cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry.

The goal of this observational study it to learn about the prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind turbine industry. The main question it aims to answer is:

- What is the prevalence of skin sensitization and dermatitis among workers in the wind turbine industry who are exposed to epoxy?

Participants will be asked to perform Patch Test, which is considered the Gold Standard test for identifying the cause of occupational contact allergic dermatitis.

Researchers will compare the results of the epoxy-exposed group with those of a control group comprising non-exposed workers from the same industry. This analysis will help determine if there is a higher prevalence of skin sensitization among workers exposed to epoxy.

Epoxy resin systems are widely used materials in various industries due to their high mechanical, chemical, and thermal resistance. These systems are commonly employed as protective coatings, adhesives, and paints, as well as in the manufacturing of composites in the plastics industry. Epoxy components are well-known sensitizers of the skin. A high prevalence of skin sensitization and dermatitis have been reported among workers exposed to epoxy components. It is recommended to use comprehensive protective equipment when handling epoxy components. In the wind turbine industry, tasks involving epoxy handling, such as lamination and filling procedures, are frequently performed. Recent study have shown a sensitization prevalence of 8.9% among workers performing these tasks, while a previous study reported a high sensitization rate of 10.5% to epoxy resins. Despite efforts to find alternatives to epoxy resin systems and improve protective measures, the use of epoxy has increased, and some countries have implemented more stringent regulations, such as Denmark. In Portugal, there are currently no specific regulations regarding epoxy handling, and no certification is required for working with epoxy. Siemens Gamesa Renewable Energy, in Portugal, faces many skin problems among production workers, however numbers are unknown. Therefore, the main purpose of the study is to evaluate the prevalence of skin sensitization and dermatitis among epoxy-exposed workers in the wind Turbine Industry.

Eligibility Criteria:
Inclusion Criteria:

* Workers from the wind turbine industry

Exclusion Criteria:

* Pregnant females
* Workers previously diagnosed with epoxy resin sensitization
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.


Eligibility Criteria:
Inclusion Criteria:

* pathological or cytological confirmed advanced hepatocellular carcinoma
* 18 years to 80 years
* liver function Child-Pugh class B
* BCLC stage B or C
* estimated life time 2 months or longer

Exclusion Criteria:

* previous target therapy
* allergy to Sorafenib
* Uncontrolled Bleeding or diarrhea
* eligible for locoregional treatment
Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa

The study will perform UC-MSCs and CM transplantation. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

The eyes which will give the transplant should be given an aseptic and antiseptic technique to prevent the contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension (for UC-MSC + NaCl group). Stem cell suspension will be injected by peribulbar and if the injection was done, patients will be given a quinolone antibiotic. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increasing of eye pressure. On day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observation results will be written in the observation table and analyzed by a statistic. After the data was completed, then make a discussion, conclusion, and suggestion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Visual field defects at initial examination with Humhprey perimetry are between 25% to 50%
* Willing to sign informed consent as research subjects
* Willing to do peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue
* Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherrent Tomography (OCT) examinations, electroretinogram examinations and fill out a quality of life questionnaire

Exclusion Criteria:

* Pregnant or nursing women
* Positive result of HIV test
* Have a history of eye tumors
* In immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
* Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma
* Do not come to control according to the schedule determined by the researcher (loss to follow up)
Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.

This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* 4 molars to be removed

Exclusion Criteria:

* pregnant
* lactating
* chronic pain
* narcotic use
* asthma
* ex-smokers
Use of Predigraft in Kidney Transplant Patients

Kidney transplantation is the treatment of choice for end-stage renal disease in terms of morbidity, mortality, and cost-benefit ratio. Graft loss is mainly related to the occurrence of rejection. Hence the importance of regular monitoring to check that the graft is functioning properly, to adapt immunosuppressive treatments and to check for side effects related to the immunosuppressed state.

In conventional management, the patient is seen at regular intervals (ranging from 2 weeks to 3 months) in the referral transplant centre with recourse to hospitalisation if necessary. In the context of the COVID-19 pandemic, in order to reduce the risks of contamination, teleconsultations have been proposed to replace face-to-face consultations. Predigraft software facilitates remote patient assessment. This software provides an estimate of the probability of renal graft survival at 3, 5 and 7 years of the assessment based on an algorithm developed and validated by the U970 unit (Loupy A et al, BMJ 2019). The software also provides an application for patients allowing secure data transfer (biological analyses, blood pressure, weight). This allows the assessment of the need for additional patient evaluation based on usual monitoring parameters (creatinine, proteinuria) that can be done in the analysis laboratory near the patient's home.

A first evaluation of the use and acceptability among care professionals has been conducted between April and June 2020 and showed excellent results. It is now necessary to obtain real-life data to evaluate the use of the tool among patients and healthcare professionals and its impact on the organisation of care.

This is a prospective interventional study with minimal risks and constraints on the active file of transplant patients followed in ambulatory care for a period of 12 months.

