cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning

A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy.

This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.

Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:

1. Occurrence of complications related or possibly related to the colonoscopy procedure
2. Scope insertion time
3. Pain during and after the procedure

The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.

Eligibility Criteria:
Inclusion Criteria:

* ability to understand and sign consent
* women and men with a BMI (body mass index) \<35 kg/m2
* age 18 - 90 years
* no liquids by mouth for ≥2 hours
* no solid food for ≥8 hours

Exclusion Criteria:

* inability to provide informed consent
* morbid obesity (BMI ≥35)
* pregnancy
* uncontrolled gastroesophageal reflux disease
* gastroparesis
* scleroderma
* achalasia
* Crohn's disease
* ulcerative colitis
* history of a colon resection
* Parkinson's disease
* brain tumor
* multiple sclerosis
* ischemic optic neuropathy
* glaucoma
* active pulmonary infection
* liquid intake \<2 hours
* solid food intake \<8 hours prior to the procedure
* intra-procedure findings of a stricture resulting in an incomplete colonoscopy or Boston bowel preparation scores of \<6
The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application

This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .

This study will describe how much time persons with type 2 diabetes mellitus spend on health management and the burden they experience from these activities.

Eligibility Criteria:
Inclusion Criteria:

* receiving medical care at Mayo Clinic endocrine subspecialty clinic
* diagnosis of type 2 diabetes

Exclusion Criteria:

* unable to provide consent
* patients who reside in an extended care of intermediate care facility
Multiple Sclerosis Pelvic Floor Telerehabilitation

The goal of this clinical trial is to compare the effects of two different pelvic floor telerehabilitation protocols on selected measures of quality of life and health in females with relapsing-remitting Multiple Sclerosis (rrMS). The main questions it aims to answer are:

* Is telerehabilitation sufficient to improve quality of life and health in females with rrMS, in particular dedicated to pelvic floor training?
* Are self-administered training protocols or remotely-supervised training protocols equally effective?

Participants will be randomized to two intervention groups: a self-administered training protocol (SELF) and a remotely-supervised (REMOTE) training protocol. Both protocols will consist in 10 sessions of pelvic floor training lasting 45 min each, once every 5 days.

At the start and at the end of the protocol, all participants will complete 6 questionnaires regarding pain, quality of life and health.

In this study, the authors aim to evaluate the efficacy of two telerehabilitation protocols dedicated to pelvic floor and urogynecological health in females with relapsing-remitting Multiple Sclerosis (rrMS).

In particular, the included participants will be randomized to:

* SELF protocol: 10 sessions of pelvic floor exercises, self-administered with a set of videos where a physiotherapist showed the different exercises in order to complete a 45 minutes session.
* REMOTE protocol: 10 sessions of pelvic floor exercises, remotely conducted and supervised by a physiotherapist with a one-to-one videocall, showing and monitoring the exercises in order to complete a 45 minutes session.

One week before the first session and one week after the last session, all the participants will be asked to complete a set of surveys and questionnaires to investigate participants' pain perception, reported quality of life and health-related parameters.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of relapsing remitting Multiple Sclerosis confirmed by a neurologist and based on the McDonald criteria from not less than 1 y
* EDSS \<4.5
* self reported symptoms of urinary incontinency

Exclusion Criteria:

* females in menopause
* previous history of bladder or urogynaecological surgery
* previous history of major abdominal surgery
* females with a delivery \< 6 months from the start of the study
* BMI \> 30
Cardiac Vulnerability in Potentially Susceptible Patients

This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project patient who have recently suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times during the year following their cardiac event. Similarly a second group of patients with moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice a week separated by 3 months. In both sets of patients home indoor pollution measures will be continuously made and used to correlate with measures of heart rate variability.

Approximately 50 patients in each group will be studied. In addition to cardiac monitoring for 24 hours at each session, overnight respiratory pattern and oxygen saturation will be monitored in both groups. The exposure monitoring will include both particle mass of PM2.5 along with detailed assessment to determine that portion of the particulate exposure from outdoor vs. indoor sources.

