cyrilzakka/clinical-trials huggingface dataset:
First in Human Study of the Infusion of ARI0003 Cells in Relapsed/Refractory to Treatment B-cell Aggressive Lymphoma

ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or refractory (that means that they did not respond to other treatments). This is a first in human study.


Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of CD19+ or CD269+ relapsed/refractory (R/R) aggressive B-cell lymphoma in one of the following circumstances:

  * Burkitt's lymphoma;
  * Histology not covered by approved CART19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous DLBCL, T-cell rich DLBCL, high-grade B-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or
  * Aggressive B-cell lymphoma that is refractory or relapsing after treatment with CART19-cell therapy.

    2. Age older than 18 years. 3. ECOG performance status of 0-2. 4. Estimated life expectancy of at least 3 months. 5. Adequate venous access and absence of contraindications for lymphapheresis. 6. Signature of informed consent. 7. In patients who have received any anti-CD19 or anti-CD269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either CD19 or CD269) will be needed at study inclusion

Exclusion Criteria:

* 1. Any experimental or non-commercialized therapy in the previous 4 weeks. 2. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.

  3. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).

  4. Active infection requiring systemic medical therapy. 5. Active HBV or HCV infection. 6. Positive serology for HIV. 7. Any concomitant and uncontrolled medical disease. 8. Severe organic impairment defined by cardiac ejection fraction \<40%, DLCO \<40%, GFR \<30 ml/min or bilirubin \>3 times the upper limit of normality (unless due to Gilbert's syndrome).

  9. Lactating or pregnant women. 10. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.

  11. CNS disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.

Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.

Eligibility Criteria:
Inclusion Criteria:

* Allogeneic stem cell transplant recipient
* Recipient or donor CMV seropositive
* Have transplant engraftment
* Able to swallow tablets

Exclusion Criteria:

* CMV organ disease
* HIV infection
* Use of other anti-CMV therapy post-transplant
Anthocyanin-rich Blackcurrant and Vascular Function

Regular consumption of fruits and vegetables may improve human health and reduce the risk of chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active components and the underlying mechanisms are poorly understood. Berry fruits are abundant in anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels, inflammation and platelet function). Further, the study will investigate the anthocyanin bioavailability from the blackcurrant beverage.


Eligibility Criteria:
Inclusion Criteria:

* Aged 30-55 years
* Non-smoker
* BMI between 20 - 30 kg/m2
* Generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample
* Blood pressure \< 140/90mmHg
* Total cholesterol \< 6.2 mmol/L
* Fasting glucose \< 7.0 mmol/L

Exclusion Criteria:

* Diabetes mellitus
* Heart problems, stroke, vascular disease
* Inflammatory disease
* Kidney, liver, pancreas or gastrointestinal diseases
* Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions
* Asthma
* Allergies
* Smokers (social smokers who agree to abstain for 1 month before and during the study not excluded)
* Taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period)
* Taking aspirin \> 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit
* History of alcohol misuse
* Consumption of alcohol \>21 units (men) or \>15 units (women)
* Vegans
* Intense aerobic exercise \>20 min 3 x per week
* Participation in another clinical trial
* Antibiotics in previous 3 months before study
* Low haemoglobin levels
* Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)
Eye Movement Modeling Examples as a Teaching Tool

This study will evaluate whether eye-tracking assisted teaching (EMME, Eye Movement Modeling Examples) changes the visual patterns and improve the inexperienced trainee's performance in executing an epidural block on an epidural simulator.

Eye Movement Modeling Examples (EMME) is the youngest topic within the field of applied eye-tracking research in Educational Science. These are video recordings of a model executing a task and explaining how he goes about that. On top of that, the model's eye movements are tracked and replayed on top of the video.

It addresses the question, how visual expertise could be trained with the help of instructional videos of real-world tasks that are explained by experts in the field. These videos include an overlay of these experts' visual focuses to support the learner in connecting the verbal explanation of the expert to the real-world complexity of the task. The aim of this study will be to evaluate whether eye-tracking assisted teaching may improve the novice, inexperienced, trainee's performance in executing an epidural block on an epidural simulator and may change its visual patterns as assessed by eye-tracking glasses.

The study will enroll 14 novice trainees who will be randomized into two equal groups to receive (study group) or to don't receive (control group) a pre-recorded video (intervention) containing the instructions on where to focus their gaze while performing the epidural procedure.

All the trainees (study and control group) will be asked to perform the epidural procedure using a standardized epidural simulator while wearing eye-tracking glasses.

For this study, the investigators will use a commercially available Tobii Pro Glasses 50 Hz wearable wireless eye tracker. This system can measure eye movements using cameras integrated into the eyeglasses which record the corneal reflection of infrared lighting to track pupil position, mapping the subject's focus of attention on video recordings of the subject's field of vision (gaze).

All the eye-tracked epidural procedures will be recorded immediately after accurate individual calibration, during which the participant, after wearing the glasses unit, focused on the center of the calibration target.

All the eye-tracking video-recordings will be stored and analyzed by using Tobii Pro Lab Software. The investigators will select six areas of interest (AOI), to define regions of a displayed stimulus, and to extract metrics specifically for those regions. The areas were the following: 1) point of the epidural needle at its insertion into the skin; 2) shaft of the epidural needle; 3) hub of the needle; 4) barrel of the syringe; 5) plunger of the syringe; 6) other fields of view.

Eligibility Criteria:
Inclusion Criteria:

* inexperienced trainees in anesthesia who have never performed an epidural block

Exclusion Criteria:

* trainees who have previously performed an epidural block
The Effect of Video Game Exercise on Dynamic Balance and Gait in Individuals With Huntington's Disease

To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise modality to improve gait and balance in individuals with Huntington's disease.

The primary purpose of this study was to determine the effectiveness of a therapist-guided Video-game Biofeedback Modulated Exercise (ViBE) program administered via Dance Dance Revolution to improve dynamic balance, gait and mobility in individuals with Huntington's Disease. Secondary aims were to explore whether the ViBE intervention would improve quality of life, fall risk, and neuropsychological functions. The investigators hypothesized that the video-game program would lead to greater improvements in walking, dynamic balance, quality of life, fall risk, and neuropsychological function than a control handheld video game program. Since motivation is essential to the long-term maintenance of an exercise program the investigators were also interested in finding out how successful people with Huntington's Disease were at playing Dance Dance Revolution, what their perceptions were of playing the game, and whether they thought that it was beneficial

Eligibility Criteria:
Inclusion Criteria:

* adults 18 - 79 with a diagnosis of Huntington's disease

Exclusion Criteria:

* cannot walk 10 feet without assistance, any other neurologic condition
Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)

This was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only Part I of the study was completed.


Eligibility Criteria:
Inclusion Criteria:

* Participant has essential hypertension who is in grade 1 or 2 hypertension according to the European Society of Hypertension (ESH) as delineated in the European Society of Cardiology (ESC) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.
* Otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator
* Participant is generally in good health with the exception of hypertension
* Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months

Exclusion Criteria:

* Participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study
* Participant has a history of stroke, chronic seizures, or major neurological disorder
* Participant has a disability that can interfere with rising from a semi-recumbent position to the standing position
* Participant has a personal or family history of a bleeding or clotting disorder
* Participant has a history of frequent nosebleeds or recurrent or active gingivitis
* Participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study
* Participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage
* Participant is categorized as class II or greater according to the New York Heart Association (NYHA) functional classification for heart failure
* Participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as St. John's Wort) during the study
* Participant anticipates using phosphodiesterase (PDE5) inhibitors \[sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®)\] during the study
* Participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)
* Participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study
* Participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food
Central Nervous System(CNS) Efficacy of Dacomitinib

This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met)
* No prior systemic treatment of advanced NSCLC (Neoadjuvant or adjuvant chemotherapy are allowed, without limitation on its treatment timing)
* Age ≥20 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Had at least one measurable intracranial lesion as ≥ 5mm in the longest diameter by magnetic resonance imaging (MRI) (≥ 5mm by thin section (1.2mm) of brain MRI image, ≥ 10mm by less thin section(2.5mm) brain MRI ), which checked within 4 weeks before enrollment. If MRI slice thickness is not appropriate, we need to recheck Brain MRI
* Number of brain metastasis =\>5
* Adequate organ function
* Female subjects must either be of non-reproductive potential
* Subject is willing and able to comply with the protocol
* Signed written informed consent

Exclusion Criteria:

* Severe symptomatic brain metastasis, needing urgent control with radiotherapy or high dose steroid: the definition of high dose steroid is the equivalent dose of dexamethasone 10 mg or higher per day (mild symptoms controlled with low dose of steroid can be enrolled)
* With leptomeningeal seeding
* Exposure to EGFR-TKIs or other EGFR targeting agents at any time in either neoadjuvant or adjuvant setting
* Local treatment (stereotatic radiosurgery or whole brain radiotherapy) for brain metastases
* Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
* Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Pain Intensity After Root Canal Instrumentation

Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.


