cyrilzakka/clinical-trials huggingface dataset:
Research on the Brain Mechanism of taVNS in Regulating PD Motor Symptoms

This study is a double blind comparative study exploring the neural underpinnings of taVNS modulating PD motor deficits. We hypothesize that taVNS might improve PD motor deficits by regulating the balance between excitation and inhibition in the primary motor cortex.

Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS with the electrodes were fixed at the left earlobe . Assessments of motor symptoms and cortical activity (using Functional near-infrared spectroscopy and Transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.

Eligibility Criteria:
Inclusion Criteria:

* (1) had a diagnosis of idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD and ON-medication Hoehn and Yahr (H\&Y) stage ≤2,
* (2) had stable pharmacotherapy for PD at least one month prior to the study,
* (3) were aged between 40 and 80,
* (4) signed written informed consent,
* (5) can cooperate with the testing and taVNS treatment.

Exclusion Criteria:

* (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) \< 24;
* (2) with severe tremor or levodopa-induced dyskinesia;
* (3) with current intake of anticholinergics or any drugs that could induce cerebral functional change;
* (4) with taVNS contraindications;
* (5) received VNS treatment during the past six month;
* (6) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.
Ciclosporin in the Management of New Erythema Nodosum Leprosum

Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum

Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinical evidence of new ENL
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive patients
Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term

Solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.

The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.

Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.

In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer non-labouring pregnant women at term (≥ 36 weeks)-
* 18 years or older
* ASA Physical Status I-III
* 50-120 kg of weight
* 150 cm of height or taller
* Ability to understand the rationale of the study assessments and to provide signed informed consent
* Written informed consent

Exclusion Criteria:

* Known pre-existing abnormal anatomy of the upper gastrointestinal tract
* History of upper GI tract surgical procedure
Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, and physical exam
* Be at least 18 years of age to 65 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Exclusion Criteria:

* Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication
* Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation
* Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer

Prospective monocentric study, non-randomized of the detection of sarcopenia in clinical practice in patients with ovarian or endometrial cancer requiring systemic oncological treatment.

main question : Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria.

Data collection will be done at 6 months, 12 months after the date of inclusion.

Primary objective:Identify the criteria correlated to the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria

Main judgment criteria : Comparison between the groups of patients with sarcopenia (Morphometric measurement of the musculoskeletal surface index \<39cm²/m² in L3 cross section) and without sarcopenia of the different evaluation criteria:

* Impedancemetry values:: muscle mass index in kg/m2 (IMS), fat-free mass in kg/m2 and metabolic activity index (phase angle)
* Percentage of weight loss
* BMI \< 18.5 kg/m2
* Quantified reduction in muscle mass and/or function for patients \< 70 years old
* Quantified reduction in muscle mass and function for patients \> 70 years old
* Physical tests: walking speed and "hand grip" dynamometer secondary objectives:- Proposal of a composite score for the detection of sarcopenia usable in clinical routine
* Evaluation of nutritional intake
* Evaluation of the severity of undernutrition
* Verification of a correlation between the sarcopenia indices of ovarian and endometrial cancer
* Evaluate tolerance profiles to systemic treatments with regard to sarcopenia figures
* Assess the relationship between PFS, OS and sarcopenia index in cancer diagnosis secondary judgment criteria :
* Statistical analysis of sarcopenia and undernutrition data
* Quantification of ingestates (SEFI scale) +/- intake of oral nutritional supplement
* Serological tests: NFS, CRP and Albuminemia
* Comparison of sarcopenia index figures between ovarian and endometrial cancer
* Collection of the grades of toxicities and adverse events to systemic treatments in parallel with the measurement of sarcopenia.
* Correlation between progression-free survival, death and sarcopenia index at cancer diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old
* Patient presenting with a diagnosis of cancer of ovarian origin with an indication for chemotherapy
* Patient with a diagnosis of endometrial cancer with an indication for chemotherapy
* Patient with no diagnosis of other types of cancer in the previous five years
* Collection of consent
* Patient affiliated to a Social Security scheme

Exclusion Criteria:

* Patient with cancer of ovarian origin not requiring chemotherapy treatment
* Patient with endometrial cancer not requiring chemotherapy treatment
* Discovery of an intercurrent cancer other than skin or cervix cancers.
* Patient wearing a Pace maker
Relationship Between Kinesthetic Perception, Motor Competence, Physical Fitness and Emotional Intelligence in Children

The benefits of an active lifestyle and physical fitness extend to physical, mental, and social aspects of well-being, including improved cardiopulmonary health, concentration, and self-confidence. The World Health Organization recommends 60 minutes of daily activity to combat childhood obesity, which is influenced by factors like lack of exercise, poor diet, and sedentary behaviors. Obesity negatively impacts children's kinesthetic perception, motor skills, and emotional resilience, crucial for their nervous system development. This study aims to explore the relationship between these factors in obese school-age children.

