cyrilzakka/clinical-trials huggingface dataset:
Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy

This study evaluates the effect of additional transcranial direct stimulation (tDCS) on pain in patients with chronic neuropathic pain undergoing treatment with regional anaesthesiological techniques.

About 3.8 Million persons in Germany suffer from chronic pain with a relevant physical and social impairment representing approximately 7% of the population. Chronic pain conditions include patients with neuropathic pain such as trigeminal neuralgia, post-zoster pain or pain after amputations. There is a significant number of patients with pain without response to optimised drug therapy. Especially in these chronic pain patients there is data demonstrating maladaptive plasticity as pathophysiological evidence of structural changes in brain connectivity. Patients are treated with multimodal pain therapy concepts including interventional procedures with nerve infiltration techniques.

One innovative therapeutic option for pain patients is transcranial direct current stimulation (tDCS): In recent clinical trials, patients reported on reduced overall pain intensity following tDCS stimulation series shown e.g. from Bolognini et al., Antal et al. and most recently from Volz and colleagues. However, there is no current data available evaluating a role of tDCS for patients with chronic neuropathic pain treated with regional anaesthesiological techniques.

Objective: To evaluate effect of additional tDCS series on pain in patients with chronic neuropathic pain

Primary study endpoint: relative reduction in pain (initial VAS measured versus VAS after completion of the therapy series) as a numeric value between 0 and 10.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neuropathic pain with indication of regional anaesthesiological interventions

Exclusion Criteria:

* \<18 years of age
* Pregnancy
* Police custody
* Epilepsy
* Participation in another prospective clinical intervention study within the last 30 days
Recent and Non United Odontoid Fractures

The purpose of this study was to determine the clinical and radiographic long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions, with particular regards to late bony fusion, cervical spine motion, neurological sequela, and patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 65 years or older who had undergone surgical or non - operative management of odontoid non-unions were sorted and their dataset of follow - up monitoring was examined for completeness and accuracy. According to our inclusion criteria, patients with complete sets of collected data and a follow-up examination of at least five years after treatment of the non - union were finally enrolled in this study. Collected data included variables, such as age, gender, mechanism of injury, fracture type, associated injuries, presence and severity of primary neurological deficits, primary treatment, clinical and neurological outcome after primary treatment, methods of treatment, clinical and radiographic outcome after treatment of the non-union, as well as morbidity and mortality of the patients.

Exclusion Criteria:

Exclusion criteria for this study contain patients with previous or subsequent surgery at the cervical spine level, patients with incomplete data sets, as well as patients with penetrating mechanism of injury or congenital cervical spine anomalies. Incomplete data set was determined, if pertinent clinical or radiographic data of follow - up monitoring (e.g. documents of clinical findings or functional results, radiographs, CT-scanning, e.g.) were missing.
Home Telemonitoring System for Patients With Heart Failure vs Usual Care

This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves quality of life and HF related-knowledge. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.


Eligibility Criteria:
Inclusion Criteria:

* were over 18 years with a primary diagnosis of HF,
* had been hospitalized at least once time as a consequence of a HF decompensation,
* had a Smartphone,
* had access to WiFi,
* had access to a weight scale and to a blood-pressure monitor

Exclusion Criteria:

* illiterate patients,
* had learning difficulties,
* had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women

Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.

The oral contraceptive pill is the most commonly used birth control method. It is debated whether the birth control pill affects how the body handles insulin and sugar, or whether the pill changes heart disease risk. The goal of this study is to evaluate whether certain factors, such as how the body processes hormones, and demographic factors (e.g. body weight and race), influence how the pill affects the handling of insulin and sugar, and heart health.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal, regular-cycling women 18-35 years
* Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
* non-smoker.

Exclusion Criteria:

* Diabetes
* Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
* Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure \>160/100 mmHg, pregnancy or lactation)
* Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months
Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge

Efficacy of transitional case management following psychiatric hospital discharge: a randomized trial

Background The movement of deinstitutionalisation in Western societies has modified the role of psychiatric hospital, which has lost its asylum function to become a place for acute care.

Psychiatric stays are now shorter and close interactions with the outpatient care network is therefore more critical than before. The first weeks following discharge from psychiatric hospital represent a period of high risk for relapse, readmission or even suicide. Case management has a proven efficacy in facilitating patients' deinstitutionalisation after very long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies exploring the impact of time limited case management following discharge from short stays (transitional case management) in earlier phases of psychiatric disorders in connection with primary care are lacking.

Working Hypotheses The investigators hypothesize that transitional case management following hospital discharge decreases risk of readmission, improves adherence to outpatient care, facilitates recovery and improves patients' satisfaction with treatment as compared to routine care.

Specific Aims In this study, the investigators will compare the impact of both intervention on number of contact and level of adherence to outpatient care. The investigators will also compare both groups on number of readmission, risk of early aggravation of the disorders, level of functioning and satisfaction with care.

Methods This is a randomized single-blind study comparing transitional case management after discharge with routine post-hospitalization care for subjects living independently without institutional psychiatric follow-up. Demographic and clinical data will be gathered during hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of outcomes using validated instruments will be: contact and level of adherence to outpatient care (primary outcomes), as well as number of hospitalization days, number of readmissions, severity of illness and satisfaction with care (secondary outcomes).

Expected Value of the Proposed Project This study should improve psychiatric patients follow-up in collaboration with the different levels of care in the global context of deinstitutionalization.


Eligibility Criteria:
Inclusion Criteria:

* Patients are 18-65 years of age
* No immediate institutional follow up after discharge
* Independent living condition

Exclusion Criteria:

* Organic brain disease
* Clinically significant concurrent illnesses
* Poor understanding of French
Testing an Intervention in Irritative Contact Dermatitis

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.

An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. Therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve SLS induced contact dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers who gave written informed consent

Exclusion Criteria:

* · skin cancer

  * skin disease
  * skin damage on measurement sites
  * use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  * use of drugs that may cause photosensitivity
  * use of emollients three days prior the inclusion in the trial
  * non-adherence to the trial protocol
  * exposure to artificial and excessive natural ultraviolet (UV) radiation
  * pregnancy and lactation
  * history of vitiligo, melasma and other pigmentation and photosensitivity disorders
  * immunosuppression
  * allergic or irritant reactions to the constituents of the cream
Anatomy-based Fitting in Unexperienced Cochlear Implant Users

The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).


Eligibility Criteria:
Inclusion Criteria:

* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
* Post-OP CT scan of the CI electrode available
* Subject implanted with MED-EL cochlear implant(s)
* Subjects received a Flex28, FlexSoft and Standard electrode
* Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
* Audio processor not yet activated on the newly implanted side
* The most apical active electrode contact has to be inserted at least 450°
* Minimum of 10 active channels can be activated
* Fluent in the language of the test centre
* Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* EAS user (user of an EAS audio processor)
* Implanted with C40+, C40X and C40C
* Implanted with an ABI or Split electrode array
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
The HIV Testing Trends and Outcomes at a Johannesburg Trauma ICU Unit

A retrospective observational study on the HIV testing trend and outcomes in a trauma population admitted to a critical care unit for care.

Trauma ICU admission of 18 years and older were enrolled in the study. The HIV status was further divided into HIV-positive, HIV-negative, and HIV-unknown subgroups. The gender, ages, mechanism of injury, injuries sustained, ISS, physiological data, septic-related complications, and in-hospital mortality were noted and further analyzed.

Descriptive statistics were utilised using STATA version 15, and a p-value of \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria: Trauma patients admitted to a Trauma ICU at CMJAH -

Exclusion Criteria: Those under the age of 18 or with incomplete data

-
Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

Alcohol is a major public health problem and its neurotoxic effects are, among other things, responsible for altering the functioning of cerebral neurotransmission pathways.

The retina is an anatomical and developmental extension of the central nervous system. It is composed of several layers of retinal neurons that share similar anatomical and functional properties with brain neurons. Retinal neurons are notably equipped with a complex system of neurotransmission constituted by the main neurotransmitters that are involved in the central effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of indirect investigation for abnormal central neurotransmission pathways following regular alcohol use. It is recognized to date as a good site for investigating central abnormalities in neuropsychiatric and addictive disorders.

The objective of this project is to study the retinal function using electroretinogram (ERG) in regular alcohol users to isolate potential markers of cerebral neurotransmission abnormalities.


Eligibility Criteria:
For alcohol consumer with alcohol use disorder :

Inclusion Criteria:

* aged between 18 and 35 years
* alcohol use disorder according to the DSM 5
* affiliation to a social security scheme

Exclusion Criteria:

* psychoactive substance consumption (other than alcohol)
* psychiatric disease in progress according to the DSM 5
* neurologic disease in progress
* mental impairment making it difficult or impossible to participate to the study
* major under guardianship or curatorship or under safeguarding of justice
* pregnant women or feeding
* people in emergency situation
* participation to another interventional study
* retinal disease in progress
* chronic glaucoma
* ophtalmic disease affecting the visual acuity
* ocular infection in progress
* urinary positive drug check the day of the inclusion
* postive Breathalyser the day of the inclusion
Hidradenitis Suppurativa Wound Care

The objective of this case series is to monitor time and outcome of healing of wounds associated with HS using Endoform \[ovine forestomach\], Hydrofera Blue \[methylene blue and gentian violet\], and Hypafix tape. a combination methylene blue, gentian violet, and ovine forestomach wound care product.

Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease most frequently affecting the axilla, groin, and inframammary regions. Symptoms include nodules, abscesses, sinus tract formation, malodorous drainage, and scarring. These symptoms interfere with everyday activities, which can lead to social embarrassment and isolation. Patients with HS suffer psychological effects, such as increased levels of anxiety, depression, and loneliness, which impair quality of life.

