cyrilzakka/clinical-trials huggingface dataset:
Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations

Considering that self-exclusion from gambling on a particular website is an intervention for and by individuals who have developed a gambling disorder, it is currently exclusively a behavioural intervention in the sense that it prevents the behaviour Resumption of commercial solicitations only in the period when gambling is not accessible in the corresponding website , through voluntary self-exclusion (where the gambler prevents himself or herself from gambling), does not appear to be sufficient to prevent relapse. Early commercial solicitations, in the immediate intercourse after the end of the self-exlcusion period may precipitate relapse in gamblers whose behaviour change is by definition recent, and who have only received a behavioural measure. The investigators hypothesize an improved efficacy as measured by reduced gambling after a self-exclusion optimized by a period of suspension of commercial solicitations extended to 9 months, compared to self-exclusion with the standard procedure. Gamblers will be randomized according to an a priori randomization list.

This is a study evaluating the impact of PMU's implementation of an optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months, the self-exclusion being referred to as a non-medical "responsible gambling" tool, compared to the standard procedure. The self-excluded gamblers will be randomized according to an a priori randomization list, and will receive either the optimized self-exclusion procedure A or the standard self-exclusion procedure B. The study consists of a comparison between two groups A and B. The study involves non-medical gambling and socio-demographic data, routinely recorded in a regulatory manner with a permanent CNIL authorization PMU.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* self-excluder during the recruitment period
* Online sports betting
* poker and horse racing player
* account opened for at least 4 weeks
* self-exclusion for 3 months or less (minimum 3 days).

Exclusion Criteria:

* Player who has objected to the use of his collected data when opening his account.
* It's not the first self-exclusion of the inclusion period.
Study to Evaluate the Effect of a Probiotic in COVID-19

A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.

In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.

Exclusion Criteria:

* Inability or refusal to sign informed consent.
* Allergy or intolerance to the intervention product or its components.
The Everolimus-Transplant Exit Strategy Trial (E-TEST)

The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.

The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.


Eligibility Criteria:
Inclusion Criteria:

* recipient of deceased or living donor kidney transplant
* Age 18-75 years (inclusive)
* Male or female
* renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
* Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
* Willing and able to provide informed consent for study participation

Exclusion Criteria:

* Prior solid organ transplant (other than kidney)
* History of donor-specific antibody
* History of biopsy-proven acute rejection within 1 year prior to enrollment
* Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
* Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
* Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
* Subjects receiving belatacept (Nulojix)
* Pregnant or nursing (lactating) women
* Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study
The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates

Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures \[1\]. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.

This study seeks to examine whether the SARS-CoV-2 (COVID-19) pandemic, an ongoing global health crisis that was declared a national emergency by the US Federal Government on March 13, 2020, has exacerbated both frailty and sarcopenia in a population of liver transplant candidates.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC

Exclusion Criteria:

* Not a patient at Liver Institute at Methodist Dallas
Promoting Smoking Cessation and Reducing Weight Gain

To test whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain.

BACKGROUND:

When the study began in 1995, more females were initiating cigarette smoking, and a growing proportion cited fear of gaining weight as a major reason for refusing to even attempt quitting smoking. It had not yet been possible, however, to prevent post- cessation weight gain through dieting or behavioral treatment without undermining abstinence from smoking. The investigators proposed that prior interventions had been unsuccessful because: (a) their weight management interventions were too complex; (b) the programs thwarted a need of the patient in nicotine withdrawal to eat hedonically appealing, high-carbohydrate snacks; and (c) the programs heightened patients' emphasis on weight control at the expense of their emphasis on smoking cessation by asking them to initiate weight control before or simultaneously with quitting smoking.

DESIGN NARRATIVE:

The investigators collected pilot data on a promising 16-week intervention that they called the LATE WEIGHT PLAN because it emphasized smoking cessation for the first half of treatment and integrated weight management for the last half. The weight management module included a pre-packaged meal plan; high-carbohydrate, low-fat snacks; and low-intensity aerobic exercise. All patients continued in the weight management phase of treatment, regardless of whether they had succeeded in quitting smoking or were preparing to make new quit attempts. Based on pilot findings, the investigators estimated the point prevalence of smoking cessation for the LATE WEIGHT PLAN group to be 74% at the end of treatment, with weight gain less than 5 lb. An EARLY WEIGHT PLAN group controlled for the timing of the intervention, using the same target quit smoking date and 16 week program but integrating the weight management module into the first 8 weeks of treatment. Like others, they found that EARLY weight management efforts, while they may have prevented weight gain, apparently did so at some cost to smoking cessation, which they estimated to be 42% at 4 months. Finally, a CESSATION ONLY group controlled for the presence of a weight management intervention, by dealing exclusively with smoking cessation for the entire 16 week program. The CESSATION ONLY group had attained the worst outcome in terms of weight control and an intermediate outcome in terms of abstinence at the end of treatment (50%). By randomizing 315 female smokers to the three treatments and comparing abstinence and weight gain after 4 months of treatment and 6 month follow-up (10 months), they tested whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
A total of 315 female smokers.
A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.