The data will be collected by both subjective and objective assessments. The data collection will be organized at the premises of the participating schools during the time allocated for physical education and breaks. Consent will be taken from each participant before any assessment. The data will be collected included anthroprometric and demographics included sex, age, class/grade level, height, weight, BMI (calculated as the weight divided by the square of height). Measurement tools such as, PMSC will be used to assess motor competence and physical fitness in young children. It is a performance based tool, PMSC will assess children's fundamental locomotion skills such as catching, running, kicking, jumping forward, skipping and hitting ball with one hand. Each question will be scored as 'good' or 'not as good'. Kinesthetic perception will be assessed by Nelson hand reaction time. It is a performance based activity. It will test the subject's kinesthetic perception visually, auditory senses and tactile senses. Emotional Intelligence will be assessed using PANAS tool.

Eligibility Criteria:
Inclusion Criteria:

* Age of the participants 10 to 15 years
* Male and female will be included.
* Obese Class 1, class 2, class 3

Exclusion Criteria:

* Children who have high risk level and poor safety as it pertains to physical activity.
* Children with disabilities that are limited in their ability to understand the testing instructions or the performance of the activities (e.g., cognitive impairments, gross motor impairments etc.). •. Children with any kind of disability and congenital deformity
Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK). Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has numerous serious complications, especially glaucoma. Loteprednol, a new generation of corticosteroid has less potency than dexamethasone and was proposed to has less side effect regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after PRK and risk of glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* the patient with epithelial defect after phototherapeutic keratectomy

Exclusion Criteria:

* the patient with systemic disease such as diabetes and connective tissue disease
* the patient with ocular surface disease such as dry eye and recurrent corneal erosion
EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.


Eligibility Criteria:
Inclusion Criteria:

- Aged \>/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.

Exclusion Criteria:

* Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.
* Participants who have received TCZ in past treatments.
* Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.
* Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).
Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice

In Denmark the vast majority of patients with chronic ischemic heart disease and/or type 2 diabetes are managed in general practice. 20% of the patients suffer from poor mental health.

Problem-solving therapy (PST) is a psychotherapeutic method that is proven effective in adults with poor mental health. PST can be provided in general practice.

The main objective of this study is to test effectiveness of providing PST to this group patients.

20% of patients with type 2 diabetes and/or chronic ischemic heart disease have poor mental health. Since these patients are managed in general practice interventions targeting poor mental health in these patients should be delivered in here.

Problem-solving therapy (PST) is a well-established psychotherapeutic method that can be delivered by health care providers in general practice.

The main objective of this study is to test the effectiveness of delivering PST for patients with T2D and/or IHS who suffer from poor mental health. We hypothesize that the patients' mental health will be improved after treatment with PST.

Health care providers from 12 general practices are trained in PST and subsequently provide PST for patients with T2D and/or IHS and poor mental health.

Patients are recruited at the annual control visit for the chronic disease. All patients are screened for impaired mental health with the WHO-5 questionnaire. Patients with a score below 50 are offered PST.

The study is conducted as a stepped wedge cluster-randomised controlled trial with a one-year follow-up. In this design clusters are stepped wise exposed to the intervention. Initially all general practices are in the control group. After four months half of the recruited GPs attend the PST training programme and switch to performing the intervention. After an additional four months the remaining GPs are educated in PST and all GPs now perform the intervention. Both general practitioners and practise nurses will perform PST consultations.

The power calculation is based on:

* The primary outcome (PHQ-9 score at 6 and 12 months. The minimal clinical effect is 5 points)
* ICC is estimated to 0,05.

Based on these assumptions we will include 188 patients with IHS or/and T2D (we expect 25% overlap) to obtain a power of 90%.

Eligibility Criteria:
Inclusion Criteria:

* +18 years
* Diagnosed with ischemic heart disease and/or type 2 diabetes
* Poor mental health defined as WHO-5 well-being index \<50 points

Exclusion Criteria:

* severe mental illness including psychotic disease and suicidal behaviour
* unable to read and understand Danish
The Long COVID-19 Wearable Device Study

To further characterize Long COVID-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve Long COVID-19 symptom management and post-exertional malaise.

