cyrilzakka/clinical-trials huggingface dataset:
SSVEP Evaluation of Brain Function

The investigational device used in this clinical investigation, the Nurochek Headset, is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a smartphone which processes the signals and transmits them to a secure cloud server for analysis and storage of the data.

The primary objective of this clinical investigation was to evaluate the performance of the investigation device (NCII) against clinical diagnosis and SCAT 5, in the accurate detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion

The aim of this study was to collect data from 100 readings from individuals with concussion. It was estimate that approximately 10-20% of baselined players would suffer a concussion during the season. There it was estimated there would be a need to baseline 500-1000 individuals in order to achieve the number of concussions required. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were required from sporting clubs, medical clinicals and schools.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 14 years and older, participating in sport-related activities.

Exclusion Criteria:

* Individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.
Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

The objective is to assess the effect of simvastatin on immunology, inflammatory, and coagulation responses, and mortality in elderly with pneumonia based. The primary outcome is mortality event.

The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia.

Elderly patients diagnosed with pneumonia after getting information and signing informed consent will be included in this trial. Simvastatin 20 mg will be administered to intervention group, while control group will receive placebo. Both groups will receive drugs (or placebo) for 30 days.

Baseline data will be collected within 24 hours after admission. Then the subject will be followed up for 30 days. At the 7th day, patients will be underwent several laboratory tests, i.e. serum TNF-α (Tumor Necrosis Factor alpha), IFN-ϒ Interferon gamma), CRP (C-Reactive Protein), and PAI-1 (Plasminogen Activator Inhibitor-1). Death from all causes until 30 days will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with pneumonia

Exclusion Criteria:

* Severe septic condition
* Hepatic Cirrhosis
* Acute coronary disease
* Total cholesterol which is too high or too low
* In anticoagulant therapy
* In steroid therapy or other immunosuppressant therapy
* Have refused to join the study
Primary Care-based Program to Enhance Positive Parenting Practices

The objective of this research is to conduct a small randomized pilot study to evaluate the feasibility of Sit Down and Play (SDP), a brief, low-cost program delivered in the primary care setting to enhance parent-child interactions and explore potential impacts on parenting behaviors.

Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and school readiness among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty.However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive intervention to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Parent is 18 years or older
* Child is present for a 2, 4, or 6 month well-child visit
* Adult present with child at appointment is parent/caregiver of child

Exclusion Criteria:

* Parent is non-English speaking
* Child is acutely sick
Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients

The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke.

Reseachers will compare the virtual reality device plus the usual treatment to usual treatment to see if virtual reality device works to recovery upper limb function.

Participants will be able to receive conventional treatment or virtual therapy plus conventional treatment 5 days a week for 4 weeks.

When they are discharged, they will come to the hospital 2 times to be reviewed, 3 months and 1 year after receiving treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke confirmed by neuroimaging.
* No previous stroke.
* Subacute phase (between 1 and 6 months after the stroke).
* Ability to sit with or without support.
* Maximum 4 on the Muscle Strength Scale (MRC) for shoulder flexion and flexion-extension of the elbow of the upper limb on the affected side.
* Ability to understand and accept study procedures and to sign an informed consent having been previously informed.

Exclusion Criteria:

* Previous history of brain injury, stroke and neurological or neuropsychiatric diseases.
* Cognitive alterations, dementia, aphasia or other alteration that causes inability to understand the meaning of the study.
* Clinical inestability
* Loss of visual capacity that difficults recognizing figures on the screen.
* Orthopedic conditions involving upper limbs.
* Refusal to participate in the study.
A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®).


Eligibility Criteria:
Inclusion Criteria:

* Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure(BP), Pulse rate (PR)), 12-lead Electrocardiogram (12-lead ECG), and clinical laboratory tests without any clinically significant abnormalities.
* Age of 18 to 35 years (inclusive).
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
* Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of BI 425809 and until 30 days after trial completion:

  * Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom.
  * Sexually abstinent.
  * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment).
  * Surgically sterilised (including hysterectomy).

Exclusion Criteria:

Subjects will not be allowed to participate, if any of the following general criteria apply:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
* History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation

Implementation of perineural catheters may lead to infection by catheter colonization. Catheters may be colonized by the bacteria present on the skin. This is most often commensal organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often silent because in the same study only 3% of patients had signs of local inflammation and one psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci (61%) and gram negative bacillus (21.6%).

Potential interest of alcoholic Chlorhexidine 2% to reduce the colonization of implanted catheters More recently, it is the antiseptic solution that has been the subject of several studies, including the latest on laying intravascular central catheters, highlights the superiority of alcoholic chlorhexidine 2% compared to povidone iodine alcohol \[ 5\]. Indeed, it was observed a reduction in the risk of bacterial infection 6 (RR 0 • 15, 95% CI 0 • 05-0 • 41) and of colonization by 5 (RR: 0.18 (95% Cl 0.13-0.24) through the use of alcoholic chlorhexidine with 2% applicator.

Such a study comparing the efficacy of the antiseptic (chlorhexidine vs Povidone-iodine) on the establishment of perineural catheters does not exist what motivated the establishment of our study.

Eligibility Criteria:
Inclusion Criteria:

* Patient classified I, II or III by the American Society of Anesthesiology
* Perineural catheterization use for pain management
* Patient should have an orthopaedic surgery

Exclusion Criteria:

* An allergy to povidone iodine
* An allergy to alcoholic Chlorhexidine 2%
* Pregnant women
* Breastfeeding women
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions

This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions.

In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

PARIET is a registered trademark of EISAI Co. Limited.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, age 18 to 55 years, inclusive.
* Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).
* Medical demographics without evidence of clinically significant deviation from normal medical condition.
* Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
* Subject does not have allergy to the drugs under investigation.

Exclusion Criteria:

* Subjects with known allergy to the products tested.
* Subjects whose values of BMI were outside the accepted normal ranges.
* Female subjects who were pregnant, nursing or taking birth control pills.
* Medical demographics with evidence of clinically significant deviation from normal medical condition.
* Results of laboratory tests which are clinically significant.
* Acute infection within one week preceding first study drug administration.
* History of drug or alcohol abuse.
* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
* Subject is on a special diet (for example subject is vegetarian).
* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
* Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
* Subject has a history of severe diseases which have direct impact on the study.
* Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
* Subject intends to be hospitalized within 6 weeks after first study drug administration.
* Subjects who, through completion of this study, would have donated more than 500 milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 ml in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.


Eligibility Criteria:
Inclusion Criteria:

* Infection with genotype 2 or 3 HCV infection
* Cirrhosis determination
* Individual is treatment-experienced
* Screening laboratory values within defined thresholds
* Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
* Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
* Excessive alcohol ingestion or significant drug abuse
Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Vitamin D use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for involvement of the vitamin D receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.

Patients with ESRD have a high incidence of acute phase inflammation. Studies have shown that C-reactive Protein (CRP) and interleukin-6 (IL-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. Both uremia and the dialysis process itself contribute to this inflammatory state. It is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.

Eligibility Criteria:
Inclusion Criteria:

1. CKD and receiving hemodialysis for greater than or equal to 3 months
2. Age greater than or equal to 18 years
3. Medically stable
4. AVF or PTFE dialysis access
5. No acute inflammatory disease within 4 weeks prior to study
6. On an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study
7. Two consecutive iPTH of 150-400 (biPTH 75 - 200) =/- 30% one week apart
8. Ca \<10.2 mg/dL; PO4 \<7.0
9. Kt/V greater than or equal to 1.2
10. On no other interventional drugs/devices in the past 30 days

Exclusion Criteria:

1. Currently receiving dialysis using a venous catheter access
2. Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
3. Pregnancy
4. Hospitalization within the last 4 weeks. -
Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery

To identify the potential serum and radiological biomarkers with regard to neonates undergoing abdominal surgery, and to further evaluate the prognostic value of these markers.

First, the investigators will collect serum biomarkers in neonate patients receiving abdominal surgery. Then the investigators will identify the characteristics and change of biomarkers expressed in neonate patients before and after abdominal surgery. The investigators will further evaluate the prognostic value of these markers for neonate patients receiving abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age up to 18 years old
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Without written informed consent
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.

This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation 24 0/7 -33 0/7 weeks'
* Diagnosed with preterm premature rupture of membranes:

  * History consistent with ruptured membranes (ie leaking, gush of fluid)
  * Sterile speculum exam with pooling
  * Fluid positive for ferning and/or nitrazine
  * With or without confirmatory test such as Amnisure

Exclusion Criteria:

* • Contraindication to azithromycin

  * Active labor, abruption, chorioamnionitis at enrollment
  * Other contraindication to expectant management of PPROM at enrollment
the Effect of Reiki Application on Depression, Anxiety and Physical Activity in Patient With Multiple Sclerosis

During Reiki application, individuals may report feeling a slight warm sensation under and near the therapist's hand. The only rule in Reiki practice is that the individual must give permission to the practitioner to facilitate the flow of energy. The person receiving Reiki during the application does not have to believe in Reiki. Because Reiki is universal life energy and is available to everyone. Reiki is generally safe and no serious side effects have been reported. Reiki practice in the last 10 years; It is increasing among physicians, nurses and other healthcare professionals.

This study was planned to investigate the effect of reiki application on depression, anxiety and physical activity in individuals diagnosed with Relapsing-Remitting Multiple Sclerosis.

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Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Having the ability to use technological devices
* Not using Reiki and similar integrative treatment methods
* No verbal communication disability (hearing and speaking)
* Not having a diagnosed psychiatric disorder
* Patients who have been receiving Relapsing-Remitting MS treatment for more than three months

Exclusion Criteria:

* Patients using any complementary alternative treatment methods
* Patients who cannot communicate by phone to participate in remote reiki application
* Patients with autoimmune diseases other than multiple sclerosis
* Patients with communication disabilities
* Patients with another known neurological system disease (dementia, Alzheimer's, etc.).
Using Virtual Reality Before Transcranial Magnetic Stimulation for the Treatment of OCD

This study will focus on the use of Virtual Reality (VR) technology in patients receiving treatment using Transcranial Magnetic Stimulation (TMS) for Obsessive-Compulsive Disorder (OCD)


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old
* Patients must have been clinically evaluated by a Yale Interventional Psychiatry Service physician who has deemed them appropriate to receive TMS for the treatment of OCD
* Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

Exclusion Criteria:

* Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
* Difficulty in understanding spoken or written English
* Pregnancy
* History of seizure disorder
* Unable to provide informed consent
* Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
* Any implanted medical device, risk of interference with which by the VR device in the investigator's judgment can put patient at additional undue risk.
* Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
* Was previously enrolled/randomized into the study