The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.

This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits.

The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.

Eligibility Criteria:
Inclusion Criteria:

* Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 resulting from degeneration of disc confirmed by history and radiographic studies.
* At least 18 years of age and maximum 80 years of age

Exclusion Criteria:

* • Presence of systemic or localized infection at the site of surgery

  * More than 2 levels to be instrumented
  * Previous fusion attempt at the involved level(s)
  * Spondylolisthesis unable to be reduced to Grade 1
  * Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
  * Diagnosis of a condition or on postoperative medication(s), which may interfere with bony/soft tissue healing
  * Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
  * History of substance abuse (drugs or alcohol)
  * Mentally incompetent or prisoner
Influence of Mandibular Nerve Lateralization on Nutrition and Speech

This study aimed to evaluate the effects of lip numbness on the nutritional status and speech of patients who underwent inferior nerve lateralization for dental implant placement in the mandibular posterior region. For this purpose, observational follow-up of two groups of patients will be performed. The control group will include patients with standard implant placement in the mandibular posterior region. The test group will consist of patients with implant placement in the mandibular posterior region with inferior alveolar nerve lateralization. The patients will be evaluated before implant surgery and followed up for four months until the final prosthesis is placed. Changes in nutritional status, masticatory performance and speech abilities will be assessed during this process.


Eligibility Criteria:
Inclusion Criteria:

* A standard dental implant with or without lateralization of the inferior alveolar nerve in the posterior region of the mandible at the Marmara University Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery clinic.
* The patient accepted to participate in the study and gave written/verbal consent

Exclusion Criteria:

* Dental implant placement in the posterior region of the mandible with additional surgical methods (onlay/inlay graft, directed tissue regeneration, etc.) other than nerve lateralization.
* Patients had a neurosensory disorder in the maxillofacial region before implant surgery
Perhexiline Therapy in Heart Failure With Preserved Ejection Fraction Syndrome

Up to half of all patients with clinical features of heart failure are found to have normal heart pumping function. Recently the investigators have shown that a drug called perhexiline markedly improved exercise capacity and symptoms in patients with heart failure associated with impaired cardiac pump function. In this proposal the investigators will assess whether perhexiline has beneficial effects in patients with heart failure and a normal heart pumping function.

Up to 50% of patients with symptoms of heart failure have a preserved left ventricular ejection fraction (HFpEF syndrome). Current therapy for systolic heart failure is targeted at inducing vasodilation and counteracting neuro-endocrine activation. There is a lack of a corresponding evidence base for the treatment of HEpEF. We have previously shown that perhexiline, an agent that increases the efficiency of energy production by shifting substrate utilization from free fatty acids towards glucose, was highly effective in improving exercise capacity, symptoms and cardiac function in patients with systolic heart failure. We have also recently shown that energy deficiency plays a major role in the pathophysiology of HFpEF. In this proposal we therefore aim to investigate the effectiveness of perhexiline in 70 HFpEF patients, in a 3 month randomised, double-blind, controlled trial. An interim analysis is planned after 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* HFpEF will be defined as:

  * Clinical features consistent with heart failure
  * LVEF ≥ 50%, with no evidence of significant valvular disease
  * No hypertrophic cardiomyopathy, and no evidence of pericardial constriction
  * Peak VO2 \< 80% predicted, with RER\>1 and with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation)
* Patients recruited will be in sinus rhythm

Exclusion Criteria:

* BMI \>35
* Objective evidence of lung disease on formal lung function testing
* Reversible myocardial ischaemia on contrast-enhanced myocardial stress Echocardiography, and no evidence of exercise-induced mitral regurgitation (\>2+)
* Impaired hepatic function; known hypersensitivity to perhexiline
Retinal Imaging in Neurodegenerative Disease

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.

The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.

This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.

The protocol for this study was amended and the record was updated accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
* Adults without neurodegenerative disease

Exclusion Criteria:

* Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.
* Eyes that have had intraocular surgery, other than cataract surgery.

If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic

The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :

1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. and to have a method compatible with screening extended to populations at risk.


Eligibility Criteria:
Inclusion Criteria:

* Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
* Person affiliated to a social security scheme

Exclusion Criteria:

* Person objecting to participation in the research after reading information
* Person under the protection of justice,
* Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
* Patient under guardianship or curatorship
Cognitive Behavioral Therapy in Helping Patients With Acute Myeloid Leukemia or Lymphoma With Cancer-Related Fatigue

This trial studies how well cognitive behavioral therapy works in helping patients with acute myeloid leukemia or lymphoma with cancer-related fatigue. Behavioral therapy uses methods to help patients change the way they think and act. Behavioral skills may help patients with acute myeloid leukemia or lymphoma cope with anxiety, depression, and other factors that may influence their level of cancer-related fatigue.

PRIMARY OBJECTIVES:

I. To determine whether acute myeloid leukemia (AML) and lymphoma patients with cancer-related fatigue (CRF) will be satisfied with the cognitive behavioral therapy (CBT) intervention, and if CBT will be feasible for AML and lymphoma patients with CRF where the feasibility will be based on adherence measurement.

SECONDARY OBJECTIVES:

I. To examine the preliminary effects of CBT on improvement of CRF (Functional Assessment of Cancer Illness Therapy (FACIT-F) - Fatigue subscale, its related symptoms, M.D. Anderson Symptom Inventory - Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDASI-AML/MDS), Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety Depression Scale (HADS), and Quality of Life (FACT-G) in AML and lymphoma patients receiving this combination regimen at the end of 8 weeks or 6 months.

EXPLORATORY OBJECTIVES:

I. To explore the effects of CBT on hope for future and burdens of treatment and their interference with patients' lives using the Herth Hope Index (HHI), and MDASI-AML/MDS.

OUTLINE:

Patients undergo CBT consisting of 7 counseling sessions, up to 45 minutes each over the phone.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML or AML secondary to MDS (myelodysplastic syndrome) and lymphoma with fatigue \>= 4/10 (0-10 scale) on the MDASI-AML/MDS.
* Presence of fatigue for at least 2 weeks.
* Normal cognition by Memorial Delirium Assessment Scale score of \< 13 at baseline.
* Hemoglobin \> 8 g/L within 2 weeks of enrollment in the study; if the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.
* Zubrod performance status =\< 2.
* Able to communicate in English or Spanish.
* Seen at leukemia and lymphoma clinics at University of Texas (UT) MD Anderson Cancer Center, Houston, Texas and its affiliates in University of Texas.

Exclusion Criteria:

* Has received CBT (cognitive behavioral therapy) for any indication (e.g. depression, sleep disturbance) in the past 1 year.
* Inability to comply with study protocol procedures.
* Prior cancer diagnosis other than noted in the inclusion criterion #1.
Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19

Many questions about management of COVID-19 are still not answered. So, we recruit this study aiming to evaluate improvement of oxygenation in COVID-19 patients with severe ARDS, to improve morbidity and mortality of ICU covid patients, to participate in understanding of real hidden pathophysiology of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Severe ARDS: PaO2/FiO2 \<200, resistant hypoxemia and tachypnoea (RR \> 40 breath/minute)
* Not relieved by high frequency nasal canula or CPAP.
* Need for invasive mechanical ventilation (uncooperative)

Exclusion Criteria:

* Patient relatives' refusal
* Not mechanically ventilated.
* Combination of female, corticosteroids administration and vecuronium muscle relaxant.
* Neuromuscular diseases (especially demyelinating diseases).
Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units

The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent form by the patient
* Patients should live in a geographic zone where allergy caused by Chortoglyphus arcuatus is a relevant problem.
* Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfil the inclusion criteria.
* A positive case history with inhalant allergy related to exposure to the allergen to be tested.
* A positive prick test (mean wheal diameter \> 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE.
* A mean wheal diameter \> 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
* Age: 18-50 years.
* Both genders

Exclusion Criteria:

* Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
* Use of drugs that may interfere with the skin reactions.
* Pregnancy
* Dermographism
* Atopic dermatitis (locally at the test site)
* Urticaria.