cyrilzakka/clinical-trials huggingface dataset:
Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study

With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain structural and functional alterations (using brain fMRI).

Pathophysiology of delirium is poorly understood; neuroinflammation and brain network disruption are claimed as possible causes of delirium.

The authors want to clarify the role of the alterations of different cellular components of neuroinflammation (neurons, glial cells, and endothelium) in delirium development. Moreover, the authors want to understand whether the neuroinflammation process could cause permanent structural and functional brain damage.

In a nested cross-sectional longitudinal case-control observational study in ICU admitted patients.

The objectives of the studies are as follow: 1) Neuroinflammation biomarkers evaluation in non-neurological ICU patients who develop delirium during ICU-stay (case) compared to matched non-delirious ICU patients (control), and 2) their correlation with brain structural and functional alterations evaluated with a resting-state fMRI protocol and PET.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* All patients admitted that would be expected to stay in ICU for at least 3 days

Exclusion Criteria:

* Acute neurological condition
* Chronic neurological condition (i.e., seizures, stroke, muscular illness).
* Hematological malignancy or immunological disease.
* Blood transfusion in the last 2 weeks
* Ongoing sedation
* Any condition which contraindicates MRI execution (presence of non-compatible devices or hemodynamic or respiratory instability).
Caregiver Support in the Quality of Life of Patients Who Are Undergoing Donor Bone Marrow Transplantation

RATIONALE: Questionnaires that measure quality-of-life may improve the health care team's ability to plan supportive care for patients undergoing donor bone marrow transplantation.

PURPOSE: This clinical trial is studying quality of life in patients who are undergoing donor bone marrow transplantation.

OBJECTIVES:

* Investigate the relative importance of having a consistent inpatient lay care-partner for patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients complete a 30-minute quality of life questionnaire in order to measure their psychosocial health while in the bone marrow transplant program, including Functional Assessment of Cancer Therapy (FACT), Profile of Mood State (POMS), and Brief COPE questionnaires, at the baseline (pre-transplant) appointment, at the first physician's visit after discharge, at day 100 post-transplant, and then at 6 months and 1 year post-transplant. Caregivers complete a 30-minute coping questionnaire at the pre-transplant appointment, at the first physician's visit after discharge, and then at day 100 post-transplant. Caregivers also keep a weekly log of the time spent with the patient in the hospital.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must be a candidate for allogeneic unrelated or related stem cell transplantation

PATIENT CHARACTERISTICS:

* Both patient and lay care-partner must have the ability to understand and the willingness to sign a written informed consent document

PRIOR CONCURRENT THERAPY:

* Not specified
GLP Analogs for Diabetes in Wolfram Syndrome Patients

Wolfram syndrome, also referred to as DIDMOAD (diabetes insipidus, diabetes mellitus, optic atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and apoptosis leading to diabetes, neurodegeneration and psychiatric illness. Accumulating evidence indicates that beta-cell failure and neuronal cell dysfunction in Wolfram's syndrome results from a high level of ER stress in affected cells. The current treatment of Wolfram syndrome is insulin, which fails to prevent the progression of beta-cell failure.

Several studies showed that GLP-1 analogs are very effective in protecting beta-cells from ER stress. Herein, the investigators suggest studying the impact of GLP-1 analogs in the treatment of patients with Wolfram syndrome.

The investigators will Study the effects of GLP-1 analog (Exanatide) on beta-cell function and glycemic control of patients with Wolfram syndrome. Evaluation of beta cell function will be done by performing meal test and IVGTT test before starting GLP-1 therapy, and after 3 month of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Genetic or definitive clinical diagnosis of Wolfram's syndrome including: diabetes mellitus, optic atrophy and at least one additional neurological dysfunction (diabetes insipidus, sensorineural deafness, neurogenic bladder or other type of autonomic or peripheral neuropathy)
2. Age \>18 years
3. Duration of diabetes of \<10 years.

Exclusion Criteria:

1. pregnant women
2. patients who are unable to give inform consent.
Glucocorticoids for Post-operative Patients With Acute Type A Aortic Dissection (The GLAD Trial)

This study is designed to evaluate the effects of glucocorticoid(GC) on improving post-operative organ dysfunction in patients with acute type A aortic dissection(aTAAD). Subjects with confirmed diagnosis of aTAAD undergoing surgical treatment will be enrolled and 1:1 randomly assigned to receive either glucocorticoids or normal treatment. All patients in the glucocorticoids group will be given methylprednisolone intravenously for 3 days after enrollment. The primary endpoint will be the amplitude of variation of Sequential Organ Failure Assessment score on post-operative day 4 compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age above 18 years old (including 18 years old), regardless of gender;
* Confirmed type A aortic dissection with computer tomography and received surgical intervention
* Life expectancy \> 3 days after surgery

Exclusion Criteria:

* History of cardiac surgery within the past 3 months or possible iatrogenic aortic dissection
* Bacterial or fungal infection in the past 30 days
* Glucocorticoid or any other anti-inflammatory drug usage in the past 14 days
* Allergic to glucocorticoid
* Pregnant
* Implantation of ICD or permanent pacemaker
* Patients diagnosed with malignant tumor undergoing chemotherapy and immunotherapy.
* Patients with pre-operative severe liver dysfunction (CTP grade C)
* Patients with pre-operative renal insufficiency (patients receiving renal replacement therapy before surgery)
Surgery for Adhesive Small Bowel Obstruction in a Defined Population: a Cohort Study

A cohort study of patients operated for adhesive small bowel obstruction (SBO) during a five-year period

It is a population-based cohort study of patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two Swedish neighboring regions. Patients were identified by a broad search of operation and ICD codes. Preoperative data as age, gender, co-morbidity, previous surgery was registered as well as mechanisms of obstruction and intraoperative data. Short and long-term complications were analyzed. Patients were followed to 31st January 2017 , last medical note or death.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Surgery for adhesive small bowel obstructions during the time period 2007-2011 in Uppsala County and Gävle County, Sweden

Exclusion Criteria:

None
4-methylpyrazole and Acetaminophen Metabolism

Oxidative metabolism of APAP will be studied with and without 4-MP.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No APAP use in previous 2 weeks
* No ingestion of alcohol or drugs that affect CYP 2E1 over previous 5 days
* No allergy to APAP or fomepizole
* BMI \< 29

Exclusion Criteria:

* Pregnant or lactating
* History of alcohol abuse
* Allergy to APAP or fomepizole
* Screening LFTs above normal range
Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease.

The aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease.

Parkinson's disease is one of the most common, insidious neurological disorders with major motor symptoms, including bradykinesia, resting tremors, rigidity, and postural disorders. Virtual reality and motor imagery are among the more innovative techniques for rehabilitation of patients with Parkinson's disease that promote motor learning through both explicit and implicit processes.This study is unique in that it examines the effects of VR versus MI on motor skills, balance, and daily living activities in individuals with Parkinson's disease

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Modified Hoehn and Yahr Scale(H\&Y stages I to III)
* Between the ages of 50 and 80 years of both genders
* Independent in transfers
* A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
* Previous lack of participation in balance or motor training.

Exclusion Criteria:

* History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
* History of orthopedic issues such as pain, fracture, or lower limb pathology,
* History of visual abnormalities,
* History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
* The participants having severe dyskinesia or "on-off" phases,
* Previous history of surgery for PD,
* History of virtual games used for treatment in the past three months, and
* Virtual game phobia.
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema

To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)

A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of primary or secondary unilateral upper extremity edema

Exclusion Criteria:

* Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
* Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
* Diagnosis of lipedema
* Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
* Diagnosis of Acute infection (in the last four weeks)
* Diagnosis of acute thrombophlebitis (in last 6 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled)
* Diagnosis of chronic kidney disease with renal failure
* Diagnosis of epilepsy
* Subjects with poorly controlled asthma
* Any condition where increased venous and lymphatic return is undesirable
* Women who are pregnant, planning a pregnancy or nursing at study entry
* Participation in any clinical trial of an investigational substance or device during the past 30 days
NS-050/NCNP-03 in Boys With DMD (Meteor50)

This is a Phase 1/2 study of Multiple-Ascending Dose (MAD) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD, who have a DMD exon deletion amenable to exon 50 skipping.


Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 4 years and \<15 years of age;
* Confirmed DMD exon deletion in the dystrophin gene that is amenable to skipping of exon 50 to restore the dystrophin mRNA reading frame;
* Able to walk independently without assistive devices;
* Able to complete the TTSTAND without assistance in \<20 seconds;
* Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study.

Other inclusion criteria may apply.

Exclusion Criteria:

* Evidence of symptomatic cardiomyopathy;
* Current or previous treatment with anabolic steroids (e.g., oxendolone, oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug;
* Currently taking another investigational drug or has taken another investigational drug within 3 months prior to the first dose of study drug;
* Surgery within the 3 months prior to the first dose of study drug or planned during the study duration;
* Having taken any gene therapy.

Other exclusion criteria may apply.
The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke

The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery

After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.

Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke with a disease interval of 6 months to 2 years
* aged based 18 years
* first stroke
* Mini mental test score ≥ 22
* upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
* Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC

Exclusion Criteria:

* hemorrhagic stroke
* history of epilepsy
* a cardiac pacemaker
* pregnancy
* Fugl Meyer upper extremity assessment score ≥44
* history of previous stroke or ischemic attack
* neurological diseases other than stroke
* metallic implant in brain or scalp (including cochlear implant)
* previous brain surgery
* orthopedic disease that prevents upper extremity movements
* diagnosis of malignancy
* receiving robotic /TMS/tDCS treatments in the last 6 months
A Comparing Transversalis Fascia Plane Block and Quadratus Lumborum Block for Post-Cesarean Pain Management: Efficacy, Execution Time, and Practicality

Transversalis Fascia Plane Block (TFPB) and Quadratus Lumborum Block (QLB) provide superior analgesia to Transversus Abdominis Plane Block (TAPB) for post-cesarean pain management. This study evaluates whether TFPB or QLB is preferable when their analgesic efficacy is nearly equal, focusing on ease of performance and execution time.

Cesarean delivery is one of the most common surgical procedures worldwide and is associated with significant postoperative pain that includes both somatic and visceral components . Effective pain management not only enhances patient comfort and satisfaction but also facilitates early mobilization and reduces maternal morbidity . Although the Transversus Abdominis Plane (TAP) block is widely used as part of a multimodal analgesia strategy, its relatively short duration of action and limited ability to relieve visceral pain have prompted the search for improved alternatives .

Recent advancements in ultrasound-guided regional anesthesia have introduced the Quadratus Lumborum Block (QLB) and the Transversalis Fascia Plane Block (TFPB) as promising techniques for post-cesarean analgesia. The QLB, first described by Blanco (2007) , offers extended analgesia due to its paravertebral spread, thereby addressing both somatic and visceral pain . In contrast, TFPB targets the transversalis fascia to block the T12 and L1 nerves, effectively reducing postoperative pain following cesarean delivery . Although both QLB and TFPB have been shown to provide superior analgesia compared to TAP blocks , limited data exist regarding their comparative ease of performance and procedural efficiency.

Given that the analgesic efficacy of TFPB and QLB appears comparable, it is essential to evaluate additional factors such as the time required to perform the block and the technical ease of the procedure. These factors are particularly critical in high-volume obstetric settings, where efficiency can significantly impact clinical workflow . Therefore, this study aims to compare TFPB and QLB not only in terms of analgesic efficacy but also regarding ease of performance and execution time, to determine which technique may be preferable for post-cesarean analgesia.

Eligibility Criteria:
Inclusion Criteria:-

1. Pregnant women aged 20-40 years scheduled for elective cesarean delivery under spinal anesthesia .
2. American Society of Anesthesiologists (ASA) physical status of II
3. Body mass index (BMI) of less than 35 kg/m² .

Exclusion criteria :-

1. History of allergy to local anesthetics.
2. Contraindications to regional anesthesia (such as coagulopathy or infection at the injection site).
3. Severe systemic diseases (renal, hepatic, or cardiovascular dysfunction).
4. weight less than 50 kg (to avoid exceeding safe doses of local anesthetic).
5. pregnancy complications like severe preeclampsia, eclampsia, or postpartum hemorrhage.

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Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

The study uses reduced intensity conditioning that is immune suppressive to achieve donor cell engraftment without exposure to radiation or high dose chemotherapy in children with non-malignant disorders. The intent is to minimize early and late regimen related toxicities in the context of a reduced intensity regimen.

In addition to maximizing opportunity for donor cell engraftment, the trial seeks to minimize toxicities associated with transplant such as graft versus host disease and employs GVHD prophylaxis that seeks to decrease rates of acute and chronic GVHD in the setting of matched and mismatched donor stem cell transplants from marrow and cord blood sources.

Eligibility Criteria:
Inclusion Criteria:

Stratum 1: Patient must have non-malignant disorder, excluding thalassemia. Must be receiving a 8/8 HLA-matched bone marrow, related or unrelated Stratum 2: Patient must have thalassemia receiving 8/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated.

Stratum 3: Patient must have a hemoglobinopathy receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated.

Stratum 4: Patient must have a non-malignant disorder (excluding hemoglobinopathy) receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB. Related or unrelated.

All strata:

* Recipient age \< 21 years
* Lansky/Karnofsky \>/= 40
* Adequate pulmonary, renal, liver, and other organ function as defined in protocol
* Negative pregnancy test
* Adequate total nucleated cell or CD34+ dose of product as defined in protocol
* If sickle cell, Hemoglobin S \<30%

Exclusion Criteria:

* HIV positive
* Invasive infection
* Pregnancy/lactating
Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease

Melanole, a Nigella sativa (Black Seed) extract , is studied for the treatment of GERD. Participants, who meet the inclusion criteria, will be divided into two arms.

Arm 1: Subjects who meet criteria for GERD will undergo 24 hour pH monitoring.

Arm 2: Subjects who meet criteria for GERD and who undergo only symptomatic monitoring of GERD on treatment.

All participants will be evaluated before and after the administration of the study product.

Volunteers were recruited in Lebanese American University campuses. Those who fit the inclusion criteria were allowed to choose between two arms: invasive or non-invasive procedures.

Volunteers who chose to enroll in the non-invasive arm were given the study product directly after completing the GERD Q questionnaire. A follow-up by phone was done on day 0, 3 , 6 and 11. GERD Q questionnaire was repeated on days 11 and 28 along with a satisfaction rating. Adverse events were reported on a log sheet.

Concerning the invasive arm, volunteers were given an appointment at Lebanese American University Medical Center Rizk Hospital to place the 24h pH-metry, after study product was administered. After 7-10 days, the 24h pH monitoring was done again.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age (18-60) with GerdQ score ≥3

Exclusion Criteria:

* Patients younger than 18 year or older than 60years
* Dysphagia, odynophagia, weight loss, palpable mass
* Nonsteroidal antiinflammatory drug intake (including aspirin)
* History of hyperparathyroidism
* Coronary artery disease or congestive heart failure
* History of liver disease
* History of renal disease
* Pregnancy
* History of active cancer or chemotherapy
* History of intake of any drug known to affect reflux (phenothiazine, anticholinergic, nitrates, calcium channel blockers and proton pump inhibitors) within 14 days of inclusion to the study
* Prior esophageal or gastric surgeries of any type
* Allergy to black seeds or Lidocaine
* Any important nasal anatomical anomaly
* Any use of chronic medications for chronic medical conditions
Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease

This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.

One of the most common causes of chronic liver diseases worldwide is metabolic dysfunction-associated fatty liver disease (MAFLD), which affects about 30% of adults. Thyroid hormones are critical in maintaining metabolic homeostasis throughout life and are intimately linked to the liver.

Dysfunctions of the thyroid gland have been implicated as one of the most important risk factors of MAFLD due to its important role in the hepatic synthesis of fatty acid and cholesterol. Maintaining liver metabolism requires thyroid function to be normal, while thyroid disorders may lead to liver disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients with metabolic dysfunction-associated fatty liver disease (MAFLD).

Exclusion Criteria:

* History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism).
* Patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day.
* Viral hepatitis.
* Pregnant women.