cyrilzakka/clinical-trials huggingface dataset:
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Objectives:

1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
* Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
* Stem cell or marrow donor willing to have apheresis for T-Cell collection.
* Written voluntary informed consent must be obtained from patient and donor.

Exclusion Criteria:

* Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
* AML French-American-British (FAB) subtype M3.
Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap

To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.

Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients dialyzing with a central venous catheter

Exclusion Criteria:

* Known allergy to chlorhexidine
Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

This trial is being conducted to determine the impact of whole body FDG PET-CT vs. conventional staging in the management of patients presenting with clinical Stage III breast cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen \& pelvis and a bone scan.


Eligibility Criteria:
Inclusion Criteria:

* Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned.
* Based on clinical information (physical exam, imaging):

  1. Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or
  2. Stage IIb breast cancer (T3N0), Note: T2N1 is not eligible
* Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent.

Exclusion Criteria:

* Age \< 18 years,
* ECOG performance status \> and = 3,
* Prior systemic therapy (e.g. neo-adjuvant chemotherapy or hormonal therapy) for current breast cancer,
* Previous staging investigations for current breast cancer,
* Breast cancer with primary histological subtypes other than ductal or lobular (Note: Patients with mixed disease will be eligible for randomization),
* Clinical suspicion of metastatic disease,
* Relative contraindications to PET (e.g. uncontrolled diabetes (i.e. inability to decrease serum glucose below 10.2 mmol/L), claustrophobia, inability to be still for 30 minutes),
* Inability to lie supine for imaging with PET-CT,
* Inability to undergo CT because of known allergy to contrast,
* History of another invasive malignancy within the previous two years (exception of non melanoma skin cancer) or a synchronous primary cancer, including a synchronous contralateral breast cancer (Note: Patients found to have a contralateral breast cancer on study imaging following randomization will remain in the study),
* Known pregnancy or lactating female,
* Inability to complete the study or required follow-up.
The Effects of Nicotine Chewing Gum in Parkinson's Disease

The objective of this experiment is:

To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.

Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes.

After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicorette™). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of PD
* a diastolic BP less than 90 mmHg
* and/or a systolic BP lower than 100mHg.

Exclusion Criteria:

* current tobacco users in all forms of tobacco
* severe dysphasia (difficulty swallowing)
* previous tobacco users who might be at risk for re-addiction.
Photodynamic and Pharmacologic Treatment of CNV

The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.


Eligibility Criteria:
Inclusion Criteria:

* All previously untreated CNV secondary to MD
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction

The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid peroxidation and isoprostane formation during reperfusion after percutaneous revascularization for acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

- Patients presenting with STEMI

Exclusion Criteria:

* Duration of symptoms \> 12 hours
* Suspected LM or proximal LAD occlusion (based on EKG interpretation)
* Hemodynamic instability
* Acetaminophen use in prior 24 hours
* Use of dipyridamole, or Aggrenox, a formulation of aspirin and extended-release dipyridamole, within 48 hours
* Current use of the following medications: phenytoin, valproic acid, phenobarbital, topiramate, rifampin, carbamazepine, cyclophosphamide, ritonavir, efavirenz, St. John's Wort
* Chronic heavy alcohol use
* Chronic liver disease (other than non-alcoholic fatty liver infiltration)
* Severe valvular heart disease
* Stroke in the past 60 days
* Active major bleeding
* Major surgery in the past 30 days
* Ongoing treatment for active malignancy
* Life expectancy less than 12 months as determined by the patient's attending physician
* Pregnancy
* asthma or severe COPD
* active wheezing on presentation
* allergy or prior adverse reaction to adenosine
Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion

The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.

Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
* Surgery more than 2 years
* Able to walk, climb stairs

Exclusion Criteria:

* Knee stiffness with less than 100 degrees of knee range of movement
* Patients who required revision surgery
* Patients who received an all polyethylene tibial insert
* Patients who received rotating platform tibial tray
Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx)

This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.


Eligibility Criteria:
Inclusion Criteria:

* ICGCT including pure germinoma and MMGCT.
* Patients with histologically proven germinoma and MMGCT, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study.
* Patients with mature/immature teratoma who have tumor marker elevations are eligible on this study.
* Patient with ONLY mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations.

Exclusion Criteria:

* Patients with ICGCTs who are newly diagnosed are excluded from the study.
* Patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study.
* Patients who are pregnant or breastfeeding are excluded from the study.
* Patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study.
* Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study.
Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis.

This is recognized nationally and internationally as the study that will answer the question as to which of these is the best treatment for decompression of varices in patients who have failed endoscopic and pharmacologic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Variceal bleeding secondary to cirrhosis and portal hypertension
* Child's Class A or B cirrhosis of any etiology
* Patients who have failed endoscopic therapy (sclerotherapy or banding) of varices; or patients who are not candidates for endoscopic therapy

Exclusion Criteria:

* Prior shunt procedure
* Portal vein thrombosis
* Polycystic liver disease
* Intractable ascites
* Prior organ transplant
* Any medical intractable disease
Laryngoscope Force During Suspension for Adenotonsillectomy

Suspension laryngoscopy is a common procedure during adenoteonsillectomy (removal of adenoids and tonsils), that consists of extending the patient's neck to allow better visualization of the tonsils. Previous studies on suspension larygnoscopy have shown that the time to maximum force during this procedure predicts complications such as pain, tounge swelling and opioid requirements. Moreover, monitoring these force during laparoscopy can reduce postoperative complications. However, no study to date has investigated the force metrics during suspension laryngoscopy in the pediatric population. Therefore, in this study, the investigators aim to evaluate the relationship of force metrics during adenotonsillectomy, adenoidectomy or tonsillectomy and postoperative pain.

Adenotonsillectomy is the most common surgery performed in North America (annual caseload in the United States 500,000). This procedure is performed with suspension laryngoscopy (SL), which consists in the extension of the patient's neck and concomitant lifting of the anterior oropharynx structures to allow direct visualization of the tonsils.

In adults undergoing microlaryngoscopy, the time maximum force recorded during suspension was a significant predictive variable for the development of postoperative complications such as tongue edema, pain and narcotic requirements. Force metrics during laryngoscopy vary significantly among different surgical procedures. Active intraoperative monitoring of force metrics has been shown to reduce postoperative complications in adults. Moreover, in adult cadaveric models, spinal cord compression associated with cord injury may be directly correlated with the force applied during laryngoscopy5,6. In patients with cervical instability, such as patients with Trisomy, adenotonsillectomy carries a significant risk of spinal injury, as laryngoscopy may result in C1-C2 subluxation.

To date, no data exist on force metric during suspension laryngoscopy children. The primary aim of this study is to investigate the relationship of force metrics during adenotonsillectomy, adenoidectomy or tonsillectomy and postoperative pain.

The secondary aim is to describe the force metrics in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Children ≤ 18 years old undergoing adenotonsillectomy, adenoidectomy or tonsillectomy
* Only patients whose parents are fluent in French or English will be enrolled

Exclusion Criteria:

* Any contraindication to suspension laryngoscopy
* Patient/legal guardian refusal.
Quality of Life and Body Image in Women Underwent Thighplasty

Obesity is a chronic disease now considered a major public health concern in the global context, as it causes or exacerbates many diseases limitations in providing quality of life and higher treatment costs. The increase in the number of patients undergoing bariatric surgery and the excess skin and subcutaneous tissue adjacent to slimming collaborate in the search for growth by plastic surgery. Currently several techniques of thighplasty has been submitted but no studies were found that evaluated the characteristic clinical and emotional resulting from this procedure. This study has as a goal to evaluate the body image and quality of life in women submitted to thighplasty.

The patients have been evaluated for two different questionnaires, the Body Dysmorphic Disorder Examination (BDDE) and Impact Weight on Quality of Life - Lite (IWQoL-Lite). The sample consists of 50 patients with the desire to undergo to the thighplasty. However 25 are from study group and 25 control group. Just the study group was undergoing plastic surgery. The questionnaires have applied by signing the consent form, after 3 and 6 months both groups. This study is a clinical trial, control, primary, longitudinal, no random, analytical, held in a single center.

Eligibility Criteria:
Inclusion Criteria:

* abdominoplasty previous
* control of systemic disease
* Adults at the age of 35 and 50 years old
* had reached massive weight loss less by bariatric surgery or similar than 30 kg/m2 for a minimum of 12 months or more.
* gender: female
* For control group: it supposed to be on the waiting list for thighplasty
* For study group:they are supposed to be scheduled for thighplasty

Exclusion Criteria:

* illiterate
* pregnant women and/or women who have been nursing for one year or less
* non-controled of systemic disease
Rapid Move Following Outpatient Surgery: Safety and Patient Characteristics

A descriptive, retrospective cohort study will be conducted to gain insight in the safety of the Rapid Move. The trial will include a group of Rapid Move patients, who were transferred to the Rapid Move after their outpatient surgery and subsequently discharged home. The Rapid Move is a short-stay PACU where patients recover from anaesthesia, are continuously monitored, and prepared for discharge within an hour after surgery.

The Rapid Move, a short-stay PACU unit, was implemented at General Hospital Maria Middelares in Ghent, Belgium. The Rapid Move is designed to alleviate the bottleneck in the day surgery unit. Overcrowding in the PACU, caused by limited space in the day surgery unit, resulted in delays in patient discharge despite patients meeting discharge criteria. The Rapid Move is designed for brief, intensive follow-up care, similar to the PACU, with continuous monitoring and a nurse-to-patient ratio of 2:9. An analysis of the occupancy rate of the PACU and the Rapid Move indicates that, despite overcrowding in the PACU, the Rapid Move is still underutilised. Despite the extensive research on PACU bypassing, to our knowledge, no research has been conducted on the safety of the Rapid Move, a short-stay PACU where patients recover from anaesthesia, are continuously monitored and prepared for discharge within an hour after surgery. The aim of this retrospective cohort study is to gain insight in the safety of the Rapid Move as an alternative postoperative pathway for outpatients.

