cyrilzakka/clinical-trials huggingface dataset:
The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19

Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Corticosteroids improve survival in patients with critical COVID-19, and likely even more so with a higher dose. However, the evidence regarding the impact on the incidence of thromboembolic and bleeding events are currently uncharted. The aim of this study is to investigate if there is a difference in the incidence of thromboembolic events during ICU stay in patients with critical COVID-19 when treated with 12 mg dexamethasone compared to 6 mg dexamethasone.


Eligibility Criteria:
All patients were recruited from the CS2-trial with following inclusion/exclusion criteria:

Inclusion Criteria:

* confirmed SARS-CoV-2 AND
* requiring at least 10l/min of O2 supplementation, non-invasive mechanical ventilation for hypoxia or invasive mechanical AND

Exclusion Criteria:

* if previously randomised to the CS2 trial
* if they had received corticosteroids for COVID-19 during ≥5 consecutive days or use corticosteroids in doses \>6 mg dexamethasone for an indication other than COVID-19.
* active tuberculosis
* hypersensitivity to dexa-/betamethasone
* active fungal infection
* fertile woman ≤60 years of age with a positive U-HCG/P-HCG test
* informed consent not obtainable

For the inclusion in this post-hoc analyses there is additional criteria:

Inclusion Criteria:

- randomised in the ICU

Exclusion Criteria:

* established thromboembolism at randomisation
* established major bleeding at randomisation
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study

use of dexmedtemodine to augment analgesia in cases of failed back surgery


Eligibility Criteria:
Inclusion Criteria:

* Age group. 25-75ys old
* Both sex.
* persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence
* Patients suffering from persistent (\> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment.

Exclusion Criteria:

* Diabetic patients.
* Refusal to participate
* MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy .
* Coagulopathic patients
Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise

The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. These sex hormones have also been purported to influence the perceived difficulty of exercise. This study aims to uncover how the different estrogen and progesterone concentrations present throughout the menstrual cycle effect perceived readiness to perform, perceptions of difficulty, and different recovery metrics.

Although nearly half of the population is female, less than 10% of research resources are allocated to understanding how their dynamic physiology impacts athletic readiness, performance, and recovery. The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. This study aims to uncover how the different estrogen and progesterone concentrations present throughout the menstrual cycle effect perceived readiness to perform, perceptions of difficulty, and the inflammatory environment and quantification of muscle damage.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age
* BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths \[15\]
* Not taking contraception or other types of medication that could influence reproductive status
* Regular menstruation
* Non-pregnant
* Medically free from chronic diseases
* Novel to downhill running
* Weight greater than or equal to 110 lbs
* Not taking exogenous hormones
* Not suffering from known gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity

Exclusion Criteria:

* Amenorrhea or oligomenorrhea
* Perimenopausal or menopausal
* Recreational or professional trail or downhill runner
* On a form of contraception
* Cardiac disability
* Pacemaker
* Arterial disease
* Uncontrolled hemorrhage
* Blood clots
* Pregnant or trying to become pregnant
* Cancerous lesions
* Sensory or mental impairment
* Unstable fractures
* Weight less than 110 lbs
* Suffering from gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity
* Taking exogenous hormones
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD

The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).

Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.


Eligibility Criteria:
Inclusion Criteria:

* Age from 9.0 to 14.0.
* ADHD diagnosis following assessment at a child \& adolescent outpatient clinic.
* Clarification for stimulant treatment.

Exclusion Criteria:

* Moderate or severe mental retardation.
* Psychosis.
* Proven brain damage.
* Sensory deficits and/or motor impairments that make the individual in question unsuitable for the relevant tests.
* Epilepsy.
* The child has previously been prescribed stimulant medication or is being treated with such medication.
* The child commutes between parents or there are other factors that substantially reduce the possibility of obtaining reliable observations from parents (The child needs to live in one place through out the whole trial since otherwise might severely influence the child's behaviour and the observations).
Rates of Positive Basal Cell Carcinomas (BCCs) in Re-excisions

Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is primarily surgical with the goal of excising the growth in its entirety. When pathology results show that this has not been achieved, a re-excision is routinely performed. This study examines retrospectively the percentage of re-excisions of BCC that actually proved to be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare Campus and Zvulun Community Medical Center during the years 2008-10.


Eligibility Criteria:
Inclusion Criteria:

All patients that underwent an incomplete BCC excision during the years 2008-2010.

Exclusion Criteria:

Patients that underwent an incomplete BCC excision and were subsequently referred to undergo a MOHS procedure.
The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

Hemodialysis patients with low bone density (total hip T-score \<-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).

Follow-up period: one year. A second bone biopsy at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Bone mineral density (T-score\<-2.5)
* Adynamic bone disease for the teriparatide group
* Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
* Calcium greater than 8.1 mg/dl

Exclusion Criteria:

* Suspected carcinoma
* Unstable clinical setting
Effects of Progressive Muscle Relaxation Training With Music Therapy on Sleep Quality and Trait Anger/Anger Expression Style of Patients at Community Mental Health Center

Aim: The aim of the study was to examine the effects of progressive muscle relaxation training with music therapy on sleep quality, trait anger, and anger expression style of patients at the community mental health center.

Method: The study is conducted as the pretest-posttest control group design. The study population consisted of chronic psychiatric patients who continue in a Community Mental Health Center located in southeastern Turkey. The days when the participants came to the Community Mental Health Center were selected and the participants divided into two groups as an intervention and control group.


Eligibility Criteria:
Inclusion Criteria:

* Having a chronic psychiatric diagnosis according to DSM-V diagnostic criteria,
* Open and cooperate for communication,
* living in the city center,
* age was between 18-60

Exclusion Criteria:

* Patients who have just started the Community Mental Health Center
* patients diagnosed with axis 1,
* patients diagnosed with mental retardation,
* patients with drug or alcohol addiction,
* patients diagnosed with organic brain syndrome,
Pharmacotoxicology of Trichloroethylene Metabolites

This project focuses on the kinetics, metabolism and human toxicology of dichloroacetate (DCA)and tyrosine catabolism. The hypothesis is that tyrosine metabolism will be greatest in subject who harbor the KRT variant for GSTz1/MAAI for which DCA exhibits a high Km.

Specific Aim 4. Quantify the effects of DCA on human tyrosine metabolism and on its own biotransformation in relation to dose and genotype.

Eligibility Criteria:
Inclusion Criteria:

* Adults scheduled for elective surgery for benign liver disease.
* Normal EKG and history
* Normal baseline labs

Exclusion Criteria:

* Pregnancy
* severe anemia, defined as a hematocrit \< 30%.
* diabetes mellitus
* renal insufficiency, defined as a serum creatinine \> 1.5 mg/dl or a creatinine clearance \< 60 ml/min
* elevated liver enzymes
* psychiatric illness requiring medication
* primary biliary cirrhosis or any other form of cirrhosis
* viral hepatitis or non-viral steatohepatitis
* coronary heart disease, defined as requiring daily administration of anti-anginal drugs or as New York Heart Association Class III or IV heart failure
* malignancy of any type in any anatomical location
Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).

The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy

Exclusion Criteria:

* Age \< 18 year
* Pregnancy
* Refusal to sign informed consent
Allografts in Surgery of the Main Arteries

The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease in the short-term and long-term postoperative periods. Histological analysis of allogeneic grafts will be carried out at various time points of graft preservation with a Roswell Park Memorial Institute 1640 cell medicum with 400mcg/ml gentamicin and 20mcg/ml fluconazole at a temperature of +4C.

The physical properties of allogeneic grafts from postmortem donors (tensile and tear strength) will be evaluated at various conservation time periods (1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). Markers of endothelial dysfunction (IL-6, endothelin-1, 6-keto-prostaglandin F1alfa, eNOS) will be evaluated in patients with critical ischemia who undergo bypass procedures with arterial and venous allografts at various time points (before surgery, 7 days, 1 month, 3 months, 6 months, 1 year after).

The study will include 200 patients of similar age, gender, and ethnicity, who will be divided into four groups:

Group I: 50 patients who undergo arterial bypass procedures using autologous venous graft derived from great saphenous vein; Group II: 50 patients who undergo arterial bypass procedures using allogeneic venous grafts; Group III: 50 patients who undergo arterial bypass procedures using allogeneic arterial grafts; Group IV: 50 patients using biological bovine decellularized grafts.

Patients will be monitored for 2 years: at inclusion, and 1, 3, 6, 12, 18, and 24 months after bypass procedures.

The primary endpoint of the study will be mortality, i.e. death of the patient from any cause. Secondary endpoints of the study will be graft thrombosis and cardiovascular events such as myocardial infarction, acute coronary syndrome, transient ischemic attack, and stroke.

Eligibility Criteria:
Inclusion Criteria:

* males or females over 18 years of age;
* critical lower limb ischemia due to atherosclerotic peripheral arterial disease.

Exclusion Criteria:

* males or females less than 18 year of age;
* decompensated concomitant pathology;
* pregnancy or lactation.
Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour.

Background. There is a growing demand for long-term care settings. Care-home residents are a vulnerable group with high levels of physical dependency and cognitive impairment. Long-term care facilities' policy need to adapt and offer more effective and sustainable interventions to address their complex physical and mental health needs. Despite the increasing emphasis on patient and public involvement, marginalised groups such as care-home residents, can be overlooked when including people in the research process. The GET READY project aims to integrate service-learning methodology into Physical Therapy and Sport Sciences University degrees by offering students individual service opportunities (placements) with residential care homes, in order to co-create the best suited intervention with researchers, older adults of both genders (end-users) in care homes, health professionals, caregivers, family members and policy makers.

