cyrilzakka/clinical-trials huggingface dataset:
Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between 18 and 80 years of age
2. Subject must present with acute myocardial infarction or unstable angina planned for PCI
3. Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
4. Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR \>0.8
5. Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
6. Target lesion must have any two of the intravascular imaging criteria of PB \>65%, MLA \<3.5 mm\^2 (OCT) or 4.0mm\^2 (IVUS), FCT \<75 μm, or maximal lipid arc \>180°
7. Subject must provide written informed consent before any study-related procedure

Exclusion Criteria:

1. Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
2. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
3. Hypotension, shock, or need for mechanical support or intravenous vasopressors;
4. Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR)
5. Left ventricular ejection fraction\<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
6. Life expectancy \<2 years for any
7. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
9. The target lesion is located within 10 mm of the proximal or distal of stent
10. The target lesion cannot be in the left main coronary artery
11. The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is \>2 mm with \>50% of stenosis)
12. The target lesion is located in severe calcification or tortuosity of vessels
13. The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
14. The target lesion is located within the bypass graft artery
Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls

The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1 secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared to healthy controls. The results of this study will expand the knowledge of the pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.

Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin responses to oral glucose challenge

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven NAFLD or NASH

Exclusion Criteria:

* additional concomitants liver disease
* T2DM
* alcohol consumption \>40g/d for male subjects and \>20g/d for female subjects
Weight Watchers Online 2015

The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program revised for 2015 (WWO2015) and WWO2015 plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015 Enhanced), over a 6-month period.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Body mass index (BMI) between 27 and 40 kg/m2
* Both genders will be recruited; At least 10% of participants will be men. Enrollment of women will be capped at n = 324 (90%) to meet this goal.
* All ethnic groups will be recruited, with a goal of recruiting 10% minorities
* English speaking
* Have access to the Internet via a computer, and basic computer skills

Exclusion Criteria:

* Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire1
* Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
* Are planning to move outside of the state within the next 12 months
* Report any cognitive or physical limitations that preclude use of a personal computer
* Have participated in a study conducted by the WCDRC or UT in the past 2 years
* Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
* Weight loss of ≥ 5% of initial body weight in the last 6 months
* History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
* Previous surgical procedure for weight loss
* Currently taking weight loss medication
* Treatment of cancer within the last 6 months
The Effectiveness of tDCS on Internet Game Addiction

In this study, the investigators aimed to investigate the effect of transcranial direct current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status of Internet game addiction includes severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity. The investigators hypothesized that real stimulation with tDCS on the dorsolateral prefrontal cortex will have higher effectiveness on severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity rather than sham stimulation with tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Internet gaming disorder based on diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5.

Exclusion Criteria:

* History of seizure
* History of significant head injury
* Mental retardation
* Schizophrenia
* History of stroke
Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.

Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.

Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.

Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility Criteria:
Principal Inclusion Criteria:

* Stage III or IV NSCLC, non irradiable non operable
* Non squamous NSCLC histologically or cytologically confirmed
* No previous treatment of NSCLC
* EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
* Presence of at least one lesion that can be measured
* PS 0 or 1

Principal Exclusion Criteria:

* Symptomatic brain metastasis or requiring immediate radiotherapy
* T790M mutation or exon 20 insertion
* Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
* Interstitial pneumopathy
Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders

The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).

The secondary objectives of this study are to evaluate and compare the two physical therapy techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms of:

A - improving postural stability and visual control on an unstable surface (with and without visual control)

B - improving levels of abdominal strength (Ito test) and erector spinae (Sørensen test)

C - the impact of back pain on daily life using questionnaires (Dallas, Québec, FABQ and Tampa questionnaires/scores)

D - Improvement of pain (Visual Analog Scale),

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 6 months of follow-up
* Patients with pain in the lumbar spine (low back pain) for at least 3 months, not in connection with an operation

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient will have difficulties with follow-up (the patient is about to move, or isn't motivated)
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has already participated in a dynamic physical therapy program
* The patient has a contraindication for a treatment used in this study
* The patient has had surgery in the past year
* The patient has a pathology that can interfere with the physical therapy regimen (heart failure, respiratory failure, major orthopedic problems)
Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient

The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

To complete qualitative study, interview will also be conducted with : patients, general practitioner, relative and home carers. An observation of geriatric multidisciplinary staff will be done for better understanding of complexity.

Eligibility Criteria:
Inclusion Criteria:

* geriatric department inpatient.
* presenting opposition to medical or diagnosis procedure
* covered by French Social Security System
* agreed to participate to the study

Exclusion Criteria:

* They did not express himself an opposition
* They disagree to participated
* For qualitative research only : major neurocognitive disorder (MMSE \<10).
Nutrition Recommendation Intervention trialS in Children's Healthcare

NuRISH is a suite of clinical trials for children from low-income families which will determine whether primary healthcare prescription for: 1) Optimal breastfeeding with support from a mobile lactation consultant vs. usual care and 2) High-quality childcare starting at 1 year vs. usual care can prevent childhood obesity, and improve cardiovascular, developmental and mental health at 2 years of age.

Canada's children are falling behind. One in 4 are overweight or obese and more than 1 in 3 have factors that put them at risk for cardiovascular disease as adults. Children from low income families are 70% more likely to be overweight or obese. Research across disciplines has shown that early life nutrition has profound effects on childhood obesity, development, mental health, and lifetime success. Optimizing early life nutrition to reduce inequalities in childhood obesity and its consequences is a promising approach. Through this application, we will be using a longitudinal factorial design within an ongoing cohort study(TARGet Kids!). The longitudinal factorial design involves randomizing the same children to multiple interventions, providing the opportunity to evaluate the effect of individual interventions as well as the multiplicative effects of a combination of interventions over time. This design increases the feasibility and lowers the cost relative to conducting 2 separate trials. This will be a pragmatic, randomized, longitudinal factorial Trials within Cohorts (TwiCs) clinical trial. This study will be a direct comparison of two primary healthcare interventions provided randomly at the individual level: 1) Lactation Consultant (LC) support vs. usual care; 2) Childcare Navigator (CN) support vs. usual care.

Eligibility Criteria:
Inclusion Criteria:

* Healthy by parental report
* \<32 weeks gestation
* 0-1 week of age
* First birth /first time parents

Exclusion Criteria:

* Children with a syndrome associated with obesity or developmental delay
The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder

Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD) often suffer from deficits in executive function, such as attentional control, inhibition, and working memory. One of these executive functions, working memory, plays a critical role in academic performance and classroom behavior. Working memory is essential for performing complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have shown that training of working memory has positive effects for ADHD and other cognitive disorder in children. However, transfer effects across studies appear to be variable and inconsistent. Event-related potentials can be a useful tool to gain insights into such mechanism. Therefore, the aim of the present study is to investigate both near and far transfer effects of N-back training in children with ADHD. In addition, the recording and analysis of event-related potentials will be adopted while children with ADHD perform the complex visuo-spatial and phonological working memory tasks.


Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosed according to criteria specified in Diagnostic and statistical manual of mental disorders (DSM-5)
* aged between 8 and 10 years
* intelligence quotient \> 80 (based on Test of Nonverbal Intelligence-Third Edition)
* had normal or corrected-to-normal vision
* right-handed

Exclusion Criteria:

* diagnosis of clinically significant oppositional defiant disorder, Autistic Spectrum Disorders, Asperger's syndrome or depression
* history of seizures
Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment.

Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe.

The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Lymphoblastic Leukemia (ALL)
* BCR-ABL positive positive by PCR (central Lab)
* No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2
* Must be able to swallow tablets
* Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase)

Exclusion Criteria:

* Heart disease
* Interval QTc Fridericia \> 480 msec
* Coumadin use
* Pregnancy
* PS = 4
* Previous medical history of etilism or/and pancreatic disease
Effects of the Manual Therapy on Brain Function in Young Chronic Neck Pain Patients

The goal of this clinical trial is to study the central remodeling mechanism of young chronic neck pain patients based on resting-state functional magnetic resonance, and also to study the central analgesic mechanism of Chinese Jingjin Manual Therapy in treating young chronic neck pain patients. The main question it aims to answer are:

Are there specific differences in functional brain activities between young chronic neck pain patients and healthy volunteers? Are there specific changes in brain network function in young chronic neck pain patients before and after Chinese Jingjin Manual Therapy?

Participants will:

The patients in the neck pain group will receive Chinese Jingjin Manual Therapy three times a week for five consecutive weeks.

Before and after the Chinese Jingjin Manual Therapy, patients in the neck pain group were assessed by pressure pain threshold, Northwick Park Questionnaire, and Hospital Anxiety and Depression Scale.

In addition, resting-state functional magnetic resonance data will be collected from the neck pain group and the healthy control group.

Chronic neck pain (CNP) is a prevalent condition of the musculoskeletal system that seriously impacts patients' quality of life. The safety and efficacy of Chinese Jingjin manual therapy, a characteristic of Chinese medicine rehabilitation therapy, have been widely recognized. Its mechanism of action is believed to be associated with the functional modulation of brain region networks.Based on the resting-state functional magnetic resonance imaging (fMRI) amplitude of low-frequency fluctuation (ALFF) technique, to observe the differences in spontaneous activity of brain regions between young CNP patients and healthy people. Additionally, the study aims to investigate the changes in brain network function prior to and following the administration of Chinese Jingjin manual therapy.

Eligibility Criteria:
Inclusion Criteria:

Compliance with the diagnostic basis of cervical spondylosis in the Expert Consensus on Typology, Diagnosis, and Nonsurgical Treatment of Cervical Spondylosis issued by China in 2018 and the Diagnostic Efficacy Criteria for Chinese Medicine issued by State Administration of Traditional Chinese Medicine in 2018.

Neck pain is the main symptom lasting over 12 weeks. Between the ages of 18 and 44 and be right-handed. Had not received treatment for neck pain within the past month. Voluntary participation in the study, ability to complete the entire treatment program, and signing the informed consent form.

Exclusion Criteria:

The condition was in the acute phase stage (within two weeks of onset). Neck pain is caused by other diseases such as fracture, dislocation, and infection.

Severe heart, liver, kidney, and other vital organ diseases or cognitive impairment.

Pregnant or lactating women, severe osteoporosis. Metal foreign bodies in the body or other contraindications to fMRI examination.
The Biological Effect of ESWT and the Role of Proinflammatory Cytokines and Cannabinoid Receptor in Shoulder Stiffness

Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT on shoulder stiffness.

1. First year:Investigators intend to further delineate the inflammatory mechanism, such as IL-1β, CB1, HSP in the incidence of shoulder stiffness.
2. Second year: Investigators intend to conduct a prospective randomized double-blind study for the clinical effect of ESWT on patients with shoulder stiffness.
3. Third year: Investigators wish to test the biologic effect of ESWT on patients with shoulder stiffness and to elucidate the molecular mechanism for this effect through a randomized comparative study.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 80 years
* receiving surgery for open acromioplasty

Exclusion Criteria:

* shoulder disorders caused by traumatic fracture
* previous surgery
* osteoarthritis
* malignant disorders
* hepatic disorders
* renal disorders
Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer

Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival.

Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival. The primary endpoint is to the evaluate the number of complete pathologic response. The secondary endpoints are evaluation of toxicity, radiologic response, metabolic response, results of the minimally invasive surgery (blood lost, number of conversion to open surgery, type of resection, R0, 1 or 2, post-op complications, time of hospitalization, 30 day post-op mortality), evaluate the viability of treatment protocol (number of patient that complete the phases), evaluate quality of life during the treatment and after the surgery. Inclusion criterias are: Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II), age between 18 and 75 years, Performance Status 0 or 1, neutrophils count \> 1500/mm3, platelets count \> 100.000/mm3, hemoglobin count \> 9 g/dL, preserve hepatic and renal function, stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0, signature of the informed consent. Exclusion criterias are: history of another cancer, except skin non melanoma, pregnancy or history of hypersensitivity to the study drugs

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II)
* Age between 18 and 75 years
* Performance Status 0 or 1
* Stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0

Exclusion Criteria:

* History of another cancer, except skin non melanoma
* Pregnancy
* History of hypersensitivity to the study drugs