cyrilzakka/clinical-trials huggingface dataset:
Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease

Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.

Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. The cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. Suspension of the cultured AMSC will then be sterilely packed and transported to the surgery site. During the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (Vitoss™, Orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine.

All subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
2. patients indicated for fusion therapy,
3. patients between 18-55 years, both sexes,
4. patients able to provide written informed consent.

Exclusion Criteria:

1. previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
2. osteoporosis,
3. diabetes mellitus,
4. pregnancy or breastfeeding,
5. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
6. fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),
7. coagulopathy,
8. malnutrition, primary biliary cirrhosis,
9. skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
10. gastrostomy,
11. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....),
12. alcohol or drug abuse,
13. cancer (compulsory clinical oncological screening),
14. ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.
The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.


Eligibility Criteria:
Inclusion Criteria:

* children must be between ages 6-17 years
* children must be able to read/speak in English. Parents must be able to read/speak in either English or Spanish
* children must be patients, students and/or residents at Reiss-Davis/Vista del Mar

Exclusion Criteria:

* children who wear a hearing device
* children with a history of heart disease
* children who are currently being treated for a seizure disorder
* children who are non-verbal
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.


Eligibility Criteria:
Inclusion criteria:

* Compliance and completion of the canakinumab PFS core study
* Unchanged significant clinical medical history from entry into core study

Exclusion criteria:

* Physician judgment of unsuitability for the study
* Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
Buspirone for Opioid Tapering

This is a pilot study to collect preliminary data to support a grant application. The goal of the study is to evaluate whether the Food and Drug Administration (FDA)-approved and generically-available medication buspirone reduces symptoms of opioid withdrawal among patients undergoing a clinically-indicated and supervised taper from their opioid pain medications. This is premised on strong preclinical scientific support but has not yet be well-examined in humans.

Buspirone (Buspar) has shown initial efficacy in reducing symptoms of opioid withdrawal in animal studies and in human patients undergoing a methadone taper. Buspirone may have pharmacologic activity in specific neurotransmitter systems that preclinical evidence suggests may be implicated in the manifestation of opioid withdrawal symptoms. Administration of buspirone during an opioid taper may improve outcomes relative to placebo. The goal of this study is to collect preliminary feasibility and efficacy data from a sample of patients undergoing clinically-indicated opioid tapering. Participant enrollment will occur at the beginning of their residential stay on the Pain Treatment Unit at Johns Hopkins Hospital. Participants will be randomly assigned to receive buspirone (15 milligrams, three times daily, for daily dose of 45 milligrams) or placebo. Daily assessments for withdrawal and requests for additional symptomatic medications will be evaluated as evidence of initial efficacy. Feasibility measures include willingness to participate and study retention.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Be undergoing taper of prescribed opioid pain medications at the study site

Exclusion Criteria:

* Being pregnant or breastfeeding
* Past 7-day use of grapefruit juice or other strong Cytochrome (CYP) P450 inhibitors or inducers
* Have medical or psychiatric condition that is contraindicated with buspirone administration
* Current suicidality as assessed by clinic staff or the Columbia Suicide Severity Rating Scale
A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)

Breast radiation treatment is burdened by acute and chronic toxicities, in most cases mild. However, considering the excellent life expectancy of patients with breast cancer, maintaining a low toxicity profile is of primary importance in order to guarantee a satisfactory quality of life. The definition of the molecular and genetic variables related to radiotoxicity and their integration into predictive molecular signatures may allow the risk of toxicity to be individualized. This would provide the clinician with a useful tool in order to personalize the radiation treatment, thus being able to choose the best technique or schedule for each patient.

