cyrilzakka/clinical-trials huggingface dataset:
Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia

The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery under neuraxial anesthesia (epidural or spinal) planned or unplanned between 8 am and 8 pm on week days when one of the investigator is present.
* Participants with fever or shivering before the cesarean section are include

Exclusion Criteria:

* No comprehension of french or english language
* Urgent cesarean delivery for non reassuring fetal tracing
* Extremely urgent cesarean delivery (grade 1)
* Weight \< 60 kg ou \> 120 kg
* Hypersensibility to dexmedetomidine
* Heart, renal or hepatic disease requiring follow up, medication or with a possibility of instability during cesarean delivery
* Pre-eclampsia
* Combined spinal-epidural anesthesia
* Conversion into general anesthesia
* Blood products transfusions or major complications during surgery
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate

Fatty acids are the main components of the cell membranes. It has been demonstrated that diet can alter the characteristics and function of many membranes in the body, which has an effect on cardiovascular and metabolic health. Over the last two decades there has been a substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on bodily function. There are two fatty acids that are of particular interest to researchers, eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique unsaturated structures, and their incorporation into biological membranes seems to generate important and positive physiological effects. The body is unable to synthesize these fatty acids in high concentrations to elicit significant effects, so they must be obtained through diet in food or via supplementation.

It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR) in humans, in part by increasing the use of fat as a fuel during rest. There are a limited number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an increase in RMR while others have found no change. These studies have some limitations, as that they have either used a small sample size, a low omega fatty acid dose and/or short supplementation periods. Due to the variable results, the investigators will improve the reliability of the RMR measurements by making measures on each subject during two consecutive days at each time point that it is measured (0, 6 and 12 weeks).

Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3 supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR and fat oxidation in some subjects and not in others. The duplicate RMR measures will determine the prevalence and magnitude of the omega 3 supplementation.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 30 years of age.
* Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study.

Exclusion Criteria:

* Current or previous supplementation with omega-3's.
* Average fish intake greater than two times per week.
* Taken any medications, have any medical condition, and hospitalization or surgeries.
* Allergy to fish/fish oil, , (rosemary extract, ascorbyl palmitate, or natural tocopherols).
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management

Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective general anesthesia requiring OTI.
* Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
* Age ≥18 years.
* ASA I-III.
* Sufficient intellectual capacity to understand the procedure and equipment used.
* Do not submit predictors of difficult airway (Mallampati class III or IV; thyromental distance \<6 cm, sternomental distance \<12.5 cm, interincisal distance\<4.0 cm, bite test II or III, cervical mobility \<90 ° or history of difficult intubation).
* Do not undergo thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology
* BMI \<30kg / m2
* Not presenting risk factors for aspiration
* Not presenting respiratory disease, coronary or cerebral vascular.
* Do not have a sore throat preoperative

Exclusion Criteria:

* Failure to meet the above criteria
* Pregnancy
* Allergy to any drug included in the protocol.
Meningitis With Cerebral Vasculitis in Children

Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome.

The investigators decide to realize a retrospective mono-centric study carried out at Montpellier university hospital which looks back at a 7-year study(2009-2016).

The Investigators selected purulent meningitis cases based on the bacteriological data provided by the HDB (hospital data base). The Investigators divides in two groups : Group A if patients present a cerebral vasculitis ( radiologic diagnostic by RMI or tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist specialised in neuropaediatrics by a second reading;Group B purulent meningitis with a cerebral vasculitis imaging.

Tuberculous meningitis, meningitis in CSF shunt, and in patients having chemotherapy were excluded.

The investigators report clinical and biological finding, inflammatory marker at the onset. The Investigators register also the clinical evolution and sequelae

Meningitis steel are a cause of death in childhood. Cerebral complication are often responsable of poor prognosis. One of these complication vasculitis is steel not weel understood. There are only few study about it on children.

It is a retrospective study about 17 cases of chil which bacterial meningitis coupled wiethe cerebral vasculitis, the Investigators will describe epidemiology, bacteriology, evolution and corticosteroid treatment in this patients.

Eligibility Criteria:
Inclusion Criteria:

* bacterial meningitis with LCR confirmation

Exclusion criteria:

* tuberculous meningitis, immunosuppressor treatment, material like DVP
Extracorporeal Shockwave Therapy for Diabetic Foot Wounds

Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.

Extracorporeal shockwave therapy is a promising safe and non invasive treatment that has been shown to improve healing in chronic ulcers and burns by promoting healing and decreasing risk of infection.

