cyrilzakka/clinical-trials huggingface dataset:
Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis

OBJECTIVES:

I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis.

II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms.

III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.

PROTOCOL OUTLINE:

This is a randomized, open label, multicenter study.

Patients are randomized to receive standard care with immunosuppression (arm I) or standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine)(arm II).

Arm I: Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days. Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year.

Arm II: Patients receive standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine).

Patients are followed for one year.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy

Heart failure and/or arrhythmia of less than 3 months duration

--Patient Characteristics--

Hepatic: AST/ALT no greater than 3 times upper limit of normal

Renal: Creatinine no greater than 2.5 mg/dL

Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to cyclosporine or muromonab-CD3; No other severe concurrent diseases
Impact of Sick Peer Relation on Adaptation to Disease and on Treatment of Cancer-suffering Adolescents & Young Adults

Adolescents and young adults (AYA) with cancer have to deal with a relatively segmented organization of care between pediatric and adult medicine structures in France. However, the third french Plan Cancer 2014-2019 helped in the recognition of the specificities of the AYA affected by cancer and allowed the creation of specific structures in some care units in France, whose primary goal is the preservation of the social link.

Indeed, peer relations contribute to access to quality social support, which is an important variable in patient adjustment with cancer. The adolescents that perceive higher social support report less psychological distress and exhibit higher adaptation scores.

It nevertheless happens that AYA experience negative social support, often from friends because of contact reduction during the disease. Patients can then elect to turn towards non-intimate relations such as support groups. The main risk when a AYA with cancer defines a sick peer as one bringing him quality social support is the installation of a sense of guilt, for example, when a young person is confronted with disease negative progress or with peer death. The more an adolescent identifies with the deceased, the more he is able to consider his own mortality.

AYA units are developing in France, creating a community of sick adolescents. These communities are precious for AYA and allow information and experience sharing, a feeling of reduced isolation and a greater emotional closeness with peers suffering from the same disease.

How is social support from peers and close friends perceived by these young people in AYA units and through the social networks? What can the consequences of the evolution of peer disease be on AYA? What is the impact of the mourning of sick peers on these young people? What are the predictors?

Methodology: Multicentric, prospective, not randomized study.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents or young adults from 15 to 27 years old (included) receiving cancer diagnose or recurrence announcement.
2. Patient information and free consent signature by the patient or his legal representative(s).

Exclusion Criteria:

1. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
2. Inability to understand, talk or write in French.
3. Patient individually deprived of liberty or placed under the authority of a tutor.
Optimize Motor Learning to Improve Neurorehabilitation

The objective of this study is to develop and evaluate novel robotic training strategies that modulate errors based on the subjects' individual motor and cognitive needs. For this purpose, healthy adults and neurologic patients will participate in robotic motor learning experiments. Patients have a diagnosis of a neurological disease (i.e., stroke, spinal cord injury, multiple sclerosis, Guillain-Barré syndrome) limiting arm motor function.

Neurological patients (e.g., after stroke) engage in intensive and expensive neurorehabilitation therapy to regain part of their former motor functional ability to perform everyday activities with often limited and unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation therapy, providing cost-effective, high repetition and task-oriented training. However, results of an initial body of work comparing the effectiveness of robotic training strategies are highly inconclusive. A possible explanation is that most current robotic systems cover only one neurorehabilitation strategy (e.g. reducing or augmenting movement errors) and may thus insufficiently address the subjects' individual needs and the characteristics of the task to be learned. In this study, Investigators will perform several motor learning experiments with healthy adult and neurological patients in order to evaluate the relative motor and cognitive benefits of newly developed robotic training strategies that modulate errors based on the subject's age, skill level and tasks characteristics. The effects of the new strategies will be compared to classical robotic assistance, and to non-robotic feedback approaches, such as visual feedback. The culmination of this work may help to optimize training benefits of already existing rehabilitation robots.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Informed Consent as documented by signature ("Informed Consent" form)
* Bodyweight \<120 kg
* Ability to communicate effectively with the examiner so that the validity of the patient's data could not be compromised

Exclusion Criteria:

* Excessive spasticity of the affected arm (Ashworth Scale ≥3)
* Serious medical or psychiatric disorder
* Orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
* Shoulder subluxation
* Skin ulcerations at the paretic arm
* Cyber-sickness (i.e., nausea when looking at a screen or playing computer games)
* Serious cognitive defects or aphasia preventing effective use of the robotic devices
* Severe visual and auditory impairments
Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients with ADHD/behavioral Addiction Comorbidity

The main objective of this pilot study is to assess preliminary data on the feasibility of CBT and its evaluation in a randomised trial in patients with co-occurring ADHD and behavioural addiction: Evaluation and comparison of the 12-week retention rate of patients randomised to CBT compared with patients in the 'treatment as usual' control arm.

In order to meet the objective, the patient will take part in a standardized assessment, followed by a therapeutic intervention and a new standardized assessment after the intervention. The standardized assessment consists as follows :

* firstly, 7 self-questionnaires to be completed by the patient, lasting around 45 min, aimed at assessing his or her socio-demographic data; current symptoms, quality of life and functional impact related to ADHD; impulsivity, emotion regulation and assessment of possible anxiety-depressive disorders.
* Then the patient will follow the 10 session of cognitivo behavioural psychotherapy.
* At 12-weeks post-inclusion, an assessment visit is carried out during which a battery of tests will be administered. This is followed by a research interview with a professional, aimed at gathering his or her experiences.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 (age ≥ 18 years)
* Patient treated in an outpatient addictology department at the CHU of Brest, Nantes or Tours and presenting an ADHD/behavioral addiction comorbidity
* Patient affiliated to a social security scheme
* For patients treated with methylphenidate: no change in treatment dosage during the previous three months.
* For patients not treated with methylphenidate: no introduction of methylphenidate within the next three months.

Exclusion Criteria:

* Patients with psychotic disorders (assessed by clinician)
* Pregnant or breast-feeding women
* Patients under protective supervision (guardianship or curatorship)
* Persons under court protection
* Persons deprived of their liberty
* Patients who do not meet the eligibility criteria for CBT (e.g., cognitive impairment, hearing impairment).
* Physical inability to participate in CBT sessions (e.g., lack of telephone, foreseeable unavailability).
* Difficulty understanding self-questionnaires, including illiteracy.
* Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome.
The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance

This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance, and airway changes by applying rapid palatal expansion appliances in patients with maxillary constriction and the post-pubertal growth spurt stage.

Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9 years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14, 15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Eligibility Criteria:
Inclusion Criteria:

* With a unilateral or bilateral morphological lateral crossbite
* Whose first molars and premolars had completely erupted at pretreatment
* With maxillary constriction of more than 4 mm and less than 10 mm
* Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs
* Individuals with a body mass index of 18-24
* Individuals with an ANB angle between 0º and 4º

Exclusion Criteria:

* craniofacial anomalies
* compliance problems
* systemic or genetic disease
* previous orthodontic treatment history
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis

This research study examines the safety and feasibility of aspirin with or without Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots - in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic (clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role in hemostasis, because it is predictive of thrombosis in cancer patients and because of promising preliminary data. We expect that sP-selectin levels will be elevated in patients before therapy with aspirin and/or statin, but that these levels will fall significantly during treatment, rise during the observation phase, and fall during the second study period. Patients who take part in the study have been diagnosed with a solid tumor cancer and are considered to be intermediate to high risk for VTE. The standard of care is to give chemotherapy for solid tumors and treat clots which develop using blood thinners.

Objectives

Primary: To determine efficacy of aspirin with and without simvastatin in solid tumor patients at high- or intermediate-risk for VTE, in reducing markers of platelet activation, levels of inflammatory and angiogenic cytokines measured using high-throughput approaches, and clinical and investigational measures of hemostatic activation.

Secondary: To determine safety and feasibility of aspirin with or without simvastatin in solid tumor patients at high- or intermediate-risk for VTE

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of malignancy of a solid organ or lymphoma
* Planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen)
* VTE Risk Score ≥1
* Written, informed consent.

Exclusion Criteria:

* Hematologic malignancies including acute and chronic leukemias, myelodysplastic syndromes, lymphoma and myeloma
* Primary brain tumors
* Active bleeding or high risk of bleeding in the opinion of the investigator
* Hepatic dysfunction (elevated transaminases or bilirubin \> 3 times normal)
* Planned stem cell transplant
* Life expectancy \< 6 months
* Acute or chronic renal insufficiency with creatinine clearance \< 30 mL/min
* Pregnancy
* Known allergy to or prior intolerance of aspirin and/or simvastatin.
* Ongoing anticoagulant, statin and/or anti-platelet therapy.
CraniSeal Post Approval Study

To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years of age
* Patient is scheduled for an elective infratentorial or supratentorial cranial procedure that entails a dural incision.
* Patient requires a procedure involving surgical wound classification Class I/Clean
* Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures.
* Patients who are able to comply with study requirements.

Exclusion Criteria:

* Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded
* Patient has had a prior intracranial neurosurgical procedure in the same anatomical location.
* Patient with diagnosis of severely altered renal (creatinine levels \> 2.0 mg/dL) or hepatic (total bilirubin \> 2.5 mg/dL) function
* Patient diagnosed with a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL)
* Patients undergoing cranial procedures involving petrous bone drilling
* Patients with traumatic injuries to the head or dural disease in planned dural closure area.
* Patients who are pregnant or lactating
* Patient with an active infection
* Patient is undergoing cranial procedures involving synthetic or non-autologous duraplasty material that are not collagen based
* Patient with a known allergy to FD\&C Blue #1 dye
* Patient is not able to tolerate multiple Valsalva maneuvers, or an intraoperative CSF shunt does not allow for transient elevation of CSF pressure during Valsalva maneuvers.
* Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of \>9% despite standard diabetes care),
* Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT\>37 seconds or INR \>1.5 units)
* Patient is not likely to comply with the follow-up evaluation schedule.
* Contraindications to both an MRI and CT scan.
* Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy.
Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma

The purpose of this study is to assess the long-term efficacy and safety of latanoprost monotherapy in patients with normal tension glaucoma (NTG) using a prospective, observational design. Visits were scheduled at 6-month intervals for 24 months. Intraocular pressure (IOP), optic nerve head findings, visual field status, and adverse events were recorded.


Eligibility Criteria:
Inclusion Criteria:

patients with normal-tension glaucoma

Exclusion Criteria:

none
Population Pharmacokinetics of Lassila Tazobactam in Patients After Aortic Dissection

The individualized drug use research on optimizing piperacillin tazobactam for CRRT of hospital-acquired pulmonary infection after cardiopulmonary bypass is still in the initial stage at home and abroad, lacking systematic research data. With the help of the population pharmacokinetic model, it can help clinicians to formulate individualized drug administration plans for such patients and provide methodological and data support for precise treatment. The rational use of piperacillin tazobactam will play an important role in reducing the use of carbapenems and curbing the occurrence of drug resistance.

The incidence of acute renal failure after aortic dissection can be as high as 30%. In order to reduce mortality, most patients need continuous renal replacement therapy (CRRT). The concentration of antimicrobial drugs in patients receiving CRRT is often lower than the treatment level, which leads to treatment failure. The drug clearance rate of critically ill patients may change every day and it is difficult to estimate, especially when the renal function deteriorates and CRRT begins.

As a time-dependent antimicrobial drug, increasing the% t \> MIC of piperacillin tazobactam is closely related to ensuring clinical efficacy. However, the molecular weight of piperacillin tazobactam is less than 2000 d, which can easily pass through the filter membrane. All CRRT methods have the same clearance rate. Meanwhile, the binding rate of piperacillin and tazobactam to plasma protein is only about 30%, which is easy to clear through CRRT. As a result, the curative effect of piperacillin tazobactam in treating hospital-acquired pneumonia after aortic dissection is not good according to the conventional dosage and administration. More and more doctors will consider choosing carbapenems as soon as possible, which is related to national health.

Therefore, the traditional pharmacokinetic study is no longer applicable, and it can't provide a basis for clinical determination of individualized drug use plan of piperacillin and tazobactam, while the population pharmacokinetic study can effectively solve this problem. The frequency of blood collection from patients is low (usually 2 \~ 4 blood collection points), which is the most advanced method for individualized drug use research in the world at present \[10\]. Methods The Nonlinear mixed effect Model (non-MEM) was used to calculate the average and variability of pharmacokinetic parameters in patients, and the synergistic effect of patient factors (such as age and weight) on pharmacokinetic parameters could be evaluated, thus providing a reliable basis for formulating individualized and accurate drug administration plan and improving the success rate of anti-infection.

Eligibility Criteria:
Inclusion Criteria:

Cardiopulmonary bypass during aortic dissection， Lung infection， Continuous renal replacement therapy

Exclusion Criteria:

Intracranial infection, Urinary tract infection
Graded Motor Imagery in Elbow Limitation

This randomized-controlled trial aims to investigate the efficacy of Graded Motor Imagery (GMI) on function, pain, and range of motion (ROM) in patients with a posttraumatic stiff elbow.

To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, voluntary patients with elbow limitation, aged between 20-55 years will be randomly divided into two groups: GMI group and standard rehabilitation (SR) group. Interventions will be applied for 12 sessions. The patients will be assessed before, after six-week treatment and six-week follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. ROM will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and extensors. Grip strength will also be assessed. Recognise™ will be used for assessing the right-left discrimination. The functional status and kinesiophobia will be evaluated by Disabilities Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia, respectively. The Global Rating of Change will be used to evaluate patient satisfaction. The Vividness of Movement Imagery Questionnaire 2 (VMIQ-2) will be used for evaluating the individuals' ability to mental imaginary.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be included with

* Aged between 20 and 55 years
* Elbow fracture in the six months before the study
* Elbow limitation in flexion or extension
* Being a volunteer to participate
* Fractures should be managed with surgically
* The "Standardized Mini Mental Test" result must be at least 24 points

Exclusion Criteria:

* Malunion or Nonunion Fracture
* The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
* Non-healing wound or infection
* Previously received physiotherapy for elbow limitation
* Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
* Could not adjust to the treatment
* Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity
* Having severe visual loss
EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).

The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal inflammation by:

1. improving clinical periodontal parameters and,
2. improving the salivary SOD levels.


Eligibility Criteria:
Inclusion Criteria:Forty patients with chronic generalized periodontitis

-

Exclusion Criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.
Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan

This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting.

Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first.

The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

Exclusion Criteria:

* None