cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.

Depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . The major form of depression is the most common psychiatric disorder in Western countries. It is considered to be the most expensive psychiatric neurological disease in Europe and is currently treated by different methods.

However, almost a third of depressed patients shows no clinical improvement. Advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. Even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it.

As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of TMS with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using TMS concomitantly. Based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing TMS at the same time.

The study will include 66 depressed patients randomly assigned into two groups : TMS and Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. This innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.


Eligibility Criteria:
Inclusion Criteria:

* Criteria of resistant depression
* Age from 18 to 65 years old included.
* Primary diagnosis of major depression in subjects according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
* Informed consent and signed to participate in the study

Exclusion Criteria:

* Pregnant woman, parturient and nursing mothers.
* Absence of DSM-5 criteria for depression in subjects.
* Refusal to participate in the study.
* Modification of drug treatment in the month preceding inclusion.
* History of neurological pathology, head trauma or mental retardation.
* Presence of an addictive comorbidity.
* Presence of a major organic pathological.
* Presence of a contra-indication to virtual reality
* Presence of intracerebral ferro-metallic material, cochlear implant, pacemaker
Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism

The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with autism spectrum disorder (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised, Chidlhood Autism Rating Scale-2)
* with sleep disturbances (based on clinical interview, and Sleep Disturbance Scale for Children score \> 38)
* stable medications for at least 2 weeks
* no planned changes in psychosocial and biomedical interventions during the intervention
* an English-speaking parent able to consistently participate in study procedures

Exclusion Criteria:

* parent or child diagnosed with severe psychiatric disorder or unstable medical problem
* children with active seizures or epilepsy
* primary sleep disorder is a circadian rhythm sleep-wake disorder, as determined by the sleep interview and Children's ChronoType Questionnaire.
Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

Bladder spasms after spinal cord injury (SCI) can result in incontinence, urinary tract infections, kidney damage, trigger dangerous increases in blood pressure and decrease independence and quality of life. The investigators' long-term goal is to develop and provide a "bladder pacemaker" able to restore bladder continence for Veterans with SCI. Electrical stimulation of sensory nerves can stop bladder spasms during a doctor visit. However, this approach has not been tested during long term home use. This proposal will 1) determine how well sensory stimulation reduces incontinence and improves quality of life for Veterans with SCI during 1 year of home use, and 2) produce an effective take home system that can be used by more Veterans and other VAs.

The clinical problem of neurogenic detrusor overactivity (bladder hyper-reflexia) is among the most serious problems encountered by Veterans with neurologic injuries such as spinal cord injury (SCI). The majority of persons with SCI suffer from neurogenic bladder (73%) and only 17% of persons with traumatic SCI manage their bladders with voluntary micturition. The investigators' long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder continence for Veterans with spinal cord injury (SCI). This proposal will 1) determine the long-term effectiveness of genital nerve stimulation (GNS) to chronically ( 1 year) reduce urinary incontinence and improve quality of life for Veterans with SCI, and 2) develop and produce an effective take home GNS system that can be used by more Veterans, given to Veterans at the end of the study and used in future multi-VA studies.

The rationale for studying chronic GNS is based on the demonstration in humans with SCI that abnormal hyper-reflexive bladder contractions can be acutely inhibited and bladder capacity acutely increased using GNS. The peripheral and easily accessible location of the dorsal genital nerve (DGN) allows surface stimulation and therefore provides the potential for a less complicated surgical intervention than is currently available, increasing the number of individuals who could benefit from bladder control neural prostheses. While GNS has been demonstrated to be effective acutely by multiple groups, relatively few groups have attempted to test this approach for more than a day.

Eligibility Criteria:
Inclusion Criteria:

* Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis
* Neurologically stable
* Skeletally mature, over 18 years of age.
* Reflex bladder contractions confirmed by cystometrogram
* At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis
* Able to understand and comply with study requirements
* Able to understand and give informed consent

Exclusion Criteria:

* Active sepsis
* Open pressure sores on penis
* Significant trauma, erosion or stricture of the urethra
* Pregnancy
* Individuals who do not speak English.
To Study the Pathophysiological Features of Multiple Sclerosis