Furthermore, the underutilisation of the Rapid Move, despite the overcrowding of the PACU, has highlighted the need to develop a patient profile of eligible patients for the Rapid Move, with the intention to expand the selection criteria for the Rapid Move and optimise its capacity.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 15 years or older;
* Patients who went to the Rapid Move after their outpatient procedure. Eligible procedures are: gastroscopy, coloscopy, vasectomy, scrotal surgery, circumcision or other minor penile surgery, intravesical Botox, insertion or removal of eardrum tubes in adults, sinus irrigation in adults, sleep endoscopy, bronchoscopy, removal of osteosynthetic material in the lower leg and foot, and tooth extraction (including wisdom teeth) and upper-forearm orthopedic surgery (excluding prosthetic surgery).

Exclusion Criteria:

* Inpatients defined as a patient who is formally admitted (or "hospitalized") to an institution for treatment and/or care and stays for a minimum of one night in the hospital or other institution providing inpatient care;
* Patients undergoing emergency procedures.
Brain Blood Flow Studies of Language and Memory

Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.

When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.

This study is designed to use positron emission tomography (PET) with radioactive water (H215O) to determine the areas of the brain associated with memory and language. Patients participating in the study will be made up of normal volunteers, patients with epilepsy, and patients with other abnormalities related to the surface of the brain (non-epileptic focal cortical dysfunctions).

This protocol will use positron emission tomography (PET) with H2015 and functional MRI to examine localization of memory and language in normal control subjects, and patients with localization-related epilepsy.

Eligibility Criteria:
INCLUSION CRITERIA:

Normal Volunteers:

The desired age range is 18 to 55 years.

Subjects will have no history of head injury or other neurological disease and must not be taking any medication.

Female subjects of childbearing potential will be administered a pregnancy test; these subjects will not be eligible for the study requiring 2 scans.

All volunteers will read and sign the consent form.

Patients:

Patients will be selected from among those referred to the Clinical Epilepsy Section, NINDS for evaluation.

EXCLUSION CRITERIA:

Patients with evidence of a progressive intracranial process, who are taking any drugs (except AEDs) that might affect the results, or active systemic disease will be excluded.
Clinical and Genetic Influencing Factors on Clozapine Pharmacokinetics

Clozapine (Clz), an atypical antipsychotic, is the reference medication for patients with treatment-resistant schizophrenia. Due to the high inter-individual variability of its pharmacokinetics and its narrow therapeutic index, a close therapeutic drug monitoring (TDM) of Clz is highly recommended.

Several factors can cause a variation in the pharmacokinetics as age, smoking habits, coffee consumption and drug interaction. Genetic factors related to hepatic expression levels of the cytochrome P450 (CYP), regulate the hepatic clearance of Clz, thereby determine its bioavailability.

The CYP1A2 and CYP2C19 isoenzymes are mainly responsible for the metabolism of several drugs including Clz. It has been demonstrated that there is an interethnic variation in the expression and function of these two isoenzymes. This variation is caused by single nucleotide polymorphisms (SNPs) of genes encoding these proteins.

While the Influence of the different polymorphisms related to CYP1A2 and CYP2C19 have been established especially in Asian and Caucasian populations, no study has examined the impact of these SNPs in the southern Mediterranean populations. Moreover, the impact of these SNPs is very controversial. The present study aims to investigate in Tunisian schizophrenic patients, the influence of genetic (CYP1A2 and CYP2C19 polymorphisms) and non-genetic factors on Clz pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic patients receiving clozapine
* Good adherence to the treatment (clozapine)

Exclusion Criteria:

* Patients who were co-prescribed drugs that affected the pharmacokinetics of Clozapine.
* Patients who presented gastrointestinal disorders disturbing absorption of clozapine.
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)

The aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.


Eligibility Criteria:
(main) Inclusion Criteria:

* age 18 - 75 years at screening
* ability to give written consent, informed written consent
* negative pregnancy test at screening
* therapy-refractory Myasthenia Gravis (generalized) or Systemic Lupus Erythematosus or Rheumatoid Arthritis

(main) Exclusion Criteria:

* Belimumab therapy within the last 6 months
* B-cell-depletion therapy within the last 9 months
* heart or kidney insufficiency
* known intolerability to Bortezomib
* participation in another interventional trial within the last 3 months
* liver cirrhosis
* preexistent sensory or motor polyneuropathy ≥ degree 2 (NCI CTC AE criteria), within 14 days before screening
* hints on clinically apparent herpes zoster reactivation
* active systemic infection, or viral infection (CMV, EBV) within last 6 month before screening
* serologically active hepatitis B and /or C, known HIV infection
* tumor disease currently or within last 5 years
* clinically relevant liver, kidney or bone marrow function disorder
* pregnancy or lactation