cyrilzakka/clinical-trials huggingface dataset:
Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting Prognosis

The goal of this observational study is to find novel serum biomarkers for the accurate diagnosis of plaque erosion (PE) from acute coronary syndrome (ACS) and help predicting the prognosis of PE. The main question it aims to answer is

• Whether novel serum biomarkers could facilitate the non-invasive diagnosis and prognosis prediction of PE ? Participants will be contacted at 1,2,5 year after the diagnosis of PE-ACS or other reasons of ACS.


Eligibility Criteria:
Inclusion Criteria:

people presenting with an acute coronary syndrome (ACS)-either non-ST-segment elevation myocardial infarction (NSTE-ACS); or ST-segment elevation myocardial infarction (STE-ACS), and subsequently underwent emergent coronary angiography followed by percutaneous coronary intervention (PCI). Culprit leisions were tested using optical coheren tomograpgy and pathological diagnosis(PE OR PR) were validated by 2 independent experienced core lab members.

Exclusion Criteria:

* patients younger than 18 years or older than 85 years
* patients in cardiogenic shock
* prior coronary artery bypass grafting,
* patients with corornary stent thrombosis
* patients with left main coronary disease
* patients with congestive heart failure
* patients with life-threatening arrhythmia
* patients with thrombocytopenia patients with significant hepatic or renal impairment
* patients with septicemia, leukopenia, active inflammatory or malignant disease
* other factors compromising high-quality optical coherence tomography (OCT) imaging (e.g., severe vessel tortuosity or calcification, persistent no-reflow, lesions in distal segments, or an indeterminate culprit lesion)
* Individuals unable to provide informed consent were also excluded.
Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Orlistat is a popular drug approved for long-term use which produces weight loss by inhibiting triglycerides, main components of fats in the diet and reducing dietary fat absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not been described yet. The FA composition of RBCs, plasma and platelets can be used to monitor of many pathological processes. This study presents alteration of FA composition in RBCM and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.

Obesity treatment requires lifestyle changes such as diet, exercise, and behavioral therapy. Orlistat is a popular drug approved for long-term use which produces weight loss by inhibiting triglycerides, main components of fats in the diet, from binding to the lipase enzyme active sites thus halting their subsequent breakdown into monoglycerides and free fatty acids necessary for fat digestion, reducing dietary fat absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not been described yet.

The FA profile is typical of each lipid and tissue, however, alterations in diets, pathological processes, drugs intervention, cigarettes and alcohol consumption can alter the FA profile. The FA composition of RBCs, plasma and platelets can be used to monitor these processes. This study presents alteration of FA composition in RBCM and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Obesity BMC (Body Mass Index) between 30 to 40 kg/m2 Women 18 to 45 years Premenopausal stage

Exclusion Criteria:

* Relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopatHy or neoplasm in the last three years)
* Chemical or natural laxatives
* Weight variation greater than 5% in the preceding 3 months
* Surgery for weight reduction
* Drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months
Application of MRI in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Rectal cancer patients who received neoadjuvant chemoradiotherapy in Peking University Third Hospital in 2021 are divided into acute myelosuppression group, chronic myelosuppression group and normal group. The differences of magnetic resonance parameters between the groups were compared. The risk identification model of acute and chronic myelosuppression after neoadjuvant chemoradiotherapy was established by clinical risk factors and quantitative parameters of magnetic resonance imaging, and the prediction efficiency of the model was evaluated.

The patients with locally advanced rectal cancer diagnosed in Peking University Third Hospital and undergoing neoadjuvant chemoradiotherapy were collected. The basic information of patients (including age, sex, BMI, TNM stage of rectal cancer (T2, T3 stage)) was collected. The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy. MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed, and the corresponding parameters were obtained. The white blood cell values and quantitative parameters of magnetic resonance (including T1WI, DWI signal intensity (b = 1000) and proton density fat fraction (PDFF) of sacrilium and proximal femur were collected. Patients were divided into acute myelosuppression group and non-acute myelosuppression group according to blood routine results 14 days after radiotherapy, and chronic myelosuppression group and non-chronic myelosuppression group according to blood routine results 90 days after radiotherapy. The magnetic resonance parameters difference between 1-2 weeks after radiotherapy and before radiotherapy, and the magnetic resonance parameters difference between 90 days after radiotherapy and before radiotherapy were calculated. By comparing the differences of clinical risk factors and quantitative parameters of MRI between the two groups, the meaningful variables were screened out, and the risk identification model of acute and chronic myelosuppression was established.

Eligibility Criteria:
Inclusion Criteria:

* From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University.
* There were blood routine before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy, and MRI examination including routine MRI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks and 90 days after radiotherapy.
* Each patient used the same chemotherapy regimen.

Exclusion Criteria:

* Patients with metabolic bone diseases such as hyperparathyroidism and Cushing's syndrome.
* Patients with history of pelvic radiotherapy or systemic chemotherapy.
* Patients with leukocytes below 4.0×10\^9/L or long-term severe anemia before radiotherapy.
* Patients with tumor bone metastases; patients with pelvic trauma, fracture, and infectious diseases.
Exploring Medical Decisions Using Functional MRI

Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated medical decisions during fMRI acquisitions, with and without explicit budgetary constraints. We will compare the fMRI data between the 2 modalities.


Eligibility Criteria:
Inclusion Criteria:

* Hospital physicians
* working in the CHU of Montpellier

Exclusion Criteria:

* Contra indication to f-MRI
Quantitative Assessment of Distal Radioulnar Joint Stability With Pressure-Monitor Ultrasonography

To quantitatively assess distal radio ulnar joint (DRUJ) stability, a pressure-monitor ultrasound system was developed. The objective of this study was to evaluate the force-displacement relationship of DRUJ in patients and normal subjects. Each subject will be imaged sitting with elbow flexed and forearm pronated. The dorsal surface of distal radius and the center of ulnar head will be displayed at DRUJ level. The pressure toward palmar direction will be applied to distal ulna with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm. The distance between the dorsal surface of the ulnar head and the dorsal surface of the distal radius will be measured. At the same time, the pressure to the transducer will be measured.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* DRUJ instability patients

Exclusion Criteria:

* the participants who had a history of previous wrist trauma and wrist pain will be excluded
Effects of PH3 in Diabetic Nephropathy

The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for patients with diabetic nephropathy.

The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.


Eligibility Criteria:
Inclusion Criteria:

1. Males and Females between 18 and 70 years of age with type 1 or type 2 diabetes
2. Sitting blood pressure of \<=140/90 mm Hg
3. Serum creatinine \<=2.0 mg/dL
4. Urinary albumin: creatinine ratio between 30 mg/g to 1000 mg/g creatinine (of the first urine sample of the day)
5. Hemoglobin A1c \<=8%
6. Women of child-bearing potential must test negative in a pregnancy test and take contraception measures to prevent pregnancy and can not be breast-feeding
7. Voluntary written consent to participate in this study

Exclusion Criteria:

1. History of major cardiovascular or cerebrovascular events within 6 months prior to screening
2. History of cancer
3. Receiving chronic nonsteroidal anti-inflammatory therapy
4. History of diabetic ketoacidosis
5. Has clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety
6. Has participated in other investigational trials within 28 days prior to study enrollment
7. Has taken herbal medical treatment as prescription medication and/or over-the- counter medication, within 28 days prior to study enrollment.
8. Has known allergy to the study drug
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.


Eligibility Criteria:
Inclusion Criteria:

* Planned HeartMate II LVAD implantation
* Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement

Exclusion Criteria:

* Prior history of mechanical circulatory support;
* Body weight \< 110 lbs;
* Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;
* Severe aortic stenosis;
* Renal failure requiring dialysis;
* Hepatic dysfunction resulting in severe coagulopathies;
* Recent serious infection;
* Current need for prolonged ventilatory support;
* Prior organ transplantation;
* Blood transfusion within 14 days of the first planned study blood draw;
* Concomitant immunosuppressant or chemotherapeutic agents;
* Pregnant women;
* Decisionally challenged or prisoners;
* Unwilling to provide written informed consent
Welcome to WellnessRX: Steps Toward a Healthier Life!

Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake County at all levels of health including those struggling with chronic disease. The classes are running across the community at all times. It is designed for patients that could benefit from healthy diet, exercise, and other healthy lifestyle modifications.

For those participants attending the classes, they have the option of engaging in this evaluation. For those that do, participants will answer questions about their current lifestyle, their and their previous history. They will register attendance at each class and answer questions about their perception of the class. Then at 45 days and 90 days the participants will revisit the same baseline lifestyle questionnaires.

As participants attend classes, and complete questionnaires, they'll unlock grocery credits from online food store ThriveMarket, a basket of fresh produce from the local farmers market and local fitness classes to help you towards your goals. The use of these credits will be tracked through the 90-day point.


Eligibility Criteria:
Inclusion Criteria:

* Lake County, California Resident
* able to attend 6 lifestyle change classes held around the community
Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial

The goal of this clinical trial is to determine if nurse-led education and tele-interventions can reduce the incidence of surgical wound infections in patients after coronary artery bypass surgery. The main questions it aims to answer are:

* Can nurse-led education reduce the rate of surgical wound infections after coronary artery bypass surgery?
* Does the addition of tele-interventions further decrease the incidence of these infections compared to standard care?

Researchers will compare three groups:

* Group A: Standard postoperative care
* Group B: Nurse-led patient education
* Group C: Nurse-led patient education plus tele-interventions

Participants will:

* Receive standard care, nurse-led education, or nurse-led education with tele-interventions
* Having regular follow-up as per group assignment
* Monitor and report infection during the study period


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who have undergone CABG with median sternotomy
* Proficiency in reading and writing in Greek
* Patients who provide written informed consent for participation in the study
* Patients who have access to a mobile phone and know how to use it
* Patients without difficulties in vision, speech, or hearing
* Patients at intermediate or high risk for developing surgical site infections, based on their scores in the risk stratification models described below

Exclusion Criteria:

* History of psychiatric illness, recent history of alcohol and/or substance abuse, dementia, and Alzheimer's disease
* Presence of an active infection within 2 weeks prior to the surgical procedure
* Preoperative hospitalization \> 2 days
* Concurrent surgery on the aorta or heart valves
* Urgent or emergency nature of the surgical procedure
* Re-sternotomy aimed at surgical re-exploration of bleeding or implementation of cardiopulmonary resuscitation (CPR) in cases of cardiac arrest
* Patients in whom the sternum has not been closed after the completion of the surgical procedure and who are transferred to the cardiothoracic unit without sternum closure
* Active endocarditis
* Life expectancy \< 6 months
* Lack of a smartphone
Phase I Study of AbGn-168H in Healthy Male Volunteers

The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males according to following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
3. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
4. Chronic or relevant acute infections including hepatitis and tuberculosis, or a positive PPD skin test (5 mm or greater) at screening or within the previous 3 months
5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
6. Use of biologic agents within 12 weeks prior to treatment
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.


Eligibility Criteria:
Inclusion criteria:

* Japanese participant diagnosed with compensated CHC GT 1
* Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
* IFN treatment naive
* No evidence of cirrhosis

Exclusion criteria:

* Co-infection with human immunodeficiency virus (HIV)
* Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
* Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
* Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant.
Feasibility of Use of BariCare App in Pre-transplant Population

This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are candidates for liver or renal transplant.
2. Individuals who own a smartphone.
3. Individuals who are obese.

Exclusion Criteria:

1. Patients with prior history of bariatric surgery.
2. Patients with active psychiatric disorder.
3. Patients with active tobacco use.
4. Patients with active substance use (alcohol, illicit drugs, etc.)
Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers

Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.

The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.

PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).


Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Age\>18y
  * Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic
  * Having received invasive or noninvasive mechanical ventilation
  * Non-opposition to participate to the telephone interviews.

Family members:

* Age\>18y
* Non-opposition to participate to the telephone interviews
* One family member per patient: the family member the most implicated in the patient's care

Healthcare providers:

* All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic

Exclusion Criteria:

* Patients:

  * Language barrier to be able to respond to the telephone interview
  * Cognitive disorders disabling patients to respond to the telephone interview
  * Person under legal protection (1121-8 of CSP, Public Health Code) Failure to obtain the non-opposition

Family members:

* Language barrier to be able to respond to the telephone interview
* Person under legal protection (1121-8 of CSP, Public Health Code)
* Failure to obtain the non-opposition

Healthcare providers:

Failure to obtain the non-opposition
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"
* Subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination

Exclusion Criteria:

* Subjects who have transient hyponatremia induced by drug administration
* Subjects who are unable to sense thirst or who have difficulty with fluid intake
* Subjects with urinary tract obstruction
* Subjects who have participated in any other clinical trial within 30 days prior to informed consent
* Subjects with serum sodium concentration of \<120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures