cyrilzakka/clinical-trials huggingface dataset:
Cortico-Spinal tDCS as Rehabilitative Intervention in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.

Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.

In this randomized, double-blind, sham-controlled study followed by an open-label phase, the investigators will evaluate whether a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and can modulate intracortical connectivity, at short and long term.

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.

Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.

The present randomized, double-blind, sham-controlled study followed by an open-label phase will investigate a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
* Disease duration ≤ 24 months
* Disease progression in the past 3 months
* Score ≥ 2 at the item "swallowing" of the ALS Functional Rating Scale Revised
* Score ≥ 2 at the item "walking" of the ALS Functional Rating Scale Revised
* Treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
* Able to give informed consent
* Written informed consent

Exclusion Criteria:

* Motor neuron diseases other than ALS
* Severe head trauma in the past
* History of seizures
* History of ischemic stroke or hemorrhage
* Pacemaker
* Metal implants in the head/neck region
* Severe comorbidity
* Intake of illegal drugs
* Pregnancy
Evaluation of Accuvein in Cirrhotics Patients

The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient presenting a liver cirrhosis
* Patient requiring the placement of a venous peripheral catheter
* Patient informed and giving free and informed consent
* Patient affiliated to a French social security scheme

Exclusion Criteria:

* Patient under 18 years old
* Patient unable to give consent
* Patient under guardianship or curatorship
Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass

This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation.

Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.


Eligibility Criteria:
Inclusion Criteria:

* Roux-en-Y gastric bypass operation ≥12 months ago
* Parathyroid hormone \> 6.9 pmol/l
* Vitamin D \> 50 nmol/l
* P-Calcium \[1.18-1.32\] mmol/l

Exclusion Criteria:

* Liver disease
* Renal disease
* Hypercalcemia
* Untreated thyroid disease
* Parathyroid disease except secondary hyperparathyroidism
* Use of diuretics, bisphosphonates, calcitonin, teriparatide, oral corticosteroids, anabolic steroids, calcimimetics, lithium, strontium, denosumab or anticonvulsants within 1 year of inclusion
* abusing alcohol
Natriuretic Peptides After Left Atrial Appendage Amputation

Surgical amputation of the left atrial appendage (LAA) is an established intervention during surgical atrial fibrillation (AF) therapy. However, its effects on the endocrine function of the left atrium are unclear. This study aims to quantify the serum levels of natriuretic peptides in patients who undergo concomitant surgical AF ablation with or without LAA amputation.


Eligibility Criteria:
Inclusion Criteria:

* Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Lack of informed consent
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls

Cardiovascular autonomic neuropathy is a common (sub)clinical symptom in persons with type 1 diabetes mellitus. Subjects in this non-commercial, monocentric, interventional study undergo autonomic function tests, a maximal ergospirometry and three questionnaires about the quality of life (EQ-5D-3L), the capacity to do physical activities (IPAQ) and the experience of possible symptoms of autonomic dysfunction in daily life (SCOPA-AUT). In this way the influence of type 1 diabetes mellitus on the quality of life, the exercise capacity and the autonomic function can be studied.

The primary aim of this study investigates the potential correlations between the severity of diabetic cardiovascular autonomic neuropathy (DCAN) and both the quality of life and the exercise capacity. As a secondary aim, the influences of gender, age, number of years since diagnosis of type 1 diabetes mellitus, VO2 max predicted, maximal heart rate during exercise, minimal heart rate in rest, maximal RER (Respiratory exchange ratio) and relevant interaction terms are studied.

In total 52 test subjects with type 1 diabetes mellitus and 27 matched control subjects are selected to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (only for the group of subjects with diabetes mellitus)
* At least two years with diagnosis of type 1 diabetes mellitus
* Subject is in a stable condition
* No hospitalization for any reason in the past three months
* 18 years or older
* Being capable of doing physical activities
* Understand the study design and the informed consent
* Sign the informed consent
* No simultaneously participation to another study
* Being capable of moving to the study center

Exclusion Criteria:

* Uncontrolled hypertension, atrial fibrillation and other cardiovascular conditions
* Severe lung disease
* Muscle deficiency
* Medication with influence on the autonomic nervous system:

  * Beta blockers
  * Alfa blockers
  * Antidepressants
  * Non-catecholamines
  * (anti) cholinergic medication
Improving Charge Nurse Conflict Resolution Communication Using Artificial Intelligence

Nurses are being challenged to provide increasingly complex care with more inexperienced nurses due to higher rates of retirement and registered nurse (RN) turnover in general.

High-performing charge nurses with excellent interpersonal, conflict management, communication, and leadership competencies are vital to achieving optimal outcomes. Implementing a charge nurse leadership development program focused on improving communication competencies in conflict management situations can support a healthy work environment.

Freedman (2019) asserts that "interpersonal conflict in nursing workplaces is a pervasive and complex phenomenon, with implications for patient safety and quality of care" (p.594). First-time leaders seldom receive adequate training for effective transition to leadership roles, with 60% reporting having no training (Gentry, Logan, \& Tonidandel, 2014). Furthermore, many novice leaders struggle with transitioning from peer to leader, specifically related to interpersonal and communication skills (Basogul, 2020; Radovich, et al., 2011).

Eligibility Criteria:
Inclusion Criteria:

* RN Clinical Team Leader or Charge Nurse employed at MMMC

Exclusion Criteria:

* Non-employees of MMMC
* MMMC staff not in the role of Clinical Team Leader or Charge Nurse
Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage

The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market.

Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old.
* Fitzpatrick phototype I to IV.
* Presence of intact skin in the test region.
* Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
* Signature of the Informed Consent Form (ICF) before carrying out any study procedure.

Exclusion Criteria:

* Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
* Presence of active dermatosis (local or disseminated) that could interfere with the study results.

istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).

- History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.
The Role of Daily Disposable Contact Lenses in Ocular Allergy

Patients with seasonal allergic conjunctivitis are normally advised to avoid contact lens wear when they are having symptoms. However, modern soft contact lenses which are disposed of daily offer the potential to protect and lubricate the ocular surface. This study examines this possible effect.


Eligibility Criteria:
Inclusion Criteria:

* contact lens wearer
* proven allergy to grass pollen

Exclusion Criteria:

* eye disease
* ocular medication
* allergy medication
* asthma
NUtriGenomic Analysis in Twins

This is an intervention study in healthy adult twins with the aim to investigate the genetic determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet.

The impact of carbohydrates, proteins and fatty acids as major components of daily nutrition on the development of metabolic illnesses is an objective of numerous clinical studies. However, the effect of an isocaloric diet on metabolism is less investigated and not well understood. This study aims to reveal genetic determinated metabolic responses to an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet in healthy twins. This study generates information for further detailed nutrigenomic analysis. Twins receive an isocaloric diet rich in carbohydrates (55% carbohydrates, 15% protein, 30% fat) with dietary counselling for 5 weeks and afterwards with nutrients supplied for 6 days, followed by an isocaloric diet rich in saturated fat (40% carbohydrates, 15% protein, 45% fat) for 6 days with nutrients supplied and for 4 weeks with dietary counselling and again followed by another 6 days when nutrients were supplied. Anthropometry, blood tests and energy expenditure are performed after the period of diet rich in carbohydrates (Carb), after the first 6 days (HFshort) and at the end of the period of diet rich in fat (HFlong).

Eligibility Criteria:
Inclusion Criteria:

* Healthy twins
* BMI 18,5-35kg/m²
* BMI difference \< 3kg/m² within the pair of twins
* Stable weight during the last 3 months
* Willingness to comply with the assigned diets over the study period

Exclusion Criteria:

* Consumptive diseases
* Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
* Diabetes type 1 and type 2
* Pregnancy
* Chronic disease of heart, kidney, liver
* High grade anaemia
* High grade infection disease
* Relevant change of body weight(+/- 2kg)during isoenergetic 12-weeks of dietary intervention
* Missing data about primary outcome measures (IVGTT, MTT, data about dietary intake from food diaries or food protocols)
* Significant deviation from dietary targets during the monitored 12 weeks isoenergetic period
* Allergies including food allergies
Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy

This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer


Eligibility Criteria:
Inclusion Criteria

* Postmenopausal women
* Newly diagnosed with non metastatic breast cancer
* Candidate for mastectomy or breast-conserving surgery

Exclusion Criteria

* Patients with invasive tumors
* Patients receiving anti-cancer treatment
* Patients who have undergone surgery

Other protocol-defined exclusion criteria may apply.
Ureteral Stent Exchange Abstention in Urinary Tract Infections

The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of US in case of USAUTI.

This study aims to evaluate whether "after guidelines group" patients treated for USAUTI had different occurrence of at least one relapse or recurrence than "before guidelines group".


Eligibility Criteria:
Inclusion Criteria:

* All patients with indwelling ureteral catheter
* AND confirmed or probable urinary tract infection

Exclusion Criteria:

* Patient's opposition
* History of ileal conduit urinary diversion
* Second or more urinary tract infection during the study period
The Efficacy of "Mindtesion"is Measuring Attentional and the Startle Response Dysregulation in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.

Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD

Mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculate the several parameters of startle reflex such as the Paired-pulse inhibition (PPI), Habituation, and startle related indices.

Data collected by the device is used to evaluate the subject levels of attention, Hyperarousal and Impulsivity, by means of physiological EMG signals of the startle response.

Evaluating baseline differences in these parameters between ADHD and age matched healthy controls, and the possible improvement after psychostimulant medications.

Eligibility Criteria:
Inclusion Criteria:

(i) Children with ADHD according to DSM-5 criteria in a semi-structured interview by a senior psychiatrist.

(ii) Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage.

Exclusion Criteria:

(i) autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes).

(iii) schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.
Opportunistic Fragility Fracture Risk Estimates From Radiographs

The proposed study will predict a patients' risk of having osteoporosis by using a combination of the IBEX BH (Bone Health) software outputs and other clinical risk factors such as age, gender, medical history and lifestyle. A comparison will be made between the IBEX BH prediction and the one calculated in current clinical practice using a tool called FRAX (Fracture Risk Assessment Tool) which combines clinical risk factors with results from a Dual Energy X-ray Absorptiometry (DXA) assessment.

The study involves conducting these assessments on several new anatomies including Knee, Ankle and Pelvis, to extend the market reach and clinical utility of IBEX BH. The expected outcome of the study is that the IBEX BH will offer better decision support to clinicians in terms of referral on for a DXA scan or osteoporosis investigations than available today.


Eligibility Criteria:
For the collection of test data in the study.

Inclusion Criteria:

* Male or female
* 50 years of age or over

Exclusion Criteria:

* Women who are pregnant or are breastfeeding.
* Participants who have sustained fractures in both hips.
* Unwilling or unable to provide informed consent.

For the collection of healthy-normal data in the study.

Inclusion Criteria:

* Male or female
* 20-30 years of age

Exclusion Criteria:

* Women who are pregnant or are breastfeeding.
* Participants who have sustained fractures in both hips.
* Unwilling or unable to provide informed consent.
A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients

This is a prospective single-arm open-labeled cohort study on dialysis patients of the conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes include the variability in haemoglobin level, average weekly dose of erythropoietin, safety profile of NESP®, patients' subjective assessment of fatigue and injection pain after the conversion.

Currently in Hong Kong, Aranesp®, manufactured by Amgen® is the only available Darbepoetin alpha licensed. NESP®, a Darbepoetin alpha agent manufactured by Kirin®, will be replacing Aranesp®.It is important to evaluate the therapeutic equivalence of the two agents, and its efficacy, tolerability and safety profile in the treatment of anemia in dialysis patients. Moreover, a new maximum preparation of NESP 120® microgram will be available to replace the Aranesp® 100 microgram prefilled syringe at the same cost. This larger Darbepoetin alpha preparation may allow extension of dosing intervals. This may subsequently allow cost saving and better convenience to medical staff and patients.

The objectives of this project are:

1. To investigate the effectiveness of NESP® in the achieving a stable anemia control in chronic dialysis patients with the same dose conversion from Aranesp®
2. To investigate the effectiveness of increasing the dosing interval of NESP® (but maintaining the same total dose) in sustaining a stable anemia control in chronic dialysis patients
3. To explore the possibility of cost saving in administering a larger dose NESP® but at an extended interval

   Patients will be divided into 3 groups.

   Group A. Same dose conversion group

   • Patients on stable low dose Aranesp® (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of NESP®

   Group B. Attempt extension of dosing interval with higher dose of NESP® preparations

   • Patients on stable dose of Aranesp® will be converted to higher dose preparation of NESP® (40 or 120 mcg preparations) with extended dosing intervals.

   Group C. Attempt dosage saving with 120 mcg preparation

   • Patients on Aranesp® 100mcg will be switched to the NESP® 120mcg preparation with slight increase in dosing interval

Eligibility Criteria:
Inclusion Criteria:

* Adult Chinese patients (age greater than or equal to 18)
* on long-term dialysis for at least 3 months
* on Aranesp® treatment for at least 3 months
* stable hemoglobin level within the range of 9 to12 g/dL, on the same stable dose of Aranesp® within the past 2 months.
* Minimum weekly kT/V of 1.7 for peritoneal dialysis patients and 1.2 per haemodialysis session for haemodialysis patients
* Able to give informed consent

Exclusion Criteria:

Presence of

* thalassaemia
* haematological diseases
* severe hyperparathyroidism (PTH \>90 pmol/L)
* iron, vitamin B12 or folate deficiency
* uncontrolled malignancy
* active blood loss or hemolysis
Cancer Biology of Retinoblastoma

Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor and sometimes the entire eye. The purpose of this study is to collect the extra tissue from patients who undergo tumor removal for laboratory experiments that will help us understand not only what occurs in retinoblastoma cells but also how cells normally function. Some of these studies will include an evaluation of how cells control the way that genes are expressed, how cells "know" to become retinal cells, how cells remain retinal cells, how cells lose their identity as retinal cells, what changes make retinoblastoma cells different from normal retinal cells, and what changes make some retinoblastomas worse than others.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have retinoblastoma
* Patient must be receiving biopsy, partial surgical excision of the tumor, complete excision of the tumor, or enucleation of the eye as part of their standard care.
* Parental consent

Exclusion Criteria:

* Diagnosis other than Retinoblastoma
* No surgical sampling of tumor is planned as part of standard care
* Parental preference to not participate.
Effect of Portion-control Training on Food Intake

The purpose of this study is to test whether food intake in response to large portion sizes differs between women who have received portion-control training and women who have not received such training. In a crossover design, women come to the laboratory on four occasions to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is determined for each meal. Participants are from two groups: women who completed a one-year weight-loss trial in which they were trained in portion-control strategies, and women who had not received such training (community controls).


Eligibility Criteria:
Inclusion Criteria:

* Participant in the Portion-Control Strategies Trial (NCT01474759) OR
* Community control who regularly eats three meals per day

Exclusion Criteria:

* Score on the Eating Attitudes Test indicating symptoms of disordered eating
* Score on the Zung or Beck questionnaires indicating symptoms of depression
* Food allergies or restrictions
* Dislike for foods served in the study