cyrilzakka/clinical-trials huggingface dataset:
Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications

Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.

Sugammadex and neostigmine are NMBD reversal agents. Neostigmine - an anticholinesterase is given to reverse NMBD; however reversal of NMBD with neostigmine may be associated with residual neuromuscular blockade in up to 64% patients postoperatively in the post anesthesia care unit. Even mild degrees of residual neuromuscular blockade can have serious clinical consequences in the postoperative period. The severity of OSA often worsens after surgery and patients with OSA are at increased risk for early respiratory complications after extubating and in the PACU. Morbid obesity is associated with critical respiratory complications in patients with OSA.

Sugammadex is a newer NMBD reversal agent that rapidly and completely reverses rocuronium. It is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agent rocuronium. It reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. It has been shown to more rapidly reverse residual neuromuscular blockade than neostigmine in obese patients without obstructive sleep apnea (OSA).

This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and other half of the patients will receive neostigmine

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosed Obstructive Sleep Apnea patients by polysomnography
* Scheduled elective bariatric surgery

Exclusion Criteria:

* Age\<18 years old
* Allergy to rocuronium
* Allergy to sugammadex
* Allergy to neostigmine
* Malignant hyperthermia
* Hepatic insufficiency
* Renal insufficiency
* Neuromuscular Disease
* Pregnancy
Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma.

This is one arm, single center non-intervention study. New diagnosed diffuse large B cell lymphoma patients were enrolled to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing, then patients received standard treatment with R-CHOP, R2CHOP and DA-EPOCH by investigate's choice according to the patients pathological characteristics. the basic characteristics and treatment response and progression-free survival and overall survival were collected and analyzed with the gene abnormalities. a total of 100 diffuse large B cell lymphoma patients will enrolled in one year and will finish after 3 years.

Eligibility Criteria:
Inclusion Criteria:

* ECOG PS 0-2;
* histological diagnosed diffuse large B cell lymphoma;
* normal hematological, hepatal, renal function;
* normal heart function with LVEF ≥ 50%;

Exclusion Criteria:

* Diagnosed as a malignant tumor other than lymphoma or receiving treatment, except for the following conditions:

  ①Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred ≥5 years before enrollment;

  ②Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease;

  ③ Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease.
* Heart disease with clinical significance, including unstable angina pectoris, acute myocardial infarction within 6 months before screening.
* Congestive heart failure (NYHA) heart function is graded in grade III or IV (Annex 3)
* Severe arrhythmia requiring treatment.
* Patients with active hepatitis B and HIV infection.
* Women who are pregnant or breastfeeding
* Patients who have received organ transplants in the past
* Patients with severe active infection
* Have a history of severe neurological or psychiatric diseases, including dementia or epilepsy
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX

Immune response to influenza vaccine in kidney transplant patients

Seasonal influenza vaccination is recommended for kidney transplant patients, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. Nevertheless, injection of influenza vaccine induces a protective immune response in only 20% to 40% of patients. Today, there are no recommendations regarding the injection time of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies conducted in healthy subjects have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza, COVID-19. On this basis, we formulate the main hypothesis that the administration of influenza vaccine to kidney transplant patients would be more effective when carried out in the morning than in the evening.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant patient;
* Follow-up at Nice University Hospital;
* Age \> 18 years;
* Indication for influenza vaccination
* Free and informed consent;
* Immunosuppressive treatment including anti-calcineurin and/or Mycophenolate Mofetil (with or without corticoids).

Exclusion Criteria:

* Known hypersensitivity to influenza vaccine or egg proteins;
* Influenza vaccination for the 2023-2024 season already performed;
* Current infection;
* Current acute medical condition;
* Treatment of rejection within the previous 3 months;
* Immunosuppressive therapy including CTLA4 agonist, mTOR inhibitor, complement inhibitor, anti-CD19;
* Polyvalent immunoglobulin infusion within the preceding 3 months;
* Vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French);
* Subjects not affiliated to the Social Security system.
Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions

Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain.

In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the Pressure Sore Status Tool(PSST).


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)
* Injury treated with conventional dressings type gauze and patch
* Patients assisted at the emergency care, or at the outpatient
* Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm)
* Patient age greater than or equal to 18 years
* Patients who have given consent to enrollment in the trial and the processing of personal data
* Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (wash-out) of "no treatment" according to the research protocol

Exclusion Criteria:

* A end-stage of disease
* Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy
* Suspected or known allergic diathesis to the product of medication
* Subjects that do not give consent to data processing
* Dry lesion with necrosis or eschar
* Presence of both local and systemic infection or inflammation
* Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol
* Patient / lesion that has already been previously recruited into the study, before a period of 10 days (wash-out) of suspension from the same research protocol
The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism

The study proposes to investigate whether acute total deprivation affects metabolism as measured through blood and peripheral tissues. Its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation.

It is predicted that acute total sleep deprivation will affect gene expression and DNA methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and affect other neuroendocrine markers and hormones in a negative manner. It is further predicted that sleep deprivation will decrease participants' memory performance.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-28y
* Healthy (self-reported) and not on medication
* Non-smoking
* Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)

Exclusion Criteria:

* Major illness
* Taking any serious medications
* Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
* Any dietary issues with the food items provided
* Current or history of endocrine, neurological or psychiatric disorders
* Shift work in the preceding three months or for a long duration
* Time travel over a significant number of time zones in the preceding two months
* Too much weight gain or weight loss in the preceding three months
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients

To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.


Eligibility Criteria:
Inclusion Criteria:

* adults, male \& female, non-pregnant
* BMI 18.5-29.9

Exclusion Criteria:

* cancer
* HIV positive
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm\^2 on the face or balding scalp.


