cyrilzakka/clinical-trials huggingface dataset:
Maternal Outcomes Following Manual Lysis of the Placenta.

Comparison of maternal outcomes following manual lysis of placenta 15 vs 30 minutes after delivery. A primary outcome of the drop in hemoglobin will be compared between the two groups. Secondary outcomes include maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Women undergoing spontaneous term vaginal delivery with epidural analgesia will be randomly assigned into one of two groups: 1. manual lysis of placenta 15 minutes after delivery. 2. waiting 30 minutes and then manual lysis of placenta. Both groups will be managed actively during the 3rd stage of delivery, including oxytocin administration and controlled cord traction. Women who develop active bleeding will be promptly treated with manual lysis and excluded from the study. Manual lysis will be performed under epidural analgesia, and prophylactic antibiotics will be administered. Primary outcome of comparison between the two groups: hemoglobin drop after delivery. Secondary outcomes include: maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Eligibility Criteria:
Inclusion Criteria:

* Term spontaneous vaginal delivery.
* Singleton Pregnancy.
* Epidural Analgesia during delivery.
* Age between 18 and 45 years.

Exclusion Criteria:

* Active bleeding after delivery that warrants prompt removal of placenta regardless of time from delivery.
* Vacuum Extraction.
* Intrapartum Infection.
* Intrapartum fever above 38 degrees celsius.
* Wide 3rd and 4th degree perineal tears that mandate suturing under general anaesthesia.
* Thalassemia Carriers.
Gender and Proper Size of Oropharyngeal Airway: Pilot Study

The purpose of this study is to assess the adequacy of mask ventilation with the different sized-oropharyngeal airway.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing surgery that requires general anesthesia

Exclusion Criteria:

* anticipated difficult intubation
* patients without teeth or with loose teeth
* cervical spine disease
* body mass index over 35 kg/m2
* pregnancy
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.


Eligibility Criteria:
Inclusion Criteria:

* Serum urate level:

  * \>= 7.0mg/dL in patients with gouty nodule or with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL
* Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type
* Outpatients

Exclusion Criteria:

* Gouty arthritis within 14 days before randomized allocation
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease
* Kidney calculi or clinically significant urinary calculi
* AST: \>= 100 IU/L or ALT: \>= 100 IU/L
* eGFR: \< 30 mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg or diastolic blood pressure: \>= 110 mmHg
Liposomal Bupivacaine Pharmacokinetic Study After Median Sternotomy Incision Infiltration in a Pediatric Cardiac Surgery

The purpose of the study is to determine the plasma concentration of bupivacaine at various time points after Exparel (bupivacaine liposome injectable suspension, Pacira Pharmaceuticals, Inc., Parsippany, NJ) is injected subcutaneously for median sternotomy incisions in pediatric cardiac surgery patients.

To determine the pharmacokinetic profile and peak bupivacaine plasma concentration with the use of an Exparel/bupivacaine mixture in children ages two through seventeen (Cohort I). Cohort II covers ages 2 \<6. We will be collecting blood samples at different times during 96 hours or until the patient is discharged from the hospital. There will be two different groups participating in the study alternating the times in which the blood samples will be collected. We hypothesize that peak plasma concentration will be significantly less than the toxic plasma concentration.

Eligibility Criteria:
Inclusion Criteria:

* Every elective pediatric surgery patient ages two through seventeen years old, inclusive.

Exclusion Criteria:

* Patients who fall outside of the age range for the study will be excluded. -Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. Any with Significant Liver Disease will also be excluded. Emergency patients will be excluded. Pregnant patients will be excluded.
Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain

This is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing

Ketamine is a unique anesthetic with neural effects that are distinct from more commonly-used γ-aminobutyric acid agonists. Evidence suggest that analgesic effect of ketamine is primarily related to the affective than the sensorial aspects of pain interpretation. The investigators investigated whether ketamine, a noncompetitive NMDA antagonist, would modify the perceived emotional valence of pain-related words when compared to non-pain-related ones in healthy volunteers. Using a single session double-blind parallel placebo-controlled design, 24 healthy volunteers were randomized to receive intravenous S-ketamine (n=12) or placebo (n=12). During infusion (plasmatic target of 60 ng/ml), the effects of ketamine were recorded using EEG and oddball behavioral data was monitored. Evoked potentials (N200 and P300 components) were recorded during performance of a semantic written word oddball task containing pain-related (targets) and non-pain-related words (standards). Expected results: The findings of this study can help in the understanding of neurophysiologic mechanisms involved in ketamine's effects both in psychiatric diseases as in the treatment of postoperative acute and chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* male healthy subjects with higher education level

Exclusion Criteria:

* do not understand Portuguese language
* obese patients (BMI \> 27 kg/m2)
* use of NSAID, steroids, analgesics, anticonvulsant drugs, as well as alpha and beta-blockers
* score ≥ 13 on Beck II Questionnaire
* sleep deprivation in the night before evaluation
BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m\^2 (inclusive)
3. Negative SARS-CoV-2 serology test
4. Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)

Key Exclusion Criteria:

1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when receiving the study drug; or interfering with the interpretation of data
2. Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that has been resected with no evidence of metastatic disease for 3 years
3. Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study
4. Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to type 1 diabetes mellitus, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease
5. Previous receipt of a licensed or investigational biologic agent (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before the randomization

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exoskeleton Robotic Assisted Gait Training in Spastic Stroke Post Botulinum Toxin a Injection

The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A(BoNT-A) injection with exoskeleton Robotic assisted gait training (RABT) in patients with post-stroke stiff-knee gait.

The aim of the study is to evaluate the effects of BoNT-A combining with overground exoskeleton robot for patients with post-stroke stiff-knee gait.

Stiff-knee gait (SKG) is a common gait pattern in patients after stroke, characterized by limited knee flexion (KF) during the swing phase of walking. Botulinum toxin A (BoNT-A) injection in rectus femoris muscle is considered the gold standard procedure to treat SKG.

Patients with this gait pattern would reduce walking speed, cause toe dragging, compromise the stability of walking, increase risk of falling, and interfere with daily activities. This randomized controlled trial will contribute to the accelerated refinement and development of efficient and effective treatment programs for patients with post-stroke spastic stiff knee gait. The Robot-assisted gait training (RAGT) has the potential to be an optimal adjunctive therapy following BoNT-A treatment. Combinations of BoNT-A and rehabilitation training are suggested to optimize the treatment effect for spasticity related disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke ≥ 3 months
* Age ≥ 20 years
* Functional Ambulation Category ≥4
* Affected rectus femoris spasticity (MAS between 1+ and 2)
* BoNT-A treatment-naive or treated with BoNT-A ≥4 months in the affected leg before recruitment
* Receiving oral muscle relaxants or other medication for spasticity were on a stable dose for≥2 months
* Can obey simple order

Exclusion Criteria:

* Pregnant
* Sensitivity to BoNT-A
* Infection of the skin, soft tissue in the injection area
* Participation in other trials
* Fixed contractures or bony deformities in the affected leg
* Previous treatment of the affected leg with neurolytic or surgical procedures (i.e., phenol block, tendon lengthening of transfer, tenotomy, muscle release, arthrodesis)
* Severe cardiovascular comorbidity (i.e., recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)
Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter?

To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.

Laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. US and/or abdominal CT scans are obtained as clinically necessary to make the diagnosis of appendicitis. All of the appendectomies are initiated laparoscopically. Postoperative orders are controlled via a standard electronic order set for all operations.

Patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /On the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. On the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy.

Exclusion Criteria:

* Patients with a documented allergy to any of the medications in the trial.
* Those with an abscess identified by computed tomographic (CT) scan before surgery are not included in the study
Repeat Sternotomy for Pediatrics

Given the relative lack of information regarding the risks associated with repeat sternotomy in the pediatric patient population, a preliminary screen of the Children's Cardiothoracic Surgery Database was performed to determine how many repeat sternotomies have been performed at this institution within the last 4 years. A total of 1281 repeat sternotomies were identified during this time period.

We propose a retrospective review of the indications, potential risk factors, and short-term outcomes for these procedures. These data would allow a multivariable regression analysis to identify risk factors associated with adverse events during repeat sternotomy.

Median sternotomy is the most common approach for cardiac surgery in adults and children. While the initial sternotomy is rarely associated with adverse events, the risks associated with repeated sternotomies for subsequent reoperations may be higher. This increased risk is primarily due to adhesions securing cardiac structures to the sternum, thus placing those structures at risk for injury during sternal re-entry. There have been several large studies examining the frequency and impact of adverse events during repeat sternotomy in adults. Roselli and colleagues from the Cleveland Clinic reviewed 1853 consecutive repeat sternotomies and found a 6.8% incidence of serious adverse events. 1 This study can be contrasted against the report of O'Brien and colleagues which reviewed the results of 546 repeat sternotomies performed over 21 years in Brisbane, Australia with only 9 (1.6%) minor cardiac injuries and no major adverse events. 2

The pediatric cardiac surgical field is somewhat different from the adult realm in that re-operations are more common, either due to planned, staged palliation requiring multiple operations or the expected failure of implanted conduits and valves which subsequently require replacement. However, while the incidence of repeat sternotomy is higher in the pediatric population, the overall number of patients is considerably smaller, so there has been a relative dearth of information in the literature regarding the risks and outcomes associated with repeat sternotomy. The largest series reported was published by Russell and colleagues in 1998 and included only 192 repeat sternotomies performed on 165 patients. 3 The authors reported a 5.2% incidence of cardiac laceration with selective utilization of femoro-femoral bypass to decompress the heart during repeat sternotomy for "higher risk" patients.

Eligibility Criteria:
Inclusion Criteria:

* Repeat sternotomy at Children's Healthcare of Atlanta between 1.1.02 and 12.31.06
* patient under 21 years of age
* "repeat" is defined as a sternotomy performed more than 1 month after the most recent previous sternotomy

Exclusion Criteria:

* Those charts that do not meet inclusion criteria
Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.

Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common pathologies, which are treated surgically.

Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of typical symptoms and an evocative clinical examination. Provocative tests performed in consultation include the Tinel and Phalen sign for the carpal tunnel, and the Tinel and prolonged flexion sign for the ulnar nerve at the elbow.

The Scratch Collapse Test (SCT) has recently emerged as a new provocation test to help diagnose nerve compression in the upper limb.

This non-invasive, pain-free test looks for a reduction in the force of external rotation of the shoulder by applying resistance (the doctor's arm), before and then after a sensory stimulus by "scratching" the area of compression. Nevertheless, this test remains controversial and not based on objective measurements.

Our aim is therefore to assess shoulder external rotation force, and thus TBS, objectively with a dynamometer, before and after stimulation in cases of median nerve compression syndrome at the carpal tunnel and ulnar nerve compression syndrome at the elbow, when these are clinically and electromyographically proven.

This test has already been studied in the literature, but the results in terms of sensitivity and specificity are highly disparate. One study has already published negative results on the subject, with the limitation that the trial was monocentric.

Through this multicenter study, principal investigator wish to highlight the very probable subjectivity of the SCT when it is performed. As the resistance is applied by the physician's arm, the investigator cannot determine the force applied against the patient, unlike with a measurement object. The principal investigator expects this study to refute the notion that external shoulder rotation force decreases after trigger zone stimulation in cases of proven nerve compression syndrome.

The results of this study will thus make it possible to discontinue the use of this technique if it does not help in the diagnosis of compression.

The literature shows a lack of prospective, objective studies involving a large number of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security plan
* Patient who has received informed information about the study
* Patient of legal age
* Patient with ulnar nerve or carpal tunnel compression confirmed by EMG during preoperative consultation

Exclusion Criteria:

* Recurrence of nerve compression
* Any history that may affect arm sensitivity
* Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)
Wiser Choices in Acute Myocardial Infarction

Patients who are hospitalized because of a heart attack are prescribed a number of medicines to help the heart heal. The investigators will examine different ways in which clinicians share information about those treatment options with patients and the impact that this can have on patients' choices and health.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 90
* Hospitalized at Saint Marys Hospital
* A primary diagnosis of AMI,
* Have heart rate, blood pressure, troponin and creatinine measurements,
* There is an intention to offer treatment medications
* Are able and willing to provide informed consent

Exclusion Criteria:

* Have not had a myocardial infarction
* Have significant cognitive, visual impairment,
* Non-English speaker
* Have a Do Not Intubate/Do Not Resuscitate (DNI/DNR) status
* Will be discharged to a nursing home
* AMI is not the presumptive diagnosis
Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.

The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.

Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalised for chest pain and potential acute coronary syndrome.
* Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
* Females must be either surgically sterile or post-menopausal.
* Activated Clotting Time (ACT) \</= 300 at the time of study treatment

Exclusion Criteria:

* Participation in another clinical study with an investigational product during the last 30 days.
* Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
* Any contraindication to ticagrelor, clopidogrel or bivalirudin.
* ST elevation myocardial infraction within 24 hours of study entry.
* Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
* Planned use of omeprazole or esomeprazole.
* Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
* Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed.
* Use of Intravenous (IV) heparin less than 2 hours before procedure.
* Sustained uncontrolled high blood pressure