cyrilzakka/clinical-trials huggingface dataset:
Gynecological Sentinel Lymph Nodes CEUS

This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.

PRIMARY OBJECTIVES:

I. To determine the concordance between lymphosonography and the standard of care in the identification sentinel lymph nodes (SLNs) in patients with cervical, vaginal or vulvar cancer.

II. To determine if lymphosonography can identify more SLNs with metastatic deposits in patients with cervical, vaginal or vulvar cancer when compared to the standard of care.

OUTLINE:

Patients receive perflubutane microbubble (Sonazoid) injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.

After completion of study intervention, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Be female
* Be diagnosed with cervical, vaginal or vulvar cancer
* Be at least 18 years of age
* If of child-bearing potential, must have a negative pregnancy test
* Be able to comply with study procedures
* Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study

Exclusion Criteria:

* Females who are pregnant or nursing
* Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:

  * Patients on life support or in a critical care unit
  * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
  * Patients with recent cerebral hemorrhage
  * Patients who have undergone surgery within 24 hours prior to the study sonographic examination
* Patients with congenital heart defects
* Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic

To find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease

An observational, retrospective, case-controlled study to determine the status of IBD during development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in therapies for active IBD during SARS COV 2 in patients with active IBD and positive or negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19 symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes resulting from adaptations to treatments during COVID-19

Eligibility Criteria:
Inclusion Criteria:

* Patients with IBD +/- flare +/- COVID 19 positivity

Exclusion Criteria:

* Patients below 16
* Patient with inactive IBD
Development and Validation of a Disability Severity Index for CMT

It is necessary for outcome measures to accurately reflect the state of health of a person in order for clinical trials to show benefit. The most commonly used outcome measure for Charcot Marie Tooth Disease (CMT) is the CMT Neuropathy Score, which uses cutoffs of points designated as mild (0-10 points), moderate (11-20) or severe (21-36). These terms are arbitrary. This study is looking to base mild, moderate, and severe on what both people affected with CMT and those who provide for people with CMT consider appropriate.


Eligibility Criteria:
Inclusion Criteria:

* patients with CMT ages 8-100,
* health care professionals who take care of patients with CMT.

  * Eligible patients will be patients that have joined the INC RDCRN Contact Registry. These will be patients or guardians with known or probable inherited neuropathies.
  * Eligible health care professionals who participate in the care of patients with inherited neuropathies (physicians, genetic counselors, physical and occupational therapists etc.) attending the 4th International CMT Consortium to be held in Potomac Maryland June 29-July 1, 2011.

Exclusion Criteria:

* Does not read or speak English.
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod

A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod

This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The first cohort was to be comprised of approximately 200 patients with RMS, who were newly prescribed commercially available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to be comprised of approximately 200 RMS patients who had been on commercially available fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years. Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1) up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post treatment..

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing forms of Multiple Sclerosis
* Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

* Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
* History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
* Baseline QTc interval ≥ 500 msec
* Treatment with Class Ia or Class III anti-arrhythmic drugs
* Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
Fear of Recurrence Pilot Intervention for Women With Breast Cancer

The primary objective of this pilot study is to examine the feasibility and acceptability of a randomized, controlled study of a mindfulness and values-based living intervention targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as usual control. Furthermore, the secondary objective of this randomized, controlled pilot study is to determine preliminary efficacy and effect size of the mindfulness and values-based living intervention compared to the treatment as usual control condition in reducing fear of recurrence in breast cancer survivors.

Fear of cancer recurrence (FCR) is pervasive, distressing and undermines quality of life in cancer survivors. For subgroups of survivors, FCR is implicated in both treatment non-adherence and medical over-utilization. Although some degree of FCR is nearly universal among cancer patients, effective psychological interventions have been understudied. Educational and cognitive approaches that have relied on reassurance may feed into the anxiety by encouraging experiential avoidance, according to behavioral theories of anxiety. Mindfulness and values based living approaches teach techniques for reducing experiential avoidance allowing patients to break this cycle and focus on functional, satisfying lives. Interventions based on these techniques offer promise for addressing FCR in breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with early stage breast cancer within the past 18 months;
* Completed active treatment within the past year
* At least mild anxiety, and/or at least moderate fear of recurrence as measured by screening questionnaires.
* Ability to give written informed consent and willingness to comply with the requirements of the protocol

Exclusion Criteria:

* Presence of clinically significant cognitive impairment, or comorbid psychiatric or physical illness, only if, in the PI's or Co-Is' opinions, such illness would interfere with the ability to participate in and complete the intervention;
* Inability to speak and comprehend English sufficiently to complete the intervention.
* We will use a screening questionnaire (administered over the phone by the Research Associate) to determine that women do not have a comorbid physical or mental illness that is so impairing that they would be unable to participate in the groups or complete the measures.
A Standard of Care Study of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to a Selective Serotonin Reuptake/Serotonin-Norepinephrine Reuptake Inhibitor Antidepressant

The purpose of this study is to assess the safety (adverse events, serious adverse events, deaths, suicidality) of participants with major depressive disorder (MDD) treated according to the standard of care (SOC).


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of Major Depressive Disorder (MDD) without psychotic features as confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Treatment with an selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 6 weeks at an adequate dose (per Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire \[MGH-ATRQ\]). Specifically, one of the following in any formulation is allowed: SSRIs: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline; SNRIs: venlafaxine, desvenlafaxine, vilazodone, or vortioxetine
* In the opinion of the treating clinician, the participant requires augmentation of the current antidepressant treatment and plans to initiate augmentation treatment in the near future. The participant has agreed to receive augmentation treatment
* Is currently an outpatient receiving psychiatric care (not inpatient care settings)
* Has a body mass index (BMI) of 18-40 kilograms per meter square (Kg/m\^2), inclusive

Exclusion Criteria:

* Taking more than one antidepressant (regardless of class) at therapeutic doses (therapeutic doses per MGH-ATRQ). A second antidepressant is allowed to be taken at a lower dose if for sleep or pain management
* Is currently taking a benzodiazepine at higher doses than the equivalent of 3 milligrams (mg) of lorazepam
* Current diagnosis of a psychotic disorder including MDD with psychosis, bipolar disorder, intellectual disability, dementia, autism spectrum disorder, borderline personality disorder, or somatoform disorders
* Has treatment resistant depression (TRD) as defined by lack of response (less than \[\<\] 25 percent \[%\] improvement) of 2 or more antidepressants of adequate dose (per MGH-ATRQ) and duration (6 weeks) in this episode
* Current diagnosis of PTSD, obsessive compulsive disorder, fibromyalgia, anorexia nervosa, or bulimia nervosa. Participants may be enrolled if they have been in remission for the past year
Delta Primary Care Provider (PCP) Survey on Asthma Management

The proposed study will utilize a survey format to examine the attitudes, perceptions, and practices of primary care providers in the Delta region of Arkansas.

Study Design. Primary care providers will be sent a providers packet to include a cover letter explaining the survey and its purpose as well as a 2-part questionnaire that includes nine selected short patient vignettes and a questionnaire regarding their personal and practice characteristics.

Study Population. Individuals who receive the survey will be the primary care provider identified by study participants enrolled in our ongoing study entitled, "Asthma in the Delta Region of Arkansas: Characterization of Disease and Impact of Environmental Factors" (ARIA#53054). We will send the survey to all identified practitioners in Lee, Phillips, Desha, Chicot, St. Francis, and surrounding counties. Future studies will include primary care providers from other Arkansas Delta counties pending funding.

Inclusion/Exclusion Criteria. We will send the survey to all identified practitioners in Lee, Phillips, Desha, Chicot, St. Francis, and surrounding counties. Future studies will include primary care providers from other Arkansas Delta counties pending funding.

Instruments. Delta Primary Care Provider Survey. The self administered survey examines the attitudes, perceptions and practices of primary care providers. The 2-part questionnaire includes nine selected short patient vignettes and a questionnaire regarding the providers personal and practice characteristics.

Eligibility Criteria:
Inclusion Criteria:

* We will send the survey to all identified practitioners in Lee, Phillips, Desha, Chicot, St. Francis, and surrounding counties.
* Future studies will include primary care providers from other Arkansas Delta counties pending funding.

Exclusion Criteria:

* None.
A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children

1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.
2. Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.
3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period


Eligibility Criteria:
Inclusion Criteria:

* Those who meet the criteria of diagnostic and statistical manual of mental disorder (DSM)-5 during screening
* During screening period, individuals who are diagnosed with ASD through ADI-R assessment
* Subject with a CGI-S score of 4 or higher as a result of Clinical Global Impression(CGI) evaluation during baseline visit(visit 2)
* Subject or/and legally authorized representative voluntarily agreed to participate in this clinical trial and provided their informed consent by signing the written consent form
* In case of subjects who were receiving non-pharmacological therapy at the time of screening, the non-pharmacological therapy lasted at least 3 months prior to participation in screening and is expected to be sustainable during this clinical trial
* Subject whose legally authorized representative is able to participate in the provision of reliable information about the subject's condition, execute all scheduled site visits, oversee IP administration, fully understand and speak Korean, and conduct survey evaluation regarding the subject

Exclusion Criteria:

* At the time of screening, subject has the medical history, concomitant condition, or surgical history
* During the screening period, uncontrolled medical conditions,
* During the screening period, display of severe self-harm or injury to others that requires medical treatment, determined by investigator
* At the time of screening, weight over 60kg
* Inappropriate to participate in the trial determined by investigator
The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy

This is a controlled trial designed to determine short- and long-term effects of repeated tDCS on the P300 component of event-related evoked potentials in patients with chronic neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as compared with healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* An affected upper limb or lower limb
* Diagnosed as : Diabetic neuropathy, Complex Regional Pain Syndrome (CRPS), Chemotherapy Induced Pain Neuropathy (CIPN), Peripheral Neuropathy.
* Have not responded to at least two medications of the following groups: Opioids. Tricyclics, SSRI, SNRI, Pregabalin, Gabapentin, Anticonvulsants.
* Positive LANSS or CRPS criteria as follows:

  1. Continuing pain which is disproportionate to any inciting event or for CRPS diagnosis.
  2. Must report at least one symptom (symptoms here are reports by subject) in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic.
  3. Must display at least one sign (signs here refer to objective observation/testing) in in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic;
* Must meet resistant neuropathic pain criteria - pain that is neuropathic in characters that at least two neuropathic medications not from the same group have been tried for at least a month without improvement or severe side-effects were experienced. Resistant neuropathic pain with a score for "average pain in the last 24 hours" ≥4 on a numeric scale 0-10
* tDCS naive

Exclusion Criteria:

* Serious health problems other than CRPS or resistant neuropathic pain (e.g. uncontrolled hypertension, uncontrolled diabetes, heart failure)
* Pain/painful conditions unrelated to CRPS or neuropathic pain
* Pregnancy
* History of seizures/epilepsy
* Implanted device (e.g. pacemaker)
* Active illicit drug/alcohol abuse
* Unable to follow directions or complete tools in Hebrew
* Previous exposure to tDCS stimulation
Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.

This single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with IBS and FAP-NOS who receive a low-FODMAP diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.

Introduction. Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders. However, in children with FAPDs, there is a need for high-quality evidence regarding the dietary management. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs.

Methods. In this trial, seventy-four children aged 8 to 18 years with a Functional Abdominal Pain Disorder (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks.A primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS).

Eligibility Criteria:
Inclusion Criteria:

* functional abdominal pain - not otherwise specified (FAP-NOS) or irritable bowel syndrome (IBS) diagnosed according to the Rome IV Criteria,
* baseline average pain intensity at least 30 mm on a 100-mm Visual Analogue Scale,
* feeding via the oral route,
* ability to read and comprehend any employed questionnaires/scales,
* signed informed consent,
* stated availability throughout the study period.

Exclusion Criteria:

* receiving any other intervention/treatment with regard to FAP-NOS or IBS or those who received any other intervention during the last 3 months,
* an organic cause of symptoms or organic gastrointestinal disease,
* chronic illness, receiving medications which affect gastrointestinal motility,
* need for any other dietary management which could make the balancing or compliance with the diet troublesome,
* previously diagnosed carbohydrate intolerance without symptoms of FAPD after implementation of an exclusion diet,
* undernutrition (defined as World Health Organization \[WHO\] growth charts \< -2 SD), decreased growth velocity (sharp decline in growth line), or overweight or obese (\> 1 or \> 2 SD on the WHO growth charts, respectively),
* unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months,
* pregnancy,
* eating disorders,
* prior surgery of the gastrointestinal tract (within last 3 months),
* recurrent or unexplained fever,
* developmental disabilities which impair the ability of the child to understand or communicate.
Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.

Prospective, interventional treatment, single-arm, open-label, multi-center trial.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke from large vessel occlusion (LVO)
* Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral artery (MCA) (TICI 0-1)
* Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion \< 70 ml)
* Suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist
* Age 18- 80 years
* Informed consent (see below)
* Decision to perform angioplasty and stenting \< 12 hours of symptom onset
* Previous passage of occlusion with microcatheter obtained

Exclusion Criteria:

* Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion \> 70 ml)
* Vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis)
* Pre-stroke disability (MRS \> 2)
* Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy
* Any sign of intracranial vessel perforation during thrombectomy
* Contraindication against treatment with double anti-platelet treatment
* Current effective use of oral anticoagulants (e.g. INR \> 1.7 for Vitamin K antagonists)
* More than 3 attempts for recanalization of target lesion prior to the use of the study device.
* Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter.
* Diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the NeuroSpeed PTA balloon catheter or is outside the indicated range of the Credo stent.
* Diameter of the target area is outside the indicated range of the Credo stent after predilation.
* Contraindication against anti-platelet or anticoagulation therapy
* Heavily calcified lesions that may prevent access or safe stent placement.
* Pregnant and breastfeeding women