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US Clinical Trial NCT03972436 – NIH – May 31, 2019

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase Ib/IIa Trial With Expansion Cohorts in Melanoma and Soft Tissue Sarcoma Patients.

Despite constant progress in the treatment of patients with advanced solid tumors failing standard systemic treatment, there is still a high unmet medical need to develop new active anticancer drugs or therapies. Although patients with advanced mela...
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US Clinical Trial NCT03805867 – NIH – Jan 13, 2019

Evaluation of the Contribution of Candesartan in the Prevention of Vincristine-induced Peripheral Neuropathies (VINP) in Patients Treated for B-cell Lymphoma. Randomized Phase II Study

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US Clinical Trial NCT00330772 – NIH – May 26, 2006

Pilot Study of Preoperative Aspirin and Postoperative Clopidogrel's Effects on Graft Patency and Cardiac Events in Coronary Artery Bypass Surgery

BACKGROUND: Platelets play a central role in the pathogenesis of ischemic complications (coronary artery bypass graft occlusion, myocardial infarction, stroke) following CABG surgery. Aspirin and clopidogrel used alone or in combination are effectiv...
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US Clinical Trial NCT00330837 – NIH – May 26, 2006

Ultrasound Scanning of Vascular Access Sites

Inadvertent puncture of an unintended object in a vascular access procedure is common and can lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while targeting the internal jugular vein (IJV), for example, is reported to...
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US Clinical Trial NCT00330850 – NIH – May 26, 2006

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US Clinical Trial NCT00330902 – NIH – May 25, 2006

Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan

104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ...
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US Clinical Trial NCT00330967 – NIH – May 26, 2006

Mechanisms of Insulin Resistance in Humans

Insulin resistance in skeletal muscle is a characteristic abnormality in obesity and the metabolic syndrome and a major factor responsible for the development of type 2 diabetes. Although the mechanisms responsible for muscle insulin resistance are...
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US Clinical Trial NCT00331019 – NIH – May 26, 2006

Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study

Early Onset Group B Strep (GBS) neonatal infections is one of the leading infections in newborns, nearly all of which are acquired by vertical transmission at the time of childbirth. Most cases can be prevented by identifying women who are colonized...
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US Clinical Trial NCT00331110 – NIH – May 26, 2006

Immediate and Short-Term Analgesic and Biomechanical Effects of a Laterally Wedged Insole With Ankle Strapping for Medial Compartment Knee Osteoarthritis

Osteoarthritis (OA) of the knee is a common cause of pain and disability and the medial compartment is involved most frequently. If conservative mechanical therapies could reduce knee OA symptoms, risks to patients might be minimized through reducti...
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US Clinical Trial NCT00331123 – NIH – May 26, 2006

Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy.

Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 52-week, multicenter, multinational study that included a 24-week, double-blind (DB), parallel-group, place...
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US Clinical Trial NCT00331162 – NIH – May 26, 2006

Alemtuzumab Versus Thymoglobulin Induction Therapy in Kidney and Pancreas Transplantation

Anti-Thymocyte Globulin, rabbit (r-ATG, Thymoglobulin®) is a polyclonal antibody against T-lymphocytes that is used for the prevention and treatment of acute allograft rejection. r-ATG induction therapy is effective in preventing acute allograft rej...
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US Clinical Trial NCT00331201 – NIH – May 25, 2006

SAFEstart Treatment for NICU Patients With Feeding Intolerance; a Phase II Randomized, Controlled Trial

Feeding intolerance is relatively common in the NICU. It can manifest as emesis, diarrhea, increased abdominal girth (bloating), or in the most severe cases as necrotizing enterocolitis. Feeding intolerance complicates the hospitalization, lengthens...
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US Clinical Trial NCT00331227 – NIH – May 26, 2006

Effect of Supplemental Flavonoids on Endothelial Function, Lipids, and Markers of Inflammation

We propose to use a supplement made by NutraMetrix (called OPC-3), consisting of oligomeric proanthocyanidins derived from grape seed, pine bark, bilberry, citrus and red wine extracts, to determine effects on endothelial function, lipoproteins and...
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US Clinical Trial NCT00331253 – NIH – May 26, 2006

A 54-WEEK, PHASE 2, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INDOCYANINE GREEN-MEDIATED PHOTOTHROMBOSIS (i-MP) FOR THE TREATMENT OF PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

Comparative, controlled, multicenter, masked, randomized study, three parallel groups, comparing the Indocyanine Green-Mediated Photothrombosis to two control groups, for the treatment of neovascular Age-Related Macular Degeneration. Only patients...
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US Clinical Trial NCT00331279 – NIH – May 25, 2006

The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study

Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious con...
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US Clinical Trial NCT00331448 – NIH – May 30, 2006

Fat Redistribution and Metabolic Change in HIV Infection (FRAM)

Changes in the amount of fat and how that fat was distributed were reported after the introduction of antiretroviral therapy (ART) for HIV infected patients. Increases in diabetes, heart disease, and blood levels of glucose and fats have also been r...
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US Clinical Trial NCT00331474 – NIH – May 30, 2006

The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants

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US Clinical Trial NCT00331526 – NIH – May 30, 2006

Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes

OBJECTIVES: - Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme. - Determ...
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US Clinical Trial NCT00331552 – NIH – May 30, 2006

Phase I - II Study of Doxil® In Combination With Daily Oral Cyclophosphamide and Herceptin for Patients With HER-2/Neu Positive Disease In Patients With Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine the optimal tolerated dose of Doxil when given in combination with daily oral cyclophosphamide in patients with stage IV breast cancer. (Phase I) II. To determine the efficacy (overall clinical response rate) of t...
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US Clinical Trial NCT00331630 – NIH – May 30, 2006

Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)

OBJECTIVES: Primary - Determine the clinical response rate, as measured by clinical exam and imaging studies, in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combination with lapatinib. Secondary - Determine the p...
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US Clinical Trial NCT00331643 – NIH – May 30, 2006

Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults With Refractory Solid Tumors

PRIMARY OBJECTIVES: I. Determine the response rate to ixabepilone in various strata of recurrent solid malignant tumors of childhood and young adulthood, including all of the following: Embryonal or alveolar rhabdomyosarcoma, osteosarcoma, Ewing's...
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US Clinical Trial NCT00331825 – NIH – May 30, 2006

A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

Objective: First generation antipsychotics frequently induced extrapyramidal side effects (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic patients. But which one of second generation antipsychotic was the be...
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US Clinical Trial NCT00331838 – NIH – May 18, 2006

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose Response Study of Subcutaneous AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

The randomization had to take place before the first study drug injection. The total duration of observation per participant was 27-33 days from surgery broken down as follows: - 4 to 10-day double-blind treatment period; - Follow-up period up to...
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US Clinical Trial NCT00331851 – NIH – May 30, 2006

Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

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US Clinical Trial NCT00331877 – NIH – May 30, 2006

A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial

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US Clinical Trial NCT00331890 – NIH – May 30, 2006

Citicoline in the Treatment of Acute Ischemic Stroke. An International Randomized Multicenter Placebo-controlled Study

The stroke or brain attack is one of the main health problems in developed countries. It is the third cause for death and the main cause of disability in adults. Cerebral infarction makes up 80 % of all the types of strokes. After a stroke, differe...
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US Clinical Trial NCT00331994 – NIH – May 30, 2006

Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study.

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US Clinical Trial NCT00332033 – NIH – May 31, 2006

Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)

Uterine leiomyomas (fibroids) represent a major public health problem with few effective therapies. Currently, the only definitive treatment is hysterectomy and women are demanding alternative therapies to surgery. We have developed a new approach t...
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US Clinical Trial NCT00332111 – NIH – May 30, 2006

Infectious Outcomes Following Pancreas Transplantation

The objectives of the study are: 1. To determine what is the frequency of infectious complications following pancreas transplantation 2. Characterize the clinical and microbiological aspects of the infectious complications following pancreas trans...
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US Clinical Trial NCT00332163 – NIH – May 31, 2006

A Phase 2, Open-label, Randomized Clinical Trial of Skin Toxicity Treatment in Subjects Receiving Second-line FOLFIRI or Irinotecan Only Chemotherapy Concomitantly With Panitumumab

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US Clinical Trial NCT00332254 – NIH – May 30, 2006

IL-1ra for Prevention of Chondropathy Following Knee Injury

Osteoarthritis is highly prevalent with significant impact on health care utilization and personal suffering. Injury predisposes to OA even after surgical correction (1, 2). Definitive therapy for established OA is lacking and current treatments are...
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US Clinical Trial NCT00332267 – NIH – May 31, 2006

Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

The combination of acute infection and a low level of oxygen in the blood is a common phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis. Conversely, healthy persons who ascend to moderately high altitudes, whic...
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US Clinical Trial NCT00332280 – NIH – May 31, 2006

A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo

The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.) The clinical benefit response - CBR, is an end point that...
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US Clinical Trial NCT00332371 – NIH – May 31, 2006

COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU

Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatmen...
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US Clinical Trial NCT00332436 – NIH – May 30, 2006

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US Clinical Trial NCT00332488 – NIH – May 31, 2006

A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.

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US Clinical Trial NCT00332605 – NIH – May 30, 2006

A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence

Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patie...
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US Clinical Trial NCT00332722 – NIH – May 31, 2006

Effectiveness of Cervical Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation

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US Clinical Trial NCT00332735 – NIH – May 31, 2006

Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial

The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lowe...
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US Clinical Trial NCT00332787 – NIH – Jun 1, 2006

Childhood Depression: Remission and Relapse

Depression is a serious medical illness that affects all ages and populations. However, it has only been within the last 10 years that sufficient attention has been devoted to researching treatments for depression in children and adolescents. Sympto...
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US Clinical Trial NCT00332930 – NIH – Jun 1, 2006

An Extension Study to Protocol VIR-NCHR-01 to Assess the Antiretrovirological Properties of a Therapeutic HIV Vaccine Candidate Based on Recombinant Fowlpox Virus (rFPV) (ITV Extension Study)

A multi-centre, double-blind, placebo-controlled, 20-week parallel group extension study to the VIR-NCHR-01 protocol (ITV study). The purpose of the extension study is to assess the safety and virological effects of a therapeutic HIV vaccine strateg...
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US Clinical Trial NCT00332995 – NIH – Jun 1, 2006

Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

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US Clinical Trial NCT00333008 – NIH – May 31, 2006

Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status

Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined by the American Society of Clinical Oncology as a...
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US Clinical Trial NCT00333125 – NIH – May 31, 2006

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US Clinical Trial NCT00333216 – NIH – May 31, 2006

Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) Versus Sham Administration in Singaporean Patients at Risk for Progressing to Exudative Age-Related Macular Degeneration (AMD)

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US Clinical Trial NCT00333229 – NIH – May 31, 2006

Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment

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US Clinical Trial NCT00333242 – NIH – Jun 1, 2006

Addressing the undertreatment of clinical pain has become a national priority, with a central goal being to identify effective interventions for those subgroups of patients most at risk for suffering unrelieved pain (NIH Program Announcement PA-01-1...
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US Clinical Trial NCT00333268 – NIH – Jun 1, 2006

Clinical Evaluation of the Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction and IOL Implantation

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US Clinical Trial NCT00333307 – NIH – Jun 1, 2006

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia

The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women w...
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US Clinical Trial NCT00333333 – NIH – Jun 2, 2006

Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure

Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One...
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