cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.

OBJECTIVES:

I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma.

PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived either from peripheral monocytes or CD34+ cells.

Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion, and are administered intralymphatically in the lower extremities for the first 2 courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in the anterior thigh. Dendritic cells are not administered to any extremity that has undergone lymph node dissection.

Patients are randomized to the following treatment arms:

Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Patients are followed at 4 to 6 weeks.

PROJECTED ACCRUAL:

A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes positive) OR completely resected metastatic melanoma within 6 months of surgery Disease free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active systemic infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative
Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study

This study aims to investigate the orofacial dysfunction in children who are subjected to passive smoking and to correlate its results to their saliva cotinine levels

The participants will be recruited from the pedodontics outpatient clinic in the, Faculty of Oral and Dental Medicine, Ahram Canadian University, Egypt. The aim and the steps of the study will be explained to the guardian.

After obtaining the informed consent, the investigator will fill an administrative questionnaire, which includes parents and child's personal data, medical and dental history, a question inquiring if one of the parents smokes in the house, the frequency of smoking, smoking type, and number of cigarettes (if present).

Then, the examination of orofacial dysfunction will be evaluated by the investigator, using Nordic Orofacial Test - screen (NOT-S)

Eligibility Criteria:
Inclusion Criteria:

* Children who are free from any systematic disease, or genetic disorders that
* Children whose families accept to participate in this study.

Exclusion Criteria:

* Children whose parents quit smoking after the child was born.
Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series

Furcation involvement represents a challenge for treatment to many periodontists due to many factors including access, morphology, and variations of anatomical features of the furcation area. Furcation involvement treatment includes non-surgical periodontal therapy, resective surgery and regenerative surgery, regenerative therapy utilizing different graft materials and membranes is of high cost and research for new materials that can be cost-effective and available for all patients is continuing, propolis have been shown to be cost-effective therapy for bone and wound healing.

Propolis is a natural resinous product of the bee workers collected from trees to use it to stick their hives and form a coat to protect their hives from all sources of bacteria and invasions. Propolis is composed of more than 300 compounds, the most important of them are flavonoids like CAPE (caffeic acid phenyl ester). Propolis have shown anti-inflammatory, anti-oxidant, anti-bacterial, anti-fungal, anti-viral and more importantly regenerative effect and bone formation capabilities.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. Lower molars with class II furcation defects.
  2. Full mouth plaque score (FMPS )\<20% at baseline.
  3. Full mouth bleeding score (FMBS )\<10% at baseline.
  4. Systemically healthy.
  5. Cooperative patients.

Exclusion Criteria:

* Exclusion criteria:

  1. Smokers.
  2. Pregnancy and lactation.
  3. Stage 4 Grade C periodontitis.
A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be hospitalized with hematologic malignancy treated by myelosuppressive therapy and/or Hematopoietic stem cell transplantation
* Participant must have a diagnosis of neutropenia with neutrophil count \< 500/microliters (mcL) (0.5 × 10\^9/ liters \[L\]) for at least 96 hours at screening
* Participant must have a diagnosis of fever and meet the following criteria: 1) Oral/rectal temperature greater than or equal to (\>=) 38 degree celsius or axillary temperature (\>=) 37.5 degree celsius and is not considered related to blood products transfusion or drug fever, 2) Not responding to broad-spectrum gram-positive and gram-negative antibiotics for 4-7 days with or without signs and symptoms that potentially attributable to deep fungal infection and 3) Defervescence within 3 days after the first broad-spectrum antibiotics but recurrence afterwards.
* A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[b hCG\]) and pregnancy test at screening
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study period and until the menstrual period following the end of study treatment

Exclusion Criteria:

