cyrilzakka/clinical-trials huggingface dataset:
Reoperation After Pancreaticoduodenectomy

The aim of this study is to outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD and its impact on patient survival and disease recurrence.

This is a retrospective cohort study of all patients who underwent PD for periampullary tumors in Gastrointestinal Surgical Center (GISC), Mansoura University, Egypt in the period between 2000 and 2018.The exclusion criteria included any patients with locally advanced periampullary tumor, metastases, patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.

Patient data were recorded in a prospectively maintained database. Preoperative variables included; age, sex, body mass index, patients' symptoms and signs, laboratory tests, tumor markers and preoperative biliary drainage. Intraoperative variables included; liver status, tumor size, pancreatic duct diameter, texture of the pancreas, operative time, blood loss, pancreatic reconstruction method and blood transfusion. Postoperative variables included postoperative complications, drain amylase, liver function, day to resume oral feeding, postoperative stay, re-exploration, hospital mortality, postoperative pathology, and surgical safety margins.

Data regarding reoperation included incidence, male to female ratio, hospital stay, interval to reoperation, number of explorations, indication of reoperation and surgical management, and postoperative outcome in terms of morbidity and hospital stay. Follow-up was carried out one week postoperatively, 3 months, 6 months and then after one year. The minimum duration of follow up was 2 years. Follow up was done by thorough history taking, clinical examination and abdominal CT in case of suspicious lesions on pelvi-abdominal ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018

Exclusion Criteria:

* Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.
Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron Disease

Levetiracetam (Keppra) is used to treat partial onset seizures. Its biological effects suggest it might also be useful in treating 3 aspects of human motor neuron diseases (MNDs) for which no effective therapy exists: cramps, spasticity, and disease progression.

Cramps in MNDs are believed to occur as a result of high-frequency burst firing of alpha motor neurons. Levetiracetam inhibits burst firing in epileptic rat hippocampus. Levetiracetam has never been tested against cramps in humans; however, it has helped another condition believed to result from burst firing of a motor nerve: hemi-facial spasm.

The mechanisms underlying spasticity in MNDs likely involve imbalance between excitatory and inhibitory influences on the alpha motor neurons. Levetiracetam may modulate these influences in a number of ways, including reducing the effects of zinc and beta-carbolines in GABA and glycine receptors. Levetiracetam reduces phasic (but not tonic) spasticity in patients with multiple-sclerosis.

Levetiracetam may have neuroprotective properties. In a model of cerebral ischemia induced by occlusion of the rat internal carotid artery, pre-treatment with levetiracetam reduced infarct size in a dose-dependent manner. In rats injected with kainic acid to induce calcium overload, oxidative stress and neurotoxicity, pretreatment with levetiracetam offset kainic acid's effects. The mechanisms for these effects may relate to levetiracetam's ability to influence calcium currents, or its ability to increase the release of growth factors from astrocytes, mechanisms that would be relevant in MNDs. Levetiracetam's ability to inhibit histone deacetylase may also help slow MNDs progression.

OBJECTIVES: 1. Assess the safety and tolerability of levetiracetam over 9 months in patients with MNDs. 2. Determine whether treatment with levetiracetam is associated with a reduction in cramps, spasticity or motor neuron disease progression.

METHODS:Open-label, Phase 2 trial of 20 adult patients with MNDs (ALS, PLS or PMA) at Duke University ALS Clinic. Eligible patients have cramps with average severity 50/100 points, are able to provide informed consent, have normal renal functions and are on a stable riluzole dose. Exclusions include pregnancy, unstable mental illness, dementia, drug abuse or non-compliance. The first 3 months of the study are a baseline period. Over the remaining 9 months, patients take levetiracetam at increasing doses up to 3000mg per day. Outcome measures include adverse events, tolerability,cramp-pain-severity score, cramp-frequency score, modified Ashworth Spasticity Score, Penn Spasm Score, FVC, ALSFRS-R and MMT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with MNDs (ALS, PLS or PMA)who have cramps with average severity 50/100 points, are able to provide informed consent, have normal renal function and are on a stable riluzole dose.

