cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Impact of Two Dexmedetomidine Dosages Added with Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Inguinal Hernia Repair

The principal outcome assessed was the duration until the initial request for analgesia post-surgery. The secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. Pain levels, measured using the Visual Analogue Scale (VAS), were evaluated at rest and during movement at many intervals following surgery (1, 6, 12, and 24 hours). The study also observed postoperative complications, such as emesis, hypotension, bradycardia, and pruritus.

One of the most frequently performed surgical procedures worldwide is the repair of an open inguinal hernia, with a postoperative pain severity of moderate to severe affecting over 60% of patients. Post-surgical analgesia frequently employs a multifaceted approach, incorporating oral pharmacotherapy and regional anesthetic procedures. Opioids are a conventional option for postoperative pain management; nevertheless, their administration is linked to adverse effects such as nausea, vomiting, sleepiness, pruritus, and respiratory depression, which may impede the recovery process. Non-opioid alternatives, however, can improve patient rehabilitation and overall outcomes. The Transversus Abdominis Plane (TAP) block efficiently reduces early postoperative discomfort and decreases narcotic usage, which is a significant advantage for patients undergoing inguinal hernia repair. To alleviate pain in the abdominal wall muscles, peritoneum, and skin, this treatment involves administering a local anesthetic into the space between the transversus abdominis and internal oblique muscles.\]2\[

Eligibility Criteria:
Inclusion Criteria:

* with ASA physical status I or II
* scheduled for elective unilateral inguinal hernioplasty under spinal anesthesia
* aged 18 to 60 years
* both genders

Exclusion Criteria:

patient refusal, BMI ≥ 40 kg/m2 incapacity to engage in pain assessment contraindications to spinal anesthesia (e.g., coagulopathy, skin infection)

- and intolerance to the research medications.
Tegaderm vs. EyeGard for Eye Protection

This study compares TegadermTM and EyeGard® in general anesthesia.

Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Surgeries scheduled for anesthesia of any duration

Exclusion Criteria:

* Any patient that does not consent
* Any patient who has:
* Pre-existing eyelid erythema or other eyelid trauma
* Eyelid piercings
* Any surgery on the head, brain, neck, teeth, mouth, eyes or face
* Surgery in the prone position
* Patients \<18 years old
Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery

The purpose of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students.

Developing objective methodology for assessing technical skill is paramount to superior surgical training. Alternatives to the traditional apprenticeship model of surgical training are necessary in today's emphasis on cost containment and professional competency.

Metrics are widely employed in virtual environments and provide a yardstick for performance measurement. The current method of defining metrics for medical simulation remains more an art than a science. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment will improve their mastery of those skills when tested in that same environment. Fewer studies have been able to document the learning curve for mastery of tasks in a virtual reality simulator. This study will investigate the learning curve for tasks in a virtual reality laparoscopic simulator.

Eligibility Criteria:
Inclusion Criteria:

* Medical students, years 1 through 4 are eligible.
* No prior clinical experience with laparoscopic surgery as the assistant surgeon.
* No prior simulation training (mechanical, PC-based or otherwise).

Exclusion Criteria:

* Persons who are not medical students.
* Medical students with prior clinical experience with laparoscopic surgery as the assistant surgeon.
* Medical students with prior simulation training (mechanical, PC-based or otherwise).
Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain

To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy


Eligibility Criteria:
Inclusion Criteria:

* women scheduled for elective gynecological laparoscopy

Exclusion Criteria:

* psychiatric disease eg. anxiety, depression, etc.
* diagnosed as cancer
* the use of vasoactive drug
* chronic pain except lower back pain
Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)

In the course of a scientific accompanying program, the project pursues the goal of gaining further insight into a possible connection between various influencing factors and the development of postoperative delirium. Against this background, in addition to the primary goal of exploring delirium rates, we aim to identify associations between other secondary end goals like the internal circadian time or the heart rate variability and the occurrence of postoperative delirium. For this purpose, patients of the QC-POD (NCT04355195) sample will be studied.

