cyrilzakka/clinical-trials huggingface dataset:
Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans

The new image reconstruction algorithm (Precise Image, Philips Healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.

The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.

Recently a new image reconstruction algorithm based on Deep-learning has been developed (Precise Image, Philips Healthcare). Initial studies on phantoms have shown that this algorithm improves image quality and reduces patient dose compared to the iDose4 iterative reconstruction algorithm. Feasibility studies have validated the image quality for low-dose levels (LD). However, this algorithm has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.

The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.

The purpose of this study is to evaluate the concordance of the global quality of thoraco-abdominopelvic images of a ULD scan acquisition compared to a standard dose CT acquisition and measure the global agreement of the global quality of the images with a 4-point Likert scale.

The ULD acquisition will allow a significant reduction in the X-ray dose delivered to patients compared to a standard dose conventional scanner. This reduction is estimated at 70%.

Eligibility Criteria:
Inclusion Criteria:

* Patient having given free and informed consent.
* Patient who has signed the consent form.
* Patient affiliated to or beneficiary of a health insurance plan.
* Patient with a BMI \< 35 kg/m2

Exclusion Criteria:

* Patient participating in research involving human subjects defined as Category 1.
* Patient in an exclusion period as determined by another study.
* Patient under court protection, guardianship or trusteeship.
* Patient unable to give consent.
* Patient for whom it is impossible to give informed information.
* Pregnant patient.
* Patient with a BMI ≥ 35 kg/m2
Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara

Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara.

Method: This interventional study included a total of 200 primipara hoping for natural birth. Patients were randomly divided into two groups, one group used routine labor, one group used cold compress and perineal massage. Record the time of second stage of labor, degree of perineal laceration, etc.


Eligibility Criteria:
Inclusion Criteria:

* want give birth naturally
* have well developed perineum

Exclusion Criteria:

* Abnormal fetal position and head basin
* Severe obstetric complications
Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD

The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated

The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.

Patients will be followed up for a period of 48 months or until it is no longer possible

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
* Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
* Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
* Man or woman aged 18 years or more
* Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;

Exclusion Criteria:

* Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
* Patient who does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
* Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
* Patient taking part in an interventional study at the time of enrolment.
Effects of Assistive Device on ADL Function in Patients With Nerve Injury

Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.

Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. The use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. But the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries.

Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.

Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.

Keywords: Neural injury, 3D printing, assistive device, hand function.

Eligibility Criteria:
Inclusion Criteria:

* The medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months
* Able to understand wearing operation instructions and have the ability to give informed consent
* Able to control shoulder lifting and bending elbows, but difficult to grasp tools

Exclusion Criteria:

* Older than 75 years old and younger than 20 years old
* Severe visual or hearing impairment
* Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.
Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients

Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.

This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.


Eligibility Criteria:
Inclusion Criteria:

* Male or female older than 18 years of age
* All ICU patients
* Expected ICU stay superior or equal to 5 days
* Anticipated to receive tube feeding for at least 3 days
* Informed consent obtained from patient or close relative

Exclusion Criteria:

* Contraindication to enteral nutrition or to the placement of an enteral feeding tube
* On enteral nutrition with superior or equal to 75% of caloric goal administered
* Restriction in full intestinal support including protein administration
* Parenteral nutrition of any kind unless due to enteral nutrition intolerance
* History of allergy or intolerance to the study product components (test or control product)
* Currently under therapeutic limitations. Non functional GI tract
* Unwilling or unable to comply with study treatments
* Currently participating or having participated in another clinical, interventional trial during the last month
Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"

The investigators propose to test the theory that smart alarms for the Triple Low State incorporated into a decision support system built into an electronic anesthesia record will prompt clinicians to intervene earlier in situations that would otherwise provoke little concern, and that the alert system will reduce 90-day mortality. Specifically, the investigators will test the hypothesis that providing Triple Low alerts reduces 90-day mortality.


Eligibility Criteria:
Inclusion Criteria:

* Adults presenting for non-cardiac surgery under volatile general anesthesia
Effect of Vachellia Nilotica Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Load Reduction in Mandibular Premolar Teeth With Necrotic Pulp

The aim of this study is to assess the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction.

Clinical compare the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction when used as root canal irrigant in necrotic pulp. The post operative pain will be recorded using Numerical rating scale, and the bacterial load reduction will be measured by Bacterial counting using agar culture technique.

Eligibility Criteria:
Inclusion criteria:

1. Systemically healthy patient (ASA I, II).
2. Age between 20 and 40 years.
3. Male or female.
4. Patient who is able to sign and comprehend the pain scale (committed patient).
5. Mandibular single rooted premolars having the following criteria:

   * With single root canal.
   * Diagnosed clinically with pulp necrosis.
   * Absence of spontaneous pulpal pain.
   * Positive pain on percussion denoting apical periodontitis.
   * Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm).

Exclusion criteria:

1. Medically compromised patients (ASA III or IV).
2. Teeth with:

   * Immature roots.
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated.
   * Deep periodontal pockets more than 4 mm.
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
3. Patients who could not interpret the NRS.
4. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
5. History of intolerance to NSAIDs.
Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.

Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo.

In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery.

The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated.

The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.

Eligibility Criteria:
Inclusion Criteria:

* Females and Males 18-80 years old
* ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
* ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
* ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
* Patients scheduled for oncological laparoscopic colectomy
* Patients who do not use opioids analgesic drugs before surgery
* Patients without cognitive impairment or mental retardation

Exclusion Criteria:

* Females and Males under 18 or over 80
* ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
* ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
* Emergency/urgency surgery
* Postoperative admission in an intensive care unit with sedation or ventilatory assistance
* Cognitive impairment or mental retardation
* Use of opiods before surgery
* Progressive degenerative diseases of the CNS
* Convulsions or chronic therapy with antiepileptic drugs
* Severe hepatic or renal impairment
* Allergy to one of the specific drugs under study
* Acute infection or inflammatory chronic disease
* Alcohol or drug addiction
* Any kind of communication problem
* Neurologic or psychiatric disease
Parent-Youth Teamwork in Pediatric Asthma Management

The purpose of this research study is to examine the effectiveness of a parent-youth teamwork treatment and an asthma education treatment in helping children use their asthma medicines correctly. We also want to learn about how these treatments affect parental involvement in asthma care, parent and youth relationships, and children's health care.

Noncompliance with medication is a prevalent problem for pediatric asthma patients, particularly for pre-adolescents and adolescents. Families reportedly struggle with the transition of expecting adolescents to assume more independence and responsibility in asthma management. Parent-child collaborative management of pediatric chronic illness regimens has been related to better adherence to medical regimens and improved health outcome. This study has four aims. The first aim is to investigate the effectiveness of a low-intensity, behavioral intervention aimed at promoting parental involvement in children's asthma management, particularly in improving medication adherence. The second aim is to examine how the role of parental involvement changes across time and participation in a 5-month study. A third aim is to determine whether parent-adolescent conflict is changed by the intervention. The fourth aim is to evaluate whether participation in the treatment program is associated with improved health status (e.g., improved pulmonary function test results).

Established asthma patients (ages 9-15) will be randomly assigned to one of three groups: Treatment Intervention (TI), Asthma Education (AE), and Standard Care (SC). The TI and AE groups will receive four 30-minute treatment sessions every two weeks. The TI intervention will consist of strategies aimed at promoting parent-youth management in asthma management. The AE group will receive structured reviews of asthma educational materials typically given to asthma patients. SC participants will have no contact with researchers beyond that necessary to gather data. Data will be collected from all participants every two weeks for the first 8-weeks of study involvement and also about 3-months after the final treatment session. Outcome data will include objective measures of medication adherence, parental involvement in asthma, and health outcome.

Eligibility Criteria:
Inclusion Criteria:

* patient has been diagnosed with asthma for at least 6 months
* patient can be managed appropriately on study medications as determined by the attending physician

Exclusion Criteria:

* patient shows evidence of neurological or significant cognitive impairment
CT TAVR Abdomen Study

A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to receive TAVR abdominal CT

Exclusion Criteria:

* cannot undergo CT scan
* Allergy to intravenous contrast not controlled by steroids or benadryl
* GFR\<30
Ankle Assistance and Resistance in Older Adults

The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.

The overarching goal of this study is to improve mobility in older adults through advances in wearable assistance (i.e. powered orthoses). This goal will be accomplished by focusing on two specific research aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.

Several powered orthosis conditions will be tested during several modes of walking or running and balance throughout the course of the study. Trials will take place over-ground and/or on a treadmill. Balance trials will take place on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue; a maximum of 15 minutes of continuous walking will take place between breaks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 85 years old, inclusive.
* Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
* Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
* The ability to read and understand English.
* Able to walk at least 30 feet with or without a walking aid
* Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking

Exclusion Criteria:

* Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time. Note: For elderly participants, a history of joint replacement or joint degeneration that does not impair their ability to walk safely is allowable.
* Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
Using Transcutaneous Auricular Vagus Nerve Stimulation to Treat Acute Alcohol Withdrawal

The purpose of this study is to see if stimulation of the vagus nerve via a non-invasive device placed behind external ear can reduce physical and psychological discomfort during acute alcohol withdrawal in patients with alcohol use disorder when people just stop drinking alcohol and in detoxification stage.

The management of acute alcohol withdrawal is a clinical challenge, in part because there are limited medications available for the condition and the majority of the medications are controlled substances, which may cause significant adverse effects and can be potentially addictive.

The rationale for using transcutaneous auricular VNS (taVNS) on a specific target area of the ear is based on anatomical studies suggesting that this area is the only place on the human body surface where there is afferent vagus nerve distribution (Mercante et al., 2018). Therefore, direct stimulation of the afferent nerve fibers on the ear can produce an effect similar to that by implanted device-generated VNS yet without the need of surgical intervention. Although taVNS has not been tested for treatment of AUD, it interestingly appears to be very similar to auricular acupuncture that has been widely used for AUD. However, acupuncture needs to be administered by medical providers who have undergone long trainings and own special licensure, which is usually unavailable in acute detoxification units where patients receive treatment for acute alcohol withdrawal.

The pilot study will enroll 70 evaluable subjects who are in inpatient detoxification unit randomized to receive single-blind treatment with vagus nerve stimulation or sham stimulation (1:1, VNS: sham). Evaluable subjects are those who complete stimulations (VNS) or sham 5 minutes twice a day for 4 days.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-65 years (men and women);
2. primary current diagnosis of DSM-V Alcohol Use Disorder as indicated at admission;
3. being admitted to inpatient detoxification unit;
4. no evidence of significant cognitive impairment with a mini mental state examination (MMSE; Folstein et al., 1975) score \> 22;
5. able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

1. current DSM-V substance use disorders (other than tobacco / cannabis/ alcohol);
2. serious psychiatric illnesses, e.g. psychotic disorders or bipolar disorder
3. severe medical illnesses, present or history of, e.g. hepatic encephalopathy, delirium
4. history of significant medical problems associated with drinking including seizures;
5. pregnancy;
6. severe intellectual/cognitive deficits due to Korsakoff's syndrome, dementia, head injury, or others
7. treatment with an anti-cholinergic medication, including over the counter medications,
8. implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.