cyrilzakka/clinical-trials huggingface dataset:
Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.

This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* provide unpaid care to a person diagnosed with early to moderate stage dementia;
* provide at least 14 hours of care a week for at least 3 months
* aged 18 years or above
* able to read
* have depressive symptoms
* use a message application

Exclusion Criteria:

* with an unstable physical or mental condition
* with cognitive impairment
* receiving medical, psychological, or psychiatric treatment for depression
* have been included in another interventional study
The Effects of L-arabinose on Intestinal Sucrase Activity in Man

The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.

Background:

The intake of common table sugar (sucrose) in the industrialised countries is relatively high. In Denmark the daily intake of sugar is in the range of 30-40 g/d exclusive the intake of sugar containing drinks. The health consequences of this relatively high sugar intake are heavily debated in the media. One of the arguments is that a high sugar intake may be one of the factors involved in the development of the metabolic syndrome, including overweight, increased blood glucose and insulin levels as well as impaired insulin action.

L-arabinose is widely distributed in plants and is a common component in plant cell walls in maize, wheat, rye, rice, plant gums etc. The isolated 5-carbon sugar has been shown to suppress the increase of blood glucose and plasma insulin after ingestion of sucrose in rats by inhibition of sucrase activity. In vitro studies on Caco-2 cells indicate that L-arabinose is a potent inhibitor on sucrase activity, possibly in a non-competitive way.

Potential nutritional advantages of consuming L-arabinose in combination with sucrose may therefore be a delayed digestion of sucrose and a lower absorption of glucose, resulting in both lower blood glucose and insulin levels. A delayed digestion of sucrose will reduce the energy utilisation with the potential of reducing weight gain in human subjects.

Methods:

This dose-response study with 14 healthy male volunteers has a randomised cross-over design based on four single "meals" separated by one week wash-out periods. Sugar rich drinks supplemented with different doses of L-arabinose will be tested with respect to postprandial blood glucose, insulin, triglyceride, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). Postprandial blood samples will be taken every 15 to 30 min for 180 min. Appetite sensations will be measured every 30 min during the experiment. After 180 minutes a lunch will be served and energy intake (EI) will be registered.

Eligibility Criteria:
Inclusion Criteria:

* healthy males
* BMI between 18.4-25 kg/m2
* age between 18 and 30

Exclusion Criteria:

* donation of blood 3 months before or during the study
* gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease (HIV or hepatitis)
* smoking
* consumption of more than 21 alcoholic drinks/week
* elite athletes
* on medication
The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery

This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are:

Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.

A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.

The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.

All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.

Eligibility Criteria:
Inclusion Criteria:

* Orthodontic indication for impacted mandibular third molar surgery
* Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)

Exclusion Criteria:

* Presence of systemic disease
* Presence of a condition that affects fibrin clot formation
* History of radiation therapy or chemotherapy
* Allergy to penicillin
* Oral contraceptive usage
* Smoking habit
* Status of pregnancy or lactation
* Presence of any acute local infection
* Missing the adjacent second molar or indicated for extraction
Cohorte Nationale VIH-2

The HIV2 study is an open cohort of prospective, multicentric, national observation. The main objective is to study HIV-2 infection in adult patients followed in France.

The secondary objectives are :

* Describe the epidemiological and clinical characteristics of participants infected with HIV-2, and the immuno-virological characteristics of the infection.
* To study the clinical and immunological progression of HIV-2 infection and the prognostic factors of this evolution.
* Study the response to antiretroviral treatment (clinical, immuno-virological) and contribute to the identification of the antiretroviral strategies and combinations most suited to the particularities of the infection.
* Allow an evaluation of the care practices of participants followed in French hospitals
* Provide a bank of clinical-biological data and samples allowing the performance of virological and / or immunological studies on HIV-2 infection.

The follow-up of the participants is different according to the therapeutic status of the participants, naive of antiretroviral treatment or already treated with antiretrovirals.

Eligibility Criteria:
Inclusion Criteria:

* HIV-2 infection only, diagnosed by ELISA, confirmed by Western-Blot test,
* Follow-up in consultation or hospitalization in one of the investigating centers,
* Age greater than or equal to 18 years,
* Prolonged follow-up possible, residence in France planned for at least one year,
* Consent to participate,
* Long-term medical care possible for the participant, or by medical aid (AME), or declaration of obtaining AME at the time of inclusion.

Exclusion Criteria:

* HIV-1 infection
* Double HIV-1 + HIV-2 seropositivity
Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to have pH studies done in order to determine is these patients suffer from reflux after surgery.

The purpose of this study is to determine if patients who have laparoscopic Heller myotomies for the treatment of achalasia suffer from reflux after the surgery. Patients at our institution who have had surgery for achalasia will be asked to have pH studies done to determine whether or not these patients have reflux.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had laparoscopic Heller myotomies for the treatment of achalasia

Exclusion Criteria:

* Patients under the age of 18 will not be included
* Patients who are receiving anti-reflux therapy will not be included
Characteristic Study on Chinese Patients With Multiple Sclerosis

Compared with MS in white populations, in people of China descent multiple sclerosis (MS)is characterized by lower prevalence, more frequent and severe involvement of the visual system at onset and during the entire clinical course, more common occurrence of optic and spinal involvement, relatively rapid progression and less common occurrence of a progressive course. Data are not available for mainland China that are focused on characteristic studies of MS. In this study, the investigators sought to explore the characteristics of MS among Chinese in China, by conducting a study on genetics, pathogenesis, pathology, neuroimaging characteristics, and so on. Based on these data, the investigators try to explore the difference in neuromyelitis optical (NMO) and MS and provide clinical data for treatment guidelines for NNO and MS.


Eligibility Criteria:
Inclusion Criteria:

* Criteria for neuromyelitis optical

  * Optic neuritis
  * Acute myelitis
* At least two of three supportive criteria:

  * Contiguous spinal cord MRI lesion extending over \>= 3 vertebral segments
  * Brain MRI not meeting diagnostic criteria for multiple sclerosis
  * NMO-IgG seropositive status
* Criteria for multiple sclerosis:

  * Two or more attacks; objective clinical evidence of two or more lesions, OR
  * Two or more attacks; objective clinical evidence of one lesion, dissemination in space, demonstrated by: MRI or two or more MRI-detected lesions consistent with MS plus positive CSF or wait further clinical attack implicating a different site, OR
  * One attack; objective clinical evidence of two or more lesions, dissemination in time, demonstrated by: MRI or second clinical attack, OR
  * One attack; objective clinical evidence of one lesion (monosymptomatic presentation; clinically isolated syndrome), dissemination in space, demonstrated by: MRI or two or more MRI-detected lesions consistent with MS plus positive CSF and dissemination in time, demonstrated by: MRI or second clinical attack, OR
  * Insidious neurological progression suggestive of MS, one year of disease progression (retrospectively or prospectively determined) and two of the following:

    1. Positive brain MRI (nine T2 lesions or four or more T2 lesions with positive VEP)
    2. Positive spinal cord MRI (two focal T2 lesions)
    3. Positive CSF

Exclusion Criteria:

* \> 65 yrs old
* Heavy damage of heart, lung, liver, renal function
* Late neuromyelitis optical or EDSS \> 6.0
* Serious hypertension and diabetes
* Serious mental disorders and depression
* Allergic to drug: atorvastatin, β-interferon, EPO, immunoglobulin
Photoplethysmographic Scaling of Dyspnoea

Timely prediction of impending respiratory failure is vital, yet relies on subjective clinical assessment of the patient's respiratory status. Pulse oximetry plethysmographic signal analysis is indicative of the effort to breathe and may provide an objective measurement of respiratory loading.

Initiating invasive mechanical ventilation is a vital and delay-critical decision. Precise and timely prediction of impending respiratory failure would be highly consequential. Subjective evaluation of respiratory loading conditions is inconsistent, imprecise and may result in erroneous management. Photoplethysmographic (POP) waveform analysis provides a non-invasive, readily available tool to estimate breathing effort in a semiquantitative fashion.

It is the aim of this study to examine:

1. if the degree of dyspnoea, when clinically assessed by means of the respiratory rate and SpO2 values, correlates with the SpO2 wave variations (ΔPOP) in ICU spontaneously breathing COVID-19 and non-COVID-19 patients.
2. if a ΔPOP threshold could be identified to adequately predict further need of orotracheal intubation and invasive mechanical ventilation.

This study consists of three main steps:

1. Clinical evaluation of dyspnoea based on:

   1.1. Respiratory rate

   1.2. Oxygen saturation (SpO2)
2. Storage of SpO2 curve for ΔPOP computation according to a proprietary algorithm after offline POP analysis .
3. Within a time frame of 10 days from when the first two steps are met, monitor for need of invasive ventilatory support.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from patient or next-of-kin according to local administrative decision
* Spontaneous breathing, including during prone position
* Sinus rhythm
* Minimum standards for ICU monitoring: ECG, blood pressure (invasive or non-invasive), respiratory rate (by ECG signal), SpO2 and temperature

Exclusion Criteria:

* Suspected pregnancy
* Weight \> 120 Kg or \< 60 kg
* Emergency or urgency
* Intubated ( and mechanically ventilated) patient
* Non- sinus rhythm
* Left ventricular ejection fraction (LVEF) ≤ 30%
* Right ventricular (RV) dysfunction ( RVEF ≤ 30% at transthoracic echocardiography (TTE))
* Significant pulmonary hypertension (PHT) (TTE: mean pulmonary arterial pressure (mPAP) ≥ 35 mm.Hg)
PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.

The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.

The outlook of current trends indicates that maximum effort is needed to tailor the initial antimicrobial therapy in patients under hemodialysis with catheter. Specific emphasis is put on early availability of antimicrobial susceptibility results by Diagnostic laboratories to optimize the management of those difficult infections.

Direct whole blood PCR could allow a rapid determination of bacterial susceptibility to antibiotics. The study is designed to assess the concordance of a direct whole blood PCR targeting staphylococcus and its susceptibility to oracillin with the classical microbiological approach of samples from hemodialysis patients with catheter suspected of septicemia. This innovative approach should allow a faster diagnostic allowing the clinicians to better tailor the initial empirical antimicrobial therapy which has been proven crucial for a good clinical management of the patients.

Moreover, the use of an adequate antimicrobial therapy early in the management of the patients, should not only lead to a better clinical outcome but also avoid unnecessary prescriptions of drugs which are the main drivers of the emergence and spread of antimicrobial resistance.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 year old,
* suspicion of septicemia in hemodialysis patient with catheter,
* patient oral consent prior to inclusion in the study.

Exclusion Criteria:

* patients who went through the A\&E department,
* patients who have received an antimicrobial therapy more than 8 hours long,
* patient under legal protection.
Ultrasound-guided Rectus Sheath Block In Children

Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.

After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated.

Primary end point was pain score using FLACC scale.

Eligibility Criteria:
Inclusion Criteria:

* The children aged 2-7 years scheduled for inguinal hernia repair

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma

PSA-recurrence prostate carcinoma is associated with two general problems.

1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \< 0.5 ng/ml according to german S3 guidelines is based on retrospective data.

These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value \>= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.


Eligibility Criteria:
Inclusion Criteria:

* postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml
* prior irradiation
* comprehension of study protocol content and signed informed consent form
* minimum age 18 years

Exclusion Criteria:

* primary therapy of prostate carcinoma
* PSA value \>= 1 ng/ml
* diagnosed distant metastases before randomisation (osseous or systemic)
* performed PET/CT before randomisation
* malignant slave tumor
* potent men that are not willing or are unable to apply consequent contraception
* ongoing drug- and/or alcohol abuse
* patients that are not willing or able to cooperate according to protocol
* patients in care
* patients that are not able to understand German language
Effects of Relaxation Response Mind-body Intervention in Patients With IBS and IBD

In this pilot study, the investigators examined whether a relaxation response mind-body intervention could be effectively delivered to mixed groups of IBS and IBD patients and determined the effects of the intervention on quality of life, inflammatory markers, and gene expression using transcriptional profiling.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented IBS (confirmed by the Rome III diagnostic criteria for 6 months) or IBD (upper limit for Harvey-Bradshaw index \[HBI\] = 20, upper limit of simple clinical colitis activity index \[SCCAI\] = 18) by their primary care provider or gastroenterologist
* 18-75 years old
* Fluent in English

Exclusion Criteria:

* Patients with IBS were excluded if they had abdominal surgery in the past 5 years (with the exception of appendectomy, cholecystectomy) or documentation of GI motility disorder.
* Patients with IBD were excluded if they used NSAIDS chronically, were on a prednisone dose ≥20 mg/day, or if surgery was anticipated in the 10-weeks following enrollment.
* Current evidence of duodenal ulcer, gastric ulcer, diverticulitis, esophagitis or infectious gastroenteritis, or any acute gastrointestinal process, as well as if concurrent total parental nutrition or tube feeding were being used.
* Recent (within the last 4-weeks) changes in IBS/IBD medications, planned changes in diet, or current use of steroids
* Currently pregnant or attempting to become pregnant
* Currently (\>3-weeks) practicing Tai Chi, meditation, yoga, individual mind/body based psychotherapy or counseling,
* Initiated psychotherapy within the last 8-weeks
* Using psychotropic medications (except at stable doses for at least 12-weeks),
* Has an untreated psychiatric disorder
Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique

The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are described as meningitis, uveitis and classical severe presentation such as lung bleedings and liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the disease.

Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic confirmation during the first week of development and before the appearance of the first antibody.

If the microagglutination test (MAT) is considered the gold standard test for diagnosis of leptospirosis. However it requires rending samples to the referent National center for the leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the second week of illness. A second sample is required 15 days after the first one, to confirm the diagnosis.

In clinical practice , the technique of real-time PCR for the detection and quantification of pathogenic Leptospira during the first week of illness . The technique of diagnosis of leptospirosis by real-time PCR has been implemented and tested in 2007 at the University Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days, regardless of the severity of the disease. The evolution of leptospiremia treated patients has not been studied to date.


Eligibility Criteria:
Inclusion Criteria:

* Adults ( more than 18 years)
* Diagnosis of leptospirosis confirmed by PCR in the five first day
* Appeal to one of the hospital departments participating in the research: in emergency room, in complete hospitalization
* Affiliated patients or beneficiaries of a national insurance scheme
* Acceptance to participate in the study and in the proposed follow-up, and signature of the consent signed by the person or by his(her) representative

Exclusion Criteria:

* Test of negative PCR
* Children under age 18
* No possible follow-up after the first visit
* Pregnant patient
* Refusal of participation in the study
* Unaffiliated patients or beneficiaries of a national insurance scheme.