cyrilzakka/clinical-trials huggingface dataset:
Survey on Sensory Processing Sensitivity in Chronic Pediatric Pain

Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.

Objectives and Aims: The aim of this project is to increase scientific understanding of 1) the distribution and correlates of high SPS among children and adolescents suffering from chronic pain, and 2) whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain.

Methods: To determine the distribution (aim 1a) and correlates (aim 1b) of SPS among a population of children and adolescents suffering from chronic pain, an online survey will be conducted. Participants will be asked to complete questionnaires about their SPS as well as pain history and pain characteristics. The distribution of SPS will then be compared to an existing distribution in a sample of healthy children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 17-19 years
* Persistent or recurrent pain for 3 months or more
* Fluent in German or English

Exclusion Criteria:

* Younger than 17 or older than 19 years
* Acute pain
Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.

The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single oral administration and in repeated oral administration to well-controlled celiac patients. Another purpose is to evaluate if BL-7010 is absorbed by the body or not.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18-75 years who have signed an informed consent form
* Body mass index (BMI) between 18.5-29.9, inclusive
* Documented history of biopsy-proven celiac disease.
* Adherence to a gluten-free diet for the last 6 months prior to randomization
* TG2 and EMA antibody (IgA) negative
* Women of childbearing potential and all men must agree to use an approved form of contraception
* Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment.

Exclusion Criteria:

* IgA deficiency.
* History of IgE-mediated reactions to gluten.
* Other food sensitivities or allergies.
* Use of oral steroids, biologics, immunosuppressants or non-steroidal anti-inflammatory drugs 6 months prior to entry (screening).
* Female subjects who are pregnant or breastfeeding.
* Clinically significant, concomitant gastrointestinal disease.
* Have clinically significant current or historical medical problems such as diabetes mellitus, clinically significant cardiac arrhythmias, arteriosclerotic heart disease, renal insufficiency or failure, autoimmune disease, history of malignant melanoma or history of cancer (excluding basal cell carcinoma) within the past 5 years prior to screening.
* Subjects receiving drugs or oral devices that, in the opinion of the Investigator, possible ineffective treatment with these drugs/oral devices for a duration of two weeks will put the subject at a medical risk
* Uncontrolled complications of celiac disease.
* Any other condition that in the opinion of the Investigator will place the subject at risk or prevent protocol compliance.
Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)

To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement, impairment of color vision)
* First episode of ADON
* Able to undergo treatment with IV steroids

Exclusion Criteria:

* History of any unexplained eye or neurological symptoms lasting longer than 48 hours
* Optic neuritis in both eyes
* Concomitant condition in either eye, other than optic neuritis
* History of heart condition/disease
* Patients with uncontrolled diabetes mellitus
* Patients with liver conditions/disease
* Inability to undergo MRI
* Pregnant or nursing women
* Women of childbearing potential who are not using highly effective method of birth control

  * Other protocol-defined inclusion/exclusion criteria may apply
An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria

With the new reimbursement criteria, we want:

To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.

To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment

100 patients will be followed for at least 1 year

Eligibility Criteria:
Inclusion Criteria:

* Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria
* Patients ≥18 year
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

N/A
Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain

The purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain.

For Patient Registries:

The participant was screened for inclusion criteria and was asked to sign the informed consent prior to participate. A randomized control trial was performed with participants randomly divided into one of the two treatment groups: core stabilization exercise with ball and core stabilization exercise without ball by using sealed envelopes.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female with low back pain (LBP) \> 3 months
2. Body mass index (BMI) = 18-25 kg/m2
3. Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold)
4. Willing and able to perform exercise programs
5. No cognitive impairment
6. Age at least 19 years

Exclusion Criteria:

1. Having experiences in the core stabilization exercise and Swiss ball exercises
2. Past history of back and abdomen surgery
3. Recent fractures of spine, hip or lower limb
4. Current use of steroids or any other drugs for resolving back pain
5. Red flags (fractures, cancer, infection, cauda equine syndrome)
6. Pregnancy
7. Neuromuscular or respiratory disorders
8. Rheumatologic disorders
9. Hip and knee stiffness
10. Pain intensity \> 60 of 100 mm assessed by the VAS
Massage Therapy on Hamstrings in Patients With Nonspecific Low Back Pain

Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain.

