cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients

The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.

Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age).

Eligibility Criteria:
Inclusion Criteria:

* 2 thru 18 years of age
* referred for MRI of the liver or CNS
* if female and of child-bearing potential, must have negative pregnancy test within 24 hours of study drug administration
* if applicable, agree to use medically accepted method of contraception throughout the study
* if necessary, patients entering the PK subgroup must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration
* understand the requirements of the study and provide written consent to participate, agree to abide by the study requirements

Exclusion Criteria:

* previously entered into this study or a previous study using Optimark
* received investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period. (patients on a research protocol using an approved drug ar acceptable)
* medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance and all prescribed follow up
* known or suspected abnormal renal function for age or requiring dialysis during the study period
* pregnant or breastfeeding
* scheduled to undergo any contrast-enhanced examination within 7 days prior to baseline examination or during the course of this study period
* condition that is a contraindication to MRI (i.e., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other condition that would preclude patient proximity to a strong external magnetic field)
* experienced a previous hypersensitivity reaction to a gadolinium-based contrast agent
* recent history of hemolytic anemia, sickle cell anemia, or other hemoglobinopathy
* undergone a surgical procedure within one week prior to study admission or are planned to undergo a surgical procedure during study participation (central line placement is acceptable)
* history of significant claustrophobia
* weighs less than 25 lbs (11 kgs)
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial

The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.

The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Low risk pregnant women
* Pregnancy at term
* Women at low risk for assisted labor / delivery and postpartum care.
* Live Fetus

Exclusion Criteria:

* Women under 18, mentally handicapped and indigenous;
* Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps;
* Instrumental Delivery by forceps or c-section
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL

Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on a new treatment strategy with high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.

All patients with refractory and relapse lymphoblastic leukemia will receive a high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+ cyclophosphamide+etoposide. At day 7 after chemo, a bone marrow aspiration and MRD study by flow-cytometry is planned. For those patients with no residual blasts will undergo allogeneic stem cell transplantation with reduced intensity condiotning regimen consisting of 5-day fludarabine and 3-day busulfan and post-infusion cyclophophamide (D+3 and +4) as GVHD prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with refractory or relapse acute lymphoblastic leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse
* age 16-60 years with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA matched related (6/6), unrelated donors (8\~10/10) or haplo

Exclusion Criteria:

* liver function/renal function damage (over 2 X upper normal range)
* mental disease
Postoperative Anemia After Bariatric Surgery

To investigate the real incidence of short and long-term anemia after bariatric surgery, and explore the risk factors.

This study aims to investigate the real incidence of short and long-term anemia after bariatric surgery and explore the risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo sleeve gastrectomy or Roux-en-Y gastric bypass
* Aged between 16 and 70 years
* Patients who is not diagnosed as anemia at baseline

Exclusion Criteria:

* Patients who have anemia at baseline
Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease

This is a randomized, single-blinded, triple crossover study focused on determining the feasibility of using transcranial magnetic stimulation (TMS) for treatment of Parkinson's disease related autonomic dysfunction and depression. Participants will undergo TMS to three brain regions: medial prefrontal cortex (mPFC) (experimental site), dorsolateral prefrontal cortex (DLPFC) (alternative experimental site), or primary sensory cortex (S1) (control site) in a triple crossover design. Participants will complete symptom questionnaires, neurologic examination and cognitive assessments, and orthostatic vital signs recording before and after each brain stimulation session.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 50 and 90 years of age, without a diagnosis of severe dementia
* Carry a diagnosis of idiopathic Parkinson's disease based on the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria
* Have had symptoms of Parkinson's disease for at least 3 years
* Hospital's study-specific informed consent must be obtained
* Must have capacity to provide informed consent in English
* For female participants, confirmation that a menstrual period has not occurred in over 12 months, or that an effective form of contraception will be used during the study

Exclusion Criteria:

* Inability to provide informed consent.
* Severe dementia
* History of epilepsy or brain surgery
* Severe tremor or dyskinesia that would interfere with EEG as determined by the PI
* Parkinson's patients with clinically significant medical or neurological conditions which may be an alternative cause of orthostatic hypotension, such as neuropathy, renal failure, heart failure, cardiac arrhythmias, severe diabetes, or spinal cord injuries
* The investigators will exclude patients who are treated with medications which can significantly lower blood pressure or heart rate, such as antihypertensive medications, diuretics, and alpha-blocking medications
* Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS
* Presence of any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.
Wound Eversion Versus Planar Closure for Face or Neck Wounds

The aim of this study is to determine whether wound edge eversion, achieved by careful placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the head or neck.

It has been established that as wounds heal, the resultant tissue remodeling results in wound contracture. Surgeons are taught that by everting wounds' edges with well-placed dermal sutures, there is less depression of the resultant scar. A prior study conducted by us at this center found that wound eversion was not associated with better cosmetic outcome (1). However, it was noted that most of the procedures were performed off the head and neck, places where the effects of eversion were thought to be most beneficial (2) Thus our goal is to now study the effects of eversion exclusively on the face and neck.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure on the face or neck
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Pregnant Women
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II

The study is an initial non-blinded, non-placebo controlled trial to determine the efficacy of L-glutamine in lowering blood sugar in patients with diabetes mellitus type II without sickle cell anemia.

The protocol will consist of starting patients on 15 g of L glutamine twice daily by mouth. This is the same dose that is used to treat patient with sickle cell anemia. They will be given this medication for a total of 3 months. Their other medications will remain the same. At the conclusion of the 3 months, the patients will be taken off of the glutamine and will continue their other medications. The investigators will monitor the patients an additional 3 months (6 months after the initiation of the study) off the L-glutamine. In this manner, the investigators will have a washout period. The outcome will be a comparison of the results before the initiation of the L-glutamine, to the results after treatment, and after the washout.

Data analysis will consist of comparing the patient's fasting glucose and hemoglobin A1c values. The investigators will also check the levels of fructosamine. This is a standard test that is done in any clinical laboratory. To help determine the mechanism for the L-glutamine effect, the investigators will also measure the complete blood count, chemistry panel, hepatic function panel, urine micro-albumin, patients' weight, and waist circumference. The investigators will use the Student t-test for statistical analysis. Significance will be tested at the 0.05 level.

The investigators will collect demographic information on the patients in the study. Age, sex, duration of diabetes, smoking history, and race will be noted. The investigators will use regression analysis to determine whether these factors have any effects on the observed results.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of diabetes mellitus type II
* Patient of Straub Medical Center, Internal Medicine Clinic

Exclusion Criteria:

* Renal and liver impairment ( GFR less than 40)
* Transaminitis (elevation of AST of ALT more than 2 fold)
* Patient with sickle cell anemia
Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection

The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
* Be on the waiting list for lung resection by Video-assisted thoracic surgery
* Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted and/or Body Mass Index \> 30 or/and \>80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
* No smoking at the time of recruitment
* Signed Informed Consent

Exclusion Criteria:

* Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
* Thoracotomies or pneumonectomies.
Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.

For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.

But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.

So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.

Eligibility Criteria:
Inclusion Criteria:

* Dated and signed informed concent
* Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
* Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
* Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
* Age \>= 18 years
* Karnofsky index \> 60%
* Expected live span \> 12 weeks
* Sufficient bone marrow reserve: Granulocytes \>= 1.5 x 109/L and Platelets \>= 100 x 109/L and Hemoglobin \>= 9 g/L
* Serum Bilirubin \< 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
* AST/ALT \< 2.5 x upper normal limit

Exclusion Criteria:

* Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
* Pregnancy or lactation
* Patients able to reproduce that do not adhere to strict contraception
* Presence of brain metastasis
* Severe, uncontrolled infection
* Preexisting peripheral neuropathy \> grade I
* Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
* Justified disbelief in the compliance of the patient
* Parallel participation in another clinical trial
Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only.

After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both combined immunization group and individual vaccination groups will be compared and the data will be analyzed.

It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be implemented soon and the immunogenicity and safety studies should be conducted. In China according to the current vaccination schedule, the arrangement of Sabin-IPV and DTaP falls on the same date -- at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the feasibility of simultaneous immunization, we design this phase 4 clinical trial of simultaneous vaccination of the two vaccines.

To be specific, the subjects were divided into 3 groups. Group 1 : Sabin-IPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) are simultaneously administrated at 3,4,5 months old ; Group 2 : subjects receive 1 dose of sIPV only at 3,4,5 months old ; Group 3 : subjects receive 1 dose of DTaP only at 3,4,5 months old .

Blood samples would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedules will be monitored too.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 3 months old at the date of recruitment;
* with informed consent signed by parent(s) or guardians;
* parent(s) or guardians are able to attend all planned clinical appointments and
* obey and follow all study instructions;
* subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;

Exclusion Criteria:

* subject who has a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathy and neurological illness;
* allergic to any ingredient of vaccine or with allergy history to any vaccine;
* subjects with immunodeficiency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
* administration of immunoglobulins within 30 days prior to this study;
* acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
* have a clearly diagnosed history of thrombocytopenia or other coagulopathy,
* may cause contraindications for subcutaneous injection;
* any serious chronic illness, acute infectious diseases, or respiratory diseases;
* severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
* any kind of infectious, purulent, or allergic skin diseases;
* any other factor that makes the investigator determines the subject is unsuitable for this study.
ZD 1839 in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to die.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have metastatic kidney cancer.

OBJECTIVES: I. Determine the efficacy of ZD 1839 in patients with metastatic renal cell cancer. II. Determine the time to disease progression in patients treated with this drug. III. Determine the safety of this drug in these patients.

OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma Bidimensionally measurable disease Bone metastasis as only site must have at least 1 bidimensionally measurable tissue mass by CT or MRI (e.g., expansile lesion) Radiologic evidence of disease progression or symptoms related to disease No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: No prior malignancy within the past 5 years unless potentially curatively treated or deemed at low risk for recurrence Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No more than 1 prior biologic regimen No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior cytotoxic therapy and recovered No more than 1 prior cytotoxic regimen No concurrent cytotoxic therapy Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No more than 1 prior hormonal regimen No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery
Molecular Mechanism of Neutrophil Necroptosis and Its Roles in RA Pathogenesis

Neutrophils play a central role in innate immunity and are rapidly recruited to sites of infection and injury. Neutrophil apoptosis and necroptosis are essential for the inflammatory.This study is designed to investigate the cells and the molecular mechanisms of neutrophil necroptosis and apoptosis.

Necrosis has recently been demonstrated to be programmatic and energy comsuming, a process termed necroptosis.

In this project, the investigators aim to investigate the mechanisms and the effects ofneutrophil necroptosis and apoptosis: 1. to investigate the cells and the molecular mechanisms that induce neutrophil necroptosis or delay apoptosis, mainly focusing on the roles of HMGB-1,TNF-α and LPS, 2. to illustrate the effects of some molecules such as TLR, TNFR, RIP1/RIP3, Caspase8, ATP and ROS in the process of sigal transduction and membrane damage during necroptosis or apoptosis , 3. to identify the similarities and differences between traditional necrosis and necroptosis in the aspects of morphologigical changes and inflammatory cytokine release, 4. to find out the effects and mechanisms of neutrophil necroptosis or apoptosis in a rheumatoid arthritis mouse model and the therapeutic effect of blocking one or several pathways in the pathogenesis of rheumatoid arthritis.

This study will not only unravel the mechanisms of neutrophil necroptosis and apoptosis, elucidate its roles and significances in inflammation and infection, but also shed new light on anti-inflammatory and anti-infection therapy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* age 18-65.

Exclusion Criteria:

* Don't agree with informed consent