cyrilzakka/clinical-trials huggingface dataset:
The EBC Recovery Study

The purpose of this research study to find out if clinically unconscious acute brain injury patients that show brain activation to music and language on electroencephalogram (EEG) (bedside test) have better outcomes and wake up in the future.


Eligibility Criteria:
Inclusion Criteria:

For ABI Participants

* ABI adult (18 years and older) patients who are admitted to the intensive care unit
* Unconscious with Glasgow Coma Scale (GCS) \&lt;8 on presentation and unable to follow bedside commands.
* A negative COVID-19 test on arrival

For Healthy Volunteers:

* 18 years and older

Exclusion Criteria:

For All Participants:

* \&lt;18 years of age
* Pregnant woman
* Patients with cardiac arrest on presentation
Markers of Atrial Cardiopathay

Marker of atrial cardiopathay as apredictor value of ischemic stroke

detection of the presence of atrial dysfunction or atrial cardiopathy and its degree among patients complaining of palpitation, with a one-year follow-up for any cardioembolic events (stroke /TIA).

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of palpitation referred for Holter monitoring

Exclusion Criteria:

* • Valvular AF, moderate to severe mitral/ tricuspid/ aortic stenosis or regurgitation.

  * Recent myocardial infarction within 3 months.
  * Acute pulmonary embolism.
  * Newly onset AF during or shortly after cardiac surgery.
  * Specific type of cardiomyopathy such as cardiac amyloidosis, obstructive hypertrophic cardiomyopathy.

Decompensation stage of organ failure
Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age

This clinical trial will assess nutritive effects on brain myelination in infants assigned to receive one of two study formula or mother's own breast milk through 18 month's of age.


Eligibility Criteria:
Inclusion Criteria:

* Singleton birth
* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
* Birth weight of 2500 g (5 lbs 8 oz) or more
* Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent obtained for infant's participation in the study
* Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through 18 months of age

Infants receiving formula:

* 3 to 60 days of age at randomization, inclusive (day of birth is considered day 0)
* Exclusively receiving infant formula for at least 72 hours prior to randomization
* Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Infants receiving human milk:

* 150-180 days of age at registration, inclusive (day of birth is considered day 0)
* Mother has intention to predominately provide mother's own breast milk through at least 10 months of age

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* First degree relative with known autism, intellectual disability, schizophrenia, or bipolar disorder or an inherited disorder of myelination
* Major pre- and/or perinatal issues (such as maternal pre-eclampsia, placental abruption, maternal alcohol or illicit drug use during pregnancy)
* Major delivery complications (such as neonatal hypoxia or neonatal illness requiring a greater than 2-day NICU stay)
* Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
* 5 minute APGAR \< 7
* Infant was born large for gestational age (LGA) (as confirmed by the hospital birth records) from mother who was diabetic at childbirth
* Infant has been identified with inadequate weight gain or failure to thrive by a health care professional (HCP)
* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
* Parent(s) or legal guardian unable to speak English at a level to provide informed consent

Infants receiving formula:

• Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization

Infants receiving human milk:

• Use of infant formula and/or donor milk more than three times per week prior to registration
Comparative Noninvasive Continuous Cardiac Output by the Clearsight® With Invasive Monitoring by PICCO® in Abdominal Major Surgery

In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the transpulmonary thermodilution and the arterial waveform analysis in the radial artery by PICCO®.

This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by ClearSight® with the transpulmonary thermodilution and the arterial waveform analysis in radial artery by PICCO® in abdominal major surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo major abdominal surgery
* Patients monitored by a PICCO® device

Exclusion Criteria:

* Patients with heart rhythm disorder
* Patients with Raynaud's disease or vasculitis
* Emergency surgery
* Significant edema fingers
MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 2 through 17 years of age
* Absolute Neutrophil Count (ANC) is below 500/microliter
* Have persistent fever (at least 4 days) despite antibiotic therapy
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.

At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl \~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.

Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.

At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and write in English and provide informed consent
* 18 years or older of age at screening
* Weighs \>= 45 kg (\~99 lbs)
* Satisfies DSM-5 criteria for childhood onset fluency disorder
* History of stuttering for \>=2 years with onset consistent to developmental in nature
* Must meet an allowed severity of stuttering at screening and baseline, scored by a central rater
* Completed an adequate course of speech therapy
* Has a qualifying IOS or Android smartphone
* Must discontinue all medications used to treat stuttering for at least 14 days prior to screening
* Sexually active females of child bearing potential must be using effective contraception during and 30 days after participation
* Sexually active males must use a double barrier method of contraception during and 30 days after participation

Exclusion Criteria:

* Stuttering is related to a known neurological cause
* Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline
* Unstable medical illness or clinically significant abnormalities on screening tests/exams
* At a significant risk of committing suicide
* Are pregnant or lactating
* Positive urine drug screen
* Lifetime history of major depressive episode
* History of seizures
* Have been previously treated with ecopipam
* Unstable use of medications prior to screening
* Use of prohibited medications or need for medications which would have unfavorable interactions with ecopipam
* Not suitable for study in the opinion of the Principle Investigator
Acute Kidney Injury in Children Operated for Congenital Heart Disease

The purpose of this study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia ("remote ischemic preconditioning") could protect children operated for congenital heart disease from developing acute kidney injury.

Remote ischemic preconditioning (RIPC) refers to an intervention of remote, brief ischemia which confers systemic protection against consequences of reperfusion injury in distant organs. RIPC has been shown to protect various organs during major surgeries. Our hypothesis was that RIPC could protect kidney function in children operated for complex congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Children admitted for surgery for congenital heart disease

Exclusion Criteria:

* heart surgeries of low complexity such as closure of septal defects, aortico-pulmonary windows, establishment of glenn shunts, subaortic membrane resection, redirection of anomalous pulmonary veins, valvotomies, repair of pulmonary artery stenosis and surgeries without the use of extracorporeal circulation
Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis

The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* Male or female patients, 18 to 75 years of age,
* Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
* Clinico-pathological remission of EoE,
* A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
* Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria:

* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
* History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus,
* Patients with PPI-responsive esophageal eosinophilia
* Achalasia, scleroderma esophagus, or systemic sclerosis,
* Other clinically evident causes than EoE for esophageal eosinophilia,
* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]),
* Any relevant systemic disease (e.g., AIDS, active tuberculosis),
* If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
* Liver cirrhosis or portal hypertension,
* History of cancer in the last five years,
* History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit,
* Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
* Existing or intended pregnancy or breast-feeding.
BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Patients with recent PMR(6 months or less) with a PMR-AS \>17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included.

Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment.

No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion.

From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age
* Fulfilling ACR/EULAR criteria for PMR
* Disease duration ≤6 months
* No oral or parenteral steroid since ≥ 2 weeks prior to randomization
* PMR-AS \>17
* Absence of connective tissue diseases or vasculitis
* Able to give informed consent

Exclusion Criteria:

* Clinical symptoms of giant cell arteritis
* Uncontrolled high blood pressure or cardiovascular disease
* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
* Planned major surgical procedure during the study.
* History of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease).
* Current active uncontrolled infection
* Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
Evaluation of an Entrepreneurship Program for American-Indian Youth

This study will use a randomized controlled design to evaluate whether a youth entrepreneurship/life-skills intervention for reservation-based American Indian adolescents (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes from baseline for up to 3 years follow-up as compared to a recreational sports league control condition.

Intervention activities will be held over a 3 night/4 day residential camp and 6 weekend workshops during the academic year. The control condition will consist of a recreational sports league held on 3 Saturdays, also during the academic year.

Eligibility Criteria:
Inclusion Criteria:

* American Indian ethnicity and primary residence within the Fort Apache Indian Reservation.
* Participants must be 13-15 years old, enrolled as a student at one of the participating high schools, and must have parent/guardian consent for participation in the study.

Exclusion Criteria:

* Youth that are currently enrolled in foster care will not be eligible to participate in the study.
* Those unable to participate in any of the evaluation assessments or intervention components will also be excluded.
Comparison of Emergence/Dysphoric Reaction Frequency of Using 2 Different Doses Ketamine

The aim of this study is to compare the effect of using different doses of ketamine on producing dysphoric reaction.

Our study is a randomized single-blind observational study. In our study, the effect of producing a dysphoric reaction will be observed by administering ketamine at doses of 0.5 mg/kg and 1 mg/kg to two randomly randomized different groups who presented to our hospital and needed interventional sedation analgesia. For this reason, our patients with an indication for interventional sedation and analgesia will be taken to the observation room and their vital values will be monitored. Two different vascular accesses with at least 18 gauge will be obtained from the two extremities. The patients will be randomized and 0.5 mg/kg IV ketamine will be given to the 1st group. The second group will be given 1 mg/kg IV ketamine. Then, the patients will be recorded in terms of blood pressure, pulse and saturation at the 5th minute, 15th minute and 30th minute. We will give iv ketamine to two different patient groups as 0.5 mg per kilogram in the 1st group and 1 mg per kilogram in the 2nd group and we will observe the patients.We scored the patients between +4 and -5 points on the RASS scale. Patients who were sedated to an extent that they could not be awakened were scored as -5, patients who were dangerously agitated +4, and patients who were awake were scored 0. We considered patients who scored +2 on the Richmond agitation sedation scale as having developed a dysphoric reaction.

Eligibility Criteria:
Inclusion Criteria:

* Glaskow coma scale should be 15
* Inability to speak, read or understand English or Turkish
* Patients needing procedural sedation and analgesia

Exclusion Criteria:

* Patients with active coronary artery disease
* Patients with liver or kidney transplant
* Patients with conditions that change consciousness such as substance intake, alcohol intake
* Patients with advanced COPD or Heart failure
Study of PBI-0451 in Healthy Subjects.

This is a phase 1, placebo-controlled, blinded, randomized, dose escalation study of PBI-0451 in healthy subjects. PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. The study is designed to evaluate the safety, tolerability and pharmacokinetics of PBI-0451 after single and multiple ascending doses and also to explore drug-drug interaction potential of PBI-0451.

Combined Three part, double blind, (sponsor open) study. Part 1: Single ascending dose study. Part 2: Multiple ascending dose study. Part 3: Drug-drug interaction study.

Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking, healthy male or female subjects aged 18-59 years.
2. Body Mass Index (BMI) of ≥ 19.0 and ≤ 30.0 kg/m2.
3. 12-Lead electrocardiogram (ECG) evaluation without clinically significant abnormalities.
4. Normal renal function, including having a creatinine clearance (CLcr) ≥90mL/min
5. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
6. Screening laboratory assessments must be without clinically significant abnormalities as assessed by the investigator.

Exclusion Criteria:

1. Pregnant and lactating females
2. Have received any investigational drug (or vaccine) within the last 30 days prior to study dosing.
3. Have a positive test result for HIV or HBsAg.
4. Have poor venous access that limits phlebotomy
5. Have taken any prescription medications or over-the-counter medications, including herbal products and dietary supplements within 28 days prior to start of study.
6. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or is expected to receive these agents during the study.
7. Have a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
8. Have a history of significant drug sensitivity, cardiac disease, syncope, palpitations, or unexplained dizziness, implanted defibrillator or pacemaker, liver disease, severe peptic ulcer disease, gastroesophageal reflux disease and a medical or surgical treatment that permanently altered gastric absorption.
9. Have received inactivated vaccinations within 4 weeks prior to randomization or receive live vaccinations within 4 weeks of Screening.
10. Received the COVID-19 vaccine either within 7 days or have not completed the series of required 2 doses.
11. Have a history of excessive alcohol use or other illicit drug use within 6 months of screening.
Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion

The purpose of this study is to examine the influence of extremity manipulation on individual's center of pressure after they adapt to an ankle based illusion.


Eligibility Criteria:
Inclusion Criteria:

* No previous surgeries
* Not knowingly pregnant
* No neuromusculoskeletal injuries or systemic diseases that could affect an individual's ability to stand on an incline for 3 minutes with their eyes closed.

Exclusion Criteria:

- Weight over the force plate operating limit of 440 lbs
Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery

Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery


Eligibility Criteria:
Inclusion Criteria:

* Scoliosis patients

Exclusion Criteria:

* None
Effect of Xalacom® (Latanoprost/Timolol) and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. The main focus of glaucoma is still directed towards a decrease in IOP. There is, however, also considerable interest whether antiglaucoma drugs influence ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of innovative techniques have been realized which cover different aspects of ocular perfusion. In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan® (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as their ocular hemodynamic effects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years
* Unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with IOP between 22 -35mmHg
* At least 3 reliable visual field testings
* 4 weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors

Exclusion Criteria:

* History of acute angle closure
* Closed or barely open anterior chamber angle
* Mean deviation of visual field testing \> 10
* Intraocular surgery or argon laser trabeculoplasty within the last six months
* Ocular inflammation or infection within the last three months
* Contact lenses
* Patients with bradycardia (heart rate \< 50 beats/min)
* Second and third degree heart block
* Asthma
* COPD
* Congestive heart failure
* Severe renal impairment (creatinine clearance \< 1.8 L/h)
* History of hypersensitivity to one of the study drugs or drugs with similar chemical structure
* Topical or systematically/oral therapy with steroids
* History of non-IOP responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues
* Pregnancy