cyrilzakka/clinical-trials huggingface dataset:
Investigating the Acute Effects of Increasing Glucagon Exposure in Healthy Participants

In this study the investigators will investigate the acute effects of increasing glucagon exposure on metabolic parameters in healthy participants.

Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. The infusion rate will be increased every 30 minutes.

Ten participants with normal health will be included, and each participant will participate in one study day.

Participants will arrive after an overnight fast and will be placed in a hospital bed in a semi-recumbent position. In each antecubital vein an intravenous catheter will be placed; one for administration of glucagon and one for blood sampling.

Two baseline blood samples will be drawn before the glucagon infusion is started. The glucagon infusion rate will be increased every 30 minutes (infusion rates are 0,01 ng/kg/min, 0,1 ng/kg/min, 0,5 ng/kg/min, 1,0 ng/kg/min, 10 ng/kg/min and 50 ng/kg/min).

Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding the participant information and signing the consent form
* Between 25 and 70 years of age at the time of screening
* Body mass index (BMI) ≤ 25 kg/m2 at the time of screening

Exclusion Criteria:

* Enrolment in other research projects that might interfere with the study
* Diabetes diagnosis (type 1 and 2)
* Pregnancy or breastfeeding
* Use of medications which, in the opinion of the investigator, may jeopardise participant's safety or compliance with the protocol
* Impaired liver function defined as either alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) ≥ 2 times normal values
* Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female
* Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the range 90-150 mmHg for systolic and 50-100 mmHg for diastolic
* Active or recent malignant disease
* Current or history of severe alcohol use or drug/chemical abuse as per investigator's judgement
* Any chronic disorders or severe diseases which, in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol
Project Jumpstart for Improving PrEP Care of Continuum Outcomes

Stigma related to PrEP interest and uptake, and medication cognitions related to PrEP adherence and persistence remain strong barriers to improving PrEP use. To address these areas, the investigators are proposing to develop an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV.

Biomedical HIV prevention tools are very promising, but are not sufficiently reaching those in greatest need. BMSM have experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and the CDC estimates that half of BMSM will be diagnosed with HIV in their lifetime. Although Pre-Exposure Prophylaxis (PrEP) is highly effective for preventing HIV, there is urgent need to improve efforts to deliver PrEP, in particular, for BMSM at-risk for HIV. Current strategies to increase PrEP interest, uptake, and adherence are not adequate and there are formidable barriers (e.g., stigma surrounding PrEP use, and adherence and retention concerns) to sufficient coverage of PrEP that must be addressed. Without considerable and targeted change to our current approach to PrEP delivery, public health initiatives will fail to adequately provide PrEP to those in greatest need. In our PrEP focused preliminary studies with BMSM, the investigators have identified two primary areas in need of critical focus and intervention - (1) stigma related to PrEP use, and (2) medication cognitions such as the perceived costs and benefits of taking PrEP, both of which can impede PrEP interest, uptake, and adherence. To address these areas the investigators have developed an intervention grounded in two novel cognitive/behavioral theories: the HIV Stigma Framework and the Medication Necessity-Concerns Framework. Our study includes: Conducting a pilot test that compares our (a) PrEP information only control (n=25), (b) PrEP counseling (n=50), (c) PrEP counseling with text messages (n=50), and (d) PrEP enhancement counseling with text messaging and on-demand counseling (n=50). Advances in biomedical HIV prevention, such as the availability of PrEP, will only impact the HIV epidemic if concurrent efforts are made to address the social and behavioral challenges that are associated with achieving sufficient coverage of PrEP among individuals at elevated risk for HIV. Low-resource burden, easily implemented, and effective social/behavioral interventions are urgently needed if the full benefits of PrEP are to be realized. If effective and disseminated, this intervention would meet current prevention needs and its potential impact on HIV infections averted could be substantial.

Eligibility Criteria:
Inclusion Criteria:

* Prior sex with a man, identify as Black, and HIV negative status.

Exclusion Criteria:

* Living with HIV
Effect of Blood Donation on Blood Pressure, Iron Metabolism, Oxidative Stress

The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress.

There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.

The regular application flow of blood donation at that blood bank of Charité is not disturbed. There are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress.

No extra puncture of the vein is necessary.

Eligibility Criteria:
Inclusion Criteria:

* first time donating blood or after a break of 12 months to last blood donation
* voluntary attending blood donation and study
* fulfilling the criteria of the blood donation center

Exclusion Criteria:

* criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...)
* missing informed consent to the study
Telehealth Program to Prevent Cancer and Chemotherapy-related Cognitive Impairment.

The present randomized controlled trial has the main objective to study the effects of a videoconferenced occupational therapy program in preventing cancer and chemotherapy-related cognitive impairment and other health outcomes, as well as in improving quality of live and occupational performance of women undergoing chemotherapy for breast cancer.

The chemotherapy-related cognitive impairment (also called chemobrain) has a great incidence among breast cancer population. However, the knowledge about effective interventions of supportive care is still inconsistent. Furthermore, the majority of programs targeted to this problem has been applied in survivorship, while the onset of cognitive impairment and the decline in quality of life occur during medical treatments. In this line, actual evidence suggests testing the effectiveness of interventions in a preventive setting in patients with breast cancer scheduled to receive neurotoxic chemotherapy. In addition, telehealth approaches have become a promising practice and increasingly more frequent among healthcare disciplines.

Our objective is to study the effects of a videoconferenced cognitive training in combination with cognitive-behavioral strategies to prevent or mitigate the cancer- and chemotherapy-related cognitive impairment in women with breast cancer who undergo this treatment, as well as to improve quality of life and allow an optimal adaptation to the occupational needs derived from medical treatment.

This study will use a two-arm, single blinded randomized clinical trial design. Eligible women will be randomized to one of the following groups: the experimental group that will receive the e-OTCAT program (12 weeks), or the control group that will receive and educational handbook and standard care. The study outcomes will be assessed after intervention and at 6-month follow-up post-randomization.

This study may contribute the need to include disciplines such as occupational therapy in the supportive care of cancer patients during the active phase of the disease, as well as the potential advantages provided by a telehealth approach related to economic, temporal and geographical barriers.

Eligibility Criteria:
Inclusion Criteria:

* Female with breast cancer who are going to start chemotherapy
* Stage I-III breast cancer
* No evidence of disease at time of screening
* Must be able to speak, read and write Spanish well to complete written and verbal assessment, neurocognitive tests and study tasks
* Must have basic phone skills

Exclusion Criteria:

* History of neurological disorder with cognitive symptoms (i.e., Parkinson's disease, Alzheimer disease, seizure disorder, multiple sclerosis, etc.)
* History of psychiatric disorder such as mental retardation, bipolar disorder, schizophrenia, etc.
* History of traumatic brain injury with ≥ 30' of consciousness or cognitive sequelae as per self-report or as documented in the medical record
* Prior history of cancer or secondary diagnosis of cancer
* Prior history of chemotherapy
* A hearing or visual deficit
Erythropoietin in Hemolytic Uremic Syndrome

This study will evaluate the impact of early administration of erythropoietin in the number of red blood cell transfusions in children with Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).

Introduction:

Anemia in STEC-HUS is treated with red blood cell (RBC) transfusions. It can causes hypervolemia, hyperkalemia, exacerbate the thrombotic state of the disease, transmit infectious agents and trigger antigenic sensitization. Anemia is mainly due to hemolysis, but deficit of erythropoietin synthesis (EPO) may aggravate it. Although recombinant human EPO is frequently used in children with STEC-HUS there is no adequate evidence of its benefit. If it is confirmed that EPO reduce the number of RBC transfusions, its administration could diminish the aforementioned risks and also reduce costs.

Objective:

To determine if EPO administration decreases the number of RBC transfusions and; secondarily, to assess if its levels influence on transfusion requirement.