Multiple sclerosis (MS) is the most common chronic inflammatory disease of the central nervous system1, whose demyelination is the pathological hallmark. MS is characterized by neuroinflammation, demyelination, axonal damage, and neurodegeneration2. The demyelination state in brain and the clinical course are difficult to predict in the early stage of disease. Recently, several neuroimaging and fluid biomarkers had been explored in MS. Using brain amyloid positron emission tomography (PET) in active MS had showed that both the damage sites and normal appearance white matter had a lower intensity than non-active MS. The result suggests a predictive role that the intensity from amyloid PET could reflect the disease activity and link to early myelin damage. The levels of tau protein in cerebrospinal fluid (CSF) had also been showed a negative correlation with brain atrophy, which is a prognostic marker for MS. In fluid biomarkers, both neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) had been used in MS and reported correlations with disease severity, the extent of neuroinflammation and progression. In current study, investigator will enroll 38 participants with MS and evaluate their clinical severity; measure the WM lesion and disease activity by magnetic resonance imaging (MRI); myelination state and amyloid deposition by amyloid PET scan; tau deposition by state of-art tau PET scan. Investigator also measure the serum levels of NfL and GFAP as the index of axonal injury and disease activity. The relationship between disease severity, brain myelination, tau deposition and serum levels of NfL will be discuss.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-75 years old
2. Multiple Sclerosis patients

Exclusion Criteria:

1. Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
2. Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous severe head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases.
3. Major psychiatric disorders, drug or alcohol abuse and major depression
4. Pregnant women or breast- feeding women.
5. Patients in whom MRI was contraindicated or patient had claustrophobia.
6. History of severe allergic or anaphylactic reactions particularly to the tested drugs.
7. History of positive test for human immunodeficiency virus (HIV).
8. Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] ≧ 3X the upper limit of normal values).
Percutaneous Recanalization in Ischemic Stroke Management (PRIISM): A Feasibility Clinical Study

The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.

The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.

Eligibility Criteria:
Inclusion Criteria:

1. NIHSS 6 to 30 within 6 hours of symptom onset
2. Pre-stroke Modified Rankin Score ≤ 2
3. Large Vessel Occlusion
4. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
5. Patients must meet at least one of the following criteria:

   * Eligible for Intravenous rt-PA
   * Eligible for Intra-arterial rt-PA - IA rt-PA initiated within 6 hours of symptom onset
   * Patient presents within 6 hours of symptom onset

Exclusion Criteria:

1. Pregnancy
2. Glucose \<50mg/dL
3. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR\>3.0
4. Patient received heparin within 48 hours with a PTT greater than 2 times the lab normal.
5. Patient has baseline platelets \< 30,000
6. Evidence of rapidly improving neurological signs of stroke at time of enrollment
7. Coma
8. Pre-existing neurological or psychiatric disease that could confound the study results
9. Known severe allergy to contrast media or nitinol
10. Patient has severe sustained hypertension
11. CT/MRI scan reveals significant mass effect with midline shift
12. Patient's angiogram shows an arterial stenosis \>50% proximal to the embolus.
13. Patient's anticipated life expectancy is less than 3 months
14. Participation in another clinical investigation that could confound the evaluation of the study device
The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. It will also reveal how the three main ethnicities in Singapore respond to isomaltulose and whether the response differs from the Caucasians.

The objective of the present study is to investigate the glycaemic effect of isomaltulose in Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in Singapore. Participants will be asked to attend two test sessions for this study. Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).

Eligibility Criteria:
Inclusion Criteria:

* Chinese, Indian, Malay or Caucasian ethnic origin

Exclusion Criteria:

* People with major chronic disease such as heart disease, cancer or diabetes mellitus
* Individuals with food intolerances or allergies to isomaltulose or sucrose
* Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
* People with a major medical or surgical event requiring hospitalization within the preceding 3 months
* Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
* Pregnant women
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer

Phase II:

Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm.

Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups.

Phase III:

Primary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).

Main secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).

Other secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary.


