cyrilzakka/clinical-trials huggingface dataset:
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery

This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group.

266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day.

It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.

Eligibility Criteria:
Inclusion Criteria:

* ASA Status I-III
* Scheduled to undergo primary unilateral total knee arthroplasty

Exclusion Criteria:

* Patients who are pregnant or nursing
* Alcohol or narcotic dependence within the last 2 years
* Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
* BMI \> 40kg/m2
* Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
* Allergies to amide-type local anesthetics
* Any disease condition or lab result that could complicate a patients postoperative recovery
* History of hypotension
* Abnormal liver, renal or cardiac function
* Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.
Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block

The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia.

This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open abdominal surgeries in the early postoperative period regarding pain relief After approval of the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal surgeries were included in the study, and were divided into three groups (n=22; each); group M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of 10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20 ml bupivacaine plus 5 ml 0.9% NaCl.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* aged 18 to 65 years
* body weight ≥ 60 kg and ≤ 90 kg
* scheduled for open abdominal surgeries

Exclusion Criteria:

* Patients' refusal to participate in the study
* history of allergy to the medications used in the study
* hepatic disease
* renal disease
* known neurologic disorders
* psychiatric disorder
* chronic treatment with calcium channel blockers
* hyper-magnesemia
* coagulopathy
* anatomical abnormalities
* hemodynamic instability
* local infection
* suspected intra- abdominal sepsis
Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients

Diabetes mellitus is associated with negative outcomes in patients undergoing surgery. Blood sugar levels are monitored by measuring a values that include but are not limited to hemoglobin A1c, capillary blood glucose, and fructosamine . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.

This study aims to compare the predictive capacity of both fructosamine and HbA1c on preoperative basal glucose level, as well as adverse events (cardiovascular events, surgical site infection, and mortality) and length of post-anesthesia care unit (PACU) stay in both Type I and Type II diabetic patients. Secondary outcomes include length of anesthesia administration, an indicator of intraoperative complications, and perioperative glucose level.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients able to consent.
2. Patients with either Type I or Type II diabetes mellitus (DM)
3. Patients undergoing non-cardiac surgeries under general anesthesia
4. ≥ 18 years of age

Exclusion Criteria:

1. Inability to read, understand or sign the consent form
2. End-stage renal disease
3. Special populations (Incarcerated individuals, pregnant female patients)
Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline

Comparison of two practices of obstetrical services between the CHU of Clermont Ferrand and the HFME Lyon-Bron in the management of arterial hypotension during an elective cesarean section

The investigators propose to carry out a bicentric strict observational prospective study between the maternity of the HFME of Lyon-Bron which uses the mixture ephedrine / noradrenaline with the PSE for many years in service protocol for the management of hypotension for cesarean section under perimedullary anesthesia and the CHU of Clermont-Ferrand which uses baby noradrenaline 10 mcg/mL PSE for this same indication according to an institutional protocol. Patients corresponding to the inclusion and non-inclusion criteria will be recruited by a physician investigator and will give their agreement of non-opposition after having received clear oral and written information about our study. The care will not be modified in any way compared to the usual practices of the service.

Eligibility Criteria:
Inclusion Criteria:

* elective caesarean
* ≥ 18 years old
* term ≥ 36 weeks amenorrhea

Exclusion Criteria:

* contraindication of local anesthetics
* contraindication of spinal anesthesia
* patient's refusal
* patient doesn't talk French
* patient not covered by the social security system
I-InTERACT Preterm

Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (\< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

The investigators will modify I-InTERACT North to reflect United States language and culture and emphasize our focus on neural plasticity and development. The modified intervention will be renamed Building Better Brains and Behavior (B4 Preterm). Then, investigators will conduct a single-arm clinical trial to establish B4 Preterm's feasibility, acceptability and preliminary efficacy in improving child and family outcomes. Additionally, neuroimaging (MRI/DTI) will be collected pre- and post-intervention. The primary neuroimaging sequence will allow the investigators to examine associations between white matter injury and treatment response as well as changes in neural activation and connectivity pre- to post-treatment. An exploratory neuroimaging sequence will also be collected pre- and post-intervention. This exploratory sequence will serve as a backup for the primary sequence in case it is affected by significant motion and allow the investigators to test this sequence in young children.

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment: ages 3-8, inclusive
* Born at \< 32 weeks gestational age
* Total T score of \> 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of \> 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale OR documented behavioral problems noted in medical chart and parent endorses current concerns about child's behaviors
* Language: English must be the primary spoken language in the home

Exclusion Criteria:

Caregiver must be 18 years or older to participate in the intervention. Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings); English is not the primary language spoken in the home. Additionally, caregivers with a psychiatric hospitalization in the past year will be ineligible to participate. Children with certain types of metal in their heads will be unable to participate in the MRI portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires.
Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID

The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.

Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.

Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences.

After the pandemic of covid-19, people found out that not only does it cause acute respiratory system symptoms, but it also affect many other systems even long after the acute symptoms have resolved, which is named the Long Covid Syndrome. Studies have shown that the gut microbiota of those suffering from long covid syndrome differ from that of healthy people and those who recovered from covid without getting long covid syndrome, which implied the possibility of probiotic supplement being an effective treatment to long covid. This double-blind parallel randomized control trail plans to supply participants with probiotics or placebo fortwo months. Symptom questionnaires, cognitive function, eeg and fecal sample will be recorded/collected before and after the supplement. Researchers will compare the two groups to see if they differ in the above measure and to see if the differences in symptoms and cognitive functions change correlate with gut microbiota change and fecal metabolite change.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 80 year old
* had been infected by SARS-CoV-2
* Stable vital signs
* Have brain fog conplaint
* MoCA\<30 at baseline

Exclusion Criteria:

* refuse to join the study or refuse to sign the Informed Consent Form
* have other neurological disease that may affect cognitive function, such as Parkinson disease, Seizure, etc.
* have other gastrointestinal disease that may affect cognitive function, including tumors.
* severe hearing loss or visual loss that may hinder cognitive function tests
* Taken anti-seizure drug in 7 days.
* Already taking probiotics supplement regularly
* Taken antibiotics in two weeks
* taking stool softener or laxative regularly
* have valvular heart disease
* have congenital or acquired immunodeficiency or is under iimmunosuppressant therapy
* Pregnant or plans to be pregnant
* BMI\>30
* Have been performed severe gastrointestinal surgery(s)
* Severe liver, kidney, cardiovascular, hematologic or metabolic disorder
* In critical condition
CONFIDENT: Supporting Long-term Care Workers During COVID-19

The CONFIDENT Study is an online three-arm randomized trial that aims to help long-term care workers in the United States feel more confident about the Coronavirus Disease 2019 (COVID-19) vaccines. The study will compare two different interventions to usual online information (website of the Centers for Disease Control and Prevention). The first intervention is a Dialogue-Based Webinar where people can interact and ask questions about the vaccines. The second intervention is a Social Media Website that will feature curated content about the vaccines from popular social media platforms.

Participants will be asked to completed four online surveys. The first survey will be completed pre-intervention and immediately upon study enrollment (Time 0). Participants will be randomized to a trial arm at the end of the Time 0 survey. Intervention follow-up surveys will be completed 3 weeks post-randomization (Time 1), three months post-randomization (Time 2), and 6 months post-randomization (Time 3).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* can read, write, and understand English
* lives in the United States
* has worked in a long-term care setting in the past two years
* can provide information to confirm they have worked in a long-term care setting
* is not pregnant or breastfeeding
* at least somewhat worried about the COVID-19 vaccines and/or has not received a COVID-19 vaccine booster shot

Exclusion Criteria:

* under 18 years of age
* cannot read, write, and understand English
* does not live in the United States
* has not worked in a long-term care setting in the past two years
* cannot provide information to confirm they have worked in a long-term care setting
* is pregnant or breastfeeding
* less than somewhat worried about the COVID-19 vaccines and has received at least one COVID-19 vaccine booster shot
Confidential Social Network Referrals for HIV Testing

Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential SMS-based social network referrals for HIV testing as a means of reaching high-risk individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5 specific aims:

Aim 1 will conduct qualitative, formative work to identify desirable provider- and client-side characteristics of a confidential SMS-based HIV testing referral system.

Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality.

Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's acceptability, performance, and potential efficacy.

Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled trial.

Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options.

If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing efforts.

No additional detail available

Eligibility Criteria:
Inclusion criteria:

* at least 18 years old
* live, work, or regularly receive care in Moshi, Tanzania
* literate

Exclusion criteria:

* under age 18 years
* does not live, work, or regularly receive care in Moshi, Tanzania
* illiterate
The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients

Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections.

Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored.

Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients.

Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or more
2. Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria
3. Admitted to intensive care unit

Exclusion Criteria:

1. Pregnancy
2. Received steroid treatment
3. Expected dead within 24 hour
4. WBC \< 500/mm3
5. Allergy to DPMAS
6. History of organ transplant
7. Terminal illness with do not resuscitation order
Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese

The purpose of the Deaf Weight Wise study is to test a 16 week, evidence-based, comprehensive program to change obesity-related health behaviors in Deaf people who use American Sign Language (ASL) as their primary language.

Participants will be randomized to one of two study arms - immediate intervention or delayed intervention. In addition to the intervention activities, participants will also take part in five study visits over the course of two years. At these study visits, the investigators will administer several surveys as well as conduct biometric assessments.

The investigators primary hypothesis is that the immediate intervention group will increase their levels of physical activity and reduce their caloric intake and body weight immediately following the intervention, compared to the delayed intervention group.


Eligibility Criteria:
Inclusion Criteria:

* Deaf men and women ages 40-70 years who use sign language and live in the Rochester Metropolitan Statistical Area (MSA), have a body mass index (BMI) of 25-45
* Permission to participate from a primary healthcare provider if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), and 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity 3) self-reported weight loss surgery in the past two years
* Must be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study
* Must be willing and able to attend group sessions and to participate in data collection requirements

Exclusion Criteria:

* Participants who had a cardiovascular disease event in the past 6 months who did not obtain medical clearance from their provider
* Participants who had self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity who did not obtain medical clearance from their provider
* Participants who had weight loss surgery in the past two years and who did not obtain medical clearance from their provider
* Pregnancy, breastfeeding, or planning a pregnancy during the study period (each of which will be determined by subject self-report through an in-person interview with a research team member)
* Those people who are unable or unwilling to provide written, informed consent
* Those people who are unable to see and interact with computer-based questionnaires and educational interventions
Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke

Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second leading cause of dementia and the third leading cause of death in France.

Clopidogrel is one of the recommended first line in the secondary prevention of AIC non cardioembolic origin. However recurrences occur in approximately 9% of patients receiving clopidogrel. Some studies in patients with coronary artery disease have made the connection between these treatment failures and non-biological response to clopidogrel. This non-biological response is found for approximately 30% to 50% of patients. Several mechanisms may explain this non-response. The most accepted mechanism is pharmacokinetic. Indeed, clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP) and a transformation by hepatic cytochrome into active metabolites. The genetic polymorphism of proteins involved in these two steps explain the low plasma concentration of active metabolites and thus the low efficacy of clopidogrel in some patients.

A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response to clopidogrel.

Interest in the biological response to clopidogrel in the AIC is innovative because few data are available in this area. In addition to testing a new pharmacodynamic hypothesis, we also wish to study and compare other measures of platelet function methods in order to be able to use commonly in treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* Consent signed
* Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications
* normal standard biological tests

Exclusion Criteria:

* Need to continue aspirin therapy
* Patients with a recurrence of clopidogrel AIC
* Patient already tacking clopidogrel
* Drugs interfering with the adrenergic system alpha blockers, alpha 2 receptor agonists (alpha-methyldopa) and alpha2 receptor inhibitors (Mianserin, Mirtazapine, yohimbine)
* Contra indication of clopidogrel and / or any of its excipients
Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®

This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.


Eligibility Criteria:
Inclusion:

* Has Eye Symptoms when using video display terminals
* Has a reported history of dry eye in both eyes.

Exclusion:

* Diagnosed with eye infection or active inflammation.
* Has worn contact lenses within the past 7 days or anticipated use during the study.
* Has used any eye drops within 2 hours.
* Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.
* Has used Restasis® within 90 days.
* Has had any eye and or/lid surgeries within 6 months.
* Has had cataract surgery in either eye.
* Has current punctal occlusion or anticipate a change in punctal occlusion status at any point during the study.
* Is currently taking any topical ophthalmic prescriptions or over-the-counter solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the trial duration.
* Use of medication known to cause ocular drying that is not on a stable dose for at least 30 days.
Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax

The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.

Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP without capnothorax. PEEP requirement and lung mechanics without capnothorax will be compared with a historical cohort population of robotic surgery with capnothorax.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing uniportal robotic lung resection under no capnothorax

Exclusion Criteria:

* Refusal to participate
* Contraindications to recruitment maneuvers