Eligibility Criteria:
Inclusion Criteria:

* mandibular molars with acute pulpitis

Exclusion Criteria:

* badly decayed non-restorable molars
* medically compromised patients
A Trial Comparing Propofol to Midazolam Plus Meperidine Sedation for Outpatient Colonoscopy

-to determine if propofol sedation leads to shorter recovery times compared to traditional sedation using midazolam plus meperidine

Colonoscopy is an important diagnostic and therapeutic procedure. It is an invasive procedure, not well tolerated by most patients if performed without sedation. There is considerable variability in the practice of sedation for endoscopic procedures worldwide. There are some centers which perform a significant proportion of gastroscopies and colonoscopies without sedation. On the other hand, general anesthesia is given to more than 90% of patients undergoing colonoscopy in France. Most centers do use conscious sedation, usually in the form of benzodiazepines and/or narcotics, with propofol sedation reserved for difficult cases. Benzodiazepines and narcotics are effective and safe. However, the onset of sedation can be delayed, and in some patients conscious sedation is inadequate, resulting in a poor experience with the procedure. Moreover, there are significant post-sedation side effects, such as nausea, vomiting, and prolonged recovery period. This can substantially increase procedure costs due to the need for prolonged monitoring after endoscopy.

Propofol, a general anesthetic agent, has been routinely used in various procedures and surgeries. It has a fast onset of action (within 30-60 seconds), a short half life (1.8-4.1 minutes) but a narrow therapeutic window. The current package insert of propofol states that only persons trained in the administration of general anesthesia should administer propofol and these physicians should not be involved in the procedure so that patients can be continuously and properly monitored due to the risk of respiratory depression. No deaths associated with propofol sedation have been reported since it was first introduced in gastrointestinal endoscopy in the mid 1980. However, need for mechanical ventilation as a result of propofol sedation has been reported. In a number of small trials propofol was shown to have a superior recovery profile following various endoscopic procedures including gastroscopy, colonoscopy and endoscopic retrograde cholangiopancreatography (ERCP). Indeed, propofol sedation is now used routinely in elective adult procedures in some centers. However, the lower cost of recovery is offset by the need for an anesthesiologist. Therefore, the use of propofol sedation is limited to selected endoscopic procedures or patients.

Although a number of small randomized trials have explored the efficacy of propofol sedation, the evidence is not definitive. Thus we conducted this study to determine if propofol sedation leads to shorter recovery times in elective outpatient colonoscopy compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* outpatient colonoscopy

Exclusion Criteria:

* allergy to propofol , midazolam, meperidine, eggs or soybean
* history of colonic resection
* inability to understand spoken/written English
* dementia
* pregnancy
* unwillingness to participate in the study
Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients

The primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. To test this, the investigators will assess the patient's pain levels immediately following separator placement and 24 hours post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS). Patients will be randomly assigned to one of three groups: treatment, placebo, and control. The aim of this study is to establish whether or not low level laser therapy can be used to reduce pain in pediatric patients following separator placement.


Eligibility Criteria:
Inclusion Criteria:

* Absence of acute or chronic dental disease and periodontal disease
* Free from severe systemic disease
* No fixed orthodontic appliances currently placed
* No ankylosis or tooth implants within dentition
* No analgesic drug consumption for 48 hours preceding the study and during the study, a minimum age of 6 years

Exclusion Criteria:

* Presence of a diastema where the separator would be placed
* Conditions that could alter nociception, such as current or previous use of anti-inflammatory and analgesic drugs, antidepressants, anticonvulsants, and oral contraceptives
* Any medical conditions or medications that may contraindicate use of certain light/laser sources such as low level laser therapy (LLLT)
Retrospective Study on Clinical Performance of Screw-retained Implant Crowns

Survival and success rates of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after at least one year in function.

Survival and success rates (clinical, radiologic and esthetic) of all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology after 2 to 10 years in function.

Establishment of a database of patients with all-ceramic implant-supported fixed reconstructions fabricated with CAD/CAM technology for future longitudinal retrospective studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one fixed all-ceramic reconstruction (single implant restoration on BL implant with individualized zirconia abutment directly screwed and directly veneered, three- to five-unit zirconia bridges directly veneered, single tooth crown made of a lithium disilicate glass-ceramic (LS2) blank)
* Written informed consent

Exclusion Criteria:

* Pregnancy at the time of the follow-up examination
* Mental handicap
* Patients that could not be contacted/located
* Patients not interested in participating
* Patients with the need of antibiotic prophylaxis prior to a clinical examination
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy children and adolescents aged \>=2 months to \<18 years at the time of first vaccination
* Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
* Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
* The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion Criteria:

* Clinical manifestation or history of any Flavivirus disease
* Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
* History of immunodeficiency or immunosuppressive therapy
* Known HIV, HBV or HCV infection
* History of hypersensitivity reactions to other vaccines
* Acute febrile infection at each visit during which the subject receives a vaccination
* Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.