cyrilzakka/clinical-trials huggingface dataset:
Development, Acceptability and Preliminary Efficacy of an Internet-Based Self-Help Program

This study aims to evaluate acceptability and initial effectiveness of an internet-based self-help program utilizing Acceptance and Commitment Therapy specifically for healthcare workers, intending to address burnout.

This pilot study is a randomized controlled trial of two parallel groups. The study will comprise of an intervention and a wait-list control group. The intention of this study is to evaluate the acceptability and preliminary efficacy of an internet-based self-help program with minimal telephone support utilizing Acceptance and Commitment Therapy for alleviating burnout among healthcare workers.

Eligibility Criteria:
Inclusion Criteria:

* Currently employed in the healthcare field as a doctor, nurse, technician, pharmacist or other healthcare profession for a minimum of six months.
* Proficiency in using computer and email.
* Experiencing symptoms of burnout related to the workplace.

Exclusion Criteria:

* Currently prescribed psychotropic medication.
* Currently undergoing psychotherapy.
* Presently experiencing thoughts of suicide or self-mutilation.
Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy and Their Role in Antitumor Activity

Examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil functions like chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients undergoing chemotherpy for solid and hematological malignancies. This data could shed new light on the mechanism responsible for the increased susceptibility to infection among these patients and aid in improving their prophylactic antimicrobial treatment.

NETs formation against tumor cell lines and their ability to kill tumor cells will also be examined. The finding of NETs activity against tumor cells could have a major contribution to the investigators understanding of the function of the immune system against cancer.

Neutrophil function, including NETs formation, chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, will be examined in 50 pediatric patientsundergoing chemotherapy for solid and hematological malignancies. Children with the following malignancies will be examined: acute lymphoblastic leukemia,acute myelogenous leukemia,Hodgkin's lymphoma,non-Hodgkin's lymphoma, primary bone sarcoma,rhabdomyosarcoma,non-rhabdomyosarcoma,neuroblastoma,Wilms' tumor,hepatoblastoma or hepatocellular carcinoma,germ cell tumors, and hystiocytosis. Also those with brain tumors such as medulloblastom,low grade glioma,high grade glioma,ependymoma,and embryonal and pineal region tumors. Data gathered on the patients will include background data (age, gender, ethnicity) and background diseases, data on current illness (histologic type, grade, stage, response treatment,infectious episodes), and on the use of ranulocyte-colony stimulating factor (G-CSF).

The following time points will be examined:

1. At diagnosis, before initiation of chemotherapy.
2. immediately before the 2nd course.
3. After the middle course.
4. A month after the last course.
5. Three months after the last course.
6. In acute myelogenous leukemia and acute lymphoblastic leukemia,time points also include the middle of the maintenance course and 3 months after the end of maintenance.

An additional blood examination will be used to examine NETs formation against tumor cell lines and their ability to kill tumor cells.

Eligibility Criteria:
Inclusion Criteria:

Included in the study were patients with:

* Acute lymphoblastic leukemia or acute myelogenous leukemia.
* Hodgkin's lymphoma or non-Hodgkin's lymphoma.
* Primary bone sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma, neuroblastoma, Wilms' tumor, hepatoblastoma or hepatocellular carcinoma, hystiocytosis, and germ cell tumors.
* Medulloblastoma, low grade glioma, high grade glioma, ependymoma, and embryonal and pineal region tumors.

Exclusion Criteria:

* A severe background disease that may affect Neutrophil function (e.g., diabetes, lupus).
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)

The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.

Up to 100 clinical sites will enroll subjects who have received CorMatrix ECM for pericardial reconstruction.

The following clinical data will be collected at a single post-operative visit:

* Demographic information
* Pre-operative risk factors
* Surgical procedure
* Blood transfusion information, if applicable
* Chest tube placement information
* Surgical complications
* Use of anticoagulation medication
* Cardiac related procedures since surgical procedure
* Device related adverse events

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received CorMatrix ECM for pericardial reconstruction
* Sign an Informed Consent

Exclusion Criteria:

* None
Pessary Satisfaction Criteria for Urogenital Prolapse

Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate.

The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.

This is a prospective observational cohort conducted at the Universitary hospital of Caen over a total period of 5 years.

Patients with a symptomatic genital prolapse will all be offered the installation of a pessary. If they agree to participate in the study, they will be asked to respond to validated questionnaires: symptom questionnaires (PFDI-20, ICIQ-SF, USP), a sexuality questionnaire (PISQ-12), a quality of life questionnaire (PFIQ-7, BIS) and Satisfaction (PGI-I), several times: Before the installation of the pessary, at one month, at 6 months, then annually over 5 years

Eligibility Criteria:
Inclusion Criteria:

* The research protocol will be proposed to all patients with a symptomatic genital prolapse, over 18 years of age, who speak French and who agree to participate in this study
* Prolapse defined according to the International Classification POP-Q-.

Exclusion Criteria:

* Minors under 18 years of age
* Pregnant or lactating women
* Women Not speaking French (the good understanding of French is necessary to answer questionnaires and for informed information)
* Women unable to understand due to cognitive impairment or degenerative disease (dementia/ Alzheimer's disease)
Zinc Pneumonia Outpatient Trial in Children < 2 Years

The purpose of this study is to determine whether zinc can be used in combination with standard antibiotics to reduce the duration of illness and the likelihood of treatment failure among children less than two years old who have non-severe, outpatient pneumonia.

This study is a follow up to an earlier study among hospitalised children less than two years old with severe pneumonia who were administered zinc as an adjuvant along with standard antimicrobial agents. That study found a 20% reduction in illness duration and hospitalisation, as well as a 3 - 9 fold reduction in treatment failure for children given zinc along with standard antimicrobial management. However, since most pneumonia is managed in an outpatient setting, it is important to know if it works in this setting as well. We hypothesise that zinc may act as an acute phase reactant in the early stages of outpatient non-severe pneumonia to reduce both the duration of illness and the likelihood of treatment failure.

To test this, we will randomise children less than two years old to receive either zinc or placebo can as an adjuvant to standard oral antimicrobial agents in the acute treatment of non-severe pneumonia in an outpatient urban setting. Oral antibiotics will be given for a standard five-day course, while zinc (20 mg) or placebo will be administered once-daily for 10 days. Patients will be followed up on a daily basis at home to monitor their progress and document compliance.

Outcomes will be a comparison between zinc and placebo groups on duration of illness, as measured by specific signs of pneumonia, and treatment failure, as measured by change of antibiotics or hospitalisation for failure to improve or worsening condition.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pneumonia

Exclusion Criteria:

* Wheezing at presentation History of chronic lung, heart or other system disease suspected tuberculosis, active measles, severe malnutrition requiring hospitalisation, signs of systemic illness (sepsis, meningitis), those who have already received zinc/placebo supplements during this study, those known to be pre-treated with antibiotics prior to presenting to clinic
Thyroid Nodule Gene Sequencing in a Danish Population

This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population.

Patients with thyroid nodules suspected of malignancy is included prospectively.

Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.


Eligibility Criteria:
Inclusion Criteria:

* Thyroid nodule \>1.5 cm
* BSRTC: IV, V, og VI

Exclusion Criteria:

* No surgical specimen available
* Purely cystic nodules
Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)

Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.

Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.

FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with \>15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning.

The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population.

Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

Eligibility Criteria:
Inclusion Criteria:

* The only inclusion criterion was the availability of tissue for biomarker studies.

Exclusion Criteria:

* Disease Progression
Ocular Effects of Scleral Lens Wear on Dry Eye Patients

The purpose of this study is to investigate the effects of scleral contact lens wear on a DE population using coated (Hydra-PEG) and uncoated (control) lenses. Symptoms of DE, quality of the tear film, quality of life, epithelial and overall corneal thickness, vision and comfort will be assessed before and after dispensing and wearing the lenses for four weeks.


Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read, understood, and signed the information consent letter.
* Has been diagnosed with dry eyes.
* Has reduced tear break up time (NITBUT) and/or reduced tear meniscus height (TMH), clinical sign of dry eye disease and contact lens discomfort or is symptomatic of dry eye.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has greater than 13 points on the OSDI.
* Has greater than 4 points on the Standardized Patient Evaluation of Eye Dryness (SPEED).

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Is using any topical medications that will likely affect the study outcome.
* Has undergone any form of corneal surgery.
* Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye not related to the signs of dry eye.
* Has any clinically significant lid or conjunctival abnormalities and active neovascularization on the cornea.
* Anatomic variations of the conjunctiva that can impair proper scleral or soft contact lens wear/fitting
* Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration) which may significantly impact visual function and assessment.
* Is participating in any other type of eye related clinical or research study.
* Has any active ocular infection and may require topical medications.
* Currently taking any systemic medication that may affect the study outcome.
* Is pregnant
* Has been diagnosed, recovered, or tested positive but asymptomatic with COVID-19.
UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability

The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.

The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as an outdoor and indoor mobility device by individuals with walking impairment.

A new powered wheelchair has recently been developed to address the ability of the user to be able to position them in an upright, standing position. This new device is called the UPnRIDE powered wheelchair and is different from other upright wheelchairs because current standing wheelchair models have limited mobility in the standing position. The UPnRIDE is an upright or seated mobility device that is intended to provide full upright standing posture in a mobile powered wheelchair. The UPnRIDE powered wheelchair provides wheelchair and scooter users the ability to engage in society in either a standing (upright mobility) or seated position (seated mobility). Additionally, the option to have upright posture throughout the day may have the potential to improve some of the secondary medical conditions associated with the extreme sedentary lifestyle that paralysis from SCI imposes. This wheeled, motorized device can provide mobility to most urban environment situations by being able to be navigated indoors and outdoors and over different surfaces in both the standing or seated positions.