Methodology:

Randomized, open controlled clinical trial. We will include 28 patients (14 per arm) \<18 years with STEC-HUS admitted to our hospital. They will be grouped after randomization:(1) One to standard of care (RBC transfusions with hemoglobin ≤7 mg / dl and/or hemodynamic instability) and (2) the other to standard of care plus EPO (50 u / kg subcutaneous three times weekly) and RBC transfusions with hemoglobin ≤7 mg / dl). Serum EPO will be measured by ELISA and together with the clinical and laboratory variables, association with RBC transfusions number will be sought. Written informed consent and assent when appropriate, will be requested prior to enter into the study.

Eligibility Criteria:
Inclusion Criteria:

* Post diarrheal HUS: Prodrome of enteritis followed by microangiopathic hemolytic anemia, thrombocytopenia and signs of renal damage (increased plasma creatinine, proteinuria, and / or hematuria). Proven STEC infection wiil not be required to enter into the study.

Exclusion Criteria:

* Atypical HUS
* HUS associated with systemic diseases (pneumococcal infection, HIV, Systemic lupus erythematosus) or drugs
* Anemia or known kidney disease
* Previously transfused or treated with erythropoietin
* Contraindications to erythropoietin
Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2

Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation.

The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.

This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.

A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Programmed cardiac surgeries
* Surgeries with cardiopulmonary bypass

Exclusion Criteria:

* Emergency surgeries.
* Acute pulmonary diseases
* Contraindication of femoral catheters.
* Need of counter-pulsation baloon
Effects of Epicatechin-rich Cocoa on Collagen Synthesis

This study will investigate the effects of dietary supplementation of epicatechin-rich cocoa in humans on collagen synthesis and power-based performance outcomes (rate of force development).

The investigators have recently completed a study looking at the expression of the collagens following consumption of increasing doses of epicatechin in rats . This data clearly shows that increasing doses of epicatechin, either 0.5 mg.kg-1 delivered once, twice, or three times a day, or 2 mg.kg-1 once a day, results in increasing expression of the fibrillar collagens (I, III, and V). This preliminary data suggests that epicatechin-rich chocolate supplementation can increase collagen expression in humans and that this may improve force transfer. From this background, the hypothesis proposed is that supplementation with epicatechin-rich chocolate will increase rate of force development and performance in athletes. Therefore, this simple nutrition intervention has the potential to simultaneously improve performance, decrease injuries and accelerate return to competition through improved collagen synthesis.

Eligibility Criteria:
Inclusion Criteria:

* Collegiate level male athletes between the ages of 18¬-25 years of age, currently participating in sport, will be recruited to participate in the study.

Exclusion Criteria:

* History of more than 3 musculoskeletal injuries within the past 12 months.
* Health and dietary restriction (e.g. lactose intolerance) that would be affected by the supplementation protocol.
* The initial phase will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen synthesis is the main outcome measure for the study this would confound the initial phase of the work. Provided this work proves successful then the investigators will aim to proceed with similar research in females.
E-Cigarettes and SNA

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be measured pre and post exposure.

Eligibility Criteria:
Inclusion Criteria:

Healthy

Exclusion Criteria:

* Cardiac disease
* Respiratory disease
* Diabetes mellitus
Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

The aim of this study is to investigate the effects of 15 mg/kg lemon verbena, in comparison to placebo, on the attention deficit hyperactivity disorder (ADHD) type behaviour and cognitive function of children who do not have a diagnosis of ADHD, but who exhibit high scores (highest tertile) on ADHD behaviour parameters. Multiple aspects of mood will also be assessed.

The proposed randomised, double-blind, placebo-controlled, parallel groups design methodology will assess the psychological effects of 15 mg/kg lemon verbena extract and a matched placebo prior to and after 4 and 8 weeks of supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) and a range of mood measures during laboratory testing visits.

Parents and children will also take part in a concomitant smartphone study, comprising the collection of the parent's assessment of the child's behaviour/cognitive function and the child's self-report of the same, plus their mood. These assessments will take place on Days -1, 14, 28, 42 and 56.


