cyrilzakka/clinical-trials huggingface dataset:
Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon

Traumatic Brain Injury (TBI) is one of the leading causes of death. Severe TBT is correlated with an exaggerated stress response due to plasma catecholamine levels known as sympathetic storming. It is also autonomic dysfunction syndrome. This phenomenon is also associated with brain tumors, severe hydrocephalus and subarachnoid hemorrhage. Patients are presented by tachycardia, tachypnea hypertension, diaphoresis, dystonia, hyperthermia, and dilated pupils with elevated levels of plasma catecholamine and blood glucose .

The sympathetic storming events can be triggered by suctioning, repositioning, or environmental stimuli. To differentiate sympathetic storming from similar conditions, symptoms and signs have to occur in TBI patients a minimum of 1 cycle per day for 3 consecutive days (body temperature of 38.5 °C or more, heart rate at least 120 beat / min, systolic blood pressure \> 140 mmHg, respiratory rate \> 20 breaths / min, in presence of dystonia, diaphoresis, agitation and laboratory investigations confirm elevated serum catecholamines. Beta blockers has a cardio protective effect via lowering heart rate, stroke volume and mean arterial blood pressure which limits myocardial O2 consumptions and guards against myocardial infarction. They also have neuron protective effects via reducing cerebral blood flow thus lowering O2 and glucose consumption as cerebral metabolism is reduced. Propranolol a nonselective B receptor antagonists works on β1 receptors in brain, heart, and kidney and β 2 receptors in lungs, liver, skeletal muscles, eye and arterioles.We suppose that using Beta - adrenergic receptor blockers as propranolol blunts the sympathetic storming phenomenon as it is a nonselective β inhibitor and has a lipophilic property which enables it to penetrate blood brain barrier.

Eligibility Criteria:
Inclusion criteria:

* Patients with isolated blunt TBI
* From 18 to 60 years old both sex
* Not in need of mechanical ventilation
* GCS on admission between 9 and 12
* Rotterdam CT score from 2-4.
* Normal Procalcitonin test to exclude infection.

Exclusion criteria:

* Preexisting heart disease
* Myocardial injury
* Craniotomy
* Preexisting cerebral dysfunction
* Spinal cord injury
* Diabetes mellitus
* Severe liver or kidney disease
* Patients with sepsis
KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

Women taking part in the National Mammography Screening Program, examined at Södersjukhuset Breast Centre at Södra station in Stockholm and recalled because of suspicion of breast cancer will be invited to participate. A Contrast Enhanced Mammography will be added to the standard of care procedures for investigating a suspicion of breast cancer and blinded from each other 2 radiologists will evaluate either the Contrast Enhanced Mammography or the standard of care examinations. When comparing the potentially extra findings with Contrast Enhanced Mammography will be calculated. Potential side effects together with the patient experience will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age: \>25 - \<85 years
* Recalled after Mx screening based on abnormal mammographic findings or refered for breast cancer related symtoms
* The woman has read, understood and signed the Informed Consent Form (ICF)

Exclusion Criteria:

* Previous breast cancer
* A breast biopsy performed within 6 weeks preceding the study
* Recent exposure (during the last week) to iodine contrast media.
* Pregnancy
* Current breast feeding
* Diagnosed with a pheochromocytoma or a paraganglioma
* Diagnosed with myeloma or other malignant plasma cell disease
* Diagnosed with myasthenia gravis
* A renal failure or kidney disorder with increased risk for developing renal failure (single kidney or kidney transplanted)
* Diabetes (other than dietary treated)
* Heart failure or liver failure
* Intake of potentially nephrotoxic substances (daily intake of NSAID, nephrotoxic antibiotics or nephrotoxic chemotherapy)
* Iodine contrast allergy
* Uncontrolled thyrotoxicosis
* A history of severe allergy
* Subjects unable to read, understand and execute written informed consent
* Any medical aspect that, according to the investigator, could jeopardize the health of the participant
clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents

It is designed to monitor the efficacy of nasal cannula or hıgh-flow nasal oxygen in geriatric patients for endoscopıc retrograde cholangıopancreatography procedures. The aim of the study is to evaluate the efficacy and safety of oxygen support obtained with low-flow nasal cannula and hıgh-flow nasal oxygen during endoscopıc retrograde cholangıopancreatography in the patient group at risk for adverse respiratory events. We hypothesized that high-flow nasal oxygen administration can prevent adverse respiratory events such as deep sedation and patient position that may endanger the airway safety of patients, and reduce the problems in cardiac and hemodynamic parameters that may develop.

In this retroprospective study, it was aimed to compare the effects of high flow nasal oxygen and standard nasal cannula use on hypoxia and oxygenation in geriatric endoscopic retrograde cholangiopancreatography cases performed under sedation in the prone position. Data belonging to the nasal cannula group will be obtained by scanning the forms and files retrospectively. Data in the high flow nasal oxygen group will be prospectively recorded during the procedure.

After the general anesthesia approval of the patients who will be applied ERCP, they are taken to the application room in the endoscopy unit. Here, standard monitoring (pulse oximetry, electrocardiography (ECG), non-invasive blood pressure measurement) is performed according to the criteria of the American Society of Anesthesiologists (ASA). in sedated patients for endoscopic retrograde cholangiopancreatography intervention, starting 5 minutes before sedation at 5-minute intervals; During the application, blood pressure, pulse, SpO2, presence of arrhythmia, interruptions due to airway interventions are monitored by the anesthesiologist and recorded in the case report form.

After the standard monitoring is established, preoxygenation is performed for 3 minutes. Then, 5 L/min of oxygen is given through the nasal cannula throughout the procedure. Patients who will receive oxygen support with high flow nasal oxygen (Inspired O2 FLO High Flow Oxygen Therapy) will be given 40 L/min oxygen with a high flow nasal oxygen system after preoxygenation. Patients will be followed for at least 15 minutes after the procedure or until the patient recovers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with physical condition class II-III of the American Society of Anesthesiologists, ----aged 65-90,
* with Spo2 of 92% and/or below in room air,

Exclusion Criteria:

Coagulation disorder, nasopharyngeal obstruction,

* bleeding tendency,
* mental status disorder,
* dementia,
* cognitive impairment,
* intubation,
* tracheostomy,
* need for oxygen therapy due to pre-existing disease,
* patients on home oxygen or ventilator,
* pregnancy,
* recent history of epistaxis or allergy to propofol patients will be excluded.
Effects of Restaurant Menu Design on Food Ordering Outcomes

High cognitive load activities can influence energy intake from food. It is unknown how restaurant menu designs may affect patrons in terms of cognitive demand and subsequent ordering of food.Objective: Our objective was to develop and experimentally test menu designs that differ in cognitive load to test the subjective and objective stress measures on food ordering.

For the first experiment, a parallel randomized trial of healthy young adults (n= 30) was conducted to compare ordering from one of two menu designs (easy - E, hard - H) developed in a prior pilot study. In the second experiment, restrained eaters were specifically recruited and asked to fast before the experiment to determine the influence of cognitive load of menus on energy ordered (n=31). Galvanic skin response was used as an objective proxy for relative cognitive load, and questionnaires were used to assess perceptions of the menus. The main outcomes were the number of items ordered and total energy of the items ordered (in kilocalories).

Eligibility Criteria:
Experiment 1

Inclusion Criteria:

* Normal vision or corrective lenses
* Normal hearing or a hearing aid
* A moderate level of English proficiency or greater
* Free from current food restrictions

Exclusion Criteria:

* Unwilling/uninterested in participation
* Currently taking any β-blocker medications
* Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)

Experiment 2

Inclusion Criteria:

* Normal vision or corrective lenses
* Normal hearing or a hearing aid
* A moderate level of English proficiency or greater
* Free from current food restrictions
* Qualifying as a restrained eater by the Cognitive Restraint scale on the Eating Inventory (score of 6 for men and 10 for women)

Exclusion Criteria:

* Unwilling/uninterested in participation
* Currently taking any β-blocker medications
* Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)
The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section.

It will be a prospective observational cohort study. The investigators will compare post-cesarean section recovery in patients receiving intravenous infusion of tramadol-ondansetron versus epidural catheter with infusion of local anesthetics.

The primary outcome is to assess the non-inferiority in terms of post-cesarean section recovery of the intravenous perfusion of tramadol + ondansetron compared to the perfusion of local anesthetics through an epidural catheter.

This will be a prospective observational cohort study, with a total N of 312 patients who underwent a cesarean section. 156 who maintain the epidural catheter as the main measure of analgesia for 24 h, and 156 who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. The following data will be collected at 24 and 48 hours: need for unscheduled pharmacological reinforcement, adverse effects, QoR (Quality of Recovery) score 15, ObsQor-10 (Obstetric Quality of Recovery) score, and Visual Analogue Pain Scale (VAS) every 4 hours for 48 hours. The incidence of chronic pain 90 days after cesarean section will be assessed using the Numerical Pain Rating Scale (NRS).

Eligibility Criteria:
Inclusion Criteria:

* Woman over 18 years old undergoing caesarean section
* She agrees to participate voluntarily.
* She is already receiving any of the analgesic strategies studied.

Exclusion Criteria:

* Receiving an analgesic medication other than the one mentioned as "routine multimodal analgesia" (either as regular medication or for acute post-surgical pain)
* Medical history that determines the baseline data of the scales and data that we collect ( pain or previous disabilities; addiction to drugs, alcohol or drugs; another disease that worsens the quality of life)
* Medical history that conditions the pharmacological effect (allergy, intolerance or atypical reaction to any of the drugs involved in its treatment or possible cross-reactions )
* Contraindication for neuraxial techniques (patient refusal, difficulty in understanding or communication, localized infection, increased intracranial pressure, or other medical criteria)
* Two or more previous caesarean sections
* Difficulty in understanding or communication
* Mother care will not be available to the newborn in the postpartum period for any reason
Tramadol Infiltration for Tonsillectomy

The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.

The study will be prospective, double-blind, randomized study of 40 children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy under general anesthesia.

Patients will be allocated into two groups. Group 1 patients will receive tramadol 2 mg / kg intravenously and saline 0.9% infiltration in tonsils; group 2, will receive tramadol 2 mg / kg infiltration and intravenous saline.

There will be evaluated: postoperative pain intensity by facial scale, supplementary analgesics and interleukin-6. For statistical analysis of the results will be used parametric and nonparametric tests, taking into account the nature of the variables. The level of statistical significance will be set at \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

Exclusion Criteria:

* coagulopathy,
* cancer,
* hepatic or renal alteration
PRP vs Corticosteroid in Baker's Cyst

This is a Prospective study with Randomized patients into either Ultrasound-guided Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months and 6 months follow ups after aspiration at our institution. There will be 25 patients in each group, including any patient with symptomatic baker's cyst.

The treatment of Baker's Cysts are based on its presentation, asymptomatic cysts are currently managed conservatively, symptomatic cysts are treated with joint aspiration and Corticosteroid injection, which have shown according to literature a decrease of the cyst size in approximately two-thirds of patients within 2-7 days but only complete disappearance in approximately 7 %. Ultrasound guided cyst aspiration and Corticosteroid injection are also used with reduction of cyst's size with recurrence in 6 months of 19%. Surgical options to remove the cyst include, Open Resection with a recurrence of 50%, 25% of patients have motion limitation recurrence, 37% have wound healing problems or tense swelling of the calf and 75% of patients have joint pain lasting more than 2 days. Arthroscopic resection, with no recurrence in ultrasound performed 6 and 12 months after procedure, pain lasting more than 3 days in 28% of patients, mild hematoma in 7% of patients and 7% where converted into an open procedure

There is no study using ultrasound guided aspiration with platelet-rich-plasma injection (PRP). The rationale for the use of PRP is the belief that the additional platelets will exponentially increase the concentration and release of multiple growth and differentiation factors at the injury site to augment the natural healing process9. PRP does not have any described negative side effect due to the fact that is being prepared from subject's own blood, with no risk of allergy or cross infection, relatively easy for a practiced clinician, and reproducible.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old.
* Patients with baker's cyst who also present with at least one of the following: swelling, local pain or discomfort, limited range of motion or any other symptom directly caused by the baker's cyst.

Exclusion Criteria:

* Patients younger than 18 years old
* Local or Systemic active infection
* Active cancer treatment
* Immunodeficiency
* Diabetes
* Hypersensitivity or allergy to Corticosteroid or Lidocaine
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to \< 50 years of age on the day of inclusion.
* Informed consent form signed.
* Able to attend both scheduled visits and to comply with all trial procedures.
* For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria:

* Subject currently breast-feeding.
* Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
* Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
* Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
* Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* Personal history of Guillain-Barre syndrome.
* Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.
* Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).
* Influenza vaccination received this season (2007-2008).
Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA

The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults in an
* age range of 18 to 65 years
* BMI \> 30 kg/m2

Exclusion Criteria:

* acute and chronic diseases
* regular intake of medications (except for contraceptives)
* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* artificial joints
* metallic implants (except tooth implants)
* claustrophobia
* pregnancy or breastfeeding period
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* current alcohol abuse
* frequent hypersensitivity reactions/allergies determ. anamnestically
* extensive tattoos at arms or legs
Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone.


Eligibility Criteria:
Inclusion Criteria:

* BMD as measured by DEXA at screening, should range between (-1)to (-2.5) SD from normal values.
* At least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
* Study participants not taking estrogen alone or estrogen/progestin containing drug products.
* Study participants not taking any anti-osteoporosis treatment for at list one year.
* The following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products:

  1. 8 weeks or longer for any prior use of estrogen and/or progestin products.
  2. 6 months or longer for prior progestin injectable drug therapy.
  3. Women between 45 and 65 years (inclusive) of age.
  4. BMI 22-30 (inclusive)
  5. Non-smoking (by declaration) for a period of at least 6 months.
  6. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
* Subjects who provide written informed consent.

Exclusion Criteria:

* Women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies.
* Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
* Any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit.
* Known history of drug or alcohol abuse according to participant declaration at screening visit.
* Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
* Subjects who are non-cooperative or unwilling to sign consent form.
T2Bacteria Panel Pivotal Study

The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".


Eligibility Criteria:
Inclusion Criteria:

* Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
* Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
* Subject is between 18-95 years of age.

Exclusion Criteria:

* Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
* Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
* Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.
Vaccine Exposure in Patients With MS

Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet.

Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS.

Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France).

Data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period.

Statistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis according to MacDonald 2010 criteria
* Age 18 and more

Exclusion Criteria:

-