cyrilzakka/clinical-trials huggingface dataset:
Meditation Based Lifestyle Modification in Healthy Individuals

MBLM is a holistic therapy for people with mental disorders whose positive effects on patients with depression have already been demonstrated in clinical use and a pilot study. In the present study, the differential effects of MBLM domains (ethical living, healthy lifestyle, and mantra meditation) on healthy volunteers will be investigated.

MBLM expands existing concepts of mind-body medicine with ethical and spiritual concepts from the traditional Patanjali yoga system, which can act as a coping factor on the one hand, and higher motivation and deepening of practice (physical yoga exercises / mantra Meditation). MBLM aims to establish an exercise routine in the daily lives of the participants, which leads to salutogenesis. The promotion of mental health through meditation and yoga has been well documented (Büssing et al., 2012, Sedlmeier, Ebert, \& Schwarz, 2012), also in clinical populations (Ospina et al., 2007). The preventive potential of the MBLM program will be examined for healthy volunteers, analogous to the already well-researched and widely used Mindfulness Based Stress Reduction program.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent

Exclusion Criteria:

1. Psychiatric disorder
2. Current participation in another meditation or yoga study
3. Regular existing meditation or yoga practice (more than once a week in the last 6 months)
Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes

The present study aims to assess and compare the anti-plaque and anti-gingivitis effects of Moringa plant extract and Fluoride toothpastes among a group of Egyptian Children.

In the last few years, the use of plant extracts in alternative medicine has evolved widely. Various herbal products, including mouthwash and toothpaste, are now available and have been shown to possess a beneficial effect on oral health .Moringa plant is used to treat various diseases including the treatment of the oral cavity or dentistry .

Eligibility Criteria:
Inclusion Criteria:

* Children of 12-14 years of age.
* Presence of gingivitis-calculus, and plaque (gingival index \[GI\]score ≥1/plaque index \[PI\] score ≥1).
* Children willing to participate.
* Children whose parents/caretakers gave informed consent.

Exclusion criteria

* Children having fixed or removable orthodontic appliances or removable prostheses.
* Children suffering from any systemic illness.
* Children who were already using mouthwashes.
* History of oral prophylaxis within 6 months.
* Children using any other oral hygiene aids.
Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars

The purpose of this trial is to study the ability of a frequently used dental anesthetic (articaine) to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique fails, a commonly used supplemental (SUP) technique with one of two possible dental anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness between the two anesthetics.

Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe.

The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits.

This study consisted of two periods of patient enrollment, treatment and data collection: Part I: 101 subjects; Part II: 100 subjects.

The goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars, either by IANB administration of 4% articaine with 1:100,000 epinephrine (NDA 022466), or in case the IANB appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine.

The proposed randomized controlled trial (RCT) aims to answer the following questions:

1. What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration?
2. Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB?
3. Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine?

This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size, giving a total sample size of approximately 200 patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* irreversible pulpitis in mandibular molar

Exclusion Criteria:

* below 18 years
Improved Oral Bioavailability of Curcumin Incorporated Into Micelles

Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers with routine blood chemistry values within the normal ranges
* Age: 18-35 years or \> 60 years

Exclusion Criteria:

* overweight (BMI \>30 kg/m2)
* metabolic and endocrine diseases
* pregnancy
* lactation
* drug abuse
* use of dietary supplements or any form of medication (with the exception of oral contraceptives)
* smoking
* frequent alcohol consumption (\>20 g ethanol/d)
* adherence to a restrictive dietary regimen
* physical activity of more than 5 h/wk
Morbidity and Mortality in Patients With Hypertrophic Cardiomyopathy: a CALIBER Study

The aim of this project is to study the association of a number of demographic and cardiovascular risk factors with death, health care utilisation and systemic embolisation by examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based cohort identified from linked electronic health records.

Most data on hypertrophic cardiomyopathy related morbidity and mortality are derived primarily from longitudinal, observational studies based at tertiary cardiac centres. It is unclear what the main causes of morbidity and death are in the general hypertropic cardiomyopathy population (outside tertiary referral centres) and it is likely that many patients have a benign clinical course and die from non-cardiac causes.

Linkage of the Clinical Practice Research Datalink (CPRD) to the Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office of National Statistics (ONS), offers the opportunities to study the natural history of hypertrophic cardiomyopathy, from the time of diagnosis to the end of life, health care utilisation and to investigate the association between clinical characteristics and common clinical fatal and non-fatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* One year or more of follow-up in the practice prior to study entry
* 18 years or older

Exclusion Criteria:

• Unknown sex and age
Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis

Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and low efficacy. The investigators aimed to evaluate efficacy and safety of naproxen sodium/codeine phosphate combination in these patients.

In this prospective, randomized, double blind, placebo controlled clinical trial, 135 patients with osteoarthritis, who were 40-65 years; applied to institution's orthopaedics outpatient clinic; had grade 1, 2, or 3 primary osteoarthritis diagnosed in last 1 year; and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score≥40, and Visual Analogue Scale score≥40,were enrolled. Subjects were randomized (1:1) to placebo (n= 67) or combination (n= 68) arms, in which 550 mg naproxen sodium/30mg codeine phosphate was given orally twice a day for 7 days. Rescue medicine was 500 mg paracetamol (max= 6 tablets/day). Demographic characteristics, medical history, adverse events, VAS and WOMAC scores were collected in study visits performed within 10days.The study was approved by local institutional ethics committee and written informed consents were obtained from all participants.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of primary osteoarthritis (knee and hip) in the recent year according to criteria of American College of Rheumatology (ACR)
* Grade 1, 2 or 3 osteoarthritis patients
* Patients 40 to 65 years of age
* Patients with WOMAC score ≥ 40
* Patients with VAS score ≥ 40
* Patients who signed the consent form

Exclusion Criteria:

* Grade 4 osteoarthritis patients / Pregnant or breastfeeding mothers
* Patients with known allergic reaction or intolerance to NSAIDs (nonsteroidal antiinflammatory drugs)
* Patients hypersensitive to naproxen sodium or codeine
* Patients who took another analgesic medicine during 24 hours before and/or a nonsteroidal anti-inflammatory medicine during 72 hours before taking study medicine
* Patients with active gastric or duodenum ulcer
* Patients with renal dysfunction and/or a kidney disease
* Patients with severe liver disease
* Patients with rare hereditary galactose intolerance, Lapp lactase insufficiency or glucose-galactose malabsorption problem
* Patients with depression treated by a medicine from monoamine oxidase class
* Patients with uncontrolled hypertension or patients with hypertension that is hardly controlled with medicines
* Patients with a known medical, psychological disturbance or social status that may negatively affect inclusion into the study or patients who may lead to increase in risk for others with inclusion into the study
* Patients with proven clinically important and unstable systemic medical disease
* Patients who have medical contraindication for study medicine
* Patients who are judged by investigator that they will not adhere or adequately adhere to the study protocol
* Patients who participated into another study with another study medicine in the last 4 week
* Patients who intent to donate blood or blood product during the study period or in the following month of the study completion
ANI-Guided Fentanyl Infusion During Living Donor Liver Resections

Thу goal of this study was to learn whether intraoperative analgesia nociception monitoring (ANI) could be beneficial during intraoperative monitoring for patients undergoing living donor liver resections. The main questions it aims to answer are:

* Could it impact the average dose of intraoperative fentanyl used?
* Could it impact the occurrence of postoperative nausea and vomiting?

Patients who were included in this study underwent living liver donor resections with fentanyl infusion and thoracic epidural analgesia. Two groups of patients were analysed - the ANI group (n = 24), in which fentanyl dose was adjusted with ANI monitoring, and the retrospective control group (n = 25) with a standard practice without ANI monitoring.

Monitoring nociception accurately during general anaesthesia has presented a long-standing difficulty. Typically, anaesthesiologists rely on changes in the autonomic nervous system, such as heart rate, blood pressure, and sweating, to help determine the need for pain relief medication. Analgesia nociception index (ANI) is a noninvasive tool for monitoring the intraoperative state of the autonomic nervous system, particularly the parasympathetic nervous system.