The project aims to improve the understanding of the internal circadian time (chronotype) and other sleep parameters, as well as further secondary end goals, in relation to the development of postoperative delirium. In the course of this the project would like to investigate the perioperative heart rate variability. Also, the association of perioperative peripheral cholinesterase activity with perioperative heart rate variability and the development of POD will be explored. Additionally, the investigator will analyze the correlation of intraoperative EEG signatures with perioperative heart rate variability, and explore any association of core body temperature and the development of postoperative Delirium.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Male and female patients
* Patients who have been included in QC-POD
* Eligible patients\* for inclusion: informed consent by the patient, preoperatively with verbal and written informed consent before the start of data collection
* Incapacitated patients for inclusion: Written informed consent by a legal representative
* surgery (elective and not elective)

Exclusion Criteria:

* Moribund patients (palliative situation)
* Insufficient knowledge of the German language
* Cardiac arrhythmia (e.g. atrial fibrillation)
* Presence of a pacemaker
* Condition after heart transplantation
* Inflammation in the area of the frontal sinus
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18-70 years (both inclusive) at the time of signing informed consent
* Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
* History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

* Known history of factor IX inhibitors
* Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
* Immunocompromised (CD4+ T cells below or equal to 200/μL)
* Known congenital or acquired coagulation disorders other than haemophilia B
* Body mass index above 35 kg/m\^²
The Effect of Femoral Nerve Block on Postoperative Opioid Use After Anterior Cruciate Ligament (ACL) Reconstruction

This study evaluates the effect of a femoral nerve block on opioid requirements following anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Schedule for primary elective anterior cruciate ligament reconstruction
* Tolerance to bupivacaine
* Tolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
* Informed consent

Exclusion Criteria:

* Patients who received a femoral nerve block more than 1 hour prior to surgery
* Complex associated injuries or pre-existing conditions that will delay time to ambulation
* Children with tibial avulsion fractures
* Allergic and/or sensitive to bupivacaine and/or NSAIDs
* 30% over ideal body weight
* Acute ACL reconstruction (done less than 2 weeks after injury)
* Pre-existing femoral nerve injury
* Psychiatric patients on psychotropic agents
* History of drug or alcohol dependence or recreational drug use
* Refusal to provide informed consent
Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

This study protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).

This is a single-center, prospective randomized open or non-blinded end-point (PROBE) clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups utilizing a dynamic minimization approach. The experimental group with randomization of patients who will undergo awake craniotomy for both high and low grade gliomas in non-eloquent areas or a control group of patients who will have asleep craniotomy for both high and low grade gliomas in non-eloquent regions.

Eligibility Criteria:
INCLUSION CRITERIA

1. Patients with age ≥18 years old.
2. WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI)
3. An elective procedure.
4. A single lesion.
5. No major comorbidities that would necessitate an extended hospital stay.
6. Newly diagnosed tumors.

EXCLUSION CRITERIA

1. Patients with age \< 18 years old.
2. Non-gliomas
3. Eloquent location (motor, sensory, language)
4. Non-elective procedure.
5. Multiple lesions.
6. Major comorbidities.
7. Recurrent tumors.
8. Patients lacking capacity to consent.
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed, written, informed consent
* Male or female subjects, 18 to 55 years of age.
* Subject must have chronic infection HCV, genotype 1.
* Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL
* No prior treatment for HCV.
* Must be negative for hepatitis B (HBV) and human immunodeficiency virus (HIV).
* Must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study.
* No known hypersensitivity to study medication or to drugs chemically related to the study.

Exclusion Criteria:

* Prior treatment with IFN-based therapies and/or anti-viral therapies.
* Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant.
* Reduced kidney function.
* Presence of concomitant liver diseases
* Signs or symptoms of hepatocellular carcinoma.
* Thyroid disease currently poorly controlled on prescribed medications.
* History of hemoglobinopathy.
* Evidence of severe retinopathy.
* Other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse.
* Subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease
* Clinically significant acute or chronic illnesses.
* History of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.
Triple Therapy With Tegoprazan in H. Pylori Positive Patients

The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.

This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori positive based on the screening test
* Peptic ulcer disease

Exclusion Criteria:

* Prior treatment for H. pylori eradication
* Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days
MEthylene Blue In Patients With Acquired Methemoglobinemia

This is an open label, uncontrolled, Phase 4 study including 10 patients who present in hospital/urgent care setting with acquired methemoglobinemia. The population may include pediatric and adult patients (males and females of all ages are included).

