cyrilzakka/clinical-trials huggingface dataset:
Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects.

The purpose of the current study is to examine the inflammatory response in a younger population (35-45 yrs old) to see whether in this population also differences in the ex vivo LPS induced cytokine response exists between healthy and compromised subjects, as is seen in elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will be included as subjects with compromised health and compared to healthy lean subjects with the same age (shifting from healthy towards unhealthy, not diseased).

Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory cytokine response in a healthy population that is different from a response of the compromised population. The investigators will include subjects aged 35-45 years that differ in health characteristics, especially blood HbA1c, fat% and waist circumference.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
2. Males aged between 35-45 years;
3. Waist circumference: healthy \< 94 cm, compromised ≥ 102 cm.
4. Body composition (InBody 720): body fat % healthy men \< 8-19% %; for compromised men \> 25%;
5. HbA1c levels for healthy subjects \< 5.5 % or fasting glucose \> 3.4 or \< 5.6 mmol/L; for compromised HbA1c \>=6 and\< 6.5% or fasting glucose between 6.1-6.9 mmol/L;
6. Regular Dutch eating habits as assessed (three main meals, including bread) by health and lifestyle questionnaires.

Exclusion Criteria:

1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
3. Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or inflammatory diseases or allergy;
4. Use of any medication within 14 days before day 01; use of paracetamol within 7 days before day 01;
5. Currently smoking or stopped smoking less than 6 months ago;
6. Alcohol consumption \>= 21 units per week;
7. Performing more than 5 hour sports activity per week;
8. Use of dietary supplements that could affect the inflammatory response (eg fish oil, polyphenols, vitamins);
9. Not having a general practitioner;
10. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
11. Not willing to give permission to have the general practitioner to be notified upon participation in this study.
Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

The purpose of this study is to compare two different treatment protocols for treating nausea and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned to one of two treatment groups.

The first group will recieve ondansetron (Zofran) tablets combined with a medicine called dexamethasone given IV. Both of these drugs are commercially available.

Patients in the second treatment consists of the first two drugs, plus a newly approved drug known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea and vomiting. It significantly decreases the delayed (more than 24 hours after therapy) nausea and vomiting seen with these regimens.

This will be a single center, comparative, randomized, double-blind, phase III trial designed to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in combination with ondansetron and dexamethasone in the prevention of acute and delayed nausea and vomiting compared to ondansetron and dexamethasone in patients receiving highly emetogenic preparative regimens prior to autologous or allogeneic (related and unrelated) stem cell transplantation.

Patients will be randomized to one of two treatments: dexamethasone 10 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day vs. 7.5 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day combined with aprepitant, 125 mg orally on the first day of their preparative regimen followed by 80 mg daily on each remaining day of the preparative regimen plus three additional days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO \& IV), and BCV
* Age 18 or older
* Alcohol intake \<100 gm/d for the last year (\< approximately 5 drinks per day)
* Renal function: estimated or measured CrCl 50 ml/min
* Liver function: T.Bili \<1.5, AST \< 2x ULN, unless due to disease
* Able to swallow tablets and capsules

Exclusion Criteria:

* Age \< 18
* High alcohol intake \[\> 100 gm/d in the last year\]
* Allergy or intolerance to: ondansetron or dexamethasone
* Renal dysfunction \[measured or estimated CrCl \< 50 ml/min\]
* Liver dysfunction \[T.Bili \> 1.5, AST \> 2x ULN, unless due to disease\]
* Inability to swallow tablets or capsules
* Concurrent condition requiring systemic steroid use
* Nonmyeloablative SCT, patients receiving the conditioning regimens not included \[see inclusion criteria\]
* History of anticipatory nausea and vomiting
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study

The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

The VALIANCE Study is a 15,000 patient, multicentre, prospective observational cohort of adults undergoing elective same-day noncardiac surgery and who will be followed for 90 days after surgery. The primary objective of the study is to determine the incidence of major cardiovascular complications after same-day surgery. Patients will also be followed for the occurence of other adverse postoperative complications and determine their change in quality of life at 90 days after surgery. VALIANCE will inform on the risk factors for postoperative complications and allow to develop risk prediction tools to guide patient selection and risk stratification of patients undergoing same-day surgery. The study will also look at validating the use of the Duke Activity Status Index questionnaire, Clinical Frailty Scale, and the Revised Cardiac Risk Index. Postoperative pain will be evaluated using the Brief pain inventory score and quality of life using the EQ-5D-5L questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 45-64 years of age with at least one risk factor, or ≥65 years of age;
* undergoing elective noncardiac same-day surgery;
* planned duration in the operating room 60 minutes or more;
* provided written consent.

