cyrilzakka/clinical-trials huggingface dataset:
Monoclonal Antibody 3F8 and GM-CSF in Treating Young Patients With High-Risk, Refractory or Relapsed Neuroblastoma

RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for neuroblastoma.

PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody 3F8 when given together with GM-CSF in treating young patients with high-risk, refractory or relapsed neuroblastoma.

OBJECTIVES:

* Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with sargramostim (GM-CSF) in young patients with high-risk, refractory or relapsed neuroblastoma.
* Assess anti-neuroblastoma effects of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of monoclonal antibody 3F8.

Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11 and monoclonal antibody 3F8 IV over 30 minutes on days 0-4 and 7-11. Treatment repeats every 4-6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody 3F8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of NB as defined by international criteria,45 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels.
* Patients must have refractory or relapsed high-risk NB (including MYCNamplified stage 3/4/4S and MYCN-nonamplified stage 4 \>18 months old) resistant to standard therapy.
* Prior treatment with 3F8 is allowed.
* Age \<21 years.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Existing major organ dysfunction should be grade 2 or less, with the exception of myelosuppression (neutrophil count \>500/ul and platelet count \>10,000/ul are acceptable), alopecia, hearing loss. Patient cannot be taking antihypertensive medication.
* History of allergy to mouse proteins.
* Active life-threatening infection.
* Human anti-mouse antibody (HAMA) titer \>1000 ELISA units/ml.
* Prior treatment with 3F8 is NOT an exclusion criterion.
* Inability to comply with protocol requirements.
* Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
Management of Glycemia Following a Pizza Meal

Glycemia following pizza consumption is typically managed with a dual wave insulin bolus. This study evaluated the effect of a simple bolus on glycemia following consumption of traditionally prepared pizzas with long (22 hours) or short (8 hours) dough fermentation periods.

All participants received pizza prepared in one of two ways, as described below, on two separate days. On the first day, they were given a pizza prepared with dough fermented for 8 hours (pizza A), and on the second study day they received a pizza prepared with dough fermented for 24 hours (pizza B). Participants and their parents were blinded to the type of pizza served on each day. Both meals were served at 7.00 pm at the pizzeria where the pizza had been prepared, and consumed within 30 minutes.

Children and adolescents aged between 4 and 18 years with type 1 diabetes were eligible for inclusion in the study if they had received SIP therapy (MiniMed™ 640G, Medtronic, Tolochenaz, Switzerland) for at least 3 months One pizza of each type was prepared for chemical analysis

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months

Exclusion Criteria:

* Patients with HbA1c \>8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness
Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents

The study 'Mindfulness and Relaxation interventions in Individual Training Psychotherapies for Children and Adolescents' (MARS-CA) aims to examine the effects of short session-introducing interventions with mindfulness elements (SIIME) on juvenile patients' psychopathological symptomatology and therapeutic alliance at the beginning of the first 24 therapy sessions.

Short session-introducing interventions with mindfulness elements (SIIME) shall be compared with session-introducing relaxation interventions (SIRI) and no session-introducing interventions (treatment as usual, (TAU)). Patients between 11 and 19 years and a primary diagnosis of hyperkinetic disorder, depressive disorder or anxiety disorder are invited to participate. Psychotherapy will be conducted by trainee therapists at a trainee outpatient clinic for children and adolescents. It is hypothesized that psychopathological symptomatology and therapeutic alliance improve more in the mindfulness condition than in the relaxation condition and TAU, and that mindfulness moderates the relationship between therapeutic alliance and psychopathological symptomatology stronger than the relaxation condition and TAU.

Eligibility Criteria:
Inclusion Criteria:

* A primary hyperkinetic disorder, depressive disorder or anxiety disorder diagnosis
* treatment at the Center for Psychological Psychotherapy, University of Heidelberg

Exclusion Criteria:

* age below 11 or above 19
* insufficient German language skills
* psychotic disorder
* acute suicidality
Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications

During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications.

Patients will be taken to the operating table after preoperative evaluation. Routine monitoring and routine anesthesia method will be applied to the patient. Access will be made through the radial artery for arterial catheterization. Patients will be ventilated with 6-8 ml/kg tidal volume, 12-14 frequency/min, 5 Positive end expiratory pressure(PEEP), 60% Fraction of inspired oxygen(FiO2) and oxygen saturation over 94. End tidal Carbon dixide(CO2) will be kept in the range of 32-37. After cardiac catheterizations are performed, the pump will be entered, and after all preparations are completed, an aortic cross-clamp will be placed and cardioplegic solution will be sent. After the patient enters the pump at full flow; Group 1: Non-ventilated patient group. Here, patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off.

Group 2: Patients will continue to be ventilated at FiO2: 40%, TV: 3 ml/kg, frequency 12 breaths/min, peep: 5 cm/H2O.

Eligibility Criteria:
İnclusion criteria:

* Patients who will undergo elective cardiopulmonary bypass surgery and agree to participate in the study
* Patients who will undergo coronary or valve surgery
* Surgeries performed on a stopped heart
* Patients over 18 years

Exclusion criteria:

* Patients undergoing emergency cardiac surgery
* Patients who will undergo redo surgery
* Patients who will undergo total circulatory arrest surgery
* Patients in a state of preoperative shock
* Patients with acute and chronic hypoxemia (PaO2 \<65mmHg, SpO2 \<95 in room air)
* Patients followed with mechanical ventilation for 7 days before surgery
* Patients with BMI\>35
* Patients with obstructive sleep apnea syndrome
* Patients with pulmonary artery pressure \>50 mmHg
* Patients with glomerular filtration rate \<30 ml/min
Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials

To lower the threshold for clinical application by reducing the testing time for recording vestibular-evoked myogenic potentials (VEMPs), we evaluated whether a simultaneous recording of ocular and cervical VEMPs after unilateral or bilateral stimulation can be achieved without a loss in diagnostic sensitivity.

The combined evaluation of ocular and cervical VEMPs permits the assessment of both endorgans and whole vestibular nerve function, as well as the ascending and descending vestibular pathways in the brainstem at once.

In about 30 healthy participants and 20 patients with acute unilateral vestibular neuritis, unilateral simultaneous cVEMP and oVEMP recordings in each side during monaural stimulation (air-conducted sound, 500Hz tone bursts, 100 nHL), and bilateral simultaneous recordings of each VEMP while binaural stimulation were compared to the conventional method of sequential recording each VEMPs on each side at a time.

Eligibility Criteria:
Inclusion Criteria:

1. acute onset of vertigo
2. the appearance of mixed horizontal and torsional nystagmus
3. impaired horizontal semicircular canal (SCC) function on head-impulse test and a unilaterally absent or reduced caloric response (i.e., a caloric paresis score \> 25%)
4. intact inferior division of vestibular nerve as evidenced by normal cVEMP and normal head-impulse test for vertical SCCs
5. the absence of auditory and neurologic signs

Exclusion Criteria:

* a previous history of vertigo or neuro-otologic diseases
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients

The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.

This study is a long term, follow up to the ACT MA09-hRPE 001 phase I/II trial, the phase I/II trial (referred to as the core protocol) was an open-label, non-randomized, dose escalation, multi-center trial. Thirteen SMD patients were treated in this trial. Ten patients with profound vision loss (visual acuity \<=20/400) received a single subretinal injection of MA09-hRPE cells, starting at a dose of 50,000 MA09-hRPE cells (three patients), 100,000 MA09-hRPE cells transplanted (three patients), 150,000 MA09-hRPE cells transplanted (three patients) and increasing to a maximum dose of 200,000 MA09-hRPE cells transplanted (one patient). Three patients with severe to moderate vision loss (visual acuity \<= 20/100) received a dose of 100,000 MA09-hRPE cells. All patients who participated in the core protocol are eligible for participation in this follow-up protocol.

The first visit of this long term follow-up protocol will correspond to the last visit of the core protocol, and will take place at 12 months post cell implantation. Informed consent will be obtained at this visit.

Patients will be evaluated at 18, 24, 36, 48 and 60 months post-transplant (or more frequently as clinically indicated). Follow-up will include obtaining information about ophthalmological findings and events of special interest as defined in the Primary Outcomes. At the last visit of this follow-up study, whether at 60 months post-transplant or at early discontinuation, patients will be invited to participate in a Safety Surveillance Study for an additional 10 years, under a separate protocol, which will continue to monitor the long term risks of MA09-hRPE cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Must have been treated with hESC-RPE cell transplant in the core protocol.
* Able to understand and willing to sign the informed consent to participate in the follow-up study.

Exclusion Criteria:

* There are no exclusion criteria
Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.

Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF.

Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF).

A- 3D strut plate without post operative IMMF:

* Pre operative computed tomography will be done for patient.
* Intra operative :all cases will under go general anathesia.
* Exposure of the fracture segments using vestubular incision.
* Inter-maxillary fixation will be done.
* The fracture segment will be reduced in normal anatomic postion guided with occlusion.
* The fracture segment will be fixed in postion using 3d srut plate.
* Closure of surgical incision.
* Post operative computed tomograghy will be done for the patient.
* Patient will be dismissed from operation room without IMMF.

B- 3D strut with post operative IMMF:

* Pre operative computed tomography will be done for patient.
* Intra operative :all cases will under go general anathesia.
* Exposure of the fracture segments using vestubular incision.
* Inter-maxillary fixation will be done.
* The fracture segment will be reduced in normal anatomic postion guided with occlusion.
* The fracture segment will be fixed in postion using 3d srut plate.
* Closure of surgical incision.
* Post operative computed tomograghy will be done for the patient.
* Patient will be dismissed from operation room with IMMF for 15 days.

Follow up for both groups :

Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
* Patient over 15 years old age and both sexes were included in this study.
* Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
* Patients with good general condition allowing major surgical procedure under general anesthesia.
* Patients with physical and psychological tolerance.

Exclusion Criteria:

* Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
* Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
* Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
A Study of Women Receiving Standard of Care (SOC) for the Treatment of Pelvic Pain Due to Suspected or Confirmed Endometriosis and the Impact on the Disease or Symptom Progression.

This study will describe historic, current, and evolving treatment pathways, treatments, and interventions in women with a suspected or confirmed diagnosis of endometriosis in order to better understand the impact of early intervention on the disease or its symptoms. Length of treatment is dependent on standard of care treatment provided and all study information will be collected during routine standard of care visits.


Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (between their first menstrual cycle and before onset of menopause).
* Women who have experienced chronic pelvic pain (CPP) and/or dysmenorrhea (DYS) for at least 6 months prior to enrollment without symptom improvement with non-steroidal anti-inflammatory drugs (NSAIDs) or hormone/medical treatment.
* Women with suspected or confirmed endometriosis (EM) at time of enrollment.
* Women with CPP and/or DYS impacting daily activities as determined by their treating physician.
* Able to read, understand and respond to patient questionnaires.
* Willing to sign a patient authorization and/or informed consent form (ICF) and agree to disclose personal health information.

NOTE: For pediatric patients, parental/guardian assent/ICF is also required.

Exclusion Criteria:

* Women with chronic pelvic pain (CPP) and/or dysmenorrhea(DYS) for reasons other than endometriosis (EM).
* Women who have had a hysterectomy and/or bilateral ovary removal (oophorectomy).
* Women who are pregnant or planning to become pregnant.
* Women currently using assisted reproductive technologies such as in vitro fertilization (IVF).
* Women with a history of, or current malignancy (with or without systemic chemotherapy) with the exception of basal cell carcinoma of the skin.
* Women who are currently participating in an interventional clinical trial.
Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion

This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Clinically isolated syndrome of less than 3 months of onset
* Informed consent to participate

Exclusion Criteria:

* Progressive primary multiple sclerosis
* Relapsing remitting multiple sclerosis
* Persons wearing contact lenses
* Ocular Infection
* Corticoid treatment at least 30 days before sampling
* Immunosuppressive or immunomodulatory treatment at least 3 months before sampling
* Pregnancy or breast feeding
* No coverage by the Social Insurance
Post-TAVI Coronary Access Study

Coronary access after trans-catheter aortic valve implantation (TAVI) remains a major challenge. With the evolution of TAVI procedure and the inclusion of lower-risk patients with aortic stenosis, future coronary access is an even greater concern, because this lower-risk patient group has a greater cumulative risk of requiring coronary angiography for acute coronary events compared to their octogenarian counterparts.

It is only speculated that the intra-annular position of the self-expandable valves together with the frame covering coronary ostia would impose a significant technical challenge as compared to the balloon-expandable valve (1). However, this remains to be proven. With any valve used, increased catheter manipulations may result in longer fluoroscopy times, larger volumes of contrast, and reduced imaging quality due to non-selective injections (2).

Although complex, coronary procedures after TAVR are considered relatively safe and feasible on experience hands (3-6). A number of techniques to increase the likelihood of successful coronary intubation after TAVR have been described in the published reports and include the use of intracoronary guidewires (1), as well as balloon-assisted tracking with guideliner extension (7). It is therefore essential to fully understand the potential challenges of coronary angiography and PCI in this specific patient population. Guidance by a specific algorithm may help to overcome difficulties in coronary angiography and facilitate selective coronary intubation particularly during primary PCI (8).


Eligibility Criteria:
Inclusion Criteria:

1. Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
2. Clinical indication for PCI

Exclusion Criteria:

1. Prior TAVI valve-in-valve procedures
2. Prior TAVI-in-TAVI procedures
Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition

The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.

Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* voluntarily agree to participate and sign in informed consent form
* aged 65 years or older
* a serum prealbumin level≤30 mg/dL and a BMI\<25 kg/m2

Exclusion Criteria:

* inability to perform oral ingestion
* known allergies to milk or eggs
* an inability to communicate, such as those with Alzheimer's disease
* malabsorption syndrome, a history of gastrectomy or enterectomy
* diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
* any other disease requiring treatment, medication or alcohol abuse
* any condition that the investigator believes may put the subjects at under risk
Effects of Maternal Obesity on Offspring Brain Development

The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.

This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-25 or \>30 with early OB visit medical records accessible
* singleton pregnancy
* about 36wks of pregnancy
* at least 18 years of age

Exclusion Criteria:

* hypertension, diabetes, or other preexisting medical conditions
* medications known to influence fetal growth
* recreational drugs, nicotine or tobacco use of alcohol use while pregnant
* pregnancy conception with assisted fertility treatment
* medical complications developed during pregnancy