During the long-lasting high nociceptive surgery, the infusion of fentanyl was used at our institution. Opioids can lead to postoperative nausea, vomiting, and other complications when an overdose occurs. Fentanyl dosage changes significantly after hours of infusion due to context-sensitive halftime. It is practically impossible to adjust an infusion dose with the subjective evaluation of standard monitoring, such as heart rate and blood pressure. Doses of opioids that we use in our daily practice, e.g. mcg.kg-1, are unpredictable and vary between individuals due to pharmacogenetics and pharmacokinetic reasons. The best method to exclude pharmacokinetic peculiarities and predict the subsequent dose is to directly measure analgesic agents' concentration in the blood, though it is practically impossible. This study aimed to assess whether intraoperative analgesia nociception monitoring (ANI) could have an impact on the average intraoperative dose of fentanyl and on the occurrence of postoperative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients, 18 - 60 years old, undergoing living donor liver resections with general anaesthesia with sevoflurane, thoracic epidural analgesia and fentanyl on infusion. ASA I, II

Exclusion Criteria:

* patients with cardiac arrhythmia (atrial fibrillation, frequent extrasystoles - more than one extrasystole in 30 seconds), total intravenous anaesthesia with propofol
Vaginal Birth After Caesarean Section and Levator Ani Avulsion

There is no data regarding the risk of levator ani avulsion in women after a vaginal birth after caesarean although a possible increased risk has been suggested. The aim of the study is to describe the incidence of levator ani avulsion and compare it to primiparous women. In addition, health related quality of life will be evaluated and compared

Levator ani muscle avulsion is a frequent postpartum trauma imposing a considerable risk of pelvic organ prolapse on women in later life. Furthermore, the trauma reduces the effectiveness of pelvic reconstructive surgery and has a detrimental effect of the sexuality of the affected women. The trauma occurs most frequently in the first vaginal delivery with an incidence of 10-30%. However, the risk of levator avulsion in women after vaginal birth after caesarean section (VBAC) is unknown although possible increased risk has been suggested.

The aim of the study is to assess the prevalence of levator ani avulsion among women who delivered vaginally after a caesarean section and make a comparison with a primiparous cohort. The secondary aim is to evaluate and compare the health related quality of life regarding pelvic floor disorders and sexuality.

Eligibility Criteria:
Inclusion Criteria:

* one term vaginal delivery in obstetric history
* agreement with the enrollment

Exclusion Criteria:

* Women with a history of repeat VBAC or a vaginal delivery prior to the index caesarean section
* women with preterm labor
* epidural analgesia
* multiple pregnancy
* dead or malformed fetus
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease

This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.

This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19 disease.

All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 \[IL-6\] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate \[DNR/DNI\] order or a resource limitation).

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed SARS-CoV-2 infection
2. Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria:

   * Interstitial pneumonia on chest x-ray or high-resolution computed tomography (findings of consolidation or ground glass opacities), OR
   * Peripheral capillary oxygen saturation \< 94% on room air, OR
   * Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to maintain SpO2
3. Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
4. Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28

Exclusion Criteria:

1. Female participants who are pregnant or nursing
2. Participation in a clinical trial with another investigational drug for COVID-19 disease
3. Anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization
4. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
MRI and Orbital Tumours (MEDORT)

Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

The MRI assessment performed routinely in a patient with an orbital mass includes morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of Gadobutrol®).

In this research protocol, during the injection of the contrast agent performed during the MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition will be preceded by two short series for calibration. The post treatment will include parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. It will also be added a magnetic susceptibility EPI sequence type. All the qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected.

The result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an MRI, before any surgical treatment

Exclusion Criteria:

* Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
* Patient under guardianship
* Patient not willing to participate.
* Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
* Motion artifact on the sequences, not corrected by the repeat sequences
* Metal artifact prohibiting the analysis of the region of interest
* Biopsy or resection not performed, particularly if the orbital mass is due to an infection
* MRI findings allowing a diagnosis without the need for pathology
Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?

Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia concerning it´s implementation in the clinical routine.

Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events such as impaired coagulation, increased risk for wound infections and patient discomfort among others. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia published in 2014 concerning it´s implementation in the clinical routine. In a first phase the current status should be recorded. If this reveals an inappropriate high incidence of perioperative hypothermia training arrangements shall be taken for non-physician personnel in the PACU in a 2nd phase of the project. The third phase is intended to evaluate the effect of the training arrangements on the incidence of hypothermia.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years undergoing elective surgery admitted to the PACU

Exclusion Criteria:

* Patients \< 18 years
* Emergency surgery
Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.


Eligibility Criteria:
Inclusion Criteria:

* The registered permanent residence or resident place are local (reside more than 3 months);
* Participant preventive inoculation of varicella vaccine in 2014-2015;
* Adverse reactions occurred and should be reported in the AEFI monitoring system.

Exclusion Criteria:

* Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
* Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
* Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.