
* Contraindications to spinal anesthesia
* Minor (age less than 18 years old)
* Guardianship/ curatorship
* Anemia less than or equal to 8 g/dl
* Allergy to any study medication
* Simultaneous participation in another study
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

The goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus (T2DM) with a common complication of T2DM: diabetic peripheral neuropathy (DNP), specifically diabetic sensorimotor polyneuropathy. Researchers will also look into factors related to DNP: inflammation, the use of energy in the cell, nerve function and the tiny blood vessels in the muscle.

The main question it aims to answer is: Are there differences in muscle fiber type composition between persons with T2DM with and without DNP, in comparison to sex and age-matched healthy peers?

Participants will partake in the following tests:

* electromyoneurography (EMNG): evaluation of nerve function, damage and repair; for diagnosis of DNP or other diseases of the nerves
* blood analysis: researchers will measure insulin, blood sugar, lipid profile, inflammation
* muscle biopsy in the calf (m. gastrocnemius): a doctor will take a small sample of muscle to evaluate the muscle shape and structure
* mechanography: patients will perform functional tests (e.g. standing up from a chair), researchers will evaluate maximal power and maximal force of the muscles by jumping tests
* questionnaires: on food intake, physical activity, smoking history, alcohol use, medical history
* measurement of height, weight, and the comparison of the hip and waist circumference
* peripheral Quantitative Computed Tomography (pQCT): scan of the calf for muscle density and bone density
* electrocardiography (ECG): evaluation of electrical signals of the heart

Researchers will compare (1) patients with T2DM with DNP, (2) patients with T2DM without DNP, and (3) healthy persons to see if there are differences in muscle fiber type composition


Eligibility Criteria:
Inclusion Criteria:

All participants:

* Between 40-70 years of age
* BMI between 18,5 - 35 kg/m2

Persons with T2DM:

* More than 10-year clinical diagnosis of T2DM

Exclusion Criteria:

All participants:

* Possible other causes of nerve impairment (vitamin B12 deficiency, excessive alcohol consumption, chemotherapy)
* Immobilisation (1) \> 3 months in past history or (2) \> 4 weeks in past 6 months
* Chronic conditions affecting the vital organs (New York Heart Association (NYHA) 3/4, Global Initiative for Obstructive Lung Disease (GOLD) 3/4, cystic fibrosis)
* Hypogonadism
* Inflammatory joint or intestinal diseases
* Chronic muscle diseases
* Active malignancy
* Malnutrition disease, eating disorder or bariatric surgery
* Medication use (anticoagulants, glucocorticoids, anti-androgen or anti-estrogen treatment) persons with T2DM:
* Insufficient control of diabetes (HbA1c \>9%)

Healthy controls:

* Fasting glucose \> 100 mg/dl
* HbA1c \> 5.7 %
Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange

Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls


Eligibility Criteria:
Inclusion Criteria:

* statin and fibrate Wash out for one week
* HbA1c\>7% and \<12% (Arms 1 and 3)
* HbA1c\<6% (Arms 2 and 4)
* Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2)

Exclusion Criteria:

* secondary CV prevention
Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation

The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.

The aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation BNP levels at admission and during the following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure Ventilation or Continuous positive airway pressure).

Because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that BNP could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.

Eligibility Criteria:
Inclusion Criteria:

* Severe respiratory distress (use of respiratory accessory muscles);
* Respiratory rate \> 25 per minute;
* Respiratory acidosis (pH \< 7.35 and PaCO2 \> 45 mmHg);
* PaO2/FiO2 \< 250

Exclusion Criteria:

* Age \< 18 years;
* Facial deformities;
* Pneumothorax;
* Shock or systolic arterial pressure below 90 mmHg with amine infusion;
* Life-threatening arrhythmias;
* Need for immediate endotracheal intubation (PaO2/FiO2 \< 100 with FiO2 100%, respiratory rate \< 10, GCS \< 8);
* Lack of co-operation from the patient;
* Recent esophageal-gastric surgery;
* Inability to clear secretions;
* Drugs that may interfere with BNP secretion;
* Severe obesity;
* Hepatic cirrhosis with ascitis;
* Endocrine disease.
Cardiovascular Diagnostic in Assessment of Risk HDS and HCT in Patients With Haemoblasts.

In this research we investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

Cancer and cardiovascular (CV) disease are the most prevalent diseases in the developed world. Evidence increasingly shows that these conditions are interlinked through common risk factors, coincident in an ageing population, and are connected biologically through some deleterious effects of anticancer treatment on CV health. Anticancer therapies can cause a wide spectrum of short- and long-term cardiotoxic effects such as heart failure, arrhythmias, systolic and diastolic dysfunction, valvular disease, pericarditis, myocarditis, ischemic heart disease, cardiomyopathy, stroke, hypertension.

A number of studies have shown that autologous and allogeneic hematopoietic cell transplantation (HCT) contribute to an increased incidence of cardiovascular disease (CVD) and worsening of cardiovascular risk factors (CVRFs) that could contribute to further CVD over time. These observations combined with a notable increase in the number of survivors after HCT in recent years highlight the need for studies aimed at modifying risk or preventing these outcomes by changing specific approaches and/or post-HCT interventions.

The aim of this study is to evaluate the prognostic value of cardiological diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.

This is an observational, prospective single- centre, non-randomized study. In this research included patients with haemoblasts. Before and after hematological treatment, all patients undergo a cardiological examination, including examination, history taking, measurement of blood pressure, as well as instrumental examination, including ECG, echocardiography with the determination of global longitudinal deformation, cardiopulmonary pulmonary test, assessment of endothelial function by Angioscan. In addition, all subjects take blood for troponin T and NT-proBNP.

Patients were followed-up from 3 to 12 month after hematopoietic cell transplantation.

In this study was included patients with confirmed hemoblastosis. Written informed consent was obtained from all subjects.

Inclusion criteria were being over 18 yers of age and expected for high dose chemotherapy and hematopoietic cell transplantation, Exclusion criteria were patient's refusal.

Eligibility Criteria:
Inclusion Criteria:

* Subject being over 18 yers of age
* Subject expected for high dose chemotherapy and hematopoietic cell transplantation

Exclusion Criteria:

* Subject's refusal
A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years or older
* 25%-75% of the target nail altered as a result of onychomycosis
* Signed written informed consent

Exclusion criteria

* Proximal subungual onychomycosis
* Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101
* Other conditions known to cause abnormal nail appearance
* Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.
* Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.
* Known allergy to any of the tested treatment products
Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis

To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke patients with symptomatic severe intracranial atherosclerosis.

Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between 110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis.

The benefits of BP lowering in the prevention of primary and secondary prevention of stroke is established well, although absolute target BP level is uncertain. Current guidelines defined the normal BP as \<120/80mmHg and recommend individualized target BP level.

Large well performed stroke prevention trials consistently showed that reduction of 10/5mmHg in patients with systolic BP below 140mmHg had clear benefits in the prevention of cardiovascular events. However, we have a dilemma about BP control in the patients with severe intracranial atherosclerosis.

Aggressive BP control will be more effective in the prevention of overall cardiovascular events than modest BP control, but aggressive BP control will reduce cerebral perfusion in the territory of severe intracranial disease and may increase the risk of ischemic damage.

The study will try to reveal aggressive BP control in the patients with symptomatic severe intracranial atherosclerosis is not increase ischemic lesion volume in hemisphere to compare modest BP control.

Eligibility Criteria:
Inclusion Criteria:

* acute symptomatic ischemic stroke having relevant lesion on DWI(Diffusion weighted image) MRI 7 days after and 42 days within onset.
* relevant stenosis(more than 50%) or occlusion from MCA(middle cerebral artery)(M1) to distal of ICA(internal carotid artery ) on MR(Magnetic resonance) angiogram or CT angiogram.
* mean systolic blood pressure\>=140mmHg or taking antihypertensive drug on screening.