Eligibility Criteria:
For the cardiac event cases patients are selected from the Brigham and Women's Hospital cardiac services at the time of discharge, aged 45-74, having suffered a cardiac event resulting in either an infarct or need for a cardiac procedure (angioplasty, stint, etc). For the CHF patients they are selected from the BWH cardiac clinics where they have been identified and classified as stage 3 or 4 CHF. For both groups residence requirements are that they reside within the Greater Boston Area as defined by an outer ring road (Route 495) and are willing to be visited at home and have the exposure assessment equipment set up in their home as well as be monitored personally.
Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution

We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution.

All injections are guided by ultrasonography.

Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Duration of tennis elbow \> 6 months
* Doppler activity on ultrasonography
* Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger.

Exclusion Criteria:

* Inflammatory disease.
* Fibromyalgia.
* Pain in hand or shoulder/neck in the same arm as being treated.
* Anticoagulation treatment.
* Wounds around the elbow.
* Treatment with steroids within the last 3 months.
Evaluation of Immediate v. Delayed CT/NG Test for Treatment in the ED

The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia and to assess changes in clinician management decisions with real-time test results.

The investigators will conduct a randomized controlled trial in patients aged 18 and older where the treating clinician is ordering a CT/NG test. Clinicians will be approached by a research assistant while they are in the ED and asked whether a CT/NG swab will be ordered and if CT/NG is in the differential diagnosis. Then, potentially eligible patients will be approached and asked for consent to enroll. For patients that consent, simple randomization procedure (i.e. random number generator) will be used to assign patients to either immediate test results or delayed test results. Typically, in the ED these tests are ordered for diagnostic rather than screening purposes (symptoms of vaginal discharge, abdominal pain, etc). Patients will be randomized to batched testing with the Roche AMPLICOR CT/NG (standard of care, control group) or immediate testing of clinical specimens with Cepheid CT/NG with real-time result reporting (within 90 minutes) to the treating clinician in the ED. Patient interview and clinician survey will be conducted to ascertain perceptions of illness and the test. A follow up interview will be conducted with the patient to determine clinical and public health outcomes.

A validation of the Cepheid CT/NG test will be conducted against the hospital standard of care on \</= 40 pilot participants. Pilot participants will be asked to provide 2 endocervical swabs and a urine specimen. All surveys and interviews will be conducted on pilot patients.

While many outcomes can be measured in this study, the investigators will power this study to reduce the overtreatment rate with antibiotics. Assuming a baseline overtreatment rate of 88% (# treated with antibiotics/# without disease), to reduce this rate by 50% (to 44%), at a power of 80% and alpha of 0.05, the investigators will need to enroll 42 patients (21 controls and 21 study patients) with negative tests. Given an estimated positive rate of 6%, and that approximately 50% of patients who receive these tests for any reason will be treated empirically with antibiotics, the investigators think that enrolling a total of 70 patients with full data (enrollment survey, clinician survey, and follow up survey) would be sufficient to identify trends with this subject matter. Due to the sensitive nature of the subject matter and the high percentages of lost-to-follow up with ED patients, the investigators estimate approximately 50% will have incomplete data. Therefore, the investigators request to enroll 150 patients in the study.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years
* clinical suspicion of CT/NG
* able to give informed consent
* willingness to wait for test result

Exclusion Criteria:

* less than 18 years
* pregnancy
* prisoners
* unable to give informed consent
A Safety Study of ARRY-502 in Healthy Subjects

This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female between the ages of 18 and 50 years.
* Females must be of nonchildbearing potential.
* Body mass index (BMI) of 18 to 32 and a total body weight \> 50 kg (110 lbs) and \< 114 kg (250 lbs).
* Additional criteria exist.

Key Exclusion Criteria:

* Evidence or history of clinically significant disease (excepting allergic rhinitis).
* Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
* Gastrointestinal surgery that may interfere with motility or absorption.
* Serious illness requiring hospitalization within the previous 6 months.
* A positive test for drugs or alcohol.
* Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days.
* Use of corticosteroids within the previous 28 days.
* Recent history of blood, plasma or platelet donation.
* Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months.
* Prior exposure to investigational study drug ARRY-502.
* Additional criteria exist.
Contribution of Image Fusion in Percutaneous Left Atrial Occlusion procédures (Fusion Image)

Atrial fibrillation is the most common rhythm disorder, affecting 2 to 3 percent of the population. One of the major complications is the occurrence of thromboembolic events, the thromboembolic risk can be predicted by the ChadsVasc score. Anticoagulant treatment is therefore almost always indicated, however, in view of the target population, anticoagulant treatment is sometimes contraindicated, justifying the appearance of alternative treatment such as occlusion of the left auricle by surgical or percutaneous means, with the placement of a prosthesis in the left auricle.

Image fusion is a new imaging technique aimed at improving the spatial view of 2D images (made during a catheterization session) by repositioning in real time a 3D model obtained by reconstruction from scanner images of the structure of interest. Once the model has been redesigned, it follows all the consequences that the hemodynamicist wants to take and thus guides the gesture as well as possible.

The purpose of this project is to evaluate the contribution of image fusion to per cutaneous occlusion procedures of the left atrium. This contribution will be evaluated by comparing the procedure time, the irradiation time, the amount of contrast material used between the procedures performed with the image fusion technique and without this new technique.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with a collegially selected indication of FAG
* Patient willing to participate in the study

Exclusion Criteria:

* Minors, adults under guardianship and protected persons
* Presence of contraindications to the procedure, including the presence of a thrombus in the left atrium
* Procedure combined with another percutaneous gesture at the same time
Evaluation of Preoperative Acceptance of Proactive Palliative Care Intervention

Advances in medicine have led to an increased life expectancy even with complex disease courses of malignant diseases.

This leads to frequent critical situations for patients and high risk surgical interventions. The majority of patients and their practitioners are not prepared for the consequences of a complex and possibly fatal course.

Palliative medicine makes it possible to anticipate the further course of the disease. As a result, palliative medicine has become increasingly important. The beginning of palliative medical interventions has extended from accompaniment limited to the dying phase to earlier phases of the disease.

An early integration of palliative medicine showed a positive effect on the quality of life, the degree of depression and survival in patients suffering from cancer, for example. Furthermore, patients were more able to accept a change in therapy goal at the end of life. Similar results were shown for patients with a non-malignant severe disease such as COPD or heart failure.

What needs further investigating is how to adequately screen and identify the patient populations who could benefit from early palliative care, so that they are prepared for potentially critical and life-threatening situations.

The investigator's objective is therefore whether the Anesthesiology Outpatient Clinic is a suitable screening location for initiating early integrated palliative care for patients with a serious, life-shortening illness and a high perioperative risk.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* one elective operation with medium or high cardiac risk

And in addition at least one of the following criteria:

* serious comorbidity pulmonary: Emphysema and / or COPD \>= 2 after GOLD cardiac: NYHA \> = 2
* and / or a metastatic malignancy
* ASA physical status classification \>= 3 and pre-frail or frail

Exclusion Criteria:

* legal care
* Emergency operation
* any reasons which contradict inclusion in studies , e.g. cognitive deficit and lack of language skills
* Pregnant / breastfeeding women
Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients

Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
* Social insurance

Exclusion Criteria:

* No affiliation to the social insurance
* Patients under guardianship
Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders

The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.

Several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (CAC) in patients with affective spectrum disorders. However, the effects of Sudarshan Kriya Yoga (SKY) on autonomic function in this population is unknown. To test the hypothesis that SKY training improves CAC, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders.

The authors will enroll patients with a diagnosis of anxiety and/or depression disorders (DSM-IV) and they will divide them in two groups: 1) conventional therapy (Control) and 2) conventional therapy associated with SKY (Treatment) for 15 days. Anxiety and depression levels will be determined using quantitative questionnaires. For the assessment of CAC and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of anxiety-depression disorder

Exclusion Criteria:

* absence of sinus rhythm on ECG
* absence of any cardiovascular and metabolic disorder
Normal Vascular Doppler Pattern of Abdominal Organ in Children

The following ultrasonic findings are obtained at both time points before and after induction of anesthesia (T1) and after induction (T2) in normal children . Positive pressure ventilation (Tidal volume of 6-8 ml/kg and a positive exhalation pressure of 5 cmH2O) is applied after anesthetic induction.

1. Inferior vena cava diameter and distensibility
2. Hepatic vein Doppler
3. Portal vein Doppler
4. Splenic artery and vein Doppler
5. Renal artery and vein Doppler Based on this, the reference values for Doppler findings before and after anesthesia in normal children are obtained.


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing simple surgery

Exclusion Criteria:

* thoracic/abdominal surgery
* surgery for congenital heart disease
* disease involving liver, kidney, spleen
* vascular disease
Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with cardiac MRI or cardiac CT scan or thoracic CT scan admitted for acute inflammatory syndrome and cardiac compromise
2. Patient with PCR or antibodies test for COVID 19 (positive of negative)
3. Patient or parents of minor patients informed about collection of personal data for the study

Exclusion Criteria:

* Patient or parents refusing personal data collection
Meal-Based Exposure and Response Prevention in Anorexia Nervosa

Patients with anorexia nervosa (AN), a serious psychiatric disorder, exhibit restricted dietary intake and endorse fear of consuming calorie-dense foods, which in turn drives weight loss. Premorbid anxious personality traits and comorbid anxiety disorders are common in patients with AN. Although intensive behavioral treatment programs can achieve weight restoration in a majority of adults with AN, relapse rates are high. Predictors of relapse include elevated state anxiety and low dietary variety, including lower intake of fat, after discharge, which suggests that relapse following weight restoration may be related to inadequate fear extinction to high energy density (ED) foods during treatment and consequent resumption of restrictive eating patterns. Despite evidence of anxiety's role in the onset and maintenance of restricted eating behavior, utilizing exposure and response prevention (EX-RP) and meal-based interventions to reduce food-related fears is understudied. EX-RP is the gold standard of treatment for Obsessive Compulsive Disorder (OCD). This proposal aims to test the efficacy of an adjunct meal-based EX-RP intervention to reduce food-related fears during intensive behavioral weight restoration in hospitalized patients with AN in comparison to a control treatment, Motivational Interviewing. The investigators will assess changes in a) self-reported anxiety regarding consumption of high-ED foods, b) physiological (skin conductance and heart rate variability) responses to imagined consumption of food items elicited utilizing a visual food cue task, and c) caloric intake of a challenging test meal pre- and post-treatment. A secondary aim is to assess the relationship of early treatment response to EX-RP, operationalized as a reduction in self-reported anxiety within the first three weeks of treatment, and end-of-treatment as well as six-month post-discharge outcomes. Helping patients tolerate food-related anxiety and increase dietary variety across meal contexts may augment treatment effectiveness in adult patients during intensive treatment for AN and has potential to decrease relapse rates.


Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 criteria for AN or Other Specified Feeding and Eating Disorder.
* Body Mass Index (BMI) \> 14.0 kg/m2 and \< 20.0 kg/m2
* Age \> 12 years, \< 66 years
* Fluency in the English language

Exclusion criteria:

* Diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type I) with active psychotic symptoms
* History of traumatic brain injury with current impairment in functioning
* Current use of benzodiazepines, as these medications may alter psychophysiological assessment
* Allergy to dairy products or chocolate contained in the test meal