cyrilzakka/clinical-trials huggingface dataset:
Seizure Recurrence After Unprovoked First Seizure

One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS.

Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood.

The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures.

200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG.

Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* This study will consider adult patients between the ages of 18-65 years seen in the First Seizure Clinics in Halifax and Kingston with unprovoked first seizure.
* The investigators will also include a sample of age, sex, and education-matched healthy controls with the same exclusion criteria.

Exclusion Criteria:

* Individuals over the age of 65 will not be included to reduce the probability of including individuals with early dementia.
* The investigators will also exclude individuals who, upon assessment during their first clinic appointment, are determined to have non-epileptic events, recurrent events or diagnosis of epilepsy (e.g. based on abnormal CT or EEG), provoked seizure (e.g. medication, substance misuse, metabolic), acute symptomatic seizures, those with an existing prescription for antiseizure drugs, significant CNS comorbidity that may affect cognition and brain networks (e.g. progressive neurological disorder, MS), previous neurosurgery, or contraindication to MRI.
* Finally, although there is no known risk to a fetus from MRI scanning, as is standard in research studies involving MRI, pregnant participants will be excluded and those that suspect that they may be pregnant require a negative pregnancy test before scanning.
Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study

This study evaluates the feasibility of an experimental protocol that combines advanced multi-modal imaging of the brain with clinical and behavioural scales to characterise the neural, behavioural, and clinical effects of transcranial direct current stimulation (tDCS) for rehabilitation in PDOC

Patients with prolonged disorders of consciousness (PDOC) have very limited therapeutic options, and they often show little to no progress over time. Here, the investigators will assess whether transcranial direct current stimulation can improve patients' responsiveness. The investigators will use a protocol designed to target specific brain networks that have been shown to play a key role in explaining the lack of voluntary responses in PDOC. The study will focus on characterising the mechanisms of action of tDCS and the bases for potential individual differences in responsiveness to the stimulation across participants. This feasibility study is the first step towards developing personalised tDCS interventions to restore external responsiveness in PDOC patients. Its results will inform the design of a future trial fully powered for characterising neural, behavioural, and clinical effects of tDCS in PDOC as well as the mechanisms underlying individual differences in responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Receiving care at a recruitment site, with a consensus clinical diagnosis of PDOC from any aetiology (i.e. traumatic or non-traumatic injury).
* Stable and with no need of mechanical support (i.e. respirator, etc.)

Exclusion Criteria:

* Scalp skin sores or any skin damage at the electrode sites
* Metallic implants in the face or skull
* Craniectomy or cranioplasty
* No evidence of auditory startle in clinical observations, or absent brainstem auditory evoked potentials in recent clinical history (if data available)
* MRI incompatible: metal plates incompatible with MRI scanners, pacemaker, inability to lay flat for prolonged periods of time, aneurysm clips, neurostimulators, brain/subdural electrodes, etc. (MRI stream ONLY)
Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy

The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* pregnant woman
* diagnosed with Sars Cov-2 during pregnancy
* singleton or twin pregnancy
* informed consent

Exclusion Criteria:

* virological or serological samples not done the day of delivery
A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients

The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for dosing with erythropoietin and intravenous iron in these patients.

This posting discloses information about Part 1 of CCSJ137X2201. Another part, Part 2, of this trial was planned for conduct subsequent to the initiation of Part 1 and would have a different design than Part 1. However, due to internal strategic non-safety related decision, Part 2 is not going to be conducted and the trial will be terminated after Part 1.

Eligibility Criteria:
Inclusion Criteria:

1. Hemodialysis-dependent for at least 2 months prior to screening.
2. Receiving hemodialysis at least 2 times per week
3. Receiving erythropoietin (EPO) therapy.
4. Hemoglobin (Hgb) ≥ 8.5 and \< 11.5 g/dL at screening.
5. Ferritin \>500 ng/mL and ≤ 2000 ng/mL at screening.
6. TSAT ≤ 50% at a minimum of one time point during the 90 days prior to baseline.

Exclusion Criteria:

1. Known diagnosis of hemochromatosis, bone marrow malignancy, lymphatic malignancy or myelodysplastic syndrome.
2. History of dialysis AV fistula thrombosis within 2 months prior to screening, or 2 or more episodes of AV fistula thrombosis within 6 months prior to screening.
3. Liver disease/dysfunction (Child-Pugh score ≥ 6), prior liver transplant, heart failure (NYHA Class III or IV); gastrointestinal bleeding.
4. A positive Hepatitis B surface antigen test result. Patients with Hepatitis C Virus (HCV) infection may be included if all other liver function eligibility criteria are met.
5. ALT, AST or bilirubin ≥ 1.5x ULN within 4 weeks prior to baseline.
6. Uncontrolled renal osteodystrophy
7. Conditions predisposing to an increased risk of serious infection, such as an indwelling vascular catheter (central venous line or non-tunneled/acute hemodialysis catheter) or active infection requiring antibiotic therapy at any time during the 2 weeks prior to screening. Tunneled hemodialysis catheters, and other "permanent" catheters are permitted.
8. Blood transfusion administered within 4 weeks prior to baseline.
9. Patients who received CSJ137 dose in the past.

Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety of Roflumilast Cream in Subjects with Atopic Dermatitis

This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 6 years at screening.
2. Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6\~17 years at screening.
3. Have stable disease for the past 4 weeks prior to screening.
4. Have mild or moderate AD at baseline.
5. Have BSA affected by AD of 3%-20% at baseline.
6. Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
7. Being in good health as judged by the Investigator.
8. Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.

Exclusion Criteria:

1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
2. Previous treatment with roflumilast cream.
3. Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
4. Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
5. Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
6. Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
9. Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).


Eligibility Criteria:
Inclusion Criteria:

* 1.Emergency patients with subarachnoid hemorrhage caused by ruptured aneurysm, aged 18-65 years; 2. ASA : II-IV grade, Hunt-Hess : I-III grade 3. For the first case, the operation time is within 24 hours. 4.After signing informed consent, underwent interventional intravascular embolization

Exclusion Criteria:

* 1. Patients with severe bleeding disorders; 2. Patients with trauma and local infection risk in the nerve block area; 3. Patients with previous aneurysm surgery and unruptured aneurysm; 4. Aneurysm located in middle cerebral artery; 5. Patients with unconsciousness cannot cooperate with the block operation; 6. Those with a history of mental illness and epilepsy; 7. Those who have a history of severe cardiovascular and cerebrovascular diseases and severe organ diseases;
Endovascular Thrombectomy in COVID-19 Infected Patients

About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.

This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.

Since the identification of the first case of Severe Acute Respiratory Syndrome (SARS) CoV-2 infection in December 2019 in Wuhan, China, the global number of confirmed COVID-19 cases is roughly 5 000 000, with 216 involved countries. Increasing evidence shows that SARS-CoV-2 may be associated with neurological manifestations, with up to 36% of patients showing neurological symptoms related to the neurovirulence of the SARS-CoV-2.

It has been reported that roughly 5% of COVID-19 infected patients may present acute ischemic stroke (AIS), and these patients may have an unfavorable clinical evolution due to the systemic involvement of the infective disease. In addition, these patients are quite young: the mean age of COVID-19 patients having AIS is lower (56 years), compared to general population of AIS patients (mean age=73 years). Moreover, most of these patients require an intensive care units (ICU) management. Stroke mechanisms may be multiple and can include hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury, and severe inflammation. Indeed, the dysfunction of endothelial cells induced by infection may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in severe COVID-19 patients can be a trigger for thrombosis, increasing blood viscosity, and inducing hypoxia-inducible transcription factors.

Outcomes related to the treatment of COVID-19 patients harboring large vessel occlusion and requiring MT is substantially unknown, but it is likely that the combined morbidity and mortality rate of the two pathologies is high. Accordingly, patient's selection, treatment-management, and results should be urgently elucidated.

Involving 4 different countries (France, Italy, Spain, and US), this multicentric cohort study aims to analyze the largest possible number of COVID-19 infected patients treated with MT for AIS, with the intention to provide treatment-results and neurological outcomes, elucidating the best patient-selection and treatment-management.

Eligibility Criteria:
Inclusion criteria:

- Patients \>18 years infected with the SARR-CoV-2 with acute ischemic stroke, and eligible for mechanical thrombectomy (based on the current guide-lines)

Exclusion criteria:

- Patients \<18 years ; no eligibility to mechanical thrombectomy ; absence of diagnosis of COVID-19
Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse

Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and substance abuse among persons with serious mental illness (SMI) treated in a community setting.

Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center, served through the Orange Person Chatham (OPC) Area Program.

Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the CBT intervention plus treatment as usual; or, 2) treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Currently receiving services at Freedom House
* Meet DSM-IV criteria for PTSD
* Meet criteria for Substance Use Disorder
* Able to understand and provide informed consent

Exclusion Criteria:

• Psychiatric hospitalization or suicide attempt in the past two months
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50, inclusive.
* Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and electrocardiogram (ECG).
* Females of child-bearing potential must be using an adequate and reliable method of contraception.
* Willing to eat all the food supplied during the study.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) (unless immunized), anti-hepatitis C antibody (HCV).
* Positive Naloxone hydrochloride (HCl) challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Risk of CKD in Diabetic Patients With MAFLD

This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions.

investigators plan to enroll 300 participants with type 2 DM to comprehensively investigate the risk of chronic kidney disease (CKD) in individuals diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.

In this study, the participant population will be grouped based on presence of MAFLD or not into 2 groups, then the group with MAFLD will be subdivided into subgroups based on the degree of hepatic involvement, considering both controlled attenuation parameter (CAP) values for steatosis and liver stiffness measurements for fibrosis via fibro scan device. This grouping strategy aims to categorize individuals into distinct cohorts, such as Low Hepatic Involvement and High Hepatic Involvement groups, facilitating a nuanced exploration of the association between hepatic conditions and the risk of chronic kidney disease (CKD) in the context of metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* Willing and agreed to be included in the study.

Exclusion Criteria:

* Type 1 diabetic patients or non-diabetic patients.
* Patient with known glomerulonephritis.
* Patient with diagnosis of or clinical features that are suspicious for another systemic disease that commonly causes kidney disease (e.g., connective tissue disorders, HIV).
* Patient with evidence of alternative kidney disease like (Documented obstructive uropathy, etc.)
* Patient with history of kidney transplantation.
* Patient with end stage renal disease or on dialysis.
* Patients with active malignancy.
* Individuals with a history of hepatitis B surface antigen or hepatitis C antibody positivity.
* history of excessive alcohol consumption (⩾30 g/day in men and ⩾20 g/day in women)
* Decompensated liver cirrhosis.
Tranexamic Acid in Total Knee Replacement

Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.

Eligibility Criteria:
Inclusion Criteria:

1. varus deformity less than 10o
2. lack of extension not more than 10o
3. flexion of at least 90o.

Exclusion Criteria:

1. uncontrolled medical diseases/comorbidities
2. allergy and/or hypersensitivity to TXA
3. a known history of thromboembolic disease, cardiovascular disease
4. coronary or vascular stent placed within the past 12 months
5. cerebral vascular disease (a history of stroke)
6. subarachnoid hemorrhage
7. preoperative coagulopathy (a platelet \[PLT\] count \<150,000/mm3 or an international normalized ratio greater than 1.5
8. preoperative renal or hepatic dysfunction
9. retinal vein or artery occlusion
10. patients with anemia (\<12 g/dL for female, \<13 g/dL for male)
Acute Kidney Injury in Critically Ill Patients

Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly increase mortality, length of stay, and costs, however detection has proven difficult as markers like elevated creatinine and decreased urine output may take days to manifest and are late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has been shown to increase within 12 hours following renal insult, allowing assessment of risk for developing acute kidney injury. Therefore, the investigators plan to assess if acute kidney injury in critically ill trauma patients can be determined earlier using urinary TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been specifically evaluated in trauma patients at risk of AKI.


Eligibility Criteria:
Inclusion Criteria:

* trauma patients with multiple injuries;
* abdominal injuries;
* crush injuries;
* those who present in shock (systolic blood pressure \<90 or mean arterial pressure \<65);
* require blood transfusions, vasopressors or mechanical ventilation

Exclusion Criteria:

* known pregnancy;
* patients under 21 years of age;
* known moderate to severe AKI prior to enrollment and end stage renal disease. known moderate to severe AKI prior to enrollment and end stage renal disease