The study will run in both the EU and the US. The aim of the study is to confirm safety and efficacy of ProvayBlueTM for the treatment of acquired methemoglobinemia and has been requested by the US-FDA as a Post-Marketing requirements.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric or adult patients (males and females of all ages are included) diagnosed with acquired methemoglobinemia and receiving treatment with ProvayBlue™ as per the treating physician's diagnosis and hospital standard of care.

Acquired methemoglobinemia is defined as a level of methemoglobinemia \>30% or ≤30% in case of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.).

* Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.

Exclusion Criteria:

* Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;
* Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of hemolytic anemia as well as lack of therapeutic effect;
* Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH) reductase.
* Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the study.
* Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of ProvayBlueTM.
Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

The aim of this study is to compare the effectiveness of ESPB versus ISB in anesthesia for shoulder arthroscopy

Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids. Among the various types of regional anesthetic techniques, the interscalene brachial plexus block (ISB) is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.

the interscalene brachial plexus block (ISB) regional anesthesia offers many advantages over general anesthesia for both arthroscopic and open surgeries of the shoulder it provides excellent intraoperative anesthesia and muscle relaxation' as well as analgesia that continues into the postoperative period

Eligibility Criteria:
Inclusion Criteria:

* Patients with Body Mass Index \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* scheduled for elective shoulder arthroscopy

Exclusion Criteria:

* Known allergy to local anesthetics
* Allergy to all opioid medications
* Diagnostic shoulder arthroscopic procedures
* Patients with chronic opioids
* Patients who converted to general anesthesia use and coagulopathy
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals

To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant

Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic hematopoietic stem cell transplant (HSCT). The primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant. If patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of ART. Failure to maintain ART will be defined as ≥ 24 hours without any anti-retroviral therapy.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. Alternatively, two HIV-1 RNA values \> 200 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent may be used to document infection.
* Patients must be ≥ 18 years of age.
* Plan to undergo a Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:
* Plan to undergo a Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:

Exclusion Criteria:

* Patients with a known history of enfuvirtide resistance will not be eligible for this trial.
Characterization of New Phenotypes of Patients with Spinal Muscular Atrophy Treated with SMN Restoring Therapy

With the advent of new treatments for ASI, new phenotypes are emerging. The investigators propose to describe these new phenotypes by prospectively following children with ASI of all types treated with TRS and aged under 16 for 2 years.

The investigators also propose to evaluate potential assessment tools to determine whether they are relevant for monitoring this population, either routinely or for future clinical trials. The investigators also aim to collect the total costs associated with ASI in order to propose a first prospective medico-economic study in France.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed infantile or juvenile spinal muscular atrophy
* Treated with a therapy that restores SMN protein expression (e.g. nusinersen, risdiplam, onasemnogene abeparvovec)
* Aged 0 to 15 years inclusive
* Informed consent signed by both parent(s)/legal guardian(s) and patient's assent
* Affiliated or beneficiary of a health insurance plan\*. \* for inclusion in France

Exclusion Criteria:

* Other condition likely to interfere significantly with ASI assessment and clearly unrelated to the disease
* Other associated neurological disease
* Current pregnancy or breast-feeding (a pregnancy test will also be performed at inclusion).

Please note that patients with a specific contraindication to MRI (i.e. metallic foreign body, claustrophobia and other reasons determined by the investigators) will be allowed to participate in the study, but MRI will not be performed.
Ocular and Cardiac Effects of Battle Ground

Mobile battle ground games are widely used in various age groups, there are ocular and cardiac affection that may affect users of this type of action games.

The aim of this study is to assess the possible ocular and cardiac changes that may affect users of this type of mobile games in real life among various age groups and especially in adults with history of recent corona virus (COVID-19) disease. There is no medical recommendations about the time and the hazards of using this games for longer periods in real practice.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects that are playing or not playing action mobile battle ground games will be included.
* Post COVID-19 subjects with average 6 months of infection and are playing mobile battle. Ground games will be included.

Exclusion Criteria:

* Subjects that refuse to enter the study.
* Users of mobile battle ground games with other diseases that may affect ocular and cardiac assessment as diabetic eye disease, cardiac congenital anomalies or recent cardiac or ocular surgery.
A Study to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body of Healthy Japanese Men

The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.