cyrilzakka/clinical-trials huggingface dataset:
Time Frequency Analysis of Electrocardiogram and Blood Pressure in Intracranial Hemorrhage Patients

Dysregulation of autonomic nervous system is evident in patients with spontaneous intracranial hemorrhage. In this study, we utilize a non-invasive method (heart rate and blood pressure variability analysis to analyze the autonomic activities in this group of neurosurgical patients. Our aim is to determine the utility of this modality in risk stratification and outcome prediction in these patients.

Spontaneous intracranial hemorrhage is an absolute emergency in the field of neurosurgery, and it is also a devastating event that commonly results in major neurological disabilities or mortalities. Since disease severities and clinical courses vary in each patient, pathophysiological studies and prognostic factors are always worth research. From previous studies, we know that dysregulation of autonomic system plays an important role in intracranial hemorrhage. Hemorrhage itself is associated with sympathoexcitation, and patients who develop rebleeding or infarction complications are found to have an even higher degree of sympathetic storm. Therefore, the degree of autonomic activities seems to be a useful predictor.

Traditionally, sympathetic activities are measured by plasma catecholamine, while parasympathetic activities are hard to measure. In recent decades, the application of engineering in biological fields makes a great breakthrough. Waveform analysis of biological signals, such as electrocardiograms and arterial blood pressure, can indirectly determine autonomic activities. The variabilities of heart rate and blood pressure are subjected to frequency analysis. This generates several dominant frequency bands. High frequency bands (0.15-0.40Hz) are attributed to the effect of parasympathetic nervous system, while, the low frequency bands (0.04-0.15 Hz) are attributed to the effect of both sympathetic and parasympathetic nervous systems.

In this study, all patients with spontaneous intracranial bleedings undergo standard treatment and monitoring. This include electrocardiography, arterial blood pressure, and cerebral blood flow using transcranial Doppler sonography. For those who also have intracranial pressure monitoring, the intracranial pressure are also recorded. All these biological signals are exported for wave form analysis. We use frequency analysis, time-frequency analysis, and multiscale entropy to analyze these data. The results of analyses were also correlated to plasma catecholamine levels, proinflammatory markers, as well as the clinical variables. Our aim is to identify predictors of complications and grave outcomes from these biological signals. We also apply the results for future pathophysiological studies.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous intracranial hemorrhage with radiographical confirmation

Exclusion Criteria:

* Traumatic or undefined mechanisms for intracranial hemorrhage
* Pre-existing cardiac arrythmia
* Patients who had previous histories of intracranial, cardiac, hepatic, renal, or lung diseases
Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment

The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning \>94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after a mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such several countries including United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.

In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.


Eligibility Criteria:
Inclusion Criteria:

* Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
* Eastern Cooperative Oncology group performance status \< 3

Exclusion Criteria:

* Previous SARS-CoV-2 infection
* Vaccination with booster vaccine more than 12 weeks before informed consent
* Intravenous inmunoglobulin therapy 60 days before informed consent
* Any condition that could interfere with the paticipant´s participation during the study in the opinion of the treating investigator.
Assessment of the Occlusal Characteristics and Orthodontic Treatment Needs for Egyptian Children( 6-12)Years Old

The objective of this study is to assess the occlusal characteristics of Egyptian children 6-12 years old and their need for orthodontic treatment.

The term malocclusion encompasses all deviations of teeth and jaws from normal alignment and relations including discrepancies between teeth and jaw size, malposition of individual teeth ,and mal-relationship of the dental arches in sagittal ,transverse, and vertical dimensions. The etiology of malocclusion may be due to genetic factors , environmental factors or more commonly a combination of both inherited and environmental acting together such as adverse oral habits , anomalies in number ,form ,and developmental position of teeth can cause malocclusion .The recognition of these disorders in dentistry implies the need for planning preventive ,interceptive ,and corrective orthodontic measures to provide adequate treatment .for such planning ,it is essential to carry out epidemiological studies of malocclusion prevalence and to assess the treatment need for such disorders ,so that early recognition of developing malocclusions and the potential for uncomplicated orthodontic treatment procedures can minimize or eliminate future costly treatment .

Eligibility Criteria:
Inclusion Criteria:

* Egyptian children of both genders born to Egyptian parents .
* Children having an age range from 6-12 years old.
* Cooperative children .

Exclusion Criteria:

* Craniofacial anomalies that affect jaw relation and dentition except for cleft lip and palate.
* History of facial trauma or surgery.
* Systemic disease that affects craniofacial growth
* Previously orthodontically treated child Those whom did not sign the consent
A Study of Navitoclax in Addition to Bendamustine and Rituximab in Patients With Relapsed Diffuse Large B-Cell Lymphoma (NAVIGATE)

This randomized, open-label, multicenter study will evaluate the efficacy and safety of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large B-cell lymphoma. Patients will be randomized to receive navitoclax in addition to bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented diagnosis of diffuse large B-cell lymphoma
* Patients must have relapsed or developed progressive disease following salvage therapy, or must have relapsed or progressed following initial therapy and in the opinion of the investigator are medically unfit to receive high dose chemotherapy with autologous stem cell transplant (SCT) or other salvage therapy of higher priority
* Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Patients who have undergone STC must be more than 100 days from autologous stem cell infusion prior to first dose of study drug, must have recovered from any transplant related toxicity and must have adequate bone marrow function as defined by protocol independent of any growth factor support
* Patients who have not undergone SCT must have adequate bone marrow function as defined by protocol independent of any growth factor support
* Adequate coagulation, renal and hepatic function

Exclusion Criteria:

* Refractory DLBCL
* History of other malignancies within 2 years prior to initiation of study treatment except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy (with and without radiation) with curative intent
* Active infection requiring parenteral antibiotics or antiviral or antifungal agents
* Inherited or acquired bleeding diathesis, anticoagulant drugs or drugs that inhibit platelet function, underlying conditions that predisposes to abnormal bleeding, or refractoriness to platelet transfusions
* Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, or ventricular tachyarrhythmias requiring medication within 1 year prior to the initiation of study treatment
* Positive for hepatitis B, hepatitis C or HIV infection
Cerebral Energy State in Cardiac Surgery

Impaired cerebral function remains an important complication of cardiopulmonary bypass (CPB) during cardiac surgery. The aim of the present study is to investigate whether the lactate to pyruvate (LP) ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a derangement of global cerebral energy state during cardiopulmonary bypass.

Patients undergoing primary, elective coronary artery bypass grafting were blindly randomized to usual range MAP (40 to 60 mmHg; n = 5) or intervention group MAP (60 to 80 mmHg; n = 5) during CPB. MD catheters were positioned in a retrograde direction in the internal jugular vein and a reference catheter was inserted into the brachial artery. The relations between LP ratio, MAP, data obtained from bi-frontal NIRS and neurological outcome measures were assessed.

Eligibility Criteria:
Inclusion criteria:

* Elective CABG on CPB

Exclusion criteria:

* Acute patients or reoperations
* Patients with epidural catheter
* Previous stroke
* Stenotic carotids
* Ejection fraction (EF) \< 50 %
* Estimated per operative risk \> 5%
COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care

The hypothesis is that problem based learning (PBL) in patient education positively affects self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The investigators therefore aim to determine whether long-term follow-up in primary health care in patient education involving PBL affects self-care behaviour in terms of patients' beliefs, self-efficacy and empowerment to make lifestyle changes. The general aim is to evaluate if PBL in patient education after CHD affects long-term self-care in relation to present lifestyle goals. Another aim of the study is to perform an economic assessment of long term effects of life style changes reached by using PBL after en event of CHD.

Even though the convincing evidence of that self-care such as regular exercise and/or stop smoking alters the course of events after an event of coronary heart disease (CHD), risk factors remain. Outcomes can improve if core components of secondary prevention programmes are structurally pedagogically applied using adult learning principles e.g. problem based learning (PBL). Until now, most education programs for patients with CHD are not based on such principles and primary health care lacks structure in the follow-up of self-care goals of the patients. All patients will receive conventional care from their general practitioner and other care providers. They will randomly be allocated to an intervention that consists of a problem based patient education program (1 year) in PHC by trained district nurses (tutors). Patients in the control group will not attend a PBL group but receive mailed patient information during the 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages with CHD verified by MI and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery by-pass surgery (CABG) within 12 months before planned start of the intervention.
* Patients should be stable regarding their cardiac conditions and have optimised cardiac medication not substantially changed during the last month, completed heart school in hospital care (if applicable), listed at one of five specific primary health care centres agreed to join the project at time of inclusion.

Exclusion Criteria:

* Planned CABG or other causes demanding continued cardiologist care; e.g. on-going contact with heart failure clinic due to drug titration or investigations e.g. myocardial scintigraphy to detect ischemia before a new PCI
* Life expectancy ≤ 1 year, documented psychiatric disease that render difficulties to cooperate with other people or obvious abuse of alcohol or narcotics.
* Patients will also be excluded if they are unable to communicate or read the Swedish language and if they participate in other studies affecting the results.
Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease

The study aims to depict the actual prescription patterns employed in clinical practice of patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy) and to analyze the outcomes of therapeutic decisions, focusing on mortality, hemorrhagic events, and ischemic events,

The combination of warfarin, aspirin, and clopidogrel represented the standard antithrombotic therapeutic strategy for patients with atrial fibrillation and suffering from acute coronary syndrome and/or undergoing percutaneous coronary intervention.

Current guidelines and clinical practice guides suggest the use of triple or dual antithrombotic therapy after a careful evaluation of the patient's hemorrhagic and thrombotic profile, without however providing indications with recommendation class I. It is not known what treatment regimens are prescribed in the real world, i.e. how clinicians behave in the absence of clear guidelines.

This observational study involves patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy), to describe the real-world prescription model used in clinical practice and to analyze the results of therapeutic choices in terms of mortality, hemorrhagic and ischemic events.

Patients are enrolled within 7 days from percutaneous coronary intervention during their hospitalization period. During the enrolment visit (i.e. baseline, T0), all patients undergo a detailed assessment of their medical history related to the recent hospitalization, laboratory blood analysis, and data related to their cardiovascular risk factors. Follow-up visits will be performed at three months (T3) and twelve months (T12). During the follow-up visit, any ischemic/bleeding events, therapeutic changes, and laboratory blood analysis will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patient with non valvular atrial fibrillation with direct oral anticoagulants therapy
* Patient on antiplatelet therapy (acetylsalicylic acid and/or inhibitor of the P2Y12 platelet receptor)
* Patient hospitalized for percutaneous coronary intervention in the previous 7 days
* Age ≥18 years
* Estimated life expectancy ≥ 12 months
* Ability to give informed consent

Exclusion Criteria:

* Patients who have contraindications to direct oral anticoagulants therapy
* Patients who are indicated for direct oral anticoagulants therapy for reasons other than non valvular atrial fibrillation
Lower Tourniquet Pressure Study

This study design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. A secondary goal is to evaluate the effect of lower tourniquet pressures on post-operative tourniquet site pain. The rationale behind the study is to provide evidence-based guidelines on tourniquet use to continue providing quality surgical care while minimizing pain and potential harm to patients.

Patients undergoing hand and upper extremity surgery at our institution will be offered participation in this study. Consenting patients will be randomized in a double-blinded fashion to either standard tourniquet pressure of 250 mmHg or lower tourniquet pressures based on SBP. Demographic data will be recorded as well as details of the surgical procedure. Post-operatively, the operating surgeon will complete a questionnaire about the quality of bloodless surgical field and the patient will complete a questionnaire about post-operative pain. This study will enroll approximately 150 patients. Statistical analysis will be completed to analyze the effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient age 18 or older
* Undergoing hand or upper extremity procedure
* Tourniquet is used for procedure
* Willingness and ability to consent

Exclusion Criteria:

* Individuals with procedures that are over 120 minutes in length
Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters

The chestnut tree (Castanea sativa Mill.) is a species widely cultivated in Portugal, which is a major producer of chestnuts. Nuts are nutritionally interesting, not only because of their content of vitamins, minerals, and phytochemicals but also of their high fiber content.

Fiber, as it is not digested by humans, has a preponderant role in the intestinal microbiota, for its maintenance, and, consequently, has an impact on metabolic status.

The inclusion of foods rich in these components, and with extensive local production, can be an excellent strategy for improving the metabolic parameters of the population.

The main objective of this single group assignment clinical trial is to evaluate the effect of including roasted chestnuts in the daily diet on the composition and diversity of the intestinal microbiota. It is also intended to evaluate metabolic parameters to determine the impact of this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian.
* Filling informed consent.
* Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.

Exclusion Criteria:

* Chestnut sensibility.
* Chestnut daily consumption in the month before the study initiation.
* Having taken antibiotics within the 6 months prior to beginning the study;
* Use of pro/prebiotics or fiber as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
* Use of laxative 6 weeks before recruitment.
* Specific dietary regimen (e.g., vegan).
* Specific nutritional therapy (e.g. high protein).
* Excessive alcohol consumption.
* Smoking.
* Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease or Diabetes Mellitus.
* Use of proton pump inhibitors, antidiabetic drugs, insulin, or statins.
* Pregnant or breastfeeding.
* Participation in another clinical trial within the last 3 months.
Diabetes Cohort in French Amazonia

CoDiAm aims to collect clinical, biological and social data of diabetic patients in French Guiana.

Diabetes is a very common disease in French Guiana. This disease is caused by the body's inability to metabolise sugar properly. A diet and treatment with tablets are enough for some patients, while others may need insulin injections. In the long term, high blood sugar levels may cause problems to the small and large blood vessels in the body. This is complicated by nerve, renal and retinal damage, as well as increased risks of cardiac and vascular events (such as strokes or heart attacks.) It appears that diabetes is more common and more severe in French Guiana than in other parts of France. It seems that the types of diabetes found here are more variable than those found in France, and that patients tend to be diagnosed at a later stage. We would this like to better understand diabetes and its evolution in French Guiana.

This research is aimed at diabetic patients and it is being carried out in the Andrée Rosemon Hospital Centre, the Ouest Guyanais Hospital Centre as well as in other Primary Healthcare Centres. At some point in the future, some private health centres may also invite their patients to take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes
* At least 18 years old

Exclusion Criteria:

* Less than 18 years old
* Patients under legal guardianship
* Patients' refusal to participate
* Patients living outside French Guiana
A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants

The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in your blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m\^2
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug, as defined in the protocol
3. Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
4. Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
2. History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (BP \<90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia
3. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
4. Was hospitalized (ie, \>24 hours) for any reason within 30 days of screening
5. Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening

NOTE: Other protocol defined inclusion / exclusion criteria apply