cyrilzakka/clinical-trials huggingface dataset:
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.

OBJECTIVES:

* Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.
* Assess the biological effects of 3F8/GM-CSF in these patients.

OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Neuroblastoma diagnosed by INSS criteria, i.e., either:

  * Histologic proof of disease OR
  * Tumor clumps in bone marrow plus elevated catecholamine levels
* Relapsed disease with poor long-term prognosis as indicated by at least one of the following:

  * N-myc amplification in tumor cells
  * Diploid chromosomal content in tumor cells
  * Distant skeletal metastases
  * Unresectable primary tumor crossing the midline
  * Bone marrow with greater than 10% tumor cells
* Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required
* No rapidly progressive disease
* Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols

PATIENT CHARACTERISTICS:

Age:

* 2 to 21

Performance status:

* Not specified

Life expectancy:

* Greater than 8 weeks

Hematologic:

* Not specified

Hepatic:

* No grade 3/4 toxicity
* LDH no greater than 1.5 times upper limit of normal

Renal:

* Creatinine clearance at least 60 mL/min
* No grade 3/4 toxicity

Cardiovascular:

* No grade 3/4 toxicity

Pulmonary:

* No grade 3/4 toxicity

Other:

* No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
* No active life threatening infections
* No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
* No allergy to mouse proteins
* No pain requiring opiates

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Coenzyme Q10 for Gulf War Illness: A Replication Study

The purpose of this study is to assess whether a high quality preparation of ubiquinone (coenzyme Q10) benefits symptoms, function, and quality of life in veterans with Gulf War illness.


Eligibility Criteria:
Inclusion Criteria:

* Meets both CDC and Kansas deployment and symptom inclusion criteria.
* Does not have a disqualifying condition.
* Able to travel to a local Quest facility for study blood draws.
* Adequate internet access to allow ZoomPro visit participation and remote survey completion.
* Health prior to the Gulf War rated as "very good" or "excellent" (to exclude persons who may have had other health conditions with different mechanisms as the cause of their symptoms).
* Willing to defer initiation of discretionary treatments or supplements during the expected course of study participation.

Exclusion Criteria:

* Participating in another clinical trial.
* Still-evolving adverse effects following another medication or health condition, such as covid or fluoroquinolone use.
* On Coumadin/ warfarin.
* Unable to participate for the required duration of the study.
Autogenous Tooth Bone Graft Versus Allogeneic Bone Graft Around Dental Implant in Aesthetic Zone

24 patienta with non restorable anterior teeth underwent extraction with immediate implant installation using bone grafts either autogenous tooth bone graft or allogenic bone graft Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement with autogenous tooth bone graft.

• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).

24 patienta with non restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement with autogenous tooth bone graft.

• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).

preparation of autogenous tooth bone graft Any restorations, caries, cementum, periodontal ligament and pulp tissue will be removed .The tooth will be grinded using dental bone mill and bone crusher Tooth particles will be sieved to particles size 300 to 1200 microns. The sorted particles will be immersed in 70 % ethanol and 5% Peracetic acid\* in a sterile container for 10 minutes to remove any soft tissue remnants, bacteria and smear layer (defatting and sterilization).

Tooth particles will be demineralized using 2% HNO3for 20 minutes to expose the dentine organic matrix.

The bacteria-free particulate dentin will be washed with phosphate buffered saline‡ twice for 5 minutes to restore the PH balance to 7.4. In the same setting, surgical procedure after atraumatic extraction immediate implant willbe inserted according to dimensions taken from CBCT and jumbing gap will be filled with bone graft according to randomization

Eligibility Criteria:
Inclusion Criteria:

Patients with non restorable maxillary anterior teeth need to be extracted.

* Thin labial plate of bone of the tooth to be extracted.
* Patients age above 20years old.
* Good oral hygiene.
* No signs of acute infection or inflammation

Exclusion Criteria:

* Prior radiation therapy.
* Soft and hard tissue pathology at the operation site.
* Any relevant systemic disease or medication that might compromise bone healing.
Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise

This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).

The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.

To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.

Exclusion Criteria:

* Unstable patients, CF-LVAD implantation less than three months ago.
In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

The relative bioavailability of different salbutamol sulphate inhaler formulations will be studied in healthy male subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (1996) after the approval of the ethical committee, Faculty of Pharmacy, The British University in Egypt.

In this study, 20 healthy, non smoking, adult male volunteers (age: 30-45 years, weight: 65-80 kg) will carry out screening procedures which include instruction and practice with the placebo metered dose inhaler devices that will be used in the study. In addition, all subjects were fully informed in writing of the objectives and implications of the trial. No subject will be considered for the study if developed any symptoms of allergic disorders. Subjects will follow a normal diet and will not receive any other medications. Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.

Each volunteer will inhale eight puffs (4 puffs at -5 min \& 4 puffs at 0 min) which are equivalent to 0.8 mg of salbutamol sulphate . To inhale through metered dose inhalers, volunteers will be trained to exhale slowly to their residual volume (as far as comfortable), put the inhaler into their mouth and seal their lips round the mouth piece. Then they will be instructed to take a slow deep inspiration to their total lung capacity over approximately 5-10 seconds. At the end of each inhalation, they will hold their breath for 10 seconds and then breathe normally (Ball et al, 2002) . Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration. The blood will be heparinized immediately and centrifuged at 3000 rpm for 10 minutes. The plasma samples will be stored at freeze temperature until analysis. Two different formulae will be compared during the first six hours following administration. The maximum plasma concentration (Cmax), the time required to reach maximum plasma concentration (Tmax) and the area under plasma concentration time curve (AUC) will be calculated using validated Excel software.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Chronic disease
* Smoking
* Hospitalization
Comparison Between a Live Canine or Toy Dog on Prosocial Behavior and Emotional Regulation in Autistic Children

This study investigated the human-animal interaction (HAI) and bond (HAB) between a canine trained in therapy techniques or a canine plush toy and youth with autism spectrum disorder (ASD) during animal-assisted therapy (AAT) sessions. The purpose of this study is to explore identified gaps in knowledge pertaining to AAT in pediatric ASD care management by documenting human interaction between either a live canine or the plush toy canine during AAT sessions and evaluating prosocial behaviors observed during and after AAT sessions.

This study addressed the following research questions:

1. How do children with autism ages 2 to 18 years interact with a live canine during AAT sessions?
2. How do children with autism ages 2 to 18 years interact with a toy plush dog during AAT sessions?
3. Is there a difference in HAI in the live canine group and the toy plush dog group?
4. Is there a difference in prosocial behavior observed during AAT sessions between the live canine group and the toy plush dog group?
5. Is there a difference in behavior after AAT sessions between the live canine group and the toy plush dog group? Participants were randomly assigned to either the live canine or toy plush dog group. Adaptive functioning and social responsiveness evaluations were obtained to compare baseline behavior between the two groups. Participants attended an AAT session once weekly for 6 to 8 weeks. Each group received the same therapy provided by the therapist; the only difference being the incorporation of a live canine during the therapy session. Caregivers completed a weekly assessment depicting participants' positive and negative affect at the beginning of each session. Caregivers also completed a monthly assessment noting strengths and difficulties in social functioning and behavior at the start of the first, middle, and final session. AAT sessions were recorded and behavior occurring during the sessions was coded to note HAI and HAB that occurred during the sessions.


Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis of autism spectrum disorder, developmental delay, or behavioral concerns.

Exclusion Criteria:

* Fearful of canines
* Allergic to canines
Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations

Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.

Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.

Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control.

Ethics and dissemination:

Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of COPD or Asthma, medicated with any kind of inhaler device (pressurized Metered Dose Inhaler (pMDI) with or without Spacer, Dry Powder Inhaler (DPI) or Soft Mist), aged ≥65 years and being a regular user of primary health care services (defined as having at least one consultation performed in the last two years with his/her own Family Doctor). In order to minimize diagnostic inaccuracy, Asthma and COPD diagnosis will be reviewed in every participant at baseline prior to enrolment and according to GINA and GOLD strategies.