The objective of this study will be to evaluate the use of the Predigraft platform by kidney transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient who received a kidney transplant from a living or a deceased donor and transplanted at least 1 month ago
* Patient over 18 years of age at the time of inclusion
* Stable renal function (glomerular filtration rate\>60 mL/min or decision at physician's discretion) at the time of inclusion
* Informed patient with signed consent
* Patient with access to an internet connection with a valid email
* Enrolled in a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant)
* Kidney transplant less than 1 month old
* Lack of recovery of kidney function following renal transplantation
* Patient unable to use the telemedicine tool
* Vulnerable participants (minors, protected adults, prisoners)
* Patient under State Medical Assistance
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV

Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.

Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following:
* HBsAg positive for a minimum of 6 months
* HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening
* Children and adolescents with compensated liver disease
* ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)
Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

Sedation is a component of the care of critically ill patients who are undergoing mechanical ventilation. Dexmedetomidine induces sedation while preserving a degree of arousability among patients in the intensive care unit (ICU), and its use has resulted in a shorter time to extubation, an increased number of days free from coma or delirium, a reduced incidence of agitated delirium, prevention of delirium, and lower mortality than other agents administered in certain populations. Hypotension and bradycardia are common side effects, which is lethal for the patients with persistent or severe hemodynamic instability.

The pharmacological properties of rimazolom suggest that it is an ideal sedative drug for critically ill patients, but there is no relevant clinical research to confirm it. Therefore, this study mainly discusses the efficacy and safety of remidazolam in ICU patients with mechanical ventilation, so as to provide theoretical basis for individualized sedation treatment of patients with mechanical ventilation.

1. Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation
2. Research center: Single Center
3. The Design of the study: Randomized, Controlled, Non-inferiority Trial
4. The population of the study: The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients
5. Sample size: Enroll 488 patients (244patients in each group)
6. Interventions: Participants in the test group received remimazolam for sedation, while participants in the control group received dexmedetomidine, The analgesia drug in two group is fentanyl.
7. The aim of the research: To investigate the efficacy and safety of remimazolam for sedation in ICU patients undergoing mechanical ventilation
8. Outcome# 1) Primary outcome# the ratio of the time to reach the target sedation (RASS score, 0 to -3)in the total duration of drug infusion, and the duration of mechanical ventilation. 2)Secondary outcome#; Length of stay in ICU and Length of stay in hospital; Incidence of complications (including re-hospitalization); Total expenses during hospitalization
9. The estimated duration of the study#2-3years

Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients.

Exclusion Criteria:

1. Refuse to participate in this study
2. Patients with severe bradycardia (HR\<50 bpm)
3. Patients who is pregnancy
4. Patients with brain injury or neurosurgery
5. Patients receiving sedation for treatment indications (such as epilepsy), not to tolerate a ventilator.
6. Patients receiving any study medication within 30 days
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

This is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG. Approximately 15 participants will be enrolled in the study.

This post-approval study is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG. There will be 3 periods in this study: Screening Period (up to 4 weeks), Treatment Period (26 weeks, including an Induction Phase and a Maintenance Phase), and Safety Follow-up Period (8 weeks). The overall study duration for an individual participant is estimated to be up to 38 weeks. Approximately 15 participants will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MG must be made by the following tests:

  1. Positive serologic test for anti-AChR Abs as confirmed at Screening, and
  2. One of the following:

     1. Abnormal neuromuscular transmission demonstrated by repetitive nerve stimulation, or
     2. History of positive anticholinesterase test, eg, neostigmine test, or
     3. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician
* MGFA Clinical Classification Class II to IV at Screening
* MG-ADL total score must be ≥ 6 at Screening and Day 1
* Participants who have:

  1. Failed treatment with 2 or more ISTs over one year (either in combination or as monotherapy), ie, continue to have impairment ADLs (persistent weakness, experience crisis, or unable to tolerate IST) despite ISTs or,
  2. Failed at least one IST and require chronic PE or IVIg to control symptoms, ie, participants who require PE or IVIg on a regular basis for the management of muscle weakness at least 2 cycles over last 12 months

Exclusion Criteria:

* Any untreated thymic malignancy, carcinoma, or thymoma
* History of thymectomy or any other thymic surgery within 6 months prior to Screening. Participants with a history of treated thymic malignancy or carcinoma are eligible if they meet all of the following conditions:

  1. Treatment completed \> 5 years prior to the Screening Visit
  2. No recurrence within the 5 years prior to the Screening Visit
  3. No radiological indication of recurrence in a computed tomography (CT) or magnetic resonance imaging (MRI) scan, including administration of intravenous (IV) contrast, performed within 6 months of first dose on Day 1
* Weakness only affecting ocular or peri-ocular muscles (MGFA Class I)
* MG crisis at Screening (MGFA Class V). However, such participants may be rescreened with Alexion approval once they are treated and medically stable, in the opinion of the Investigator
* History of N meningitidis infection or unresolved meningococcal disease
Sleep Spindles Organization as an Early Neural Marker of Neuromotor Outcome

The goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram (EEG), namely sleep spindles, as predictors of early sensorimotor maturation and long-term motor outcome. Spindles are discrete events, prominent over sensorimotor areas, that reflect motor learning overnight consolidation. They represent a potential marker for the investigation of altered early sensorimotor reorganization and long-term motor outcomes in the case of neuromotor pathologies. To test this hypothesis, we will validate the prognostic accuracy of a semi-automated EEG sleep-spindles analysis in two clinical populations: 1) infants with a perinatal brain lesion, at risk of Cerebral Palsy (CP), 2) infants with Spinal muscular atrophy type 1 (SMA1), a neuromuscular disease detectable at birth with variable response to early pharmacological treatment. A group of typically developing infants (at very low neurological risk) will be enrolled in the study as control group. All participants will undergo two sleep EEG recordings at 2-5 months (T1) and 12 months (T2), respectively. Short-term neuromotor outcome will be evaluated at T1 and T2, through standard and validated assessment. Long-term neuromotor development will be defined at 18 months (T3; i.e. CP vs NO CP; SMA treatment responders vs No responders). Primary clinical and motor outcomes will be used for estimating the effectiveness of spindles' features at T1 and T2 as predictors of later clinical and motor outcomes at T3. EEG sleep features will be considered both cross-sectionally, at each time point (T1, and T2), and from a longitudinal perspective. Differences in the EEG sleep-spindle features will be evaluated within- and between-groups.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 0-5 months who are at high-risk of Cerebral Palsy (CP): preterm and at term infants with a documented pre- or perinatal brain lesion at the neonatal brain MRI (i.e. hypoxic-ischemic brain injury, ischemic or hemorrhagic stroke, cystic periventricular leukomalacia, periventricular hemorrhagic infarction associated with germinal matrix-intraventricular haemorrhage);
* Infant aged 0-5 months who have received the diagnosis of SMA1, according to the perinatal genetic screening, and undergo early pharmacological treatment;
* Infants aged 0-5 months at very low neurodevelopmental risk (Control group): infants born preterm or at term in absence of perinatal neurological complications.

Exclusion Criteria (apply all groups):

* Presence of drug-resistant epilepsy or active epilepsy at T1,
* Severe sensory deficits (blindness or deafness)
* Diagnosis of progressive neurological disorders, other than SMA.
Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress

The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Men \& women, aged 30-70 years
* BMI 27-34.9 kg/m2
* waist:hip ratio \> 0.8 for women and \> 0.9 for men

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use within last 6 months
* Individuals taking estrogen or testosterone
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use (\> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Immune deficiency conditions
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 139 mmHg and/or diastolic blood pressure \> 89 mmHg
* Regular use of systemic steroids, oral or injectable
* Regular daily intake of ≥ 2 alcoholic drinks
* Infrequent (\< 3/week) or excessive (\> 3/d) number of regular bowel movements
* Gain or loss of ≥ 5% of body weight in the last 6 months
* Pregnancy
* Strict vegetarians
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes

The JACARDI trial is a multicenter study involving an educational training, with the general objective to improve the eHealth of older adults in relation to the management of type 2 diabetes.

The JACARDI trial is a multicentric study organized as a blended didactic and interactive educational training, with the general objective to improve the eHealth of older adults in relation to the management of type 2 diabetes, thus contributing to independent living, and reduce risks of negative consequences for the health status and quality of life.

The trial will be preceded by a pre-study, needed to personalize and finalize the contents of the training, together with the beneficiaries of the study. In particular, during the pre-study, a population with similar characteristics of the target group will be involved in focus groups to refine the contents and practicalities of the training before the recruitment starts.

The primary end-point of the JACARDI trial is the improvement of the eHealth literacy after the conduction of the training, to be measured through the eHEALS scale, after 10 weeks of training. The training consisting of 5 modules and will be conducted over 10 weeks (one session every other week), with each session lasting an average of 90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Low eHealth literacy (eHeals scale ≤ 29)
* No acute or untreated medical problems
* Mini Mental State Examination (MMSE) ≥ 24
* Geriatric Depression Scale (GDS) \< 2

Exclusion Criteria:

* A myocardial infarction or stroke within 6 months
* Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility
* Uncontrolled hypertension
* Advanced Parkinson's disease or other neuromuscular disorder
* Metastatic cancer or immunosuppressive therapy
* Significant visual or hearing impairment
Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars

Keloids and hypertrophic scars are a common subject of dermatologic consultations. Therapeutic management of such conditions remains challenging because of their high rate of recurrence and lack of curative treatment.

Silicone gel Sheeting (SGS) is one treatment modality that has proven effective for treatment of hypertrophic scar. One disadvantage of SGS is its application technique. To be effective, SGS must be applied on the scar for at least 12 hours daily. Topical silicone gel is a novel therapy that has shown promising result on scar prevention. However, the efficacy and safety of topical silicone gel for treatment of hypertrophic scar has not been confirmed.

Eligibility Criteria:
Inclusion Criteria:

* subjects at least 18 years old
* subjects with hypertrophic abdominal scar
* Have not received treatment on the scar at least 1 month prior to the enrollment.

Exclusion Criteria:

* subject who has previous history of silicone allergy
* subject who smoke cigarette
* subject who was treated with x-rays irradiation in the past