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#Study Description Brief Summary Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months. #Intervention - OTHER : change in temperature - increase in ambient room temperature	#Eligibility Criteria: Inclusion Criteria: * All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery 'West' Unit (operating rooms 1, 2, 3, and 5) during the study period. Exclusion Criteria: * Subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed ('comfort care only' provided), or a neonatal temperature is not available. Sex : FEMALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes	NCT02436382	{ "brief_title": "Hypothermia and the Effect of Ambient Temperature", "conditions": [ "Hypothermia" ], "interventions": [ "Other: change in temperature" ], "location_countries": [ "United States" ], "nct_id": "NCT02436382", "official_title": "The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08", "study_completion_date(actual)": "2015-09", "study_start_date(actual)": "2015-02" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-05-11", "last_updated_that_met_qc_criteria": "2015-05-01", "last_verified": "2016-05" }, "study_registration_dates": { "first_posted(estimated)": "2015-05-06", "first_submitted": "2015-01-30", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Demonstrating the effectiveness of an economical and feasible intervention such as guided imagery on factors associated with preterm birth, along with better understanding of pathways leading to adverse birth outcomes has tremendous health, social, and financial benefits. This project has the potential to significantly advance the field of nursing and knowledge development in the areas of maternal stress reduction in African American women and to provide scientific evidence of the effectiveness of guided imagery. Detailed Description Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality and has tremendous health and economic costs for the infant, family, and society. There has been little success in reducing PTB; rates are at an all time high. Of particular concern is the major racial disparity in PTB rates; African American women have the highest proportion of PTB compared to women of other races or ethnicities. There is growing evidence suggesting that PTB may be the end point of sub-acute or chronic pathophysiological changes that occur before clinical symptoms of preterm labor are present. There is also evidence to suggest that psychosocial factors such as maternal stress and the related symptoms of fatigue, anxiety, depression, as well as unhappiness about the pregnancy are associated with negative birth outcomes. It is proposed that these behavioral factors could influence birth outcomes through two possible pathways: (1) a neuroendocrine pathway in which maternal stress may lead to early and/or greater activation of the maternal-placental-fetal endocrine systems, with CRH playing a key role, thereby promoting labor; and/or (2) immunologic or inflammatory pathways which may promote labor through pro-inflammatory mechanisms. Experts agree primary prevention interventions are needed to address the issue of PTB. Guided imagery (GI) has been effective in decreasing self-reported measures of stress, depression, and fatigue as well as influencing neuroendocrine and immune measures in the general population. However, there are only limited studies examining the effects of GI on maternal stress, neuroendocrine measures, and/or birth outcomes, and there are no published studies examining the effect of GI as a primary prevention intervention to improve birth outcomes by reducing stress and related symptoms and influencing the proposed immunologic pathway to PTB. The specific aims of this randomized clinical trial are (1) to test the effects of a GI intervention on maternal stress (perceived stress), related symptoms (fatigue, anxiety, depression, and unhappiness), neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF), and birth outcomes (gestational age and neonatal birthweight) in African American women; and (2) to test the proposed theoretical model by examining predicted relationships among stress, fatigue, anxiety, depression, unhappiness, patterns of neuroendocrine and immunologic factors, and birth outcomes. An analysis of covariance (ANCOVA) model will be used to test for group differences between the GI and control groups. To test the proposed theoretical model descriptive statistics, graphical methods and pairwise correlations will be calculated for all baseline data and canonical correlation analysis will be used to look for relationship among groups of the baseline variables. Demonstrating the effectiveness of an economical, easy to distribute and use, intervention on the psychosocial factors associated with PTB and the proposed pathways leading to adverse birth outcomes has tremendous health, social and financial benefits. This project will provide baseline data for further research to test the biobehavioral efficacy of this intervention in larger samples with multiple races/ethnicities as well as test the model during the postpartum period for maternal well-being and infant development. #Intervention - OTHER : Guided Imagery - The 12 week intervention consists of a set of 4 GI compact discs (CDs), each 20 minutes in length. Participants will be instructed to listen to the CD once a day in a recommended order for weeks 1-4 and used in any order for weeks 5-12.	#Eligibility Criteria: Inclusion Criteria: * Being pregnant between 14 <= age <= 17 weeks gestation * Being African American * 18 years or older * able to read, write and understand English * verbalize a source of social support * self-report of no change in level of stress management strategies used within the last month. Exclusion Criteria: * carrying multiples * have had cervical cerclage * currently use oral corticosteroids * have uterine or cervical abnormality * have dissociative disorders, borderline personalities or psychotic pathology * have medical and/or pregnancy complications known to impact cytokine levels (e.g., gestational diabetes) * currently use GI techniques. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No	NCT01436786	{ "brief_title": "Effectiveness of Guided Imagery Intervention on Factors Associated With Maternal Stress and Preterm Birth", "conditions": [ "Preterm Birth", "Maternal Stress" ], "interventions": [ "Other: Guided Imagery" ], "location_countries": [ "United States" ], "nct_id": "NCT01436786", "official_title": "Guided Imagery Effects on Pregnancy Symptoms and Outcomes", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08", "study_completion_date(actual)": "2012-08", "study_start_date(actual)": "2010-06" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "SCREENING", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2014-05-16", "last_updated_that_met_qc_criteria": "2011-09-19", "last_verified": "2014-05" }, "study_registration_dates": { "first_posted(estimated)": "2011-09-20", "first_submitted": "2011-09-06", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. The origin of SCAD remains uncertain but a strong and frequent association with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only. The aim of our study is to assess the presence of FMD and its genetic determinants i in a sample for haematoma or spontaneous coronary artery dissection. From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than 30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging data will be reviewed by two experienced interventional cardiologist experts in SCAD diagnosis. For each patient a genetic analysis will be performed. A systematic screening for FMD will be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac arteries and reviewed by two experienced radiologists. A one year follow-up is expected. This study aims to confirm the presumed association of FMD and SCAD through the exploration of several artery beds and the study of confirmed genetic determinants, which has never been described previously to our knowledge. Detailed Description The recruitment of patients takes place in each interventional cardiology department. The patients can be included in a retrospective way (for SCAD occurred from 2010) or forward-looking way. The patients are informed about this study by the investigator. After a reflection period and an answer to the possible questions, the patient is included. The informed consent is signed. Every patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France. #Intervention - PROCEDURE : blood sample for genetic analysis	#Eligibility Criteria: Inclusion Criteria: Inclusion criteria : * Patients over 18 year's old * Patient with a possible diagnosis of spontaneous coronary dissection defined by: * A picture of SCA * Compatible angiographic signs * More or less confirmed by intracoronary imaging (OCT/IVUS) or check angiographic control (upper to 1 month) * Patient having given his informed consent and signed to participate to the study * Subject accepting the use of its personal data in the form of an anonymous codification including in the scientific publications. Exclusion Criteria: * - Minor patient * Major patient submitted to a protective measure (guardianship, supervision guardianship) * No affiliation to the French social security system * Coronary dissection with traumatic or iatrogenic origin Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02799186	{ "brief_title": "The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection.", "conditions": [ "Spontaneous Coronary Artery Dissection", "Spontaneous Coronary Artery Haematoma" ], "interventions": [ "Procedure: blood sample for genetic analysis" ], "location_countries": [ "France" ], "nct_id": "NCT02799186", "official_title": "PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-04", "study_completion_date(actual)": "2019-11-04", "study_start_date(actual)": "2016-05" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "DIAGNOSTIC", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-01-24", "last_updated_that_met_qc_criteria": "2016-06-09", "last_verified": "2016-06" }, "study_registration_dates": { "first_posted(estimated)": "2016-06-14", "first_submitted": "2016-06-09", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6 days. After a 7-day washout period subjects will receive the alternative treatment. On the day of treatment with Treatment A and on the first and last days of treatment with Treatment B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after administration of study drug. For Treatment B study drug will be administered in the clinic each day after a trough blood sample has been drawn. #Intervention - DRUG : Proellex Formulation A - Other Names : - telepristone acetate - DRUG : Proellex Formulation B - Other Names : - telepristone acetate	#Eligibility Criteria: Inclusion Criteria: * Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures; * Healthy, premenopausal female age 18 <= age <= 47; * History of menstrual events that occur in regular cycles * Agreement not to attempt to become pregnant * Agrees to use a condom and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) over the course of the study; * Has a negative pregnancy test at the Screening visit. An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history * Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator; * Subject is willing to remain in the clinic overnight for PK assessment on Days 0, 6 or 8 and Day 14. Exclusion Criteria: * Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy * Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study * Women with abnormally high liver enzymes or liver disease. Alanine transaminase (ALT) or aspartate aminotransferase (AST) exceeding 1.5 x upper limit of normal (ULN) AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat). * Received an investigational drug in the 30 days prior to the screening for this study * Women with a history of polycystic ovary syndrome (PCOS) * Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study. * Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months. * Has an intrauterine device (IUD) in place * Women currently using narcotics * Women currently taking spironolactone * Infectious disease screen is positive for HIV or Hepatitis A, B or C. * Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 47 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT01962805	{ "brief_title": "Comparison of Two Formulations of Proellex for Vaginal Administration", "conditions": [ "Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules" ], "interventions": [ "Drug: Proellex Formulation A", "Drug: Proellex Formulation B" ], "location_countries": [ "United States" ], "nct_id": "NCT01962805", "official_title": "A Double-Blind, Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Vaginal Administration", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12", "study_completion_date(actual)": "2013-12", "study_start_date(actual)": "2013-10" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "QUADRUPLE", "phase": [ "PHASE1" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2014-01-24", "last_updated_that_met_qc_criteria": "2013-10-10", "last_verified": "2014-01" }, "study_registration_dates": { "first_posted(estimated)": "2013-10-14", "first_submitted": "2013-10-09", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately 60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is very good, as widely demonstrated in the literature. On the basis of data produced by the only complete hip register in Italy that is run in our Lab (RIPO, Register of Orthopedic Implants in the Region Emilia-Romagna) survival rate of primary total hip prosthesis is 95.6% at 9 years. Reasons for revision are mainly aseptic loosening of one or both components (40% of the total) and dislocation (26%), being the latter much more frequent in the first two years. Less frequently revision is due to sepsis (7% of the total),bone fracture (11%), prosthesis fracture (3%) or pain (3%). Revision is relates, among the others, to prosthesis-related factors, such as fixation to bone and articular coupling. In our experience, during the last ten years 32% of implants had both articular component in ceramic , 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both components in metal. Each solution has strengths and weakness and they have been identified and clinically applied in order to overcome step by step limitations observed in the previous one. The most recent are the hard-on-hard bearings, that is ceramic on ceramic and metal on metal. These two solutions, beside very promising results on wear resistance, show some peculiar failures: respectively fracture of the ceramic component and hypersensitivity induced by metal ions. Aim of research proposal is to investigate two uncommon and less investigated early symptoms of failure: * 'noising hip' in ceramic on ceramic total hip arthroplasty * pain without radiographic signs of loosening in metal on metal total hip arthroplasty These two situations are extremely relevant, as they prelude to a failure of the prosthesis. If clearly identified they could represent a powerful tool in early diagnosis of pending failure To reach this goal our patients wearing hard-on-hard total hip arthroplasty, suffering for described symptoms will undergone a specific diagnostic procedure. The first group will be studied through CT scan of the patients to evaluate impingement or instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be examined to identify ceramic wear debris, according to a method of separation and analysis in scanning electron microscopy that was set in our Lab. Sound will be recorded by means of a wearable sensor set capable of recording the articular noise produced during level walking. This instrumentation will be coupled to motion analysis technology. This would make possible a diagnostic approach able to correlate the involved factors to clinical occurrences, on the basis of the recorded frequencies. -Second group will be studied through the dosage of circulating ions, deriving from the articular surfaces and through the histological classification of vasculitis in periimplant tissues. There is increasing evidence, indeed that locale release of submicron particles worn out from articular surfaces can release metal ions (mainly Chromium and Cobalt) responsible for lymphocyte local infiltration. In particular CD20 positive B lymphocyte and CD3 positive T lymphocyte and sometimes CD68 positive plasma cells are present. The cells could justify the development of pseudotumors in metal-on metal hip prosthesis. Data collected from patients matched to in vitro results will allow us to to avoid or at least propose a more appropriate timing for revision surgery. Detailed Description Every single year approximately 60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is very good, as widely demonstrated in clinical experience and in the literature. On the basis of data produced by the only complete hip register in Italy, that is run in our Lab (RIPO, Register of Orthopedic Implants in the Region Emilia-Romagna http://ripo.cineca.it) survival rate of primary total hip prosthesis is 95.6% at 9 years. Reasons for revision are mainly aseptic loosening of one or both components (40% of the total) and dislocation (26%), being the latter much more frequent in the first two years. Less frequently revision is due to sepsis (7% of the total),bone fracture (11%), prosthesis fracture (3%) or pain (3%). Revision can be related, among the others, to prosthesis-linked factors, such as fixation to bone and articular coupling. In the experience of RIPO, during the last ten years 32% of implants had both articular component in ceramic, 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both components in metal. Each solution has strengths and weakness and they have been identified and clinically applied in order to overcome step by step limitations observed in the previous one. Alumina ceramic-on-ceramic (COC) bearings have been shown to produce substantially less wear debris than traditional metal/ceramic on polyethylene bearings. In addition, the alumina ceramic material itself is essentially bioinert in both bulk and particulate form . Unlike metal-on-metal bearings (MOM), this bearing couple does not release metal ions into the body either from the articulation or from breakdown of wear debris. Weakness of ceramic-on-ceramic bearings are represented by brittleness of the material. Ceramic can fracture, even in very few cases, due to trauma or to malpositioning. Beside this occurrence of noise during gait of patients can be extremely disturbing for patient itself, leading to request of revision. These two solutions represent more recent proposal that technology suggested to overcome problem of wear. Hard components on plastic has the unsolved problem of wear debris, leading to osteolysis and consequent failure of he im plant. The problem has only partially solved by the introduction of cross linked polyethylene, aimed to improve tribological behaviour of the plastic. Rizzoli Institute is the only public mono-specialistic research hospital in Italy. Nearly 500 hip prosthesis revisions are performed here every year in the structure. Due to its high specialization difficult cases from all the country are treated here, not on ly when anatomy of the patient is damaged (dislocation of the hip, post traumatic arthritis) but .even more frequently when failure of the implant occurred. Aim of research proposal is to investigate two uncommon and less investigated early symptoms of failure: * 'noising hip' in ceramic on ceramic total hip arthroplasty * pain in metal on metal total hip arthroplasty Even if not numerically so important, these two situations are extremely relevant, as they prelude to a failure of the prosthesis. If clearly identified they could represent a powerful tool in early diagnosis of pending failure. The first point will be studied through CT scan of the patients to evaluate impingement or instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be examined to identify ceramic wear debris, according to a method of separation and analysis in scanning electron microscopy that was set in our Lab. Sound will be recorded by means of a wearable sensor set capable of recording the articular noise produced during level walking. This instrumentation will be coupled to motion analysis technology, so as to provide a temporal correlation between the recorded noise and the gait cycle. It will be developed in the first phase of the project. In parallel surface analyses will be conducted on retrievals that are stored in the Lab since 2000, in one of the biggest retrieval study ever conducted in our country. Type of damage, surface roughness of both ceramic components will be analysed and compared to clinical data. Finally the study will be completed in vitro, using an hip simulator, to reproduce the possible clinical scenarios leading to hip noise, record, and analyse it in a reproducible and robust manner. This would make possible a diagnostic approach able to correlate the involved factors to clinical occurrences, on the basis of the recorded frequencies. Second point will be studied through the dosage of circulating ions, deriving from the articular surfaces and through the histological classification of vasculitis in periimplant tissues. There is increasing evidence, indeed that locale release of submicron particles worn out from articular surfaces can release metal ions (mainly Chromium and Cobalt) responsible for lymphocyte local infiltration. In particular cluster of differentiation antigen 20 (CD20) positive B lymphocyte and cluster of differentiation 3 (CD3) positive T lymphocyte and sometimes cluster of differentiation antigen 68 (CD68) positive plasma cells are present. The cells could indicate a specific phlogistic condition responsible for pain and eventually subsequent revision. Data collected on studied population will allow a better understanding of the two phenomena and possibly will suggest new therapeutic approaches to the problems. #Intervention - OTHER : Metal ions dosage and evaluation of local/systemic reaction - Dosage of Chromium and Cobalt on several biological matrices deriving from each patients. Determination of local/systemic reaction - OTHER : Noise registration and metal ions determination - Dosage of Vanadium and Titanium on several biological matrices deriving from each patients. Determination of range of noise - OTHER : Metal ions dosage, evaluation of local/systemic reaction, noise registration - Dosage of Chromium, Cobalt, Vanadium and Titanium on several biological matrices deriving from each patients. Determination of local/systemic reaction - Other Names : - Controls comparison for variables considered	#Eligibility Criteria: Inclusion Criteria: * Patient waiting for primary total hip arthroplasty (THA) * Patients MoM and CoC referring to our ward * Informed consent approved * Questionnaire on habits filled Exclusion Criteria: * Sepsis or suspected sepsis * Patients exposed to other font of metals Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02427984	{ "brief_title": "Pending Failure in Hard-hard Total Hip Arthroplasty", "conditions": [ "Infection and Inflammatory Reaction" ], "interventions": [ "Other: Noise registration and metal ions determination", "Other: Metal ions dosage, evaluation of local/systemic reaction, noise registration", "Other: Metal ions dosage and evaluation of local/systemic reaction" ], "location_countries": [ "Italy" ], "nct_id": "NCT02427984", "official_title": "Early Diagnosis of Pending Failures of Total Hip Arthroplasty With Hard to Hard Bearings", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02", "study_completion_date(actual)": "2016-02", "study_start_date(actual)": "2012-08" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-05-25", "last_updated_that_met_qc_criteria": "2015-04-27", "last_verified": "2016-04" }, "study_registration_dates": { "first_posted(estimated)": "2015-04-28", "first_submitted": "2015-02-19", "first_submitted_that_met_qc_criteria": "2016-04-18" } } }
#Study Description Brief Summary This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Detailed Description PRIMARY OBJECTIVES: I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug. IV. Determine the frequency of clinical response in patients treated with this drug. V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients. VI. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. #Intervention - BIOLOGICAL : bevacizumab - Given IV - Other Names : - anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF - OTHER : laboratory biomarker analysis - Correlative studies	#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed ovarian epithelial or primary peritoneal carcinoma * Recurrent or persistent after initial standard surgery or chemotherapy * Incurable with standard surgery, chemotherapy, or radiotherapy * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques * At least 10 mm by spiral CT scan * Outside the area of prior radiotherapy * Accessible to guided core needle biopsy * Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease * May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months * Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy * No tumors involving major blood vessels * No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years * Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population) * Performance status - GOG 0 <= age <= 2 (patients who have received 1 prior regimen) * Performance status - GOG 0 <= age <= 1 (patients who have received 2 prior regimens) * Absolute neutrophil count >= 1,500/mm^3 * Platelet count >= 100,000/mm^3 * No known bleeding disorder or coagulopathy * No active bleeding * Bilirubin <= 1.5 times upper limit of normal (ULN) * serum glutamate oxaloacetate transaminase (SGOT) <= 2.5 times ULN * Alkaline phosphatase <= 2.5 times ULN * PT (INR) <= 1.5 (INR 2 <= age <= 3 if on stable dose of therapeutic warfarin or low molecular weight heparin) * Partial thromboplastin time (PTT) < 1.2 times control * Creatinine <= 1.5 times ULN * Creatinine clearance > 60 mL/min * No proteinuria, as indicated by 1 of the following: * Negative urine dipstick * Urine protein < 30 mg/dL * Urine protein < 1,000 mg on 24-hour urine collection * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension * Myocardial infarction within the past 6 months * Unstable angina within the past 6 months * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease >= grade 2 * No stroke within the past 5 years * No pathologic condition that carries a high risk of bleeding * No significant traumatic injury within the past 28 days * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No uncontrolled seizures within the past 5 years * No neuropathy (motor and sensory) >= grade 2 * No serious non-healing wound, ulcer, or bone fracture * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * No active infection requiring parenteral antibiotics * No known claustrophobia that would preclude MRI tolerance * No ferromagnetic implants or pacers * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study treatment * At least 3 weeks since prior immunologic therapy directed at malignancy * No prior bevacizumab * No other concurrent immunotherapy directed at malignancy * One additional prior cytotoxic regimen for recurrent or persistent disease allowed * No prior non-cytotoxic chemotherapy for recurrent or persistent disease * No concurrent chemotherapy directed at malignancy * At least 1 week since prior hormonal therapy directed at malignancy * No concurrent hormonal therapy directed at malignancy * Concurrent hormone replacement therapy allowed * Recovered from prior radiotherapy * No concurrent radiotherapy directed at malignancy * At least 28 days since prior major surgery or open biopsy and recovered * At least 7 days since prior core biopsy or placement of vascular access device * No anticipated need for major surgical procedure during study participation * At least 3 weeks since other prior therapy directed at malignancy * No prior anticancer therapy that would preclude study entry Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT00022659	{ "brief_title": "Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer", "conditions": [ "Primary Peritoneal Cavity Cancer", "Recurrent Ovarian Epithelial Cancer", "Stage IV Ovarian Epithelial Cancer" ], "interventions": [ "Biological: bevacizumab", "Other: laboratory biomarker analysis" ], "location_countries": [ "United States" ], "nct_id": "NCT00022659", "official_title": "A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03", "study_completion_date(actual)": "2010-03", "study_start_date(actual)": "2002-04" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-07-24", "last_updated_that_met_qc_criteria": "2003-01-26", "last_verified": "2019-07" }, "study_registration_dates": { "first_posted(estimated)": "2003-01-27", "first_submitted": "2001-08-10", "first_submitted_that_met_qc_criteria": "2015-04-23" } } }
#Study Description Brief Summary Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes, several types of cancer and all-cause mortality. In combination with static and awkward postures, the prevalence of musculoskeletal diseases can increase further. Although the implementation of sit-to-stand or active workstations can help to reduce sitting time, improve physical activity at work and promote health benefits, it might also lead to changes in cognitive functions such as productivity The purpose of this study is to evaluate the mid-term effect of a novel two desk sit-to-stand workplace on sitting time as well as physiological and cognitive parameters for healthy people of working age in comparison to their traditional workplace. Detailed Description Measurements were made both in the field and in a laboratory. Field measurements were made and processed continuously over the 23-week intervention period. Laboratory measurements were made on two different days, one day prior to intervention, and one day following intervention (due to cross-over design, each subject underwent 4 total days of laboratory measurements). Field measurements were collected automatically at the participants' workstation in their working office. Laboratory tests were conducted in a controlled, simulated work-space located at the University of Applied Sciences Campus Linz. All laboratory measurements were made in a controlled laboratory at the campus site Linz of the University of Applied Sciences Upper Austria. Temperature, air flow, humidity, lighting conditions (artificial light only) and noise level were controlled and set to be consistent with the subjects' typical working environment. During the laboratory measurements, subjects either stood or sat upright in an ergonomic office chair, according to the study protocol. Subjects were encouraged to work as fast and as accurately as they could. To ensure identical testing conditions between subjects and to not unduly influence physiological parameters such as salivary cortisol level or heart rate variability, subjects were required to minimize excessive movement (e.g. standing up during the sitting periods). In the first (initial) phase, participants were familiarized with the study protocol. Sitting time and weekly physical activity were determined via the IPAQ-questionnaire. Examples of each cognitive test implemented in the cognitive phase were executed according to their guidelines. A 30 minute break in a sitting posture was used to ascertain baseline heart-rate and cortisol level. Baseline heart-rate was calculated after a 20 minute rest for a 5 minute interval and saliva samples were collected at the end (30min) of the break. In the second (cognitive) phase subjects participated in a test battery containing five blocks. Each block consisted of a working speed test (text editing task), an attentional test (d2R-test of attention) and a reaction time test (Stroop-test). These tests lasted for 30 minutes to fulfill recommendations regarding postural changes. To simulate 'common' working conditions (computer based and non-computer based tasks), digital (text editing task, Stroop-test) as well as pen \& paper (d2R-test) versions of the implemented tests were used. All blocks were executed in alternating postures (sit - stand - sit - stand - sit) and at the end of each block - after a 5 minute break - salivary samples were collected. The order of posture was not changed within groups or time. In the third (final) phase participants were asked to estimate their workload by means of the NASA-TLX questionnaire followed by a 30 minute resting phase in a sitting posture. During both 30 min resting phases (initial \& final) participants watched documentaries and were encouraged not to talk. Salivary samples were collected after each break during the study protocol and on the following morning, 20 minutes after waking up, to ascertain cortisol awakening response (CAR). Salivary samples were centrifuged and stored at -80 °C for subsequent testing using a chemiluminescent immunoassay. Heart-rate and trunk movements were measured from the start of the study protocol until the CAR measurement. #Intervention - OTHER : Workplace consisting of two height-adjustable desks - Desk arrangements: self-determined by the participants Desk equipment: depending on pre-intervention condition - 1 or 2 screens per desk Build-up: one day prior to the intervention period at the location of the workplace Adjustment: together with the study leader	#Eligibility Criteria: Inclusion Criteria: * Healthy Caucasian (no acute or chronic diseases) * Normal weight or slightly overweight (BMI: 18.5 - 27.5 kg/m²) * Regularly working in sedentary office environments * Regular computer users * Fluent German speakers * Consented to participate Exclusion Criteria: * Heavily overweight & Obesity (BMI > 27.5 kg/m²) * Short office stay duration (< 8 h / day or < 20 h / week) * Experience in sit-to-stand workstations * Acute or chronic diseases * Inability to stand * Visual impairments that had not been corrected * Color blindness * People planning to change their physical activity level * Regular smokers (> 1 cigarette /day) * Not consented to participate Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT02825303	{ "brief_title": "Mid-term Effect of a Novel Sit-to-stand Workplace (ACTIVE OFFICE) on Cognitive and Physiological Parameters", "conditions": [ "Sedentary Lifestyle", "Worksite" ], "interventions": [ "Other: Workplace consisting of two height-adjustable desks" ], "location_countries": [ "Austria" ], "nct_id": "NCT02825303", "official_title": "Mid-term Effect of a Novel Sit-to-stand Workplace (ACTIVE OFFICE) on Cognitive and Physiological Parameters", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03", "study_completion_date(actual)": "2015-03", "study_start_date(actual)": "2014-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-07-15", "last_updated_that_met_qc_criteria": "2016-07-04", "last_verified": "2016-07" }, "study_registration_dates": { "first_posted(estimated)": "2016-07-07", "first_submitted": "2016-07-04", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers. #Intervention - DRUG : Lovaza - Lovaza one gram twice a day for 24 weeks - Other Names : - Omega-3 fatty acid - DRUG : Placebo - Placebo	#Eligibility Criteria: Inclusion Criteria: * HIV+ * Ages 18 <= age <= 70 * HIV-1 RNA <400 copies/ml. * On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos. Exclusion Criteria: * Active infection * Inflammation or malignancy * Uncontrolled diabetes or hypothyroidism * LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750 * Framingham risk score <6. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01001767	{ "brief_title": "Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease", "conditions": [ "HIV Infections", "Heart Disease" ], "interventions": [ "Drug: Placebo", "Drug: Lovaza" ], "location_countries": [ "United States" ], "nct_id": "NCT01001767", "official_title": "Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03", "study_completion_date(actual)": "2010-06", "study_start_date(actual)": "2009-04" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "TRIPLE", "phase": [ "PHASE2" ], "primary_purpose": null, "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2015-01-07", "last_updated_that_met_qc_criteria": "2009-10-26", "last_verified": "2014-12" }, "study_registration_dates": { "first_posted(estimated)": "2009-10-27", "first_submitted": "2009-10-22", "first_submitted_that_met_qc_criteria": "2012-03-12" } } }
#Study Description Brief Summary This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of selatogrel (ACT-246475). #Intervention - DRUG : Selatogrel - A single subcutaneous injection of 16 mg. - Other Names : - ACT-246475	#Eligibility Criteria: Inclusion Criteria: All participants (Groups 1,2 and 3) * Signed informed consent in a language understandable to the participant prior to any study-mandated procedure. * Male or female participant aged between 18 and 79 years (inclusive) at screening. * Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening. * Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (pre-dose). They must consistently and correctly use (from screening, during the entire study, and for at least 30 days after last study treatment administration) an acceptable effective method of contraception method, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must have been initiated at least 1 month before treatment administration. * Women of non-childbearing potential. Additional principal inclusion criteria for participants with hepatic impairment (Groups 1 and 2) * Hepatic impairment due to liver cirrhosis according to the Child-Pugh classification: * Group 1: Mild hepatic impairment, Child-Pugh A = score 5 <= age <= 6. * Group 2: Moderate hepatic impairment, Child-Pugh B = score 7 <= age <= 9. * Systolic blood pressure (SBP) 95 <= age <= 160 mmHg, diastolic blood pressure (DBP) 60 <= age <= 95 mmHg, and pulse rate 50 <= age <= 100 bpm (inclusive), measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 (pre-dose). * Estimated glomerular filtration rate (eGFR) at screening using the Modification of Diet in Renal Disease (MDRD) formula of: * greater than or equal to 60 mL/min/1.73 m2 for participants with mild hepatic impairment (Group 1) * greater than or equal to 45 mL/min/1.73 m2 for participants with moderate hepatic impairment (Group 2). * Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1 and expected to be stable during the conduct of the study. Additional principal inclusion criteria for healthy participants (Group 3) * Normal blood pressure measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 pre-dose defined as: * SBP 90 to 140 mmHg, DBP 60 to 90 mmHg, and pulse rate 50 to 100 bpm (inclusive) for participants less than 60 years. * SBP 95 to 160 mmHg, DBP 65 to 95 mmHg, and pulse rate 50 to 100 bpm (inclusive) for participants 60 years and older. * eGFR greater than or equal to 80 mL/min/1.73 m2 at screening using the MDRD formula. Exclusion Criteria: All participants (Groups 1, 2 and 3) * Pregnant or lactating woman. * Previous exposure to selatogrel. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. * Known hypersensitivity to P2Y12 receptor antagonists or any excipients of the drug formulation. * Known platelet disorders. * Legal incapacity or limited legal capacity at screening. Additional exclusion criteria for participants with hepatic impairment (Groups 1 and 2) * History or clinical evidence of any disease and/or existence of any surgical or medical condition (e.g., cholecystectomy), which might interfere with the absorption, distribution, metabolism, and excretion (ADME) of the study treatment (except for hepatic impairment, appendectomy, and herniotomy). * Acute hepatitis, hepatic cancer, primary biliary cirrhosis, or any form of cholestatic disease. * Clinical evidence or suspected acute liver failure as judged by the investigator. * Severe ascites and/or pleural effusion. * Encephalopathy greater than grade 2. * Clinical evidence of current alcohol or drug abuse. * Clinically relevant abnormalities on a 12-lead ECG, except for abnormalities related to hepatic impairment, after 5 minutes in the supine position at screening and on Day 1 pre-dose. Additional exclusion criteria for healthy participants (Group 3) * History or clinical evidence of any disease and/or existence of any surgical or medical condition (e.g., cholecystectomy), which might interfere with the ADME of the study treatment (except for appendectomy and herniotomy). * History or clinical evidence of alcohol or drug abuse within the 3 years prior to screening. * Family or personal history of prolonged bleeding or bleeding disorders, intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers. * Previous treatment with any prescribed medications or over-the-counter medications within 2 weeks or 5 times the terminal half-life (t½), whichever is longer prior to study treatment administration (excludes contraceptives and hormone replacement therapy). Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT04406896	{ "brief_title": "The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics", "conditions": [ "Healthy Subjects", "Hepatic Impairment" ], "interventions": [ "Drug: Selatogrel" ], "location_countries": [ "Germany" ], "nct_id": "NCT04406896", "official_title": "An Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of Selatogrel in Subjects With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Subjects", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-23", "study_completion_date(actual)": "2020-10-23", "study_start_date(actual)": "2020-07-22" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "SEQUENTIAL", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-11-16", "last_updated_that_met_qc_criteria": "2020-05-25", "last_verified": "2022-11" }, "study_registration_dates": { "first_posted(estimated)": "2020-05-29", "first_submitted": "2020-05-25", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease.. Detailed Description Anterior Cervical Discectomy and Fusion (ACDF) is a common surgical treatment option for symptomatic degenerative cervical disk disease in patients who fail conservative treatment. i-FACTOR bone graft is a unique anorganic bone mineral (ABM) and small peptide, P-15™. P-15 is a synthetic fifteen amino acid polypeptide that mimics the cell-binding domain of Type I human collagen and is responsible for osteogenic cell attachment via alpha2-beta1 integrins. This is randomized, controlled, multi-center, prospective FDA IDE study conducted to assess the safety and effectiveness of i-FACTOR bone graft (Cerapedics, Inc. Westminster, CO) in patients treated with single level ACDF. Patients received i-FACTOR bone graft or local autologous bone inside a structural allograft. #Intervention - DEVICE : P-15 Synthetic osteoconductive bone substitute - Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery - Other Names : - i-Factor - OTHER : Autologous bone - Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring	#Eligibility Criteria: Inclusion Criteria: * Age between 18 and 65 * Radiographically determined discogenic origin to include at least one of the following characteristics: degenerated/dark disc on MRI, decreased disc height compared to adjacent levels on radiographic film, CT, or MRI and disc herniation on CT or MRI * Radicular symptoms by history and physical exam to include at least the following characteristics: Arm/shoulder pain, decreased flexes, decreased strength and abnormal sensation * Pain level arm/shoulder >4 on 0 <= age <= 10 VAS * Pain level neck >4 on 0 <= age <= 10 VAS * Neck disability Index >30 * Involved discs between C3 and C7 * Undergoing anterior cervical fusion at a single level * Failed to gain adequate relief from non-operative treatment * Able and willing to give consent to participate in study * Understand and read English at elementary level Exclusion Criteria: Systemic infection such as AIDS, HIV, and active hepatitis; Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis or osteomalacia; Taking medication for the prevention of osteoporosis; Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk; Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.); Multiple level symptomatic degenerative disc disease; Previous cervical fusion; Previous cervical decompression at the same level; Acute cervical trauma or instability (i.e., subluxation > 3 mm on flexion/extension radiographic film); Undergoing treatment for tumor or bony traumatic injury to the cervical spine; Rheumatoid disease of the cervical spine; Myelopathy; Pregnant or planning to become pregnant in the next 2 years; Posterior cervical spine procedure scheduled; More than one level to be operated; Has a history of substance abuse (recreational drugs, alcohol); Is a prisoner; Is currently involved in a study of another investigational product for similar purpose; Has a disease process that would preclude accurate evaluation (e.g., neuromuscular disease, significant psychiatric disease). Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT00310440	{ "brief_title": "An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation", "conditions": [ "Intervertebral Disk Degeneration" ], "interventions": [ "Device: P-15 Synthetic osteoconductive bone substitute", "Other: Autologous bone" ], "location_countries": [ "Canada", "United States" ], "nct_id": "NCT00310440", "official_title": "An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05", "study_completion_date(actual)": "2019-05-23", "study_start_date(actual)": "2006-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-03-12", "last_updated_that_met_qc_criteria": "2006-04-03", "last_verified": "2020-03" }, "study_registration_dates": { "first_posted(estimated)": "2006-04-04", "first_submitted": "2006-04-03", "first_submitted_that_met_qc_criteria": "2016-01-13" } } }
#Study Description Brief Summary Although it is stated in the literature that development should be considered as a whole and sensory, cognitive and motor outcomes are interrelated, it is seen that interventions for sensory and cognitive skills are not included in early intervention studies. For this reason, the study examined the effects of an early occupational therapy intervention program, which includes sensory, cognitive and motor strategies based on the principles of Goal, Activity and Motor Enrichment-GAME, an evidence-based early intervention program, on the sensory, cognitive and motor skills of babies at risk of developmental delay for 24-36 months. Detailed Description Children with developmental delays benefit from early intervention. Therefore, it is very important to detect developmental delays as early as possible. In recent years, there has been increasing interest in designing and providing early intervention programs to improve developmental outcomes for infants at risk for developmental delay for neurodevelopmental disorders. Early intervention includes services provided to children from birth to age five to promote the child's health and well-being, develop emerging skills, minimize developmental delays, correct existing or emerging disabilities, prevent functional impairment, and promote parental compliance. When the literature is examined, it is seen that early intervention approaches are mostly implemented in preterm babies and focus on motor skills. An example of studies carried out with this attitude is Neurodevelopmental Treatment (NGT), which is frequently used in early intervention approaches in Turkey. Another early intervention approach that includes intensive motor training is Goal, Activity and Motor Enrichment (GAME). GAME early intervention approach is also used in extremely preterm babies with a high risk of developmental delay; It has been used in studies as an intervention approach that includes goal-oriented motor training, environmental enrichment and family education. Another early intervention approach that addresses parent education and environmental enrichment principles is the Supporting Play, Exploration and Early Development Intervention (SPEEDI). The SPEEDI program was applied to preterm babies in a similar way to the GAME program. Other approaches used by occupational therapists for children at risk of developmental delay in the literature are home-based and routine-based approaches. When the literature is examined, it is seen that early intervention programs are mostly carried out with premature babies and/or for the diagnosis of cerebral palsy (CP). Early intervention approaches in the literature include intensive motor training, parent training, environmental enrichment, participation support and home visits. Although it is stated in the literature that development should be considered as a whole and sensory, cognitive and motor outcomes are interrelated, it is seen that interventions for sensory and cognitive skills are not included in early intervention studies. Therefore, the aim of our study is to improve the sensory, cognitive and motor skills of the early occupational therapy intervention program, which includes sensory, cognitive and motor strategies based on the principles of Goal, Activity and Motor Enrichment-GAME, which is an evidence-based early intervention program, in babies at risk of developmental delay of 24-36 months. to examine its effect. #Intervention - OTHER : Early Intervention - Based on the principles of the Goal, Activity and Motor Enrichment (GAME) approach, which is an evidence-based early intervention approach for children at risk of developmental delay between 24-36 months, activity-based training is aimed at the development of sensory and cognitive skills in addition to the training of motor skills, which are intensively discussed in the content of the approach. Individualized early occupational therapy intervention including strategies was implemented. - OTHER : Home Programme - For the control group, evaluation tests were first applied to the babies selected by simple random sampling method. An individualized home program was given according to the evaluation results. Home programs include activities for every skill area and were prepared together with the parents, taking into account the criteria suggested for the success of the home program. Based on these criteria, it was checked whether the family had received another home program, and while preparing the program, care was taken not to overload the parents, importance was given to the family's willingness to receive the home program, activities and goals were decided in cooperation with the parent, thus facilitating the applicability of the activities in daily life, ensuring that the number of activities was 6. Care was taken to ensure that the activity was not too much, the parent was given the necessary time to implement the program, and a phone call was made to the parent every 3 weeks.	#Eligibility Criteria: Inclusion Criteria: * Being at risk of developmental delay between 24 and 36 months * Not having received any neurological, psychiatric or orthopedic diagnosis, * The family is willing to participate in the study and agrees to participate regularly in the intervention program and evaluations. Exclusion Criteria: * Babies staying in institutional care, * Having any neurological, psychiatric or orthopedic diagnosis Sex : ALL Ages : - Minimum Age : 24 Months - Maximum Age : 36 Months - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No	NCT06052410	{ "brief_title": "Early Intervention in Children at Risk of Developmental Delay", "conditions": [ "Developmental Delay" ], "interventions": [ "Other: Home Programme", "Other: Early Intervention" ], "location_countries": [ "Turkey" ], "nct_id": "NCT06052410", "official_title": "The Effect of Early Intervention on Sensory, Cognitive and Motor Outcomes in Children at Risk of Developmental Delay: A Randomized Controlled Study", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-26", "study_completion_date(actual)": "2022-12-03", "study_start_date(actual)": "2022-09-03" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-10-11", "last_updated_that_met_qc_criteria": "2023-09-19", "last_verified": "2023-10" }, "study_registration_dates": { "first_posted(estimated)": "2023-09-25", "first_submitted": "2023-09-19", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Background: Shared decision making (SDM) is a patient-centered and evidence-based model of clinical decision making. The feature of SDM is that clinicians work together with patients to plan the most appropriate and practical treatment for patients based on the patients' preferences and values. Recently, SDM has been implemented throughout the world to improve patients' health literacy and to have a better understanding of the treatment options, thereby improving patient-doctor communication and promoting the quality of care. Lumbar degenerative disease is a critical public health issue in the aging society. SDM now becomes an important process because there is no consensus of evidence-based practice guidelines among the multiple complex treatment options for patients with lumbar degenerative disease. In addition, there is a lack of evidence to support the effect of patient decision aids (PDAs) to promote the quality of healthcare for patients with lumbar degenerative disease in Taiwan. Purposes: This project has two purposes. The first purpose is to develop a multimedia interactive patient doctor communication system called the Taiwan Shared Decision Making for Lumbar Spine Treatment (Taiwan SDM LumST). The second and ultimate purpose is to conduct a cluster randomized controlled trial (cRCT) for the validation of the integrated SDM model and the effectiveness of SDM related outcome indicators. Methods: In the first year of the 3-year project, investigators will develop the SDM communication teaching materials, PDAs, as well as the computerized platform of Taiwan SDM LumST through focus groups and consensus meetings. In the second to third year, investigators will recruit 130 patients with lumbar degenerative disease to participate in double blind cRCT in the affiliated hospitals of Taipei Medical University. Investigators will use structural equation modeling to validate the factors of the SDM model and adopt generalized linear regression models with generalized estimating equations to examine the immediate, short-term, and long-term benefits of the Taiwan SDM LumST in implementing the SDM model among patients with lumbar degenerative disease. Expected results: Investigators expect that the implementation of the Taiwan SDM LumST system will significantly improve the patients' decision preference, health literacy in the care of lumbar degenerative disease, and self-efficacy in SDM. It will also promote the health care quality and health outcomes (e.g., participation in SDM, quality of decisions, regret in decisions, health outcomes, and quality-of-life) in patients with lumbar degenerative disease. Expected impacts on the society, economy, and academic developments: The Taiwan SDM LumST will be an efficient and effective way to facilitate patient doctor communication and thereby, promote health outcomes and improve the quality of decisions made by patients with lumbar degenerative disease. No computerized interactive PDA of SDM system for patients with lumbar degenerative disease exists in Taiwan yet. Thus, our system would be the first in Taiwan for the lumbar degenerative population. Investigators hope that the Taiwan SDM LumST will not only contribute to academic research, but also facilitate SDM between patients and healthcare professionals in order to improve patient safety and enhance the quality of care in Taiwan. #Intervention - OTHER : Shared decision making support tool - Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	#Eligibility Criteria: Inclusion Criteria: * First-time diagnosis of Spine Degeneration Diseases ICD-10 codes M48.05 <= age <= 08, M43.05 <= age <= 08, M43.15 <= age <= 18, M54.5; ICD-9 codes 724.01 <= age <= 02、724.09、724.2、738.4 * Ability to follow instructions and complete the interviews * Age>20 years * Interested to participate and able to sign consent Exclusion Criteria: * Cognitive impairment (Mini-Mental State Examination scores<24) * Having major mental diseases (i.e., depression, dementia, delirium, etc.) * Inability to read/answer questionnaires Sex : ALL Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT03679494	{ "brief_title": "Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.", "conditions": [ "Lumbar Degenerative Disease", "Shared Decision Making", "Patient Decision Aids", "Evidence-based Medicine", "Quality of Care" ], "interventions": [ "Other: Shared decision making support tool" ], "location_countries": [ "Taiwan" ], "nct_id": "NCT03679494", "official_title": "Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-29", "study_completion_date(actual)": "2019-12-29", "study_start_date(actual)": "2018-09-26" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "NA" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-02-19", "last_updated_that_met_qc_criteria": "2018-09-18", "last_verified": "2019-12" }, "study_registration_dates": { "first_posted(estimated)": "2018-09-20", "first_submitted": "2018-09-06", "first_submitted_that_met_qc_criteria": "2020-02-18" } } }
#Study Description Brief Summary OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery. STUDY DESIGN: Randomized (single-blind) control trial. SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group. PLACE AND STUDY DURATION: (single center) SICU at the National Institute of Cardiovascular Diseases Hospital, Karachi over a period of six months, from January 1, 2021 up to June 30, 2021. METHODS: Sixty patients (30 in each group) were randomly assigned to receive either Paracetamol (control) or Ketorolac (treatment), along with the usual Nalbuphine infusion, over the first 48 hours postoperatively. The control group received injection Paracetamol 1gm six hourly, whereas treatment group received injection Ketorolac 30mg eight hourly. PRIMARY OUTCOME: The VAS (pain score) was evaluated at 6, 12, 18 and 24 hours post-extubation and a score of 4 or less was taken as a cut-off for adequate pain control. SECONDARY OUTCOMES: The time taken to extubation postoperatively. The total dose of Nalbuphine administered to each patient and total chest tube drainage recorded over 48 hours postoperatively. Detailed Description DATA COLLECTION: Computer randomization was done for the numbers 1 to 60, having 50% probability of being in either of two groups: Ketorolac (treatment) or Paracetamol (control). After randomizing each number into either group, which ever patient (consenting and meeting the inclusion criteria) came, was allotted these numbers consecutively, as they presented for elective cardiac surgery. Thus randomly allocating the presenting patients into either Ketorolac/treatment (30 patients) and Paracetamol/control (30 patients). Each patient was explained about the VAS pain rating score twice; first at preoperative interview and second time after they recovered their alert state in the SICU post operatively( at time of extubation). The patients were taught to finger-point their intensity of pain on a line between two endpoints: marked 0 to 10. Mark at '0' meant no pain at all and '10' worst pain ever felt. The number that the patient pointed to, defined the patient's pain. For the purposes of this study 'adequate pain relief' was defined as achieving a pain score of four or less, this designation was also included on the VAS scale and explained to the patients so that they may indicate numbers higher than four if they felt any pain. Standard anaesthesia was given in the operative room, total analgesia given intra-operatively was 0.4 mg/kg Nalbuphine (not exceeding 30mg). After completion of the surgery all patients were shifted to SICU. Initially both groups received a bolus dose of 10mg Nalbuphine and then an infusion of Nalbuphine was started at 2.5mg/hr as maintenance, up to 24 hours post-operatively. In addition, (according to randomization) the patients in treatment group received Ketorolac 30mg 8 hourly for 48 hours post-operatively and the patients control group received Paracetamol 1gm 6 hourly for 48 hours post-operatively. Postoperative analgesia assessment using VAS was performed at 6 hours, 12 hours, 18 hours and 24 hours postextubation. Time taken to extubation, total dose of Nalbuphine administered to each patient and total chest tube drainage were also recorded over 24 hours postoperatively. #Intervention - DRUG : Ketorolac Injection - dosage form: intravenous dosage: 30mg frequency: 8 hours apart (TDS) duration: for 48 hours post operatively - Other Names : - Toradol - DRUG : Paracetamol - dosage form: intravenous dosage: 1gm frequency: 6 hours apart (QID) duration: for 48 hours post operatively - Other Names : - Bofalgan, Provas	#Eligibility Criteria: Inclusion Criteria: * Males and females between 18 years and above of age. * Undergoing elective cardiac surgery. * American Society of Anesthesiology (ASA) Physical Class 3 or 4. Exclusion Criteria: * * Patients pre-planned for delayed extubation (due to moderate to severe pulmonary artery hypertension, poor right ventricular function, rhythm disturbances or unstable vitals) * Low cardiac output (cardiac index < 2.0 l/min/m2, using transesophageal echocardiography, intraoperatively) after weaning off cardiopulmonary bypass or paitients already having pre-op ejection fraction < 30%. * Patients not comfortably ventilated or oxygenated, requiring high doses of sedation and neuromuscular blockage. * Sensitivity or allergy to nonsteroidal anti-inflammatory drugs. * History of peptic ulcer or gastrointestinal bleeding. * Serum creatinine = 2.0 mg/dl or increase in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days. * Hepatic dysfunction. * Bleeding disorder. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT05361824	{ "brief_title": "Ketorolac-an Option for Post Operative Pain Management After Elective Cardiac Surgery.", "conditions": [ "Coronary Artery Disease", "Post Operative Pain", "Analgesia", "Coronary Artery Bypass Grafting Surgery" ], "interventions": [ "Drug: Ketorolac Injection", "Drug: Paracetamol" ], "location_countries": [ "Pakistan" ], "nct_id": "NCT05361824", "official_title": "Ketorolac Verses Paracetamol as an Adjunct to Nalbuphine in Post Operative Pain Management in Elective Cardiac Surgery", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-30", "study_completion_date(actual)": "2021-07-06", "study_start_date(actual)": "2021-01-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "PHASE4" ], "primary_purpose": "SUPPORTIVE_CARE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-09-30", "last_updated_that_met_qc_criteria": "2022-04-30", "last_verified": "2022-09" }, "study_registration_dates": { "first_posted(estimated)": "2022-05-05", "first_submitted": "2022-04-30", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later. Detailed Description Doctors need to develop tests which inexpensively and reliably evaluates brain metabolism. Current diagnostic tests sample other tissues which often run on different fuels (fats), utilize unproven and often insensitive brain imaging scanners, or sequence thousands to millions of base-pairs of DNA. All of these tests are expensive. None of these tests accurately or completely capture the interactions between the 1000s of proteins involved in brain metabolism. The investigators suspect that mathematical analysis of the resting heart rate may provide some insight into brain metabolism. The brain controls heart rate in response to changes in blood pressure and blood gases like carbon dioxide and oxygen. Tight control of heart rate is necessary to make sure that the brain has the right mix of fuel and air. Because the brain can't respond instantly to changes in its fuel supply, this system acting as a biological carburetor has a natural oscillatory rhythm that can be monitored just like frequencies on the radio. The investigators propose to amplify these rhythms by modestly metabolically stressing the brain with metformin, a inhibitor of complex 1 in the mitochondria. #Intervention - DRUG : Metformin - 500 mg orally after baseline testing of heart rate - Other Names : - Glucophage	#Eligibility Criteria: Inclusion Criteria: EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications Exclusion Criteria: * recent infection, * renal failure, * pre-existing cardiac disease, * chronic obstructive pulmonary disease * inability to participate in informed consent, * lack of transport to return home from study site, * severe fasting intolerance or hypoglycemia, * history of stroke-alike episode, * uncontrolled migraine or cyclic vomiting, * diabetes on insulin or sulfonylurea, * non-English speaker, * medications with strong effects on baseline heart rate variability Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02500628	{ "brief_title": "Heart Rate Variability in Response to Metformin Challenge", "conditions": [ "Fibromyalgia", "Mitochondrial Diseases", "Movement Disorders", "Diabetes Mellitus, Type 2" ], "interventions": [ "Drug: Metformin" ], "location_countries": [ "United States" ], "nct_id": "NCT02500628", "official_title": "Heart Rate Variability in Response to Metformin Challenge", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02", "study_completion_date(actual)": "2016-02", "study_start_date(actual)": "2015-07" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "DIAGNOSTIC", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-01-03", "last_updated_that_met_qc_criteria": "2015-07-14", "last_verified": "2017-12" }, "study_registration_dates": { "first_posted(estimated)": "2015-07-16", "first_submitted": "2015-07-11", "first_submitted_that_met_qc_criteria": "2017-12-30" } } }
#Study Description Brief Summary a prospective non-randomized study conducted upon 24 patients with severe lower punctual stenosis (grade 0 according to Kashkouli scale) attending at Menoufia University hospitals. The upper punctum and canaliculus were patent. All patients were complaining of epiphora and had a thorough ophthalmological examination including dye disappearance test, and slit-lamp examination. Pigtail probe was used from patent upper punctum to detect the lower stenosed punctum which was opened with a scalpel. Syringing of the lower lacrimal passages was done to confirm its patency and self retaining silicone bicanalicular stent was inserted. The silicone tube was left in place for 6 months before it was removed. Patients were then followed up for 1 year after the surgery. Detailed Description This is a prospective non-randomized study which was conducted upon 24 patients with total lower punctual occlusion attending at Menoufia University hospitals in the period from January 2014 to January 2018. Ethics approval from the institutional review board was obtained, and a written informed consent was taken from every patient according to the Declaration of Helsinki. All patients of the study were complaining of epiphora and had a thorough ophthalmological examination including dye disappearance test, and slit-lamp examination. The dye disappearance test was performed with a drop of 2% fluorescein sodium and assessment after 5 minutes of the remaining dye in the tear meniscus was done and results were graded. Surgical procedure All operations were done under general anesthesia and were performed by two authors (SSM, KES). The authors performed lacrimal probing and syringing test through the normal punctum to exclude concomitant occluded common canaliculus or nasolacrimal duct. The pigtail probe was passed through the canalicular system from the normal punctum to the occluded aspect. When the tip of the pigtail probe was positioned near the occluded punctal area, the surgeon pushed the area to be tented with the pigtail probe. After they advanced the pigtail probe back and forth several times until they could locate the correct position of the occluded punctum, the authors incised the tented area with a scalpel No. 11 to make a new punctal opening. To ensure punctal and canalicular patency, syringing was repeated through the perforated punctum. To prevent re-occlusion of punctal opening, a self retaining bicanalicular tube (FCI®; Paris, France) was inserted through the normal and perforated puncti. The silicone tube was left in place for 6 months before it was removed. Patients were then followed up for 1 year after the surgery (6 months after removal of the tube). During the follow-up period, the authors investigated the improvement of subjective epiphora symptoms based on Munk score, fluorescein disappearance test, maintenance of newly formed punctal opening, and incidence of complications. #Intervention - PROCEDURE : insertion of self retaining bicanalicular stent - The pigtail probe was passed through the canalicular system from the normal punctum to the occluded aspect. When the tip of the pigtail probe was positioned near the occluded punctal area, the surgeon pushed the area to be tented with the pigtail probe. After they advanced the pigtail probe back and forth several times until they could locate the correct position of the occluded punctum, the authors incised the tented area with a scalpel No. 11 to make a new punctal opening. To ensure punctal and canalicular patency, syringing was repeated through the perforated punctum. To prevent re-occlusion of punctal opening, a self retaining bicanalicular tube (FCI®; Paris, France) was inserted through the normal and perforated puncti	#Eligibility Criteria: Inclusion Criteria: * severe lowee punctual stenosis * patent upper punctum and canaliculus as well as patent nasolacrimal duct * normal lower eyelid margin position - Exclusion Criteria: * patients with punctal stenosis with grades more than 0 according to Kashkouli scale * patients with previous eyelid surgery * a lump overlying or involving the punctum or other part of the tear drainage system. Sex : ALL Ages : - Minimum Age : 17 Years - Maximum Age : 67 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT03731143	{ "brief_title": "Management of Lower Punctal Stenosis.", "conditions": [ "Epiphora" ], "interventions": [ "Procedure: insertion of self retaining bicanalicular stent" ], "location_countries": null, "nct_id": "NCT03731143", "official_title": "A Simple Surgical Approach for the Management of Acquired Severe Lower Punctual Stenosis", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-12", "study_completion_date(actual)": "2018-01-12", "study_start_date(actual)": "2014-01-12" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-11-06", "last_updated_that_met_qc_criteria": "2018-11-02", "last_verified": "2018-11" }, "study_registration_dates": { "first_posted(estimated)": "2018-11-06", "first_submitted": "2018-10-26", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Maternal smoking during pregnancy although it is known to be associated with fetal growth restriction, it's effect on postpartum breastfeeding is not yet clear. The aim of the present study was to examine the impacts of smoking in pregnancy on breastfeeding as well as its impacts on placental immunoreactivity. Detailed Description The study was conducted on 70 women who gave birth via spontaneous vaginal delivery. Groups were classified as Smokers (n=35) and Non-smokers (n=35). The breastfeeding conditions of both groups were evaluated prior to discharge and after postpartum 10th day. Cross-sections were taken from the placenta tissues after which their IGF-1 (insulin like growth factor-1), Leptin, HPL (human placental lactogen) immunoreactivities were examined.	#Eligibility Criteria: Inclusion Criteria: * Pregnant women who have started smoking at least 100 cigarettes in her lifetime and who now smokes every day, * Pregnant women who have never smoked throughout their life, including pregnancy(16), * Pregnant women who gave birth at term, * Multiple pregnancy, preeclampsia, gestational diabetes, thyroid dysfunction, those who do not have a systemic disease and due to systemic disease during pregnancy those who do not use * Pregnant women who had spontaneous vaginal delivery, * In order not to encounter communication barriers and because cultural differences may vary, the pregnant woman is not a foreign national, * Pregnant women who do not have any barriers to communication by phone, * Those who do not have any health problems that prevent breastfeeding Exclusion Criteria: * multiple pregnancy * insulin dependent diabetes * pregnant women who have had a cesarean section * preeclampsia * thyroid disease Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT06456645	{ "brief_title": "Effects of Smoking on Placenta and Lactation", "conditions": [ "Smoking, Tobacco", "Placenta Diseases", "Breastfeeding", "Fetal Conditions" ], "interventions": null, "location_countries": [ "Turkey" ], "nct_id": "NCT06456645", "official_title": "The Impacts of Maternal Smoking During Pregnancy on Breastfeeding and the Correlation of IGF, Leptin, HPL Expression in Placenta Tissue", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-17", "study_completion_date(actual)": "2019-11-05", "study_start_date(actual)": "2017-05-01" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-06-13", "last_updated_that_met_qc_criteria": "2024-06-07", "last_verified": "2024-06" }, "study_registration_dates": { "first_posted(estimated)": "2024-06-13", "first_submitted": "2024-05-29", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a Phase I study consisting of 2 parts: Part 1 aims to investigate the relative bioavailability of tablet formulation (test treatment) and Powder in capsule (PiC) formulation (reference treatment) of M7583 under fasted conditions. The aim of Part 2 is to determine and compare the single dose Pharmacokinetic (PK) profile of M7583 tablet under fasted and fed conditions to assess the food effect. #Intervention - DRUG : M7583 - Subject will receive either M7583 PiC or M7583 tablet formulation orally under fasted conditions in part 1 followed by M7583 tablet formulation under fed condition in part 2 of the study.	#Eligibility Criteria: Inclusion Criteria: * Adult males and females between 18 and 55 years (inclusive) with total body weight between 50.0 and 100.0 kilogram (kg) (inclusive) and body mass index (BMI) between 19.0 and 30.0 kilogram per meter square (kg/m2) (inclusive) at the time of the Screening examination. * A female participant is eligible to participate if she is not pregnant, not breastfeeding. * Females must have a negative serum pregnancy test at Screening visit and at Day -1 before randomization/first dosing. * Men must agree to use a barrier method (specifically, male condom with or without spermicide) and to have their female partners use a highly effective method of contraception during the treatment period, and for at least 3 months after the last IMP administration. Men must also refrain from donating sperm during this period. * Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to subject safety or interfere with the trial evaluation, procedures, or completion. * Stable non-smokers for at least 3 months preceding Screening. * Must agree not to consume any alcohol during the treatment period of the trial. * Able and willing to give written informed consent and has signed the appropriate written informed consent form, approved by the Investigator's Independent Ethics Committee (IEC), prior to the performance of any trial activities. Exclusion Criteria: * History of clinically relevant disease of any organ system, that may interfere with the objectives of the trial or provide a risk to the health of the subject. * History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening. * History of Herpes zoster within 12 months prior to Screening * History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the subject and/or outcome of the trial per the Investigator's discretion. * History of alcoholism or drug abuse within 2 years prior to Screening and the subject is unwilling to abstain from alcohol and drug of abuse during the trial * Consumption of an average weekly intake of greater than (>) 14 drinks/week for males or > 7 drinks/week for females. One drink is equivalent to (12 g alcohol) = 5 ounces (150 milliliter (mL)) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 40 Vol% distilled spirits. * Positive for drugs of abuse, nicotine/cotinine or alcohol at Screening or at admission. * Supine systolic blood pressure > 140 mmHg or less than (<) 90 mmHg, diastolic blood pressure > 90 mmHg or <50 and pulse rate >100 or <= 50 bpm, at admission. * 12-Lead ECG showing a QTcF > 450 ms, PQ > 200ms, or QRS > 120 ms or other clinically relevant abnormal findings Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT03297983	{ "brief_title": "M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule", "conditions": [ "Healthy" ], "interventions": [ "Drug: M7583" ], "location_countries": [ "Germany" ], "nct_id": "NCT03297983", "official_title": "Phase I, Open-label, Randomized, Two Part, Three-Period, Two-Sequence, Cross-over Study to Investigate the Relative Bioavailability of a Tablet Formulation Compared to Powder-in-Capsule of M7583 Including a Food Effect Evaluation for the Tablet in Healthy Volunteers", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-06", "study_completion_date(actual)": "2017-12-06", "study_start_date(actual)": "2017-10-09" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-07-23", "last_updated_that_met_qc_criteria": "2017-09-27", "last_verified": "2018-07" }, "study_registration_dates": { "first_posted(estimated)": "2017-09-29", "first_submitted": "2017-09-27", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation Detailed Description Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v. #Intervention - DRUG : Alemtuzumab - Consolidation after CHOP induction - Other Names : - MabCampath	#Eligibility Criteria: Inclusion Criteria: * all risk groups in international prognostic index * diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment. * these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma * Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0 <= age <= 3(Karnofsky index 40 <= age <= 100%) * written consent of the patient * Declaration of center participation Exclusion Criteria: * Already initiated lymphoma therapy(exept for the prephase treatment specified for this study) * Serious accompanying disorder or impaired organ function * bone marrow involvement>25% * Known hypersensitivity to medications to be used * Know HIV-positivity * Active hepatitis infection, active CMV infection, prior florid tuberculosis * floride systemic infections * suspicion that patient compliance will be poor * Simultaneous participation in any the study protocol * prior chemo-or radiotherapy for malignancy * other concomitant malignant disease * Pregnancy or lactation period Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01806337	{ "brief_title": "CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma", "conditions": [ "Peripheral T-Cell Lymphoma" ], "interventions": [ "Drug: Alemtuzumab" ], "location_countries": null, "nct_id": "NCT01806337", "official_title": "Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07", "study_completion_date(actual)": "2011-02", "study_start_date(actual)": "2003-07" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2013-03-07", "last_updated_that_met_qc_criteria": "2013-03-06", "last_verified": "2013-03" }, "study_registration_dates": { "first_posted(estimated)": "2013-03-07", "first_submitted": "2013-02-25", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures. #Intervention - DRUG : 35 mg risedronate DR tablet - 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet - DRUG : 35 mg risedronate DR tablet - 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner - DRUG : 35 mg risedronate DR tablet - 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast	#Eligibility Criteria: Inclusion Criteria: * female, 40 <= age <= 70 of age * non-lactating and either surgically sterile or postmenopausal * body mass index less than or equal to 32 kg/m2 at screening Exclusion Criteria: * no use of a bisphosphonate within 1 month * no history of GI disease * no use of any medications within 7 <= age <= 14 days prior to scheduled dosing day Sex : FEMALE Ages : - Minimum Age : 40 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT00868907	{ "brief_title": "Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food", "conditions": [ "Healthy" ], "interventions": [ "Drug: 35 mg risedronate DR tablet" ], "location_countries": [ "United States" ], "nct_id": "NCT00868907", "official_title": "A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-04", "study_completion_date(actual)": "2009-04", "study_start_date(actual)": "2009-03" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2011-10-12", "last_updated_that_met_qc_criteria": "2009-03-24", "last_verified": "2011-10" }, "study_registration_dates": { "first_posted(estimated)": "2009-03-25", "first_submitted": "2009-03-23", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Precise assessment of postoperative volume status is important to administrate optimal fluid management. Bioelectrical impedance analysis (BIA) which measures the body composition using electric character. Extracellular water (ECW) ratio by BIA represented as the ratio of ECW to total body water (TBW) and is known to reflect the hydration status. Based on this, we aimed to determine whether aggressive fluid control using ECW ratio could improve clinical outcomes through a single blind, randomized controlled trial. Detailed Description Critically ill patients admitted to an intensive care unit (ICU) after surgery have commonly experienced a large amount of wide organ injury and profuse bleeding resulting in vessel damage during surgery. Severe systemic inflammatory reactions and pathophysiological stress could consequently occur in these patients. For patients in an acute postoperative phase, it is important to maintain organ perfusion by correcting hemodynamic instability through fluid resuscitation. Bioelectrical impedance analysis (BIA), a non-invasive method, is useful for quantitatively measuring body composition such as body fat and muscle mass. It is also useful for evaluating volume status based on resistance and reactance of cells known to have different electrical conductivity according to biological characteristics of body composition. In our previous study using BIA, the results showed that changes in ECW ratio after surgery were related to conventional parameters of overhydrated status such as daily fluid balance or capillary leak index (CLI). In addition, overhydration with value of ECW ratio above 0.390 on 3rd postoperative day appeared to be a risk factor for postoperative morbidity and mortality. Herein, we aim to set the ECW ratio as a guideline for postoperative volume status and confirm a hypothesis that active intervention with fluid management to control the ECW ratio by BIA could lower clinical outcomes in patients with fluid imbalance through a prospective randomized controlled study. #Intervention - DRUG : Active fluid management with BIA monitoring - The participants in active fluid management with BIA monitoring arm received fluid supplementation targeting specific range of ECW ratio by BIA (0.390-0.406). If a patient with dehydrated status indicated by the ECW ratio was less than 0.390, a bolus infusion was performed using 250ml of crystalloid fluid (PlasmaLyte). If a patient with overhydrated status indicated by the ECW ratio was more than 0.406, 10mg of furosemide was administered. Changes in the ECW ratio were measured at one hour after initial intervention for fluid adjustment, and these processes continued until the ECW ratio was within the normal range (0.390-0.406). - DRUG : Conventional fluid management without BIA monitoring - The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA.	#Eligibility Criteria: Inclusion Criteria: * Patients admitted to the surgical ICU after surgery under general anesthesia regardless of the type of surgery * Patients who showed abnormal range of baseline ECW ratio by BIA (less than 0.390 or more than 0.405) that measured at the time of ICU admission Exclusion Criteria: * aged under 18 years * underwent surgery under local or regional anesthesia * pregnant * had bone fixation or underwent limb amputation * had any prosthetic medical devices such as pacemaker or metallic intravascular device * stayed in ICU for less than 48 hours * readmitted within 48 hours after ICU discharge * diagnosed with renal failure and receiving renal replacement therapy * underwent extracorporeal membrane oxygenation treatment before surgery * agreed for do-not-resuscitate Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT06097923	{ "brief_title": "Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)", "conditions": [ "Fluid Overload", "Fluid Loss" ], "interventions": [ "Drug: Active fluid management with BIA monitoring", "Drug: Conventional fluid management without BIA monitoring" ], "location_countries": [ "Korea, Republic of" ], "nct_id": "NCT06097923", "official_title": "Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer of Postoperative Patients in Surgical Intensive Care Unit (SICU); a Novel Guidance to Set an Ideal Fluid Status of Patient in Acute Postoperative Phase", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31", "study_completion_date(actual)": "2022-12-31", "study_start_date(actual)": "2021-11-30" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-10-24", "last_updated_that_met_qc_criteria": "2023-10-16", "last_verified": "2023-10" }, "study_registration_dates": { "first_posted(estimated)": "2023-10-24", "first_submitted": "2023-10-16", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed. Detailed Description Recurrence of CDI following a course of standard antibiotic therapy is high, especially in the elderly patients over 65 years of age, in hospitalized and in the immunocompromised patients. As CDI is characterized by intestinal dysbiosis. Fecal Microbiology Transplantation (FMT) has been investigated as alternative treatment for CDI and has been determined to be effective and safe. One of the major challenges of offering FMT is the availability of suitable donors. A donor may no longer be able to continue to donate for a number of reasons and this may lead to temporary interruption of FMT in centers which offer the program. In order to continue to offer FMT whenever needed, we will investigate the efficacy of lyophilized FMT. The lyophilization (freeze-drying) process works by dehydrating a frozen donor stool sample to complete dryness, using controlled temperature and pressure gradients. This lyophilized process results in a powdered form of the sample. Studies have shown that lyophilized donor stool samples have similar microbial compositions as the same fresh sample.The technique of freeze drying has been used for decades for the industrial storage of microbes and has been used. Preliminary study of lyophilized stool for FMT has been performed in dogs. Preliminary efficacy data in dogs with inflammatory bowel disease suggest equal efficacy as compared to fresh stool, although controlled study has yet to be performed. Should the lyophilized FMT (L-FMT) demonstrate to be equally or more effective than frozen FMT, there would be significant advantages. As with frozen FMT, lyophilized FMT will allow patients to receive FMT immediately as it can take up to two weeks for a donor's screening laboratory testing results to be available. Lyophilized FMT will also be more cost effective as less number of donors will need to be screened given the prolonged shelf life of lyophilized FMT which can be kept at above the freezing temperature. 9 This will also allow wider distribution and accessibility especially to the regions with limited capacity to manufacture FMT. #Intervention - DRUG : Lyophilized Fecal Microbiota Transplantation - Lyophilized FMT	#Eligibility Criteria: Inclusion Criteria: * Age >= >= 12 years. * Able to provide informed consent. * Willing and able to comply with all the required study procedures. * A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment unless patient taking treatment specifically for CDI for more than 3 months. * History of at least >= 2 recurrent CDI where recurrence is deﬁned as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy for each episode and/or ongoing symptoms consistent with CDI* (defined below) despite at least 7 days of treatment using oral vancomycin at a minimum dose of 250 mg four times daily. * Symptoms of CDI include: diarrhea deﬁned as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea Exclusion Criteria: * Planned or actively taking another investigational product * CDI symptom-free for 3 or more weeks following completion of CDI treatment * Patients with neutropenia with absolute neutrophil count <0.5 x 109/L * Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray * Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter. * Presence of colostomy * Unable to tolerate FMT or enema for any reason. * Requiring systemic antibiotic therapy for more than 7 days. * Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed * Severe underlying disease such that the patient is not expected to survive for at least 30 days. Sex : ALL Ages : - Minimum Age : 12 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT03834038	{ "brief_title": "Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection", "conditions": [ "Recurrent Clostridium Difficile Infection" ], "interventions": [ "Drug: Lyophilized Fecal Microbiota Transplantation" ], "location_countries": [ "Canada" ], "nct_id": "NCT03834038", "official_title": "Prospective, Open-label Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Transplantation for Treatment of Recurrent C. Difficile Infection", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-01", "study_completion_date(actual)": "2020-03-17", "study_start_date(actual)": "2015-10-01" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-09-23", "last_updated_that_met_qc_criteria": "2019-02-06", "last_verified": "2024-05" }, "study_registration_dates": { "first_posted(estimated)": "2019-02-07", "first_submitted": "2019-02-06", "first_submitted_that_met_qc_criteria": "2024-05-30" } } }
#Study Description Brief Summary Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH). #Intervention - DRUG : ZSP1601 - ZSP1601 tablets be taken orally for 28 days. - DRUG : ZSP1601 Placebo - Subjects will receive matching placebo of ZSP1601	#Eligibility Criteria: Inclusion Criteria: * Subjects are required to meet the following criteria in order to be included in the trial: 1. Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions. 2. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study. 3. Subjects(including partners)have no gestation plans and must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product. 4. Male and female subjects aged 18 <= age <= 65 (including 18 and 65). 5. B ultrasound confirmed fatty liver. 6. NASH diagnosis or NASH phenotypic diagnosis. 7. Liver fat >=10% at baseline (MRI-PDFF) Exclusion Criteria: * Eligible subjects must not meet any of the following exclusion criteria: 1. Excessive drinking for 3 consecutive months within 1 year before screening. 2. Allergic constitution. 3. Subjects who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening. 4. Subjects having a history of bariatric surgery or preparing for bariatric surgery recently. 5. Subjects having a history of liver transplantation or plans for liver transplantation 6. Any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers. 7. Liver biopsy indicates cirrhosis or previous clinical diagnosis of cirrhosis. 8. Type 1 diabetes mellitus. 9. Uncontrolled type 2 diabetes mellitus (HbA1c>=8.0%)。 10. Any clinically significant abnormality upon physical examination or in the clinical laboratory tests, history or presence of other causes of liver disease,but not limited to above disorders: hepatitis b or hepatitis c virus (HCV) infection and chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson 's disease, alpha 1 - antitrypsin deficiency, liver, obvious abnormal liver function (ALT and AST acuity 5 x ULN or TBIL acuity 1.5 x ULN), etc. 11. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs. 12. History of having any special food(including dragon fruit,mango,grapefruit,etc.),strenuous exercises,or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 2 weeks prior to screening. 13. Participated in another clinical research study and received any investigational products within 3 months prior to dosing. 14. Presence of clinically significant abnormalities in ECG or QTcB>450ms in males,or QTcB>470ms in females. 15. HIV positive. 16. Clinically significant nephropathy or renal dysfunction, blood creatinine >1.5×ULN, eGFR< 60 mL/min/1.73m2 [calculation formula: Ccr:(140-age)× weight (kg) /0.818×Scr(mumol /L), female ×0.85]. 17. Platelet count <100×109/L. 18. Antinuclear antibody (ANA) confirmed positive and clinically significant. 19. Abnormal TSH with clinical significance. 20. Female during pregnancy and lactation or positive serum pregnancy test. 21. Patients with contraindication of MRI scan. 22. Take any product contains alcohol within 24 hours prior to dosing. 23. Have chocolate, any food or beverage that contains caffeine or xanthine within 24 hours prior to dosing. 24. Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening. 25. Any acute illness or concomitant medication from screening to first dosing. 26. As judged by the researcher, it is not suitable to join the clinical researcher. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04140123	{ "brief_title": "Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)", "conditions": [ "Non-Alcoholic Steatohepatitis (NASH)" ], "interventions": [ "Drug: ZSP1601 Placebo", "Drug: ZSP1601" ], "location_countries": [ "China" ], "nct_id": "NCT04140123", "official_title": "A Multi-center, Randomized, Double-blind, Dose-increasing, Placebo-controlled，Multi-dose, 28-day Continuous Administration Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, Efficacy, and PK of ZSP1601 in Patients With Nonalcoholic Steatohepatitis", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-03", "study_completion_date(actual)": "2021-08-03", "study_start_date(actual)": "2020-06-23" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "QUADRUPLE", "phase": [ "PHASE1", "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-10-11", "last_updated_that_met_qc_criteria": "2019-10-23", "last_verified": "2021-10" }, "study_registration_dates": { "first_posted(estimated)": "2019-10-25", "first_submitted": "2019-10-15", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C. Detailed Description The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition (SC). We expect that, relative to the SC condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV. #Intervention - BEHAVIORAL : Cognitive behavioral treatment for depression - Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C	#Eligibility Criteria: Inclusion Criteria: * Currently undergoing HCV treatment at RIH * Enrolled in MMT for at least 6 months Exclusion Criteria: * Current major depressive episode * Current suicidality * Currently taking antidepressant medication * Received HCV treatment in past Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT00218556	{ "brief_title": "Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1", "conditions": [ "Depressive Disorder, Major", "Hepatitis C" ], "interventions": [ "Behavioral: Cognitive behavioral treatment for depression" ], "location_countries": [ "United States" ], "nct_id": "NCT00218556", "official_title": "Preventing Depression in MMT Patients on Interferon", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06", "study_completion_date(actual)": "2008-06", "study_start_date(actual)": "2004-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2017-01-12", "last_updated_that_met_qc_criteria": "2005-09-20", "last_verified": "2015-10" }, "study_registration_dates": { "first_posted(estimated)": "2005-09-22", "first_submitted": "2005-09-20", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400 mg \[14C\]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to 6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1. Detailed Description The present study is designed to investigate the absorption, metabolism, excretion as well as safety/tolerability of pacritinib following the administration of a single oral dose to healthy male volunteers. The pacritinib dose is administered with a \[14C\]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation. The study design allows detection of potential human specific metabolites that have not been detected in the animal species. Subjects are confined at the clinical site from the time of Check-in until Day 14 post-dose, but may be discharged from the clinical site between Day 10 and 13 post-dose if study discharge criteria are met (i.e. completion of sufficient radioactivity excretion). All remaining subjects will be discharged from the clinical site on Day 14 post-dose irrespective of the study discharge criteria. The data obtained in this study will be used for the further clinical development of the compound. #Intervention - DRUG : Pacritinib - 400 mg \[14C\]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose following at least a 10-hour fast (not including water) on Day 1	#Eligibility Criteria: Inclusion Criteria: * Non-smoking men between 18 and 55 years (inclusive) * ECG within normal limits (according to the criteria used by QPS Netherlands BV including QTc interval (less than or equal to 450 m/sec) * Normal vital signs measurements [defined as blood pressure (BP) between 90 <= age <= 140 mmHg systolic and 50 <= age <= 90 mmHg diastolic, resting heart rate (HR) between 40 <= age <= 100 beats/min, temperature (T) less than or equal to 37.6 degree C]) * Body mass index of 19.0 <= age <= 29.0 kg/m2 inclusive * Negative history of drug abuse or alcoholism within 1 year prior to Day 1 * Negative tests on drug and alcohol screen at Screening and Check-in * Negative hepatitis panel including hepatitis B-surface antigen HBsAg], hepatitis C antibody [anti-HCV] and negative human immunodeficiency virus antibody (HIV) * No clinical laboratory value outside of the normal reference range unless deemed not clinically significant by the Investigator in consultation with the Sponsor * Fertile male subjects and fertile female sexual partners of male subjects agree to use effective birth control methods throughout the entire study. Female partners of childbearing potential must use highly effective methods (defined as those resulting in a failure rate of <1% per year when used consistently and correctly). The contraceptive methods considered highly effective are intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release). Male subjects must use a condom with spermicide paste for the duration of the study and for 90 days after the EOS evaluation. When abstinence is used as a method of birth control, only true abstinence is acceptable, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, ovulation, symptothermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception * Agreement to not donate sperm throughout the entire study and for 3 months after the end of the study * Willingness to comply with the protocol, including restrictions on diet, physical activity, and use of alcohol, medications, and other drugs during the study * Comprehend and willingness to sign an approved informed consent form for the study * At least one bowel movement a day Exclusion Criteria: * Participation in another radioactive clinical trial within the past 12 months * Actively participating in an experimental therapy study or who have received experimental therapy within 90 days of Day 1 * Use of any other prescription medication within 21 days of Day 1, unless approved by Sponsor * Use of over-the-counter (OTC) medications or nonprescription preparations (including vitamins, minerals and phytotherapeutic/herbal/plant-derived preparations) that is known to induce drug-metabolizing enzymes, including CYP450 enzymes within the 7 days preceding Day 1 (except for spermicidal/barrier contraceptive products and paracetamol) * Consumption of alcoholic beverages within 72 hours prior to Check-in (Day -1) * Consumption of grapefruit- and grapefruit-containing products within 7 days prior to Day 1 * Consumption of xanthine containing beverages such as coffee, including energy drinks containing caffeine or tea within 2 days of Day 1 * Clinically significant abnormal physical finding at Screening * Any severe acute or chronic medical condition, psychiatric condition, or laboratory abnormality that in the Investigator's opinion may increase the risk associated with study participation or administration of study treatment, or interfere with the interpretation of study results (such as gastrointestinal surgical history (except appendectomy), ileus or obstructive uropathy) * Diarrhea, nausea or vomiting within 7 days of Day 1 * History of additional risk factors for torsade de pointes (TdP) (e.g. heart failure, hypokalemia defined as serum potassium <3.0 mmol/L, family history of Long QT Syndrome) * Any illness during the 4 weeks prior to Day 1, unless deemed NCS by the Principal Investigator * Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens) * Known history or presence of food allergies or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs * Any surgical procedures within 72 hours of Day 1 * Blood draws of more than 400 mL during the conduct of any clinical study within 90 days prior to Day 1 * Poor peripheral venous access * Donation of blood 30 days prior to Screening through end of study * Employment in a position that exposes the subject to radiation or requires that the subject's degree of radiation exposure be monitored (e.g. radiology technician) Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT02803762	{ "brief_title": "Investigate Absorption, Metabolism, Excretion, and Mass Balance of Pacritinib", "conditions": [ "Healthy" ], "interventions": [ "Drug: Pacritinib" ], "location_countries": [ "Netherlands" ], "nct_id": "NCT02803762", "official_title": "A Phase 1, Open-Label Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of [14C] Pacritinib Following a Single Oral Dose in Healthy Male Subjects", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10", "study_completion_date(actual)": "2014-10", "study_start_date(actual)": "2014-07" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": null, "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-06-17", "last_updated_that_met_qc_criteria": "2016-06-14", "last_verified": "2016-05" }, "study_registration_dates": { "first_posted(estimated)": "2016-06-17", "first_submitted": "2016-05-03", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Data Collection of OCT and OCTA-based Ocular Measurements Detailed Description The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology. #Intervention - DEVICE : SD-OCT - Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures	#Eligibility Criteria: Inclusion Criteria: * No glaucoma * No retinal pathology * No systemic disorders impacting the eye * No ocular surgery or medical treatment of ocular condition Exclusion Criteria: * High IOP * Poor vision * Clinical findings consistent with pathology * Unable to complete the study Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT03887104	{ "brief_title": "Data Collection of OCT and OCTA-based Ocular Measurements", "conditions": [ "Eyes Without Ocular Pathology" ], "interventions": null, "location_countries": [ "United States" ], "nct_id": "NCT03887104", "official_title": "Data Collection of OCT and OCTA-based Ocular Measurements", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-11", "study_completion_date(actual)": "2019-08-30", "study_start_date(actual)": "2019-02-08" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-09-03", "last_updated_that_met_qc_criteria": "2019-03-20", "last_verified": "2019-08" }, "study_registration_dates": { "first_posted(estimated)": "2019-03-22", "first_submitted": "2019-03-11", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Equine-assisted interventions (EAI) are an emerging form of alternate psychotherapy that has been increasingly found to produce improvements in various treatment outcomes. However, the paucity of randomized-controlled trials (RCTs) in the EAI literature prevents any definitive conclusions to be made about the general effectiveness of EAI. This study tests whether one form of EAI, Equine-Assisted Psychotherapy (EAP), reduces aggression and alters risk factors associated with aggression in young adults, and whether emotion regulation mediates any effect of EAP on aggression. In a single-blind RCT, undergraduate students will be randomly assigned to either an intervention group, an active-control group, or a placebo-control group. Participants in the intervention group will undergo a 5-week EAP program consisting of structured, interactive activities with horses followed by a clinical processing component. Participants in the active control group will undergo a 5-week program that only involves interactions with horses without any clinical input (i.e. commonly coined as animal-assisted activities). Participants in the placebo-control group will undergo 5 weeks of 1-hour movie sessions related to horses. There will be three waves of data collection measuring key outcome variables - t1 before the 1st session, t2 after the 3rd session, and t3 after the final session. Participants will complete questionnaires assessing the key outcomes of aggression, emotional well-being and academic performance. Other risk factors of antisocial behaviour such as psychopathy, level of empathy, emotion regulation and executive functioning will also be measured. To the author's knowledge, the current study is the first in Singapore to investigate if EAP can lower aggression levels and alter psychological risk factors for aggression in healthy young adults. In turn, these results could help inform the utility and validity of EAP in the forensic populations. Detailed Description The EAP program will span over the duration of 5 weeks, each week having a 1-hour session. 50 minutes will be allocated to interacting with the horses and the activities while the remaining 10 minutes will be allocated to the clinical processing of the behavior, thoughts and emotions that are observed during the session. This processing will be guided by trained therapists who hold the relevant qualifications (i.e. equine-assisted psychotherapy certification). 2 horses (an Oldenburg and a pony, aged 19 and 14 respectively), 2 therapists, and 2 experienced horse handlers will be present throughout the sessions. Each 1-hour session will consist a maximum of 8 participants that will be split into two groups of 4 such that 1 horse, 1 therapist and 1 experienced horse handler are attached to them. The design of the experiment will be a single-blind Randomized Controlled Trial. Participants will be told that this study aims to investigate the therapeutic effects of two different EAP programs (either watching video clips related to horses or actual interactions with horses) and that they will be randomly assigned to either one. In actuality, participants are randomly assigned to either an intervention group, an active-control group or a placebo-control group. 3 time points of data collection are measured throughout the 5-week duration - t1 before the 1st session, t2 after the 3rd session, and t3 after the final session. All participants will go through the same questionnaire administered at each time point during the 5-week duration regardless of their assigned group. Participants in the intervention group will go through the 5-week EAP program consisting of the clinical processing following some activities found in EAP manuals. Participants in the active-control group will undergo a 5-week program that only involves interactions with horses without any clinical input (i.e. commonly coined as animal-assisted activities). Participants in the placebo-control group will undergo a 5-week movie screening of 1 hour each session that is related to horses in the lab. Participant recruitment will begin as soon as possible once approval has been given and should not take longer than 2 weeks to recruit a total of 120 undergraduate students from both NUS and NTU. The 5-week intervention program will be briefly structured as such: Session 1: Introduction to grooming and horse safety This introductory session is aimed at getting participants to be familiar with the safety features when working with these horses as well as to be attentive to the warning cues that horses display that is indicative of their mood. Once that has been briefed, participants will be taught how to groom the horse as part of learning natural horsemanship skills. These includes brushing and cleaning the hooves of the horse. Session 2: Review of grooming, learning to put on halter and leading the horse The second session is built upon the previous session in that reviews of grooming and horse safety will continually be surfaced throughout the program as such lessons is always an ongoing process. On top of that, participants will be taught how to put on a halter on the horse and to lead the horse. The session ends with a modified activity called Catch and Release which allows participants to have personal interaction with the horse. Session 3: Review of grooming and Give-and-Take The third session is more focused on the importance of proper communication as this helps convey the investigators intentions across with greater accuracy while still remaining respectful and mindful of the other party on the receiving end. After the grooming segment, participants will engage in an activity called Give-and-Take which work improving communication in a non-verbal manner only through the string they are provided with to guide the horse. Session 4: Review on grooming and Life's Little Obstacles This session is aimed at utilizing participants' critical thinking skills to achieve the objective of the activity. This is meant to push participants' out of their comfort zones which could bring about feelings of frustration and worry that can be processed after the activity is over. The activity that is meant to create such a roadblock is the Life's Little Obstacles whereby participants are told to make the horse jump over a low obstacle with multiple restrictions. Session 5: Review on grooming, Equine Billiards, and closing This final session is aimed at utilizing participants' problem-solving skills through the use of non-verbal communication. This is done using the Equine Billiards activity whereby the lessons learnt from previous sessions would culminate in this one task. Following the processing of the activity after it ends, the therapy team and participants would gather in a circle for the program closure to integrate whatever they have learnt from the past 5-weeks. GPower 3.1 was used to calculate an appropriate sample size for a medium effect size of 0.15, power at 0.95 and alpha error probability at 0.05. For a multiple linear regression analysis with 2 tested predictors and total number of 4 predictors, the calculation yielded a total sample size of 119. This number was rounded up to 120. All data will be analyzed using SPSS version 22. Some potential analyses include multiple linear regression, ANCOVAs and their respective post-hoc t-tests, paired-sample t-tests to demonstrate significant changes between pre and post intervention groups, and PROCESS Macro for the mediator analysis. #Intervention - BEHAVIORAL : Equine-Assisted Psychotherapy - Equine-Assisted Psychotherapy (EAP) involves working on the psychological goals set between the client and the mental health professional. This is done through the experiential interactions between the clients and the horse. This experiential aspect is vital as it allows clients to process the emotions, thoughts and behaviors that were expressed during sessions with the horse. - Other Names : - Equine-Facilitated Psychotherapy - BEHAVIORAL : Equine-Assisted Activities - Simple interactions with the horses that does not necessarily involve any goals being set between the client and the personnel handling the session. These can involve activities such as grooming or petting of the horse. - OTHER : Placebo-control group - This group will only be watching movies related to horses and they are told that this is another form of EAP even though this is not the case. This type of intervention has not been known to provide any therapeutic effect relevant to the study and thus is used as the placebo-control.	#Eligibility Criteria: Inclusion Criteria: * Do not have any medical allergies or discomfort from interaction with horses. Exclusion Criteria: * Participants who self-report an existing diagnosis for a psychological disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition: DSM-V Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 28 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT04200612	{ "brief_title": "The Therapeutic Effects of Equine-Assisted Psychotherapy", "conditions": [ "Aggression", "Stress", "Psychopathy", "Empathy" ], "interventions": [ "Other: Placebo-control group", "Behavioral: Equine-Assisted Activities", "Behavioral: Equine-Assisted Psychotherapy" ], "location_countries": [ "Singapore" ], "nct_id": "NCT04200612", "official_title": "The Therapeutic Effects of Equine-Assisted Psychotherapy on Lowering Aggression Levels Through an Increase of Emotion Regulation", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-09", "study_completion_date(actual)": "2020-11-06", "study_start_date(actual)": "2020-01-20" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-03-03", "last_updated_that_met_qc_criteria": "2019-12-13", "last_verified": "2021-03" }, "study_registration_dates": { "first_posted(estimated)": "2019-12-16", "first_submitted": "2019-12-11", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines. Detailed Description Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines. Secondary objective is * To evaluate pathological response determined by histological work up of the surgical specimens according to TNM stages. * To evaluate the metabolic response determined by PET analysis. * To assess overall survival (OS) (median survival time and percentage of 1-year survival). OS is defined as time elapsed from the date of patient inclusion until recorded date of death. * To characterize and quantify toxic effects of the scheduled therapy. Safety profile and tolerability will be assessed by recording adverse events, clinically significant laboratory abnormalities, physical examination and vital signs. Toxicities will be evaluated according to the NCI-CTC Toxicity Criteria and adverse events which are not reported in NCI-CTC will be graded as mild, moderate, severe or life-threatening. All patients who received any of the scheduled therapy will be included in the overall toxicity analysis. * To evaluate the immunological response determined by regulatory T-cells and immune activation markers, to define chemoresistance by pharmacogenomic testing. #Intervention - DRUG : Docetaxel - 75mg/m², day 1,22 - Other Names : - Taxotere - DRUG : oxaliplatin - 40mg/m², d1,2,22,23 - Other Names : - CDDP - DRUG : cetuximab - 400mg/m² (day1), 250mg/m² (day 8,15,22,29,36) - Other Names : - Erbitux - PROCEDURE : surgery - 28 days after end of induction chemotherapy	#Eligibility Criteria: Inclusion Criteria: Histology and staging of the disease * Histological confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC. * Anatomically and functionally resectable NSCLC stage IB (T2N0) stage II (T1 <= age <= 2 N1, T3 N0) or stage IIIA (T3 N1) (see TAKO guidelines 2006, www.tako.or.at) * Measurable disease according to RECIST criteria General conditions * 18 <= age <= 80 years. * WHO 0 <= age <= 2; life expectancy of more than 3 months * Effective contraception for both male and female patients if the risk of conception exists * Adequate respiratory function, sufficient for necessary surgical treatment * Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 10 9/L, platelets > 100 x 10 9/L). * Adequate renal and hepatic functions: total bilirubin within normal limits, serum creatinine within normal limits, in case of limit value the creatinine clearance should be > 60 ml/min, ASAT and ALAT < 2.5 x UNL, alkaline phosphatase < 5 x UNL. Initial work-up * Complete initial work-up within three weeks prior to first infusion includes chest CT scan, abdominal CT-scan, brain CT scan if indicated, PET-scan, bronchoscopy and mediastinoscopy, pulmonary function. Within 7 days prior to inclusion laboratory investigations and biological work up. * Signed initial consent prior to protocol specific procedures. Exclusion Criteria: Diagnosis * Evidence of brain metastases or other distant metastasis equivalent to stage IV disease * History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years * Other serious concomitant illness or medical condition: * Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia * History of significant neurological or psychiatric disorders, including dementia or seizure * Active infection requiring i.v. antibiotics * Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy * Current peripheral neuropathy WHO grade > 2 Prior or concurrent therapy * Prior chemotherapy or immunotherapy for NSCLC * Prior surgery or radiotherapy for NSCLC * Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy * Concurrent continuous treatment with systemic steroids for antiemetic use, intermittent application is allowed General conditions * Pregnant (absence to be confirmed by ß-HCG-test) or lactating patients * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements * Participation in other clinical trials with experimental agents or non approved medical procedures during study and within 30 days prior to study entry * Psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with the study protocol. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT00406302	{ "brief_title": "Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)", "conditions": [ "Carcinoma, Non-small-cell Lung" ], "interventions": null, "location_countries": [ "Austria" ], "nct_id": "NCT00406302", "official_title": "Multicenter Phase II Study Evaluating Docetaxel, CDDP, and Cetuximab as Induction Regimen Prior to Surgery in Chemo-naive Patients With NSCLC Stage IB, II and IIIA", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06", "study_completion_date(actual)": "2011-06", "study_start_date(actual)": "2007-01" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2014-04-29", "last_updated_that_met_qc_criteria": "2006-12-01", "last_verified": "2014-04" }, "study_registration_dates": { "first_posted(estimated)": "2006-12-04", "first_submitted": "2006-12-01", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study will evaluate the effect of endoscopic clipping of colonic diverticula in treatment of symptoms related to diverticular disease. Half of the participants will undergo colonoscopy without the clipping procedure and half will have colonoscopy with clipping of all visible diverticula. Detailed Description Colonic diverticular disease (DD) is characterised by the presence of sac-like protrusions (diverticula), which form through defects in the muscle layer of the colon wall. It is prevalent in western countries, affecting approximately 70% of individuals by the age of 80. The risk of acquiring diverticular disease increases uniformly with age, with approximately 40% of people aged over 60 years affected in western countries. Diverticular complications may be severe and include pain, inflammation, infection and bleeding. Although the majority of people with diverticular disease are asymptomatic, approximately 25% will experience an episode of acute diverticulitis (the principal inflammatory complication of diverticulosis); of these, 15% will develop other significant and often serious complications such as abscess, fistula or perforation. King's College Hospital operates a tertiary referral service for patients with diverticular disease that integrates a gastroenterological and colorectal surgical approach to treatment. The investigators increasingly find that many patients have characteristic DD pain and IBS like symptoms with or without a clearly defined episode of diverticulitis. The link between symptomatic diverticular disease and Irritable Bowel Symptoms is reflected to some extent in the literature, however, it remains a matter of significant controversy. Nevertheless, these symptoms are often difficult to control and can be debilitating. Current treatment options for the IBS like symptoms in symptomatic uncomplicated DD are limited. In this age group, a low FODMAP diet, the mainstay treatment for IBS, is impractical and there are few if any controlled studies that address these issues. There is hence a need for alternative therapeutic options. Secondly, complications related to DD are associated with significant morbidity and mortality and comes at significant cost to the health service. At present there is no proven prophylactic intervention to prevent the complications. The investigators have recently published the results of a feasibility study carried out at King's College Hospital, which assessed the effectiveness of elective endoscopic clipping of diverticula in patients with a history of significant diverticular bleeding. Here, all visible diverticula were closed endoscopically using 'Instinct' endoclips. A diverticula closure rate of 87.2% (129/148) was demonstrated at follow up colonoscopy. In this group, there were no post-procedural complications and no diverticula-associated symptoms reported up to the follow-up colonoscopy. Notably, incidental complete resolution of chronic left sided abdominal pain was noted in one of our subjects. The investigators now propose the use of elective diverticular clipping in patients with symptomatic diverticulosis with a view to alter the natural history of the disease i.e. to prevent complications of the disease. At the same time the investigators wish to assess their symptomatic response. Patients with symptomatic diverticular disease will be eligible. The trial will be carried out at King's College Hospital endoscopy suite, a tertiary referral centre for endoscopic procedures. The study will include 84 patients. Each patient will be in the study for a period of 12 months. #Intervention - PROCEDURE : Endoscopic clipping - Endoscopic clips fired to close mucosa over diverticular defects. - OTHER : Placebo - colonoscopy without clipping - Colonoscopy performed, no clipping of diverticula	#Eligibility Criteria: Inclusion Criteria: * Confirmed symptomatic diverticular disease (5 or more diverticula) * Age range 18 <= age <= 90 years * Retains capacity and medically fit for colonoscopy Exclusion Criteria: * Does not meet inclusion criteria * Unable to give informed consent * Patients with severe co-morbidities and substance misuse Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT03935100	{ "brief_title": "Prophylactic Endoscopic Clipping of Diverticula (PECoD)", "conditions": [ "Diverticular Disease" ], "interventions": [ "Procedure: Endoscopic clipping", "Other: Placebo - colonoscopy without clipping" ], "location_countries": [ "United Kingdom" ], "nct_id": "NCT03935100", "official_title": "A Prospective Randomised Placebo Controlled Trial on Prophylactic Endoscopic Clipping of Colonic Diverticula (PECoD)", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-01", "study_completion_date(actual)": "2023-03-16", "study_start_date(actual)": "2019-09-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-03-20", "last_updated_that_met_qc_criteria": "2019-04-30", "last_verified": "2023-03" }, "study_registration_dates": { "first_posted(estimated)": "2019-05-02", "first_submitted": "2019-04-30", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. This study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat. #Intervention - OTHER : RS4 enriched flour - Wheat flour with 30% resistant starch (type-4) - OTHER : Control flour - Wheat flour without resistant starch (type-4)	#Eligibility Criteria: Inclusion Criteria: * Any individual aged 18 <= age <= 80 years Exclusion Criteria: * Pregnant * Lactating * Requires special diets or dietary regimens * On long term antibiotic therapy * Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis) * Immune compromised * Have cancer Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT01887964	{ "brief_title": "Effect of Resistant Starch (Type-4) on Metabolic Syndrome", "conditions": [ "Metabolic Syndrome" ], "interventions": [ "Other: RS4 enriched flour", "Other: Control flour" ], "location_countries": [ "United States" ], "nct_id": "NCT01887964", "official_title": "Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10", "study_completion_date(actual)": "2012-10", "study_start_date(actual)": "2012-03" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "DOUBLE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-09-27", "last_updated_that_met_qc_criteria": "2013-06-24", "last_verified": "2021-09" }, "study_registration_dates": { "first_posted(estimated)": "2013-06-27", "first_submitted": "2013-06-20", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo development in Assisted Reproduction Techniques (ART) procedures. Detailed Description In the study male patients diagnosed with oligoasthenozoospermia - with an abnormal sperm concentration and motility, irrespective of the morphology of spermatozoa - treated with their female partner with assisted reproduction techniques (ISCI) will be included. In the double blind study male patients will be given astaxanthin with vitamin E (study group, 40 patients) or placebo (control group, 40 patients) for three months prior to ART. In the study and the control group the quality of sperm (spermiogram), DNA fragmentation and mitochondrial membrane potential of semen before and after the dietary supplementation will be evaluated. In the ART procedure (ICSI) the fertilization rate, the quality of embryos, pregnancy rates and miscarriages rates in 1st trimester will be compared between the study and control group. #Intervention - DIETARY_SUPPLEMENT : astaxanthin with vitamin E - Four tablets of 4 mg astaxanthin with 10 mg vitamin E daily, taken at once. Daily dose is 16 mg astaxanthin with 40 mg vitamin E. Continuously for three months. - Other Names : - Astasan, Sensilab, Slovenia - OTHER : Placebo - Four tablets of placebo daily, taken at once. Continuously for three months.	#Eligibility Criteria: Inclusion Criteria: * oligoasthenozoospermia with of without teratozoospermia by WHO criteria from the year 2010 * fresh semen * female partner younger than 38 years * idiopathic or tubal infertility in female partners * at least 4 oocytes retrieved in previous ovarian punction in ART cycle, if previously performed * 1st, 2nd or 3rd cycle of ART Exclusion Criteria: * genetic indication for ART procedure * donated semen * polycystic ovary syndrome in female partner * dietary supplementation intake of antioxidants (selenium, zink, vitamin E, vitamin C, vitamin A) in male participant in the last three months * smoking in male participant >20 cigarettes per day Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02310087	{ "brief_title": "Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures", "conditions": [ "Infertility, Male" ], "interventions": [ "Other: Placebo", "Dietary Supplement: astaxanthin with vitamin E" ], "location_countries": [ "Slovenia" ], "nct_id": "NCT02310087", "official_title": "Effect of Oral Administration of Astaxanthin on Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01", "study_completion_date(actual)": "2019-01", "study_start_date(actual)": "2014-11" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "TRIPLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-03-29", "last_updated_that_met_qc_criteria": "2014-12-03", "last_verified": "2019-03" }, "study_registration_dates": { "first_posted(estimated)": "2014-12-05", "first_submitted": "2014-12-03", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking, adult subjects. Detailed Description Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods #Intervention - DRUG : Ondansetron - 1 x 8 mg Orally Disintegrating Tablet - DRUG : Zofran® - 1 x 8 mg ODT	#Eligibility Criteria: Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years. * Subjects will have a BMI (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study. * Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant. * Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study. * Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required. * All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate. * Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study. * Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate. * Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate. * All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study. * Subjects who do not tolerate venipuncture will not be allowed to participate. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT00934921	{ "brief_title": "Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions", "conditions": [ "Healthy" ], "interventions": [ "Drug: Ondansetron", "Drug: Zofran®" ], "location_countries": [ "United States" ], "nct_id": "NCT00934921", "official_title": "A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Non-Fasting Conditions", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-02", "study_completion_date(actual)": "2003-02", "study_start_date(actual)": "2003-02" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-08-21", "last_updated_that_met_qc_criteria": "2009-07-07", "last_verified": "2024-08" }, "study_registration_dates": { "first_posted(estimated)": "2009-07-08", "first_submitted": "2009-07-06", "first_submitted_that_met_qc_criteria": "2009-07-08" } } }
#Study Description Brief Summary This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute, topical, intranasal administration to healthy male and female volunteers. Detailed Description This is a Phase I, single dose, single-center, open-label study of the plasma and urinary pharmacokinetics of RX004-002 and its major metabolites in male and female healthy subjects. #Intervention - DRUG : RX0041-2 - Pharmacokinetic study - Other Names : - TS	#Eligibility Criteria: Inclusion Criteria: * Male or female >=18 but <= 80 years at the time of dosing. * BMI >= 18 and <= 32 at the screening visit. * Females (if of child-bearing potential and sexually active) and males (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method from the first dose and for 8 days following administration of study drug. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm, intrauterine device (IUD), condom, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method or withdrawal. * Willing and able to provide written informed consent and able to understand and comply with protocol requirements. * During the period of study confinement, subjects will be required to abstain from beverages containing grapefruit juice or caffeine. Exclusion Criteria: * Has a known allergy to any ester based anesthetics including cocaine HCl, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine Amide based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, mepivicaine, bupivicaine, levobupivicaine, ropivicaine, etidocaine, prilocaine, and articaine. * The use of amphetamines, methylphenidate or other stimulant prescription and nonprescription products such as pseudoephedrine, bronchial inhalers containing sympathomimetics (epinephrine or other beta-receptor agonist) or herbal products in the 7 days prior to screening or has a need to use these drugs during the course of the study. * Use of any SNRIs/SSRIs antidepressants or tricyclic antidepressant up to7 days or 5 half-lives (whichever is longer) prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial. * Use of MAO Inhibitor drugs up to14 days prior to screening or has a need to use these drugs during the screening period and throughout the time period of the trial. * Has a history of abuse of controlled substances, nasal or otherwise, or has damage to the nasal space, that in the opinion of the investigator might interfere with the ability to absorb RX0041 <= age <= 002. * Has severely traumatized mucosa or sepsis in the nasal cavity. * Has participated in an investigational study or received an investigational drug within 30 days preceding the randomization. * Is a pregnant or nursing mother. * Has a positive pregnancy test at Screening or Day 1. * Has a history of seizure, with the exception of febrile seizures. * Has glaucoma, symptomatic cardiovascular disease, or moderate to severe hypertension (defined as an average SBP >=160 mmHg or an average DBP >= 100 mmHg at the dosing visit). * Has a known personal or family history of hereditary pseudocholinesterase deficiency. Study participants will be screened by asking about personal or family history of anesthetic reaction, anesthetic death, and previous diagnosis of psuedocholinesterase deficiency in a relative or personally. Subjects identified with pseudocholinesterase deficiency are at risk for delayed recovery with certain anesthetics (e.g. succinylcholine and ester-based anesthetics). * Has a known personal or family history of pheochromocytoma. Study participants will be specifically asked if they have been treated for a pheochromocytoma previously or if they have a family member who has been diagnosed with pheochromocytoma (since 10% of these are familial). * Has a known personal or family history of adrenal tumor. * ECG abnormalities judged clinically significant by the investigator. * Has a positive urine test result for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and oxycodone) at Screening or Day 1 * Hematocrit, WBC, or platelets outside the normal limits and judged clinically significant by the investigator. * Serum potassium outside normal limits and judged clinically significant by the investigator. * Serum ALT, AST, and bilirubin exceeding 2X ULN for the lab's reference values. * Evidence of impaired renal function based upon laboratory tests and investigator opinion. * Clinical chemistry abnormalities judged clinically significant by the investigator. * Donation of blood (one pint or greater) within four weeks prior to administration of study medication. * Not suitable for entry into the study in the opinion of the investigator. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT02667106	{ "brief_title": "Phase I Pharmacokinetic Study of RX0041-2", "conditions": [ "Drug Reaction to Analgesic Nos" ], "interventions": [ "Drug: RX0041-2" ], "location_countries": null, "nct_id": "NCT02667106", "official_title": "Systemic Pharmacokinetics of Acute, Topical, Intranasal Administration of RX0041-002 in Healthy Male and Female Subjects", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10", "study_completion_date(actual)": "2015-10", "study_start_date(actual)": "2015-10" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-01-28", "last_updated_that_met_qc_criteria": "2016-01-25", "last_verified": "2016-01" }, "study_registration_dates": { "first_posted(estimated)": "2016-01-28", "first_submitted": "2016-01-18", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary It is of great importance to obtain optimal surgical conditions for the surgeon in order to increase patient safety. The effect of different interventions on surgical conditions has been assessed by various surgeon-assessed rating scales. A 5-point surgical rating scale has previously been tested in a proof-of-concept trial - but not validated - during radical retropubic prostatectomy by asking different surgeons to evaluate the surgical workspace using video sequences. In an ongoing study (The Hernia Study, Trial registration NCT02247466) performed by investigators group, investigators are using a 5-point scale to rate the surgical workspace during laparoscopic ventral herniotomy with or without neuromuscular blockade. This scale is based on previously used scales by already published studies and has a description connected to each point. To the authors' knowledge the scale has never been validated in a laparoscopic setting, where the intra-abdominal pressure during pneumoperitoneum can have a great influence on visualization. In fact, to investigators knowledge, no validated surgeon-assessed rating scale regarding the surgical workspace during laparoscopic surgery does exists. Purpose: Primary aim: To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. Using intra-abdominal video recordings. Secondary aims: To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. To test the agreement between the two rating scales. To assess which of the two rating scales has the highest inter-rater agreement To assess the intra-rater agreement of both rating scales. Hypothesis: Investigators hypothesize that the 5-point rating scale has an intra-class correlation coefficient (ICC) \> 0.6., validated by video-sequences obtained during laparoscopic surgery. Detailed Description Scales: The 5-point scale used to assess the surgical workspace during laparoscopic herniotomy: 1. (Extremely poor conditions) Unable to complete surgery without interventions\* 2. (Poor conditions) Several minor adjustments needed to complete surgery. (ie. changes in patient positioning, surgeon position) 3. (Acceptable conditions) After few minor adjustments surgery can be completed. 4. (Good conditions) Surgical workspace is good, but there is some interference, but no need for adjustments. 5. (Optimal conditions) Surgical workspace is optimal and procedure can be completed without any interference. * Interventions are defined as change in depth of neuromuscular blockade and/or pneumoperitoneum. The 10-point scale used to assess the surgical workspace during laparoscopic herniotomy is a Visual Analog Scale, where the surgeon specify their rating of the surgical workspace by indicating a position along a continuous line between two end-points Video recordings: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under different levels of pneumoperitoneum during desufflation after surgery is completed. Each video-sequence will last 20-30 seconds and. three video-sequences during different levels of pneumoperitoneum will be made from each patient. The patients are randomized to one of three groups regarding level of pneumoperitoneum during the three video-recordings. Group 1: 12-9-6 mmHg, 2: 11-8-5, 3: 10-7-4 mmHg. Three video-sequences during different levels of pneumoperitoneum (according to group allocation) will be made from each patient. We will record 5 pilot video-sequences and have them evaluated by two experienced surgeons in order to design a standard setup for filming the surgical workspace. From the 30 recorded video-sequences investigators will choose the 24 video-sequences best illustrating different levels of surgical workspace. The video-sequences will be embedded in an internet form, and each sequence is followed by a question about the rating of that particular surgical workspace. Each surgeon will be presented to the 24 sequences in a randomly selected recordings of different patients. After each recording the surgeon will evaluate the surgical work space on one of the two rating scales. After rating all recordings, using one scale, the recordings will repeat in a random order and the second scale should be used. When doing the assessment the surgeon should imagine that he/she is about to do a laparoscopic inguinal herniotomy, and the evaluation/rating is based on this situation. The surgeons are not allowed to discuss their ratings with each other during the study. To observe intra-rater agreement the surgeon will assess the same sequence at least twice using the same rating scale. Therefore the surgeons will see all recordings four times during the study. Sample size requirements are calculated by estimating the width of the confidence interval(CI) as described by Shoukri et all. An ICC of 0.8 with a 95% CI of \[0.6-1.0\] can be achieved with 8 surgeons assessing 24 recordings. To ensure sufficient variation in the recordings investigators will include a total of 10 patients and make three recordings from each. Sample size requirements are calculated by estimating the width of the confidence interval(CI) as described by Shoukri et all. An ICC of 0.8 with a 95% CI of \[0.6-1.0\] can be achieved with 8 surgeons assessing 24 recordings. To ensure sufficient variation in the recordings we will include a total of 10 patients and make three recordings from each. Investigators assume that the 24 recordings can be seen as 24 independent subjects. Both the inter-rater agreement and the intra-rater agreement will be calculated using Kappa and intraclass correlation statistics. with statistical software6. The model for ICC will be a two-way random, single measures, absolute agreement, ( ICC(2,1) ) Calculated using SPSS (ver 22.0). The agreement between the two rating scales will be tested with regression analysis using Spearman correlation coefficient. To assess which of the two rating scales that has the highest inter-rater agreement the two scales corresponding ICC with confidence intervals will be compared. Investigator and co-authors will be responsible for analyzing the study data with assistance from Statistician located at Herlev Hospital. Investigators will include 8 surgeons (Specialist level of training and proficient in laparoscopic inguinal surgery). #Intervention - PROCEDURE : Level of pneumoperitoneum 12-9-6 mmHg - Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation. - PROCEDURE : Level of pneumoperitoneum 11-8-5 mmHg - Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation. - PROCEDURE : Level of pneumoperitoneum 10-7-4 mmHg - Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.	#Eligibility Criteria: Inclusion Criteria: * Patients >= 18 years * Elective laparoscopic inguinal herniotomy. * Can read and understand Danish Exclusion Criteria: * Technical difficulties making video recording impossible. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02545270	{ "brief_title": "Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy", "conditions": [ "Hernia, Inguinal" ], "interventions": [ "Procedure: Level of pneumoperitoneum 10-7-4 mmHg", "Procedure: Level of pneumoperitoneum 11-8-5 mmHg", "Procedure: Level of pneumoperitoneum 12-9-6 mmHg" ], "location_countries": [ "Denmark" ], "nct_id": "NCT02545270", "official_title": "Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07", "study_completion_date(actual)": "2016-08", "study_start_date(actual)": "2016-03" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "TRIPLE", "phase": [ "NA" ], "primary_purpose": "HEALTH_SERVICES_RESEARCH", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-06-17", "last_updated_that_met_qc_criteria": "2015-09-08", "last_verified": "2019-03" }, "study_registration_dates": { "first_posted(estimated)": "2015-09-09", "first_submitted": "2015-08-06", "first_submitted_that_met_qc_criteria": "2019-03-18" } } }
#Study Description Brief Summary To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2). To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2). #Intervention - DRUG : BAY1834845 - Orally administered. - OTHER : Matching Placebo - Orally administered. - DRUG : Midazolam - Part 1: Orally administered 1mg as a single dose.	#Eligibility Criteria: Inclusion Criteria: Part 1 (healthy male subjects) * Healthy male subjects, 18 <= age <= 50 of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening * Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis) * Male patients, 18 <= age <= 70 of age (inclusive) or female patients of non-child bearing potential, 30 <= age <= 70 of age (inclusive) * Body mass index above or equal to 18.5 and lower or equal to 35 kg/m2 and a body weight above 50 kg A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2. Exclusion Criteria: * History of hypersensitivity to any of the components of the study drug * Any clinically relevant abnormal findings in safety laboratory parameters and ECG * History of tuberculosis (TB) or active or latent tuberculosis * Receipt of live or attenuated vaccine 90 days prior to the first dosing Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT03493269	{ "brief_title": "A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis", "conditions": [ "Healthy Volunteers", "Psoriasis" ], "interventions": [ "Drug: Midazolam", "Drug: BAY1834845", "Other: Matching Placebo" ], "location_countries": [ "Germany" ], "nct_id": "NCT03493269", "official_title": "A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-16", "study_completion_date(actual)": "2021-02-05", "study_start_date(actual)": "2018-04-16" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "QUADRUPLE", "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-02-26", "last_updated_that_met_qc_criteria": "2018-04-04", "last_verified": "2021-02" }, "study_registration_dates": { "first_posted(estimated)": "2018-04-10", "first_submitted": "2018-04-04", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers. The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography. Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement. The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry. #Intervention - DEVICE : MRI - DEVICE : cardiac echography transthoracic	#Eligibility Criteria: Inclusion Criteria: * Autonomous ADULT patient, patient Marfan: * under their usual treatment(processing) (including ß blocking) * diagnosis confirmed by the molecular biology (transfer(transformation) of the gene FBN1) * Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta on an echocardiography or an imaging in cups(cuttings) dating less than 6 months. PATIENT Aortic bicuspid : * Diagnosis confirmed by cardiac echography and/or imaging in cups(cuttings) * Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta, and absence of valvulopathy aortic significant (IA of rank I in II, absence of significant RA), on the echocardiography or the imaging in cups(cuttings) dating less than 6 months. patients Insufficiency mitral organic moderated in severe asymptomatic: * SOR > 30 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months * Absence of ischemic or functional cause * Patient recovering from a functional evaluation by echography of effort patients Insufficiency mitral organic severe surgical * SOR > 40 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months * Absence of ischemic or functional cause * Status functional: stage(stadium) II of the NYHA * Patient recovering from a functional evaluation by echography of effort Volunteer healthy : * affiliated to the Social Security * having given its agreement by signed consent * not presenting contraindication to the realization of a MRI Exclusion Criteria: * Patient claustrophobic, * patient refusing the protocol or the examination Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT02018835	{ "brief_title": "Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.", "conditions": [ "Dilated Cardiomyopathy" ], "interventions": [ "Device: MRI", "Device: cardiac echography transthoracic" ], "location_countries": [ "France" ], "nct_id": "NCT02018835", "official_title": "Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-30", "study_completion_date(actual)": "2022-10-28", "study_start_date(actual)": "2013-12-05" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-11-14", "last_updated_that_met_qc_criteria": "2013-12-17", "last_verified": "2022-11" }, "study_registration_dates": { "first_posted(estimated)": "2013-12-23", "first_submitted": "2012-11-26", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens. #Intervention - DEVICE : etafilcon A toric contact lens with new wetting agent - Investigational toric contact lens made of etafilcon A material with a new wetting agent. - DEVICE : etafilcon A toric contact lens - Marketed toric contact lens made of etafilcon A material.	#Eligibility Criteria: Inclusion Criteria: * The subject must be between 18 and 40 years. * The subject must have normal eyes. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. * The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye. * The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye. * The subject's refractive cylinder axis must be 180 +/- 30 in each eye. * The subject must be an adapted wearer of soft toric contact lenses in both eyes. * The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye. * Subjects must already possess a wearable pair of spectacles. - Exclusion Criteria: * Ocular or systemic allergies or disease that may interfere with contact lens wear. * Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. * Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. * Clinically significant tarsal abnormalities that might interfere with contact lens wear. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Pregnancy or lactation * Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * Diabetes * Strabismus - Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No	NCT01120782	{ "brief_title": "Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types", "conditions": [ "Astigmatism" ], "interventions": [ "Device: etafilcon A toric contact lens", "Device: etafilcon A toric contact lens with new wetting agent" ], "location_countries": [ "United States" ], "nct_id": "NCT01120782", "official_title": null, "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02-01", "study_completion_date(actual)": "2010-02-01", "study_start_date(actual)": "2010-02-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-06-19", "last_updated_that_met_qc_criteria": "2010-05-10", "last_verified": "2017-09" }, "study_registration_dates": { "first_posted(estimated)": "2010-05-11", "first_submitted": "2010-05-04", "first_submitted_that_met_qc_criteria": "2011-11-04" } } }
#Study Description Brief Summary The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS. Detailed Description The AC-058B303 study (extension study) is the long-term extension for the AC-058B301 study (core study). The core study has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with RMS. The subjects are treated with either ponesimod or the active comparator, teriflunomide in the core study. The purpose of this long term extension of the core study is to characterize the long-term safety and control of disease of ponesimod in subjects with RMS. In particular, the study will allow to observe potential adverse events which may only occur after long term treatment with ponesimod. The study will also investigate the effect of re-initiation of ponesimod after a brief interruption in a relatively large population (all subjects treated with ponesimod in the core study and eligible for the extension study) on disease activity in terms of relapses and MS-related MRI lesions. There is currently limited guidance on when a new MS treatment should be started after discontinuation of teriflunomide and the study will contribute with data on safety and efficacy of switching from teriflunomide to ponesimod after an interruption as mandated by the protocol. The study will also allow confirmation of sustained efficacy of ponesimod in terms of relapses, MRI lesions and reduction of disability accumulation during long-term treatment. In addition, combined data from the core study together with the results of the current extension study will allow comparison of MS activity in subjects who were switched from teriflunomide to ponesimod versus those who were treated with ponesimod in both studies. A vaccination sub-study will be conducted in a sub-set of up to 50 eligible study participants from selected countries who consent to be vaccinated with the Janssen coronavirus disease-2019 (COVID-19) vaccine (Ad26.COV2.S) to investigate the immune response induced by the Janssen COVID-19 vaccine. #Intervention - DRUG : Ponesimod - Ponesimod; Film-coated tablet; Oral use. From Day 1 to Day 14, ponesimod is gradually up-titrated until a maintenance dose of 20 mg is reached from Day 15	#Eligibility Criteria: Inclusion Criteria: * Signed informed consent * Subjects with MS having completed the double-blind treatment in the core study as scheduled * Compliance with teriflunomide elimination procedure * Women of childbearing potential (WOCBP) must have a negative pre-treatment urine pregnancy test, must agree to undertake 4-weekly urine pregnancy tests, and must have been using reliable methods of contraception. Fertile male subjects participating in the study must agree to use a condom. Exclusion Criteria: * Any of the following cardiovascular conditions on Day 1 pre-dose: 1. Resting heart rate (HR) < 50 bpm; 2. Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval > 470 ms (females), > 450 ms (males); * Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study: 1. Lymphocyte count: < 0.2 x 109/L; 2. Neutrophil count <1.0 × 109/L; 3. Platelet count < 50 × 109/L; 4. Creatinine clearance < 30 mL/min * At Visit 14 of the core study (EOT) >30% decrease from core study baseline FEV1 and/or FVC; * Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study. * Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study. * Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose: 1. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug; 2. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms. * Need for and intention to administer forbidden study treatment-concomitant therapy * Women who are pregnant or lactating. * Male subjects wishing to parent a child; * Treatment with any MS Disease Modifying Therapies; * Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study; * Subjects unlikely to comply with the extension study protocol based on investigator best judgment Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT03232073	{ "brief_title": "Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis", "conditions": [ "Multiple Sclerosis" ], "interventions": [ "Drug: Ponesimod" ], "location_countries": [ "United States", "Poland", "Germany", "Romania", "Serbia", "Bosnia and Herzegovina", "Finland", "Belarus", "Czechia", "United Kingdom", "France", "Israel", "Sweden", "Russian Federation", "Hungary", "Italy", "Turkey", "Croatia", "Georgia", "Mexico", "Latvia", "Lithuania", "Ukraine", "Portugal", "Canada", "Spain", "Bulgaria", "Greece" ], "nct_id": "NCT03232073", "official_title": "Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-16", "study_completion_date(actual)": "2024-01-16", "study_start_date(actual)": "2017-07-05" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE3" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2025-01-10", "last_updated_that_met_qc_criteria": "2017-07-26", "last_verified": "2025-01" }, "study_registration_dates": { "first_posted(estimated)": "2017-07-27", "first_submitted": "2017-07-20", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The mechanism by which heart failure initiates and progresses and the mechanisms of heart repair remain unclear. The left ventricular assist device (LVAD) is a therapy to stabilise patients while they await their transplant. The LVAD helps pump blood around the body, giving the heart an opportunity to recover. During surgery, the apical core tissue is routinely removed to allow the implantation of the device (this tissue is normally discarded). Some patients demonstrate cardiac recovery, allowing the device to be removed without later needing a transplant. As part of the LVAD removal procedure, the section around the device might need to be removed (this tissue is normally discarded). To further understand the cellular and molecular mechanisms by which the heart is repaired, the investigators wish to utilise this surplus tissue for research purposes. The collection of this tissue is part of routine treatment and does not represent additional risk for the patient for research purposes. Some patients might still require a transplant following VAD treatment. The native heart is removed from these patients (routinely discarded) and replaced by a donor heart. The investigators wish to utilise this discarded tissue for research purposes, so that the investigators can identify the cellular and molecular factors involved in cardiac repair and which distinguish responsive and non-responsive patients. Heart transplant recipients who require extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for research purposes when performed as part of routine clinical practice. There is no additional risk to the patient for research purposes. Heart failure patients scheduled for transplantation (who have not received a VAD) will be recruited prior to transplantation and their native heart retained for research purposes. An additional peripheral blood sample will be collected from all patients for research purposes when performed for routine clinical practice.	#Eligibility Criteria: Inclusion Criteria: * Patients must be able to provide informed consent; informed consent may be provided retrospectively if this cannot be provided pre-surgery. * Patients must be aged between 18--70 years. * Patients who have been clinically diagnosed with chronic heart failure and require mechanical unloading using a left ventricular assist device. * Patients who have received a heart transplant but require extracorporeal membrane oxygenation. Exclusion Criteria: * Patients under 18 or > 70 years. * Patients unable to provide informed consent. * Patients who are prisoners. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT06026215	{ "brief_title": "Assessing the Effects of Mechanical Unloading on Repair Version-1", "conditions": [ "Heart Failure", "Transplant; Failure, Heart" ], "interventions": null, "location_countries": null, "nct_id": "NCT06026215", "official_title": "Assessing the Effects of Mechanical Unloading on Tissue and Immunologic Characteristics Indictive of Cardiac Repair", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-31", "study_completion_date(actual)": "2019-05-31", "study_start_date(actual)": "2015-01-15" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-09-07", "last_updated_that_met_qc_criteria": "2023-09-04", "last_verified": "2023-09" }, "study_registration_dates": { "first_posted(estimated)": "2023-09-07", "first_submitted": "2023-08-04", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design. #Intervention - DRUG : GLPG3667 oral suspension - GLPG3667 oral suspension - DRUG : Placebos - Placebo oral suspension - DRUG : GLPG3667 capsules - GLPG3667 capsules	#Eligibility Criteria: Inclusion Criteria: * Male between 18 <= age <= 55 years (extremes included), on the date of signing the informed consent form (ICF) * A body mass index (BMI) between 18 <= age <= 30 kg/m2, inclusive * Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator Exclusion Criteria: * Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator * Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part) * Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT04097938	{ "brief_title": "A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667", "conditions": [ "Healthy" ], "interventions": [ "Drug: GLPG3667 oral suspension", "Drug: Placebos", "Drug: GLPG3667 capsules" ], "location_countries": [ "Belgium" ], "nct_id": "NCT04097938", "official_title": "A First-in-human Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-04", "study_completion_date(actual)": "2020-07-06", "study_start_date(actual)": "2019-09-18" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "SEQUENTIAL", "masking": "QUADRUPLE", "phase": [ "PHASE1" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-09-19", "last_updated_that_met_qc_criteria": "2019-09-19", "last_verified": "2020-07" }, "study_registration_dates": { "first_posted(estimated)": "2019-09-20", "first_submitted": "2019-09-19", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime. #Intervention - BEHAVIORAL : Back care intervention program - The back care intervention consists of: 1. Nine oral presentations. Include 'Programa Suma't' programme developed by the Provincial Council of Majorca. 2. Multisubject Teaching Unit. 3. Information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.) 4. 'The Back Care Day' at school.	#Eligibility Criteria: Inclusion Criteria: * Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school. Exclusion Criteria: * Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally. Sex : ALL Ages : - Minimum Age : 10 Years - Maximum Age : 12 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes	NCT06668129	{ "brief_title": "Effects of a Postural Education Multicomponent Intervention in Primary School Children.", "conditions": [ "Physical Activity", "Back Pain Lower Back" ], "interventions": [ "Behavioral: Back care intervention program" ], "location_countries": [ "Spain" ], "nct_id": "NCT06668129", "official_title": "Effects of a Postural Education Multicomponent Intervention in Primary School Children.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-11", "study_completion_date(actual)": "2021-06-11", "study_start_date(actual)": "2021-02-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-10-31", "last_updated_that_met_qc_criteria": "2024-10-29", "last_verified": "2024-10" }, "study_registration_dates": { "first_posted(estimated)": "2024-10-31", "first_submitted": "2024-10-21", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device. #Intervention - DEVICE : SmartFlex - Device used with smartflex engaged. - Other Names : - DeVilbiss AutoAdjust with SmartFlex - DEVICE : Standard - Other Names : - DeVilbiss AutoAdjust without SmartFlex	#Eligibility Criteria: Inclusion Criteria: * Epworth Sleepiness Scale >10 * Body Mass Index > 26 * Apnea-hypopnea index (AHI) >=15 (mod to severe range) * AHI <= 10 at therapeutic continuous positive airway pressure (CPAP) pressure * CPAP naïve patients * Polysomnogram (PSG) within 3 months of enrollment * Average oxygen saturation by pulse oximetry (SpO2) > 90% during titration * Sleep efficiency on titration night >= 78% Exclusion Criteria: * Diagnosis of mild obstructive sleep apnea (OSA) * Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness * Allergies to mask materials * Difficulties with nasal breathing * Evidence of another primary sleep disorder * Evidence of arousing periodic limb movements during titration * Contraindications as listed on product labeling. * Pregnant * Currently diagnosed with depression if symptomatic * Predominately central sleep apnea * Deemed medically unsuitable by investigator * Evidence of any type of infection or treatment of an infectious condition during the period of research participation * Full Face Mask during titration * Have a bi-level requirement * CPAP pressure >15cmH2O * Subjects with tracheotomy * Uncontrolled hypertension * Require supplemental oxygen * Stimulants, major tranquillizers or antipsychotics. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01203956	{ "brief_title": "DeVilbiss AutoAdjust With SmartFlex Comparative Study", "conditions": [ "Obstructive Sleep Apnea" ], "interventions": [ "Device: Standard", "Device: SmartFlex" ], "location_countries": [ "United States" ], "nct_id": "NCT01203956", "official_title": "A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; 'AutoAdjust With SmartFlex Study'", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05", "study_completion_date(actual)": "2011-05", "study_start_date(actual)": "2010-09" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "TRIPLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2015-04-28", "last_updated_that_met_qc_criteria": "2010-09-16", "last_verified": "2015-04" }, "study_registration_dates": { "first_posted(estimated)": "2010-09-17", "first_submitted": "2010-08-31", "first_submitted_that_met_qc_criteria": "2015-04-08" } } }
#Study Description Brief Summary The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD). Detailed Description This is an open-label (all people know the identity of the intervention), multicenter (study conducted in multiple sites), non-randomized (patients are not assigned by chance to treatment groups), Phase 2b study. Up to 75 patients with MCD will be eligible for the study, the majority of whom will be on active therapy with siltuximab at the time of enrollment. Patients will be either siltuximab-naive or have not progressed on siltuximab in the opinion of the investigator. Duration of disease control and survival will be assessed. Data collection for patients who discontinue treatment will be limited to survival, occurrence of malignancies, and subsequent therapies for MCD, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first. An interim analysis will be conducted (no later than 2 years after the start of enrollment) to further evaluate the benefit and safety of long-term treatment with siltuximab in patients with MCD. A data will occur at 6 years after the start of enrollment and for those patients remaining on treatment after the data cutoff, data collection will be limited to pregnancies and serious adverse events (SAEs), including information on study agent administration and concomitant medications associated with an SAE. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient. #Intervention - DRUG : Siltuximab - Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.	#Eligibility Criteria: Inclusion Criteria: * Has multicentric Castleman's disease * Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm) * Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose * Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible * Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study Exclusion Criteria: * Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study * Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study * Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01400503	{ "brief_title": "A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease", "conditions": [ "Multicentric Castleman's Disease" ], "interventions": [ "Drug: Siltuximab" ], "location_countries": [ "France", "Israel", "China", "United States", "Germany", "Singapore", "Taiwan", "United Kingdom", "New Zealand", "Canada", "Egypt", "Spain", "Norway", "Brazil", "Hong Kong", "Belgium", "Korea, Republic of" ], "nct_id": "NCT01400503", "official_title": "An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-01", "study_completion_date(actual)": "2017-03-01", "study_start_date(actual)": "2011-04-01" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-05-22", "last_updated_that_met_qc_criteria": "2011-07-21", "last_verified": "2018-04" }, "study_registration_dates": { "first_posted(estimated)": "2011-07-22", "first_submitted": "2011-04-21", "first_submitted_that_met_qc_criteria": "2018-03-01" } } }
#Study Description Brief Summary Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention. #Intervention - DRUG : Sodium Bicarbonate - Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure - DRUG : Isotonic Saline - Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure	#Eligibility Criteria: Inclusion Criteria: * patients with creatinine clearance < 60 mL/min Exclusion Criteria: * contrast medium administration within the previous 10 days * end-stage renal failure requiring dialysis * refusal to give informed consent Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT00606827	{ "brief_title": "Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy", "conditions": [ "Contrast-Induced Nephropathy" ], "interventions": [ "Drug: Isotonic Saline", "Drug: Sodium Bicarbonate" ], "location_countries": [ "Italy" ], "nct_id": "NCT00606827", "official_title": "Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null, "study_completion_date(actual)": "2006-03", "study_start_date(actual)": "2005-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "PHASE4" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2012-05-08", "last_updated_that_met_qc_criteria": "2008-01-22", "last_verified": "2012-05" }, "study_registration_dates": { "first_posted(estimated)": "2008-02-05", "first_submitted": "2008-01-22", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Once participants have been recruited, their grip strength shall be tested and they will all complete baseline questionnaires to assess functional status and symptom severity. Following the recruitment stage, participants will be asked to attend Medway Maritime Hospital once a week for four weeks, to receive the massage protocol. At the first session participants shall be asked to rate their pain (NPRS), before receiving a massage treatment. This will be followed by instructions on how to perform self-massage, which they will be asked to complete daily over the four-week period, and record in a diary. At the remaining three sessions, participants shall just complete the NPRS prior to receiving the massage treatment. After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended prior to recruitment. They will be asked to complete a final pain score, record any changes in their condition, repeat the initial symptom questionnaire, and finally preform a grip strength test. The duration of four weeks was chosen as this is the time-frame within which the specific massage protocol advises a 'significant symptom improvement' should be seen. #Intervention - PROCEDURE : Clinical Massage Therapy	#Eligibility Criteria: Inclusion Criteria: * Aged 18 years or above. * Pain paraesthesia and/or hypoesthesia in the hand, in the area innervated by the median nerve. * Participants must have a clinical diagnosis of Carpal Tunnel Syndrome (CTS). * Participant must be able to comply with the study procedures. * Participant must have attended the Medway Maritime Hospital (Kent), for assessment of the present condition. * Participant is willing and able to give informed consent for participation in the study. * Participant must not be contra-indicated for the receipt of massage. * Participants must be able to speak and read English fluently. Exclusion Criteria: * Participants who are receiving any additional treatment for their carpal tunnel pain that is not part of standard care (topical pain relief, bracing). * Participants that have had any surgery on the anatomical sites relevant to the condition and/or treatment (neck, shoulder, arm, wrist, hand). * Participants that have any suggestion of an additional condition related to carpal tunnel pain (i.e. previous trauma, pregnancy, etc). * Planning to undertake any activities or lifestyle changes which may affect their levels of carpal tunnel pain (e.g. changing/ceasing occupation, alternative symptom therapy, adopting/ceasing a hobby). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02706418	{ "brief_title": "Clinical Massage Therapy as a Treatment for Carpal Tunnel Syndrome", "conditions": [ "Carpal Tunnel Syndrome" ], "interventions": [ "Procedure: Clinical Massage Therapy" ], "location_countries": [ "United Kingdom" ], "nct_id": "NCT02706418", "official_title": "A Standardised Massage Protocol as an Effective Treatment for Chronic Carpal Tunnel Syndrome", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08", "study_completion_date(actual)": "2017-08", "study_start_date(actual)": "2016-12" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-02-28", "last_updated_that_met_qc_criteria": "2016-03-07", "last_verified": "2018-02" }, "study_registration_dates": { "first_posted(estimated)": "2016-03-11", "first_submitted": "2016-02-26", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of patients. Patients can become disabled early in life by OA. The Osteoarthritis Research Society International (OARSI) is concerned to publish guidelines with the respective levels of evidence on the various forms of treatment of osteoarthritis of the knee and hip.It is believed that an education program has a positive impact on quality of life of patients with OA. Changing the habits of those patients is imperative for clinical improvement. The investigators propose the creation of an educational program consisting of various health professionals so that we can educate the patients about OA disease, and their role in treatment. This program will be administered in a single day and reviewed/reinforced after an interval of time. Half the patients will be monitored monthly by phone when questions specific to each health area will be made to participants. This way we will evaluate the strength of the telephone follow-up. The investigators are going to create educational printed an audiovisual materials for patients, so the patients can access the information given in the theoretical course at home. Calculation of cost-effectiveness and presentation of data to the authorities. Detailed Description INTRODUCTION Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of patients. Patients can become disabled early in life by OA.(1,2,3) Osteoarthritis is primarily a genetic disease but can be triggered by trauma, intra-articular fractures, axis deviations and joint overloading, including overweight / obesity. Perhaps the most common type of disease is hand OA, as debilitating to the patient as the changes generated by rheumatoid arthritis. On the other hand, among the most debilitating, is knee OA, that greatly diminish the quality of life of the affected patients. (4) At the Knee Surgery Group of Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IOT-HCFMUSP) - Orthopedics and Trauma Institute of University of São Paulo's General Hospital - there is a large number of young adult patients who were economically active, until the advent of a joint trauma, which led to early OA. There is also a large number of people seeking our group for a Total Knee Arthroplasty (TKA) without been offered all non-surgical alternatives of treatment. As there are also patients who underwent surgical treatment but suffer from consequences of OA and clinical treatment is their current need. These patients do not receive an appropriate OA clinical care. Those patients should be reabsorbed by the basic health network. But the patient is returned by the social services at IOT-HCFMUSP, because there is no such reference in the Unified Health System The OARSI is concerned to publish guidelines with the respective levels of evidence on the various forms of treatment of osteoarthritis of the knee and hip. Those guidelines show the importance of education, phone calls, non-drug methods such as physical therapy, exercise, acupuncture, mind and body therapies, the use of insoles and orthotics, canes, crutches and knee pads, and finally the drugs for pain and to slow the progression of the disease. (5,6) It is believed that an education program has a positive impact on quality of life of patients with OA. In England, the simple delivery of educational material showed no different from a course associated with the delivery of educational material. But in countries like Sweden, primary care is concerned to give courses on OA. In France, teaching about the pathology associated with medical consultation was superior to simple medical consultation to improve patients' symptoms and treatment adherence. (6) No paper on only telephone follow-up was performed, but the addition of patient care by phone, always shows better results than a single intervention. (6) The Osteometabolic Diseases Group of IOT-HCFMUSP, initially focused on the care of osteoporosis and other diseases of bone metabolism such as thalassemia and osteogenesis imperfecta. More recently took over the care and research in the treatment of OA, starting with the knee OA, since it's among the most prevalent and debilitating types of OA.(3) Obesity and knee OA are the most frequent comorbidities in the elderly in the United States (U.S.). Although not presenting the same level of obesity of U.S. patients, our patients with OA also are overweight, and often have diabetes and hypertension. Changing the habits of those patients is imperative for clinical improvement. Those patients should incorporate healthier eating habits as well as daily physical activity. But to change behavior, it is necessary: * to perceive the problem as important and serious. * to perceive that behaviour change is beneficial. Patients are more prone to health information when it is presented in terms of potential gain (11) and when these gains are presented in patients of the same sex and race. (12) We have a diverse population of patients with level of education ranging from illiterate patients at university level. With this diversity of patients, and a number of patients who can easily reach four digits, and the total lack of possibility of referral of patients to primary or secondary care in the city of São Paulo, we designed a pilot program in three phases: Phase 1 - Creation of an educational program consisting of various health professionals so that we can educate the patients about OA disease, and their role in treatment. This program will be administered in a single day and reviewed / reinforced after an interval of time. Half the patients will be monitored monthly by phone when questions specific to each health area will be made to participants. This way we will evaluate the strength of the telephone follow-up. We're going to create educational printed an audiovisual materials for patients, so they can access the information given in the theoretical course at home. Calculation of cost-effectiveness and presentation of data to the authorities. Phase 2 - If we can demonstrate effectiveness in improving the quality of life of patients, we will hold training courses for health professionals from the West Region Project to create a system of reference and cross-reference with the primary and secondary care centers. Patients who have been through the course and demonstrate improved quality of life, will be accompanied closer to their homes in the western region of São Paulo. Phase 3 - Expansion to all the city of São Paulo and other cities. In this pilot, we focus exclusively on Phase 1. The variables that can interfere with patient compliance to the program and, therefore, to the final result, are: * Length of Interval between interventions (1, 2 or 3 months) * Phone follow-up or not * Attending the course or just receiving the educational material GENERAL OBJECTIVES To assess the improvement of quality of life of patients with osteoarthritis exposed to an education program multi-professional and / or telephone follow-up. Develop knowledge, experience and indicators that support the expansion of the project to: West Region Project Municipal Programs, State and National. Subprojects: Social Work - improving the quality of life by the introduction of leisure Nutrition - Decrease in body mass index (BMI) by improving the quality and quantity of diet. Physical Therapy - Improves the autonomy, function and pain for the introduction of daily exercise habits. Occupational Therapy - Improves autonomy, function and pain by improving the ergonomics and-administration of daily tasks. Physical Education - Improvement of autonomy, function and pain for the introduction of daily exercise habits. Psychology - Improving quality of life for the patient and behavior change induced by the intervention. METHODS Two hundred and forty patients from the public, healthcare at IOT-HCFMUSP, already identified with OA of the knees Given the inclusion criteria, patients undergo pre-assessment by the group composed of multi-professional teams of physicians, orthopedic surgeons, nutritionists, psychologists, physiotherapists, occupational therapists, social worker, and physical educators: Orthopedics - We treat patients according to the OARSI guidelines, offering everything at our disposal for the treatment of OA at IOT-HCFMUSP. Thus, the orthopedic surgeon: 1. - request and evaluate exams, and classify the disease by knees x-rays, 2. - prescribe medications to delay the disease (we work with diacerein in our service), analgesics, muscle relaxants, and Non-Steroidal anti-inflammatory Drugs (NSAIDs), if necessary, 3. - prescribe orthotics (insoles, knee pads, sticks and crutches, braces); 4. - will report to Social Security and Departamento de Transportes (DETRAN) - Transports Department (this, if the social services confirm the need); 5. - Apply evaluation questionnaires SF 36, Visual Analog Pain Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in the first visit and after six months, will make the referral to physiotherapy and physical activity on the network offered by the government, refers to acupuncture and / or dry needling physiatry in the IOT-FMUSP for cardiac evaluation and clearance for physical activity. Apply the Consent Report to patients. Each of the professional staff will assess the effects of its intervention in a personalized way through a subproject: Nutritionist - anthropometric Social Worker - Level of education, autonomy and limited mobility to the hospital. Psychologist - assess cognitive ability, application of World Health Organization Quality of Life (WHOQOL) Physical Therapist - assess range of motion, pain, strength and quality of life. Occupational Therapy - range of motion and quality of life. Physical Educator - Evaluate the physical capacity and prescribe appropriate exercise for the patient. The 240 patients will be randomly assigned to 4 groups of 60. 3 groups will be subjected to 2 interventions, varying the time interval between each intervention: Group 1 to 3 months apart Group 2 - 2 months apart Group 3 - 1-month interval Group 4 will only receive the printed material. Patient Flow Interventions take place on Saturdays at IOT-HCFMUSP, using the classrooms and the dependencies of physiotherapy. We will have a 'home simulation' to teach ergonomics in the home. The course will take place between 8:00 and 17:00 hours. Course Schedule - 30 students per week 7:00 Reception of patients 8:00 Opening 8:10 Orthopedics Class 8:30 Psychology Class 9:30 Interval - Morning Snack 10:00 Theoretical Lecture - Physical Therapy 10:20 Theoretical class - Occupational Therapy 10:40 Practices: Physical Therapy (15 students) and Occupational Therapy (15 students) 12:10 Lunch 13:00 Practices: Physical Therapy (15 students) and Occupational Therapy (15 students 14:30 Nutrition 15:20 Physical Education 15:50 Interval - Afternoon Snack 16:20 Fitness with the Physical Educator 16:30 Social service 17:00 Closure COURSE CONTENT 1 st Intervention Education program for 8 hours, with the multidisciplinary team, covered the following: Psychologist the disease, the role of team and patient in treatment and self-care Nutritionist basics of balancing food Social Worker the importance of leisure experiences and advice about places close to home for recreation and physical activity Physiotherapist Importance of exercise, activities to do at home, experiences Occupational therapy how to deal with daily activities and the limitations caused by OA Physical Educator Differences between physical activity and exercise and the importance for patients with OA Orthopaedist what is the disease can be treated as the daily self-care. The program will take place on Saturdays at IOT - HCFMUSP, from 8 am to 17 pm 50% of all groups (number of 30 patients in each group 1A, 2A, 3A, and 4A) will receive monthly follow-up by phone. Groups 1B, 2B, 3B, and 4B, will not receive phone calls. 2nd Intervention Education program for 8 hours, with the multidisciplinary team in order to check and reinforce learning of the first intervention. Psychologist The disease, the role of team and patient in treatment and self-care Nutritionist Check how patients are feeding anthropometric measures + Social Worker Check the difficulties encountered by the patient access to physical activity and leisure Physiotherapist Assessment of range of motion more reinforcement orientation exercises Occupational therapy Check the difficulties encountered by patients in their daily activities Orthopaedist Check learning about the disease and self-control Physical Educator Reinforcing the need for physical activity The program will take place on Saturdays, the premises of the IOT - HC - FMUSP, from 7 am to 16 pm AGENDA 2nd. INTERVENTION Schedule Activity 07:00 Reception of patients 08:00 Reviews 09:00 Activity 1 - Orthopaedics 09:20 Activity 2 - Nutrition 10:00 Snack 10:30 Activity 3 - Psychology 11:30 Activity 4 - Physical Therapy 12:30 Lunch 13:30 Activity 5 - Occupational Therapy 14:30 Activity 6 - Social Services 15:30 Assessment Program for Patients and Closure At the end of 6 months, all groups will return to revaluation with all the teams for reassessment and analysis of the results. All professionals involved in the program will be paid. The medications used are those provided by the HC complex for patients enrolled with a diagnosis of OA. Any medication that is not in the arsenal of Pharmacy HC for normal service to patients with OA will not be prescribed. To carry out the interventions on Saturdays (Saturdays 12 in total) will require support services that receive extra payment: * Secretaries * Food (snacks morning and afternoon + lunch) * Computer Support Estimated Number of sample: This is a pilot study without a similar estimate for the number of patients. The sample was then left with the number 30 for each subgroup. Statistical Analysis We will use basic descriptive analysis for sample parameters according to collected data, and Student t test and U Mann-Whitney test to compare pre and post-intervention results. #Intervention - BEHAVIORAL : Educational Course - 2 Educational courses - BEHAVIORAL : Phone Calls - Phone Calls - BEHAVIORAL : Printed Material - Printed Material	#Eligibility Criteria: Inclusion Criteria: * Men and women diagnosed with primary or secondary osteoarthritis of the knees,classified as grades I to IV Kelgreen and Lawrence (KL), ie, any degree of knee osteoarthritis Exclusion Criteria: * Patients who have psychiatric or neurological disorders, whose symptoms during the evaluation to the school are related or significantly interfere in the functions of attention, memory, logical reasoning, understanding and interaction with the group in order to undermine the assimilation of the guidelines given Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT01572051	{ "brief_title": "Project Osteoarthritis: Recovering Quality of Life Through Education", "conditions": [ "Osteoarthritis", "Knee Osteoarthritis" ], "interventions": [ "Behavioral: Phone Calls", "Behavioral: Printed Material", "Behavioral: Educational Course" ], "location_countries": [ "Brazil" ], "nct_id": "NCT01572051", "official_title": "Project Osteoarthritis: Recovering Quality of Life Through Education", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10", "study_completion_date(actual)": "2014-10", "study_start_date(actual)": "2011-10" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "FACTORIAL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "HEALTH_SERVICES_RESEARCH", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2015-01-15", "last_updated_that_met_qc_criteria": "2012-04-04", "last_verified": "2013-10" }, "study_registration_dates": { "first_posted(estimated)": "2012-04-05", "first_submitted": "2012-01-23", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Background: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We will assess whether remotely delivered complex interventions including internet-based training for health care provider, and an educational intervention for parents could improve prescribing practices for respiratory tract infections (RTI) in Spain. Methods: We will develop and evaluate the feasibility of two interventions in a 16-months randomized controlled factorial trial. Primary care (PC) centres will be allocated to one of the following four groups: 1. Intervention targeting healthcare providers (paediatricians, nurses and pharmacists): i) Internet based training about communication skills and optimal antibiotic prescribing (including delayed prescribing); ii) bimonthly antibiotic prescription feedback. 2. Intervention targeting parents: PC centres allocated to this group will display posters and flyers presenting a mobile app that will include information about respiratory tract infections and optimal use of antibiotics. The app can be used before, during and after the consultation, providing condition specific and patient tailored information. 3. Intervention targeting both providers and parents 4. No intervention. During the trial duration we will conduct a process evaluation and a cost-effectiveness analysis. Our primary outcome will be change in the total antibiotic prescription rate. Our secondary outcomes will include: respiratory complications (e.g. pneumonia), antibiotic related adverse effects, repeated consultations, and antibiotic consumption in relation with antibiotic prescribing (delayed antibiotic prescribing). Assuming an average cluster size of 200 RTI consultations per centre, we will need to recruit 222 PC centres. Detailed Description This project will evaluate the effectiveness of two complex interventions to optimize the use of antibiotics in acute uncomplicated respiratory tract infections (RTI). We will first develop the different components of the interventions and evaluate their feasibility (user testing). We will then conduct a multicenter, randomized, controlled trial to evaluate the effectiveness of the overall intervention and its two main constituents in reducing antibiotic consumption. For this reason we will implement a 2x2 factorial randomized cluster clinical trial based on healthcare practices. They will be randomized to receive the intervention targeted to parents, intervention targeted health care professionals, both interventions, or none of them. We will need to recruit a sample size of 222 primary care centres, allocated in a ratio of 1:1:1:1 to one of the four intervention groups (assuming an average cluster size of 200 RTI consultations per centre). Study setting will be defined as primary care centres in four Autonomous Communities in Spain (Catalonia, Balearic Islands, Navarra and Basque Country) with a total of more than 600 PC centers, 1,200 pediatricians, and more of one million children. Finally, during the trial duration, we will conduct a process evaluation and an economic evaluation with a cost-effectiveness analysis. The interventions include the main characteristics of successful interventions to reduce antibiotic prescribing identified in a systematic review: engage children, occur prior to an illness episode, employ delayed prescribing, and provide guidance on specific symptoms (Andrews 2012). Furthermore, the factorial design will inform about their relative merits and the process evaluation about the potential effect of the individual components. The research team in in Barcelona (Spain) will coordinate the overall running of the project. A research coordinator in Barcelona will run the day to day of the project from day one under the supervision of the principal investigator. The research teams in four different Spanish Autonomous Communities will contribute to all the stages (intervention development, clinical trial, and economic and process evaluation). Patient representatives will be involved in the project as co-investigators and members of the Steering Committee. Throughout the project groups of parents at each of the regions will be providing feedback. #Intervention - BEHAVIORAL : Communication skills training - This intervention consists of a course on communication skills for healthcare professionals. It will be done remotely via the internet and will include: communication skills training and optimal management of acute non-complicated RTI and delayed antibiotic prescription. Training modules will be delivered via a specific website password protected. Healthcare professionals will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI. - BEHAVIORAL : Mobile phone application on RTI - This intervention involves the use of a mobile phone application by parents and caregivers. The mobile app will provide information, education and interactive tools about acute noncomplicated respiratory tract infections. PC centres allocated to this group will display posters and flyers to inform parents and caregivers about the mobile app. Healthcare staff will also promote the use of this app by parents and caregivers. The app information will be useful before the consultation, and will also allow the patient to interact with the physician during the consultation, potentially improving share decision-making. Importantly, the app will allow tailoring the guidance provided according to the type of infection or the number of days with symptoms. Healthcare professionals in the primary care centres allocated to this group will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI.	#Eligibility Criteria: Inclusion Criteria: * Healthcare professionals who care for children in primary care centres and community pharmacists of reference in four Autonomous Communities of Spain (Catalonia, Balearic Islands, Navarra and Basque Country). Exclusion Criteria: * None Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT05166369	{ "brief_title": "Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)", "conditions": [ "Acute Respiratory Tract Infections" ], "interventions": [ "Behavioral: Mobile phone application on RTI", "Behavioral: Communication skills training" ], "location_countries": [ "Spain" ], "nct_id": "NCT05166369", "official_title": "Optimisation of Antibiotic Prescription in Acute Non-complicated Respiratory Tract Infections in Children: a Multicenter Factorial Randomised Controlled Trial Targeting Health Professionals and Parents.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-04", "study_completion_date(actual)": "2023-09-05", "study_start_date(actual)": "2022-01-03" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "FACTORIAL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-09-28", "last_updated_that_met_qc_criteria": "2021-12-20", "last_verified": "2023-09" }, "study_registration_dates": { "first_posted(estimated)": "2021-12-21", "first_submitted": "2021-11-24", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer. Detailed Description Esophageal cancer ('EG cancer') affects over half a millions people worldwide every year. Early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. As a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. As a consequence, 7 out of 10 new cases of EG cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. Better ways of diagnosing esophageal cancer earlier are therefore needed. An ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective. The investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. In this study that is being conducted in collaboration with researchers in the United Kingdom (UK), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. By studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease. The investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. The investigators will also attempt to measure different bacteria #Intervention - OTHER : Exhaled VOC breath test - To determine longitudinal variation in exhaled VOC concentrations during intended curative therapy for EC cancer.	#Eligibility Criteria: Inclusion Criteria: * Aged 18 <= age <= 90 years * Newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer * Planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection Exclusion Criteria: * Pregnant females * Without malignant esophageal disease * Malignancy at a secondary site other than the esophagus * Undergoing palliative treatment for esophageal cancer * Not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer * Inability or unwillingness to provide written informed consent Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT06453993	{ "brief_title": "Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients", "conditions": [ "Esophageal Cancer" ], "interventions": [ "Other: Exhaled VOC breath test" ], "location_countries": [ "United Kingdom", "United States" ], "nct_id": "NCT06453993", "official_title": "Temporal Variation in Exhaled Volatile Organic Compounds in Response to Therapeutic Intervention in Esophageal Cancer Patients", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-30", "study_completion_date(actual)": "2023-11-30", "study_start_date(actual)": "2019-12-01" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "DIAGNOSTIC", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-08-27", "last_updated_that_met_qc_criteria": "2024-06-10", "last_verified": "2024-08" }, "study_registration_dates": { "first_posted(estimated)": "2024-06-12", "first_submitted": "2024-03-11", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors. Detailed Description This is an open-label, non-randomized, dose-escalation, Phase 1 study of TAS-102 administered in combination with CPT-11. The study will be conducted in 2 parts: a Dose Escalation Phase (Part 1) to determine the maximum tolerated dose and an Expansion Phase (Part 2) to further evaluate the safety, pharmacokinetics, and preliminary efficacy of the maximum tolerated dose. Patients will be assigned to sequential dose-level cohorts with each cohort corresponding to a pre-specified dose of TAS-102 and CPT-11 combination. Escalation to the subsequent dose level will occur only after the previous dose level is determined to be safe. #Intervention - DRUG : TAS-102 - Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. - DRUG : CPT-11 - Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met. - Other Names : - camptothecin-11, irinotecan - DRUG : Bevacizumab - Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met. - Other Names : - Avastin	#Eligibility Criteria: Inclusion Criteria: * Has provided written informed consent * Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy * ECOG performance status of 0 or 1 * Is able to take medications orally * Has adequate organ function (bone marrow, kidney and liver) * Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control. Exclusion Criteria: * Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration * Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure * Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies * Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components * Is a pregnant or lactating female * Has had either partial or total gastrectomy Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01916447	{ "brief_title": "A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.", "conditions": [ "Advanced Gastrointestinal Tumors" ], "interventions": [ "Drug: TAS-102", "Drug: CPT-11", "Drug: Bevacizumab" ], "location_countries": [ "United States" ], "nct_id": "NCT01916447", "official_title": "A Phase 1, Open-label, Non-randomized, Dose-escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-102 in Combination With CPT-11 and Bevacizumab in Patients With Advanced Gastrointestinal Tumors", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09", "study_completion_date(actual)": "2017-09", "study_start_date(actual)": "2013-09" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-09-05", "last_updated_that_met_qc_criteria": "2013-08-02", "last_verified": "2024-08" }, "study_registration_dates": { "first_posted(estimated)": "2013-08-05", "first_submitted": "2013-07-19", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a multicenter study recruiting patients with angioedema induced by ACEI. Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which the investigators have been previously treated in the investigators centers with current 'standard' therapy (250 mg methylprednisolon and 2 mg clemastine). In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention. Detailed Description Sudden occurrence of subcutaneous or submucosal non-itchy swelling, so-called angioedema, is a well known side effect of angiotensin-converting enzyme inhibitors (ACEi), which may become life-threatening if the upper airway is involved. To be note, ACEi induced angioedema were always located in the head and neck region. The pathophysiology of ACE inhibitor (ACEi) induced angioedema most likely resembles that of hereditary angioedema (HAE), i.e. it is mainly mediated by bradykinin induced activation of vascular bradykinin B2 receptors (BKR-2). In contrast to an increased bradykinin generation in HAE, treatment with ACEi decreases the bradykinin degradation in plasma and increases the biological activity of bradykinin. The current pharmacotherapy of ACEi induced angioedema is not satisfactory. Antihistamines and corticosteroids may be effective in the treatment of urticaria with cutaneous edema and itchy, but are theoretically ineffective and hence superfluous in bradykinin induced angioedema. However, glucocorticoids still belong to the standard treatment of angioedema. We hypothesized that the BKR-2 antagonist icatibant might be an effective therapy for ACEi-induced angioedema. Patients with ACEi induced angioedema, located in the upper aero-digestive tract will be randomized and treated either with icatibant and plazebo or cortisone with clemastin and plazebo. #Intervention - DRUG : Icatibant (subcutaneous) and plazebo (intravenous) - DRUG : Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)	#Eligibility Criteria: Inclusion Criteria: * Age >= 18 <85 years * Patient is currently treated with an ACEI * Patient must have acute angioedema attack caused by an ACEI * Treatment should be administrated within 10 hrs after onset by an ACEI * Patient with angioedema of head and /or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx) * At least one moderate to severe severe angioedema symptom as assessed by the investigator, requiring a medical intervention * Signed written Informed Consent Form Exclusion Criteria: * Diagnosis of angioedema that was not caused by ACEI: e.g. hereditary angioedema (C1-INH deficiency), allergy, anaphylaxis, insect bite, trauma, infection, abscess, tumor, post-radiation or post-operative or processes related to salivary glands and others where it is unlikely that the ACEI is causing the angioedema * Participation in a clinical trial of another investigational medicinal product (IMP) within 30 days * Patients with acute urticaria * Patients with a medical history of any angioedema before taking an ACEI * Patients with an acute rash or hives in the face or somewhere else * Unstable angina or acute myocardial infarction * Acute heart failure * Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial * Pregnancy and/or breast-feeding * Mental condition rendering the patients, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; * Unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for the follow-up visit, or unlikely to complete the study for any reason. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 84 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01154361	{ "brief_title": "AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study", "conditions": [ "Angioedema" ], "interventions": [ "Drug: Icatibant (subcutaneous) and plazebo (intravenous)", "Drug: Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)" ], "location_countries": [ "Germany" ], "nct_id": "NCT01154361", "official_title": "A Multicenter Study, Randomized, Double-blind With 2 Groups as Prove of Concept for the Treatment of ACEI Induced Angioedema With Subcutaneous Icatibant", "recruitment_information": null, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "TRIPLE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2011-12-23", "last_updated_that_met_qc_criteria": "2010-06-29", "last_verified": "2011-12" }, "study_registration_dates": { "first_posted(estimated)": "2010-06-30", "first_submitted": "2010-06-29", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The study will evaluate the effect of a therapeutic dose and a supratherapeutic dose of ITF2357 on the QT/QTc interval. #Intervention - DRUG : ITF2357 10 mg/mL - Dose: 100 mg (administered as 10 mL); Dosage form: suspension; Route of administration: oral - Other Names : - Givinostat - DRUG : ITF2357 10 mg/mL - Dose: 300 mg (administered as 30 mL); Dosage form: suspension; Route of administration: oral - Other Names : - Givinostat - DRUG : Placebo - Dose: 20 mL; Dosage form: suspension; Route of administration: oral - DRUG : Moxifloxacin Hydrochloride - Dose: 400 mg; Dosage form: tablet; Route of administration: oral - DRUG : Placebo - Dose: 30 mL; Dosage form: suspension; Route of administration: oral	#Eligibility Criteria: Inclusion Criteria: * Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than or equal to (>=) 18 and less than or equal to (<=) 55 years, with body mass index (BMI) greater than (>) 18.5 and less than (<) 30.0 kilograms per meter square (kg/m^2) and body weight >=55 kilograms (kg) and <=100 kg for females and body weight >=60 kg and <=100 kg for males. * Healthy as defined by: 1. The absence of clinically significant illness and major surgery within 4 weeks prior to dosing. Participants vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing of the patient in the study is at the discretion of the Investigator, depending on his/her clinical judgement. 2. The absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. * