cyrilzakka/clinical-trials huggingface dataset:
Haploidentical Stem Cell Transplantation and IL-15 NK Cell Infusion for Paediatric Refractory Solid Tumours

The investigators propose a new antitumor cell therapy for treating childhood refractory solid tumours. The aim of this study is explore the graft versus tumour effect mediated by allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor killer immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I alleles mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell activation and elimination of those target cells. Reduced risk of relapsed has been described in malignant cancer after haploidentical stem cell transplantation when HLA ligands against the inhibitory KIRs present in the donor were absent in the recipient (KIR-HLA receptor-ligand mismatch). NK alloreactivity could also be obtained by Natural Killer Receptor (NCR), Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by cytokines or tumour cell lines.

This will be an open, non randomized, Phase I/II clinical trial, with a double objective: therapeutic exploratory. The investigators aim at studying safety and efficacy of haploidentical stem cell transplantation for the treatment of these malignancies with no cure known. Patients will receive an haploidentical stem cell transplantation, followed by IL-15 stimulated NK cells infusion one month after transplantation. Efficacy of the procedure will be evaluated with up-to-date radiological techniques, molecular studies and functional assays.

The investigators propose a new antitumor cell therapy for treating childhood refractory solid tumours. The aim of this study is explore the graft versus tumour effect mediated by allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor killer immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I alleles mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell activation and elimination of those target cells. Reduced risk of relapsed has been described in malignant cancer after haploidentical stem cell transplantation when HLA ligands against the inhibitory KIRs present in the donor were absent in the recipient (KIR-HLA receptor-ligand mismatch). NK alloreactivity could also be obtained by Natural Killer Receptor (NCR), Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by cytokines or tumour cell lines.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 22 years.
* Histological solid tumor confirmation.
* Measurable solid tumor by image or molecular techniques.
* Solid tumors that have failed to at least 2 chemotherapy protocols.
* Suitable haploidentical donor available.
* Lansky score \> 60%.

Exclusion Criteria:

* Serum bilirubin \> 3 mg/dl
* GFR \< 40 ml/min/1.73 mw
* Cardiac left ventricular ejection fraction \< 40%
* HIV+
* Pregnant
* Unfavorable psycho-social report.
* Antecedent of abandonment treatment.
Oocyte Vitrification for In Vitro Fertilization (IVF) Patients and Women With Fertility Threatening Conditions

Vitrification is a method of cryopreserving tissue for future use. It is widely used to preserve extra, good quality embryos generated from infertility treatments. It is becoming popular for the preservation of oocytes (eggs) as well, but is still considered investigational in this respect. The purpose of this study is to provide egg freezing for patients desiring fertility preservation. Although commonly used in clinics around the world, it should be offered as an IRB approved study procedure until it is no longer considered investigational by the American Society of Reproductive Medicine.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 37 and who require IVF for a successful pregnancy will be approached to consent for the study,. They must also have a cycle day 3 FSH \< 10 mIU/ml, estradiol \< 70 pg/ml and a baseline follicle count \> 10. The BMI must be between 20 and 32kg/m2. If they do consent, eggs will only be vitrified if 13 or more mature metaphase II oocytes are collected.
* Women between the ages of 14 and 42 who are seeking treatment for fertility preservation. In addition they must also meet the following criteria.
* Patient is willing and able to delay any relevant therapy for up to 40 days.
* Have functioning ovaries as determined by blood / ultrasound testing.
* Patient is willing to undergo infectious disease testing for HIV, hepatitis B and C, syphilis, gonorrhea and Chlamydia.
* The patient must have clearance from their oncologist or medical specialist, if any, to undergo ovarian stimulation and transvaginal oocyte retrieval.
* The patient must not have a past history of blood clots in the veins or in the lungs.
* The patient must be willing to undergo transvaginal, internal ultrasound examination and pelvic examination.

Exclusion Criteria:

* Patients with a cycle day 3 FSH \> 10 mIU/ml, cycle day 3 estradiol \> 70 pg/ml and a baseline follicle count \< 10 will be excluded.
* Patients with a BMI \<20 and \>32 will be excluded.
* Patients who are not willing or are unable to meet the above mentioned eligibility requirments.
* Patients with expected low ovarian reserve \[evaluated on day 3 by an antral follicle count of \<3 follicles at 2-5 mm diameter and/or an increased concentration of follicle stimulating hormone (FSH) \>15 IU \[15\] on cycle day 3 \].
* Patients with possible poor quality of oocytes, based on medical history including previous exposure to chemotherapeutics or radiation.
Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS)

This study evaluates the addition of translational manipulation under interscalene block, to a course of orthopaedic manual physical therapy for treatment of adhesive capsulitis of the shoulder. Half the patients will receive a translational manipulation under interscalene block, plus 6 sessions of orthopaedic manual physical therapy. The other half will receive 7 sessions of physical therapy. The investigators hypothesize that the translational manipulation under interscalene block will provide additional benefit beyond the effect of in-clinic orthopaedic manual physical therapy alone.

Both translational manipulation under interscalene block and in-clinic orthopaedic manual physical therapy are thought to be useful for treating adhesive capsulitis of the shoulder. However, no single intervention for this condition has been proven to be superior to others.

The translational manipulation under interscalene block may improve pain-free motion of the involved shoulder, by releasing tight tissue without the guarding and motion-limiting effect of active muscle tension. The interscalene block prevents the patient from actively contracting the muscles that control the involved shoulder, during the manipulation procedure.

One additional possible benefit of the translational manipulation under interscalene block, is that the technique loads the joint structures--bone, joint capsule--in a safer way with less angular torque than conventional/traditional manipulation under anaesthesia. This minimizes the risk of physical/mechanical harm from the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Military healthcare system beneficiaries 18 years old or older
* Chief complaint of loss of shoulder range of motion
* Passive glenohumeral abduction less than 75 degrees
* Sufficient English-language skills to understand the study protocol.

Exclusion Criteria:

* Clinical diagnosis of diabetes (type I or II)
* Clinically evident and symptomatic rotator cuff tear or cervical radiculopathy
* Pain as the primary impairment (versus limitation of motion as the primary impairment)
* Having contraindications to an interscalene block.
3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders

3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.

Until now, it has been used only in adult population to evaluate defecatory disorders.

Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.

The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.

It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.

Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* age:1-18 yr
* after surgery for Hirschsprung's disease,
* after surgery for Anorectal malformations,
* after total procto/colectomy
* with parental agreement for the procedure

Exclusion Criteria:

* parental disagreement
* children \<12 months of age and \>18 years
Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions

Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The radiotherapy is currently the most widely used treatment, with complete response rate close to 100% for a lesion treated. However, it has limits when there are outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in three), or during recurrences. In these situations, conventional chemotherapy is not recommended and multi-field radiotherapy is often used empirically, but its effectiveness has never been studied prospectively.

Recently, retrospective studies with small numbers patients (totaling sixty patients) reported complete response rates of 80 to 100% with rituximab (anti-cluster of differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized treatment by intravenous with a recurrence rate of less than one case in three. These data suggest that rituximab by intravenous with a standardized initial cycle followed by a maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with multiple lesions or of recurrent lesions.

Compare the efficacy and safety of two treatment strategies for indolent cutaneous B cell lymphomas with multiple or recurrent lesions: Rituximab by intravenous versus multi-field radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* patients with histological diagnosis of indolent cutaneous B cell lymphomas
* patients with multiple lesions inaccessible to a single field of radiotherapy or patients with a recurrence outside the field of first radiotherapy
* patient with a lesion of at least 15 mm in major axis and a total tumor surface area greater or egal than 4 cm2
* patient with a negative staging
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* contraindication for rituximab or radiotherapy
* immunosuppressive therapy
* immunosuppression
Osteopontin Gene Polymorphism in Stroke Patients in Egypt

This study aims to investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients and correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients

The Global Burden of Disease estimated that one person in four aged 25 years will have a stroke in the rest of her/his life. Among them, ischemic stroke (IS) represents 80%.

Stroke is accompanied by a neuroinflammatory response involving immune system. These long-term processes following IS are still far from being understood. So, despite the significant improvement in the diagnosis and treatment of IS, the disability and mortality rate of IS are still rising. An assessment of the prognostic risk of IS should be carried out as early as possible and corresponding interventions should be adopted clinically, in order to have a significant impact on the prognosis of patients with IS.

Predicting the outcome in individual patients solely based on clinical and radiological parameters is challenging for clinicians. Measuring blood biomarkers associated with inflammation, endothelial function, matrix remodeling, and immune functions, may improve prediction performance .

Osteopontin (OPN) is a matricellular protein participating in many physiological and pathologic processes including wound healing, bone turnover, tumor genesis, inflammation, and immune responses . It is well accepted that OPN is an important mediator in stroke pathophysiology. OPN expression is upregulated in microglia surrounding the infarcted area and in microglia and infiltrating macrophages in the infarct area. OPN and microglia seems to exhibit an intimate relationship in stroke with rather beneficial functions for the clinical outcome. However, the role of OPN in stroke-related diseases as atherosclerosis and diabetes should be further disentangled as in this early phase of disease OPN may ultimately culminate in cerebrovascular dysfunction. OPN may exert opposing effects and should be therefore addressed differently.

Eligibility Criteria:
Inclusion Criteria:

* For acute ischemic stroke cases:

( Acute ischemic stroke will be defined as an episode of focal neurological deficits lasting for more than 24 hour with relevant lesion in brain computerized tomography (CT) or magnetic resonance (MR) image\>)

1- both sex 2- Age between 18 to 70 years old. 3-symptoms suggestive of acute ischemic stroke: presenting within 24 hours of onset of these symptoms

* For old ischemic stroke:

  1. both sex
  2. Age between 18 to 70 years old.
  3. Duration of3to 6 month of development of ischemic symptoms
* For control cases:

  1. both sex
  2. Healthy people
  3. Age: above 18 years old

     Exclusion Criteria:

     Patients with a previous history of stroke; Patients with hemorrhagic stroke. Patients with coronary heart disease, heart failure, chronic inflammation, intracranial infection/brain tumor and malignant tumor.

     Patients with liver, kidney and other important organ dysfunction. Patients with severe abnormal coagulation function
Perioperative Immunonutrition Under Enhanced Recovery After Surgery

The goal of this clinical trial is to compare the effect of perioperative immunonutrition supplement in gynecologic cancer patients. The main questions it aims to answer are:

* is there any difference in the nutritional outcomes and functional outcomes between intervention and conventional groups?
* is there any difference in the post-surgical outcomes between intervention and conventional groups?

Participants (intervention) will be provided the immunonutrition supplement before and after operation.

Researchers will compare intervention group with conventional group to see if there is any difference in postoperative outcomes.

The clinical trial aims to determine the effectiveness of perioperative IMN intervention on postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS) setting. Patients will prescribed with immunonutrition supplement before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Those who diagnosed with GC
2. Candidates for elective operation treatments

Exclusion Criteria:

1. Those are involved gastrointestinal tract (complication)
2. Those are diagnosed with GC (metastasis)
3. Allergy to milk/soy/whey protein
4. Participate in other intervention study
Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion

The purpose of this study is to determine the effects of a combined physiotherapy treatment (including vestibular rehabilitation and treatment for the cervical spine) in youth and young adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related concussion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sport-related concussion as per the Third International Consensus Guidelines
* Persistent symptoms (greater than 10 days) of dizziness, unsteadiness, neck pain and/or headaches reported on the Sport Concussion Assessment Tool 2 (SCAT2)
* Clinical examination findings suggesting vestibular and/or cervical spine involvement

Exclusion Criteria:

* Fracture, other neurological conditions, musculoskeletal injuries (other than the cervical spine) that restrict activity and medications that affect neural adaptation
Benzoylphenylurea in Treating Patients With Advanced Cancer

This phase I trial is studying the side effects and best dose of benzoylphenylurea in treating patients with advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy.

II. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral benzoylphenylurea weekly for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of benzoylphenylurea until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy

  * Metastatic or unresectable
  * No standard curative or palliative measures exist or are ineffective
* Brain metastases allowed provided 1 of the following criteria is met:

  * Lesions were previously treated with surgery, radiotherapy, or chemotherapy AND are currently asymptomatic AND no steroid therapy or antiseizure medication within the past 2 weeks
  * Untreated, asymptomatic metastases AND no requirement for steroid therapy or antiseizure medication
* Performance status - ECOG 0-2
* More than 12 weeks
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* SGOT/SGPT no greater than 2.5 times upper limit of normal
* Albumin at least 3.0 mg/dL
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* No prior allergic reactions to compounds of similar chemical or biologic composition to benzoylphenylurea
* No neuropathy greater than grade 1
* No other uncontrolled medical or psychiatric illness that would preclude study compliance
* No ongoing or active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prior immunotherapy allowed
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
* At least 2 weeks since steroids for CNS disease
* At least 4 weeks since prior radiotherapy and recovered
* Prior surgery allowed
* At least 2 weeks since antiseizure medications for CNS disease
* More than 7 days since prior CYP3A4 or CYP2D6 inhibitors
* More than 7 days since prior CYP3A4 inducers
* No concurrent CYP3A4 or CYP2D6 inhibitors
* No concurrent CYP3A4 inducers
* No other concurrent investigational agents
* No concurrent combination anti-retroviral therapy for HIV
The Long Term Impact of Bariatric Surgery on Quality of Life

The primary purpose of this study is to examine the breadth, nature, and factors affecting the long term changes in physical and psychological health and quality of life (QOL) following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey), postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes. Archival data available from patient medical records will also be gathered.

Information from existing databases and medical records will be used to obtain a list of phone numbers for persons who had roux-en-y bariatric surgery at the SVBCE five or more years ago at the St. Vincent Bariatric Center of Excellence (SVBCE. The interview includes scripts that the caller will use to recruit subjects in either direct conversation, in voice mail or by leaving a message. Recruitment will cease after 400 complete post pilot interviews are obtained.

The interview covers topics related to physical and psychological health and quality of life. The number of questions asked will vary from subject to subject since some questions are asked only if a prior question is answered affirmatively. For example, if a subject responds "yes" when asked "have you had plastic surgery?" the subject is then asked what type of procedure they had. The topics covered are as follows: weight, current health, post surgery complications, relationships, work, cross addiction, mental health, diet, television viewing, exercise, and life satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had surgery at least 5 years before the survey was administered.

Exclusion Criteria:

* Patients having bariatric surgery at facilities other than St. Vincent Bariatric Center.
* Patients who had bariatric surgery less than 5 years before the survey period.
Colchicine in Postoperative Fontan Patients

The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the inflammation in the chest tube drainage after the Fontan operation, and can decrease the amount of time that patients having this surgery will have drainage.


Eligibility Criteria:
Inclusion Criteria:

* Ages 20 months to 5 years and 364 days are eligible
* Diagnosed with single ventricle heart disease requiring Fontan palliation
* Undergoing Fontan palliation at the University of Michigan Congenital Heart Center
* Ability to take oral or enteral medication

Exclusion Criteria:

* Treatment with another investigational drug within 3 months
* Pre-existing myelosuppression or decreased bone marrow activity.
* Current or recent treatment with certain drugs
* Renal or hepatic impairment deemed by the study team
* Conditions and/or post-operative complications that would increase risk to the patient such as mechanical support (ECMO) or issues in the intensive care unit (ICU)