The study will recruit patients on a hospital ward and outpatient departments who have a diabetic foot wound. Participants will be informed about the study, given an patient information sheet and invited to give informed consent.

Consenting participants will undergo shockwave therapy three times in the seven days after their operation, in addition to standard wound care.

Wound measurements, blood perfusion, tissue integrity, quality of life and pain scores will be recorded at baseline, after the third treatment, 4 weeks, 8 weeks and 12 weeks after recruitment to the study.

The study aims to recruit 25 patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Open wound of the foot
* ABPI \>0.8
* Age greater than 18 years old
* Able and willing to give written informed consent
* Be able to adhere to protocol and attend all follow up appointments

Exclusion Criteria:

* Pregnancy or breast-feeding
* Current malignancy
* Allergy to materials used in the treatment
* Palliative
* Unable or unwilling to give consent
* Anticoagulation
An mHealth Intervention to Improve Medication Adherence and Health Outcomes

Investigators evaluated the efficacy of a pilot-tested mHealth intervention to improving medication adherence and health outcomes among patients with coronary heart disease.

This was a two-arm parallel randomized controlled trial, in which 116 and 114 participants were assigned to the experimental and control groups, respectively. The mHealth intervention in this study had been pilot tested and tailored. Specifically, the experimental group received a medication-taking reminder every morning via WeChat app and educational materials of coronary heart disease and medication adherence every five days via Message Express app. The control group received only general educational materials, which were irrelevant to coronary heart disease or medication adherence, every 5 days via Message Express app. All participants were diagnosed with coronary heart disease. The specific recruitment criteria of participants had been published in peer-reviewed journal.

Eligibility Criteria:
Inclusion Criteria:

* (1) had a medical diagnosis of coronary heart disease;
* (2) aged 18 years or older;
* (3) had an antihypertensive medication regimen for 90 days or more from enrollment;
* (4) able to read messages through mobile phone;
* (5) had a mobile phone that could receive messages from WeChat and reminders from Message Express;
* (6) capable of giving his/her own consent; and
* (7) had an electronic blood pressure cuff to check blood pressures and heart rates.

Exclusion Criteria:

* was enrolled in other research studies
Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer cells.

PRIMARY OBJECTIVES:

I. To determine the immunogenicity of recombinant human papillomavirus nonavalent vaccine (GARDASIL 9) administered after allogeneic stem cell transplant (SCT) in patients with hematologic malignancy by comparing HPV 9-plex competitive Luminex immunoassay (9-plex cLIA) titers before and after GARDASIL 9 administration.

II. To evaluate the safety and tolerability of GARDASIL 9 administered after allogeneic SCT in patients with hematologic malignancy.

OUTLINE:

Patients undergo standard of care allogeneic stem cell transplant. 6-12 months following transplant, patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) on day 0 and at 2 and 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study intervention, patients are followed up within 3 days.

Eligibility Criteria:
Inclusion Criteria:

* All English-speaking adult MD Anderson patients with hematologic malignancy at 6-12 months +/- 8 weeks post allogeneic stem cell transplantation who will receive usual post-stem cell transplant vaccinations
* All patients from approved protocol 2015-0795 will be invited to this vaccine study

Exclusion Criteria:

* Prior allogeneic SCT
* Platelet count less than or equal to 25,000 K/uL
* Absolute neutrophil count less than or equal to 500/uL
* Patients who have ever received HPV vaccination (at least one dose of HPV vaccine)
* Patients with a prior history of HPV-related malignancy
* Female patients who tested positive for pregnancy during pre-SCT evaluation
Pain in Subjects with High Capacity Cognitive Abilities

In many books and website focused in high cognitive abilities talks about pain in these subjects. However, when the investigators look for in sites like pubmed there are no literature about this topic. With this study the investigators will try to know better pain experience in this population and chronic pain prevalence

It's said that people with high cognitive abilities suffered pain. However, there are no scientific literature. With this study the investigators would like to know better pain experience in this population. There are two target groups include inside this population that we consider to study: Children population and adults population.

The aim of this study is to know the prevalence of chronic pain in this population and to analize the pain experience of this population and the related psychosocial variables that can modify it, like catastrophicing, kinesiophobia, anxiety, quality of life and level of physical activity,

The investigators will use a questionnaire that includes different questionnaires like TSK-11SV, PCS, STAI, SF-36 and IPAQ and many question to evaluate the demographic factor of the sample and the prevalence

The investigators will do an statistical analysis to observe the relationship and the predictors factors

Eligibility Criteria:
Inclusion Criteria:

* People with a diagnosis of high cognitive abilities

Exclusion Criteria:

* People with incapacity to answer the questionnaire
* People that's not have a good level of Spanish language
Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

This study will generate new information on how to optimise brain targets with ECT stimulation.

This study will differentiate the brain regions which are related to the effectiveness of electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4 different forms of ECT, which stimulate the brain differently; 2) in a subset of participants, use computer modelling to assess the pattern of brain stimulation with the 4 forms of ECT, and match these results to memory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years; right-handed
* DSM-5 Major Depressive Episode
* Prescribed with a course of ECT

Exclusion Criteria:

* Diagnosis (as defined by DSM-V) of psychotic disorder (apart from Major Depressive Episode with Psychotic features), current drug or alcohol abuse or dependence;
* ECT treatments in last 3 months from a prior course of ECT;
* Score \<23 on the Montreal Cognitive Assessment Battery (MoCA);
* Past or current neurological illness or injury, medical illness which may significantly affect neuropsychological function;
* Inability to give informed consent or comply with study procedures; or
* Not having worked or studied in an English speaking background (to ensure validity of neuropsychological testing).
* Not be claustrophobic (if having an MRI brain scan).
* Not have any metal in your head or body (if having an MRI brain scan).
* Likely non response to RUL forms of ECT, as indicated by past non response to RUL ECT
Treament of Rumination

Background. Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestion. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of rumination. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of rumination. Selection criteria. Rumination after meal ingestion. Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed after ingestion of a probe meal during the first 3 weeks of the 4 weeks intervention period.

Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Primary Outcome Measure:

Number of rumination events measured by electromyography in response to the challenge meal before and after treatment.

Secondary Outcome Measures:

* Number of self perceived rumination events measured by questionnaires administered daily for 10 days will before and after treatment.
* Associated abdominal symptom measured by questionnaires administered daily for 10 days before and after treatment.
* Follow up: number of self perceived rumination events measured at 1, 3 and 6 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* Relevant organic diseases
Age Dependency of Biological Reaction on Wear Particles

Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (\<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.

The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.


Eligibility Criteria:
Inclusion Criteria:

* having received a total hip arthroplasty 4 weeks before blood sample for this study

Exclusion Criteria:

* no informed consent
A Study of Long-term Safety and Efficacy of VX-670 in Participants With Myotonic Dystrophy Type I

The purpose of the study is to evaluate the long-term safety and tolerability, efficacy and pharmacokinetics of VX-670 in participants with Myotonic Dystrophy Type I (DM1).


Eligibility Criteria:
Key Inclusion Criteria:

• Completed study drug treatment in parent study VX23-670-001 (NCT06185764)

Key Exclusion Criteria:

• History of any illness or any clinical condition as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.
Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements

The proposed research has the potential of contributing to the limited empirical literature on the relationship between maternal sensitivity and motor development of preterm infants. If indeed maternal attuned behaviors will be found to be associated with the quality of motor development, such a finding will support the effectiveness of physical therapy in guiding caregivers to attune their holding and touch of preterm infants.

We hypothesize that mothers and infants' attunement during observed interaction will be related to the quality of preterm infants' spontaneous movements in the following ways: First, better maternal attunement to the infants needs, and in particular attunement of holding and touch will be associated with better quality of spontaneous movements of the infants. Second, more initiations and/or involvement of infants in interaction will be associated with better maternal attunement to the infant. Third, more initiations and/or involvement of infants in interaction will be associated with better quality of spontaneous movements and better achievements in developmental milestone. All hypotheses will be examined while controlling for maternal use of SSC method during hospitalization after birth and family demographic backgrounds.

Sixty preterm infants at 3-4 months of corrected age and their mothers will be recruited. Infants will be evaluated for their spontaneous movements and their developmental milestones achievement, and mothers and infants will be evaluated for their attunement during observed interaction, especially on maternal attunement in holding and touching their infants. Mothers will report on demographic background of the family, temperament of their infants and previous Skin to Skin Contact treatment in the Neonatal Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:preterm infants born between 26-34 weeks of gestation, whose mothers speak and write Hebrew fluently.

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Exclusion Criteria:preterm infants who suffer from perinatal asphyxia, genetic or metabolic diseases, necrotizing colitis that requires operation, intra uterine growth retardation, deafness, retinopathy of prematurity (ROP) or major congenital defects.

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Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults

The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.

Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.

Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete
* Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season

Exclusion Criteria:

* Has had any hospital admissions for asthma
* Has smoked within the past year, or has a ≥10-pack per year smoking history
* Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™
* Has used Xolair within the past 12 months
* Has a history of anaphylaxis