Eligibility Criteria:
Inclusion Criteria:

* Are in good health as reported by themselves and their parent/guardian
* Are aged 8 to 17 years at the time of giving assent and parents giving consent
* Have a sex and age-related BMI less than the 98th centile according to the local NHS guidelines
* Are rated by their parents as having a high score (T score of ≥60) on both the Connors 3 subscales of Inattention and Hyperactivity/Impulsivity.
* Have no current diagnosis of ADHD
* Have no relevant food intolerances/ sensitivities/ allergies
* Are not currently using any illicit, herbal or recreational drugs including alcohol and nicotine products
* Are not currently taking prescription medications
* Have not taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks
* Do not have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism)
* Do not suffer from visual (including colour blindness) impairment that cannot be corrected with glasses or lenses (that may impact task performance in the opinion of the PI).
* Do not have any pre-existing diagnosed medical condition/illness which will impact taking part in the study
* Consume less than 250 mg/day of caffeine.
* Can complete all of the study assessments at the training visit
* Are not currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
* Are compliant with regards to treatment consumption
* Have not taken antibiotics within the past 4 weeks
* Do not have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
How Does a Synbiotic Supplement Affect Iron Status During Iron Repletion in Iron Depleted Female Athletes?

Iron deficiency (ID) affects \~30% of female athletes, and its consequences are highly relevant to athletic performance. Poor iron (Fe) uptake remains a major factor in the development of ID. While animal studies suggest that prebiotics may improve Fe uptake, this has not been well-studied in humans. The main objective of the proposed study is to determine the effects of synbiotic supplementation on the Fe status of ID female athletes during Fe repletion.

Iron deficiency (ID) affects \~30% of female athletes, and its consequences are highly relevant to athletic performance. Poor iron (Fe) uptake remains a major factor in the development of ID. While animal studies suggest that prebiotics may improve Fe uptake, this has not been well-studied in humans. The main objective of the proposed study is to determine the effects of synbiotic supplementation on the Fe status of ID female athletes during Fe repletion. At the beginning of a training season at a Division III University, the Fe status of 28 female athletes (cross-country, lacrosse, basketball, field hockey) was screened. Twenty eligible athletes (baseline Hgb:12.3±0.9g/dL; sFer:18.1±9.2µg/L) were then randomized to receive either a daily synbiotic supplement (5g prebiotic fiber + 8 billion CFU probiotic B. lactis) or placebo, along with a daily Fe supplement (140 mg FeSO4/d) for 8 weeks using a double-blind design. Fe status and body composition were assessed at baseline, mid-point and after the trial. Participants were instructed to keep daily logs of supplement intake, physical activity, GI and other symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Female, \>18 y of age, athlete at Marywood University, passed NCAA-required medical screening (e.g. healthy enough to participate in sport).

Exclusion Criteria:

* Current, acute, chronic illness; severe asthma; pre-existing GI disorders known to affect iron status or aggravated by iron supplementation; not pregnant or breastfeeding; clinically-diagnosed with eating disorder; consuming iron supplement within 4 weeks of screening; hemolytic anemia, excessive alcohol consumption.
Nitrate - Clopidogrel - Acute Coronary Syndrome

This study aims to investigate whether intravenous nitrate given during non-ST-elevation myocardial infarction (non-STEMI) affects the platelet inhibition of clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with non-STEMI
* Patients aged 18 to 75 years
* positive troponin levels,
* blood pressure above 120/70 mmHg

Exclusion Criteria:

* Hemodynamically unstable and requiring urgent intervention,
* ST elevation on electrocardiography, atrial fibrillation,
* recurrent angina,
* use of narcotic analgesics (e.g., morphine), nitrates and glycoprotein IIb/IIIa inhibitors during hospitalization,
* history of coronary artery bypass graft (CABG) surgery,
* active infection,
* uncontrolled hypertension,
* diabetes, cerebrovascular accident, Use P2Y12 inhibitor, proton pump inhibitor, oral anticoagulant, statin, CYP enzyme-inducing or inhibiting drugs at the time of admission,
* active systemic disease (e.g., malignancy, thyroid disorders chronic inflammatory diseases, liver dysfunction),
* left ventricular systolic dysfunction (ejection fraction \<50%),
* glomerular filtration rate \<60 mL/min/1.73m2,
* allergy to ASA or clopidogrel, coagulopathy,
* platelet counts below 100,000/μl and hematocrit levels below 29%, or exceeding 52%.