The main objective of this study is to test the effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain. Secondary objectives are assess whether the technique of dynamic massage therapy increases the extensibility of the hamstrings, assess whether the treatment of hamstrings decreases low back pain and determine whether the application of this technique decreases the disability associated with nonspecific low back pain.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old.
* Low back pain with over three months of evolution.
* Practice sports regularly (at least three times a week).

Exclusion Criteria:

* Fractures, Tumors, congenital anomalies, rheumatic diseases, infectious or inflammatory processes.
* Pathology Nerve root
* Presence of neurological deficit or neuromuscular diseases.
* Surgery
* Physiotherapy treatment for low back pain in the last 30 days.
* Drugs in previous 24h
Knowledge and Attitude Towards Fertility Among Emirati Infertile Patients

Infertility is on the rise worldwide due to multiple reasons. Proper and timely diagnosis makes the treatment easier and more acceptable by the couple. Lack of fertility knowledge however delays necessary investigations and sometimes reduces chances of success as a consequence of a delay in patients / couples approaching infertility clinics. Assessing the fertility knowledge of the Emirati infertility patients would help us to understand better the cultural aspects of fertility, the driving forces for having children and how much patients actually know about predisposing factors for infertility. This in turn would improve counseling and possible set knowledge campaigns to increase awareness.


Eligibility Criteria:
Inclusion Criteria:

* United Arab Emirates nationals coming for their first consultation in ART Fertility Clinics
* Any age group
* males and females

Exclusion Criteria:

- none

Kindly note that ART is the name of the fertility clinic and not an abbreviation
Pregabalin and Remifentanil - Analgesia and Ventilation

In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.

Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).

Side effects such as nausea and sedation were registered.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers,
* \> 18 yrs \< 55 yrs,
* negative pregnancy test

Exclusion Criteria:

* Pregnancy,
* nursing,
* known heart-, lung- or liver disease,
* kidney failure/peptic ulcers,
* use of liver enzyme-inducing medications,
* known allergy against the medications used in the trial,
* use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial,
* body weight \> 100 kg or 30% deviation from normal weight,
* participant in other studies during the last 2 months,
* individuals who do not master Norwegian language
Abnormal Plantar Pressure in Patients With Diabetes

The prevalence of abnormal plantar pressure distribution (APD) and its connection with various factors among patients with diabetes is not known. The purpose of this study was to evaluate the prevalence of the APD and its connection with selected factors among patients with diabetes.

The abnormal plantar pressure distribution (APD) plays a key role in the formation of plantar calluses which are responsible for diabetic foot ulcer.

The knowledge of APD is necessary to plan proper prevention in the group of patients with diabetes mellitus (DM).

Medical records from previous patients' visits of non-ulcer patients with diabetes were retrospectively analysed. The relationship between APD, obtained during a pedobarographic test as a semi-quantitative assessment with colourful print analysis, and neuropathy, gender, age and BMI was searched.

Eligibility Criteria:
Inclusion Criteria:

* subjects with diabetes mellitus diagnosis
* citizens
* no previous foot ulceration and/or foot surgery

Exclusion Criteria:

* previous foot ulceration and/or foot surgery
Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery

Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered as the reference technique for the management of post-operative pain after shoulder surgery. It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus, this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate block appears to be an effective analgesic alternative in this context.

Two ultrasound-guided approaches of the suprascapular nerve (anterior and posterior approaches) have been described in the literature. From an anatomical point of view, the anterior approach could expose patients to the risk of ipsilateral PhD by phrenic nerve block secondary to diffusion of the local anesthetic into the supraclavicular region.

By measuring the diaphragm excursion during a sniff test, ultrasound allows reliable and reproducible analysis of the diaphragm function.

No study has evaluated the incidence of PhD after ultrasound block of the suprascapular nerve. Knowing the influence of the approach on this complication could be of major interest in this context.

Eligibility Criteria:
Inclusion Criteria:

* to benefit from scheduled arthroscopic surgery of the shoulder under general anesthesia
* Affiliate or beneficiary of a social security scheme
* Having signed the informed consent

Exclusion Criteria:

* the existence of contralateral diaphragmatic paralysis
* pre-existing respiratory insufficiency
* impossibility of performing diaphragmatic ultrasound
* the patient's refusal
* the existence of major spontaneous or acquired haemostatic disorders
* an infection at the point of puncture
* allergy to local anesthetics
* Pregnant or likely to be pregnant
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Patients whose cognitive state does not allow assessment by the scales used
Portuguese Inguinal Hernia Cohort (PINE) Study

Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective inguinal hernia repair in a portuguese hospital
* Willing and able to consent and comply with the follow up protocol

Exclusion Criteria:

* Urgent/emergent inguinal hernia repair
The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy
* ASA 1-3
* BMI 18-35
* Written consent

Exclusion Criteria:

* Do not understand danish
* Drug allergy
* Pregnancy
* Alcohol or drug abuse
* Chronic pain with consumption of opioids
* Consumption of NSAID, COX2inhibitors or paracetamol within 24 hours before the investigation
* Infection at the needle site.
Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery

Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.

Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery.

Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In this study, we will compare platelet-activated markers and conventional coagulation tests.

Eligibility Criteria:
Inclusion Criteria:

* age : 20-80
* elective OPCAB
* informed consent

Exclusion Criteria:

* coagulation disorder
* emergency operation, re-operation
* co-existing valvular disease
* less than 6 months after cerebral vascular accident
* heparin induced thrombocytopenia
* heparin resistance
* menstrual phase
* preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application
* less than 12 months after myocardiac infarction
* less than 10 days after unstable angina
* less than 30 days after percutaneous coronary intervention
* less than 6 wks after bare metal stent insertion
* less than 12 months after drug eluting stent insertion
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection
* Have a confirmed diagnosis of a serious infection (eg, bacteremia \[unless due to an excluded infection\], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy

Exclusion Criteria:

* Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
* Anticipated length of antibiotic therapy less than 7 days
* For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (eg, oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)
The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way

Preoperative fasting is considered to be refraining from taking meals for at least 6 hours and clear fluids for at least 2 hours before anesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of chyme and the occurrence of Mendelson's syndrome, and on the other hand, it is one of the causes of water and carbohydrate disturbances in patients undergoing general anesthesia. Most of them experience some degree of dehydration in the preoperative period. It is associated with a worse prognosis. Due to the negative impact of fasting on homeostasis, as well as significant changes in heart rate in participants in the previous study, we decided to measure the hemodynamic parameters during fasting. The development of impedance cardiography techniques enables the measurement of these parameters by a non-invasive method.

After obtaining the participant's written consent to participate in the study, the first measurement of body weight, blood pressure using a non-invasive method and hemodynamic parameters using a non-invasive impedance cardiography method using the Niccomo ™ device (Medizinische Messtechnik GmbH) will be performed in the evening. The subject will then be asked to refrain from food for at least 10 hours and fluid for 6 hours before the next measurement. The next morning, another measurement will be made and the participant will be randomly assigned to one of two groups: subjects in the first group will be asked to refrain from eating and drinking for another 2 hours, while subjects in the second group per os will receive 400 milliliters of PreOp® (Nutricia ™ preparation intended for preoperative dietary management in surgical patients, containing carbohydrates and electrolytes). After another two hours, the third measurement of the tested parameters will be performed. The obtained results will be subjected to statistical analysis consisting in comparing the values of hemodynamic parameters between the studied groups at appropriate measurement points.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) general condition assessment 1 or 2

Exclusion Criteria:

* Chronic kidney disease
* Circulatory failure
* Lung diseases
* Diseases of the heart valves
* History of hypoglycaemic episodes or any carbohydrate disturbance.
* Height less than 120 cm or greater than 230 cm
* Body weight less than 30 kg or greater than 155 kg.
Longitudinal HPV Pap in CIN and VAIN

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+. The study will include three arms to complete the follow-up data for the previous cohort constructed, and prospectively recruit new subjects with the appropriate inclusion/excluding criteria in order to increase sample size of this study.

The long-term outcomes of patients with antecedent cervical intraepithelial neoplasia (CIN) were lacking. A systematic review published in 2008 identified no studies that met the review eligibility criteria for the prevalence of HPV types among vaginal precursors and cancers. Two sporadic studies containing 16 and 81 cases were reported in that review. Given that vaginal intraepithelial neoplasia (VAIN) post-hysterectomy for CIN is an uncommon disease which has a prevalence of being 1 to 6 %; it has the potential to progress to malignancy. Although the etiology of VAIN has not been as thoroughly investigated as that of CIN, evidence implicates that the human papillomavirus (HPV) as the probable carcinogenic agent for the onset and evolution of some VAIN and vaginal cancers.

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 20 years
2. Those with a previous history of CIN+