cyrilzakka/clinical-trials huggingface dataset:
Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)

Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.

This is a prospective observational study using non-invasive NIRS for microvascular monitoring in the ICU. The study involves no interventions above standard of care other than the application of the NIRS monitors.

NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU admission. Vital signs are extracted continuously from the ICU monitor and clinical data are recorded from patient records.

The broad goals of the study are:

1. Determine the feasibility of longitudinal NIRS monitoring in ICU patients
2. Determine the ability to derive patient-specific microvascular metrics using NIRS
3. Explore the relationship between microvascular metrics and ICU mortality

Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU
* Receiving invasive mechanical ventilation

Exclusion Criteria:

* Body Mass Index \>40
* More than 24 hours has elapsed since ICU admission
* Death is deemed to be imminent and inevitable during the next 24 hours
* Known allergy to the textile components of the device
* Significant clinical jaundice, ecchymosis
* COVID positive microbiological result
* The treating clinician believes that participation in the domain would not be in the best interests of the patient
* Consent declined from patient or authorized third party
Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia

Schizophrenia is a mental pathology that concerns 1% of the French population, characterized by heterogeneity of symptoms. One of them, apathy is defined as a multidimensional psychopathological state manifested by a decrease in motivation. This deficit is most common in schizophrenia and impacts the functional outcome of patients. To date, no treatment has shown a significant effect on this symptom. In other pathologies with a motivational deficit, the technique of Mental Contrasting and Implementation Intention (CM-II) showed interesting effects in improving motivation, reducing the effort related to the action.

The investigators aim to propose the CM-II technique to individuals with schizophrenia to improve apathy.

The investigators expected that the CM-II technique will allow an improvement of apathy which will have beneficial effects on other psychological factors (e.g., depressive symptoms). In addition, the implementation of the CM-II will provide help to global management.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \< 60 years old
* Diagnosis of schizophrenia according to DSM 5 criteria.
* Score greater than or equal to -18 on the Lille Apathy Rating Scale
* Ability to understand and speak French.
* Obligation to belong to or be a beneficiary of a social security scheme.
* Signature of the consent. If the participant has a representative, signature by the representative.

Exclusion Criteria:

* History of head injuries or neurological pathologies.
* Current treatment with sismotherapy or repetitive Transcranial Magnetic Stimulation (rTMS).
* Treatment targeted at and/or influencing negative symptoms (CBT, cognitive remediation), or therapeutic trial.
* Participant under safeguard of justice.
* Pregnant or breastfeeding woman.
A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia

We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.

An increased serum cholesterol level is an important risk factor for the development of cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through dietary modification, behavioral changes, and medicinal intervention has already substantially decreased the incidence and mortality from cardiovascular and cerebrovascular disease. Supplementation of the diet with certain biofactors may further reduce such risk factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing platelet responsiveness to activating agents.

Eligibility Criteria:
Inclusion Criteria:

* Mild hypercholesterolemic subjects aged from 20 to 80 years
* had no received lipid-lowering drugs for at least 3 months prior to the recruitment

Exclusion Criteria:

* self-reported pregnancy,lactation
* prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications
Beta-2 Microglobulin and Serum Cytokines x HAART

Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.

Objective: To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ \< 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic, clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α, IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+ lymphocytes tests were performed.

Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic failure, genotyping.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1-infected individuals
* Over 18 years old
* Sign the "written consent form" (WCF)

Exclusion Criteria:

* Do not presenting other immunosuppression causes, such as neoplasias, transplantations
* Do not presenting treatment by immunosuppressive substances
* Do not presenting auto-immune diseases
* Not be using any type of immunostimulating substances
* Not at any time of gestation
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 30.0 kg/m2
* In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
* Agreement to comply with protocol-specified contraceptive requirements

Exclusion Criteria:

* Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before Screening
HIPEC Surgery and Hemodynamics

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) involves the intraoperative administration of heated chemotherapeutic agents into the abdominal cavity following cytoreductive surgery (CRS). The increasing use of CRS combined with HIPEC has introduced certain procedural and physiological considerations that distinguish it from other surgical interventions, posing unique challenges for researchers and clinicians alike.

Despite advancements in surgical and anesthetic techniques, this combined approach is frequently associated with significant hemodynamic instability, coagulation abnormalities, respiratory complications, and nutritional imbalances.

The study aims to contribute to the existing body of knowledge by examining the physiological alterations induced by HIPEC, thereby offering practical insights and guidance for investigators involved in the management and study of this complex therapeutic modality.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old Patients planned to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
* ASA II-III-IV physical class

Exclusion Criteria:

* \<18 years
* Emergency cases
CPAP Versus NPPV in ACPE

To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.

Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.

Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.

Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.

Inclusion criteria were: severe dyspnoea, respiratory rate \> 30, PaO2/FiO2 \< 200, muscle fatigue.

Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.

Eligibility Criteria:
Inclusion Criteria:

* rapid onset of the symptoms
* severe dyspnoea at rest
* respiratory rate \> 30 breath per minute
* use of accessory respiratory muscles
* PaO2/FiO2 \< 200, radiological findings of ACPE

Exclusion Criteria:

* ST elevation myocardial infarction
* hemodynamic instability (systolic arterial pressure \< 90 mmHg
* need for immediate endotracheal intubation (respiratory arrest, bradypnea
* inability to protect the airways, impaired sensorium (agitation or unconsciousness
* inability to clear secretions, respiratory tract infections
* chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
* pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
* gastrointestinal bleeding
* facial deformities
* haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
Intensive Motor Rehabilitation with Technology for Patients with Central Neurological Disease

This project will consist of 1 large clinical trial with 2 core concepts: (1) Clinical benefits of an intensive rehabilitation programme using advanced technology, compared to the control group; (2) A full health economic evaluation combined with model-based estimation of costs and benefits.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
2. A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:

   1. Stroke: Participants must have received a diagnosis of stroke for the first time, have been diagnosed at least 3 months ago, and live at home.
   2. SCI: Participants have a rating A, B, C or D on the American Spinal Injury Association (ASIA) measurement scale, which refers to patients with complete or incomplete impairment. All levels of SCI can be included, if there is a clear patient need linked to the upper and/or lower extremities.
3. At least 3 months post discharge from hospital/rehabilitation centre, living at home;
4. Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);
5. Had a normal functional state prior to the pathology: a pre-pathology Barthel Index \> 85/100;
6. Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum score in all affected limbs = motricity index: score 5 on 3/3 segments)
7. Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist;
8. Age of \> 18 years;
9. Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;.

Exclusion Criteria:

1. Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist;
2. No ability to initiate movements against gravity in the upper and lower limbs;
3. Severe visual impairment, communication, cognitive and language formation problems that would prevent the intervention and measurement process, assessed by a specialist;
4. Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP;
5. Female who is pregnant, breast-feeding.
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): a Pilot Supportive Care Intervention

The goal of this research study is to conduct an open pilot of a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools and to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer.

The name of the intervention used in this research study is:

PROWESS (behavioral change intervention)

This research study is to test a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools with wearable technology, to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer on androgen deprivation therapy (ADT).

Study procedures include screening for eligibility, intervention sessions, questionnaires and surveys, and an exit interview with study staff.

Participation in this research study is expected to last for up to four months.

The goal and primary outcome of this open pilot study is refinement of the intervention and study procedures to allow for us to conduct a larger feasibility study in the future.

It is expected that about 10 people will take part in this research study.

This research study is being supported by the MGH Cancer Center

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer.
* Planning to be on androgen deprivation therapy (ADT) for at least three months
* Black Race AND/OR Hispanic/Latino Ethnicity (confirmed by patient self-report)
* Verbal fluency in English or Spanish.
* Receiving ongoing oncology care at MGH Cancer Center.
* Age ≥ 18 years.
* Self-Report less than or equal to 150 minutes of moderate or vigorous structured exercise per week, as assessed by the Exercise is Medicine Physical Activity Vital Sign Assessment
* Completion of baseline assessment

Exclusion Criteria:

* Unwilling or unable to participate in the study.
* Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study.
* Currently receiving chemotherapy.
* Prognosis less than 6 months, per the judgment of the primary oncologist.
* Medical contraindication to physical activity, as assessed by outpatient oncologist.
YF476 and Type I Gastric Carcinoids

The aim of the study is to find out if the experimental medicine, YF476, can make gastric carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur mainly in patients with chronic atrophic gastritis (CAG), a condition in which the acid-producing cells in the lining of the stomach can't make acid. Acid production is controlled by gastrin, a hormone (chemical messenger) that's released into the bloodstream. If the stomach can't make acid, blood levels of gastrin rise. High blood levels of gastrin in patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and, over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign, but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a mini video camera, which enables the user to inspect the lining of the stomach and a 'snare' to take samples of tissue (biopsies). YF476 (netazepide) is a gastrin receptor antagonist (blocks the effects of gastrin), so it's a potential new medical treatment for gastric carcinoids in patients with CAG. Up to 10 of these patients will take YF476 daily for up to 12 weeks. If they benefit from that treatment, they may take YF476 daily for up to another 52 weeks. They'll make several outpatient visits for tests, including checks on the safety of YF476. At some of the visits, they'll have a gastroscopy. At each gastroscopy, the gastric carcinoids will be measured and biopsies taken for laboratory tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the outpatient clinic of the investigator;
* Men, postmenopausal women, premenopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophrectomy, or premenopausal women using reliable contraception: condom and spermicide or intrauterine device;
* Adults ≥ 18 years;
* Good general health; and
* Able to give fully-informed, written consent.

Exclusion Criteria:

* Women who are pregnant, lactating or using a steroid contraceptive;
* History of gastric surgery, apart from surgery for gastric carcinoids;
* Evidence of Zollinger-Ellison syndrome;
* Prolonged QTc interval (\>450 msec);
* Certain medicines and herbal remedies taken during the 7 days before visit 1;
* Previous treatment with somatostatin; or
* Participation in other clinical trials of unlicensed medicines within the previous 3 months.
Effect of Emotional Freedom Technique on Postoperative Pain and Anxiety in Patients Undergoing Total Knee Replacement

Since pain is a complex and unpleasant feeling that affects the individual physically, mentally and socially, it should be controlled. It is also known that major surgeries such as orthopedics and traumatology, general surgery and cardiovascular surgery cause fear of death in the patient, and this fear is then replaced by general anxiety and post-operative pain. The emotional freedom technique is a method that uses cognitive functions and physical components (tapping acupuncture points) to bring about psychological changes. It is also defined as "needle-free acupuncture" or "an emotional form of acupressure" because it is a gentle, non-invasive procedure and uses acupuncture meridians. This method, which is very old in Eastern cultures, started to be used in the West in the 1980s. In this developed technique, all 12 points on the 12 basic meridians, which are the flow paths of the energy in the body, are used. In the emotional liberation technique tour, general anxiety, phobias, post-traumatic stress disorder, fears and the discomfort caused by anxiety are eliminated and all kinds of targeted problems are cured.

Considering the patients as a whole in terms of biopsychosocial is the basic element of nursing. It is inevitable to experience pain and anxiety in the post-operative period in individuals who are in a foreign environment such as a hospital and who have undergone major surgery such as total knee replacement. With this study, it is expected that the emotional freedom technique will contribute to the national and international literature on the effect of pain and anxiety in the post-operative period and will be a source of information in the development of nursing science on the use of non-pharmacological treatments that can be used in the treatment of pain and anxiety in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Elective patients undergoing total knee replacement surgery for the first time,
2. Volunteer to participate in the research,
3. 18 years and over,
4. Cognitive level scales are suitable for application,
5. Having no vision, hearing, or speech problems that would prevent communication,
6. Patients who do not have any other disease causing pain and anxiety

Exclusion Criteria:

1. EFT was applied before,
2. If any complication develops within 3 days before, during, or after the operation,
3. Patients with health problems (fever, infection, DVT, etc.) that prevent the application of the Emotional Freedom Technique were not included in the study.
Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner

The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.


Eligibility Criteria:
Inclusion Criteria:

* pelviscanner indication in women

Exclusion Criteria:

* In the disqualification of another study or under the "national register of volunteers."
CTHRC1 Abiomarker in Rheumatoid Arthritis Diagnosis

The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity.

Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints. Characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in the plasma .Of interest, CTHRC1 is a secreted modulator of Wnt signaling, which is a key regulator of joint remodeling, and promotes cell proliferation and migration. Therefore, CTHRC1 may contribute to multiple aspects of the pathogenic FLS behavior in RA and modulate processes that promote synovial hyperplasia and invasion.The expression pattern of CTHRC1 in pannus, its role in the function of FLS relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis and monitoring of disease activity in patients

Eligibility Criteria:
Inclusion Criteria:

* -Patients diagnosed as RA.
* Patients ( \>18)who are age and sex matched with the controls

Exclusion Criteria:

. Other Rheumatologic diseases. .Patients with malignancy . .Patients with hepatic disease .