cyrilzakka/clinical-trials huggingface dataset:
Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach (GLUCOPULSE)

Eating Disorders (ED) are a major public health problem. Current care remains only partially effective and the pathophysiology of the disorders remains to be deepened. With regard to compulsive ED (bulimia and binge eating disorder), our clinical experience suggests that one of the major triggers for crisis may be related to glycemia. In fact, bulimia could be considered as a vicious circle where the binge eating disorder is going to be followed by a food restriction in order to control weight , putting the subject in a situation of "energy deficiency" which will favor the emergence of new crises . Technological advances have resulted in the emergence of new measuring devices, such as "tracking", which records continuous glycemia, which would allow us to explore these clinical hypotheses.

This is an open-label, exploratory, proof-of-concept study.

20 patients will be recruited from the day hospital of the Endocrinology and Nutrition Department of the University Hospital of Montpellier, Lapeyronie and from Emergencies and Post-psychiatric Emergencies Department.

During the inclusion visit, the dietician will explain to the patient the use of the dietary book and the glycemic sensor which will be allocated to it. The patient will also answer to self-questionnaires about his eating behavior.

No nutritional approach will be addressed so as not to alter the patient's eating behavior and not to influence the results.

They will be followed-up during 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Subject suffering from eating disorders with at least 3 episodes of bulimia per week for at least 2 months
* Subject affiliated to a health insurance or beneficiary of such a plan
* Subject able to understand the nature, purpose and methodology of the study
* Subject signed informed consent

Exclusion Criteria:

* Subject suffering from eating disorders such as anorexia nervosa
* Subject unable according to the investigator's opinion to keep updated a dietary book or to perform correctly the glycemic recordings
* Subject suffering from somatic pathology (ex: diabetes) or psychiatric pathology assessed by the MINI (ex : severe current major depressive episode) that may interfere with the protocol according to the the investigator
* Major subject legally protected (guardians or curators) or deprived of freedom by judicial or administrative order
* Pregnant or nursing woman
Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only

A pilot study exploring whether individuals receiving usual treatment (CBT) from the specialist NHS Tayside Eating Disorders Service and accessing the online self-help "Smart Eating" programme have improved treatment outcomes compared to those receiving usual treatment only. The study will also explore acceptability of the "Smart Eating" self-help programme via a feedback questionnaire.

This controlled-comparison pilot study will explore whether individuals receiving usual treatment (CBT) from the specialist NHS Tayside Eating Disorders Service and accessing the online self-help "Smart Eating" programme have improved treatment outcomes compared to those receiving usual treatment only. All participants would be involved in the trial for 6 months, capturing their motivation for change, eating disorder psychopathology and quality of life at four time-points (pre-treatment, mid-treatment, end of treatment, 3-month follow-up). Some participants may continue to receive usual treatment after study end, which will be detailed in the study analysis. Following trial completion, all participants will be able to access the "Smart Eating" programme. The study will also explore acceptability of the "Smart Eating" self-help programme via a feedback questionnaire to inform programme adaptations and a possible pragmatic randomised controlled trial planned for the future. Currently, no other UK study is piloting the use of the "Smart Eating" programme as an adjunct to specialist NHS eating disorder treatment.

Eligibility Criteria:
Inclusion Criteria:

* aged 16-65 years
* meet diagnostic criteria for an eating disorder
* commencing treatment under the NHS Tayside Eating Disorders Service
* fluent in English
* provide written consent
* literate to the extent of understanding self-report questionnaires \& following verbal instructions
* access to a computer

Exclusion Criteria:

* deemed too emotionally or physically frail to participate by clinical staff;
* currently presenting with active suicidal intent;
* unable to read English or follow verbal English instructions.
Active KC: a Text Message Based Intervention for Physical Activity

Active KC will involve delivering PA support tools to individuals interested in increasing their physical activity. The tools involve provision of a Garmin wearable activity monitor and participant-tailored behavior change supports (e.g., goal setting and monitoring) delivered through text messaging and a corresponding study website.


Eligibility Criteria:
Inclusion Criteria:

* Individual has a smart device with internet or data and app downloading and texting capability
* Can read or write in English
* At least 8 years old (there is no upper age limit)
* Willing to complete study measures, participate in intervention, and share data collected in Active KC with the main study

Exclusion Criteria:

* Does not meet the above inclusion criteria
* Non-adherent to study measurement (wearing the Garmin less than 4 days) during baseline period
* Averaging over 60 minutes per day of physical activity (children) or 30 minutes of physical activity per day (adults) during the baseline period as measured by the Garmin
* Participant has a disability that interferes with their ability to carry out daily activities
Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.

Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.

However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.

In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.

In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.

Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.

However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.

In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.

In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Affiliated to a french public health insurance
* ED admission for migraine evocative headache, regarding ICHD3 criterions
* written informed consent

Exclusion Criteria:

* COPD or other chronic respiratory failure conditions
* Pregnant or breastfeeding women or women of childbearing potential not using any means of contraception. A pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
* Under legal protection
* Patients who have received treatment with triptan in the past 2 weeks
* Patients who have consumed NSAIDs in the hour before the doctor's examination
* State of migraine headache (crippling attack for more than 72 hours)
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

Factorial 2x2, all-comer, multicentre, single-blinded, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be patient-observer blinded (participant and investigator doing follow-ups) for the stent type and open-label for the antiplatelet regimen.


Eligibility Criteria:
Inclusion Criteria:

* All-comers patients;
* Age \>18 - \< 95 years;
* Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);
* Able to provide informed consent and willing to participate in the trial.

Exclusion Criteria:

* Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
* Known severe hepatic impairment Child-Pug stage C;
* Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
* Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;
* Active major bleeding or major surgery within the last 30 days;
* Known stroke (any type) within the 30 days prior to the randomization;
* Known pregnancy at time of randomization;
* Female who is breastfeeding at time of randomization;
* Women of childbearing potential. Defined: a woman is considered potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Currently participating in another randomized controlled trial and not yet at its primary endpoint;
* Life expectancy less than one year due to non-cardiovascular comorbidity.
Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic and at Risk of Chronic Low Back Pain in Primary Care

Low back pain is a public health problem with major individual and socio-economic repercussions. In primary care, strong disparities are observed in the management of low back pain patients. While general practitioners (GPs) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. Systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.


Eligibility Criteria:
Inclusion Criteria:

Adult patients between the ages of 18 and 65

* Patients consulting their GP for a first or new eisode of acute low back pain (more than 12 months from the previous one) with a STarT Back screening tool score greater than 3.
* OR low back pain at risk of chronicity (presence of yellow flags, according to the recommendation of the High Health Authority (HAS) of 2019
* OR recurrent low back pain: in the event of recurrence of low back pain within 12 months after the previous episode, then considered to be at risk of chronicity
* OR having chronic low back pain (low back pain for more than 3 months)
* Patients benefiting from the general social security system
* Patients who understand and speak French fluently
* Patients who have given their consent after having received complete information on the protocol

Exclusion Criteria:

* Minor patients
* Pregnant women (declared pregnancy) or immediately postpartum (up to 3 months)
* Patients with "red flags" (serious neurological impairment, cancer, infection, fracture or inflammatory disease), according to the 2019 HAS recommendation
* Patients referred immediately for imaging or specialist advice during the first consultation with the GP (suspicion of underlying pathology)
* Patients with no history of acute low back pain, at low risk of chronicity (STarT Back screening tool score less than or equal to 3)
* Patients with a contraindication to rehabilitation by physiotherapy
* Patients who have already undergone spine surgery
* Patients with cognitive impairment
* Patients whose life expectancy is less than 12 months
* Patients under guardianship or curatorship, under judicial protection or safeguard of justice
* Patients not affiliated to the general social security system
* Patients with difficulties in understanding the French language
* Patients with an inability to give express consent
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.


Eligibility Criteria:
Inclusion Criteria:

1. Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
2. For Group A,

   * Males and females 18 - 95 years of age.
   * Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification.
3. For Group B,

   * Males and females 18 - 95 years of age.
   * Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and
   * Subject is confirmed to not have fungemia as evidenced by diagnostic blood culture and subsequent species identification.