Methods. Stage 1 will integrate a service-learning methodology within a Physical Therapy module in Glasgow and Sport Sciences module in Barcelona, design two workshops for care home residents and conduct a co-creation protocol. Stage 2 will assess the intervention feasibility, safety and preliminary effects of the co-created intervention in a group of 33 care home residents, within a two-armed pragmatic randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

- Care Home residents ≥ 70 years old.

Exclusion Criteria:

* Comorbidity preventing participation (e.g. severe breathlessness, pain, or severe neurological disease).
* Life expectancy of less than one year.
* Being unlikely to undertake the intervention regularly.
* Severe dementia.
Examining the Feasibility of a Mindfulness Booster Course for Healthcare Staff Who Attended an 8-week Mindfulness Course

The goal of this clinical trial is to examine the feasibility and acceptability of a mindfulness booster course for UK healthcare staff who have previously participated in an eight-week mindfulness course. The measures of feasibility and acceptability that will be examined include: 1. the ease with which participants are recruited to the clinical trial; 2. the extent to which participants choose to remain in the mindfulness booster course; 3. the extent to which participants choose to remain in the clinical trial; 4. how acceptable the participants find the mindfulness booster course; 5. the level of outcome measure completion; 6. whether there is a preliminary indication that the course may reduce stress. Participants will be randomly allocated to either a mindfulness booster course or a control group, who will be encouraged to continue taking care of their wellbeing as they normally would. Participants will be asked to complete questionnaires at three time-points.

This pilot randomised controlled trial seeks to examine the feasibility and acceptability of a mindfulness booster course for UK National Health Service staff who have previously completed an 8-week mindfulness-based intervention. Participants will be randomised to either the 8-week mindfulness booster course or a control group, in which participants will be encouraged to continue taking care of their wellbeing as they normally would. A battery of self-report measures will be administered online at baseline (weeks 0-1), mid-intervention (week 7), and post-intervention (weeks 11-12). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (stress). These indices will be compared to progression criteria (which are detailed in the outcome measures section) to determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research.

Eligibility Criteria:
Inclusion Criteria:

* UK National Health Service staff member from the South-East, South-West and/or London, including, but not limited to, Sussex Partnership NHS Foundation Trust;
* have completed an 8-week staff mindfulness course within the past three-years (individuals will be considered to have "completed" a mindfulness course if they attended four or more sessions (Simpson et al., 2017; Verweij et al., 2018)).

Exclusion Criteria:

* currently on sick leave;
* planning on undertaking another 8-week mindfulness course;
* have previously found practicing mindfulness distressing.
An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks

The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time.

The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with age 18 to 70 years and a self-reported foot size between 8 and 14
* Subjects with regular knee pain
* Subjects with a baseline pain level of pain of ≥20 mm to ≤90 mm on 100 mm VAS scale at baseline (Visit 1)
* Subjects must be able to walk unaided by cane or walker.

Exclusion Criteria:

* Subjects with knee pain which is due to a recent injury
Gender-specific Preoperative Anxiety Level and Postoperative Opioid Requirement After ENT Surgery.

The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.

The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.

Background Due to the frequency of surgeries, acute postsurgical pain (APSP) is a common clinical problem. In this study, the investigators will investigate pre-surgical psychological factors associated with the experience of APSP in ENT surgery.

The study will be designed to investigate the impact of gender-specific preoperative anxiety states, using the STOA, APAIS, PCS and VAS-A scoring systems, on postoperative opioid consumption after elective ENT surgery.

These findings may have important implications for developing more personalized strategies in acute postoperative pain therapy in selected patients.

Aim Study aim is to investigate the impact of the preoperative anxiety level, using the validated STOA questionnaire, on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.

The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.

The investigators hypothesize that a higher preoperative anxiety state, is a predictive factor of opioid requirement in the early postoperative period after ENT surgery.

Methods Surgery-related psychological factors like anxiety state will be assessed gender-specific, in patients scheduled for elective ENT surgery by validated questionnaires (STOA, APAIS, PCS and VAS-A), filled out by the patient the day before surgery and on the day of surgery, to investigate the correlation with the postoperative opioid consumption.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) physical status I-IV
* able to read and understand the information sheet and to sign the consent form
* being scheduled for elective ENT surgery under general anesthesia
* written informed consent
* age≥18 years

Exclusion Criteria:

* difficulty to understand study procedure, pain scoring system or questionnaires
* surgical procedure warranting elective postoperative ventilation