Exclusion Criteria:

* intervention does not require the presence of an anesthesiologist;
* procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology);
* intervention is an ophthalmologic procedure;
* previously enrolled in the VALIANCE study.
Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation

Chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. Despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival.

Different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (HLA) incompatibilities between the donor and the recipient. However, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies.

Also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation.

The onset of acute rejection is caused by the ability of the recipient's T cells to recognize alloantigens. The CD45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the T cell.

Investigators showed that the level of expression of CD45RC on T lymphocytes was associated with the risk of acute rejection. Thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating CD8 lymphocytes expressing high CD45RC (CD45RChigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of CD8+CD45RChigh.

The purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 and under 70 years old
* Patients in care for a first priority renal transplant.
* Patients with low immunological risk
* Patients with prior written informed consent

Exclusion Criteria:

* Poor understanding of the French language
* Pregnant, breastfeeding or partying women
* Persons deprived of liberty by an administrative or judicial decision
* Persons undergoing psychiatric care under duress
* Adults who are subject to a legal or non-state protection measure to express their consent
The Effect of Covered Eye Walking on Electroencephalogram in Stroke Patients Compared With Open Eye Walking

Post-stroke walking abnormalities present significant rehabilitation challenges. Visual deprivation training has been shown to be more effective than open-eye training. The investigators intend to examine the changes in electroencephalography patterns in stroke patients during visually deprived walking tasks.

The stroke participants will be fitted with a brain cap. The participants will walk with their eyes open for 60 seconds, and then their eyes will be blindfolded as they continue walking for another 60 seconds. Electroencephalography will monitor the signals in real-time during both walks.

The electroencephalography data collection will be conducted in the Rehabilitation Department of Geriatric Hospital Affiliated with Nanjing Medical University. Upon commencing the experiment, participants will walk at a comfortable pace with their eyes open for a duration of 60 seconds. Following this initial test, a rest period of five minutes will be provided. For the visual deprivation walking trial, participants will be instructed to keep their eyes open throughout the trial. Investigators will apply an adequately sized blindfold to ensure complete visual deprivation, and the participants will proceed to walk for 60 seconds. During both trials, one investigator will remain one step behind the participant at all times to ensure safety.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke
* Disease duration of more than 14 days
* Ability to walk at least 10 m without assistance,

Exclusion Criteria:

* Visual impairment
* Severe cognitive impairment
Change in MAPSE During Treatment of Sepsis

Patients with bloodstream infections (sepsis) have been found in prior studies to have infection-related heart dysfunction, even if they did not have preexisting heart problems. Factors related to the infection may cause the heart to not pump as well as it should, causing critical illness in the form of low blood pressure (shock) and heart failure. Ultrasound is frequently used in the emergency department to evaluate why a patient might have low blood pressure. Part of that evaluation may include obtaining ultrasound images and making measurements about how well or poorly the heart is pumping. The investigators will evaluate a certain measurement that relates to cardiac function, determine how it changes in patients before and after they are treated for septic shock. This will involve placing an ultrasound probe on the patient's chest, measuring the upward and downward movement of the mitral valve, the mitral annulus systolic plane excursion (MAPSE), and comparing the measurements before and after treatment is started. The investigators are attempting to determine if this measurement improves before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sepsis or Septic Shock

Exclusion Criteria:

* Age equal to or less than 17
* patient in the emergency department
* Unable to perform POCUS exam due to medical necessity
* Patients without sepsis
* unable to obtain consent or have a legal representative consent
Medical Telemonitoring Plus Individual Teleconsultation in Elderly

The aim of this study is to explore the requirements and conditions of medical teleconsultation and remote diagnostics (telemonitoring) of older people in the residential environment with an emphasis on the need for adaptation, feasibility and acceptance of telemedicine services to a web based documentation and communication platform (Ambient Assisted Living Wizard).

