cyrilzakka/clinical-trials huggingface dataset:
The Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area

The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed voluntarily.
* Aged at least 18 years.
* Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
* Sufficient bone volume for implant placement without bone augmentation;
* The minimum number of residual teeth was seven teeth.
* Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene.

Exclusion criteria:

* Systemic disease that would interfere with dental implant surgery.
* Bisphosphonate treatment.
* Untreated, uncontrolled periodontal disease.
* Heavy smoker (more than 10 cigarettes per day).
* Poor oral hygiene.
Application of Motor Unit Estimation Index in Amyotrophic Lateral Sclerosis and Related Diseases

This was a cross-sectional study in which patients were divided into 20 patients with amyotrophic lateral sclerosis, 20 patients with peroneal muscular dystrophy, 20 patients with Kennedy's disease and 30 healthy controls, in which patients with amyotrophic lateral sclerosis continued to be followed up for 1 year and the results of 4 cross-sectional examinations were taken.

Background Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that usually starts in middle age and manifests mainly as progressive atrophy and weakness of skeletal muscles throughout the body, with death from respiratory muscle involvement after 3 to 5 years. There are no biomarkers for early diagnosis and no effective treatments. Because of the rapid progression of amyotrophic lateral sclerosis, it is important to find indicators that can objectively reflect early changes in the disease. The motor unit number index (MUNIX) is a non-invasive, rapid and objective method to assess the number of motor units, which reflects the loss of motor neurons and has its theoretical basis in monitoring early disease progression.

Objective To explore the diagnostic value of MUNIX in motor neuron disease and other related disorders.

To investigate the role of the 1-year rate of change of MUNIX in monitoring the disease progression in patients with amyotrophic lateral sclerosis.

To investigate the role of MUNIX in predicting survival analysis of ALS patients

\[Design\] This was a cross-sectional study in which patients were divided into 20 patients with amyotrophic lateral sclerosis, 20 patients with peroneal muscular dystrophy, 20 patients with Kennedy's disease and 30 healthy controls, in which patients with amyotrophic lateral sclerosis continued to be followed up for 1 year and the results of 4 cross-sectional examinations were taken.

Eligibility Criteria:
Inclusion Criteria:

* ALS patient group: 20 patients with confirmed or proposed ALS meeting the 1998 revised El Escorial diagnostic criteria for limb onset ALS.
* CMT group: 20 patients with peroneal muscular dystrophy meeting the genetically confirmed diagnosis, who signed an informed consent form.
* KD group: 20 patients with genetically confirmed Kennedy's disease consistent with genetic diagnosis, signed informed consent.
* healthy controls:

  1. age-matched healthy adults who volunteered to participate;
  2. definite exclusion of tremor, tonicity, and prior brain disease;
  3. exclusion of common disorders affecting peripheral nerves such as entrapment peripheral neuropathy, diabetic peripheral neuropathy, and alcoholic peripheral neuropathy;
  4. signed informed consent.

Exclusion Criteria:

1. signs of sensory impairment;
2. significant sphincter dysfunction;
3. visual and oculomotor impairment;
4. autonomic dysfunction;
5. signs of extravertebral symptoms;
6. severe cortical dysfunction;
7. ALS-like syndrome.
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.


Eligibility Criteria:
Inclusion Criteria:

* healthy male or female subjects
* BMI 18 to 26.9
* must give informed consent

Exclusion Criteria:

* clinically significant disease
* narrow angle glaucoma
* positive drug screen
Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL

The purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a Medicontur monofocal (877PAY) or a Medicontur extended depth of focus (877PEY) IOL models.

The visit schedule included a total of 6 visits, in addition to the IOL implantation surgery, with the listed follow-up timeline:

* screening and baseline assessments
* day 0 (IOL implantation surgery)
* day 1
* month 1
* month 3
* month 6
* month 12


Eligibility Criteria:
Inclusion Criteria:

* cataractous patients who wish to be partly spectacle independent
* cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms\*
* best corrected visual acuity to be better than 20/25 (0.1 logMAR) after cataract removal and IOL implantation\*
* ≤ 1.0 D of preoperative keratometric astigmatism;
* clear intraocular media other than cataract;
* given written informed consent by subject;
* subjects are willing and able to comply with schedule for follow-up visits;
* adult patient

Exclusion Criteria:

* corneal astigmatism \> 1.00 D
* irregular astigmatism
* diabetic retinopathy
* iris neovascularisation
* serious intraoperative complications
* congenital eye abnormality
* uncontrolled glaucoma or glaucoma with changes in optical nerve and visual field
* pseudoexfoliation syndrome
* amblyopia
* uveitis
* long-term anti-inflammatory treatment
* AMD
* retinal detachment
* prior ocular surgery in personal medical history
* corneal diseases
* severe retinal diseases (dystrophy, degeneration)
* severe myopia (if required IOL power is lower than 10 D)
* inadequate visualization of the fundus on preoperative examination
* patients deemed by the clinical investigator because of any systemic disease.
* eye trauma in medical history

Intraoperative exclusion criteria:

* tear in capsulorhexis\*
* zonular dehiscence\*
* posterior capsular rupture vitreous loss and other unexpected surgical complication\*

  * According to coordinator investigator's decision, the marked inclusion and exclusion criteria were not applied.
Application of Probiotic PS128 in Children With ASD

The purpose of this study is to explore the role of probiotics PS128 in improving gastrointestinal dysfunction and core behavioral symptoms in children with ASD, and investigate the underlying etiological mechanisms of ASD.

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner(participant and investigator) in a 1:1 ratio to probiotics PS128 group or placebo group. Each patient acts as his or her own control, and they receive both the study drug as well as the placebo. After a washout period, the participants will be switched throughout to different treatments（probiotics placebo group or PS128 group）.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 2-5 years with ASD from Tongji hospital (both boys and girls);
2. meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS-2 diagnostic criteria;
3. No significant abnormalities on head MRI or EEG;
4. If psychotropic medication is required during the project, the psychiatrist must confirm that medication is stable during this period (no change in dose or type of medication);
5. Willing to provide samples such as blood, urine and feces.

Exclusion Criteria:

1. Take antibiotics or antifungal drugs within 15 days prior to the project.
2. Take probiotic products within 30 days prior to the project.
3. Have acute diarrhea within 30 days prior to the project.
4. Start taking new psychotropic medication within 15 days prior to the project.
5. Have severe hearing, visual or motor impairment.
6. Accompany with other mental behavioral disorders, such as schizophrenia, bipolar disorder.
7. A history of Rett syndrome, chromosomal, inherited metabolic disorders and other significant somatic disorders.
8. A history of organic gastrointestinal disorders (e.g., gastroesophageal reflux, food allergies, inflammatory bowel disease), history of intestinal surgery, intestinal obstruction, intestinal perforation, intestinal bleeding, multi-organ failure, and severe immunodeficiency disorders
9. Have a special diet (e.g., gluten-free diet, casein-free diet, ketogenic diet, etc.)
10. Co-morbidities in children with ASD were documented and discussed in detail by two or more behavioral developmental behaviorists, and children with ASD who required immediate rehabilitation or neurological analogs for co-morbidities were not allowed to enter this study.
FDG Uptake in Vaginal Tampons is Due to Urine

The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and can potentially impair image interpretation.

The aim of this study is to determine the etiology of this artefact and identify potential means how to prevent it.

In this prospective, Institutional Review board approved study we included 44 women referred to FDG PET/CT for staging or follow-up in an oncology setting. All women were provided a normal commercial or modified vaginal tampon with a silicon coated base to be used during examination. Images were analyzed to determine the localization and the FDG uptake in the tampons. Between the uptake phase and imaging, all patients were asked to void. After image acquisition, tampons were individually analyzed for creatinine concentration, blood traces, position relative to the pubococcygeal line, and FDG activity. Statistical significance was determined by means of the Mann-Whitney U test.

Eligibility Criteria:
Inclusion criteria: premenopausal women with known or suspected malignancies who regularly used vaginal tampons during menstruation and thus were familiar with their use

Exclusion criteria: No cervical or genital carcinoma. No vaginal infection.
Value of Follicular Flushing. Randomised Controlled Trial

The purpose of this study is to evaluate whether the addition of follicular flushing to the initial aspiration during oocyte retrieval increases the number of oocytes retrieved in women undergoing ovarian stimulation.

There is an ongoing debate regarding the effectiveness of follicular flushing during oocyte retrieval. Currently published studies and metanalyses suggest that follicular flushing does not improve live birth rate, clinical pregnancy rate or the number of oocytes retrieved. However, currently published studies may be confounded by the types of needle used, aspiration pressures, number of times flushing is repeated, etc. Additionally, follicular flushing should be examined in specific patient populations according to their response to ovarian stimulation.

In the current study, each woman will have one ovary (right or left) randomly assigned to be aspirated with or without the addition of follicular flushing. This study design ensures that clinical and demographic characteristics of the couple will not affect the outcomes evaluated. The primary endpoints will be the number of oocytes retrieved per ovary assigned to each group. Secondary outcomes will be the oocyte recovery rate (oocytes retrieved per follicle aspirated) oocyte maturation rate, fertilization rate, and embryo development per ovary assigned to each group.

The study population will include three subgroups according to observed ovarian response to ovarian stimulation (poor responders, normal responders, hyper responders). Assuming a minimum clinically significant difference in oocyte yield of 1 oocyte, a sample size of twenty patients per subgroup is required to yield 80% power.

Patients aged \<43 years with the presence of at least one follicles \>11mm in each ovary on the day of triggering final oocyte maturation will be eligible for inclusion in the study. 60 patients (20 in each of the aforementioned subgroup) will be recruited and just prior to oocyte retrieval their left and right ovaries will be randomly allocated into flushing or the no-flushing group. In both ovaries all follicles greater than 11mm will be punctured by the same 16G double lumen needle, using the same aspiration pressure. In the flushing group, flushing will be performed up to a maximum of five times or until a cumulus oocyte complex (COC) is retrieved.

In the control group all follicles greater than 11mm will be aspirated by the same double lumen needle and no flushing will be performed.

All COCs will be grouped according to the ovary they originated from by the embryologists and their development will be recorded until Day 3 following fertilization (Number of MII oocytes, number of fertilized oocytes, number good quality Day 3 embryos).

Eligibility Criteria:
Inclusion Criteria:

* Presence of both ovaries
* 18-43 years old
* At least one follicle \>11mm present in each ovary on day of triggering final oocyte maturation.

Exclusion Criteria:

* Ovarian surgery
* Monofolicular development
Assessment Of MRI In Patients With Implanted Cardiac Devices

The research goal is to continue to add to the extensive body of peer-reviewed evidence that demonstrates MRI may be safely performed in patients with cIEDs, after they have been evaluated and cleared by cardiology. This study will allow the researchers to collect data from the facilities ongoing clinical practice regarding the number and types of any adverse clinical reactions, and also to document any changes in the implanted cardiac device that may have occurred during the MRI scan. The researchers will also be assessing the results of the MRI and how the imaging findings impact patient care and the clinical outcome of the patient. This data will then be presented to the FDA and the Centers for Medicare and Medicaid Services to further influence federal guidelines and payment structures.

Cardiac implantable electronic devices (cIEDs) generally refer to implanted pacemakers and defibrillators for patients with cardiac disorders affecting their heart rhythm. Previously, cIEDs have been regarded as a contraindication to magnetic resonance imaging (MRI) scans, with concerns that the magnetic fields of the MRI may cause problems with the patient's cIED. However, this is a major healthcare issue, as approximately 50-75% of patients with implanted cIEDs are expected to need a future MRI as part of their clinical care. The inability to get such a test may negatively impact the ability to diagnose and treat future diseases.

However, many of the initial concerns regarding the capability of performing MRI in patients with cIED have likely been overstated. There is peer-reviewed literature dating back to the 1990s regarding the ability to safely perform MRI in patients with cIEDs, if certain protocols are followed regarding patient selection and monitoring. In 2011, Nazarian et al from Johns Hopkins University published a study on 438 patients with cIED that received MRI. There were no adverse clinical effects from this study. In fact, the American College of Radiology updated it's guidance document for Safe MR Practices, and cIEDs are no longer listed as a relative contraindication to obtaining an MRI. However, the presence of cIEDs are still regarded as a relative contraindication to performing MRI at some centers. In addition, performance of MRI in the setting of cIED is denied by the Centers for Medicare and Medicaid Services. Continued accrual of data regarding the safety of performing MRI in patients with cIEDs is needed, including outcomes studies that document the clinical impact of improved diagnostics provided by the MRI on patient care.

Eligibility Criteria:
Inclusion Criteria:

* All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .

Exclusion Criteria:

* patient does not require an MRI for their medical care
* patient does not have a cIED
* patient has not been seen or approved by cardiology to be a candidate for MRI
* patients under the age of 18
* pregnant patients
* prisoners
A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders

The study is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation.

The aim of this study is to investigate the feasibility of a 16 week physical exercise intervention combining strenght and aerobic training in group for patients with psychotic disorders. In addition, the feasibility of the test protocol and participants subjective experience with the intervention will be investigated.

Research shows positive effects of physical exercise for patients with psychotic disorders regarding maximal aerob training, maximal muscle strength, physical, cognitive and social functioning, and symptom levels. Effects and the degree of feasibility of physical exercise for patients with psychotic disorders are amplified by regarding their preferences and needs, and if they experience support and guidance during the intervention. Earlier studies have focused mostly on either strength og endurance training, or combined interventions of moderate intensity. We now want to investigate the feasibility of an invidually adjusted combined program of high intensity.

After the intervention, participants will be interviewed about their experience with participating.

Eligibility Criteria:
Participants with psychotic disorder:

Inclusion Criteria:

* Signed informed consent
* Diagnosed with psychotic disorder
* Physically able to participate in physical exercise
* Is a patient at Solli DPS
* Motivated for participating in physical exercise

Exclusion Criteria:

* Physical conditions precluding the participant from the physical testing/training
* Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder

Participants with psychiatric disorder, but no psychotic disorder:

Inclusion Criteria:

* Signed informed consent
* Diagnosed with psychiatric disorder, but not a psychotic disorder
* Physically able to participate in physical exercise
* Is a patient at Solli DPS
* Motivated for participating in physical exercise

Exclusion Criteria:

* Physical conditions precluding the participant from the physical testing/training
* Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder
The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction

The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease
* Left ventricular systolic dysfunction
* Sinus rhythm: heart rate (HR) \>= 60 beats per minute (bpm)

Exclusion Criteria:

* Unstable cardiovascular condition
* Severe congestive heart failure
Role of Candidate Proteins in Capillary Leakage During Acute Circulatory Failure

* Testing the association between circulating candidate proteins and the level of vascular leakage for three distinct forms of circulatory failure: cardiogenic shock, septic shock, and post-resuscitation syndrome.
* Describing immuno-inflammatory profiles associated with massive vascular leakage during those three forms of circulatory failure in humans

Circulatory shocks are responsible for one third of intensive care unit (ICU) admissions (20,000 patients per year in France) and are associated with 40% mortality \[1,2\]. Vascular hyperpermeability (also called vascular leakage) is a major feature of circulatory failure. During systemic inflammatory response syndrome (SIRS), massive vascular leakage affects macro and micro-circulation, and participates in the development of multiple organ failure \[1,3\]. Accordingly, fluid balance (the difference between fluid input and output) correlates independently with mortality during both septic and cardiogenic shock \[4-7\] and controlling capillary leakage was highly beneficial in numerous animal models of circulatory failure \[8-10\]. However, the determinants of vascular leakage remain poorly understood in humans.

The purpose of this study is to evaluate the link between circulatory levels of several proteins and the level of vascular leakage, in three distinct types of circulatory shocks.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent from patient or a legal representative/family member/close relative. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
2. Affiliation to social security (AME excluded)
3. Patient with one of the circulatory failures described below:

   * septic shock
   * cardiogenic shock
   * post-resuscitation syndrome
   * Cardiogenic shock:

     * Need for a catecholamine support to maintain mean arterial pressure\>65 mmHg, AND
     * Cardiac index \<2 L/min/m2 or left ventricular ejection fraction (LVEF)\<35%, AND
     * Lactate \>2.0 mmol/l
   * Post-resuscitation syndrome:

     * Cardiac arrest (absence of spontaneous respiration, palpable heartbeat, and responsiveness to stimuli\> 1 min) with a compatible electrocardiogram (asystole/pulseless electrical activity/ventricular tachycardia), AND
     * Need for a catecholamine support to maintain mean arterial pressure\>65 mmHg, AND
     * Lactate \>2.0 mmol/l
   * Septic shock:

     * Suspected or proven bacterial infection
     * Need for a vasopressor support to maintain mean arterial pressure\>65 mmHg
     * Lactate \>2.0 mmol/l
     * Cardiac index\>3L/min/m2 or LVEF\>40%

Exclusion Criteria:

1. Onset of shock (catecholamine infusion) \>12 hours prior to inclusion
2. Age \<18 year old
3. Pregnancy