Breast radiation treatment is burdened by acute and chronic toxicities, in most cases mild. However, considering the excellent life expectancy of patients with breast cancer, maintaining a low toxicity profile is of primary importance in order to guarantee a satisfactory quality of life. Currently there are numerous predictive models of toxicity (Normal Tissue Complication Probability, NTCP) which are based on dosimetric and sometimes also clinical data. To date, they do not include individual genetic variability. However, it is believed that inter-individual variability may be responsible for up to 40% of actinic toxicity. Multiparametric models that consider genetics, dose and clinical aspects probably better reflect the complexity of radiotoxicity than models that rely on a single parameter and it is possible to integrate such parameters using a machine learning approach. The definition of the molecular and genetic variables related to radiotoxicity and their integration into predictive molecular signatures would therefore allow the risk to be individualized. This would provide the clinician with a useful tool in order to personalize the radiation treatment, thus being able to choose the best technique or schedule for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Ability to express appropriate informed consent to treatment;
* Distant nonmetastatic breast cancer;
* Histology: infiltrating NST(no special type)/lobular carcinoma or ductal carcinoma in situ;
* Stage: pTis; pT1-3 pN1-3 M0;
* Hormone receptors, HER-2 status: Any;
* Breast-conserving surgery. Both the sentinel lymph node biopsy and axillary lymphadenectomy. Negative surgical margins.
* Candidates for postoperative radiation treatment.

Exclusion Criteria:

* Refusal of radiotherapy treatment (i.e., absence of signed informed consent);
* Previous radiation therapy at the same site;
* Concomitant chemotherapy with anthracyclines or taxanes;
* Inability to maintain treatment position;
* Partial breast radiotherapy (PBI);
* Male breast cancer;
* Mastectomy surgery.
Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

The objective of these cohorts is to detect potential genetic, neurophysiological psychological and cognitive risk factors for the development of chronic postsurgical pain including neuropathic pain.

This new study will enroll patients undergoing mastectomy or thoracotomy for cancer. They will be three cohorts :

* one prospective cohort constituted of women undergoing breast surgery in René Huguenin Hospital (Saint Cloud) and followed for up to one year after surgery.
* another cross sectional cohort constituted of patient association (Seintinelle) including women operated up to 2 years previously from breast surgery.
* One prospective cohort constituted of women or men undergoing thoracotomy in Foch hospital (Suresnes) and followed for up to one year after surgery.

The main objectives of these cohorts will be to detect potential genetic, neurophysiological, psychological and cognitive risk factors for the development of chronic postsurgical neuropathic pain.

These patients will questioned about demographics, age, sex, body mass index. A large neuropsychological and psychological battery of tests will be conducted. Sensory function will assessed using quantitative sensory testing. Biological samples will analyse potential genetic factors in the development of neuropathic pain after surgery. Conditioned pain modulation, threshold tracking and quantitative sensory testing will also be assessed in subgroup of patients.

The prospective cohort will be assessed before surgery then 3, 6 and 12 months after surgery. The cross sectional cohort will be assessed during one to two visits in hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for breast cancer or thoracotomy for lung cancer followed during the course of the study or patients from the French cohort Seintinelle already operated from breast surgery over the past 2 years.

Exclusion criteria :

* Patients are not included if they have clinically significant or unstable psychiatric or somatic conditions (e.g. major depression, psychosis, uncontrolled diabetes mellitus or hypertension, neurological disorders, immune disease, body mass index \> 45), past or present substance abuse or any cognitive deterioration based on past medical history, semi-structured interview and lack of completion or full understanding of questionnaires.
* Bilateral mastectomy (for women undergoing breast surgery)
* Presence of pain before surgery
Agitation in Alzheimer's Disease

Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.


Eligibility Criteria:
Inclusion Criteria:

* Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD)
* Agitation symptoms for at least the past 2 weeks
* Patient has caregiver who can participate
* Patient lives in the same household as the caregiver
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities

The investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. On admission to labor and delivery, patient will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment patients will be screened for Bacterial vaginosis by doing a speculum exam and testing for Amsel's criteria. BV +ve patients will be randomized to receive either metronidazole 2 grams PO once or identically appearing placebo. The PI, study coordinator, or a collaborator will be responsible for the informed consent.

This will be a double-blinded randomized clinical trial. Neither the patient nor provider will be aware of treatment assignment. As with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. The patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected.

