cyrilzakka/clinical-trials huggingface dataset:
Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery

This study evaluates the addition of tramadol, or nefopam or opioid to paracetamol and ketoprofene in the treatment of pain in adults after shoulder ambulatory surgery. In a first step, 30 patients will receive tramadol as rescue analgesia in combination with paracetamol and ketoprofene, while the other will receive nefopam or opioid in a sequential analysis that will be performed every 20 patients using the QoR 40 survey.

Multimodal analgesia using acetaminophen with non steroidal anti inflammatory is commonly used for pain relief after ambulatory surgery. Tramadol achieves pain relief when rescue analgesia is needed after this surgery, but induces side effects (nausea, vomiting, discomfort, sleep disorder...). Other drugs could be used to reduce the side effects of tramadol and improve postoperative experience : nefopam or opioid (immediate or delayed release medication). Using a survey that describes pain, comfort, emotion or physical status (QoR 40), the investigators analyse the impact of various multimodal strategies using tramadol or nefopam or opioid that is necessary to improve postoperative experience.

Eligibility Criteria:
Inclusion Criteria:

* shoulder surgery
* under general anesthesia with an nterscalenic block
* written informed consent
* age \> 18 years

Exclusion Criteria:

* age \< 18years
* emergency surgery
* refusal
* drug or opioid abuses
A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)

The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications:

  * Fresh fracture of the radial head which is not amendable to an adequate -steosynthesis
  * Post-traumatic deformity or arthroses
  * Failed open reduction internal fixation (ORIF)
  * Failed conservative radial head fracture treatment
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information / Informed Consent Form
  * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  * Signed and dated Ethics Committee (EC) / Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

* Active infection at the affected elbow
* Any not medically managed severe systemic disease
* Pregnancy
* Prisoner
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
SIFIB As an Anesthesia Method for Lower Extremity Surgeries

The Ultrasound-guided Supra-inguinal Fascia Iliaca Block (SIFIB) is an advanced regional anesthesia technique strategically directed at the three primary nerves of the lumbar plexus. As the scope of regional anesthesia methods continues to grow in clinical application, this approach emerges as a versatile method. It can be used independently for pain management or as the primary anesthetic method, particularly in well-selected patients undergoing isolated limb surgeries or in combination with other regional anesthesia approaches.

The study follows a retrospective cohort feasibility design, conducted within the confines of a tertiary hospital. The requisite data for analysis was acquired by accessing patient records and electronic data systems. A cohort of 16 patients was carefully chosen for inclusion in the study, and the administration of blocks was carried out before the surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients who underwent elective lower limb surgical procedures.

Exclusion Criteria:

* Patients who received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded.
ClearView Predicate Comparison Testing

This study serves as a comparison study between the EPIC ClearView and a predicate device.

The EPIC ClearView is a galvanic skin response (GSR) measurement system that is intended to be used to determine autonomic response as psychological indicators by measuring the electrical resistance of the skin. The EPIC ClearView is a non-invasive digital bioelectrography instrument that is used to assess the electrophysiology of humans. The measurements are digital photographs taken in a brief exposure to an electric field. These measurements are quantified to produce a standardized Response Scale.

Eligibility Criteria:
Inclusion Criteria:

* Sex: Male or Female.
* Age range: 18 to 85.
* The subject is able to understand and provide signed consent for the procedure.
* Every effort will be given to balance subjects by gender, age, and race.

Exclusion Criteria:

* Subjects \< 18 years in age or \> 85 years in age.
* Inability or unwillingness to provide informed consent.
* Subjects with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body.
* Subjects missing all or part of any of their fingers.
* Subjects with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.
Open Bifurcation Surgery Study

Different cross clamping techniques in aortic surgery causes different cardiac stress


Eligibility Criteria:
Inclusion Criteria:

* AAA \> 5cm

Exclusion Criteria:

* emergency cases
Magnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety

The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea (OSA).

Magnap is a magnet-activated treatment for obstructive sleep apnea (OSA) designed to be less invasive than reconstructive surgery, more tolerable than positive airway pressure, and more effective than non-invasive therapies for OSA. The Magnap device consists of a neodymium-iron-boron rare earth magnet with a ferromagnetic directional back-plate encased in titanium. The device will be implanted surgically on the hyoid bone. Following surgery, the patient is fitted with a custom, removable external neck accessory containing a second magnet, which is worn during sleep and prevents airway collapse by attracting the internal hyoid magnet with sufficient force to keep the airway open .

Eligibility Criteria:
Inclusion Criteria:

* Patient is between 21 and ≤70 years of age
* Subject has moderate to severe obstructive sleep apnea (defined as apnea-hypopnea index of 15-50 events/hour on baseline/screening polysomnogram)
* Subject is intolerant of positive airway pressure therapy (defined as \<2 hours of sleep time with use per night for at least 5 nights per week as measured objectively by evaluation of continuous positive airway pressure (CPAP) machine memory chip and interpreted by the study sleep medicine specialist)
* Subject signs and dates a written informed consent form and indicates understanding of the study procedures and risks

Exclusion Criteria:

* Any evidence that apnea is not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
* Any condition likely requiring MRI or has a metal implant
* Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of a long-term implanted device
* Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to Magnap treatment
* Congenital anomalies of the larynx, pharynx, or trachea or any other anatomical abnormality of the head, neck, or chest that would be a contraindication to placement of the Magnap device and usage of the external device
* There are no exclusion criteria based on gender, race or ethnicity
Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.

Eligibility Criteria:
Inclusion Criteria:

* hip osteoarthritis requiring a total hip replacement
* \>18 years old
* agrees to participate

Exclusion Criteria:

* total hip replacement not indicated
* general anesthesia contraindicated
* previous surgery on the ipsilateral femur
* follow-up not possible
Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.

OBJECTIVES:

* Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine.
* Document the safety profile and tolerability of this regimen in these patients.
* Phase I: Patients receive high-dose cytarabine IV over 3 hours followed by clofarabine IV over 2 hours on days 1-5. Treatment repeats for up to 4 courses (1-2 induction courses, 2-3 post-remission courses) in the absence of disease progression or unacceptable toxicity.

A cohort of 3-6 patients receives the starting dose of clofarabine. If 1 of 6 patients experiences dose-limiting toxicity (DLT), a subsequent cohort of patients receives clofarabine at the next higher dose. If ≥ 2 of 6 patients experience DLT, the dose of cytarabine is reduced and subsequent cohorts of patients receive cytarabine at reduced doses and clofarabine as per the dose-escalation scheme above.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)

  * No M3 AML
* Meets 1 of the following criteria:

  * In first relapse
  * In second relapse after a second complete remission (CR) that lasted ≥ 3 months
  * Refractory to initial induction therapy
* No symptomatic CNS involvement

PATIENT CHARACTERISTICS:

* ECOG performance status ≤ 2
* Creatinine \< 2 mg/dL
* Bilirubin ≤ 2 mg/dL
* AST and ALT ≤ 4 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
* Ejection fraction ≥ 45% by echocardiogram
* No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
* No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
* No other severe concurrent disease that would preclude study treatment

PRIOR CONCURRENT THERAPY:

* At least 1 week since prior therapy and recovered
* No other concurrent chemotherapy

  * Hydroxyurea to control WBC count before starting study treatment allowed
* No concurrent corticosteroids unless used for diseases other than leukemia
* No concurrent palliative radiotherapy
* No concurrent growth factors (e.g., epoetin alfa, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\]) in patients with AML
Clinical Outcomes Following Primary Intracerebral Hemorrhage

The investigators design an observational multi-center cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalized adult patients with primary intracerebral hemorrhage.

This cohort was an analysis based on patients from six stroke centers: the 2nd Affiliated Hospital of Zhejiang University; the First People's Hospital of Pinghu, Jiaxing; the First People's Hospital of Taizhou; the People's Hospital of Haiyan, Jiaxing; Tiantai County People's Hospital, Taizhou; the 2nd People's Hospital of Quzhou (Please see more information of this cohort in supplement). All hospitals are located in Zhejiang Province. Patients' data were entered by local trained registrars using standardised protocols, and the overall process of case registration, monitoring of the data quality, and inquiry and correction of erroneous data was managed and supervised by a steering committee.

We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures. We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS \>2 before the current ICH episode (according to past medical records or description from guardians.

This study was approved by human research ethic committees at all participating centers, and conducted in compliance with the principles set forward by the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

- We included adult patients who (1) admitted for primary ICH ; (2) underwent blood routine test (hemoglobin included) and CT scan as soon as they arrived at hospital; (3) were not treated with neurosurgical procedures.

Exclusion Criteria:

* We excluded patients who (1) had ICH secondary to known causes, including trauma, intracranial neoplasm and systemic diseases12, as well as anticoagulative agents; or had isolated intraventricular hemorrhage (IVH); (2) mRS \>2 before the current ICH episode (according to past medical records or description from guardians.
Taste of Medicines in Children

Some but not all children will refuse to take medicine because of its taste, which can lead to substantial worsening of disease, antibiotic resistance, increased health care costs, and even death. The investigators are systematically assessing individual variation in the taste of liquid clindamycin among genotyped pediatric patients prescribed clindamycin for standard of care treatment, to determine whether (1) genetic variation underlies differences in taste ratings of the antibiotic; (2) initial taste responses, genetics, or both predict likelihood of side effects and medication non-adherence.

Taste plays an integral role in whether a child accepts a medicine. Some children will like the taste of a given medicine and complete the full course of treatment, whereas others will strongly reject its taste, suffer taste-modulated side effects, or both. This study will systematically measure initial palatability and reactions to the first dose of an antibiotic (clindamycin, liquid formulation) by pediatric patients who are receiving clindamycin as part of their standard of care treatment. Saliva will be collected from all patients for GWAS. Taste response, tolerance of the medication, adherence and clinical outcomes will be assessed. Subjects will be followed to determine if they complete the prescribed medication regimen (adherence) and/or experience side effects (tolerability). Because medication-specific side effects have patient-specific variability, the investigators will determine whether the child's initial taste responses, genes, or both predict subsequent side effects and medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* Children age 3 to 12
* Child being treated in Children's Hospital of Philadelphia
* Being prescribed clindamycin liquid
* Parental/guardian permission (informed consent) and if appropriate, child assent
* Parent age 18 or older, or a minor permitted by state law to consent for their own participation and for the participation of their child
* Parent must have primary responsibility for the patient including biologic parents and adoptive parents (if legally allowed to consent to research)
* Parent must be English speaking and able to understand study materials

Exclusion Criteria:

* Unwilling or unable to produce saliva sample
Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery

We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does by using high resolution impedance manometry. We expected that the patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.

Background: More and more older patients required to receive orthopedic surgery recently. The intubation or supraglottic airway device are required to maintain airway during general anesthesia. Previous studies only reported the subjective swallowing discomfort feeling, however, the objective data was limited. The high-resolution impedance manometry could detect the swallowing muscle power changes with multiple pressure sensors and impedance channels.

Objectives: we aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does Patients and methods: The patients receive orthopedic surgery with older than 60 years old. They received high resolution impedance manometry examination at preoperative day, in the post-anesthetic care unit, postoperative day 3 to 7 (pick a day) along with subjective questionnaires. We also followed the IDDSI guideline to test different viscosity of the patients' tolerance for food.

Expected result: The patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.

Eligibility Criteria:
Inclusion Criteria:

* The patients receive orthopedic surgery with older than 60 years old including 60 years old.

Exclusion Criteria:

* The patients had severe major organ dysfunction
Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints

This study will examine the activity of 2 different doses of PF-06273340 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen
Impact of Mandibular Canal Trajectory on Paresthesia After Inferior Alveolar Nerve Lateralization

This prospective cohort study aims to investigate the relationship between mandibular canal trajectory and the duration of postoperative paresthesia in patients undergoing inferior alveolar nerve lateralization. The study will assess mandibular canal trajectory using anatomic factors and evaluate nerve sensory function using subjective and objective tests. Implant success criteria will also be assessed. The study will be conducted on patients who underwent IANL due to mandibular atrophy and were unable to receive standard or short implant placement. Data will be collected at regular follow-up visits up to 1-year post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atrophied posterior mandible with less than or equal to 6 mm of bone over the inferior alveolar canal
* No previous grafting or implant surgery at the site where nerve lateralization is planned
* No neurosensory impairment
* No contra-indications for implant surgery

Exclusion Criteria:

* Patients who have undergone radiotherapy in the associated area
* Patients using bone-modifying agents
* Smokers with daily consumption of more than ten cigarettes
* Patients with neurosensory impairment due to trauma, tumor, or cancer
Effects of Palatinose™ on Weight Management and Body Composition

The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy at the time of pre-examination
* Subject has a BMI of 25 - 35 kg/m² and motivated to lose weight
* Subject is aged 18 - 60 years at the time of pre-examination

Exclusion Criteria:

* Person suffers from an acute or chronic disease
* Person has known dietary restrictions or allergies to Foods
* Intake of medications which interfere with body composition, appetite, satiety or food intake
Catheter Ablation of Longstanding Persistent Atrial Fibrillation

This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.

Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with longstanding persistent atrial fibrillation (lasting for\>1 year)
* Exhibited refractoriness to at least one antiarrhythmic drug
* Left atrial diameter \<=60mm

Exclusion Criteria:

* Patients with uncontrolled congestive heart failure
* Having significant valvular disease and/or prosthetic heart valve(s)
* With myocardial infarction or stroke within 6 months of screening
* With Significant congenital heart disease;ejection fraction was \<40% measured by echocardiography
* Allergic to contrast media
* Contraindication to warfarin or heparin
* Severe pulmonary disease e.g. restrictive pulmonary disease
* Chronic obstructive disease (COPD)
* Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography
* Having any contraindication to right or left sided heart catheterization
* Poor general health
* Life expectancy less than 6 months