cyrilzakka/clinical-trials huggingface dataset:
'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations

With the aim to inspire and motivate workplaces in their work to prevent and reduce occupational health and safety hazards, the Danish Working Environment Authority (WEA) developed the intervention 'Dialogue and Guidance' aimed at workplaces receiving notices (prohibition notice, immediate improvement notice and notice with time limit) from WEA during inspections. At present, WEA gives dialogue and guidance as standard practice during WEA inspections to all workplaces receiving a notice with the purpose to help workplaces resolve the occupational health and safety problem that led to the notice. In the intervention 'Dialogue and Guidance' the experimental groups are receiving additional dialogue and guidance at a subsequent meeting (over the telephone or physical presence) that takes place after the inspection and after the deadline for appealing the notice has expired. The control group is receiving dialogue and guidance during inspection as usual.

The aim of this RCT study is to evaluate the policy-developed intervention with additional 'Dialogue and Guidance' in regards to the effect on motivation and priority of occupational health and safety work at the workplace after 6 months follow-up and for WEA notices by next WEA inspection (approx. follow-up by 12-18 months).

Study is risk assessed and approved under Danish Data Protection Agency via the National Research Centre for the Working Environment's umbrella approval.


Eligibility Criteria:
Subjects under inspection are workplaces, and respondents of the questionnaires are the workplace manager and a work environment representative or shop steward.

Inclusion Criteria:

• Workplaces (production units) who receives a WEA notice during WEA inspection through the period of intervention. The following WEA notices are included:

* Immediate improvement notice
* Notice with time limit (material)

Exclusion Criteria:

* Companies with 0-1 employees.
* Production units from the construction industry met on temporary worksites (such as construction sites) that have more than one employee and does not have a certified occupational health and safety management system.
* Companies receiving notices only about issues in the formal/procedural aspects of the work environment (such as flaws in the workplace risk assessment) and no other notices.
* Companies receiving more than four reactions from WEA at the inspection (as these receive a competency notice and are not included in the study).
* Companies that receive a prohibition notice by the WEA inspector due to severity of work environment violations.
* A WEA improvement notice is not eligible for inclusion in the study if the workplace has entered into a collaborative agreement with WEA on improvement of the issue, or if they have received a competency notice on the WEA issue.
* Companies receiving WEA inspections in relation to initiatives targeting social dumping
Effects of Daily Supplementation of 5-HTP on Body Composition

The purpose of this investigation was to compare supplementation with 5-HTP to placebo on indices of body composition. A randomized trial compared a sample of 48 resistance-trained individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo.

The investigators tested anthropometric measurements using a multi-frequency bioelectrical impedance device (InBody® 270). The primary outcome (i.e., changes in anthropometric measurements) was assessed at the first visit (pre-test-) and post-test (8 weeks). Secondary outcomes include resting heart rate, blood pressure, and dietary intake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or free of disease
* Minimum of 1 year of regular physical activity. Regular physical activity is defined by a minimum of 150 minutes of aerobic activity or performing muscle-strengthening exercises at least 2 days a week.

Exclusion Criteria:

* Physically inactive
* Regularly used sleep aids of any kind
* Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.
Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses

The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital.


Eligibility Criteria:
Inclusion Criteria:

patients and spouses aged 18 years or older patients diagnosed with colorectal cancer Patients scored ≥ 22 points on the Kessler Psychological Distress Scale assessment patients and spouses able to read simplified Chinese

Exclusion Criteria:

psychiatric problems requiring active treatment other terminal illnesses, such as advanced cancer currently undergoing psychotherapy or participating in similar trials
Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty

Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for the repair of primary unilateral inguinal hernia. Previous studies showed that patients underwent TEP have less post-operative pain and earlier return to normal activities. However, chronic pain is still a major issue affecting quality of life after TEP with a reported incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation to prevent mesh migration but nerve entrapment by staples causing intractable pain had been reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS) in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for application of FS laparoscopically is now available which can achieve mesh fixation by using fewer amounts of FS.

In this study, the investigators aim to compare the effectiveness of using fibrin spray for mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized controlled trial by allocating patients in two study arm in random manner. The treatment group will have the mesh fixed by fibrin sealant spray, whereas the control group will have conventional mechanical staples for fixation. Operative procedures and post-operative management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month after operation to evaluate the operative results and the incidence of chronic pain. Any complications related to the mesh and operation will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive male patients aged between 18 to 70 years with reducible unilateral inguinal hernia undergoing day-case TEP under general anaesthesia will be considered eligible.