Eligibility Criteria:
Inclusion Criteria

1. Males and non-pregnant, non-lactating females
2. Ages 18-70
3. Suffered from a SCI which caused Tetraplegia, ASIA A-B-C
4. At least 1 year after SCI
5. Height of 155 to 190 cm;
6. Weight less than 100 kg
7. Able to sign informed consent.
8. Power or manual wheelchair user as a primary means of mobility
9. Regular user of a standing frame or tilt table for at least 30 minutes a week Exclusion Criteria

1. History of severe neurological disorder other than SCI (multiple sclerosis, cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury, stroke, etc.) 2. Concurrent severe medical disease 3. Pressure sores 4. Unstable spine 5. Unhealed limb or pelvic fractures 6. Psychiatric or cognitive status that may interfere with the trial
Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

The purpose of this study is to evaluate the potential effect of multiple doses of neratinib on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or excretes) of a single dose of digoxin.


Eligibility Criteria:
Inclusion criteria:

* Healthy men and women of non-childbearing potential, age 18-50
cTBS Targeting Cerebellum for Drug-refractory Epilepsy

This study aims to observe the effect and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-refractory epilepsy(DRE), in order to provide a new treatment for DRE and improve the quality of life of those patients. A total of 44 patients with DRE will have cTBS via accurate navigation to bilateral cerebellar dentate nuclei. Patients will be randomised into 2 groups in a crossover trial design to have 2 week periods of cTBS separated by 8 week washout periods, following which the patient will cross over to have the opposite condition for a further 2 week. Frequency and symptoms of seizures, scalp EEG, clinical scores, and QOLIE-31 were assessed at baseline and after 1 and 2 month of treatment.


Eligibility Criteria:
Inclusion Criteria:

* a) Participants who are in line with the diagnostic criteria for epilepsy,
* b) Participants who are diagnosed as drug-refractory epilepsy,
* c) Participants who has duration of epilepsy ≥2 years and seizure frequency ≥2 times per month,
* d) The type and dosage of anti-epileptic drugs do not change during the experiment,
* e) Participants or their families reject invasive therapy, such as operation,
* f) Participants and their families are aware of this study and sign informed consent.

Exclusion Criteria:

* a) Participants who are in status epilepticus,
* b) Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders,
* c) Participants who are diagnosed as syncope, hysteria or other non-epileptic attacks,
* d) Participants who are in pregnancy or lactating,
* e) Participants who have incomplete clinical data,
* f) Patients have contraindications of repeated transcranial magnetic stimulation.
Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions

Depression and chronic medical conditions are common in older adults. Qigong is increasingly documented to have anti-depressive effects for older adults. Nevertheless, the scientific concepts behind qigong remain a mystery. To fill the knowledge gap, the neurobiological mechanism of the effects of qigong was explored. In addition, the benefits of qigong on subjective well-being, functional independence, sleep quality, mobility, and muscle strength were also tested. After random assignment, intervention group (n = 14) went through individual qigong exercise twice a week and for 12 weeks,whereas control group (n = 16) was involved in cognitive training activities with mobilization elements. The psychosocial, physical, and neurobiological outcomes of the two groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 or above
* have been suffering from chronic medical conditions for more than one year
* have depressive symptoms as indicated by Geriatric Depression Scale (GDS ≥ 6)

Exclusion Criteria:

* have practiced or received training of any form of mind-body exercises (including tai chi, yoga, and qigong) during the 6 months prior to intervention.
* have changed medication or the dosage prior to or during intervention
* have obvious cognitive and language impairment or score less than 20 in Mini-Mental State Examination (MMSE)
* undergo electroconvulsive therapy, psychotherapy, or psychoeducation
* cannot demonstrate satisfactory sitting balance
Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation

The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Adult patients \> 18
* ASA score I-III
* Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* Emergency surgery
* Sore thoat ≤ 1 month
* Risk of aspiration of gastric contents
* Body mass index (BMI) \> 35
* Patients with expected airway difficulties
* Contra-indication for any of the devices (symptomatic hiatal hernias, pathological obesity, poly trauma or serious injury, delayed gastric emptying, use of opiates during fasting)
* Patients who are not fasting for routine and emergency anesthesia
* Trismus, limited mouth opening, abscess or pharyngoperilaryngeal mass
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.

An interim analysis will be performed when 25 patients per group will be included.

Secondary objectives of this clinical trial :

* To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.
* To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with Atorvastatin, CPAP and placebo.
* To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men or women \> 18 years old
* Subjects diagnosed with OSAS (apnea/hypopnea index = AHI \> 30/h)
* Subjects with clinical ATH from grade I or II controlled with mono-therapy(140\<SAP\<180 mmHg and 90\<DAP\<110 mmHg)

Exclusion Criteria:

* Patients with a history of prior stroke or coronary ischemic disease
* Chronic respiratory disease (PaO2 \< 60 mmHg and/or PaCO2 \> 45 mmHg)
* Lung disease
* Hypothyroidism
* Statin treatment
* Antihypertensive treatment with more than one drug
* Pregnant or lactating women
* Alcohol consumption \> 3 units/day
* Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin.
* Hypersensitivity to one of the drug compounds
* Patients with modified concomitant treatments during the 3 months before inclusion
* Potentially dangerous sleepiness
* Jobs at risk