cyrilzakka/clinical-trials huggingface dataset:
Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)

PMX-60056 is being developed as a rapid and effective reversal agent for use in those situations where anticoagulation by heparin, or LMWH must be quickly stopped. Potential uses include reversal of anticoagulation induced to prevent clotting during surgical procedures, and rescue from cases of inadvertent or unexpected overdose.

Eligibility Criteria:
Inclusion Criteria:

1. The patient will undergo PCI for diagnostic and/or therapeutic purposes with a procedure that uses anticoagulation before the instrumentation and reversal of anticoagulation immediately after the procedure.
2. Male or female patients of any race, aged 18-80 years old.
3. The patient will be anti-coagulated with unfractionated heparin.
4. The patient is medically stable and physically and mentally able to participate in this study.
5. The patient has given written informed consent to participate in this study after fully understanding the implications and constraints of the protocol.

Exclusion Criteria:

1. The patient requires emergency surgery under conditions which prevent compliance with this protocol or which might cause unacceptable risk to the patient.
2. The patient requires any concomitant surgical procedures (e.g., carotid artery, CABG) during the PCI.
3. The patient has received any investigational drug within 30 days of study enrollment, or has had any prior exposure to PMX-60056.
4. The patient has any condition or abnormality which may, in the opinion of the Investigator, compromise the safety of the patient.
5. The patient is pregnant or breast feeding.
6. The patient is of childbearing potential and not under adequate contraceptive protection.
7. The patient has a history of clinically significant hematologic disease including heparin-induced thrombocytopenia, bleeding disorders, or platelet count \<100,000.
8. Severe impaired hepatic function (SGOT, SGPT \>2 x ULN).
9. History of AIDS, ± HIV.
10. History of allergy to heparin (beef or pig), protamine, or salmon.
11. History of chronic alcohol or drug abuse within the last one year.
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE

To assess the long-term safety and tolerability of XEN496 in pediatric subjects with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) who had participated in the primary study (XPF-009-301).

This is an open-label, long-term extension study of XEN496 for the treatment of seizures in subjects with KCNQ2-DEE, that will be open to eligible subjects who participated in the primary study, XPF-009-301. The primary objective is to assess the long-term safety of XEN496. A double-blind transition/titration period will be used to maintain blinding to the treatment allocation in the primary study (XPF-009-301). After completion of the blinded transition/titration period, subjects will receive the open label study drug at their optimal dose for approximately 35 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed participation in the primary study, XPF-009-301. A subject who withdraws from the primary study due to meeting protocol-specified worsening criteria will be considered as having completed participation in the primary study.
* The caregiver is willing and able to be compliant with diary completion, visit schedule, and study drug administration.
* Subject's caregiver achieved a minimum of 85% compliance with daily diary completion during both baseline and the double-blind period of the primary study.

Exclusion Criteria:

* Any adverse event(s) or serious adverse event(s) during the primary study XPF-009-301, which in the opinion of the investigator and sponsor's medical monitor, would preclude the subject's entry into the OLE study.
* A clinically significant condition or illness, or symptoms other than those resulting from KCNQ2-DEE, present at screening/baseline that, in the opinion of the investigator, would pose a risk to the subject if s/he were to enter the study.
* Any conditions that were specified as exclusion criteria in the primary study, XPF-009-301.
* It is anticipated that the subject will require treatment with at least 1 of the disallowed medications during the study.
* Any change in cardiac rhythm or atrioventricular conduction in the primary study that, in the investigator's opinion, is a significant risk to subject safety.
Deep Enhanced Imaging in Stroke and Vascular Neurology

To investigate the performance of enhanced computed tomography (CT) or magnetic resonance (MR) imaging by deep learning relative to conventional CT or MR imaging in brain stroke and vascular neurology. We expect that the deep enhanced imaging method can shorten the time stay in the imaging session of stroke patients, optimize the overall imaging quality and improve the patients' care in imaging session.

Early diagnosis of cerebral infarction, detection of ischemic penumbra, evaluation of collateral circulation and identification of vascular lesions by imaging are critical for treatment decision and outcome improvement in cerebral stroke. Multimodal computed tomography (CT) and magnetic resonance (MR) imaging are most prevalent and accessible approaches in clinical scenarios. These two approaches are downgraded either by radiation exposure or long scanning time which may hinder the rapid treatment for patients. Deep learning has shown substantial achievements in medical imaging enhancement. The added value of deep learning method in stroke and vascular neurology has not been thoroughly validated. In this study, we aimed to investigate the performance of enhanced computed tomography (CT) or magnetic resonance (MR) imaging by deep learning relative to conventional CT or MR imaging in brain stroke and vascular neurology. We expect that the deep enhanced imaging method can shorten the time stay in the imaging session of stroke patients, optimize the overall imaging quality and improve the patients' care in imaging session.

Eligibility Criteria:
Inclusion Criteria:

* suspecting to have experienced stroke or cerebral ischemia and needed to undergo brain imaging and vascular imaging including CT or MRI
* no history of kidney failure
* a minimum age of 18 years
* obtained written informed consent

Exclusion Criteria:

* severe movement artifacts
* incidental finding of tumor lesion or craniocerebral surgery history
* poor imaging failed to perform deep learning method
* women who pregnancy
Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
* Age 7-18 years
* Enrolled in the ImproveCareNow (ICN2) registry
* Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.

  * Potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist.

Exclusion Criteria:

Complex and Unstable IBD:

* Currently or within the past 9 months has had an abscess, fistula, stricturing CD, or ostomy
* Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of \>45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of \>60 assessed within three weeks of enrollment
* Ever had history of full colectomy
* Hospitalization or surgery planned within 3 months
* Ongoing active gastrointestinal infection
* Severe Malnutrition (BMI less than 5th percentile)
* Recent medication changes including:

  * Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment
  * Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment
  * Vedolizumab started within 16 weeks prior to enrollment
  * Increase in corticosteroids within 4 weeks of screening or have dose \>20 mg prednisone or equivalent

Evidence of Other Complicating Medical Issues:

* Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
* Serious psychological or psychiatric conditions such as eating disorders or self-harm
* Pregnancy
* Tobacco, alcohol, or illicit drug abuse

Inability to Complete the Protocol

* Non-English speaking participants
* On SCD or modified SCD anytime within 8 weeks of enrollment

  * If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study.
* Participants on a vegan diet
* Lack of smart phone and data plan for participating caregiver
* Participating in another concurrent intervention study
Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test

A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI).

A study on patients in preterm labor for whom the managing physician plans to perform amniocentesis to evaluate for possible infection using conventional, currently available methods. Vaginal fluid will be collected and analyzed and amniotic fluid will also. These tests will be run remotely and not reported to the clinician.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. Subject has singleton gestation
3. Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
4. Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:

   1. Cervical dilation \> 2cm
   2. Cervical length of ≤25 mm via transvaginal ultrasound
5. Subject has onset of contractions was within 48 hours of enrollment in the study
6. Subject has documented intact amniotic membranes
7. Subject's care provider plans to perform an amniocentesis procedure -

Exclusion Criteria:

* 1. Subject has documented ruptured amniotic membranes 2. Subject has a fetus with major fetal or genetic anomaly or chromosomal aneuploidy 3. Subject has maternal or fetal indication for preterm birth (e.g., pre-eclampsia) 4. Subject is unable to provide written informed consent 5. Subject has evidence of non-reassuring fetal heart rate tracing requiring immediate delivery 6. Subject has vaginal bleeding within the past 24 hours 7. Subject has advanced labor (cervix \>4 cm dilated) 8. Subject has HIV, hepatitis 9. Subject has not been enrolled previously in this study and/or is participating in another study (that in the opinion of the Investigator) may interfere with participation in this study
Effects of tDCS and VNS on Postoperative Analgesia

This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery.

Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.

Patients will be divided in the following comparison groups:

* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Two nonpharmacologic interventions have shown promise in treatment of chronic pain. Afferent Vagus nerve simulation (VNS) can modulate nociception, even though the exact mechanism is unclear. Clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. Alternatively, transcranial direct current stimulation (tDCS) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tDCS has also been shown to modulate chronic pain and has been shown to produce EEG signatures similar to those seen in states of adequate intraoperative analgesia.

This study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups:

* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Patient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia

Exclusion Criteria:

* cardiac bradyarrhythmia: taking beta-blockers;
* patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
* pregnancy
* history of epilepsy or seizures.
* patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass
Add-on Low Dose Dextromethorphan and Memantine in Patients With Amphetamine-type Stimulants Use Disorder

The current study will investigate whether add-on dextromethorphan (DM) and memantine (MM) is able to improve the treatment outcomes for ATSUD, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.

In current study, we will conduct a randomized double-blind placebo-controlled study. We will recruit 100-120 patients with ATSUD in three years and allocate them to add-on low dose dextromethorphan and memantine (DM 30mg/day+MM 5mg/day) or placebo group in a 1: 1 ratio (patients will also undergo usual psychosocial interventions). We will follow up the participants for 12 weeks and measure the treatment responses, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of add-on DM+MM. Neuropsychological assessments and tests for inflammatory parameters and neurotrophic factors will also be measured during 12-weeks follow up. The study results will show that whether add-on DM+MM is able to improve the treatment outcomes for ATSUD, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of these inclusion criteria to be eligible for enrollment into the study:

1. Signed informed consent by patient or legal representative.
2. Male or female patient aged ≧20 and ≦65 years.
3. A diagnosis of ATSUD according to DSM criteria made by a specialist in psychiatry.
4. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

Exclusion Criteria:

The presence of any of the following will exclude a patient from study enrollment:

1. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
2. Females who are pregnant or lactation.
3. Other major Axis-I DSM-IV diagnosis other than ATSUD, except for tobacco use disorder, ATS induced mood or psychotic disorders.
4. Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
5. History of allergy or intolerable side effects of DM or MM.
6. Suicidal attempts or risks during screen or study period.
7. Presence of active infectious or autoimmune disease.
Effect Of Balance Training With Foot Orthosis On Falling In Elderly

this study will be conducted to investigate effect of balance training with foot orthosis on falling in elderly.

The concept of physiology of ageing implies that a series of complex events occur which ultimately lead to a progressive reduction in function of all organ systems. This process, also called "homeostenosis," is influenced by gene variations and differences in exposure to environmental factors .Reduction in muscle strength and coordination of the lower extremities accompanied by decreased gait assurance and balance control are the result of a physical deterioration in an older body. Together with decreased cognitive functions, these impairments lead to a higher risk of falling among the elderly. The foot is the first point of contact between the body and the external environment, and it plays an important role in postural sway. Its plantar mechanical receptors provide spatial and temporal information about contact pressures and shear forces resulting from body movement being a valuable feedback mechanism to the postural control system. Interventions to optimize sensory information from plantar sole such as vibration stimuli, customized foot orthoses, textured insoles, and sandals with textured insoles and magnetic insoles have been tested before, some of them showing balance improvement .Sixty elderly patients will be allocated randomly to two groups; group 1 will receive balance training program beside orthotic prescription and group 2 will receive orthotic prescription alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-75years
* Both gender
* Body mass index 25-29.9 kg/m2
* All participants will use foot orthosis
* Clinically and medically stable patients
* having a Berg Balance Scale (BBS) score between 35 and 45
* Scored 19-21 will be regarded as being at moderate risk of falling,
* Scored 19-23 in the Tinetti tool score
* Scored more than 13.5 sec in timed up-and-go test

Exclusion Criteria:

* Bedridden subjects.
* Previous vestibular diseases, central nervous system pathologies (such as stroke, dementia, Parkinson, etc.).
* Previous diagnosis of peripheral neuropathy.
* current use of medications affect the result of the study
* Use of insoles in the last month
* Previous history of foot surgery, and amputation of the lower limbs.
* severe foot deformity (not able to wear regular shoes), difficulty in adapting insoles inside his/her own shoes,
* Patient with life threatening disorders as renal failure, myocardial infarction.
* Patients who suffering from myasthenia gravis, hyperthyroidism, haemorrhage, acute viral disease, acute tuberculosis, mental disorders or those with pacemakers.
* Un controlled diabetes, hypertension and smokers
OPTImized RESTing Environments in Rehabilitation

This study investigates whether an individually designed environment can support and improve the quality of daytime resting periods in in-hospital neurorehabilitation of patients suffering severe acquired brain injury.

The effect of a individually optimized resting environment will be tested against a standard resting environment.

Aim:

The aim is to identify differences in quality of rest as reflected by clinical evaluation, pulse rate, motor activity and autonomic balance between the optimized resting environment (ORE) and the standard resting environment (SR).

Method: A Randomized controlled time-series study. Randomization to either SR or ORE for each of the 9 resting periods during a three-day recording session. A period of three days will allow collection of sufficient data. This will also allow the analysis to take the random effects of time and weekday into account. Outcome measures will be differences in mean heart rate during daytime resting periods, aggregated measures of heart rate variability and proportion of resting minutes according to accelerometry.

Eligibility Criteria:
Inclusion Criteria:

* Severe Acquired brain injury
* \>= 18 years
* Relatives/Surrogate can give informed consent
* Classified as being ≤ 7 on the level of cognitive functions scale (also known as Rancho Los Amigos Scale)

Exclusion Criteria:

* Admitted due to polyneuropathies e.g. Guillain-Barré
* Terminal illness
* Spinal lesions
* Expected stay \< 3 weeks
* Paroxysmal Sympathetic Hyperactivity