cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Age: older than 18 years of age.
* Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine
* Good physical condition as established by clinical examination and history taking at the time of entry.
* Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
* Written informed consent obtained from the subjects

Exclusion Criteria:

* Positive at screening for anti-HBV antibodies
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous participation in any other clinical trial.
* Previous vaccination with an MPL containing vaccine.
* Administration of immunoglobulins 6 months before and during the whole study period
* Vaccination one month before and one month after each dose of the study vaccine
Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site

The purpose of the study is to evaluate the use of a magnetodynamic instrument (Magnetic Mallet®, Metaergonomica, Turbigo, Italy) to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.

From October 2019 to May 2022, a sample of 15 patients, 11 men and 4 women, age between 39 and 78 years, was analyzed. A total of 18 conical-shaped implants with a diameter of 3.80 mm and a length between 10 and 11.5 mm were inserted in the maxillary region in the area between the lateral incisor and the first upper molar. The patients were treated by two different surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Patients with maxillary mono-edentulism between the lateral incisor and the first upper molar with a bone crest measuring between 4-6 mm;
* Insertion of conical implants with dimensions 3.80 x \> 10 mm;
* Correct occlusal relationships between upper and lower jaw;
* Patients willing to cooperate and follow the instructions given by the clinicians.

Exclusion Criteria:

* Smokers \> 15 cigarettes per day;
* Patients with systemic diseases;
* Irradiation to the head/neck region within 12 months prior to surgery;
* Pregnancy or breastfeeding;
* Poor oral hygiene and lack of motivation to return for checkups;
* Edentulous area for less than 1 year;
* Edentulousness of the lower jaw.
ReSTOR Natural +3.0D Study In Japan

The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.


Eligibility Criteria:
Inclusion Criteria:

* Planned bilateral cataract removal by phacoemulsification
* Potential postoperative best corrected visual acuity of 0.5 or over
* 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Exclusion Criteria:

* Poorly controlled glaucoma
* Progressive diabetic retinopathy
Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting

This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures

A history of PONV risk factors will be recorded. After consenting, patients will be assigned using a computerized randomization function to Ringer solution (group R) or 5% dextrose (group D) or control group (group C). Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia. Group R will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia. Group C will receive no fluids. The anesthesia providers, surgeons, perioperative nurses, postanesthesia care unit (PACU) nurses and investigators will be blinded to group assignment throughout.

As for pre-medication, all patients will receive IV midazolam (0.02 mg/kg). Anesthesia will be induced with propofol (1.5-2 mg/kg), fentanyl (1-2 μg/kg) and atracurium(o.5mg/kg) to facilitate endotracheal intubation. The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2/air. Intraoperative IV maintenance fluid will be standardized at 3 mL/kg/h with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased \&gt;20% from baseline. For postoperative pain relief, paracetamol 1 g will be given I.V. during surgery in all patients and continued orally after operation (1g every 6 h). In addition, all patients will be ambulated within 6 h after completion of surgery. Standardized antiemetic and analgesic rescue medications will be available. Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2; 1 dose of rescue medication when the VRS score is 3 to 6; and ≥2 doses for nausea score of 7 to 10, to reduce the nausea score to 0 to 2.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients scheduled for elective laparoscopic gynecological/hysteroscopic procedures will be considered for inclusion
* ASA physical status I and ll.

Exclusion Criteria:

* patients with a previous history of PONV.
* Patients with motion sickness, coagulopathy, diabetes mellitus, or severe hypertension
* patients with cardiac, renal or hepatic dysfunction.
* patients receiving an antiemetic agent within 24 h before surgery or cases where complications occurs during the surgery
* patients who have abnormal blood glucose on the night before surgery
* patients who are unable to understand and use the verbal rating scale (VRS);Growth developmental, and motor-mental retardation.
Evaluation of Clinical Airway Assessments With a Gray Zone Approach

Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity of pre-existing airway assessment tests and scoring system using a gray zone approach in patients undergoing general anesthesia required endotracheal intubation.

POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)

Eligibility Criteria:
Inclusion Criteria:

* 20 to 80 years old patients undergoing general anesthesia for any operation.

Exclusion Criteria:

* previous difficult airway history
* upper airway obstruction disease
* congenital disorders that are known to relate with difficult airway
* neurologic symptom associated with neck extension
* emergent operation
National Covid-19 Surveillance Physicians

The investigators will analyze the presence of antibodies against SARS-COV2 in physicians working in emergency and intensive care medicine and in those who treat Covid 19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Qualified as physician

Exclusion Criteria:

* none
Cardiac Power Output in Cardiogenic Shock Patients

The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.

This study is designed as a prospective, observational, crossover study to assess the feasibility of using differences in invasive hemodynamics of cardiac function, representing myocardial reserve, to predict clinical outcomes for heart failure patients. Patients with heart failure referred for right heart catheterization (RHC) by the advanced heart failure team as part of 1) evaluation for advanced heart failure therapies, including left ventricular assist device (LVAD), orthotopic heart transplant (OHT), temporary or long-term inotrope therapy, or counter-pulsation (temporary intra-aortic balloon pump (IABP) or long-term with NuPulse device), 2) for accurate assessment of invasive hemodynamics due to worsening clinical status, 3) assessment of myocardial recovery for consideration of LVAD or NuPulse decommissioning or removal or mechanical circulatory support removal, or 4) accurate assessment of cardiac function in patients with reduced LVEF prior to valve replacement for aortic insufficiency (AI) or mitral regurgitation (MR).

Eligibility Criteria:
Inclusion Criteria:

1. LVEF ≤ 35%
2. Referred for RHC for:

   1. Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR
   2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR
   3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR
   4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI
3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
4. Age ≥ 18 years-old
5. Intent for admission based on RHC data

Exclusion Criteria:

1. eGFR \< 30 ml/min/1.73 m2
2. Severe, non-revascularized coronary artery disease
3. Concurrent acute coronary syndrome
4. Age \< 18 years-old
5. History of significant ventricular arrhythmia without an ICD
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy.

* The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
* The secondary objective of this study is to assess the peri-operative clinical outcomes of robotic- assisted single incision cholecystectomy with da Vinci Single - Site Instruments™ in comparison to a multiport laparoscopic approach.
* The third objective of this study is to evaluate hernia incidence at 1 year and 18 months after surgery

Eligibility Criteria:
Inclusion Criteria:

* Patient between ages of 18- 80 year
* Patient with symptomatic gallbladder disease
* Patient willing to participate in this study and able to provide informed consent

Exclusion Criteria:

* Patient pregnancy
* Emergency patient
* Patient with acute cholecystitis
* Patient with upper midline visible abdominal scars or keloid
* Presence of umbilical hernia , or prior umbilical hernia repair
* Inability of patients to tolerate Trendelenberg position or pneumoperitoneum
* Patient with cirrhosis
* Patients with mental impairment that preclude giving informed consent
Postoperative Analgesia After Total Knee Arthroplasty

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.

The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted consecutively to primary total knee arthroplasty.
* Provided informed consent

Exclusion Criteria:

* Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
* Severe chronic neurogenic pain
* Medical treated diabetes
* Contraindications for spinal aesthesia and epidural analgesia
* Known hypersensitivity towards study drugs
* Rheumatoid arthritis
* Treatment with narcotics
* Treatment with antidepressants
* Severe obesity BMI\>35
* Treatment with antacid
* Not able to speak and understand Danish
Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance

Severe hemoptysis is a life-threatening condition, with an unpredictable course. The efficacy of bronchial artery embolization (BAE) is well established for the treatment of severe hemoptysis, with short and long-term bleeding controls obtained in 70 to 100% and 50 to 90% of cases, respectively. As complications related to vascular interventional radiology may occur in 5 to 10% of cases, the benefit-risk balance might be less clear in acute hemoptysis of mild-to-moderate abundance (volume between 100 and 200 ml) and no criteria of severity (respiratory failure or hemodynamic instability). There is no available data comparing the safety and efficacy of BAE combined with medical measures to those of medical measures alone in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance.

The study is a multicentric (n=8) randomized study, involving two parallel groups of patients with non-severe acute hemoptysis of mild-to-moderate abundance, related to a systemic bronchial or non-bronchial hypervascularization, and comparing the bronchial artery embolization combined with medical measures and the medical measures alone in this field.

The primary aim of the study is to evaluate the efficacy of BAE combined with medical measures in the treatment of non-severe acute hemoptysis of mild-to-moderate abundance, as compared with that of medical measures alone, by assessing the percentage of recurrence of hemoptysis at one month. Bleeding recurrence is defined as a volume of blood expectorated of at least 50 ml.

The second objectives of the study are to compare the efficacy of the two strategies at 3 months and to assess the safety of both strategies during hospitalization and follow-up.