The technical development of the so-called "AAL Wizard" is basis for the study. The AAL-Wizard is an IHE(Integrating the Healthcare Enterprise)-compliant, web based documentation and communication platform with an integrated electronic patient record, which can be used by the study participants during the study. Vital parameters are collected with the help of certified medical products according to the guidelines "93/42/EEC(European Economic Community) on medical devices" (e.g. blood pressure devices, scales, pedometers), transmitted electronically, documented and archived directly in the system. Vital parameters out of range will be prioritized displayed in the AAL Wizard (e.g. traffic light system, short message notification, pop-up function, etc.) and the study participant will be contacted by the tele doctor (teleconsultation) . The decision on the necessary intervention (e.g. contact of the in-house home care, therapeutic and diagnostic recommendations or recommendation of a primary care consultation /hospital submission) are in the responsibility of the tele doctor based on the communication with the patient and the family doctor's recommendations for the treatment of his patient.

At the beginning of the study, the tele doctors of the Clinical Telemedicine at the University Hospital Zurich (USZ) perform an appointment with the respective study participants. The electronic patient record will be set up and the process of the telemonitoring will be defined.

Eligibility Criteria:
Inclusion Criteria:

* german speaking
* voluntary participation
* written consent of the trial participant after enlightenment

Exclusion criteria:

* apply to health conditions (physical and / or psychological) when verbal communication and / or the operation of the AAL Wizard and an independent living in their own living area is not possible.
The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. males or females, aged 18-45
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg and 50mmHg ≤DBP\<90mmHg;
3. body mass index (BMI) between 18 to 28, and a total body weight: male ≥50.0 kg and \<90.0 kg; female ≥45.0 kg and \<90.0 kg
4. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin \> 1X ULN during screening/baseline;
2. Abnormal coagulation function;
3. A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
4. Subjects with severe trauma or surgery within 3 months prior to the screening；
5. Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
6. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
8. Pregnant or Serum β-hCG \> 5mIU/mL at baseline or women who are breastfeeding; etc.
Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects (SAD)
* Healthy Subjects (MAD) with untreated elevated cholesterol
* Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
* Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of liver or renal disorders
* Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration
Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients

Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.

Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores.

The dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase.

the investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility.

The current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.

Eligibility Criteria:
Inclusion criteria:

* age over 18 years old,
* acute chest pain

Exclusion criteria:

* traumatic chest pain,
* hemodynamic instability;
* arrhythmias;
* holders of a pacemaker;
* STEMI
the Effect of Reflexology in Migraine Patients

The aim of this randomised controlled trial was to evaluate the effect of foot reflexology on pain intensity, fatigue and quality of life in migraine patients.

The main questions it aims to answer are:

Is foot reflexology effective in reducing pain intensity in migraine patients? Is foot reflexology effective in reducing the fatigue level of migraine patients? Is foot reflexology effective in improving the quality of life of migraine patients? Comparison group: The researchers will evaluate the effects of foot reflexology by comparing the group receiving reflexology intervention with the control group receiving only routine treatment.

Participants were selected according to the following criteria:

Intervention group: Individuals diagnosed with migraine will receive foot reflexology twice a week for a total of 10 sessions.

Control group: No additional intervention will be applied to this group, only their routine treatment and medical follow-up will continue.

Both groups will be evaluated at the beginning and at the end of the study with the Patient Information Form, Migraine 24-Hour Quality of Life Scale (QoLQS), Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS). After the completion of the study, reflexology will be applied to patients in the control group who are willing to receive reflexology.


Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 18-60 (to conduct the study with adult individuals and to minimise the effect of age-related variables)
2. Being diagnosed with migraine
3. Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
4. Migraine with a severity of 4 or more with VAS (Visual Analogue Scale) (To prevent mild headaches from affecting the study)
5. Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
6. To participate and continue to work as a volunteer

Exclusion Criteria:

1. For female participants: Being pregnant or breastfeeding (as hormone changes may change the effect of migraine and reflexology)
2. Having another chronic neurological disease (epilepsy, MS, Parkinson's, etc.) (to avoid the effect of symptoms that may be confused with migraine)
3. Being treated with another alternative medicine method (acupuncture, biofeedback, etc.) at the same time (to measure the independent effect of reflexology)
4. Regular use of Botox, nerve blockade or invasive treatment for migraine in the last 3 months (to reduce the influence of external factors on migraine severity)
5. Severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) or a history of severe depression/anxiety (to isolate the effect of stress and psychological factors on reflexology)
6. No previous serious side effects or intolerance to reflexology (important for safety)
7. Diabetic neuropathy, severe peripheral neuropathy or severe dermatological disorders (infection, open wound, etc.) in the foot area (as it may affect the applicability of reflexology)