cyrilzakka/clinical-trials huggingface dataset:
Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

Benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in children. It is known to be age-dependent and presumably genetic. Age of onset ranges from one to fourteen years and it represents fifteen percent to twenty five percent of epilepsy in children under 15 years of age.

Generally, Benign epilepsy with centro-temporal spikes is characterized by infrequent focal sensorimotor seizures in the face during sleep, which may secondarily generalize, along with spike-wave discharges, reflecting nonlesional cortical excitability from rolandic regions.

The prognosis is usually considered to be excellent. Over the past years, however, some investigators have questioned whether Benign epilepsy with centro-temporal spikes is indeed benign, considering the variety of different presentations associated with the disorder.It is not uncommon for Benign epilepsy with centro-temporal spikes to be associated with neuropsychological deficits, such as linguistic, cognitive, and behavioral impairment. In particular, reading difficulties and speech/language disorders are more common in children with Benign epilepsy with centro-temporal spikes than in healthy controls.Various neuropsychological deficits seem to be very dependent on the spike index, as well as the predominant localization of epileptiform discharges.Furthermore, the frequency of epileptiform discharges is closely related not only to the degree of neuropsychological deficits, but also to an atypical evolution of benign epilepsy with centro-temporal spikes.

The high comorbid prevalence of attention deficit hyperactivity disorder and epilepsy suggests that there is a bidirectional relationship between these disorders .Cognitive impairment and attention problems are particularly crucial issues in children with epilepsy who are in a vigorous phase of neurodevelopment.

Resolution of continuous spike-and-wave during sleep had been achieved with conventional antiepileptic drugs including ethosuximide, valproic acid, levetiracetam, and sulthiame. When these agents fail to normalize the EEG, a trial with second-line agents such as steroids or high-dose diazepam is attempted.

Eligibility Criteria:
Inclusion Criteria:

* History and EEG findings of benign epilepsy with centrotemporal spikes

Exclusion Criteria:

* Genetic disorders.
* Metabolic or neurodegenerative disease.
* Gross motor delay.
Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.


Eligibility Criteria:
Inclusion Criteria:

* Daytime sleepiness with ESS score ≥ 5.
* Patient's prior sleep study with AHI between ≥ 10 and ≤ 45 (4% scoring criterion).
* On treatment for OSA, failed or not willing to use all other OSA treatment options
* Has access to a weight scale at home or able to come into the Sleep Clinic to be weighed after the 8-week plant-based diet period.

Exclusion Criteria:

* Pregnancy or lactation.
* Current use of a vegan diet.
* BMI ≤ 22.
* Complex, central sleep apnea.
* Pre-existing significant degree of cardio-pulmonary disease-heart failure with reduced EF of 35 or lower, unstable arrythmia, severe degree of pulmonary hypertension, severe degree of obstructive or restrictive lung disease including COPD and Interstitial lung disease.
* On weight loss medications or starting new exercise regimen during the 8-week plant-based diet period.
Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years

This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in children aged 5 to \<12 years and 12 to \<18 years with adults aged 18 to 40 years. Children aged 12 to \<18 years and adults received 25 µg of the recombinant protein together with 15 mg of Advax-SM. Children aged 5 to \<12 years received a half-dose of the adjuvanted vaccine. The injection was given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The vaccine immunogenicity was evaluated at 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Unsolicited adverse events were collected through one month after the second dose. Safety monitoring was continued through six months after the second dose in children aged 5 to \<12 years and 12 to \<18 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 5 and 40 years of age inclusive
* Willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests
* Healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit
* Females must not be pregnant or breastfeeding
* Children with a body mass index equal to or greater than the 3rd percentile for age and sex as per the World Health Organization child growth standards

Exclusion Criteria:

* Subjects with signs of active SARS-CoV-2 infection at the screening visit.
* Subjects with epilepsy or a history of febrile seizures
* Subjects who receive immunosuppressive or cytotoxic medications.
* Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products.
* Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study.
* Subjects who have been vaccinated with any vaccine or vaccine candidate against SARS-CoV-2.
* Subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study.
* Subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection.
* Subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period.
* Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.
* Subjects who have donated ≥450 mL of blood or blood products within 28 days prior to the screening visit.
Does the Harmonic Scalpel Reduce Blood Loss and OR Time in Major Head and Neck Cancer Surgery Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma?

The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* oral cavity scc
* primary surgery including either uni or bilateral neck dissection (levels I-IV)

Exclusion Criteria:

* previous treatment for head and neck cancer
* unable or unwilling to give informed consent
* history of bleeding disorder
* other contraindications to surgery
A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors

The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors


Eligibility Criteria:
Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

* Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1)
* Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting
* Eastern Cooperative Oncology Group performance status of ≤ 1

Exclusion Criteria:

* Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded
* History of congenital or autoimmune hemolytic disorders
* History or presence of hypersensitivity or idiosyncratic reaction to methylene blue

Other protocol defined inclusion/exclusion criteria could apply
Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy

Hematopoietic Stem Cell Transplantation (HSCT) and CAR T-cell therapy are effective treatments for blood cancers, extending patients lives. However, these treatments can cause side effects like muscle weakness and fatigue. Recent findings suggest these issues can significantly affect patient quality of life during CAR T-cell therapy.

Patients undergoing HSCT and CAR T-cell therapy often face frequent infections and strong immune responses, requiring long periods of rest. This worsens their physical condition and impacts their quality of life, muscle strength, and fatigue levels. Minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments.

This study aims to assess the physical abilities (main goal) of patients preparing for HSCT or CAR T-cell therapy. It also aims to examine their quality of life and describe the symptoms and complications they may experience. The results will help identify rehabilitation needs for these patients.

This is a prospective observational study following STROBE guidelines for observational studies in epidemiology. The study will take place at the Azienda USL-IRCCS di Reggio Emilia, Northern Italy.

Participants will include adults with blood cancer scheduled for HSCT or CAR T-cell therapy. They must be able to understand and speak Italian and make an informed decision to participate in the study.

Patients will be identified at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia. Medical records will be reviewed to confirm eligibility. Eligible patients will receive detailed information about the study and can decide to participate by signing a consent form.

The study will last 24 months, with an 8-month enrollment period and an 8-month follow-up. Approximately 20 participants will be enrolled based on the number of patients who received HSCT and CAR T-cell therapy in 2023.

Data on participants Sociodemographic and clinical characteristics will be collected at the start of the study. Complications and hospitalizations will be monitored after treatments to understand their impact on patients health.

This study aims to provide valuable insights into the rehabilitation needs of patients undergoing HSCT and CAR T-cell therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy;
* Age ≥18 years
* Able to provide informed consent to participate in the study
* Able to understand and participate in the study
* Able to understand and communicate in the Italian language

Exclusion Criteria:

• Patients who are unable to perform physical tests or have contraindications to movement
Chronic Effect of Mat Pilates on Neuromotor, Cardiovascular Functions and Inflammatory Markers in Individuals Post-Stroke Stroke and High Blood Pressure

The Pilates method aims to develop conscious control of body movements. In the literature there are studies that relate the method to postural stabilization, joint rehabilitation, treatment of low back pain, cancer and chronic obstructive pulmonary disease. However, studies on the modality\&#39;s potential for improving isokinetic and antihypertensive strength are scarce, particularly in post-stroke hemiparetic individuals with high blood pressure (BP). The objective of the study is to investigate changes in isokinetic strength and BP, in addition to functional capacity, balance, autonomic modulation, blood biomarkers and endothelial function in hemiparetic individuals due to stroke sequelae and/or with high BP (prehypertensive and hypertensive), after 12 weeks of training with Mat Pilates. Eligible volunteers will be randomly divided into a Mat Pilates group with stroke (GP-AVE), Mat Pilates group with high blood pressure (HA) (GP-HA), control group with stroke (GC-AVE) and control group with HA (GC-HA ). On the first and second visit, measurements of isokinetic strength, functional capacity, static and dynamic balance, heart rate variability, cardiac output, stroke volume, endothelial function, total peripheral vascular resistance and blood biomarkers will be carried out. In addition, 24-hour BP will be measured by ambulatory monitoring (ABPM). GP-AVE and GP-HA will participate in a 12-week Mat Pilates program, totaling 36 training sessions lasting approximately 60 minutes, with an increasing degree of difficulty and complexity throughout the training period. GC-AVE and GC-HA will be instructed to maintain their daily activities during the intervention period, then they will be invited to participate in the Mat Pilates program. The initial measurements will be repeated at the end of the intervention in the Mat Pilates and control groups. Intra and intergroup comparisons will be carried out for all outcomes, for a significance level set at p ≤ 0.05.


Eligibility Criteria:
Inclusion Criteria: Hemiparetic individuals with a history of stroke and/or high blood pressure (prehypertensive and hypertensive patients) who are controlled and do not practice the Pilates method.

Exclusion Criteria: Diagnosis of cardiovascular, respiratory, metabolic or locomotor disease that makes it impossible or contraindicates the practice of the proposed exercises; Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic pressure and ≥105 mmHg at rest); Spasticity: 3 according to the modified Ashworth Scale; Smoking and frequencies in exercise sessions below 75%.
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* On a stable dose of metformin as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Comparative Study Evaluating Performance of Celliant Fibers on Tissue Oxygenation

The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred change in local cutaneous blood flow, in healthy subjects wearing a control and a 100% Celliant® fiber upper torso garment.

Adequate blood supply is necessary for many physiologic processes. However, there are few valid, reproducible, non-invasive methods with which to assess it. One such measure is transcutaneous partial pressure of oxygen (tcPO2). This measurement is a non-invasive method of measuring oxygen tension at the skin surface; represents the amount of oxygen diffusing outward across the skin; and can be used as a surrogate for arterial perfusion. This method is reproducible with clinically acceptable intrasubject variability; is used for a variety of conditions, including peripheral vascular disease evaluation, predicting the outcome of patients requiring amputation and survival of skin grafts; and correlates well to angiography and increases in blood flow rates. However, tcPO2 is affected by many variables, including oxygen concentration in inspired air, lung function and hemoglobin saturation, as well as local factors, such as skin thickness, sympathetic tone, the presence of inflammation, capillary formation and skin oxygen consumption.

Eligibility Criteria:
Inclusion Criteria:

* Subjects greater than or equal to18 years of age
* Men and women between the ages of 18 and 60 years
* Able to understand and consent to the study
* Able to follow directions of the Study Coordinators and/or the Principal Investigator
* Able to complete the study
* Male or female subjects of any ethnic origin such that the balance across ages and among population groups is reflective of the site population

Exclusion Criteria:

* Active smokers
* No history of cardiovascular disease
* No history of peripheral vascular disease
* Engaged in recreational drug use for the six months prior to the start of the study
* Eaten within two (2) hours of the study
* Consumed caffeine within four (4) hours prior to the study
* Consumed alcohol with forty-eight (48) hours prior to the study
* Subjects with any unstable medical or psychiatric problem
* Subjects who are pregnant or nursing mothers
* Subjects who are currently taking part in another clinical study or have taken part in a drug or device study, in the past month.
Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients

The use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population, specifically oncology pediatric patients. Pediatric oncology patients routinely experience anxiety during therapy and as cure rates increase, attention has progressively turned to treating psychosocial aspects of care.

A randomized 2x2 cross-over design will be utilized for this study. The study team will randomize participants to one of two sequences: 1) weighted blanket first then usual care or 2) usual care first then weighted blanket. The cross-over design allows the researchers to compare both within and between group differences. The advantages of the cross-over design allow minimize potential confounding bias as patients will serve as their own controls as well as potential for adequate power with smaller patient enrollment. As this study is conducted during chemotherapy treatments, the 30-day period in between patient treatments will be considered the washout period. This timeframe between chemotherapy infusions was chosen to try to capture patients in a similar state of baseline anxiety. This helps to provide adjustments to variability but should not limit accrual based on the number of patients that get chemotherapy within a 30-day period.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in one of the two designated out patient locations (Anschutz Campus and Colorado Springs Hospital)
* Patients who have a "liquid tumor" (leukemia or lymphoma), "solid tumor", or a neuro-oncologic diagnosis
* Patients who can complete the CAM-S and CAM-T as proven by seriation screening.
* Patients who are great than 13.5kg in weight, due to weighted blanket size options
* Patients whose second and third outpatient chemotherapy occur within 30 days of each other.
* English and Spanish speaking

Exclusion Criteria:

* Patients who are younger than 4 years of age, or older than 17 years of age
* Relapsed patients
* Patients who are undergoing bone marrow transplant or had a previous bone marrow transplant
* Patients receiving chemotherapy infusions at North Campus and South Campus locations
* Patients in the inpatient setting
* Patients who utilize a weighted blanket at home currently or previously
* Patients who fail seriation screening during enrollment
* Patients who start initial chemotherapy infusions in the outpatient setting
Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection

A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.


Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent
* Patient is an adult (≥ 18 years of age at the time of informed consent) with a diagnosis of melanoma
* Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma

Exclusion Criteria:

- Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

This study is a phase 2 study of SHR-1905 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of SHR-1905 in subjects with severe uncontrolled asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged between 18 and 75 years (inclusive)
2. Weight ≥ 40 kg
3. Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
4. Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
5. At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
6. At least 2 exacerbations within 12 months before screening
7. No birth plan and must agree to take effective contraceptive methods
8. Sign informed consent form voluntarily for the trial

Exclusion Criteria:

1. Any clinically important pulmonary disease
2. Any disease other than asthma that may affect lung function
3. Any disease other than asthma related to elevation of eosinophils
4. Any immunodeficiency disease
5. Any clinically important serious cardiovascular diseases unstable or uncontrolled
6. Uncontrolled Hypertension
7. Uncontrolled Diabetes Mellitus
8. Any clinically important infections within 4 weeks before randomization
9. Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator
10. Any parasitic infections within 6 months before randomization
11. Malignancy diagnosed within 5 years before randomization
12. Abnormal laboratory tests during screening and baseline
13. Positive infectious disease test
14. Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject
15. Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
16. Drug or alcohol abuse
17. Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study
18. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
19. Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening
20. Any other circumstance inappropriate for participating in the clinical trial considered by the investigator