cyrilzakka/clinical-trials huggingface dataset:
Sleep and Wellbeing Study

Most people will experience a psychologically traumatic event, such as a life-threatening accident, at some point in their life. In the initial days after such an event, it is common to be haunted by intrusive memories: image-based memories of the event that spring to mind unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark symptom of post-traumatic stress disorder (PTSD).

Sleep is important for many functions involved in how people perceive, respond to and remember events, including stressful/traumatic events. Studies with patients who have experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma are associated with later PTSD symptoms. However, in a previous study with healthy volunteers exposed to experimental trauma (film footage), those who were sleep-deprived in the first night, compared to those who slept, had fewer intrusive memories in the following week. This raises the question of how sleep in the first night, but also the first week, after real-life trauma is related to subsequent intrusive memories and PTSD symptoms.

The current study is an observational study of patients recruited from a hospital emergency department after a traumatic event. After completing brief baseline questionnaires in the emergency department, participants will be asked to fill in a daily diary of their sleep and intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and depression will be assessed by post/online at one week and two months. Participants will be telephoned after two months to complete an interview to assess PTSD symptoms and an optional feedback interview.

This clinical study will be the first to assess the relationship between sleep in the first night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings may have implications for developing simple sleep-based preventive treatments after trauma in the future.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Experienced or witnessed a traumatic event (i.e. one in which they were exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence)
* Present to the emergency department on the same day as the traumatic event
* Report memory of the event
* Fluent in written and spoken English
* Alert and orientated, Glasgow Coma Scale score (GCS) = 15
* Willing and able to give informed consent and complete study procedures

Exclusion Criteria:

* Loss of consciousness
* Current intoxication
* History of severe mental illness
* Current substance abuse or neurological condition
* Currently suicidal
ACTiF- Assessment of Closed Tibial Fractures

The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure


Eligibility Criteria:
Inclusion Criteria:

* Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;
* Closed tibial fractures Types A, B \& C (See OTA fracture classification) can be included.

Exclusion Criteria:

* Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis;
* Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb;
* Subjects with a fracture gap of \>1cm after initial surgery and prior to drug administration;
* Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.
Role Of Phospholipid Transfer Proteins (Pltp) On Endotoxemia Caused By Buccal Inflammation

This is a transversal double-centre study. Patients will be recruited from outpatient consultations. They will have buccal inflammation caused by periodontal disease (frequent oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding to slight, moderate and severe periodontal disease, will be formed according to the results of radiological and clinical examinations.


Eligibility Criteria:
Inclusion Criteria:

Pre-Inclusion criteria:

* Persons aged from 35 to 80 years old
* Persons who have provided written informed consent
* Patients with periodontal disease whatever the severity with at least one molar or one premolar on the dental arch
* Possibility to examine the oral cavity (patient able to open mouth)
* Possibility to do an orthopantomogram (sitting position required and patient able to clench jaws)
* Patient able to understand French
* Patient who accepts to provide fasting blood sample within the five days following the initial consultation

DEFINITIVE INCLUSION CRITERIA

- Patient present for the fasting blood sample within five days following the initial consultation Patients will be matched for sex and, as much as possible, for age in the three groups and for the severity of the periodontal disease

Exclusion Criteria:

* Persons not covered by the national health insurance agency
* Patients with a high risk of infectious endocarditis who require prophylaxis for any medical act involving blood
* Patients who have taken at least once during the 8 days preceding the definitive inclusion an anti-inflammatory dose of NSAIDS and/or a salicylate (blood sample)
* Patients who have had long-term treatment (\>6 months) with corticoids at a dose of at least 15 mg per day
* Patients on antibiotics less than 15 days before the blood sample
* Patients with oral inflammation requiring treatment with antibiotics or anti-inflammatory drugs during the pre-inclusion
* Scaling during the 24 hours before the blood sample
* History of oral cancer or cancer of the pharynx
* Active cancer (patient undergoing treatment or diagnosis within the previous 5 years)
* Iatrogenic, spontaneous or therapeutic immunodepression (patient on immunosuppressants or antiretrovirals),
* Systemic or organ specific inflammatory syndrome not related to the periodontal disease

  * proven bacterial, viral or fungal Infection either developing or being treated (urinary, prostate infection)
  * Inflammatory cancer (solid tumour, malignant hemopathy)
* Pregnancy
* Impossibility to cooperate due to a psychiatric disease, dementia
* Patients unable to understand the protocol
Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease

The prevalence of peripheral arterial disease is 12.2% in France. Intermittent claudication is the most common symtom of this disease. During physical exercise, such as walking, blood oxygen (O2) requirements increase. The development of atherosclerosis in the lower limbs, causes narrowing of the arteries and limits the increase in blood flow required for muscular effort. Patients then experience muscle pain, the intensity of which gradually increases until it forces them to stop. After stopping, the pain subsides and disappears in less than 10 minutes.

The location of the pain (calves and/or thighs and/or buttocks) is related to the location of the ischemia (distal in the calf, proximal in the thigh or buttock, or proximo-distal if several locations). This can have different consequences on the biomechanical parameters of walking and muscle activity. To date, the impact of this localization on physical capacity has never been studied.

These limitations are very disabling and impact the quality of life of patients.

In addition, poor lower limb performance is associated with higher mortality. Reducing symptomatology and improving functional abilities is therefore a major issue in patients with peripheral arterial disease. This can be achieved through the practice of an Adapted Physical Activity, an essential recommendation in the care of patients with peripheral arterial disease.

Our main hypothesis is that the physical activity rehabilitation protocol "Activ'AO" will improve the functional capacities of patients with peripheral arterial disease who have followed the program with the localization of ischemia with a greater consideration than in patients in the group following a "standard" APA protocol. Improvements in functional abilities (such as walking) will lead to improvements in quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Lower Limb Peripheral Arterial Disease with IPSC \< 0.90, arterial stenosis in the lower limbs and intermittent claudication
* No contraindication to physical activity

Exclusion Criteria:

* Severe or unstable cardiopulmonary pathologies, contraindicating exercise training
* Unstable angina or myocardial infarction \<3 months
* Severe rheumatological pathology of the lower limbs
* Amputee of a lower or upper limb fitted with a device
* Extensive dermatosis of the lower limbs
* Known NYHA grade III or IV heart failure
* Known severe respiratory pathology
* Parkinson's disease, hemiplegia or paraplegia
Interest of Pain Assessment by the Family of Patients in Limiting and Stopping Active Treatment Process Admitted in ER. Study DOFAMILA

Decisions to limit and stop active therapeutics are common in the emergency unit. They are framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable obstinacy and care of the patient's pain in later life. The pain assessment is an issue for these patients whose in majority, are not communicating. Moreover, no specific tool and the teams in charge, not knowing the patient make the recognition and treatment of pain symptoms very complex. This is the potential interest of directly involving the family or the person of confidence in this management , the first step being the detection and evaluation of pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18
* non communicating patients admitted in emergency ward
* unanimous decision of stopping and limiting active treatment according to Leonetti's law of April 22nd, 2005
* Presence of a member of the patients family or one of his legal representative

Exclusion Criteria:

* Children
* no health insurance
Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

The central aim of this study is to improve understanding of how metabolic pathways that contribute to adiposity also amplify risks of kidney disease progression and cardiovascular disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose the following aims through a randomized 2x2 factorial design trial in subjects with moderate to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric restriction interventions, and (b) To examine the effects of aerobic exercise and caloric restriction on a metabolic risk profile, including systemic measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction.

Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to severe CKD.

Interim analysis may be performed (no specific plan at this time).


Eligibility Criteria:
Inclusion Criteria:

* Stage III-IV CKD measured by the MDRD equation with eGFR 15-60 ml/min/1.73m2;
* Age 18-75 years;
* BMI ≥ 25;
* Life expectancy ≥ 1 year;
* Ability to understand and provide informed consent.

Exclusion Criteria:

* Any acute inflammatory condition (including chronic infection requiring treatment, and collagen vascular disease including active gout);
* Pregnancy;
* Taking high-dose anti-oxidants (Vitamin E or C);
* Chronic use of anti-inflammatory medication except low dose (\< 10mg/d) prednisone and aspirin (\< 100 mg/day);
* Significant cardiac or vascular disease (symptomatic disease or CV event including congestive heart failure within 6 months);
* Significant occlusive atherosclerotic disease or ischemic disease (on non-invasive or invasive diagnostic procedures);
* Significant physical immobility or disabilities (joint replacement, muscular disorders);
* Type I diabetes mellitus, or Type II requiring insulin therapy;
* History of poor adherence to medical regimen;
* Those subjects who have a diagnosis of atrial fibrillation or a pacemaker will be allowed in the study but will not undergo Arterial Tonometry (PWV) studies.
Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients

The goal of this clinical trial is to compare the pharyngeal airway changes after treatment with Myobrace and after treatment with Twinblock in developing skeletal Class II patients.