This study will have two components:

One study group will consist of up to 100,000 individuals who own wearable devices and are willing to share their data. These participants will be randomized and will receive educational materials. The investigators will study these dynamic wearable data along with participant survey responses that focus on diagnoses, symptoms, and quality of life to improve disease characterization and understanding of differences within and between individuals.

The other group in the randomized trial will participants who do not already own a wearable device. The study will distribute wearable devices and pacing educational materials to 500 individuals who do not already own them and experience post-exertional malaise, or the worsening of symptoms following exertion.

The investigators hypothesize that access to personalized information from a wearable device will enable participants to reduce post-exertional malaise. The investigators will include up to 25% individuals whose post-exertional malaise is caused by a condition other than Long COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old.
* Has a self/and or physician diagnosis of:
* Long COVID (based on the WHO working definition),
* ME/CFS (myalgic encephalomyelitis / chronic fatigue syndrome, self-diagnosis based on IOM criteria), and/or
* POTS (Postural Orthostatic Tachycardia Syndrome).
* Is interested in tools to manage ME/CFS, POTS, and/or Long COVID symptoms.
* Owns a wearable device they are willing to use for this study or does not own a device and agrees to utilize a study-provided one.
* Agrees to wear the device throughout the study period, share the data with the study, and sync data at least weekly.
* Has access to a smartphone or tablet to enable syncing wearable data and viewing device feedback.
* Agrees to disclose involvement in other ME/CFS, POTS, and/or Long COVID interventions such as medical treatment, self-management, and other interventional studies.
* Agrees to complete at least 75% of the study surveys.

Exclusion Criteria:

* As long as they meet inclusion there is no exclusion
Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors

The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older
* Obesity (BMI ≥30)
* Recurrent binge eating (≥12 episodes in the past 3 months)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Has a smartphone with Internet access and capacity for calls and text messaging
* Has a valid email address
* Has access to a scale
* Not pregnant
* English-speaking

Exclusion Criteria:

* Diagnosis for which the study/intervention is not clinically indicated
* Not currently receiving clinical services for weight management or binge eating
VIRTUAL WALKING and TRANSCRANIAL DIRECT CURRENT STIMULATION for CHRONIC NEUROPATHIC PAIN DUE to SPINAL CORD INJURY

The goal of this feasibility study is to assess the feasibility of the combined treatment intervention "virtual walking (VW) and transcranial direct current stimulation (tDCS)" of neuropathic pain in patients with spinal cord injury. The main question aims to answer:

• To assess the feasibility of combining VW and tDCS for longer-term use from the patients' point of view.

Participants will:

Receive a two week intervention in the Swiss Paraplegic Centre in Nottwil, where the participants undergo VW and tDCS for ten sessions, each lasting around 20 minutes.

The participants keep a diary and a pain drawing of their symptoms and will fill out some questionnaires about their impression of feasibility, the pain intensity, chronicity, the impression of change, depression, anxiety, stress and adverse events. At the beginning and end of the study the participants will be interviewed about their expectations, hopes and the feasibility of the procedures from a participants point of view.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18y, ≤ 75y
* traumatic SCI (\> 6 month after SCI) with a SCI severity grade AIS A, B, C or D
* At or below level spinal cord injury neuropathic pain on trunk or lower extremities according to the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023) with in the last 7 days (WiderströmNoga et al., 2023)
* Good communication in German to understand the instructions, assessments and to fill in questionnaires
* Adequate siting balance
* Ability to draw with a pencil
* Ability to swing arms

Exclusion Criteria:

* severe psychiatric disorder requiring psychiatric hospitalisation or mental disease that could interfere with their ability to participate
* Previous brain surgery
* Metal implants in the skull or brain, including cochlear implants, intracranial electrodes or a pacemaker (Datta et al., 2010)
* Drugs that affect cortical excitability (McLaren et al., 2018): Alcohol, Amphetamines, Theophylline (asthma treatment), Chlorpromazine, Clozapine, Amitriptyline, Doxepine, Imipramine, Maprotiline, Nortriptyline, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine, Gamma-hydroxybutyrate (GHB), Ketamine, MDMA, ecstasy Phencyclidine
* Previous adverse effects of stimulation with tDCS
* A scalp or skin condition (e.g. psoriasis or eczema)
* History of epilepsy or seizure
* Pregnancy (anamnestic)
* Inability to give consent