Exclusion Criteria:

* taking more than 3 antihypertensive drugs and mean systolic blood pressure\>=150mmHg on screening.
* history of recent thrombolysis but stenosis or occlusion remained after thrombolysis.
* evidence of orthostatic hypotension
* suspicious embolic cerebrovascular stenosis
* planned state of cerebrovascular surgery or angioplasty or stent 7 months within screening.
* severe stroke-NIHSS\>=16
* mean systolic blood pressure\>=200mmHg which is not able to control on screening.
* abnormal blood test finding (abnormal LFT(liver function test), anemia, renal insufficiency)
* pregnant or breast-feeding
* severe stroke sequela or medical problem
* suspicious secondary hypertension
* disease causing edema or significant ankle edema on screening.
* severe heart failure which correspond to NYHA (New York Heart Association )heart failure classification class III or IV.
* inappropriate condition determined by investigator
* Patient who do not have FLAIR image on or two months prior to screening.
Acute Immune Modulation by Probiotic Strain

Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.

Clinical proof-of-concept study comparing the acute immune effects of 3 doses of a probiotic compared to a placebo. The probiotic strain is characterized as Bacillus coagulans JBI-YZ6.3 (BC4U).

24 subjects will participate in a placebo-controlled, escalating dose, cross-over study design, wherein they will be taking placebo, dose 1, dose 2, and dose 3, each separated by a 1-week washout period.

Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 3 hours following administration.

A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults;
* Age 18-75 years (inclusive);
* Veins easy to see in one or both arms (to allow for the multiple blood draws);
* Willing to comply with study procedures, including:

  * Maintaining a consistent diet and lifestyle routine throughout the study,
  * Consistent habit of bland breakfasts on days of clinic visits,
  * Abstaining from exercising and nutritional supplements on the morning of a study visit,
  * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
  * Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
* Taking anti-inflammatory medications on a daily basis;
* Currently experiencing intense stressful events/ life changes;
* Currently in intensive athletic training (such as marathon runners);
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
* Unwilling to maintain a constant intake of supplements over the duration of the study;
* Anxiety about having blood drawn;
* Pregnant, nursing, or trying to become pregnant;
* Known food allergies related to ingredients in active test product or placebo.
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments

This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.


Eligibility Criteria:
Inclusion Criteria:

* Patient currently is undergoing treatment for cancer
* Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer
* \> 18 years of age
* Willing to travel to a Legacy Health facility if necessary
* Agree to attend study visits outside of standard of care visits, if needed
* Willing to stop other supplements or medications that are aimed at treating menopausal symptoms at least 7 days before beginning study treatment
* Willing to engage in pre/post testing and survey/phone calls

Exclusion Criteria:

* Patient is currently undergoing chemotherapy treatment
* \< 18 years of age
* Unable to comply with protocol
* Unable to provide written informed consent
* Investigator does not believe study participation is in the best interest of the patient
* Patient had concurrent menopausal symptoms prior to the start of cancer treatment
* Menopausal symptoms are unrelated to surgical or medical treatment of breast or gynecologic cancers
A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles

This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a) and other atherogenic particles associated with cardiovascular disease risk.

Lipoprotein(a) is a carrier of oxidized low-density lipoprotein and is a particularly atherogenic biomarker. Lp(a) has been previously documented to be resistant to dietary therapies and its concentration is thought to be determined by genes. A plant-based diet has not been previously used in an attempt to influence the concentration of Lp(a).

Participants were instructed to follow a defined, plant-based dietary intervention for four weeks. All animal products were excluded. Cooked foods, free oils, soda, alcohol, and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.

Serum biomarkers were obtained from participants at baseline and after 4-weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index ≥25.0 kg/m\^2
* Serum low-density lipoprotein cholesterol concentration ≥100
* Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90

Exclusion Criteria:

* Tobacco use
* Drug abuse
* Excessive alcohol consumption (\>2 glasses of wine or alcohol equivalent per day for men or \>1 glass of wine or alcohol equivalent for woman)
* Current cancer diagnosis
* Estimated glomerular filtration rate \<60 mg/dL
* Clinically defined infection
* Mental disability
* Hospitalization \<6 months
* Previous exposure to plant-based diet