The main question it aims to answer is: Is the efficacy of the twin-block Vs Myobrace appliances in the improvement of pharyngeal airway dimensions in adolescents having skeletal Class II malocclusion with retrognathic mandible utilizing sagittal pharyngeal airway area measurements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* 9-12 Years
* Skeletal Class II with mandibular defeciency and normal maxillary growth depending on clinical diagnosis and confirmed with lateral cephalometric x-reay readings ( ANB angle \>4 and SNA angle \<78)

Exclusion Criteria:

* Previous Orthodontic treatment
* Previous extractions
* mandibular shifts
* Severe Crowding
* Anterior open bite
* Any perioral habits
Effects of Transcranial Direct Current Stimulation on Cigarette Addiction

Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. It is currently being tried in disorders where there is abnormal brain excitability, such as epilepsy and depression. A few studies have also been able to diminish drug craving, suggesting that brain excitability might also be altered in drug addiction.

This study aims at non-invasively changing the excitability of certain brain areas-a procedure called neuromodulation- in order to help smokers quit smoking more easily.


Eligibility Criteria:
Inclusion Criteria:

* smokers

Exclusion Criteria:

* use of psychoactive drugs
* age above 70
Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

The investigators developed a real-time 2-axis mirror robot system as a simple add-on module for conventional mirror therapy using a closed feedback mechanism, which allows for real-time movement of the hemiplegic arm. The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training.

The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training. These tasks included more complicated tasks so that the participants would be interested in the tasks without the robot system.

Before and after 10 sessions of the therapy, the investigators conduct functional evaluations: the Fugl-Meyer assessment scale of the upper extremity (FMA-UE), the modified Ashworth scale, the modified Barthel index of upper extremity (MBI-UE: personal hygiene, bathing, feeding, and dressing), and the Jebsen hand function test, hand power measurement, and hemispatial neglect test (line bisection test and Albert's test) with the same occupational therapist. The motor evoked potential was measured for the patients without the history of brain surgery or seizure.

The investigators selected a thumb finding test (TFT) among various tools for assessing proprioception, because TFT is widely used and reliable. The TFT can be assessed, after confirming normal proprioception in the unaffected arm, by the patient touching the nose with their eyes closed while the examiner lifts the affected arm to eye level. The patient is then asked to grasp the thumb of the affected hand with the unaffected hand, and this is repeated. The examiner then places a hand over the patient's eyes and raises the patient's affected hand to well above the patient's head. The patient is then asked to grasp the thumb as before.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Supratentorial stroke diagnosed between 4 months and 6 years ago
* Upper-limb hemiplegia with Medical Research Council grade 2 or less.

Exclusion Criteria:

* Severe spasticity with modified Ashworth scale of grade 3 or more;
* Mini-mental state examination score less than 12
* Global or sensory aphasia.
Motor Imagery in Healthy Individuals

The research will be the first to examine the relationship between mental fatigue induced by motor imagery and upper extremity performance. This study, it is aimed to examine whether the effects of mental fatigue created by motor imagery on upper extremity performance can be reduced by diaphragmatic breathing exercises.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed dominance (it will be decided according to Edinburgh Hand Questionnaire Result)
* Volunteer to participate in the study.
* To be sedentary
* Not having any problems that prevent breathing exercises
* Be between the ages of 18-30

Exclusion Criteria:

* Have any mental or sensory problems in the past 6 months
* Presence of acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc.
* Having had Covid-19
* Having any respiratory disease (asthma, COPD, etc.)
* Having any upper extremity injury and/or operation (trauma, surgery, fracture, etc.) in the -Last 6 months doing regular exercises (at least 30 minutes a day / 5 times a week for a total of at least 150 minutes)
* Be on regular medication
* Be smoking
Safety Assessment of Over-the-counter Personal Care and Cosmetic Products Ingredients Based on Product Description

"Personal care and cosmetic products maintain hygiene, enhance aesthetics and promote wellbeing. This category includes various formulations for cleansing, grooming and beautification products for skin, hair, nails, lips and teeth.

This study evaluates the safety of ingredients in 100 over the counter personal care and cosmetic products. Stratified sampling selects products from various categories, brands and retailers.

Eligibility Criteria:
Inclusion Criteria:

* Over the counter personal care products available for consumer purchase,Products from various categories (e.g., skincare, haircare, makeup, eye care),
* Products from different brands and manufacturers,Products with ingredient labels or lists available,Products marketed for general consumer use (not specialized or prescription products).

Exclusion Criteria:

* Prescription-only products or those requiring medical supervision,Products intended for specialized use (e.g., medical conditions, sensitive skin)
* Products without ingredient labels or lists.
* Products from obscure or unreliable manufacturers
* Products with expired or near-expired ingredients.
* Products with unclear or misleading labelling,Products not intended for general consumer use (e.g., professional salon products),Products with ingredients already known to be harmful or banned by regulatory agencies.
CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles

INTRODUCTION: Particle contamination is suggested to have substantial negative effects on health, with candles emitting huge amount of particles, thus being one of the largest contributors to indoor air pollution. Chronic low levels of exposure to indoor particles over time is an important risk factor for the health of the population as a whole and it becomes particularly important for vulnerable groups like people suffering from respiratory diseases such as asthma.

AIM: In a randomized controlled cross-over trial the difference in health effects between two candles I) a standard candle and II) a low emission candle modified from the standard candle is studied.

INTRODUCTION; Particle contamination is suggested to have substantial negative effects on health, with candles emitting the huge amount of particles, thus being one of the largest contributors to indoor air pollution. Chronic low levels of exposure to indoor particles over time is an important risk factor for the health of the population as a whole and it becomes particularly important for vulnerable groups like children and the elderly or people already suffering from allergies and respiratory diseases such as asthma.

AIM: To study the difference in health effects between two candles I) a standard candle and II) a low emission candle modified from the standard candle. The following hypothesis will be examined: Short-term exposure to particles generated by the standard candle is associated with more objectively measurable effects in metabolomics inflammation compared to exposure to modified low-emission candle particles.

METHODS: Separated by two weeks 20 young asthmatics will be exposed in a randomized cross-over double-blind study under controlled conditions in a climate chamber to three different exposures; A) a standard (Scandinavian) stearin candle, B) a modified low emitting version of the same candle, and C) clean air from the adjacent chamber. The experiment will be carried out in groups of 3-6 participants.

MEASUREMENTS: TSI P-TRAK Ultrafine Particle Counter and SMPS will be used for particle counts. Health effects, including spirometry and fraction of exhaled nitric oxide (FeNO) will be evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.

ANALYSIS: Mixed methods approach taking both time and exposure into account.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* Medically treated / physician diagnosed mild seasonal asthma GINA guidelines step 1 or 2 (https://ginasthma.org/)
* Never smoker or ex-smoker ≥ 6 months
* Allergy \> 1 common allergy

Exclusion Criteria:

* Any other disease that could influence the study parameters
* Conditions that prevent safe access to the climate chambers (such as claustrophobia)
* Perennial asthma
* Need for continuous medical treatment for asthma
* Pregnancy
Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes

The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.

Participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. This blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Celiac Disease by histology and serology
* For those with Type-1 Diabetes, at least one anti-islet antibody
* HLA-DQ2.5 genotype

Exclusion Criteria:

* Not following a gluten free diet for at least 12 months
* Known gluten exposure within the prior 2 months
* Treatment with systemic immune modifying biological agents (adalimumab, etanercept, infliximab, certolizumab pegol) in prior 6 months
* Treatment with systemic immunomodulatory agents in prior 30 days
* Human immunodeficiency virus infection, untreated hepatitis B virus, or hepatitis C virus infection
* Nut allergy
* Hemoglobin level below normal range
* History of angina
* Pregnant or lactating
* Severe symptoms to gluten challenge in the past
* Elevation in transglutaminase-IgA or deamidated gliadin peptide IgA or IgG greater than or equal to 50% above upper limit of normal
* Uncontrolled complications of type-1 diabetes or celiac disease which pose a risk to participation