Eligibility Criteria:
Inclusion Criteria:

* Patient's consent form obtained, signed and dated before beginning specific protocol procedures.
* Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
* Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion (e.g. lymph node).
* Performance status Karnofsky index \> 70%.
* Life expectancy of more than 3 months.
* Adequate haematological and biochemistry parameters
* No prior palliative chemotherapy, previous adjuvant (and/or neo-adjuvant) chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant (or neo-adjuvant) therapy and first relapse.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures.
* Other tumor type than adenocarcinoma (leiomyosarcoma ; lymphoma).
* Any prior palliative chemotherapy. Prior adjuvant (and/or neo-adjuvant) chemotherapy with a first relapse within 12 months from the end of adjuvant (or neo-adjuvant).
* Prior treatment with taxanes. Prior CDDP as adjuvant (and/or neo-adjuvant) chemotherapy with cumulative dose \> 300 mg/m².
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)

This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female human subjects, age 18 - 45 years.
* Body Mass Index between 18.5-30 Kg / m2 .
* Subjects with normal findings .
* Willingness to follow the protocol requirements

Exclusion Criteria:

* History of allergy or hypersensitivity intolerance to paracetamol and ethanol
* Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
* Lactating or nursing female subjects;
* History of difficulty in accessibility of veins in arms.
Effect of StRess and ExeRcize on the Outcome After Chemo-Radiation

Glioblastoma (GBM) is a highly malignant, incurable primary brain tumor. Due to the nature of this disease and the extent of the treatment (surgery followed by chemoradiation according to the Stupp trial) patients undergo considerable psychological distress. It is known that stress hormones are involved in a wide range of processes involved in cell survival, cell cycle and immune function, and can cause therapy resistance. In this study the effect of stress on outcome after chemoradiation in patients with GBM will be investigated.

Psychological stress will be measured using multiple approaches; Physiological measures, stress biomarker and questionnaires. Using this approach, a broad insight in the relationship between stress and outcome after chemoradiation will be obtained and the potential influence of physical activity and sleep evaluated. In addition, the results of this study will help to identify patients which experience high stress levels during chemoradiation to pilot (in the future) interventions to reduce stress before and during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Stupp or Elderly protocol: GBM WHO IV, astrocytoma WHO IV IDHmt, astrocytoma WHO II IDHwt (GBM-like).
* willing to wear the smart watch during the treatment protocol

Exclusion Criteria:

* younger than 18 years
* not in possession of a smart phone
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome

This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers

Eligibility Criteria:
Inclusion Criteria:

1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines
3. Have a histologically-confirmed diagnosis of breast cancer
4. Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
5. Age ≥ 21 years
6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
7. Completed definitive therapy (surgery ± radiation)
8. Candidates for adjuvant AI therapy

Exclusion Criteria:

1. Have received adjuvant or neo-adjuvant chemotherapy
2. Prior endocrine therapy (AI or tamoxifen)
3. History of rheumatoid arthritis or other autoimmune arthritis
4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
5. Current use of daily corticosteroids or immunosuppressive therapies
Nutritional Assessment in Idiopathic Pulmonary Fibrosis

In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients.

Aim of this study is to assess the nutritional status of patients with IPF at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.

Preliminary studies on Idiopathic Pulmonary Fibrosis (IPF) seem to suggest that nutritional status has an impact on clinical outcomes, as already demonstrated in COPD. However, few data regarding this subject are available for patients with IPF.

Primary aim of this study is to assess the nutritional status of patients diagnosed with mild to moderate IPF at the time of disease diagnosis. To do so, the investigators assess the prevalence of nutritional disorders at baseline through nutritional scores evaluated with specific questionnaires and through the identification of the following metabolic phenotypes (based on those previously applied in COPD): cachexia, sarcopenia, normal nutritional status, obesity, sarcopenic obesity.

Secondary aims of this study are:

* the evaluation of the impact of the introduction of an anti-fibrotic pharmacological agent (pirfenidone or nintedanib) on the nutritional status of patients (modification of metabolic phenotypes and nutritional scores) evaluated at 6 months from the initiation of antifibrotic therapy.
* the assessment of calcium and vitamin D metabolism, by blood sampling, in patients diagnosed with mild to moderate IPF at the time of disease diagnosis and at 6 months from the initiation of antifibrotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 18 years;
* diagnosis of IPF according to the ATS / ERS 2011 guidelines with multidisciplinary discussion

Exclusion Criteria:

* severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min;
* NYHA class IV;
* severe liver failure, defined as Child-Pugh score class C;
* active solid or haematological neoplasms;
* having already received (currently or in the past) therapy with pirfenidone or nintedanib;
* inability to walk without help;
* need for oxygen therapy at rest;
* participation in other interventional experimental protocols with use of a medicinal product.