Exclusion Criteria:

* Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large inguinal-scrotal hernia, previous abdominal incision (including previous contralateral hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs, end-stage renal failure, cirrhosis, impaired cognitive function and those not consent to study.
Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion channel properties similar to amiodarone.

Several case reports have shown promising results with Dronedarone for this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:

* CHF NYHA IV OR DECMPENSATED III
* PERMANENT AF
* LIVER DYSFUNCION
* CR CLEARANCE \<30
Chest CT for the Placement of the Uniblocker

Video laryngoscope and chest CT iminge for the placement of the Uniblocker

Comparing the traditional method of Uniblocker intubation and video laryngoscope combined with chest CT iminge guide the precise localization of Uniblocker

Eligibility Criteria:
Inclusion Criteria:

BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia

Exclusion Criteria:

* Age younger than 18 yr or older than 65 yr
* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* First metastatic breast cancer relapse after treatment for early stage disease
* A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging
* Patient prescribed cytotoxic, endocrine or biological therapies
* Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring
* Written informed consent

Exclusion Criteria:

* Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia
* Diagnosis of brain metastases.
* Contraindication to magnetic resonance MR imaging
The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE patients and determined alterations in inflammatory, hemostatic markers as well as disease activity before and after vitamin D supplementation.

248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months. Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18, TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12 months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were classified as vitamin D insufficiency, and levels \< 10 ng/ml as vitamin D deficiency.The mean 25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women and males of the same body mass index and ethnicity

Exclusion Criteria:

Patients with:

* other inflammatory disorders,
* hepatic disease
* renal disease
* malignant disease.
Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Because of the non-interventional nature of the study, there is no predefined treatment protocol. The patients will be treated according to the routine practices of the centers. In observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. The participating physician will continue to treat the patients according to their routine practices. Not only newly diagnosed patients, all aTTP patients within participated centers will be recruited and 12 months follow-up data will be collected. 21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as aTTP after 01.01.2015
* Patients with ADAMS13\<10%
* Thrombocytopenia (\<100.000)
* Coombs (-)
* Microangiopathic hemolytic amenia
* 18 years and older

Exclusion Criteria:

- Patient who does not sign informed consent form
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects

Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.

It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age: 18 - 45 years
* CYP2D6 phenotyped as extensive metabolizer
* CYP2C19 phenotyped as extensive metabolizer

Exclusion Criteria:

* Alcohol or drug abuse
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure

The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.

The term "cardiorenal syndrome" has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients. The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium. A vicious cycle may then ensue and be associated with increased cardiovascular complications. In this regard, renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought.

Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction.

Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand. By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemic,anti-stunning effect. To date, the effects of levosimendan on renal function in patients with worsening chronic HF, remain unknown.

Eligibility Criteria:
Inclusion Criteria:

* an ejection fraction (EF) 40% by transthoracic echocardiogram,
* a baseline pulmonary capillary wedge pressure (PCWP) 20 mm Hg
* a MDRD (Modification of Diet Renal Disease) score \> 30 and \< 60
* and a standard therapy for HF that should include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone blocking agents (spironolactone) and beta-blockers, unless contraindicated

Exclusion Criteria:

* patients receiving other oral or i.v. inotropes,
* oral or i.v. diuretics
* or receiving nitroglycerine or nitroprusside,
* patients with systolic blood pressure \<110 mmHg,
* mechanical ventilation,
* anticipated survival \<30 days,
* absence of thoracic windows for echocardiography,
* acute coronary syndromes,
* sustained ventricular tachycardia or ventricular fibrillation,
* documented renal artery stenosis, requiring dialysis,
* requiring admission primarily for concurrent morbidity,
* severe aortic or mitral regurgitation,
* left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy,
* uncorrected thyroid disease,
* known amyloid cardiomyopathy
* or known malfunctioning artificial heart valve.
Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in the HL patient and compare to existing historical control data.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical antifungal therapy.

Patient must have:

* Newly diagnosed clinical and histological hairy leukoplakia.
* Positive HIV antibody by licensed ELISA or Western blot.

Exclusion Criteria

Co-existing Condition:

Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.

Concurrent Medication:

Excluded within 2 weeks of study entry:

* Systemic antifungal treatment.
* Excluded within 6 weeks of study entry:
* Immunomodulators.
* Systemic antiviral treatment.

Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.

Prior Medication:

Excluded within 2 weeks of study entry:

* Systemic antifungal.
* Excluded within 6 weeks of study entry:
* Immunomodulators.
* Systemic antiviral treatment.
* Excluded within 8 weeks of study entry:
* Zidovudine (AZT) or other antiretroviral therapy.
Oral Functions and Malocclusions

The aim of our research is to establish a link between malocclusions and oral dysfunctions. The clinical examination includes: caries screening (DMFT and dft scores), a quantification of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute Autorité de Santé HAS). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.


Eligibility Criteria:
Inclusion Criteria:

* All the pupils benefit from the clinical examination

Exclusion Criteria:

* NONE
Tumor Exosome Liquid Biopsy Strategy to Diagnose Pancreatic Cancer

This is an observational study of patients diagnosed with pancreatic cancer by pathology, with a control group of patients with pathology suggestive of benign pancreatic lesions and normal subjects, and the diagnostic ability of exosomes to identify patients with pancreatic cancer was assessed through the detection of exosomes in the peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of pancreatic cancer confirmed by imaging (case) Diagnosis of chronic pancreatitis confirmed by imaging (hospital control)

Exclusion Criteria:

The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis

To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis


Eligibility Criteria:
Inclusion criteria;

-Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)

Exclusion criteria;

* Patients with a history of hypersensitivity to any ingredients of PARIET.
* Patients on atazanavir sulfate.
Pain Comparison Whit Visual Analog Scale (EVA) Between Four Analgesic Methods During Trans Rectal Prostatic Biopsy

Define the best analgesic method between peri prostatic blockage, analgesic suppository, oral analgesic and topic anesthetic gel, during trans rectal prostate biopsy

Comparison between four analgesic methods during trans rectal prostatic biopsy.

OBJECTIVE: To define the best analgesic method between the peri-prostatic block, the analgesic suppository, the oral analgesic, the final anesthetic gel, during the trans rectal prostate biopsy determined at the end of the procedure with a visual analogue scale for pain (VAS pain) in a Interview 15 to 30 minutes at the end of the procedure.

METHODS: experimental, retrospective, longitudinal, comparative, during May to July 2017, 350 trans rectal prostate biopsies were performed, all cases were randomly assigned to one of the four study groups. The data analysis will be performed by calculating measures of central tendency and dispersion for quantitative variables and ANOVA test, for qualitative variables Chi square to determine statistical differences between the three moments of pain in the parameters of introduction of the ultrasound transducer, sampling of Prostate of the minimum 12 biopsies and discomfort in general of the procedure

Eligibility Criteria:
Inclusion Criteria:

* Male patients older than 18 years with indication for trans rectal prostate biopsy

Exclusion Criteria:

* Bad intestinal preparation.
* Painful anorectal pathologies.
* Clotting disorders without previous assessment by hematology.
* Acute prostatitis
Blood Flow Restriction Strength Training in Professional Soccer Players

The aims of this clinical study are evaluated the effects of Blood Flood Restriction training on the sport performance of professional and semi-professional soccer players. The participants are twenty male professional and semi-professional soccer players who are playing at RCD Mallorca. Participants will be assigned in two different groups. Both groups develop for six weeks a strength training programs. The first group will base their training in Low Load using Blood Flow Restriction (20-50% of one maximum repetition). The second group will base their training in High Load (60-80% of one maximum repetition). This training program includes three type of exercises in each training session; back squat, single deadlift and barbell hip thrust. Before and after this program the investigators will collect sociodemographic and anthropometrics data. On top of that, the investigators will evaluate the muscle mass, the electrical activity produced by skeletal muscles, the muscle strength and the sprint ability of every participant. Before to the evaluation, the soccer players will warm-up during 15 minutes under the control of the evaluators.

PARTICIPANTS:

Participants are soccer players of RCD Mallorca (Second Spanish Football Division) and RCD Mallorca B (Third Spanish Football Division).Before to start the study, every participant will receive an informed consent about the clinical study. This informed consent will be signed by them according to Declaration of Helsinki. At the same time, the data will be anonymized and only the main researcher of the study will have access to it, to ensure compliance with the Data Protection Law.

W-UP:

The warm-up will consist of 5 minutes running slow (treadmill), 5 minutes mobility, and 5 minutes of running exercises. In addition, the warm-up will contain a familiarization with the jump test

Eligibility Criteria:
Inclusion Criteria:

* No injuries in the last 6 months
* 1 years experience minimun in the division.

Exclusion Criteria:

* Amateurs players