Based on a previous study of our group (Reference 8), the number of patients in each group is 105, assuming a one-month bleeding recurrence rate of 11% in the group receiving BAE, as compared with 26% in the group assisted medically (a=.05; β=0.8).

Eligibility Criteria:
Inclusion Criteria:

* Non-severe acute hemoptysis (mild-to-moderate abundance and no criteria of severity).
* Age \> 18 years
* Patients with social insurance

Exclusion Criteria:

* Pregnant and/or lactating women
* Traumatic hemoptysis
* Severe hemoptysis (volume \> 200 ml; respiratory failure; hemodynamic instability)
* Patients already enrolled in the study within the preceding 3 months
* Patients in palliative care, for whom there is no therapeutic plan at short-term
* Moribund patients
Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen

* To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
* each treatment beeing allocated by randomization

* 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval
* according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics :

  * paracetamol 1 gr
  * ketoprofen 100 mg
  * the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient.
* if VAS was above 40 on two consecutive measurements a morphine injection was given.
* the number and total amount of morphine was recorded.
* satisfaction was recorded within the 3 postoperative day by a telephone inquiry.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* medical abortion performed in day case surgery under local anesthesia
* informed written consent

Exclusion Criteria:

* under 18 year old
Sleep to Activate Mood Promotion

The investigators are aiming to examine the acceptability and feasibility of a portable bright light therapy instrument to improve sleep disturbance in a preventive intervention for depression. The investigators will conduct an intervention that trials the use of bright light glasses called "re-timers" as a preventive intervention in older adults with sleep disturbance and subsyndromal symptoms of depression.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* 6 or greater on the Pittsburgh Sleep Quality Index
* A score of 5 to 9 on the Patient Health Questionnaire-9 Depression Scale

Exclusion Criteria:

* Active suicidal ideation
* Presence of mania or bipolar disorder
* Presence of an eye disease
* Prescription of a photosensitizing medication
* Having previously had eye surgery
Lumbosacral Muscle Sensitivity & Pressure Pain Threshold After Kettlebell Swings

The primary purpose of the study is to assess the muscle contractility and sensitivity of lumbar erector spinae, biceps femoris, and gluteus maximus short-term response to Tabata kettlebell swing protocol.

While there are many studies that combine resistance exercise with TMG, there are no studies that combine TMG or pressure algometry with an isometric hold of a kettlebell. This will be the first study that will observe the relationship between these specific variable

It has also been noted that kettlebell swings have an acute effect on muscle sensitivity. A study conducted by Hanney et al. (2017) demonstrated that there was an increase in the mean lumbosacral muscle pain pressure threshold across three locations measured.

Research by Hanney et al. is also the only article that has combined kettlebell swings and pressure algometry. As mentioned earlier, these researchers measured the effects of kettlebell swings on pressure pain threshold in the quadratus lumborum, paravertebral muscles, and the piriformis after an acute bout of 2 handed kettle-bell swings. Compared to a control group, the kettlebell swing group had significantly higher pressure pain thresholds for all three of the testing sites.

Researchers believe this may be due to an increased hyperemia-state post exercise, where the increased blood flow and vasodilation flushes out muscle metabolites. Clearing of these metabolites which normally activate chemo-nociceptive free nerve endings, are theorized to decrease pain sensitivity. This post-exercise hyperemia, leading to decreased pressure pain thresholds, may be directly related to the changes in contractility of the muscle after resistive exercise.

Eligibility Criteria:
Inclusion Criteria:

* Participant is a male or female between the ages of 18 and 35 years old
* Participant is asymptomatic for low back pain

Exclusion Criteria:

* Participant is unable to participate in physical activity, as determined by the PAR-Q+
* Have any injuries or other chronic pain that would prevent them from performing a high intensity kettlebell swing protocol
Percutaneous Neuromodulation on the Anterior Pain Knee

Anterior knee pain (AKP) is one of the most frequent pathologies of the lower limb, in young and adult subjects. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the femoral nerve produces statistically significant changes in pain, joint range and knee functionality in patients with chronic AKP. Thirty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the femoral nerve of the pain knee; and group 2 to which PNM will be applied to the femoral nerve of the non-pain knee. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)


Eligibility Criteria:
Inclusion Criteria:

* chronic anterior knee pain \>3 months
* older than 18 years-old

Exclusion Criteria:

* Surgical intervention in the intervention area
* Prosthesis or osteosynthesis in the intervention area
* Cardiac or tumoral diseases
* Coagulopathies
* Be under the effects of certain medications
* contraindication characteristic of the puncture