Exclusion Criteria:

* Pregnancy; unstable medical illness, dementia; drug abuse or non-compliance
Leveraging Autism Intervention for Families Using Telehealth (LIFT)

The purpose of the LIFT study is to develop a technology-assisted adaptation of the JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation: Kasari et al., 2021) social communication intervention for young children with autism spectrum disorder (ASD). In partnership with community early intervention (EI) and early childhood special education (ECSE) practitioners in Oregon, implementation strategies to help caregivers learn to the use the intervention strategies with their young children will delivered in a pilot randomized trial. The pilot trial will compare primarily self-directed learning through online materials and brief practitioner support (ONLINE) with the addition of live synchronous coaching (ONLINE + COACH) on caregivers' strategy use (primary) and children's joint engagement and social communication (secondary).


Eligibility Criteria:
Inclusion Criteria:

* Receiving Early Intervention (EI) or Early Childhood Special Education (ECSE) services from partnered providers in Southern Oregon Education Service District (SOESD).
* Child has received or is awaiting a diagnosis of autism spectrum disorder (ASD)

Exclusion Criteria:

* Child is not receiving services from a partnered educational service district
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)

This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.

This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks:

* Screening: 4 weeks
* Treatment: 16 weeks
* Follow-up: 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities
* Male or female subject.
* Age between 18 and 75 years, both inclusive.
* Overweight or obesity (body mass index BMI ≥ 25.0 kg/m2 and ≤ 45.0 kg/m2) with or without type 2 diabetes mellitus (T2DM with an HbA1c ≤ 9.5%).
* eGFR ≥ 30 and \< 90 (mL/min/1.73 m²).
* Presumed mild to higher liver fibrosis as shown by a FIBROTEST score ≥ 0.28 and/or FIB-4 score ≥ 1.3.

Exclusion Criteria:

* Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation.
* Previous participation in this trial. Participation is defined as randomised.
* Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
* History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction.
* Known non-MASH liver disease.
* History or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices).
* Total body weight loss of \>5% within 6 months prior to screening.
* If female, pregnancy or breast-feeding.
* Women of childbearing potential who are not using a highly effective contraceptive method and whose male partner is not using a highly effective contraceptive method for the entire study duration and for at least 6 weeks after last dosing
Gene Therapy Study in Severe Hemophilia a Patients with Antibodies Against AAV5

This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe Hemophilia A patients with pre-existing antibodies against AAV5.


Eligibility Criteria:
Inclusion Criteria:

1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as evidenced by medical history, at the time of signing the informed consent.
2. Detectable pre-existing antibodies against the AAV5 vector capsid as measured by AAV5 total antibody ELISA.
3. Subject must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry.
4. No previous documented history of a detectable FVIII inhibitor, and results from a Bethesda assay or Bethesda assay with Nijmegen modification of less than 0.6 Bethesda Units (BU) (or less than 1.0 BU for laboratories with a historical lower sensitivity cutoff for inhibitor detection of 1.0 BU) on 2 consecutive occasions at least one week apart within the past 12 months (at least one of which should be tested at the central laboratory).
5. Sexually active participants must agree to use an acceptable method of effective contraception. Participants must agree to contraception use for at least 12 weeks post-infusion.

Exclusion Criteria:

1. Any evidence of active infection including COVID-19, or any immunosuppressive disorder, except for HIV infection. HIV positive patients who meet all other eligibility criteria may be included if they have a CD4 count \> 200/mm3 and an undetectable viral load (unquantifiable viral load as defined as less than the limit of quantification by the testing laboratory's assay is permitted) while receiving an antiretroviral therapy (ART) regimen that does not contain efavirenz or another potentially hepatotoxic ART.
2. Evidence of liver dysfunction as assessed by liver tests and most recent, prior FibroScan or liver biopsy showing significant fibrosis of 3 or 4 as rated on a scale of 0-4 on the Batts-Ludwig (Batts 1995) or METAVIR (Bedossa 1996) scoring systems, or an equivalent grade of fibrosis if an alternative scale is used.
3. Chronic or active hepatitis B or C as evidenced by testing at screening.
4. Active malignancy, except non-melanoma skin cancer, or history of hepatic malignancy.
5. Any condition that, in the opinion of the investigator or Sponsor would prevent the patient from fully complying with the requirements of the study (including corticosteroid treatment and/or use of alternative immunosuppressive agents outlined in the protocol) and/or would impact or interfere with evaluation and interpretation of subject safety or efficacy result.
High vs Low Volume Intensity Training With IMT On Pulmonary Function And Breathing Efficiency On Recreational Swimmers.

This study aims to evaluate the impact of inspiratory muscle training (IMT) on respiratory function and swimming performance in competitive swimmers. Given the importance of optimal respiratory function in swimming, this trial investigates whether IMT can improve swimming performance metrics, such as lap times and endurance, and overall respiratory health.

Effective respiratory function is crucial for swimmers, given the demanding nature of the sport. Inspiratory muscle training (IMT) has been shown to improve respiratory muscle strength and endurance in various populations. This study aims to explore the effects of IMT specifically on competitive swimmers, assessing both physiological and performance-related outcomes. To assess whether a structured IMT program improves swimming performance, respiratory muscle strength, and overall respiratory efficiency in recreational swimmers. A randomized controlled trial involving 56 competitive swimmers will be conducted. The study duration will be 8 weeks, with assessments conducted at baseline, mid-point, and at the end of the intervention. The IMT groups will participate in a 20-30 minute training session, 4 to 5 times per week, using power breath device . The training will focus on enhancing inspiratory muscle strength and endurance. This study aims to provide robust evidence on the benefits of IMT for swimmers, potentially informing future training practices and enhancing competitive performance.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female Swimmers
* Age; 18-25
* Minimum of 2 years of regular swimming training experience, with at least 3 swimming sessions per week.

Exclusion Criteria:

* Refusal to participate in the study.
* History of respiratory or cardiovascular conditions that could impact participation or results.
* Participation in any other respiratory or exercise-related intervention study within the last 6 months.
* Consumption of any medications or supplements that could potentially influence respiratory or cardiovascular function.
Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction

The purpose of this study is to assess the effectiveness of new software available on a new PET/CT scanner in the Molecular Imaging Research PET/CT Facility. Further, the study aims to evaluate the data acquisition and image processing workflow.

The study will be separated into three cohorts: Motion Correction, Parametric Imaging, and MAP Reconstruction. The motion correction (Aim 1) cohort will involve a group of 30 subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system in the PET/CT Molecular Imaging Research Center in Charlton 6 of Mayo Clinic Rochester. The data gathered from this cohort will assess the effectiveness of motion correction software for patients undergoing PET brain scans. The parametric imaging (Aim 2) cohort will include 30 subjects that have recently undergone a brain or whole body oncologic PET/CT scans on the V600-R1. The purpose of this cohort is to assess the data acquisition and image processing workflow for parametric analysis of brain and whole body scans. The MAP Reconstruction Cohort (Aim 3) is a retrospective study to assess the quality of PET images reconstructed with maximum a posteriori (MAP) reconstruction algorithm.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Subjects who are able and willing to sign the informed consent
* Subjects who are able to follow verbal commands
* A negative urine pregnancy test within 48 hours prior to PET imaging procedures in females of childbearing potential
* Subjects who are scheduled for a PET/CT study under Mayo Clinic Rochester IRB research protocol 08-005553 (Aim 1 cohort only)
* A positive 18F-FDG oncology PET/CT exam in the last six months (Aim 2 cohort only)

Exclusion Criteria:

* Patients who are unable to lay still for an additional 15 minutes (for Aim 1 cohort)
* Patients who are unable to lay still for 90 min for 18F-FDG scans or 100 min for 18F-AV1451 scans (for Aim 2 cohort)
* Patients who cannot follow the prep instructions
The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults

Background: Transcranial direct current stimulation(tDCS) has been used to improve cognitive functions in healthy young adults.

Purpose: To investigate the effect of TDCS application on different cortex regions on cognitive function.

Methods: Sixty individuals aged 18-30 were included in the study. The participants were randomly divided into the left dorsolateral prefrontal cortex (Left DLPFC Group)(n=20), the right posterior parietal cortex (Right PPC Group)(n=20), and the sham group (Sham Group)(n=20). tDCS was applied for 20 minutes on weekdays for 2 weeks. The participants were evaluated in terms of cognitive functions with Neuropsychometric Test Battery before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* being 18-30 years old

Exclusion Criteria:

* alcohol and substance addiction
* previous mental illness
* having mental and cognitive problems
* a history of head trauma
* having cardiovascular disease.
Study of Blood Samples and Risk of Infection in Patients With Newly Diagnosed Malignant Supratentorial Astrocytoma

RATIONALE: Gathering information over time from laboratory tests of patients with newly diagnosed malignant supratentorial astrocytoma may help doctors learn more about the effect of treatment on white blood cell count and the risk of infection.

PURPOSE: This clinical trial is studying blood samples and risk of infection in patients with newly diagnosed malignant supratentorial astrocytoma.

OBJECTIVES:

* Determine the frequency and severity of decreases in CD4 counts as a function of therapy in patients with newly diagnosed malignant astrocytoma.
* Determine whether the decrease in CD4 counts is a significant predictor of infections or adverse outcomes in these patients.

OUTLINE: This is a multicenter study.

Patients undergo monthly collection of blood for serial CD4 counts and heme-8 with differential for 1 year for quantitative analysis. Patients also complete a monthly questionnaire about infections and antibiotic use.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 125 patients (100 with high-grade disease and 25 with low-grade disease) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary malignant brain tumor in 1 of the following groups:

  * High grade (grade III or IV) supratentorial glioma receiving antineoplastic treatment and with 1 of the following histologies:

    * Anaplastic astrocytoma
    * Glioblastoma multiforme (giant cell glioblastoma or gliosarcoma)
    * Anaplastic oligodendroma
  * Low grade (grade I or II) supratentorial glioma not planning to receive treatment of any kind (including steroids) and with 1 of the following histologies:

    * Astrocytoma
    * Oligodendroglioma

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* No HIV positivity

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for brain tumor except polifeprosan 20 with carmustine implant (Gliadel® wafer)
* No prior cranial radiotherapy or radiotherapy for brain tumor
* No prior immunotherapy or biologic agents for brain tumor, including any of the following:

  * Immunotoxins
  * Immunoconjugates
  * Peptide receptor antagonists
  * Interleukins
  * Interferons
  * Tumor-infiltrating lymphocytes
  * Lymphokine-activated killer cell therapy
  * Gene therapy
  * Antisense therapy
* No prior hormonal therapy for brain tumor

  * More than 14 days since prior and no concurrent steroid therapy for patients with low-grade (grade I or II) astrocytoma
  * Prior glucocorticoid therapy allowed
Effects of Neuromuscular Electrical Stimulation on Glucose Variability in Patients With Type 2 Diabetes

In patients with type 2 diabetes mellitus (T2DM) chronic hyperglycemia is the main cause of complications, promoting several micro and macrovascular damages. In order to understand other mechanisms that could have an impact on the development of these diabetic complications, the assessment of glycemic variability have been widely used. Glucose control can be achieved with multiple interventions, including exercise training. Some individuals, however, especially those with autonomic neuropathy, can have exercise intolerance. In this context, physical therapy proposes neuromuscular electrical stimulation (NMES) as a therapeutic that has been applied in research and clinical practice as an alternative to the training of patients who cannot perform conventional exercise. In patients with T2DM, NMES was shown to improve glycemic control and insulin sensitivity, but quality of these trials is poor. In addition, the effects of NMES on glycemic variability of T2DM patients have not yet been reported. The aim of this study is to evaluate the effects of NMES on glucose levels and glucose variability in patients with T2DM.

Patients with T2DM will be recruited from outpatient clinic of the Hospital de Clinicas de Porto Alegre. Patients will be randomized to NMES session, with maximal intensity tolerance by to induce visible contractions or to NMES-placebo, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction. Subjects will attend to research facility four times. On the first visit clinical, physical examination and autonomic evaluation (Ewing test) will be performed and a blood sample will be collected. On the second visit CGMS will be placed for glycemic variability evaluation. On the third visit NMES or NMES-placebo will be performed in a randomized way. On the fourth visit the CGMS will be removed. Blood pressure and heart rate will be evaluated during the protocol each 5 minutes and oxygenation tissue will be evaluated before, during and immediately after the protocol, through NIRS.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes;
* HbA1c from 7,5 to 10%;
* Fasting plasma glucose lower to 250 mg/dL
* Drug therapy maintained for at least one month before inclusion in the study.

Exclusion Criteria:

* Insulin use;
* Pregnancy;
* Documented arrhythmia;
* Unstable angina;
* Chronic renal failure (GFR lower than 15 ml/min);
* Varicose vein problems;
* Clinical musculoskeletal disease.