Patients suffer with the burden of at home wound care for recurrent, draining nodules. Persistent lesions affect patients' lives by limiting their daily activities. Currently, patients are instructed to use gauze and tape to cover draining wounds, but this can be insufficient and difficult due to the nature and location of lesions associated with HS. Patients suffer with caring for their wounds, which can lead to frustration. Providing patients with a standard wound care regimen to take home can improve patients' quality of life and control of their disease. General recommendations for wound care in HS patients are limited. Improvements in the standard of care for wound management in HS are needed to aid patients.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules
* Individuals over 18 years of age

Exclusion Criteria:

* Individuals younger than 18 years of age
* Individuals without a diagnosis of HS
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA

To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.


Eligibility Criteria:
Inclusion Criteria:

* Healthy child
* Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
* Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose

Exclusion Criteria:

* Receipt of more than 3 doses of any Hepatitis B containing vaccine
* History of clinical diagnosis of infection due to Hepatitis B
* History or current close contact with known carriers of Hepatitis B virus
* Prior known sensitivity or allergy to any component of HBVAXPRO
* Chronic illness / medical condition that could interfere with study conduct or completion
* Coagulation disorder that would contraindicate intramuscular injection
* Subject is pregnant
* Receipt of corticosteroids for more than 14 days in the 30 days prior to study
* Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
* Planned participation in another clinical study
Collagen Alterations in Patients With Abdominal Wall Hernias

The aim of this study was to evaluate collagen turnover in patients with multiple hernias

Venous blood was collected and markers for type IV and V collagen synthesis and breakdown was measured

Eligibility Criteria:
Inclusion Criteria:

* patients with a history of three hernia repairs (multiple hernia group)
* patients without any history or presence of hernias (control group)

Exclusion Criteria:

* connective tissue disorder (Ehlers-Danloss/Marfan)
* presence of hernia upon clinical examination (control group)
Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

The purpose of this study is to compare the diagnostic validity (sensitivity and specificity) and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.

After screening,each asthmatic patient will visit the investigators' center 4 times.

During the first week, the patient will be randomised to undergo methacholine bronchial challenge with Wright or Devilbiss 646 nebulizer on two separate days, which are at least 24 hours but not more than 7 days apart.The above procedure will be repeated for each patient in one month. But the nebulizer will be selected in a reverse order.Provocative concentration induced a 20% decrease in forced expiratory volume in one second (PC20) will be calculated for each test. Record all the adverse events during the tests.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of asthma;
* stable for more than 4 weeks with FEV1≥65%pred

Exclusion Criteria:

* exacerbation within 3 months;
* upper airway infections within 4 weeks;
* concomitant of hypertension or heart diseases;
* pregnancy;
* under immunotherapy
China PEACE-Retrospective CathPCI Study

Coronary heart disease (CHD) is one of the leading causes of mortality and morbidity. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. Within a nation-wide and regional representative probability sample of hospitals in China, 14,000 CAG/PCI inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will be reviewed and abstracted in the national coordinating centre, in order to evaluate the treatment pattern, outcomes, and cost for PCI, during the past decade. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve patients outcomes in future finally.

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the magnitude and quality of PCI, which has developed rapidly during the past several decades. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

To investigate the treatment pattern and outcomes of PCI during the past decade in China, using a stratified two-stage cluster sampling design, from 70 sampled hospitals, 7,000 CAG/PCI cases will be selected in 2011, and 3,500 in 2001 and 2006 separately. Photocopies of the 14,000 medical records of CAG/PCI cases will be sent to the national coordinating centre. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted by well trained professional abstractors. By characterizing differences in patients' features, comparing the use of medications and procedures, and examining the in-hospital outcomes, we'll define the gaps between clinical practice and guidelines, as well as the disparities across different regions and hospitals, to evaluated the treatment pattern and outcomes in the last decade in China. New knowledge will be generated about PCI management all over China, to provide evidence for policy-making and clinical guidelines, and to improve patients prognosis in future finally.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients undergoing a diagnostic cardiac catheterization and/or percutaneous coronary intervention (PCI) for coronary lesions.

Exclusion Criteria:
Extracellular Vesicles and Endothelial Function in Transgender Subjects

Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Hormonal treatment is prescribed in transgender subjects to promote the development of sexual characteristics of the desired sex. Early cardiovascular effects of hormonal treatment have been reported in transgender men, while long-term mortality is higher in transgender women. The aim of this project is to study the effects of gender affirming hormonal treatment on arterial stiffness in young transgender subjects followed at the University Hospital of Nancy.


Eligibility Criteria:
Inclusion Criteria:

* Trasgender subject demanding gender affirming hormonal therapy

Exclusion Criteria:

* Previous hormonal therapy
* Pregnancy
* Chronic disease
* Cancer
* Obesity
* Drug abuse
* Alcohol
* Tabac