cyrilzakka/clinical-trials huggingface dataset:
PREventing Pain After Surgery

The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
* age 22 and older
* able to communicate fluently in English

Exclusion Criteria:

* inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
* have a history of severe neurologic movement disorder
* are pregnant or intent to become pregnant during study
* have undergone previous spinal surgery
* have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
* have undergone Acceptance and Commitment Therapy in last 2 years
How Bone is Made in Children Receiving Dialysis

The study outlined is designed to measure and to determine whether the combined use of vitamin D2 (ergocalciferoI) and 1-alpha-hydroxyvitamin D2 (doxercalciferol)) or doxercalciferol alone will correct the mineralization defect in pediatric patients with established secondary hyperparathyroidism (2°HPT) undergoing regular peritoneal dialysis. Serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder; (obtained at baseline and after 8 months of treatment) sevelamer. Indices of bone mineralization obtained at baseline and after 8 months of treatment will be measured by quantitative histomorphometry in iliac crest bone biopsies after double tetracycline labeling. Immunohistochemistry will be done in specimens of bone biopsies from iliac crest to examine the expression for selected markers of bone turnover and mineralization such as FGF-23, DMP1, MEPE and OPG. Serum PTH levels will be measured with the 1st and 2nd generation immunometric assay (PTH-IMAs) and fibroblast growth factor-23 (FGF-23) will be determined by one assay with specific detection antibodies that are against epitopes within the C-terminus of FGF-23 and another assay that uses antibodies against epitopes within the N- and C-terminal portions of the molecule respectively. The value of non-invasive assessment of bone mass by quantitative computed tomography (QCT) and its relationship with vascular disease determined by ultrasound (US) of intimal carotid thickness (CIMT) will be correlated with bone histomorphometry and the different biochemical determinations.


Eligibility Criteria:
Inclusion Criteria:

* medically stable patients
* 6-21 years old
* undergoing treatment with continuous cycling peritoneal dialysis
* evidence of mineralization defect and secondary hyperparathyroidism

Exclusion Criteria:

* histopathological lesion of bone such as adynamic bone or osteomalacia
* poor compliance
* current treatment with prednisone or other immunosuppressives
* treatment with human recombinant growth hormone
* parathyroidectomy
Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT

Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm cells by positive testicular extraction and those with a negative extraction.

One third of infertilities is of exclusive male origin and one third of mixed origin (presence of a male factor). Ten percent of infertile male have azoospermia with a secretory origin in most of cases. Surgical extraction of spermatozoa from testicle is the unique possibility to increase the chance for these men to have children using in vitro fecundation. However, surgical extraction of spermatozoa is successful in 50% of these patients. To date, none of the methods for exploration of male fertility (spermogram, hormonal investigation - with dosage of FSH (follicle stimulating hormone) and inhibin B - and scrotal ultrasound) can predict the success of surgical sperm cells extraction. We also miss the prognostic markers of the testicular function recovery after sterilizing treatments (chemotherapy, radiotherapy). The presence of GLUT3 (glucose) transporters, which are responsible for the fluoro deoxyglucose uptake, has been reported in seminiferous tubules. We have previously shown in a pilot study on a population of men without testis cancer that FDG PET-CT parameters - including the standardized uptake value mean, the standardized uptake value max, and the functional testicular volume - were correlated with the parameters of spermogram (sperm count, motility, vitality). These findings open the way to investigations on the role of the FDG PET-CT in evaluation of secretory azoospermia.

Eligibility Criteria:
Inclusion Criteria:

absence of sperm cells on 2 spermograms in 3 months interval testicular size has to be determined in order to categorized in a group to accept surgery-

Exclusion Criteria:

allergy to fluoro deoxyglucose clinical varicocele
Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults

Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin.

Both groups will be treated twice, once at inclusion and the second time 10 days later. Both treatment regimens have been used widely and are safe to use.

Scabies is a common condition, even in European countries, and the annual incidence seems to have increased over the past several years.

Children and infants represent one-third of patients with scabies. Diagnostic features comprise pruritus, skin burrows and the delta jet wing dermoscopic sign.

In many countries, topical permethrin is the first line therapy. Moreover, oral treatment with ivermectin represents an interesting alternative therapy, usually used as one dose of 200μg/kg, and more and more frequently recommended as two doses (one on day 1 and one between day 8 and day 15) without strong evidence. Management of scabies requires giving a treatment not only to the patient but also to the patient's close contacts.

The objective of our study is to compare efficacy and safety of topical permethrin applied twice at day 1 and day 10 versus oral ivermectin given twice at day 1 and day 10 to treat scabies in children and their close contacts. Children (2 to15 years) with scabies and their close contacts - or first circle- will be randomized 1:1 to receive permethrin or ivermectin.

A clinical follow-up will be performed 28 days (V2) and 56 days (V3) after the inclusion, including a dermatological examination and to collect safety data.

Eligibility Criteria:
Inclusion Criteria:

* children or adult
* For children, weight more than 15 kg
* Documented diagnosis of scabies, defined by positive dermoscopic examination.

Exclusion Criteria:

* Previous scabies therapy during the past 4 weeks
* Known allergy to ivermectin or permethrin
* Widespread eczematization or impetiginization
* Liver or renal failure
Surgical Admission at the Weekend and 30-day Mortality in Ontario, Canada: a Matched Cohort Study

Surgery is performed at the weekend for risk to life or limb, when mandated by clinical guidelines, or depending on resource availability. Weekend healthcare interventions have been associated with increased mortality and adverse clinical outcomes in the majority of the literature examining the weekend effect, but these findings are not consistent. Results from recent observational studies argue against a true weekend effect. Higher rates of adverse outcomes associated with hospital activity at weekends do not appear to be due to altered medical staffing as commonly hypothesized, but are thought to be in part a result of data artefact and confounding by severity or indication. For this study, we hypothesized that patients who are admitted to hospital at the weekend and require surgery have an increased risk of death compared with patients who are admitted and undergo surgery on weekdays. The primary aim was to examine whether patients who underwent surgery and were admitted at the weekend had an increased risk of 30 day all-cause mortality compared with patients who were admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for patients admitted at the weekend is associated with increased risk of 30 day all-cause mortality.


Eligibility Criteria:
Inclusion Criteria:

* any hospital admission associated with an eligible surgical procedure in the Ontario discharge abstract database
* between 2005 and 2015

Exclusion Criteria:

* cardiothoracic or cardiology therapeutic procedures
* non-surgical therapeutic interventions (e.g. dialysis)
* obstetric procedures.
Brief Interventions in General Hospital (BIG)

Alcohol abuse is a widespread concern internationally with a significant threat to world health. Research suggests a relationship between heavy drinking and certain clinical presentations such as injuries, physical and psychiatric illnesses and frequent sickness absence from employment. This research aims to establish whether brief interventions delivered to harmful and hazardous alcohol drinkers admitted to hospital impacts of their alcohol consumption levels on discharge from hospital.

Purpose To evaluate the effectiveness of brief interventions for hazardous and harmful alcohol abusers admitted to medical and surgical wards at the Southern General Hospital

Evidence for brief interventions in general hospital Further research is required to prove the benefits of brief interventions within general hospital, based on evidence from the Cochrane systematic review 'Brief interventions for heavy alcohol users admitted to general hospital wards' (McQueen et al 2009).

Links with national and international agendas The European Health Target12 supports a reduction in harm from alcohol drugs and tobacco. By the year 2015 the adverse health effects from the consumption of addictive substances such as alcohol should be reduced by all member states (European Health for all targets 1998) The Scottish government has set HEAT (Health improvement, efficacy and governance access and treatment) target for the NHS to deliver 149,449 alcohol brief intervention cumulatively over the period of 2008/9-2010/11 (Scottish Alcohol and Drugs Workforce 2008).

Research Design This study will employ a randomised control trial design. The primary outcome measure will be grams of alcohol consumed per week, measures will be taken at baseline, six months and one year post intervention. Secondary outcomes will consist of brief intervention's impact on hospital re-admission rates, attendance at A\&E and mortality rates.

Eligibility Criteria:
Inclusion Criteria:

* Scores between 3-12 on FAST
* Admitted to hospital
* Speaks english

Exclusion Criteria:

* Under 18 years
* Cognitively impaired
* Medically Unfit
Vital Pulp Therapy to Treat Irreversible Pulpitis

The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.

In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit.

In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria:

  1. Patient reports pain of endodontic origin
  2. Diagnosis of irreversible pulpitis
* Eligibility criteria:

  1. Molar tooth
  2. Patient chooses to have tooth extraction for pain relief
  3. Age 9-65 years
  4. Both gender
  5. The patient had read and thoroughly understood the questionnaires; and
  6. Written informed consent
* Exclusion Criteria:

  1. Moderate or severe periodontitis
  2. None restorable tooth
  3. Internal or external root resorption
  4. Root canal calcification
  5. No bleeding after access cavity preparation
  6. Analgesic taken within the last 4 h
  7. Active systemic disease
  8. The patient was pregnant or nursing
  9. History of opioid addiction or abuse
  10. Temporary residency
Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study (STAFE)

The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.

The duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results.

Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Patients requiring empiric antifungal therapy the first time in the ICU
* Predictable duration of hospitalization in the ICU ≥ 6 days

Exclusion Criteria:

* Neutropenia (WBC \<1000 or neutrophils \<500/mm3)
* Immunosuppressive therapy (chemotherapy within 3 months prior to the ICU admission, solid organ graft under immunosuppressive therapy)
* invasive fungal infection documented in the three previous months
* Antifungal treatment in the three previous months
* Pregnant or lactating women
Adaptation of Mindfulness Training to Treat Chronic Pain in the Military

The overall aim of this study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain.

The overall aim of study is to test the acceptability and feasibility of an interactive, web-based mindfulness training with active duty soldiers being treated for chronic pain. We will adapt the evidence-based Mindfulness-based Stress Reduction (MBSR) training for use with this population. The adapted training will be enhanced by mobile applications (apps) for skills practice, using an existing apps platform.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have experienced chronic pain for at least 6 months

Exclusion Criteria:

* Do not have any of the following conditions: substance abuse or dependence, psychosis, suicidal ideation in the last 2 months, high levels of trauma symptoms,
* plans to have a permanent change of station or deploy in the coming 6 months, or
* pregnancy
Prescribing Vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients with Postoperative Pain:

This is a research project in which two standard of care practices will be evaluated to examine the difference in outcomes. The goal is to improve patient care and safety. One group will receive prescriptions for acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and magnesium. The other group will receive the recommendation to take acetaminophen, NSAIDs, and magnesium as over-the-counter drugs in the same dosage as the prescription group. The same doses and routes for non-opioid medications will be used in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery

Exclusion Criteria:

* Contraindications to taking acetaminophen or NSAIDs
* Significant analgesic medication use before surgery
* Inability to receive emails or phone calls for follow up assessment
* Patients who have reoperation, another surgery, or experience complications within 14 days after surgery
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma

The purpose of this study is to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma.

ONL1204 Ophthalmic Solution is a first-in-class inhibitor of fragment apoptosis stimulator (Fas) receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease. Apoptosis of retinal ganglion cells is associated with progressive glaucoma. Nonclinical data on ONL1204 Ophthalmic Solution suggest that ONL1204 Ophthalmic Solution may inhibit the cell death pathways in these cells.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged ≥18 years old
2. Able and willing to give informed consent and attend study visits
3. Controlled intraocular pressure (IOP) (≤21 mmHg) in both eyes for all previous 3 visits before Screening and at Screening in both eyes
4. Prior to screening, 3 or more Humphrey Visual Field (HVF) tests (with acceptable reliability standards) or 3 or more Optical Coherence Tomography (OCT) studies of the study eye on record
5. Open angle glaucoma that is progressing in the study eye
6. HVF 24-2 at Screening with acceptable reliability standards and MD scores

Exclusion Criteria:

Considerations for either eye

1. Best Corrected Visual Acuity (BCVA) at Screening of ≤64 letters (Snellen equivalent of worse than 20/50)
2. Severe open angle glaucoma
3. Glaucoma due to non-open angle causes
4. Worse than mild non-proliferative diabetic retinopathy

   Considerations for study eye:
5. Visual field results suggestive of another disease (eg, altitudinal field defect)
6. Evidence of macular edema based on OCT imaging and Investigator's judgement
7. Previous intravitreal (IVT) injections, history of retinal surgery, history of retinal laser
8. Cataract surgery within 3 months of Screening or yttrium-aluminum-garnet capsulotomy (YAG) within 4 weeks of Screening
9. Anticipated need for surgical or procedural intervention for glaucoma, cataract, posterior capsular opacity, refractive error, or retinal conditions during the study

   Other general exclusion criteria:
10. The requirement for oral carbonic anhydrase inhibitors to control intraocular pressure
11. Severe, unstable, or uncontrolled cardiovascular, diabetic, renal, or pulmonary disease, based on Investigator's judgement
12. Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
13. Women who are pregnant, breastfeeding, or contemplating pregnancy during the study period and men who are contemplating contributing sperm for a biologic child during the study period
14. Participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in either eye or systemically for 3 months before Screening (Visit 1)
Comparison of Different Propofol Formulations

The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for an intravenous induction of anesthesia with propofol

Exclusion Criteria:

* Age under 18
* Pregnancy or breastfeeding
* Allergy to propofol, soya or peanuts,
* Allergy to lidocaine,
* History of central neurological disorder or brain injury,
* Patients receiving psychotropic drugs,
* Patient with a pacemaker.
ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants

Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)

Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.

In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.

Eligibility Criteria:
Inclusion Criteria:

* Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments \[SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV\]
* Fibrosis-4 score in non-cirrhotic participants is \<1.45-3.25: (None or moderate fibrosis)
* Fibrosis-4 score in cirrhotic participants is \>3.25: (Advanced fibrosis or cirrhosis)

Exclusion Criteria:

* HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* had any liver disease other than chronic HCV GT4 infection.
* had a history of liver decompensation
* serum a-fetoprotein (AFP) \> 100 ng/ml
* evidence of hepatocellular carcinoma
* major severe illness such as respiratory, renal, heart failure or autoimmune disease
* non-compliance with treatment.
A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain

A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed the informed consent form prior to screening
* Age 18-74 years at screening (both included)

Exclusion Criteria:

* Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
* Previous participation in this trial. Participation is defined as having received at least one injection
Dandelion Juice in the Treatment of Dyshidrotic Hand Eczema

Dandelion juice has been used in herbal medicine for at least 1000 years. Vesicular hand eczema is a rare, but difficult to treat, type of hand eczema. One case report has shown that ingestion of dandelion juice could induce a beneficial effect on this type of eczema. The purpose of this study is to test whether this effect can be retrieved in other patients.

Dandelion juice has been used in herbal medicine for at least 1000 years. One case report has shown a beneficial effect of this herbal remedy on dyshidrotic hand eczema, and the purpose of this pilot study is to test whether this effect can be retrieved in other patients.

The patients are recruited from our out-patient clinic. Only patients with negative patch tests to Compositae are offered treatment with dandelion juice for 20-30 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with dyshidrotic eczema for at least 1 year and negative patch test reactions to Compositae (tested within the last 3 years) and normal renal and hepatic blood tests.

Exclusion Criteria:

* Treatment with systemic steroids or other immunosuppressive/-modulating drugs, including UV therapy, within the last 3 months.
* Pregnancy, lactation.
* Compositae contact allergy.
* Liver or gall bladder disease.
* Abnormal renal or hepatic blood tests.