cyrilzakka/clinical-trials huggingface dataset:
Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder

The goal of this exploratory, interventional, multicentre study is to compare the prefrontal activity during a negative emotion regulation task in women with Binge-Eating Disorder (BED) and healthy women with and without Emotional Eating (EE).

The aim of this study is to compare the prefrontal processing of cognitive control of emotions between BED and EE and to compare the emotional processing and emotional experience between BED and EE.

The study will thus compare four experimental groups: patients with BED, BMI-matched healthy volunteers with EE, BMI-matched healthy volunteers, and healthy volunteers of normal weight without BED.

Participants will perform a down-regulation task of negative emotions elicited by negative pictures. During this task, their cerebral activity will be recorded using functional near-infrared spectroscopy (fNIRS), as well as their autonomous activity (skin conductance, pulse rate, respiration rate).


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 60 years old (including 60)
* Right-handed.
* For patients only : diagnosed with Binge Eating Desordors according to DSM criteria.
* Membership of a French social security scheme or beneficiary of such a scheme.
* Non-opposition of the subject to participate in the study.

Non inclusion Criteria:

Healthy volunteers only :

* Suffering from an eating disorder or any other psychiatric disorder.
* History of bariatric surgery.

All subjects (healthy volunteers and patients) :

* Rare obesity (genetic or syndromic).
* Specific addictions (substances or behaviors).
* Neurological disorders and/or history of stroke or head trauma.
* Presence of lesions, wounds or dermatitis at the sites where the recording devices are applied.
* Any serious acute or chronic illness other than the pathology under study, or any treatment likely to interfere with the evaluation of the parameter under study.
* Inability to follow protocol requirements.
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
* Subject unable to speak French and/or unable to read.
* Pregnant or breast-feeding women.
* Persons deprived of their liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social institution for purposes other than research.
Postoperative Management for Degenerative Spinal Conditions

The overall objective of this study is to conduct a two-group randomized control trial (RCT) to compare which of two treatments provided by telephone - a cognitive-behavioral based physical therapy (CBPT) program focusing on self-management strategies or an education program about postoperative recovery - are more effective for improving patient-centered outcomes in older adults recovering from lumbar spine surgery for degenerative conditions. Our central hypothesis is that the CBPT intervention focusing on self-management will decrease pain and disability and improve general health, physical activity and physical function in community-dwelling adults undergoing spine surgery, through reductions in fear of movement and increases in pain self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes
2. Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis procedures
3. English speaking due to feasibility of employing study personnel to deliver and assess the study intervention
4. Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition).

Exclusion Criteria:

1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or laminectomy without arthrodesis)
2. Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion population)
3. Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor
4. Presence of back and/or lower extremity pain \< 3 months indicating no history of chronic pain
5. History of neurological disorder or disease, resulting in moderate to severe movement dysfunction. Including but not limited to Parkinson's disease, Multiple Sclerosis, Epilepsy, Brain tumors, Huntington's disease, Alzheimer's disease, Muscular Dystrophy, Stroke, Autonomic Nervous System disorders, Traumatic Brain Injury, Cerebral Palsy, and Amyotrophic Lateral Sclerosis
6. Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder
7. Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel limitation
8. Patients having surgery under a workman's compensation claim
9. Unable to provide a stable address and access to a telephone indicating the inability to participate in either the telephone-based CBPT or education program.
Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting

There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics

this is a multicenter multiregional cohort study including about 3000 stroke code patients. In all patients an application will be filled out before hospital arrival including items that enable us to reconstruct all previously published stroke scales.

Data from the application will be related to in hospital data of the same patient. In order to do this we will use a trusted third party for data coupling.

Eligibility Criteria:
Inclusion Criteria:

* patients for whom a stroke code is activated

Exclusion Criteria:

\< 18 years
Effects of Treatments for Anemia and Iron Deficiency on the Electrolyte Balance in Lung Transplant Recipients: A Special Focus on Hypophosphatemia

The aim of this study is to generate evidence regarding hypophosphatemia after iron infusion in lung transplant recipients in context of anemia and/or iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

* lung transplant recipient
* treated at the University Hospital Zurich between 2015 until 2022

Exclusion Criteria:

* Denied general consent
Critical Care Ultrasound Oriented Shock Treatment in ICU

Objective

To investigate whether critical care ultrasound oriented shock management in shock patients in intensive care unit(ICU) can improve outcome.

Methods

Randomized controlled research. Patients were randomly allocated to two groups. In the critical care ultrasound oriented shock management group (CUSS group), treatment was oriented by the findings of critical care ultrasound in each shock phase, while in the control group the decisions about the monitoring and management were made by the clinical team. The goal of treatments in both groups were decreasing lactate by 20% or more per 2 hours for the Optimization phase in shock management, and no increase lactate level when removing the fluid in de-escalation phase. The primary outcome measure were hospital mortality and 28-day mortality, the secondary outcome measure were the length of ventilation and the length of ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* SBP \<90 mm Hg or MAP \<65 mm Hg or SBP decrease \>40mmHg or need vasoactive drugs；
* Skin that is cold and clammy，capillary refill time \>4.5s，urine output of\<0.5ml/Kg.hr and lactate \>2mmol/L；
* SHOCK presented within 6 hr.

Exclusion Criteria:

* \<18 years old；
* Pregnancy；
* Patient or family member refuse to be enrolled.
Extended Follow up of the TARGIT-A Trial

All UK patients who participated in the TARGIT-A Trial were initially treated for early breast cancer between 2000-2012. A total of 3451 patients from 33 hospitals in 11 countries participated in the trial and a comparison was made between traditional radiotherapy given over several weeks (external beam radiotherapy, EBRT) with TARGeted Intraoperative radioTherapy (TARGIT-IORT) as a single dose given during the operation to remove the breast cancer. The trial was funded by the Health Technology Assessment (HTA) programme of the Department of Health, UK and sponsored by University College London. The results from this trial have been published in major medical journals and have already started changing the way breast cancer in treated around the world; please see www.targit.org.uk for more details. We would like to continue to collect data about the health status of all patients to enable us to learn about longer term differences in the effects of these treatments on health. An analysis of this information could improve treatment for patients with breast cancer. For this, HTA have granted us further funding.


Eligibility Criteria:
Inclusion Criteria:

* All patients who participated in the TARGIT-A trial (NCT00983684).

Exclusion Criteria:

* Any patient who has withdrawn consent for further follow-up, or died.
MitralStitch Mitral Valve Repair System for Mitral Regurgitation

The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.


Eligibility Criteria:
Inclusion Criteria:

1. The age of patient is ≥18yrs;
2. Severe mitral regurgitation patients (The area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; VC≥0.07cm；regurgitant volume ≥60ml；RF ≥50%; EROA≥0.4cm2 (Satisfy any condition).
3. LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated.
4. The subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the ICF and agreed to complete the follow-up and the inspection required during the follow-up period.

Exclusion Criteria:

1. Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
2. Subjects with active endocarditis or rheumatic mitral valve disease.
3. Life expectancy \<1 year for cardiac or other malignant tumors.
4. Participate in other clinical trial
5. In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair

Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.

A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection.

Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.

This study is a subproject of the MitraClip® Registry (NCT02033811)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Severe Mitral Regurgitation (3+ to 4+)
* Symptom status: NYHA functional class ≥ II
* Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high

Exclusion Criteria:

* Life expectancy \< 1 year
* Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
* Contraindication for transoesophageal echocardiography
* Active endocarditis
* Pregnant or planning pregnancy within next 12 months
Choose2Quit: Improving Equity in Smoking Cessation for Low Income Adults

The goal of this study is to evaluate the effectiveness of a tobacco treatment navigator to improve primary care patient engagement in tobacco cessation support. We compare an ask, advise and connect to the quitline approach vs. the novel tobacco treatment navigator approach on the primary outcomes of receipt of tobacco cessation counseling sessions and receipt of tobacco cessation medications.

Our novel intervention, Choose2Quit, builds on our prior successes with the Ask, Advice, Connect study, but now 1) allows personalized choice of counseling modality (phone, text, web, in-person); 2) conveys the value and low/no-cost availability of medications to support quit attempt success and sends providers the patient's request in e-prescription to transmit to patient's pharmacy; 3) assesses patient's need to manage social barriers to quitting by linking them to Unite-US; and 4) uses an initial phone contact from a recognizable local number, will increase the engagement of patients in cessation treatment and in tobacco cessation. This study aims to:

1. Test the effect of a traditional eReferral vs. a Choose2Quit personalized guidance and choice approach on the ability to contact patients, and the proportion of patients that initiate tobacco cessation treatment, use tobacco cessation medications and make quit attempts.
2. Assess the impact of each intervention arm on equitable engagement in tobacco cessation treatment, medication use and quit outcomes across gender, race and age groups.
3. Evaluate intervention experience from the patient perspective.
4. Evaluate the cost to implement, and per engagement in each of the intervention arms.

The study is accomplished using a 2-arm randomized trial. Randomization into the traditional eReferral vs. Choose2Quit intervention arms will occur at the patient level with a 1:1 group assignment. Individuals that are ready to quit in the next 30 days and are interested in being connected with tobacco cessation resources will be randomized. Randomization of eligible patients occurs automatically with an electronic health record algorithm that routes the eReferral to the Quitline (traditional eReferral) or the Choose2Quit intervention. The Ask-Advise-Connect process is exactly the same for medical assistants; medical assistants and patients are blind to group assignment

Eligibility Criteria:
Inclusion Criteria:

* patient care visit to one of the participating primary care clinics during the study period
* reports current tobacco use
* reports interest in quitting tobacco in the next 30 days
* accepts offer of referral to tobacco cessation support

Exclusion Criteria:

* not interested in quitting in next 30 days
* not interested in assistance
Prevalence of MTHFR Polymorphisms in Venous Disease

The etiologies of varicose veins and the progression to more serious forms of chronic venous disease and identification of appropriate diagnostic tests to better aid patient management by identifying individuals who may benefit from more aggressive treatment and/ or prophylactic measures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* No venous disease (N=30); or C2-C3 venous disease (N=30); or C4-C6 venous disease (N=30)

Exclusion Criteria:

* Pregnancy
* Cancer
* Chronic obstructive pulmonary disease (COPD)
* Any systemic inflammatory disease
* Any of the following within the previous 30 days:

  * Trauma
  * Any surgery
  * Periods of prolonged inactivity
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
* Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
* Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
* Were judged to be in good health.
* Must have participated in protocol AUX-CC-857 (NCT00528606).

Exclusion Criteria:

* Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
* Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
* Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease

This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.

This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galantamine administration and to investigate the effect of study drug after 12 weeks administration (the difference in the improvement of attention after the administration of galantamine). The secondary objective of this study is to clarify the causal relationship between improvement of attention and activities of daily living (ADL). The design of this study is prospective, open-label, multi-center study. Study populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive function, attention and behavioral symptoms before and after the treatment using the following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale), computerized attention test and activities of daily living. Safety evaluations include adverse event monitoring and clinical lab tests. The patient is administered oral galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is increased up to 24 mg if tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA
* K-MMSE (Korean - Mini Mental State Exam) is 10 to 24
* Reliable Guardian available to the patients
* Patient or guardian provided written informed consent before entering into the clinical trial

Exclusion Criteria:

* Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial
* Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
* Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
* brain tumor, nerve syphilis, meningitis, encephalitis
* epilepsy
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)

It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the "ideal" donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria "extension" ( "marginal" graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts.

The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient.

The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patients, included in COLT cohort, thus having given a signed written consent
* Who received a lung transplant

Exclusion Criteria:

* Lung transplanted patients in a context of national priority
* Lung transplanted patients who died within 3 months after the surgery
* Patients for whom it is a second lung transplantation