cyrilzakka/clinical-trials huggingface dataset:
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy

Intravitreal topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that we hypothesize may exhibit high efficacy for the treatment of proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). A high efficacy for intravitreal topotecan has been exhibited in cell cultures of PVR. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.


Eligibility Criteria:
To be enrolled, patients need to meet the following inclusion criteria:

1. patients aged 18 years and older
2. patients who undergo PPV and/or SB for recurrent RRD due to PVR
3. patients with RRD and PVR grade C or D
4. patients who have failed standard of care surgery for RRD in the same eye previously. In order to satisfy this inclusion criterion, patients need to have previously received at least one vitreoretinal surgery for RRD, including pneumatic retinopexy, pars plana vitrectomy and/or scleral buckle, and to have clinical documentation supporting re-detachment of the retina after one or more vitreoretinal surgeries for RRD in the same eye. This cohort of patients is expected to have an extremely guarded visual prognosis and visual potential.
5. patients who are voluntarily able and willing to participate Patients undergoing combined phacoemulsification and PPV and/or SB will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during PPV.

The following subject exclusion criteria will be considered:

1. patients with a history of tractional or exudative retinal detachment
2. patients with severe non-proliferative or proliferative diabetic retinopathy
3. patients with other planned ocular surgery following PPV
4. patients with primary RRD
5. female patients of childbearing age (i.e. less than 50 years old).
6. patients with pre-existing bone marrow suppression or cytopenias
7. patients with pre-existing interstitial lung disease (ILD) Any other medications or treatments, including rescue therapy, will be permitted before and/or during the trial.
Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device

Airway management in out-of-hospital cardiac arrest is still debated. Several options exist: bag-valve-mask ventilation, supraglottic devices and endotracheal intubation. Intermediate and advanced airway management strategies could be useful devices to increase chest compression fraction. A previous study shows that early insertion of an i-gel device significantly increases chest compression fraction and enhances respiratory parameters. However, the compressions were found to be shallower in the experimental group using the i-gel device. Although, the shallower compressions found in the supraglottic airway device group did not appear to be linked to their provision in an over-the-head position, it is reasonable to assume that the addition of a feedback device to the use of an i-gel® device could fix this issue. The feedback devices seem to be able to provide a benefit, and allow deeper compressions / more often in the depth target. There is a mismatch between perceived and actual cardiopulmonary resuscitation performance supporting the need for such a feedback device's study.


Eligibility Criteria:
Inclusion Criteria:

* Registered EMTs and paramedics actively working in any of the participating study trial centers will be eligible for inclusion.

Exclusion Criteria:

* Members of the study team
* EMTs will be randomly excluded if there are more EMTs than paramedics.
Security Efficacy COVID-19 Vaccination

Preliminary data support a possible molecular mimicry between SARS-CoV-2 and autologous components. This suggests the occurrence of autoimmunity during COVID-19. Consistently, autoimmunity may occur after SARS-CoV2 vaccination. The study aims to investigate the production of autoantibodies after vaccination in healtcare workers.

Healtcare workers undergoing SARS-CoV-2 vaccination (with RNA-vaccines) will be included on a voluntary basis. Blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). All the vaccination side effects will be registered.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers undergoing SARS-CoV-2 vaccination

Exclusion Criteria:

* Pregnancy
* Full blown autoimmune diseases
* Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
* Previous vaccination severe side effects
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.

This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.

Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).

The trial was stopped after 7 months for lack of recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at 1,250-2g000 grams birth weight
* \<12 hours of age
* Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)
* Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent

Exclusion Criteria:

* Receiving mechanical ventilation
* Air leak
* Pulmonary hemorrhage
* Major congenital anomaly
* Congenital non-bacterial infection
* Parental refusal of consent
* Refusal of attending neonatologist
Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction

Background: According to the International Association for the Study of Pain (IASP), the term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck on one or both sides as well as joint sounds, limited mandibular movements or mandibular deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain. Thus, there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (LLLT and LED) in the same apparatus.

Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain, activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine the cumulative effect 24 and 48 hours after a six session.

Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous TMD. The participants will then be randomly allocated to two groups totaling 15 individuals per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one group will receive placebo therapy (0 Joules). The following assessment tools will be administered on four separate occasions (baseline and immediately after, 24 h after and 48 h after phototherapy). Pain intensity will be assessed using the visual analog scale for pain, meter for range of movement, and electromyographic EMG analysis on the masseter and anterior temporal muscles.

Discussion: The study will support the practice of evidence-based to the use of phototherapy in individuals with a myogenous TMD. Data will be published after the study is completed.


Eligibility Criteria:
Inclusion Criteria:

* All volunteers will have a diagnosis of myogenous TMD based on the RDC/TMD with moderate to severe pain in the masseter and temporal muscles rated by an expert dentist. To standardize the sample, the body mass index of all participants must be less than 25 kg/m2, as the amount of adipose tissue between the electrode and surface of the muscle can affect that reading of the electromyographic (EMG) signal. All volunteers must also have an initial pain score greater than 3 points on the VAS.

Exclusion Criteria:

* The exclusion criteria will be missing teeth, the use of dentures, systemic or neuromuscular diseases, a history of trauma to the face or temporomandibular joint, history of temporomandibular joint luxation, currently undergoing orthodontic treatment, or currently undergoing medicinal treatment that can affect the musculoskeletal system (analgesic, anti-inflammatory agent or muscle relaxant).
Intracerebral Gene Therapy for Sanfilippo Type A Syndrome

The clinical trial P1-SAF-301 is an open-label, single arm, monocentric, phase I/II clinical study evaluating the tolerance and the safety of intracerebral administration of adeno-associated viral vector serotype 10 carrying the human SGSH and SUMF1 cDNAs for the treatment of Sanfilippo type A syndrome The treatment plan consists on a direct injection of the investigational medicinal product SAF-301 to both sides of the brain through 6 image-guided tracks, with 2 deposits per track, in a single neurosurgical session.

The primary objective is to assess the tolerance and the safety associated to the proposed treatment through a one-year follow up.

The secondary objective is to collect data to define exploratory tests that could become evaluation criteria for further clinical phase III efficacy studies.

Four patients will be included in the clinical trial and will be followed during one year.

The enrollment and the follow-up of the patients will take place at Bicêtre Hospital. The Neurosurgery will be performed at Necker-Enfants Malades Hospital.

Safety will be evaluating on clinical, radiological and biological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 (eighteen) months to end of 6 (six) years
* Onset of clinical manifestations related to MPSIIIA during the first 5 years of life
* SGSH activity in peripheral blood cell and / or cultured fibroblast extracts of less than 10% of controls.
* Patient affiliated to the French social security or assimilated regimens
* Family understanding the procedure and the informed consent
* Signed informed consent
* Vital laboratory parameters within normal range

Exclusion Criteria:

* Presence of brain atrophy on inclusion MRI judged on a cortico-dural distance of more than 1cm
* No independent walking (Ability to walk without help)
* Any condition that would contraindicate permanently anaesthesia
* Any other permanent medical condition not related to MPSIIIA
* Any vaccination 1 month before investigational drug administration
* Intake of aspirin within one month
* Any medication aiming at modifying the natural course of MPSIIIA given during the 6 months before vector injection
* Any condition that would contraindicate treatment with Prograf®, Modigraf®, Cellcept® and Solupred®
Training Therapists to Administer Contingency Management-Patient Phase - 3

The purpose of this study is to train therapists to administer contingency management (CM). This project will train up to 42 community-based treatment providers about the rationale for and the specifics of administering CM. Initial training will occur in 2-day workshops, followed by weekly supervision in delivery of CM with test cases. We expect that the majority of therapists will achieve high levels of competence and adherence in administering CM treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the efficacy of CM, each therapist who achieves adherence and competence in delivering CM will administer standard treatment alone or standard treatment plus CM to substance-abusing outpatients. In the CM condition, patients will have the opportunity to win prizes for submission of negative samples, and the treatment will be in effect for 12 weeks. In total, up to 200 patients will be randomly assigned to one of the two conditions. A research evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment initiation.


Eligibility Criteria:
Inclusion criteria:

* age 18 years or older
* meets DSM-IV criteria for cocaine abuse or dependence
* English speaking (est. \>90% of patients)

For those in drug-free programs, they must have initiated treatment within the past week. For methadone patients, they must be stabilized on a dose of methadone, defined as being on the same dose for at least 30 days and not currently requesting or being considered for a dose modification. Methadone patients must also have submitted at least 30% cocaine positive urine samples in the past 3 months.

Exclusion criteria:

* acute uncontrolled psychiatric disorder (psychosis, suicidality) as determined by the SCID
* dementia (\<23 on the Mini Mental State Exam; Folstein \& Folstein, 1975)
* in recovery for pathological gambling
Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol

The study objective is to acquire composite images generated by the Carestream Long Length Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI software and the images stitched using a approved predicate device are acceptable for clinical use.

The study consists of subject enrollment to collect images in a clinical setting, followed by a review of the stitched images by radiologists or qualified orthopedic surgeons to assess overall usability of the composite images.

This study includes clinical data collection of individual (raw and processed) and composite DR images from a Carestream device using alpha rotation to acquire the images. There is no subject involvement other than obtaining informed consent in order to use patient images and Case Record Forms (CRF), including supporting radiology reports. This study has no effect on clinical treatment and no foreseen risks to enrolled subjects.

The predicate software is currently in place at the sites. Carestream will harvest that data and reconstruct with investigational software offsite. A comparison reader study will be performed upon completion of data collection.

Please note this study is considered to be observational because there were no imaging of subject using investigational device. Subjects requiring standard of care diagnostic images were exposed using the commercially available Cedara system. The images captured on the Cedara system were then re-processed using the Carestream investigational software. Subjects gave informed consent for Carestream to reprocess their image data. They did not require any additional imaging using the investigational device.

Eligibility Criteria:
Inclusion Criteria:

* subject has provided informed consent
* Male or Female who require Long Length Imaging

Exclusion Criteria:

* Not able or willing to provide Informed Consent, or consent is withdrawn
* Not able to collect all required case information
* Patients who are unable to stand
* Images which are not clinically acceptable to the user
* Images without a reference object such as a ruler in the image.
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment

The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus of less than 5 years in duration
* Have never received hypoglycemic therapy
* Aged 18 to 65 years
* Fasting blood glucose between 130 and 220 mg/dL (7.2 to 12.2 mmol/L) for Cohorts A-D and between 140 and 220 mg/dL (7.8 to 12.2 mmol/L) for Cohort E
* HbA1c between 6.8 and 10.0% for Cohorts A-D and between 7.5 and 11.0% for Cohort E
* Body Mass index \> 25 and \< 35 kg m -2

Exclusion Criteria:

* Medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
* Clinically significant abnormalities in medical history or physical exam
* Clinically significant abnormalities on laboratory examination
* History of HIV infection
* Active infection requiring antiviral or antimicrobial therapy
* Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> one year at the time of screening)
* Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in or interfere with compliance
* Alcohol or drug abuse
* Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening
* Abnormal serum creatinine concentration defined as \> 1.5 mg/dL (132.6 micro mol/L) for males and \> 1.2 mg/dL (106 micro mol/L) for females
* Medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.
* Allergy to sulfur-containing medications
The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis

In addition to the typical motor and sensory impairments, individuals with multiple sclerosis (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder. The research believes that aerobic exercise improve cognitive function and improve sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of relapsing remitting or secondary progressive MS
* score 3-7 on the EDSS
* score \< 55 on the Symbol Digit Modalities Test
* score \> 5 on the Pittsburgh Sleep Quality Index

Exclusion Criteria:

* history of alcohol/drug abuse or nervous system disorder other than MS
* severe physical, neurological, or sensory impairments that would interfere significantly with testing
* developmental history of learning disability or attention-deficit/hyperactivity disorder
* relapse and/or corticosteroid use within four weeks of assessment
* unable to give consent
* uncorrected vision loss that would interfere significantly with testing
* score less than 24 on MMSE
* Acute ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
* Either unable to physically perform the exercise test using the recumbent stepper or demonstrate absolute indications for terminating exercise that follows the American College of Sports Medicine's (ACSM) guidelines
* Uncontrolled blood pressure with medication (BP \> 190/110mmHg)
The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications

To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy.

Two groups of patients scheduled for gastrointestinal endoscopy will be compared in terms of desaturation and respiratory complications by applying 15 litres of oxygen therapy to the first group and 30 litres to the second group with double nasal cannula.

Eligibility Criteria:
Inclusion Criteria:

18-65 years old

PATIENTS WHO WILL HAVE ENDOSCOPY AND OR COLONOSCOPY

Exclusion Criteria:

* Chronic obstructive pulmonary disease Having low saturation Lung cancer