* Is concomitantly using other systematic antifungal drugs as empirical treatment
* Has evidence of inadequately managed bacterial infection
* Is currently receiving any Cytochrome P450 3A4 (CYP3A4)-metabolized/P-glycoprotein-transported drugs (including but not limited to cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, terfenadine, astemizole, mizolastine, bepridil, sertindole, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase) inhibitor \[for example, simvastatin, lovastatin\], oral midazolam, triazolam, ergot alkaloids \[eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine\] and nisoldipine) that should be prohibited in this study
* Has known allergy, intolerance or hypersensitivity to azole and echinocandin antifungals or its excipients
* Has a contraindication to the use of sodium chloride injection
Probiotic Chocolate Study in Multiple Sclerosis

The goal of this study is to assess the effects of probiotics on persons with multiple sclerosis (MS), persons at higher genetic risk for MS (first degree family members of persons with MS), and healthy controls. Participants will be asked to consume probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum per day) for 6 weeks. Participants will undergo blood draws before and after the 6 weeks of probiotic containing chocolate and microbial metabolites and immune markers will be compared before and after the probiotics, as well as between groups.

The goal of this study is to assess the effects of probiotics in persons with MS (PwMS), persons at high genetic risk for MS (first degree family members of PwMS), and healthy controls. PwMS. Subjects undergo blood draws and will complete surveys on neurological symptoms (as relevant). Subjects are given a supply of individually wrapped probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains) along with instructions on proper storage, dosage, and a diary to complete regarding supplement adherence. After a "ramp up" period of 3 days during which participants will consume take 2 chocolates per day, participants consume 5 chocolates per day (10 billion CFUs of bifidobacterium longum per day) for 6 weeks. After 6 weeks participants return the adherence diaries and answer questions about probiotic tolerance. They also repeat similar surveys and again undergo blood draws. Serum levels of microbial metabolites and peripheral blood immune profiles are assessed before and after supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls
* Age 18-45

Exclusion Criteria:

* diabetes
* tree nut allergy
* pregnancy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP)


Eligibility Criteria:
Key Inclusion Criteria:

* Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics.
* Evidence of pyuria, confirmed by either of the following:

  * A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or
  * A urine specimen with either \> 10 white blood cells (WBCs) per microliter from an unspun urine or \> 5WBCs per high power field from a centrifuged specimen
* Symptomatic or asymptomatic cUTI or AP as specified in the protocol.

  * Acute Pyelonephritis (qualifying symptoms specified in protocol)
* Have a pretreatment "baseline" urine specimen obtained for culture by an acceptable method, including suprapubic aspiration (SPA), clean urethral catheterization, in dwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from externally placed urine bags will not be allowed) within 48 hours before the start of the administration of the first dose of IV study drug therapy.
* Must, based on the judgment of the Investigator, require hospitalization initially and 7 to14 days of antibacterial therapy for the treatment of the presumed cUTI.

Key Exclusion Criteria:

* History of hypersensitivity or allergic reaction to beta-lactam antibiotics (for example \[e.g.\],cephalosporins, penicillins, carbapenems, monobactams).
* Known Vabomere-resistant gram-negative organism from study-qualifying urine or blood culture, confirmed cUTI or AP only due to gram-positive organism from study-qualifying urine or blood culture, or known or suspected infection with organisms that are not adequately covered by Vabomere (e.g., viral, mycobacterial, fungal).
* Receipt of a potentially effective antibacterial drug therapy for cUTI for a duration of more than 24 hours during the previous 72 hours prior to enrollment. Exceptions: participants with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms); urine culture confirms resistance to the initial antibiotic; or the participant developed signs and symptoms of cUTI or AP while on antibiotics for another indication.
* Participants undergoing dialysis or with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2, as calculated using the updated bedside Schwartz formula.
* Evidence of significant hepatic disease or dysfunction, including known acute viral or inactive chronic hepatitis or hepatic encephalopathy, or aspartate aminotransferase or alanine aminotransferase \> 3 × upper limit normal (ULN), or total bilirubin \> 1.5 × ULN.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

This is a cluster-randomized trial of nursing homes to assess whether decolonization with routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant organism (MDRO) prevalence. The comparator arm will be routine bathing care.


Eligibility Criteria:
Inclusion Criteria

Nursing homes will be eligible to participate if they meet the following criteria:

* Licensed nursing home in Orange County or Southern Los Angeles County serving adults
* Minimal use of chlorhexidine bathing\*
* Minimal use of nasal decolonization\* \*Minimal use defined as \<15% of residents receiving at least one chlorhexidine bath or nasal decolonization treatment during their nursing home stay.

Exclusion Criteria

Nursing homes will not be eligible to participate if they meet the following criteria:

* Facilities routinely using decolonization
* Dedicated psychiatric nursing homes
* Facilities with a resident population with \>=20% combative patients
* Pediatric facilities

Note: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded
Allogeneic Transplantation For Severe Osteopetrosis

The purpose of this research is to explore what we believe may be a safer and more effective means of performing stem cell transplantation in patients with Osteopetrosis, using chemotherapy and radiation designed to bring about engraftment and lessen transplant mortality. Prior multi-institutional data in past studies found that approximately 30% of Osteopetrosis patients do not engraft. Therefore, in this study, we utilize a reduced intensity design of pre-transplant drugs to try to make transplants safer for this disease, as well as to provide a second infusion of stem cells in patients with matched related or unrelated donors.

This revised transplant protocol will test the following: 1) the ability to achieve engraftment with the reduced intensity protocol and a second infusion of stem cells on day 42, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based on differential imaging and biologic evaluations prior to transplantation and at designated points after transplantation (day 100, 6 months, 1, 2 and 5 years). Additional biologic studies will include microarray analysis, and evaluation of blood parameters and genes that may be important in the disease process. In older patients, studies to evaluation osteoclast differentiation and function will also be offered.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for transplantation under this protocol will be \< or = 45 years of age, and will be diagnosed with severe osteopetrosis. This will be defined as having the following manifestations of the disease.

  1. Bones that are uniformly markedly dense based on skeletal survey
  2. No history that would suggest autosomal dominant inheritance
  3. Evidence of hematologic changes that are attributed to the underlying disease, including
* the need for ongoing transfusions, OR
* the presence of progressive anemia or thrombocytopenia, OR
* a white blood cell differential with a predominance of immature forms and evidence of extramedullary hematopoiesis, OR
* persistence of serious infectious complications that are thought to be due to the abnormal architecture of the bone that are resistant to surgical and medical interventions.

Exclusion Criteria:

* Patients \>45 years of age
* Evidence of hepatic failure
* Pulmonary dysfunction sufficient to significantly increase the risk of transplant.
* Renal dysfunction with glomerular filtration rate (GFR) \<30% of predicted.
* Cardiac compromise sufficient to substantially increase the risk of transplantation
* Severe, stable neurologic impairment.
* Human immunodeficiency virus (HIV) positivity.
* Pregnant or lactating females
Chloroquine Diphosphate for the Treatment of Severe Acute Respiratory Syndrome Secondary to SARS-CoV2

In December 2019, the Municipal Health Committee of Wuhan, China, identified an outbreak of viral pneumonia of unknown cause. This new coronavirus was called SARS-CoV-2 and the disease caused by that virus, COVID-19. Recent numbers show that 222,643 infections have been diagnosed with 9115 deaths, worldwide. Currently, there are no approved therapeutic agents available for coronaviruses. In this scenario, the situation of a global public health emergency and evidence about the potential positive effect of chloroquine (CQ) in most coronaviruses, including SARS-CoV-1, and recent data on small trials on SARS-CoV-2, the investigators intend to investigate the efficacy and the safety of CQ diphosphate in the treatment of hospitalized patients with severe acute respiratory syndrome in the scenario of SARS-CoV2. Preliminary in vitro studies and uncontrolled trials with low number of patients of CQ repositioning in the treatment of COVID-19 have been encouraging. The main hypothesis is that CQ diphosphate will reduce mortality in 50% in those with severe acute respiratory syndrome infected by the SARS-COV2. Therefore, the main objective is to assess whether the use of chloroquine diphosphate reduces mortality by 50% in the study population. The primary outcome is mortality in day 28 of follow-up. According to local contingency plan, developed by local government for COVID-19 in the State of Amazonas, the Hospital Pronto-Socorro Delphina Aziz, located in Manaus, is the reference unit for the admission of serious cases of the new virus. The unit currently has 50 ICU beds, with the possibility of expanding to 335 beds, if needed. The hospital also has trained multiprofessional human resources and adequate infrastructure. In total, 440 participants (220 per arm) will receive either high dose chloroquine 600 mg bid regime (4x150 mg tablets, every 12 hours, D1-D10) or low dose chloroquine 450mg bid regime (3x150mg tablets + 1 placebo tablet every 12 hours on D1, 3x150mg tablets + 1 placebo followed by 4 placebo tablets 12h later from D2 to D5, and 4 placebo tablets every 12 hours, D6-D10). Placebo tablets were used to standardize treatment duration and blind research team and patients. All drugs administered orally (or via nasogastric tube in case of orotracheal intubation). Both intervention and placebo drugs will be produced by Farmanguinhos. Clinical and laboratory data during hospitalization will be used to assess efficacy and safety outcomes.


Eligibility Criteria:
Inclusion criteria:

1. Male and female participants aged over 18 years old
2. Hospitalized
3. presenting:

   * respiratory rate higher than 24 breathing incursions per minute AND/OR
   * heart rate higher than 125 beats per minute (in the absence of fever) AND/OR
   * peripheral oxygen saturation lower than 90% in ambient air AND/OR
   * shock (defined as mean arterial pressure less than 65 mmHg, requiring vasopressor or oliguria or lowering level of consciousness)

Exclusion Criteria:

• None.
Multifactorial Evaluation of COVID-19 Respiratory Reliquates

The present study aims to evaluate how commonly diagnostic tools employed in the preoperative evaluation of respiratory function in thoracic surgery can identify pathological alteration due to a previous SARS-CoV-2 infection. In particular, the investigators will gather information concerning imaging (lung ct and lung ultrasound), arterial blood gas analysis, and pulmonary function tests.


Eligibility Criteria:
Inclusion Criteria:

* previous SARS-Cov2 infection
* awaiting lung resection surgery

Exclusion Criteria:

* less than 18 years of age
* unable to consent to enroll
* refuse to enroll
Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors

The intended study is designed as a prospective randomized controlled trial (RCT), comparing and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum anchorage by retracting the maxillary incisors.

The objective of the clinical study proposal will be to investigate the performance of early root resorption in order to find out if the magnitude and direction of retraction is appropriate for the retraction of maxillary incisors following the mini-screw anchorage.

Therefore, the study will compare and contrast the efficacy and results of the volumetric measurement by CBCT.

Patients

Males or females whose diagnoses require implant anchorage treatment will be included in the study. Inclusion criteria for the study are as followings:

Orthodontic indication for skeletal anchorage Adequate bone quantity for a palatal implant in the CBCT Good oral hygiene and normal wound healing capacity

Eligibility Criteria:
Inclusion Criteria:

* Orthodontic indication for skeletal anchorage
* Adequate bone quantity for a palatal implant in the CBCT
* Good oral hygiene and normal wound healing capacity

Exclusion Criteria:

* Patients with cheilognathopalatoschisis and other system syndromes associated with craniofacial anomalies
* Patients with immunodeficiency, diseases requiring a prolonged steroid usage, previous radiation therapy or chemotherapy
* Patients with metabolic bone diseases or uncontrolled endocrine disorders
* Alcohol or drug abuse
* Pregnancy
Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation

Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.

Aims are to measure Macrophage Migration Inhibitory Factor, Macrophage Migration Inhibitory Factor II and its' soluble receptor CD74 in serum, liver graft effluent and urine in and evaluate MIF's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.

Eligibility Criteria:
Inclusion Criteria:

* End stage liver disease, chronic liver failure, orthotopic liver transplantation

Exclusion Criteria:

* Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure