cyrilzakka/clinical-trials huggingface dataset:
Seizures After Cardiac Surgery -- A Study With Continuous EEG Monitoring

The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.

Background: Most patients do not have any neurological complications after cardiac surgery, but fewer than 1% may have a seizure (abnormal brain activity), with or without a convulsion. This can be due to a reaction to certain types of drugs or less commonly stroke or inflammation. Some seizures in post-operative and intensive care unit patients do not result in convulsions, but rather the abnormal brain activity simply causes confusion or unresponsiveness. The incidence of this type of "nonconvulsive"seizure after cardiac surgery is unknown.

Purpose of the study: The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.

Design of the study: The investigators target is to enroll 150 patients undergoing cardiac surgery. The investigators are including patients greater than 18 years of age who are admitted to the CSRU immediately after cardiac surgery. Included patients are of normal mentation and are able to give their own consent. The investigators will exclude only those patients for whom technical issues prevent us from recording the EEG.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients able to give informed consent and undergoing cardiac surgery

Exclusion Criteria:

* Inability to record subhairline EEG data due to technical/mechanical reasons Patients not giving informed consent
Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease

Structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease (COPD) have been linked to impaired muscle function, reduced exercise capacity, and increased mortality associated with this disease. Muscle dysfunction also contributes to dyspnea intensity and the ability to sustain exercise, making aerobic exercise training intolerable at the intensity and/or volume required to achieve clinically important changes. Resistance training (RT) is an attractive exercise modality because it is efficacious and more tolerable initially. No work has examined whether a short-term RT program can reduce exertional symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with COPD.

Skeletal muscle dysfunction is common in patients with COPD and has been recognized as a contributing factor to reduced exercise capacity, health related quality of life and increased mortality associated with this disease. Several structural changes in the limb muscles of patients have previously been reported and have been linked to the known reductions in muscle strength and endurance commonly reported in COPD. Muscle dysfunction, lower extremity muscle strength, and muscle fatigue also contribute to the intensity of dyspnea and the ability to sustain exercise mostly through stimulation of type III and IV muscle afferents. As such, many patients who primarily perform aerobic exercise training as part of pulmonary rehabilitation are unable to tolerate the intensity and/or volume of exercise required to achieve clinically important changes in exercise capacity or symptom relief. Resistance training (RT) is an attractive exercise modality for patients with COPD because it is efficacious and often more tolerable initially. To our knowledge no one has examined whether similar benefits to those elicited by longer RT programs can be attained in just 4 weeks using multi-joint, multi-muscle exercises and individualized progression. If a short term RT program can improve muscle quality, enhance endurance, and reduce type III and IV afferent activity then it would reduce the drive to breathe and thus dyspnea. These adaptations would likely translate into improved exercise tolerance making it feasible to "pre-habilitate" COPD patients with tolerable RT, allowing them to achieve a higher volume/intensity of endurance training, thus making pulmonary rehabilitation more effective.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers \>6 months
* FEV1/FVC \<0.7 and lower limit of normal
* 30%\< FEV1 pred \<70%
* Stable (no exacerbation for \>3 months)

Exclusion Criteria:

* Cardiovascular and cerebrovascular disease
* Diabetes
* Cardiovascular contraindications to exercise
* Uncontrolled hypertension
* Currently performing regular structured exercise \>3x/week for 30 minutes
Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.

The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.

The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.

-As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate
* Patient must be ineligible for traditional myeloablative transplantation according to treating physician
* Lack of 6/6 or 5/6 HLA-matched related, 8/8 HLA-matched unrelated donor, or unrelated donor not available within a time frame necessary to perform a potentially curative stem cell transplant
* 18-65 years of age
* ECOG Performance Status 0-2

Exclusion Criteria:

* The following hematologic malignancies are excluded:

  * Myelofibrosis unless there has been exposure to cytotoxic chemotherapy for the treatment of progression to acute myeloid leukemia
  * Chronic Myelogenous Leukemia, unless there has been exposure to cytotoxic chemotherapy for the treatment of blast phase, 3) Aplastic anemia, in the absence of transformation to Myelodysplastic disorder
* Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension
* Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of \< 50% of predicted, corrected hemoglobin
* Renal disease: serum creatinine \> 2.0mg/dl
* Hepatic disease: serum bilirubin \> 2.0mg/dl (expect in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT \> 3 x upper limit of normal
* Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
* HIV antibody
* Uncontrolled infection
* Pregnancy or breast feeding mother
* Inability to comply with the requirements for care after allogeneic stem cell transplantation
Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS)

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.

The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Eligibility Criteria:
Inclusion Criteria:

* users of health centre's with more than 4 weeks of benzodiazepines use.
* users of health centre's over 18 years of age.

Exclusion Criteria:

* users of health centre's with mental disorder.
* users of health centre's terminal.
* users of health centre's with alcohol dependence.
* users of health centre's with dementia.
* users of health centre's who had intellectual disabilities.
* users of health centre's unable to cooperate with the questionnaires.
Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness

Survivors of critical illness commonly experience long-lasting cognitive, mental health and physical impairments. Clinically significant symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) may occur in 40%, 34% and 20% of ICU survivors respectively, compared to 6%, 8% and 4% in the general population. These symptoms can persist for more than 8 years.

Evidence shows the existence of a two-way, communication network between gut microbes and the brain referred to as the gut-brain axis. Changes in the microbiome and dysregulation of this communication network in relatively healthy people is associated with cognitive dysfunction and mood disorders such as anxiety and depression. The physiological stress associated with critical illness itself and many ICU interventions including the use of mechanical ventilation and medications such as antibiotics, antacids, vasopressors, and steroids can influence the balance of the gut microbiome and associated metabolites.

This observation study aims to:

1. Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.
2. Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.

This knowledge will provide the potential to create interventions that alter the gut environment and microbiome both during and following a critical illness in order to reduce long-term adverse psychological effects. Examples of such potential interventions include dietary modifications with the use of prebiotics or probiotics.


Eligibility Criteria:
Inclusion Criteria:

* Unplanned admission to critical care
* Aged ≥18 years old
* Requiring mechanical ventilation
* Commencing ventilation within the previous 24 hours
* Expected to be ventilated for minimum of ≥72 hours

Exclusion Criteria:

* Known prior diagnosis of cognitive impairment
* Known prior mental ill health
* Known malignancy
* Admitted after presenting with any of the following conditions:
* trauma
* brain injury
* surgery
* cardiac arrest
* immunosuppressed
* underlying pyogenic infection
* Not expected to survive to completion of the study
Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease

A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC).

A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC

Eligibility Criteria:
Inclusion criteria:

* normal EKG
* normal stress test

Exclusion Criteria:

* abnormal EKG
* abnormal stress test
* presence of a chronic inflammatory disease
* presence of malignancy
* immunosuppressive therapy
Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children

Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.

Blistering distal dactylitis are very common in children. About 60% are caused by Staphylococcus aureus and some are caused by Group A Streptococcus (GAS) or Streptococcus pyogenes. While these forms have been known for fifty years, few publications are interested in it. Some studies have confirmed that a single antibiotic treatment against the SGA allows the healing of these dactylitis but few surgical teams have adopted this strategy. As all streptococcal infections, they face the risk of acute complications (septicemia, streptococcal toxic shock, etc.) or late (post-streptococcal glomerulonephritis, acute rheumatic fever, etc.). The involvement of the SGA in these dactylitis is easy to demonstrate through the use of rapid GAS test already widely used in other GAS infections (tonsillitis, scarlet fever, streptococcal perianal infections).

This study aims to assess the clinical course of positive GAS test blistering distal dactylitis in children after antibiotic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-18 years
* Distal blistering dactylitis collected or not collected
* Positive rapid Group A Streptococcus test
* Informed consent signed by the parents

Exclusion Criteria:

* Subungual or pulp Whitlow
* Children not affiliated to the social security scheme
* Refusal by the parents to participate in the study
Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 (Follow-up Studie)

"Silent" strokes are more frequent than clinical apparent strokes and can be detected noninvasively by MRI-investigations of the brain. Persons with silent strokes have a considerably increased risk for clinical apparent strokes as well as for the development of dementia. Intention of the study is the detection of silent strokes and microbleedings by standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for cerebrovascular accidents) after a standardized neurological and neuropsychological examination. Results will be the base of early detection and early preventive strategies of cerebrovascular accidents in high-risk persons.

In the course of a systematic follow-up examination without MRI the same 1000 patients (500 high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the sites. In addition to the standardized neurological and neuropsychological examinations a surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded by several tests in order to assess symptoms of cerebral microangiopathy.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent for NPV-2
* ongoing participation in INVADE-2
* completed participation in Neuroprävention study (NPV-1)

Exclusion Criteria:

* not completed Neuroprävention study (Drop-out)
* disagreement of notification of incidental findings
* lack of capacity to consent of study participant
* lack of willingness to cooperate of study participant
Continuous Epidural Analgesia Versus Continuous Supra-Inguinal Fascia Iliaca Block in Total Hip Replacement Surgery

comparison of continuous epidural analgesia and ultrasound guided continuous supra-inguinal fascia iliaca compartment block after total hip replacement surgery

supra-inguinal FICB is a promising safe approach for lumbar plexus that may be useful for analgesia in hip surgeries.In this study the investigators are comparing continuous S-FICB with continuous epidural analgesia after total hip arthroplasty surgeries with the primary aim to assess efficacy of post-operative analgesia, and secondary aim to assess rehabilitation indices, side effects and radiological pattern of local anaesthetic distribution after S-FICB.

Eligibility Criteria:
Inclusion Criteria:

* orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip replacement surgery via lateral approach

Exclusion Criteria:

* 1- History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.

  2- Patients younger than 18 years or older than 80 years. 3- Patients with Body Mass Index (BMI) \<18.5 or \>30 kg/m2. 4- Coagulation disturbances (INR\>1.4, platelet count\<100 000). 5- History of opioid dependence (opioid use within the last 4 weeks). 6- History of allergies to study medications. 7- Other contraindications to neuraxial blockade (e.g., patient refusal, local/systemic sepsis, low fixed cardiac output).

  8- Contraindications to continuous fascia iliaca compartment block (e.g., infection overlying the injection site or previous femoro-popliteal bypass surgery).
Cardiovascular Function in Adult Survivors of Childhood Malignancies

Anthracyclines have been used commonly to treat children with solid tumours and haematological malignancies and have led to their increased survival. Nonetheless, anthracycline has the side effect of cardiotoxicity. The purpose of this study is to assess the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel interaction, usefulness of circulating biomarkers in the assessment of heart function and potential genetic predisposition to heart failure in adult survivors of childhood cancers.

Incorporation of anthracyclines into chemotherapy protocols has improved the survival of children with solid tumours and haematological malignancies. Nonetheless, longitudinal studies have implicated the absence of a safe anthracycline dose that is free of cardiotoxicity. Substantial risk for cardiovascular disease has been shown recently in large cohorts of adult survivors of childhood and adolescent survivors. Serial monitoring of cardiac function is hence of paramount importance in childhood cancer survivors for early detection of myocardial damage and timely institution of interventions. The optimal monitoring of cardiac function in the long term in these at-risk patients remains to be established. Novel noninvasive imaging modalities including echocardiography and cardiac magnetic resonance allow interrogation of myocardial deformation and fibrosis, while circulating biomarkers are increasingly used to monitor the cardiac status in heart failure patients. Additionally, genetics of heart failure are increasingly unveiled.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 35 years old
* history of acute leukaemia diagnosed before 18 years old
* completion of cancer directed therapy for at least 5 years.

Exclusion Criteria:

* history of congenital heart disease
* presence of syndromal disorder such as Down syndrome, neurofibromatosis, etc,
* hypothyroidism not on replacement therapy
* claustrophobia or other reasons rendering MRI assessment not feasible.
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard treatment in participants with advanced solid tumors to be conducted in conformance with Good Clinical Practices.

Six different treatment regimens will be investigated in combination with robatumumab.

The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will consist of an expansion of each robatumumab regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent for the study.
* Be ±18 years of age of either sex and of any race/ethnicity;
* Part 1: Have a histologically or cytologically confirmed advanced malignant solid tumor;
* Part 2: Have a histologically or cytologically confirmed, with measurable disease (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]), advanced, malignant solid tumor.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of \<=2.
* Have adequate organ function within 3 weeks prior to first study drug administration.

Exclusion Criteria:

* Not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion.
* Not have a history of another malignancy
* Not have received prior therapy with any anti-insulin-like growth factor receptor 1 (anti-IGF-1R) monoclonal antibody.
* Not have received radiation therapy within 2 weeks prior to first study drug administration.
* Not have received radiation therapy to \>25% of his/her total bone marrow during his/her lifetime.
* Not have undergone major surgery within 3 weeks prior to first study drug administration.
* Not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy.
* Not have known active hepatitis B or C.
* Not have any serious or uncontrolled infection.
* Not have uncontrolled diabetes mellitus.
* Not have had any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.
Influencing Factors and Their Approach of Kinesiophobia in Patients With Traumatic Fractures

This study aims to investigate the relationship between kinesiophobia and pain catastrophizing, as well as the relationship between pain catastrophizing and pain level, anxiety and depression, self-efficacy and psychological resilience in patients with traumatic fractures, and to explain the approach and effect relationship between kinesiophobia and these variables.

At present, there are few studies on kinesiophobia in patients with traumatic fractures. This study adopts structural equation model to analyze the current situation of kinesiophobia in patients with traumatic fractures, and explores the effect of pain level, pain catastrophizing, anxiety and depression, self-efficacy and psychological resilience on kinesiophobia in patients with traumatic fractures, which provides a scientific basis for predicting the occurrence of kinesiophobia in patients with traumatic fractures and developing intervention plans.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as fractures due to accidental trauma and were diagnosed by X-rays and clinicians and required surgical treatment.
* Age 18 and above.

Exclusion Criteria:

* Those with a history of chronic pain (pain persisting or indirectly persisting for more than 3 months).
* Those who have serious postoperative complications (such as deep vein thrombosis, infection, etc.) and need other treatment or transfer to another department.
* People with physical disability or abnormal muscle strength before injury.
* Those who have a history of mental illness or who have taken anti-anxiety, depression drugs, or cognitive impairment within one month.
* Patients undergoing emergency surgery on the day of admission.
* Those who cannot communicate normally due to physical or psychological barriers.