cyrilzakka/clinical-trials huggingface dataset:
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage

The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.

Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.

All patients will undergo the following

I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.

III. Laboratory: Hemoglobin, Hematocrit before \& after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.

VI. Calculation of blood loss:

The quantity of blood loss (ml) is calculated from 3 components :

* (weight of used towels during surgery - weight of used towels prior to surgery),plus
* (volume of blood sucked in suction container after placental delivery) ,plus
* (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)
* Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al).

VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .

All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.

Eligibility Criteria:
Inclusion Criteria:

* High risk women undergoing elective C-section

  * Hypertensive patients.
  * Obese patients.
  * Patients on LMWH.
  * Transverse lie
  * DM ( Type 1 \& Gestational )
  * Cardiac ( Not on Anticoagulants )
  * Placenta Previa ( Not in PAS )
  * Previous uterine scar ( \> previous 2 C- section )

Exclusion Criteria:

* Patients with bleeding tendency.
* HELLP Syndrome.
* Emergency C- section.
* Mechanical prosthetic valve
* Atrial Fibrillation.
* Allery to tranexamic acid
* Placenta Accreta , Increta , percreata.
Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.

The objective of the present study is to evaluate the capability of the probiotic strain Lactobacillus coryniformis K8 CECT5711 (Lc K8) to enhance the immune response to influenza vaccine in elderly and the effect on respiratory symptoms related to respiratory infections.

A randomized, double-blind, placebo-controlled trial was conducted between November of 2015 and April of 2016. A total of 98 residents of nursing homes aged more than 65 years were randomly assigned to receive Lc K8 or placebo for two weeks previous to influenza vaccination.

Primary outcome was the percentage of seroconversion. Secondary outcome were the incidence of influenza-like illness and respiratory symptoms associated to respiratory infections during the follow-up period of 5 months. Serum cytokines and immunoglobulins levels were also evaluated.

The objective of the present study is to evaluate the capability of Lc K8 to enhance the immune response to influenza vaccine in elderly and the effect on respiratory symptoms related to respiratory infections.

A randomized, double-blinded, placebo controlled, multicenter trial was performed. The study was started on October 2015 and ended on April 2016. The recruitment of volunteers was carried out in five nursing home of Granada (Spain) at the beginning of the vaccination program.

Volunteers were randomly assigned to one of two groups. Those in the placebo group daily consumed a capsule containing 300 mg of maltodextrin. Those in the probiotic group daily consumed a capsule containing 3x10(9) colon-forming units of the strain Lc K8 in a matrix of maltodextrin.

From two weeks previous to the beginning of the intervention the consumption of any probiotic supplement was restricted until the end of the study. During two weeks before flu vaccination volunteers daily received a capsule of probiotic or placebo. Day 15 of the study all volunteers received intramuscular vaccination against flu (inactivated trivalent influenza: A/California/7/22009\[H1N1\]pdm09, A/HongKong/4801/2014\[H3N2\], B/Brisbane/60/2002) for the vaccine campaign of 2015/2016 (Sanofi Pasteur Europe, Lyon, France). All volunteers were vaccinated during the same week (second week of November 2015). After vaccination volunteer were followed-up until 31 of April 2016.

Eligibility Criteria:
Inclusion Criteria:

* Residents in nursing home aged more than 65 years

Exclusion Criteria:

* Frequent gastrointestinal diseases, antibiotic treatment during the intervention, allergy to any groups of antibiotics, egg proteins or adjuvants and excipients of the flu vaccine
Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity in pediatric amplified musculoskeletal pain syndrome.

Adolescents with amplified musculoskeletal pain syndrome (AMPS) are invited to take part in this research project that studies two different audio-visual relaxation technologies in reducing amplified musculoskeletal pain. In addition, the investigators are interested in studying if they have an effect on some of the ways adolescents think about their pain and cope with it. Both of these technologies provide the user with a similar natural environment designed to have a calming effect, along with guided relaxation and soothing music. The adolescents will be assigned to use one of these for a total duration of about 10 minutes. Pain related outcomes including pain intensity, pain catastrophizing and self-efficacy to manage pain will be collected before and after the relaxation session.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of AMPS, including CRPS, or localized or diffuse amplified pain syndrome as determined by the primary pediatric rheumatologist and coded in EMR.
2. Informed consent for caregivers and child assent for participants.

Exclusion Criteria:

1. An underlying organic cause can explain the pain including inflammatory, infectious, traumatic or malignant etiologies as determined by the primary pediatric rheumatologist.
2. Participant or caregiver report of any history of motion sickness, underlying epilepsy, severe headaches in the participant or other conditions where the use of visual exposures to stimuli is contraindicated.
3. Inability to report a pain score and/or incapacity to give assent due to intellectual deficit.
4. Blindness.
5. Non-English-speaking subjects will be excluded due to the unavailability of the content of the VR application used in this study in languages other than English.
6. Any other condition that the investigators think can compromise the integrity of the study or subject safety.
Should my New Knee Rotate?

Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to relieve pain, restore function and correct deformity. It is a very common surgical procedure with figures showing more than 500'000 arthroplasties performed annually worldwide. Total knee arthroplasty is considered one of the most successful types of joint reconstruction in that surgical results usually meet and even exceed expectations. Much of the current literature focuses on the issues relating to implant wear as a potential failure mode for artificial knee implants. It has been suggested that knee with mobile or rotating bearing options, such as the comparative device proposed for this clinical investigation, may survive longer than fixed bearing knee designs because of the greater contact surface area possible with more congruent components with unconstrained, mobile component design.

This is a prospective, comparative, randomised, open-label, single center, multiple surgeons clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be implanted for evaluation in this study. Patients will be randomised to one of two equal sized groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in the second group patients will be treated with the Scorpio PS mobile bearing implant.

Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring cemented primary total knee replacement.
* Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA)
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
* Patient who have intact collateral ligaments.
* Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.

Exclusion Criteria:

* Patient where patella will not be resurfaced.
* Patients with active or suspected infection.
* Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
* The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weightbearing or places an extreme load on the implant during the healing period.
* Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule
Simulation-based Curriculum to Enhance Culture of Safety in Operating Rooms

Communication in the operating room (OR) is a key factor to prevent deleterious events for the patient. French national health authority made the implementation of safety checklist mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key elements for better patient outcomes. Observational studies in the OR showed low compliance to this checklist, either on the way it is used or on the information implemented.

The primary objective of this project is to assess the efficacy of a simulation-based curriculum involving OR medical and non-medical personnel in order to improve communication in the OR.

Operating theater is a complex system where efficient communication is critical to patient safety. Patient safety check-list are used worldwide as a way to improve communication and teamwork in the operating room in order to decrease perioperative morbidity and mortality. Previous studies have shown that communication failure in the OR may be associated with adverse events. The improvement of safety culture (including communication and team work) may be obtained by simulation based training.

The primary objective of this before-after study is to assess the efficacy of a simulation-based curriculum involving OR medical and non medical personnel in order to improve communication in the OR.

In brief, in a first period, an audit to assess communication efficacy and teamwork will be realized during 125 surgical procedures. Communication failures and consequences will be recorded using a standardized form filled by trained personnel. In a second phase, all the OR personnel (surgeon, anesthesiologist, nurses) will be invited to participate to a special training on communication and teamwork. This curriculum will include formal presentations and also simulation-based training. Scenarios are built to improve the ability to communicate in specific situations (fire in the OR, haemorrhage, wrong side, anaphylaxis).

In a third phase, an audit on communication and teamwork, similar to the first phase will be realized. The primary endpoint is the frequency of surgical interventions having at least one communication failure with a consequence. The investigators expect a significant decrease in the rate of communication failures between phase 1 and 3. A fourth phase will consist in a last audit two years after phase 1 to evaluate long-term effect of this curriculum.

Eligibility Criteria:
Inclusion Criteria:

* All surgical interventions occuring in Grenoble University Hospital, North site, between November and January

Exclusion Criteria:

* Interventions supposed to last more than 4 hours
* Interventions in situations of vital emergencies
Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.

At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.

Eligibility Criteria:
Inclusion Criteria:ASA physical status I or II

* Age 2-15 yr
* Scheduled for elective tonsillectomy and/or adenotonsillectomy

Exclusion Criteria:

* History of diabetes
* History of mental retardation
* Obesity (BMI = \> 95th percentile for age and sex)
* Intake of antiemetic or psychoactive medication within 24 hours before surgery
* Known gastroesophageal reflux
Effects of Neuromobilization on Median Nerve

The median nerve is a mixed nerve with motor and sensory functions in the upper extremity. It is observed that the median nerve slides longitudinally during upper extremity movements. However, in entrapment neuropathies (eg, Carpal Tunnel Syndrome), longitudinal displacement of the nerve is partially limited. In addition, the presence of adhesion, fibrosis, and possible scar tissue may cause difficulties for peripheral nerve adaptation in certain positions and movements. This, in turn, can result in the limitation of nerve trunk movements with respect to the surrounding tissues and a reduction in the normal shift of nerve fibers and fascicles relative to each other and to the connective tissues. Any pathology that reduces the normal stretch and slip of the medial nerve produces abnormal tension during extremity movement and the pressure on the nerve increases. This may cause symptoms such as paresthesia, weakness, and pain in the hand. With neuromobilization exercises, the tension and pressure on the median nerve are reduced and the nerve is prevented from being compressed in the carpal tunnel.

Neuromobilization is part of manual therapy and has been reported to be an effective practice for some conditions, including low back pain and carpal tunnel syndrome. The inclusion of neuromobilization in the treatment of patients with carpal tunnel syndrome, cervicobrachial pain, and lateral epicondylitis, in particular, has been associated with a reduction in the degree of pain and disability. Recently, neuromobilization techniques have started to be used in the treatment of nerve compression. These techniques consist of a series of therapeutic active and passive movements aimed at restoring the normal mechanical properties of the nerve during limb movements.

When the literature is examined, there are not many studies that objectively reveal the effects of neuromobilization techniques on nerve elasticity. Shear Wave Elastography is a method that quantitatively reveals the elasticity of tissues by measuring the speed of shear waves formed in the tissues through non-invasive high-frequency ultrasound waves. In recent studies, Shear Wave Elastography has shown promising results in demonstrating the elasticity of peripheral nerves.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-30 years
* Healthy individuals without any known systemic disease

Exclusion Criteria:

* Those who had an upper extremity such as bone-tendon-muscle operation in the last six months
* Those with a systemic disease such as rheumatoid arthritis, diabetes mellitus
* Those with any neuromuscular disease (such as Multiple sclerosis, myopathy)
Modification of Posttetanic Count (PTC) for Monitoring Deep Neuromuscular Block II

The purpose of this study is to examine the relationship between post-tetanic count (PTC) and time to first response to Train of four (TOF) stimulation during deep neuromuscular blockade induced by rocuronium.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* General anaesthesia \>1 hour
* Surgery in supine position with possibility of monitoring the neuromuscular blockade at the thumb (n.ulnaris stimulation).
* Written informed content

Exclusion Criteria:

* Neuromuscular disorders, hepatic and renal dysfunction
* Medication expected to interfere with the neuromuscular blocking agent
* Allergy to any medication used during anaesthesia
* Body weight less or exceeding 20% of the ideal body weight
* Pregnancy or breastfeeding
Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy

Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status of I , II or III;
* Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria:

* History of craniotomy;
* Expected delayed extubation or no plan to extubate;
* Participants who cannot use a patient-controlled analgesia (PCA) device;
* • Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Allergy to opioids, methylprednisolone or ropivacaine;
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
* Pregnant or at breastfeeding;
* Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
* Preoperative Glasgow Coma Scale\< 15;
* Suspicion of intracranial hypertension;
* Peri-incisional infection;
* Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be receiving hemodialysis three times per week for a minimum of six months.
* The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
* The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium \< 10.0 mg/dL; phosphorus \< 7.0 mg/dL.

Exclusion Criteria:

* In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
* Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
* The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
* Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
90% Effective Dose of Phenylephrine Infusions Under Intensive and Standard Treatment

The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl