cyrilzakka/clinical-trials huggingface dataset:
Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain

Myofascial pains are frequently found during the clinical examination of the patients presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology of this component of the pain characterized by triggerpoints found in the clinical examination, remains uncertain; its coverage contributes to the improvement of the global pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent fibers) but are they superior to the injections of local anesthetics of triggerpoints? The literature remains poor on the subject, justifying this randomized double-blind protocol comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as long as the patient remains improved and maximum in 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient presenting a "dysfunctional" pain of the pelvis or the perineum (without lesional pathology justifying a specific treatment) by an endopelvic touch
* Pain evolving since at least 6 months and persisting in spite of the analgesic treatments and the physiotherapy
* Patient presenting to the clinical examination one or several active triggerpoints found on the internal obturating muscles and/or elevators of the anus, with a maximum of 10 triggerpoints on the whole body.
* Patient presenting an average of the maximal pains of the week before the inclusion superior or equal to 4 and inferior or equal to 9/10 (evaluation of the daily maximal pain on a digital scale from 0 to 10)
* Signed informed consent
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Patients with bleeding risk and anticoagulant therapy
* Intolerance of botulinum toxin A, ropivacaïne and nitrous oxide
* Injection of botulinum toxin in any place whatsoever in the previous 3 months
* Pregnancy and breast feeding
* Antibiotic treatment by aminoglycosides
* Recent anti-inflammatory treatment
* Severe myasthenia
* Lambert-Eaton syndrome
* Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
* Beck score \> 16
* Patients having an average of the maximal pains of the previous week lower than 4
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial

The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.

Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.

Eligibility Criteria:
Inclusion Criteria:

* Veteran status
* Current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; CAPS-5)
* If taking psychotropic medication, on a stable dose for at least 30 days prior to study entry

Exclusion Criteria:

* Current engagement psychosocial treatment for PTSD
* Current diagnosis of substance dependence

  * abuse will not be excluded; determined with severe combined immunodeficiency (SCID)
* Current psychosis or unstable bipolar disorder diagnosis

  * determined with the Mini International Neuropsychiatric Interview (MINI)clinician-administered interview
* High suicidal risk

  * i.e., intent with a plan; assessed with the MINI suicide module
* Significant cognitive impairment (assessed with the Montreal Cognitive Assessment \[MoCA\] and clinical judgment)
Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance

In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.

An improved technique of PTBD may provide better results for coming comparative studies.

The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance.

When Endoscopic Retrograde Cholangiopancreaticography (ERCP) is not successful or is not possible to be performed due to anatomical reasons (altered anatomy after abdominal surgery) in patients with malignant extrahepatic bile duct obstruction, an alternative method is necessary for biliary drainage. In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.

An improved technique of PTBD may provide better results for coming comparative studies.

The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance considering technical and clinical success, access route, procedure time, fluoroscopic time, radiation exposure, adverse events and survival probability in an observation time of six months.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* not curatively operable, malignant disease with proximal or distal bile duct obstruction
* elevated serum bilirubin level and/or elevated alkaline phosphatase to at least a twofold degree
* histologically verified diagnosis
* at least one cross-sectional imaging method like computed tomography or magnetic resonance imaging of the abdomen has to be performed

Exclusion Criteria:

* uncorrectable coagulopathy (prothrombin time \< 50%, platelet count \< 50.000/nl, partial thromboplastin time (PTT) \> 50 sec.
* advanced tumor disease with limited life expectancy (\< 1 month)
* diffuse liver metastasis
* pregnant or breast feeding women
* potentially curatively, operable, malignant bile duct obstruction
* diseases which can be cured by chemotherapy (for example aggressive non Hodgkin-lymphoma).
Evaluation of a Dietary Supplement Containing Melissa Officinalis Formulated in Phospholipids on Mood Well-being and Cortisol Modulation

This is a randomized, double-blind, placebo-controlled pilot study designed to evaluate the effect of an oral nutritional supplement containing Melissa officinalis formulated in phospholipids on mood and cortisol levels in healthy adults. Participants will be randomly assigned to receive either the active supplement or a placebo daily for 3 weeks. The primary outcome measures include changes in mood well-being, perceived stress, and salivary cortisol levels. The study aims to assess both efficacy and safety of the supplement in modulating stress response and emotional balance.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Healthy volunteers as assessed by medical history and physical examination
* Willingness to comply with the study procedures

Exclusion Criteria:

* Current use of medications or supplements that may affect mood or cortisol levels
* Known allergy or sensitivity to Melissa officinalis or phospholipids
* History of psychiatric disorders (e.g., major depression, anxiety disorders)
* Significant comorbidities (e.g., cardiovascular, hepatic, renal diseases)
* Pregnant or breastfeeding women
* Participation in another clinical trial in the past 30 days
Adolescents Committed to Nutrition and Physical Activity

Community based participatory research principles will be used to create, implement and evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who are overweight or obese. The intervention will be implemented through school-based health centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use of a community advisory council to develop obesity risk reduction strategies that will be delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION intervention, overweight/obese adolescents will be recruited to either the intervention condition or the usual care condition. Students will have pre- and post- intervention measurements to assess if adolescents in the intervention condition will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students in the usual care condition.


Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to the 85th percentile in BMI
* in 9th through 11th grades at participating schools

Exclusion Criteria:

* BMI greater than or equal to 40
* previously diagnosed type 1 or type 2 diabetes
* blood pressure in the range of stage 2 hypertension
* medications that significantly interfere with weight
Comparison of Video Laryngoscopy and Macintosh Laryngoscopy in Pediatric Patients Undergoing Elective Surgery

In this study, we aimed to observe the intubation conditions in patients using Endolarenx video laryngoscope and Macintosh Blade in laryngoscopy to identify the advantages and disadvantages of using video laryngoscopy in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* One hundred pediatric patients, aged under 18 years, weighing between 10-40 kg, and classified as American Society of Anesthesiologists (ASA) I-II-III risk group

Exclusion Criteria:

* Patients with congenital airway deformities, patients with known or predicted difficult intubation, patients undergoing emergency surgery, patients classified above ASA III, and patients whose parents did not consent were excluded from the study
Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test in an Assisted Fertility Setting

Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, we would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot will help us to better understand how this tool complements existing monitoring protocols. If a suitable addition, replacement to repeat blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make assisted fertility treatments more patient-friendly. This study seeks to test this innovation by asking women assigned to perform a dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis for up to 4 weeks after embryo transfer.

We hypothesize that the test, which can be used at home by women, will provide confirmation of the presence of a pregnancy compared with standard serum hCG testing because 1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can be used at home and thus earlier to determine presence of hCG. Furthermore, a pregnancy can be assured only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3 weeks after the next menses expected.

We hypothesize that women seeking assisted fertility treatments will be able to monitor their hCG at home as well. Further, we plan to develop revised instructions to better suit the needs and questions we think would be relevant to women desiring to use this test as part of assisted fertility services.

We hypothesize that the simple instructions we will develop for use in this study will enable women to use the test on their own. Provider counseling will complement these instructions and contribute to overall quality of care given to each participant.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for assisted fertility treatment according to hospital guidelines
* Agrees to have blood drawn several times for serum hCG tests
* Agrees to return for a series of follow-up visits
* Willing to follow provider instructions regarding use of at-home pregnancy test
* Willing to provide an address and/or telephone number to be contacted for purposes of follow-up
* Willing and able to consent to study participation

Exclusion Criteria:

* Women not eligible for assisted fertility treatment
* Women who do not agree to have blood drawn several times for serum hCG tests
* Women who do not agree return for a series of follow-up visits
* Women unable to follow provider instructions regarding use of at-home pregnancy test
* Women unable to provide contact information
* Women unable to sign the consent form
Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery

The purposes of this study are:

1. To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia during spine surgery and
2. To investigate the influence of Dexmedetomidine on the evoked potentials.

