cyrilzakka/clinical-trials huggingface dataset:
S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury

The purpose of the study is to determine if a specific blood protein, S-100B, can help predict who will have a traumatic abnormality on head CT scan after a concussion. We will compare the levels of this protein in the subject's blood to the initial head CT scan and to how the subject is feeling one month after injury. We hope that the information we collect in this trial will help us determine who needs a head CT scan after a concussion and who may be more likely to have trouble recovering from a concussion.

The primary objective of this study is to determine the ability of a serum S-100B to predict traumatic abnormalities on brain CT scan after mild traumatic brain injury (mild TBI). The secondary objective is to determine the relationship between initial S-100B levels and cognitive outcome at one month.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with head trauma to any of the AHCC/ERNES EDs, meeting the following criteria will be eligible to participate:

  * Presence of mild TBI per study definition
  * Arrival at the ED within 4 hours of injury
  * ED workup includes a Head CT

(Controls are eligible if they present to the Outpatient Lab for routine bloodwork during enrollment hours)

Exclusion Criteria:

* Time of injury not able to be determined
* Head CT not done as part of clinical emergency care
* Incarcerated
* Non-English or Spanish speakers
* Absence of parent/guardian for minor subjects
* Subject and/or parent/guardian do not have capacity to consent
* Head injury due to birth trauma, anoxia, inflammatory, toxic, infectious or metabolic encephalopathies that are not complications of head trauma
* Ischemic or hemorrhagic stroke without associated trauma

(Controls are excluded if they have any of the following:History of brain tumor, melanoma and/or Alzheimer's disease; History of concussion, bone fracture or stroke (CVA or TIA) in the past month; History of surgery in the past month; Inability to obtain consent from subject and/or parent due to lack of capacity or absence of parent/guardian of minor; Inability to speak or read English; Incarceration)
Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

The goal of this study is to determine whether external neuromodulation using repetitive transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and morbidity is high. The goal of the study is to determine whether rTMS can suppress the rocking dizziness of MdDS.

Participants will maintain web-based diaries of their symptoms for two weeks prior to treatment with rTMS. Up to 20 treatments with rTMS with either anatomically or functionally determined targets will be administered. Post treatment diaries will continue for up to 12 weeks after rTMS administration.

Eligibility Criteria:
Inclusion criteria:

1. Age ≥18 years old
2. Willing and capable of interacting with the informed consent process
3. Primary disorder being a persistent rocking dizziness triggered by passive motion such as from water, land, or air travel and with no other central nervous system or peripheral vestibular disorder determined after appropriate evaluation.

Exclusion criteria:

1. Subjects who cannot comply with study conditions.
2. Active psychiatric condition such as mania or psychosis
3. Unstable medical condition
4. Implanted metal anywhere in the body (infusion pumps, pacemakers, metal or shrapnel in the body, deep brain stimulators, aneurysm clips, metal prostheses, joints, rods or plates). Dental fillings are acceptable.
5. Personal history of seizures or a first-degree relative with epilepsy
6. Medications known to lower seizure threshold such as: typical (high-potency) neuroleptics and tricyclic antidepressants: Subjects who take one or a combination of the following drugs will be excluded: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine. clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine (including MDMA, ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), theophylline, haloperidol, fluphenazine, bupropion.
7. Pregnancy or planning to become pregnant during study enrollment.
A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

PFS


Eligibility Criteria:
Inclusion Criteria:

.≥65 years or PS 2

* Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
* Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
* Presence of at least one index lesion measurable by CT scan or MRI

  * leucocyte ≥ 3.5×109/L
  * neutrophil ≥ 1.5×109/L
  * platelet ≥ 80×109/L
  * Hemoglobin ≥ 9g/L
  * ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
* BUN≤ 1.5×ULN
* Signed written informed consent

Exclusion Criteria:

* squamous carcinoma or small cell lung cancer
* Patients were allergic to pemetrexed
* Patients received chemotherapy before
* Uncontrolled acute infection

  .Uncontrolled pleural effusion
* Severe symptomatic heart disease
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception

  * Mental disorientation of disorder
  * Glucocorticoids taboo
Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension.

The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.

Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.

Eligibility Criteria:
Inclusion Criteria:

Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery
Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients

The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid

Aim of this study was testing the possible therapeutic effects of an 8-week therapy with PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive complaints and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab;
* subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day;
* mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission;
* complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection.

Exclusion Criteria:

* prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions;
* clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease;
* anaemia;
* current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study
Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools

Children with intellectual and developmental disabilities (IDDs) often engage in problem behavior, and functional communication training (FCT) is a commonly used treatment for problem behavior in clinical settings. During FCT, children learn prosocial ways to request functional reinforcers (e.g., "their way") instead of using problem behavior. For example, a child who engages in self-injury to escape math instruction may be taught to exchange a break picture card to receive a brief break from the math task as an alternative to self-injury. While the efficacy of FCT is well established, less is known about its effects in school settings when procedures are necessarily adapted for feasibility. The purpose of this investigation is to develop and evaluate methods for implementing FCT for children with IDDs in school settings. The investigators will use single case experimental design, in which each participant will serve as their own control, to address the research questions. First, the investigators will evaluate the effects of providing higher quality, longer duration reinforcement for appropriate requests relative to problem behavior (e.g., 1-minute break with a preferred activity versus 20-s break alone) during FCT compared to providing equal reinforcement for appropriate requests and problem behavior. Next, the investigators will develop a treatment extension to teach children to complete academic work to gain access to their way. The investigators will use visual cues, such as a green and red index card to teach children when it is time to work and when they may access their way. The investigators will evaluate the effects of the treatment extension on academic work completion, appropriate requests, and problem behavior. Finally, the investigators will examine how visual cues influence children's behavior when educators implement intervention across different academic activities. The investigators will measure the extent to which educators implement programmed intervention procedures to inform treatment feasibility.


Eligibility Criteria:
Inclusion Criteria:

Child Eligibility Criteria

* Preschool or elementary school students between 3-11 years old
* Has an intellectual or developmental disability
* Has a functional behavior assessment and behavior intervention plan or has been identified as needing a functional behavior assessment
* Exhibits problem behavior that occurs at least daily

Adult Eligibility Criteria

* Educator who provides direct services to the child participant

Exclusion Criteria:

Child Exclusion Criteria

* Excessive absences from school
* Problem behavior occurs less frequently than daily
The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway

The goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers. Utilizing Magnetic Resonance Imaging (MRI), this study aims to investigate:

* How does soft palate anatomy change in different body positions?
* What is the impact of positive pressure therapy, in the form of non-invasive ventilation (NIV) on soft palate anatomy? Researchers will compare MRI data without positive pressure to with positive pressure imaging to see if the addition of positive pressure impacts the size and shape of the soft palate.

Researchers will also utilize measures of upper airway resistance to assess the impact of soft palate anatomy of airflow dynamics.

Participants will be asked to:

* Lie inside an MRI scanner for up to 90 minutes (including breaks), in different body positions
* Undergo NIV therapy for 5-10 minutes while breathing normally inside an MRI scanner
* Have their upper airway resistance measured, in different body positions


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18+
* Willing and able to consent to the study

Exclusion Criteria:

* Contraindications for MRI (such as metal implants)
* Contraindications for NIV (such as pneumothorax)
* No history of lung or upper airway disease
* Claustrophobia
* Symptoms of a cold, flu, or significant congestion, within the last 3 days
* Self-reported confirmed or suspected pregnancy
* Palatal abnormalities or previous upper airway surgery (such as cleft palate and/or UPPP)
* Prior major head or neck surgery with or without irradiation (such as radiotherapy of cutaneous cancers, robotic surgery for an oropharyngeal cancer)
Effects of Urban Afforestation Activity on Pain Mechanisms

This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on pain thresholds.

Participants will perform an afforestation activity for a single session of 90 minutes. The therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment. A battery of quantitative sensory tests pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Free of pain in the hands, cheeks, lower back, wrists and trapezius muscles in the previous 3 months.
* Adults between 18 and 65 years.
* Any sex and gender.

Exclusion Criteria:

* Intake of any analgesic or psychotropic medication.
* Other severe or medically unstable diseases that may interfere with participation.
* Severe cognitive impairment (Mini-Mental State Examination score \< 17 out of 30 points).
* Severe mental disorders in the acute phase or symptomatic phase.
* Severe intellectual disability.
* Behavioural alterations as this may interfere with their participation.
* Pregnant or breastfeeding.
Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment

Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by polygraphy.

This project includes two parts:

* Genomic screening
* Biomarkers

Eligibility Criteria:
OSA-patients with moderate and severe OSA (n=15+15)

1. Adult, 18-75 years of age
2. Moderate (AHI 15-30) or Severe (AHI \>30) OSA that are currently untreated and planned for CPAP-treatment
3. Otherwise healthy except for well controlled hypertension since 3 month, Max BP 140/90
4. Non-smokers
5. Not pregnant
6. No medications with antioxidants
7. BMI of \<40

Controls (AHI\<5) Two groups of controls

1. Matched controls The same age, sex and BMI ± 3 and eventual hypertension. These controls should also fulfill criteria 4-6 above.
2. Healthy controls with normal BMI (19-25) These controls should also fulfill criteria 1., 4-6 above.

Exclusion Criteria:

* If they no not fulfil the inclusion criteria
Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes

Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.

The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated with PPROM-related complications without increasing the morbidity associated with a shortened pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Women with recent PPROM between 31 weeks + 6 days and 35 weeks + 6 days (estimated gestational age based on an ultrasound examination before 18 weeks of gestation), not in labour 24 hours after admission\*, will be considered eligible for the study provided the following inclusion criteria (\*For patients transferred from a remote level 2 centre to one of the participating sites within the first hours after PPROM, the onset of the 24-hour screening period will be the time of admission in the centre of origin. Patients in Group A will be given their first dose of antenatal steroids before the transfer)
* Single and otherwise uncomplicated pregnancy
* Recent history (less than 48 hours) of leaking with the two followings within 24 hours after primary medical assessment: Documentation of fluid from the vagina and Positive Fern test, or positive Nitrazine test, or Positive ACTIM PROM test
* Antenatal steroids course initiated after the rupture for women with PPROM between 31 + 6 and 33 + 6 weeks
* Normal fetal heart rate trace using an external ultrasound transducer
* Written informed consent obtained before inclusion and randomization

Exclusion Criteria:

* Multiple pregnancy
* HIV positive mother
* Active HSV cervical lesions
* Major fetal anomaly on ultrasound examination performed after admission
* Intrauterine growth restriction estimated on ultrasound below the 5th percentile or preeclampsia
* Placenta abruption present at the time of the diagnosis of PPROM or occurring within the first 24 hours after rupture
* Clinical chorioamnionitis existing before or at the time of the diagnosis of PPROM or developing within the first 24 hours after rupture
* Non-reassuring fetal testing present at the time of the diagnosis of PPROM or occurring within the first 24 hours after the rupture. It implies that expected criteria for standard fetal assessment parameters have not been met, including the Non-Stress test and the Biophysical profile Score. This will be diagnosed at the discretion of the attending physician.
* More generally, any maternal or fetal reason for an immediate delivery, either existing at admission or occurring within the 24 hours after admission.
* Mother refusal or inability to provide consent
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV

This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.

This proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of MSM. The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as MSM: (1) born male who (2) has sex with men
* Age: 18 or older
* Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months.
* Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event.
* Able and willing to provide informed consent

Exclusion Criteria:

* HIV positive
* Glomerular filtration rate \< 60 mL/min (calculated using the Cockcroft-Gault formula)
* Hepatitis B surface antigen positive
* Symptoms suggestive of acute HIV seroconversion at screening or enrollment
* Have used PrEP or PEP within the previous 3 months
* Currently enrolled in another study involving medications, investigational drug, or medical device
* Has other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

The purpose of this study is the evaluation of using bi-level positive airway pressure ventilation in candidates for fiber-optic bronchoscopy regarding benefits and drawbacks.

In this study patients who will be candidate for fiber-optic bronchoscopy for diagnostic or therapeutic reasons will be evaluated by the Chest Medicine Department, Mansoura University Hospitals. All patients will be subjected to full history taking, full examination, routine laboratory investigations, arterial blood gases (ABG), chest X-ray, chest computed tomography (CT). Non-invasive ventilation: Group 1 (hypoexemic patient who will undergo bronchoscopy under non- invasive ventilation{NIV}) will be on NIV half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 2 (hypoxemic patients who will undergo conventional bronchoscopy ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 3 (non- hypoxemic patients who will undergo conventional bronchoscopy ) will be on NIV throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients who admitted to the pulmonology ward or intensive care unit with any (diagnostic and/or therapeutic) bronchoscopy indication.

  1. Age 18 years or more.
  2. Patients accepted to participate in the study.

Exclusion Criteria:

* Patients with:

  1. Cardiac or respiratory arrest.
  2. Impaired consciousness or confusion.
  3. Type II respiratory failure.
  4. Hemodynamic instability.
  5. Inability to cooperate or to protect the airway.
  6. Vomiting, bowel obstruction, recent upper gastrointestinal tract surgery and esophageal injury.
  7. Patients refusing participation in the study.
  8. Patients unfit for NIV and or NIV mask.
  9. Intubation and or invasive ventilation candidates.
  10. Presence of contraindications for bronchoscopy procedure such as insufficient platelet number or coagulopathy.