cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .

Secondary Objective :

* To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia.
* To determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia.
* To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib.
* To determine the complete molecular remission length.
* To evaluate medical and economical impact of stopping imatinib treatment.

Study design : multicentric trial

Eligibility Criteria:
Inclusion Criteria:

* Patients must have reached their 18th birthday
* Women of childbearing potential must agree to use effective methods of contraception
* Patients must be affiliated to a social security regime
* Patients must have received imatinib therapy for at least 36 months.
* Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts.
* Patients must be HIV, HCV and HBV negatives
* Patients who have molecular follow-up realized in accordance with international recommendations
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion Criteria:

* Patients who are protected by the law. Patients who are unable to give their consent to participate to the study.
* Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α):

Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain

The purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the neck, when added to a multidisciplinary treatment program.


Eligibility Criteria:
Inclusion Criteria:

* Referred to the multidisciplinary clinic for treatment of pain in the neck
* Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific neck pain,
* Pain intensity ≥ 4 on numerical rating scale (0-10)

Exclusion Criteria:

* Severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis)
* Psychiatric condition/disease that severely impairs group functioning
* Insufficient comprehension of Norwegian language to participate in group sessions and fill out questionnaires
* Awaiting surgery of neck
* Alcohol or drug abuse
* Ongoing compensation case or applying for disability benefits due to pain in the neck
* Engaged in high-intensity resistance training on a regular basis the last 6 months
* Contra-indications for high-intensity resistance training (i.e. shoulder complications)
LYT-100 in Patients With BCRL

This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema

This trial will utilize a randomised, double-blinded, placebo controlled design that will assess the safety, tolerability, and secondarily clinical efficacy of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.

Eligibility Criteria:
Main Inclusion Criteria:

1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy \[FNA\]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.
3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.
4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.
5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.
6. Documented evidence of Stage 1 or 2 lymphedema.
7. Receiving standard of care compression or agreeable to using care compression, or no compression at all ≥ 4 weeks prior to screening and throughout the study.

Main Exclusion Criteria:

1. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e., sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or lymphatic or vascular malformation, determined at screening.
2. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the PI.
3. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected extremity.
4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 4 years, determined at screening.
5. Initiated use of compression or manual lymphatic drainage or other lymphoedema therapies at the start of the study within 4 weeks of the screening visit. Rescreening is allowed following a course of stable compression regimen of \> 4 weeks.
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide preliminary data concerning cost-effectiveness of the intervention.

The core study hypotheses are that children receiving the intervention will (1) have lower severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2) show greater adherence to discharge instructions and better health-related quality of life at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury, compared to those receiving usual care.

The purpose of this study is to examine the effectiveness of a stepped care model for prevention of psychosocial distress (especially posttraumatic stress) after injury. The model includes screening for risk, standard follow-up with those at risk, and additional evidence-based interventions matched to individual need.

The study will evaluate the impact of the intervention on psychosocial outcomes (PTSD and depression symptoms); as well as health outcomes (adherence to discharge instructions, health-related quality of life), and will provide preliminary data to inform cost-effectiveness analyses by describing the costs of providing the intervention and examining its impact on subsequent health service utilization.

Study Design: 180 children at risk for persistent psychosocial distress post-injury, based on a screening assessment, will be randomized to the Stepped Preventive Care intervention or usual care. An additional comparison group of 90 low risk children will also receive usual care and be followed for assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age 8 to 17
* Admitted to hospital for treatment of unintentional injury
* Sufficient English fluency to participate in an interview
* Family has access to a telephone (for telephone follow-up contacts)

Exclusion criteria:

* Child's medical status or cognitive functioning precludes participating in an interview
* Child has moderate to severe head injury, defined as Glasgow Coma Score (GCS) \<= 12
* Child's injury involved family violence or abuse (physical or sexual)
* No parent or guardian available to consent
Intervention for Low-performing First Graders in Mathematics

The aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. .

There were sent a request to a school in the central of East-Norway to participate. The principal answered yes, and then asked the teachers at first grade if they would like to participate. The teachers were positive to the study, and therefore the students and parents were asked to participate. It was total 74 students and 54 of them accepted to participate in the study. The inclusion criteria of the study is that the participants talks and understand Norwegian approximate fluently. In this study that means one participant was excluded.

The study will use a design of randomized control trial (RCT) where the population of 53 students will be doing av screening-test. After the screening 20% of the lowest-performance will make up the sample and they will be departed in a clinical-group and a control-group. These students will then be tested with Test of Basic Arithmetic and Numeracy, the Norwegian test called Arithmetic fact-test, the vocabulary and calculation tasks from Wechsler Intelligence Scale for Children - Fifth Edition and Ravens colored progressive matrices. The randomization will be conduct using randomize.org and the parents will get information about which group their child will participate in. The intervention are eight week long with 4 lessons per week. Each lesson are about 45-50 minutes long. The start of the intervention will be in week 42, 2022 and end in week 49, 2022. The intervention-group will follow an intervention conducting elements from an education program called "ThinkMath" and self-developed tasks. The control-group will follow ordinary classroom-lessons. After ended intervention-period the students will be tested with the same test-battery as were used in front of the start point.

Eligibility Criteria:
Inclusion Criteria: Performing under the cut off score of a screening tool for first graders, i.e. 20th percentile

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Exclusion Criteria:

* not proficient Norwegian language skills
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects

Primary Objective:

To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).

Secondary Objective:

To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine

The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 IM reference vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Able to attend all scheduled visits and to comply with all trial procedures.
* Subject with renal transplant for at least 6 months.
* Subject with stable renal function, i.e. with a variation of creatinin value \< 20% and with a creatinin clearance estimated according to Cockroft and Gault calculation \> 20 mL/min during the 3 months preceding inclusion.
* Aged 18 to 59 years on the day of the screening visit.
* Informed Consent Form signed.
* Subject entitled to national social security.
* Subject under immunosuppressive therapy.
* For a woman, inability to bear a child or negative urine pregnancy test.
* Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.

Exclusion Criteria:

* Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
* Breast-feeding.
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
* Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Blood or blood-derived products received in the past 3 months .
* Any vaccination in the 4 weeks preceding the trial vaccination.
* Vaccination planned in the 4 weeks following the trial vaccination.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
* Previous vaccination against influenza in the preceding 6 months.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers

To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers aged between 18 and 55
* Body Mass Index (BMI) between 18 and 30 kg/m2 with normal laboratory data
* negative for Tuberculosis test
* normal Electrocardiogram (ECG)
* adequate contraception for females
* given informed consent

Exclusion Criteria:

* Any significant abnormality in medical history, physical examination, laboratory testing
* Intake of concomitant medication
* smoking more than 10 cigarettes per day
* alcohol or drug abuse
* pregnancy or breast feeding
* history of tuberculosis
* participation in another trial within 3 months prior to this study
* previous administration of certolizumab pegol
Description and Modeling of Swallowing Disorders After a Stroke

The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing, Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered, isolated or associated manner, causing major disorders and representing a source of handicap for patients.

Understanding the swallowing mechanisms is therefore a major challenge to guide the rehabilitation and improve the initial and long-term prognosis of patients with stroke.

The main objective of this study is to describe and modeling, thanks to a clinical, physiological and radiological knowledge base, swallowing, speech and breathing, in patients with stroke and in healthy subjects.


Eligibility Criteria:
For patients after stroke

Inclusion Criteria:

* First stroke confirmed by MRI \< 15 days
* No severe leukoaraiosis
* Swallowing disorders identified (GUSS scale \< 20)
* Neurological deficit identified (NIHSS scale \<15)
* Patient able to cooperate for investigations
* Informed consent signed

Exclusion Criteria:

* Cerebral hemorrhage
* History of neurological disease that can lead to swallowing disorders
* History of laryngological disease such as previous surgery or radiation neck
* Tracheotomy
* Vigilance disorders
* Pregnant, parturient or nursing woman
* Protected adult
* Simultaneous participation in another study
* Non registered to the French social security system

For healthy subjects

Inclusion Criteria :

* Age between 18 and 40 years old
* French native speaker
* Normal hearing with or without corrective
* No oral or written language disorders
* No neurological or psychiatric disorders
* Informed consent signed

Exclusion Criteria

* MRI contraindication
* Pregnant, parturient or nursing woman
* Simultaneous participation in another study
* Non registered to the French social security system
Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone

The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

Post-operative pain in patients undergoing osteotomy can be severe. Current methods of treatment involve parenteral narcotics and regional anesthesia. Several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations. However, to our knowledge there have been none that directly compare bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). Parenteral narcotic alone is associated with the possibility of significant side effects, overdose, and inadequate analgesia. Epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics (4). We believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed, and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain. Further, the prolongation of pain control shown with epidural clonidine may be beneficial during the transition (5,6).

Eligibility Criteria:
Inclusion Criteria:

* Age 4-16
* English speaking
* Elective lower extremity osteotomy
* Expected length of stay greater than 24 hours

Exclusion Criteria:

* History of previous spine surgery
* Current infection overlying catheter insertion site
* Coagulopathy
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed recurrent SCCHN
* 18 years or older
* Tumor site accessible by biopsy
* Measurable disease
* Receiving no other therapy
* ECOG performance status 0-1
* Adequate bone marrow, renal function and hepatic function

Exclusion Criteria:

* Active infection or fever within 3 days of treatment
* Active CNS metastases
* Prior malignancy within 5 years
* Hypersensitivity to study drugs
* Chemotherapy within 30 days of treatment
* Concurrent investigational therapy within 30 days
* Radiotherapy of more than 25% of bone marrow
* Peripheral neuropathy of grade 2 or greater
* Pregnant or lactating patients
* History of allogeneic transplant
* Active or previously treated HIV or Hepatitis B or C
* Patients with a tracheostomy
Language Processing and TMS

This study will examine the effect of TMS on people with stroke and aphasia as well as healthy individuals.

To examine the brain's structure and specific language function and interactive relationships, investigators will implement repetitive or rapid TMS protocols in an active (or sham)-controlled, within-subject, randomized studies. Aims will evaluate the effects of short-term changes on each of the semantic or phonological language process of interest in isolation and changes in the interaction between language sub-processes and their interaction with other cognitive domains that directly or indirectly affect language functions. The brain targets for TMS application will be informed by existing evidence on (correlational but not causal) associations between language regions and specific language processes from numerous prior neuroimaging (e.g., functional magnetic resonance imaging or fMRI) and neuropsychological studies. Healthy individuals and/or stroke survivors with aphasia will be recruited to address these aims.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with left hemisphere stroke
* Consent date \>= 1 month after stroke onset
* Right-handed
* Fluent in English
* 18 years of age or older

Exclusion Criteria:

* Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
* Non-decisional per decisionality questionnaire or other clinical assessment
* Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
* A chronic medical condition that is not treated or is unstable
* Presence of

  1. cardiac stimulators or pacemakers or intracardiac lines
  2. neurostimulators
  3. medication infusion device
  4. any other implants near the scalp (e.g., cochlear implants) or in the eye
  5. metal in the body
* Pregnancy
* History of skull fractures, or skin diseases
* History of ongoing or unmanaged seizures or a family history of epilepsy
* Presence of factors that potentially decrease seizure thresholds
* On pro-convulsant medications
* Untreated Sleep deprivation or insomnia
* Ongoing alcoholism or illegal drug abuse (e.g., cocaine or MDMA users)
* History of dyslexia or other developmental learning disabilities