Use of evoked potentials can significantly improve neurologic outcome after major spine surgery. Modalities of evoked potentials commonly used are Somato-Sensory Evoked Potentials (SSEP's), Motor Evoked Potentials (MEP's), and Visual Evoked Potentials (VEP's).

Dexmedetomidine (DEX) is an alpha-2 agonist and has been FDA approved as an adjunct sedative agent to general anesthesia. It has been purported to reduce the amount of anesthetic required and potentiate the analgesic effect of opiates. In addition, DEX was shown to have minimal effect on SSEP's and VEP's in both rats and humans. Any decrease in the dose of general anesthesia that improves the monitoring of evoked potentials, supports DEX as an adjunct.

It is known that all anesthetic agents can interfere with the recording of evoked potentials. The choice of anesthetic however, depends on the modality of neurophysiologic monitoring planned for the patient. Total intravenous anesthesia (TIVA) and Sevoflurane, a low dose inhalational anesthetic are the usual agents for spine surgery. Both have a dose-related depressant effect on the quality of evoked potentials. As a result, it is common practice for the anesthesiologist to adjust the depth of anesthesia to improve signaling. The use of either anesthetic must accompany continuous infusion of Propofol and an opioid, Remifentanil or Fentanyl. The anesthesiologist then decides whether DEX should be as an adjunct. In our experience, DEX did not impair evoked potentials. In fact, it improved the quality of signals in a few patients. Yet, there are no published data of such effects in medical literature.

We hypothesize that Dexmedetomidine will not influence evoked potentials when used as an adjunct to general anesthesia. Our study is prospective, randomized, double-blinded and will be carried out on a set of anesthetics. We will first evaluate DEX as an adjunct in TIVA, then as an adjunct to Sevoflurane. The probable benefit of DEX may avoid the use of potent inhaled anesthetics which would improve VEP's monitoring. Quality recording of evoked potentials can enhance our ability to detect iatrogenic injury to the spinal cord and vision.

Eligibility Criteria:
Inclusion Criteria:

* Adult spine surgery patients requiring evoked potentials monitoring.

Exclusion Criteria:

* Age younger than 18 and older than 80 years
* Patients with moderate neurological deficit
* ASA grade above 3
* Any chronic psychiatric disorder
* Body mass index (BMI) above 35
* Patients with cortical blindness, cataracts, retinal or optic neuropathy, glaucoma, untreated diabetes, active hepatitis, active coronary artery disease, untreated arrhythmias and patients with renal or hepatic insufficiency
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation

Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.


Eligibility Criteria:
Inclusion Criteria:

1. ToF with pulmonary stenosis repaired with a TAP within the first two years of life.
2. RVOT anatomy is suitable for implantation of an adult sized conduit ( 18 mm homograft or Contegra graft) as assessed by MRI.

Exclusion Criteria:

1. ToF with pulmonary atresia, ToF with common atrioventricular canal, ToF with absent pulmonary valve syndrome, major aortopulmonary collateral arteries and other significant associated anomalies.
2. Palliation with a shunt (Blalock-Taussig or central) at any time.
3. The patient is symptomatic.
4. Sustained supraventricular or ventricular arrhythmia.
5. RVEDVi \> 140 mL/m2 as assessed by MRI (appendix 1).
6. RVESVi \> 60 mL/m2 as assessed by MRI.
7. RVEF \< 50 % as assessed by MRI.
8. Moderate or severe tricuspid regurgitation as assessed by echocardiography or MRI.
9. Significant residual lesions requiring intervention (e.g. ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis).
10. Co-morbidity preventing exercise testing (e.g. genetics, neuro-cognitive dysfunction, physical disability).
11. Contraindication for MRI (e.g. permanent pacemaker, intra-cardiac defibrillator, intracranial ferro-magnetic device).
12. Pregnancy at time of inclusion.
13. Age \< 12 or unable to comply with instructions given during MRI or exercise testing.