Exclusion Criteria:

1. Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
2. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
Top Set and Parkinson's Disease

This project will focus on improving power in adults with Parkinson's disease, since power is related to performance of daily activities and memory and decision making. The study will compare traditional power training, where the participant does all exercises as fast as possible to top set resistance training, where the participant does power training, but it is preceded by warm-up sets that progress in weight until the participant reaches 90% of the person's maximum strength. If the top set method is better than traditional power training, it could be more beneficial than existing methods in improving independence in adults with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Parkinson's disease
* Between the ages of 30-90 years of age
* A Hoehn and Yahr score of ≤3, which will be provided by the participant's medical provider within 1 year of the study's inception.

Exclusion Criteria:

* Uncontrolled cardiovascular disease that prevents participation in a training program
* Documented HIV infection or another immunodeficiency syndrome
* Other neuromuscular diseases besides Parkinson's disease
* Current musculoskeletal injury that prevents exercise.
* Having a pacemaker
* Pregnancy
* Incarcerated individuals
* Montreal Cognitive Assessment Score below 18
Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses

Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

* Exclusion criteria include patients with diabetes, HIV, cancer or other immunocompromised patients.
* Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
* Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
* Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
* Patients with fever or evidence of systemic infection
* Finally, patients with sulfa allergy will be excluded.
Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension

The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.

The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.

Three studies comprise this OM5 Program

* Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636.
* Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293

Eligibility Criteria:
For OM5/LOV111858 -

Inclusion Criteria:

* Men and women ages 18-79 years, inclusive
* Triglyceride levels between 500 mg/dL and \<1300 mg/dL
* Body mass index between 25 and 43 kg/m2
* Willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level
* Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Sensitivity to fibrate drugs or omega-3 fatty acids
* Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia
* History of pancreatitis
* Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer)
* Poorly controlled diabetes mellitus
* Type 1 diabetes
* Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
* Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
* Use of isotretinoin (Accutane)
* Use of warfarin (Coumadin)

For OM5X/LOV111859 -

Subjects were included in the study if they met the following criteria:

1. Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation
2. Successfully completed the previous OM5 double-blind study to Week 8
3. Provided written informed consent on or before the Week 8 clinic visit of the OM5 double-blind study (i.e., Visit 1X of the OM5X extension study)
Technique for Localization of Pulmonary Nodules Using Spy Thoracoscope System

This study will determine the feasibility of the novel Indocyanine Green (ICG) fluorescence localization technique with a Laser fluorescence thoracoscope system.

The primary objective of this study is to prove the validity and safety of our novel fluorescent localization method with utilized ICG and novel near infra-red fluorescence videoscope system.


Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled for a VATS wedge lung resection using CT guided micro-coil lung implantation for the localization of the lung lesion.

Exclusion Criteria:

* Any patients with an allergy to iodine, shellfish, or cough mixture, betadine or other iodine contrast agents.
* Pregnant or potentially pregnant women.
DEEP Substrate Mapping Versus Activation Mapping for VT

Substrate-based DEEP mapping and activation mapping are two of the main techniques used for guiding ventricular tachycardia (VT) ablation. There is no data comparing directly the extent of applicability, procedural results, and the long-term outcomes between the two mapping strategies.This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.

The primary endpoint of the study is to compare recurrence-free survival rate of ventricular tachycardia at 12 months and procedural feasibility of substrate-based DEEP mapping versus activation mapping for VT ablation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an implanted ICD (all brands)
* Patients with the indication for Ventricular Tachycardia Ablation (both first and redo procedures), supported by EnSite 3D mapping system, for the following disease aetiologies: previous MI, myocarditis, arrhythmogenic right/left ventricular dysplasia
* Age: 18 years or more.
* A participant is willing and able to give informed consent for participation in the trial and is available to respect the assessments described in the protocol and informed consent form.

Exclusion Criteria:

* Contraindication to anticoagulants.
* Presence of thrombi.
* Presence of Mitral and Aortic prosthetic valve.
* Recent (less than 3 months) myocardial infarction, unstable angina, or Coronary Artery Bypass.
* Ventricular Tachycardia caused by reversible pathology.
* Life expectancy less than 1 year, according to the investigator.
* Contraindications to the use of ablation/diagnostic catheters or to cardiac catheterization.
* Female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.