Patient will be assessed intrapartum for development of chorioamninoitis. Postpartum patient will be assessed for infective complications up to 4 weeks. Neonates will be assessed for morbidities by chart review for 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Women ≤50 years at the time of admission with the ability to give informed con-sent.
* Admission for induction of labor or early spontaneous labor with cervix ≤3 cm.
* Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated
* Gestational age ≥ 34 weeks

Exclusion Criteria:

* Spontaneous rupture of membranes
* Plan for elective cesarean delivery
* Allergy or contraindications to metronidazole
* Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications.
* Hemodialysis
* Severe liver dysfunction
* Diagnosis of chorioamnionitis at the time of admission
Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance

The aim of the study is to test a Fasting Mimicking Diet (FMD) for its efficacy on improving muscular resistance and endurance. The investigators will perform a randomized clinical trial to test the efficacy of the FMD on improving muscular strength, muscular resistance and endurance in physically active young adults (18-40 years of age). The study will include two arms: Placebo (Placebo diet) and FMD (3 cycles of 5-day fasting-mimicking diet within two months). Study endpoints will include muscular strength evaluation of lower limbs, cardio-pulmonary responses, neuromuscular function and muscle architecture. Subjects will be evaluated 4 times within 3 months: at baseline (T1), after the 1st cycle of diet (T2), 7 to 15 days after the 3rd cycle of diet maintaining baseline intensity (T3) and with re-assessment of Peak Power Output (T4).


Eligibility Criteria:
Inclusion Criteria:

* Male sex;
* Age Range: 18-40 years old;
* Body Mass Index (BMI) range between 18.5 and 30;
* METs minutes per week - calculated by International physical activity questionnaire (IPAQ) - between 600 and 3000.

Exclusion Criteria:

* Female sex;
* History of muscle, joints and nerves injuries to the upper and/or lower limbs in the previous 12 months;
* Body Mass Index (BMI) below 18.5 and above 30;
* METs minutes per week - calculated by International physical activity questionnaire (IPAQ) - below 600 or above 3000.
Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with chronic sinusitis and/or nasal polyps.

Exclusion Criteria:

* Patients with previous nasal or sinus surgery.
* Patients with sinonasal Malignancy.
* Immunocompromised patients.
* Patients with ciliary motility disorders.
* Pregnant women
Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies

Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. With the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine.

The study consists of an initial visit coinciding with the start of treatment, a subsequent visit after 6 months of treatment and finally another after 12 months, coinciding with the end of treatment. In case of worsening after suspension, a clinical visit will be carried out at the time of worsening to evaluate the reintroduction of the drug and in case of reintroduction, a visit will be carried out after 3 months. If patients do not worsen, a visit will be made 6 months after completing treatment.

At each visit, demographic and clinical variables will be collected. In addition, 3 blood tests will be performed corresponding to the beginning of treatment, after 6 months and a month and a half from the last infiltration. Likewise, a brain MRI will be obtained prior to the start of treatment. These blood samples and neuroimaging data will be processed for subsequent analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years.
* Caucasian ethnicity.
* Patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the International Classification of Headache Diseases, 3rd edition (ICHD- 3).
* Have at least one year of history of migraine.
* Patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody.
* Patients able to describe their clinical situation and the characteristics of their headache.
* Grant your informed consent.

Exclusion Criteria:

* Patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication.
* Neurological focus in the examination.
* Pregnancy or breastfeeding period.
* Patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study.
* Patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies.
* Patients who present any significant adverse effect that requires withdrawal or change of anti-CGRP drug.
Potential Optimization Training in Simulation.

Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and planification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare individual and team performances with or without an optimization personal potential training.

The investigators aim to compare the individual and team performances for resident who were taught personal optimization skills (positive reinforcement, personalized psycho-physiological relaxation, mental rehearsal) and those who didn't.

The investigators are going to compare groups of anesthesiology residents going through same scenarios of simulated critical events in high fidelity simulation session. Scenarios will be recorded to be analyzed by 2 reviewers independently. A specific checklist of appropriate treatment and a non technical skill checklist will be use to cote team performance (OTTAWA and TEAM scales). Stress of the participants will be assessed by visual analogic scale of participants anxiety and stress. The two groups will be compare to see if improvement in team performance is associated with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology and Intensive care resident in the simulation education curriculum

Exclusion Criteria:

* Refusal to participate (written approval required)