cyrilzakka/clinical-trials huggingface dataset:
fMRI in Impulsivity

This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.


Eligibility Criteria:
Inclusion criteria:

* Healthy Controls: Volunteers (age 18-50 yrs) in generally good Psychiatric and non-Psychiatric medical health
* Borderline Personality Disorder subjects: Research volunteers (age 18-50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder

Exclusion criteria:

All Participants:

* Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications
* Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines
* Positive breathalyzer test for alcohol
* History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes
* Clinically significant non-psychiatric medical disorder requiring ongoing treatment.
* Unwillingness or inability to sign a written informed consent form
* Pregnancy as assessed by a urine test for ß-HCG at each visit
* Medical or physical contraindications for participation based on medical history interview, labs, and physical exam
* Metal fragments or other bodily metal (e.g., pacemaker, orthopedic prosthesis),claustrophobia, or any other condition that would put the subjects at risk for MRI scanning

In addition, Healthy Controls excluded, if:

* DSM-5 diagnoses of Personality Disorders (based on SCID-II)
* DSM-5 diagnoses based on the SCID-I (including the eating disorders module)
* History of arrest or incarceration

In addition, Borderline Personality Disorder Subjects excluded if:

* DSM-5 diagnoses
* DSM-5 Personality Disorder other than Cluster B Personality disorders
* Current psychoactive medications
* Further exclusion criteria apply
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.


Eligibility Criteria:
Inclusion Criteria:

* children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations
* lives within the greater Toronto area.

Exclusion Criteria:

* known diagnosis of nocturnal hypoventilation
* current ventilatory support
* physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).
Four-week Open-trial Extension TNS for ADHD

The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.

This study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.

In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible residual treatment effects. Participants' randomized condition is unblinded at Week 5.

All participants randomized to sham in the double-blind trial are invited to participate in a 4-week open-trial of TNS to allow all participants the opportunity to benefit from the active intervention.

During this 4-week open-extension trial, interested participants will receive nightly active TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as baseline for this open-extension. Participants will return for clinic assessments at Weeks 2 and 4. Participants who achieve clinically significant improvement from active TNS over the 4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of a 12-month extension study.

Eligibility Criteria:
Inclusion Criteria:

* male and female children ages 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
* participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
* parents able and willing to monitor proper use of the TNS device and complete all required rating scales
* parent and participants able to compete study rating scales and other measures in English

Exclusion Criteria:

* currently requiring any medication with CNS effects
A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics

The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study to find out how genetic variations in GLP1R alter insulin secretion, in the fasting state and when blood sugars levels are elevated.


Eligibility Criteria:
Inclusion Criteria:

* 40 nondiabetic subjects will be recruited.
* 20 subjects with the AA genotype at rs3765467 and remainder will have the GG genotype.
* Individuals encompassing the age span of 25-65 years.

Exclusion Criteria:

* Individuals under 25 and over 65 years of age.
Educational Impact of a Tablet Application on Nutrition in Maintenance Hemodialysis Patients

The investigator examines of the impact of digital training on the sodium, potassium and phosphate content of various foods in dialysis patients. The training takes place visually as self-study in the form of a computer-based application.

The working hypothesis is that trained dialysis patients have consistently better plasma electrolyte values than untrained participants.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis Patient

Exclusion Criteria:

* Pregnancy
* Not preparing own meals
Japanese P III vs Voglibose and Placebo

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.


Eligibility Criteria:
Inclusion criteria:

1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
3. Age: \>= 20 and \<= 80
4. Body Mass Index (BMI) \<= 40 kg/m2

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
2. Impaired hepatic function
3. History of severe allergy/hypersensitivity
4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
5. Fasting blood glucose \>240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.

This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1

  ≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause.
* Participants must have a moderate exacerbation of COPD according to the Rome guidelines
* ≥ 10 pack-years smoking history.

Exclusion Criteria:

* Endotracheal intubation or mechanical ventilation.
* Participants with severe exacerbation of COPD according to the Rome guidelines
* Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status
* Interstitial lung disease.
* Current or prior history of asthma.
* Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)
* Preexisting autoimmune disease: History of autoimmune disease and/or use of chronic steroids of \>10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment
* Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.
* Has confounding medical conditions, including:

  1. diabetic coma,
  2. uncontrolled New York Heart Association Class IV congestive heart failure,
  3. uncontrolled angina,
  4. stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
  5. clinically significant arrhythmias not controlled by medication, or
  6. idiopathic pulmonary fibrosis,
* Has a weight \>120 kg at Screening.
* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
* Has systemic immunosuppression/immune deficiency
Lacosamide IV and EEG/EKG (LIVE) Study

The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.

The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
2. Adult patients 18-65 years
3. Diagnosis of focal epilepsy
4. Continuous EEG and video monitoring
5. Continuous EKG
6. Active EEG showing frequent spikes, electrographic or clinical seizures

Exclusion Criteria:

1. Subject has no IV access.
2. Subject is hemodynamically unstable.
3. Previous use of Lacosamide
4. Primary generalized epilepsy
5. Non-epileptic seizures
6. No significant cardiac, renal or hepatic disease
7. No cardiac arrhythmias including heart block
8. Subject is a pregnant or lactating woman.
Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography

The primary objective of the study aims to evaluate frequence of acute renal insufficiency in patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré hospital.

The secondary objectives are:

* identify factors of risks associated with the occurrence of acute renal insufficiency after coronarography.
* establish a preprocedure score, predicting of acute renal insufficiency after urgent coronary angiography in patients with ST+ acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* patient aged ≥ 18 years;
* evocative symptoms of myocardiac ischemia: typical chest pain; ST-segment elevation and 1 mm in two consecutive peripheral leads and 2 mm in two consecutive precordial derivations, or appearance of a bloc of left branch of novo;
* need urgent coronarography;
* Covered by french social security scheme included CMU.

Exclusion Criteria:

* dialysed patient for chronic renal insufficiency;
* cardio-resporatory arrest;
* cardiogenic choc state;
* prior emergency passage to hospital;
* patient under tutor, gardianship;
* patient covered by french AME scheme;
* pregnant women or breastfeeding;
* all medical, psychological or social situation which should influents the compliance to protocol according to investigator;
* patient refusal.
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease

This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Subjects with Crohn's disease diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).
3. Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
4. Subjects with perianal fistula confirmed by clinical assessment and MRI.
5. Subjects aged between 18 and 70, both male and female.
6. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
7. Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.

Exclusion Criteria:

1. Subjects with active infection evaluated by the investigator.
2. Subjects with Crohn's disease requiring immediate therapy.
3. Subjects with abscess or collections \>2 cm.
4. Subjects with rectal and/or anal stenosis and/or active proctitis.
5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
6. Subjects with abnormal laboratory results: liver function: total bilirubin \>=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \>=1.5 × upper limit of normal (ULN).
7. Subjects with malignant tumors or a history of malignant tumors.
8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
10. Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
11. Subjects allergic to MRI contrast.
12. Subjects who has received stem cells in a previous clinical study or as a therapeutic agent.
13. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
14. Subjects who has received any investigational drug within 3 months prior to the screening.
15. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
16. The female participant who is pregnant, or is lactating.
Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache

To improve treatment for post dural puncture headache, its pathophysiology needs to be explored. Dural puncture alters CNS dynamics; using advanced MRI, we aim to investigate PDPHs pathophysiology explained by brain movement, cerebral blood flow, CSF dynamics and the effect of epidural blood patch.

Post dural puncture headache (PDPH) is an iatrogenic and most common serious complication that can occur after a lumbar puncture or accidental dural puncture (ADP), as is often the case in women receiving epidural analgesia (EDA) during labour.

It is linked to substantial distress for patients specially mothers during the postpartum period, resulting in difficulties in forming a satisfying emotional bond with their newborns.

PDPH is a clinical diagnosis, based on symptoms and chronology of events and is therefore subjective since it relies on the patients' descriptions of symptoms and the clinician's interpretation of those symptoms.

Despite the lack of clear understanding of the pathophysiology of PDPH, several treatments have been suggested where an epidural blood patch (EBP) is considered the most effective option. Even though application of an EBP carries risks, symptom-relief is almost instantaneous, and the treatment has been shown to shorten hospital stay.

However, to improve treatment of these patients, a better understanding of its pathophysiology is needed to understand this condition more clearly. Even though PDPH is classified as a low-pressure headache it has been shown that the presence of PDPH does not always relate to a low CSF pressure nor does a normal pressure exclude PDPH. Our hypothesis is that the dural puncture, and the resulting outflow of CSF, changes intracerebral hemodynamics and dynamics of the CSF in a way that has never been fully investigated and described. Using magnet resonance imaging (MRI), including 4D phase contrast MRI it will be possible to quantify changes in hemodynamics and CSF dynamics in a new manner.

The main objective of this study is therefore to investigate the effects of dural puncture on cerebral blood flow (CBF) and cerebrospinal fluid (CSF) volume and pulsation and their relation to PDPH. This project will help to better understand the pathophysiology of PDPH and pave the way for improved management strategies in the future.

Eligibility Criteria:
Inclusion Criteria:

Postural puncture headache Age 20-40

Exclusion Criteria:

* Other central neurological disorders except the actual
* Acute medical condition
* Pregnancy
* Pacemaker, or other medical implants that are not MRI-compatible
* Invasive procedures on the central nervous system or surgery on the spine or brain in the last 12 months.
Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

Two methods of pain control in children undergoing surgery on the groin and scrotum are caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an injection of local anaesthetic around the nerves supplying the area). A pilot study at our hospital showed a significant decrease in post-operative pain and nausea and vomiting in these two methods when compared to intravenous morphine and local anaesthetic to the wound.

One potential side effect from caudal injections is temporarily decreased motor power in the legs due to the local anaesthetic - it is thought that this might be overcome using a more dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that this method is as effective as the use of a regional nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing day case elective inguinal-scrotal surgery

Exclusion Criteria:

* Contraindication to technique
* Significant comorbidities
* Patient/parent refusal
Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)

Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. This can damage healthy parts of the body because the exact location of the tumor is unknown.

Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of X-rays or other radiation.

The research doctors are studying to see if the position of a tumor can be tracked using MRI scans and tracking sensors placed on the skin. MRI scans and the tracking system used to calculate the location and position of the tumor are both FDA approved technologies.

The research doctors will also use the MRI scans to evaluate any changes in your lung function during and following your radiation treatments.

In this study the participant will undergo a series of MRI scans with and without contrast dye.

This study is being funded through grants from the National Institutes of Health (NIH).

In this protocol, we seek to assess whether tumor motion can be inferred using dynamic MRI and external surrogates. We propose to (1) investigate the feasibility of tracking the real-time tumor position using dynamic MRI and inferring tumor position using external surrogates placed on the skin of the subject and (2) determine lung function during and following radiation by assessing lung perfusion maps obtained via dynamic MRI with dose maps in order to determine image-based biomarkers for lung toxicity following radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or older
* Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.

Exclusion Criteria:

* Pregnant or breast-feeding women are excluded. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives (birthcontrol pill), intrauterine devices (IUDs), contraceptive implants under skin or contraceptive injections and condoms with foam.
* Patients with kidney disease of any severity or on hemodialysis.
* Patients who have metallic dental fillings or other metallic implants.
* Patients with known allergies to gadolinium-based contrast agents.
* Patients who have difficulty lying flat on their back for extended periods of time will be excluded
Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners

PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail

SECONDARY OBJECTIVES :

To evaluate :

* The main locations of blisters.
* The severity of blisters
* The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

MAIN JUDGEMENT CRITERIA :

Prevention methods used before an ultra-trail via a self-questionnaire

SECONDARY JUDGING CRITERIA : Location of blisters, via a self-questionnaire Presence or not of blisters at the end of the ultra-trail or at the time of abandonment

STUDY SCHEME : Post-race questioning

Eligibility Criteria:
Inclusion Criteria:

* Ultra-trail participants with validated registration

Exclusion Criteria:

* Presence of blisters or other skin lesions on the feet before the race