Exclusion Criteria:

* Severe or acute illness (such as unstable cardiovascular status, unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax (within one month), recent thoracic, abdominal or eye surgery (within one month), acute nausea or vomiting, severe respiratory distress, dementia). Patients with intermittent asthma, as well as COPD patients with mild obstruction (GOLD class I) will be excluded, since these patients do not need to take inhaler medication on a daily basis, and tend to have a low frequency of disease exacerbations.
Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support

The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.


Eligibility Criteria:
Inclusion Criteria:

* Syme or Pirogoff or ATCT or arthrodesized Chopart type amputation
* Age \> 18 years old,
* First fitting or renewal of Syme type prosthesis delivered to IRMA between January 2008 and December 2018

Exclusion Criteria:

* Refusal documented in the file that the data be used for scientific purposes,
* Congenital etiology of the condition.
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age.
* The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics.
* It is allowable for the patients to be treated with IV inotropes and vasodilators.

Exclusion Criteria:

The following criteria would exclude the patient from study:

* invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization),
* rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate),
* severe ventricular outflow obstruction,
* angina,
* hypotension,
* uncorrected hypokalemia,
* CNS (e.g. stroke, TIA),
* respiratory (e.g. COPD, intubated patients, oral,
* intravenous or intramuscular steroids),
* renal insufficiency (e.g. increased serum creatinine, dialysis),
* hepatic impairment (e.g. significant increase in liver enzymes),
* decompensation from active infection and acute bleeding (e.g. severe anemia).
* Female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions.
* Also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine

Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain of less than 3 months
* No symptoms below the shoulder
* Baseline Neck Disability Index score of 10 or greater

Exclusion Criteria:

* Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)
* History of whiplash injury within the past two months
* Diagnosis of cervical spinal stenosis
* Uni-lateral or bi-lateral upper extremity radicular symptoms
* Evidence of central nervous system involvement
* Two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes
* Prior surgery to the neck or thoracic spine
* Pending legal action regarding their neck pain, or patients with no fault or workers compensation claims
* Insufficient English language skills to complete the questionnaires
* Inability to comply with treatment and follow-up schedule
* Women who may be pregnant
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.

To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.

Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)
* Bladder capacity \</= 300 mL by cystometry

Exclusion Criteria:

* History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
* Current urinary tract infection
* Neurological bladder dysfunction
* Treatment with drugs that may interfere with CYP3A4 metabolic function
* History of stress urinary incontinence
PAF for the Treatment of Osteoarthritis

This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis

This study will look at blinded standard of care (SOC) steroid injection vs. amniotic fluid injection (pAF) to treat and reduce osteoarthritis (OA) inflammation and pain. The main objectives of this study are to establish the safety and tolerability of allogeneic intra-articular pAF injections. Secondary objectives include pain levels and functional outcome scoring in patients over a 12 month time frame.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are between the ages of 18-70 years
* A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease
* Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months
* Unilateral or bilateral chronic knee joint pain \>4 months
* Patients who are able to ambulate (i.e. not wheelchair bound)
* Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10)
* Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection

Exclusion Criteria:

* Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months
* A focal chondral defect, defined by x-ray evaluation
* BMI \>40 as defined by NIH Clinical Guidelines Body Mass Index
* Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period
* Clinical suspicion of infection at injection site
* Any surgeries within 4 weeks, other than diagnostic surgery
* Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics
* Unable to consent to an English Language Consent Form
* Frank mechanical issues (i.e. locking of the knee)
* Workman's Compensation cases
* Rheumatoid arthritis
* Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection)
* Patients with vascular claudication or neurologic disorders affecting the index lower limb
* Patients with inflammatory arthropathies or connective tissue disorders; or
* Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment
* Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee
* Women who are nursing or pregnant
* Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection