cyrilzakka/clinical-trials huggingface dataset:
The Effect of AI-assisted cEEG Diagnosis on the Administration of Antiseizure Medication in Neonatal Seizures

This is a prospective randomised clinical trial study to test an artificial intelligence (AI)-assisted continuous electroencephalogram(cEEG) diagnostic tool for optimizing the administration of antiseizure medication (ASM) in neonatal intensive care units(NICUs).

The occurrence of neonatal seizures may be the first, and perhaps the only, clinical sign of a central nervous system disorder in the newborn infant. The promoted treatment of seizures can limit the secondary injury to the brain and positively affect the infant's long-term neurological development. However, the current antiseizure medication (ASM) are both overused and underused. Studies indicated that early automated seizure detection tool had a high diagnostic accuracy of neonatal seizures. However, there is little evidence that early automated seizure detection tool could the optimize the administration of ASM and improved the neurological outcomes in neonatal seizures. Therefore, the primary study aim is to investigate whether the utility of AI assisted cEEG diagnostic tool could optimize the administration of ASM in NICUs.

This project will enroll the neonates with suspected or high risk of seizures who will receive at least 72 hours cEEG monitoring during hospitalization. All the cEEG monitoring methodology is standardized across recruiting hospitals.

The intervention will be an artificial intelligence (AI)-assisted continues electroencephalogram (cEEG) diagnostic tool.

The individuals were randomly allocated to one of the two groups using a predetermined randomisation sequence and block randomisation generator (block of 4). The group 1 will be monitored with cEEG and the cEEG recording will be assessed by neonatologists with AI assisted cEEG diagnostic tool in real time during cEEG monitoring. The group 2 will be monitored with cEEG and the cEEG recording will be assessed by neonatologists when as routine during cEEG monitoring. Both groups will follow the standard clinical protocols for ASM administration of the recruiting hospitals The reference standard is the electrographic seizures interpreted by 3 clinicians who had attended the uniformly training program and were certified by the Chinese Anti-Epilepsy Association. These 3 clinicians are blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Postnatal age \< or = 28 days;
* cEEG monitoring at least 24hours monitoring;
* Suspected seizures；
* Abnormal movement;
* Brain infarction；
* Risk of Intracranial hemorrhage;
* Abnormality of brain MRI or ultrasound;
* Hypoxic-ischemic encephalopathy or suspected Hypoxic-ischemic encephalopathy;
* Central nervous system (CNS) or systemic infections;
* Suspected genetic diseases or Positive genetic diagnoses;

Exclusion Criteria:

* The neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for cEEG monitoring during hospitalization.
Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.

The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

The objective of this study is to investigate the possible association between 60 single nucleotide polymorphisms (SNPs) related to obesity, metabolism and cardiovascular disease with the body mass index (BMI), intestinal microbiota related to the metabolism of polyphehnos and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

The volunteers (n=423) with ages ranging from 5 to 18 years consumed for three days a daily serving of walnuts (30g) and provided a sample of urine (to determine mirobial-derived metabolites from walnut polyphenols) as well as a swab specimen from the inner cheek to provide DNA for further genotyping.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 5 to 18 years.
* Informed consent signed by the parent / legal representative, and by volunteers who are already 18 years old.

Exclusion Criteria:

* Known or suspected allergy or intolerance to nuts or pomegranate.
* Intake of antibiotics 1 month before the start of the study.
* If the participant could perceive stress or psychological damage due to his participation.
* Any other circumstance different from previous ones (illness, etc.), according to which it is considered that the intervention in the study may involve some type of affectation.
What Matters to You on the Day of Surgery 2024?

Research show that between 48-97% of patients referred to surgery experience anxiety and fear related to the procedure. High levels of anxiety and fear lead to increased use of anesthetics and pain as well as increased morbidity after the surgical procedure.

June 6 2024 is the international "What matters to you-day" and thus we mark this day in several Danish hospitals by asking patients referred to surgery: "What matters to you on the day of surgery"? This observational study has three goals:

1. To explore what matters to patients on the day of surgery
2. To explore associations between patients' degree-of-worry and their surgical fear on the day of surgery
3. To explore the characteristics and intensity of degree-of-worry

From 7.00 AM to 11.00 PM patients will be invited to answer:

1. What matters to them on the day of surgery and why it matters
2. How worried they are about their situation using a scale from 1 to 10, and to state why they worry.
3. Eight questions about their fear related to anesthesia and surgery on a scale from 0-10

In the analysis we will investigate the possible association between patients' degree of worry and fear related to anesthesia and surgery. Secondly, we analyse the prevalence of degree of worry and fear according to gender, age, type of surgery and medical speciality.

Finally, we will investigate what themes appear when we analyse the answers to what matters and why patients' worry.


Eligibility Criteria:
Inclusion Criteria:

* Danish speaking
* 18 years old or above

Exclusion Criteria:

* Patients who are not cognitively intact
* Do not consent to participation
* Patients requiring immediate surgical intervention.
Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers

A group of 120 school teachers (male=60, female=60) was divided into four subgroups for sixteen weeks of an interventional study. One group was kept in control while the other three groups were assigned intervention. One group was assigned intervention of lifestyle modification (LSM), the other group assigned the intervention of 5 gm psyllium husk fiber (PSH) two times a day, and the third group assigned the combined intervention of LSM \& PSH. Each group comprised of 30 subjects with equal gender bifurcation (15 male and 15 female).

The school teachers who qualified for the initial screening and eligibility criteria were formally enrolled in the intervention. An informed consent form was signed by each subject explaining the data privacy and the subject's obligation. School teachers with lifestyle modification were advised to adhere to three major components, i.e., diet modification, physical activity, and behavioral therapy. subjects in the psyllium husk fiber group were assigned the consumption of 5gm psyllium husk fiber (in swelled form) two times a day, i.e., 30 minutes before breakfast and 30 minutes before dinner. subjects in the combined group of psyllium husk fiber and physical activity were assigned both the intervention of psyllium husk fiber @ 5gm two times a day, 30 minutes before breakfast and dinner in swelled gel form with the combination of lifestyle modification, while one group remained as control (without any intervention).

Eligibility Criteria:
Inclusion Criteria:

* School teachers aged 40-60 years (male and female)
* central obesity (where central obesity for Asians is defined as the waist circumference for men ≥ 90 cm and for women ≥ 80 cm
* with no history of any chronic disease like hypertension, Diabetes, Cardiovascular diseases, taking of any regular medication, food allergies, smoking
* physical disabilities impairing the food intake and mobility, qualified the inclusion criteria.

Exclusion Criteria:

* Pregnant or lactating female school teachers were also excluded during screening.
* Subjects with an allergy to psyllium husk fiber, history of drug abuse, or any psychological or emotional disorder that might prevent the completion of the study were also excluded.
Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)

A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.

Eligibility Criteria:
Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study.

Exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems.
A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Brentuximab Vedotin especially myelosupression, peripheral neuropathy, and lung disorder.

During the study, pediatric participants with HL will take Brentuximab Vedotin injection and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine) according to their clinic's standard practice. The study doctors will check for side effects from Brentuximab Vedotin for 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Treatment-naive participants
2. CD30 positive participants
3. Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
4. Participants aged \< 18 years at the start of this drug.

Exclusion Criteria:

Participants with contraindications to the study drug.
Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain

To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids.

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

To assess improvements among patients and compare steroid groups with each other and local anesthetic group.

To evaluate and compare the adverse event profile in all patients

Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises.

A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups.

* Group 1. local anesthetics only
* Group 2. local anesthetic with 6mg of non-particulate Celestone
* Group 3. local anesthetic with 6 mg of brand name Celestone
* Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol

All patients will be unblinded in 12 months.

Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* History of chronic, function-limiting low back pain of at least 6 months duration
* Able to give voluntary, written informed consent to participate,
* Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
* No recent surgical procedures within last three months

Exclusion Criteria:

* Cauda Equina symptoms and/or compressive radiculopathy
* Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine
* Uncontrolled major Depression or uncontrolled psychiatric disorder
* Uncontrolled or acute medical illnesses
* Chronic severe conditions that could interfere with outcome assessments
* Women who are pregnant or lactating
* Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
* Patients with multiple complaints involving concomitant hip osteoarthritis
* Inability to achieve proper positioning and inability to understand informed consent and protocol
* History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men

the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.


Eligibility Criteria:
Inclusion Criteria:

* 21 and older, BMI between 25.0-34.6, Weight Stable for at least 6 mths, body \>25%, non smoking, clinically normal blood profiles, non-diabetic.

Exclusion Criteria:

* intermittently been involved in a diet and/or exercise program within the last 3 months, Have no allergies to eggs.
Pain Phenotyping in Patients with Neuropathic Pain After Spinal Cord Injury

The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Spinal injury cohort - general inclusion criteria:
* Aged between 18-80 years
* Traumatic and non-traumatic etiology
* Para- and tetraplegic SCI
* Complete and incomplete SCI
* SCI with and without neuropathic pain
* Additional inclusion criteria for longitudinal study:
* SCI since less than one month
* Additional inclusion criteria for cross-sectional study:
* SCI since more than one year
* Control cohorts with peripheral neuropathy:
* General inclusion criteria:
* Aged between 18-80 years
* Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
* Peripheral neuropathy with or without neuropathic pain
* Additional inclusion criteria for longitudinal study:
* Peripheral neuropathy since less than one month
* Additional inclusion criteria for cross-sectional study:
* Peripheral neuropathy since more than one year
* Control cohorts without neuropathy / healthy volunteers
* General inclusion criteria:
* Aged between 18-80 years
* No medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder)

Exclusion Criteria:

* Inability to follow study instructions
* Pregnancy
* Medically manifested psychological disorder
* Medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the SCI cohort)
LOIS: Long-Term Follow-Up in INSITE/SIFI

The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).

Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:

* SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and
* INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement


Eligibility Criteria:
Inclusion Criteria:

1. Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.
2. Patient has signed study-specific LOIS informed consent form.
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

Exclusion Criteria:

1. Treated with iFuse as a "crossover" in INSITE.
2. Currently pregnant or planning pregnancy within 5 years of iFuse Implant.
3. Patient is a prisoner or a ward of the state.
4. Known or suspected active drug or alcohol abuse.
5. Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
6. Unwilling to perform the long-term follow up requirements of this study.
7. Patient has any condition that could substantially prevent long-term follow-up.
8. Unwilling to return to site at pre-specified study visits.
Use of Beta-blockers and Risk of New Onset Diabetes

This study used an observational, retrospective cohort design to compare the presence and timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate (referred to hereafter as 'other BB').

The aim of the study was to investigate the likelihood of developing NOD among hypertensive patients initiating carvedilol therapy vs other BB therapy in a real world setting derived from data contained in a large United States (US) managed care database.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a plan captured in the IMS LifeLink Health Plan Claims Database between July 1, 2000 and December 31, 2007
* aged ≥18 years
* at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release \[IR\]/controlled-release \[CR\], atenolol, metoprolol succinate, or metoprolol tartrate)
* Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period
* Continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date
* at least 1 diagnosis of hypertension (International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM): 401.xx-405.xx) during this time frame.

Exclusion Criteria:

* Diagnosis of diabetes mellitus (ICD-9-CM: 250.xx) and/or a prescription for antidiabetic therapy in the 6 months prior to and/or 3 months after the index date
A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer

This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of second-line systemic chemotherapy sequential NKG2D CAR-NK cell therapy for pancreatic cancer


Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 18\~75 years old (including boundary value), both male and female.
* 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis with at least first-line systemic therapy failure.
* 3. Zubrod-ECOG-WHO score (see Annex 2) on a scale of 0-2.
* 4. Life expectancy of at least 3 months at screening, as judged by the investigator.
* 5. At least one stably evaluable target lesion according to RECIST1.1 criteria.
* 6. Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, with no ongoing supportive care (\&#34;yellowing\&#34; therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct).
* 7. Remission of all toxicities due to prior antineoplastic therapy to Grade 0\~1 (according to NCI CTCAE version 5.0) or to acceptable levels for inclusion/exclusion criteria.
* 8. Childbearing status: not pregnant, and if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form to 6 months after the last cell infusion (females of childbearing potential include premenopausal females and females within 2 years of postmenopause).
* 9. Subjects must sign and date written informed consent.
* 10. Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up, and other study requirements.

Exclusion Criteria:

* 1. Pregnant and lactating females.
* 2. Positive serology for HIV, Treponema pallidum or HCV (those who are HCV antibody positive but HCV-RNA negative, stable syphilis and inactive patients can be included).
* 3. Any active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of laboratory testing), Epstein-Barr virus (EBV) DNA positive, cytomegalovirus (CMV) DNA positive or novel coronavirus (new coronavirus) nucleic acid positive, and other bacterial, viral, or fungal infections requiring drug treatment;
* 4. History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
* 5. Any other health condition that, in the judgment of the investigator, would preclude participation in the study.