Eligibility Criteria:
Inclusion Criteria:

* Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm\^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF
* Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
* Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines

Exclusion Criteria:

* Presence in the TF of

  1. Clinically atypical and/or rapidly changing AK lesions in the TF
  2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn
  3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria)
  4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF
  5. Any other dermatological disease that causes difficulty with examination
* Previous treatment with tirbanibulin ointment 1%.
* Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57
* Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit
* Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study

This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.

This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy.

It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* Provided informed consent
* Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months)
* Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management
* Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
* Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 years

Exclusion Criteria:

* Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D
* Concomitant immunosuppression / immunomodulatory therapies
* Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
* Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
* Current Child Pugh class C classification (current Child Pugh score \> 9)
* Other known or suspected cause of chronic liver disease
* Any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.
Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia

The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery (DBS) are not completely understood. The recording data that is used routinely as part of the procedure to map the target structures, however, may be analyzed in order to better understand the neural network dynamics in PD. The purpose of the study is to perform simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus \[STN\] or globus pallidus internus \[GPi\]) and the cerebral cortex. These simultaneous recordings may provide insight in the pathology of PD and the mechanism of DBS. The researchers will also study the effects of anesthesia level on neuron synchronization . Recordings with micro-ECoG grid electrodes in the cortex show improved spatial resolution and these will be used to gain better understanding of cortical network dynamics and the synchronization with subcortical structures.

Subjects will be identified exclusively from the researchers' clinical practice for evaluation of DBS surgical candidacy for Parkinson's disease. Once it is determined that a patient is an appropriate candidate for DBS placement (multidisciplinary team consensus) and has met inclusion criteria,the researchers will discuss the study with the subject and explain the rationale for the study as well as the implications the subject's participation has to their treatment. Informed consent will be obtained prior to study procedures being performed. Subjects will be in the study from the time of enrollment before surgery until all post-operative visits and tests are completed, usually by 6 months after surgery. Follow-up during this time will consist of the standard follow-up schedule that all patients who undergo DBS follow. This includes a clinic visit at 10-14 days, 12 weeks, and 6 months after DBS surgery. Subjects will also have a follow-up neurocognitive evaluation consisting of the same evaluative tests administered pre-operatively. These post-operative visits are standard for all patients undergoing DBS for Parkinson's.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease per Queens Square criteria
* Appropriate DBS candidate for multi-disciplinary team consensus
* Age 18 - 85 years of age
* Motor skills allowing for capability to complete evaluations
* Medically cleared for undergoing anesthesia and DBS surgery

Exclusion Criteria:

* Dementia per DSM-V criteria
* Medical or other condition precluding MRI
* History of supraspinal CNS disease other than PD
* Alcohol use of more than 4 drinks per day
* Pregnancy
* History of suicide attempt
* Currently uncontrolled clinically significant depression (BDI\>20)
* History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.

OBJECTIVES:

Primary

* Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma.

Secondary

* Determine the duration of response in patients treated with this drug.
* Determine tolerability of this drug in these patients
* Determine the tumor expression of the cellular repair mechanisms which repair DNA damage (O6-methylguanine-DNA methyltransferase \[MGMT\] and mismatch repair \[MMR\] systems) in patients treated with this drug.
* Correlate MGMT and MMR expression with outcomes in patients treated with this drug.
* Determine if MGMT and MMR expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug.
* Determine the activity of MGMT in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug.

OUTLINE: This is a multicenter, open label, nonrandomized study.

Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 2 courses. Patients achieving stable or responding disease after completion of the 2 courses may receive up to 10 additional courses of treatment in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven neuroblastoma

  * High-risk relapsed or refractory disease, defined as 1 of the following:

    * Metastatic disease
    * Localized MYC-N amplified disease
    * Localized non MYC-N amplified disease at second relapse
* Measurable primary or metastatic disease by cross-sectional imaging or MIBG scan

PATIENT CHARACTERISTICS:

* Lansky performance status 40-100%
* Life expectancy \> 2 months
* Not pregnant or nursing
* Fertile patients must use effective contraception during the course of this study and for 6 months after study completion
* Organ toxicity \< grade 2
* Platelets ≥ 100,000/mm\^3 (50,000/mm\^3 after stem cell transplant or in case of marrow involvement)
* Neutrophil count ≥ 500/mm\^3
* Bilirubin \< 1.5 times normal
* AST and ALT ≤ 2.5 times normal
* No known HIV positivity

PRIOR CONCURRENT THERAPY:

* More than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose)
* More than 30 days since prior radiotherapy except local palliative treatment for pain control
* No more than 2 prior treatments for neuroblastoma
* No other concurrent investigative treatment for neuroblastoma
Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome

The consumption of fermented soy foods can alter the human microbiome and may confer health benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus ("QC") fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters.

The study will start with a detailed testing of the microorganisms present in the QC fermented soy liquid, using deep sequencing. Subsequently, the researchers will determine the effect of the QC fermented soy product on the microbiome and inflammation in lean and obese individuals, as obese individuals are known to have dysbiosis. The work on inflammatory changes will be supplemented by studies to investigate the cellular and molecular mechanistic pathways responsible for the biological action of QC fermented soy liquid.

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10)
* Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10)

Exclusion Criteria:

* Allergy to soy or soy derivatives.
* Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair).
* History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) and/or gastrointestinal bleeding.
* Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment).
* Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function.
* Patients will be excluded if using medications which are known to be affected by modest dietary changes. This will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin.
* Alcohol use disorder, anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use.
* Major changes in dietary habits in past six months.
* Pregnancy or intent to get pregnant during study period
* Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes within 30 days of enrollment.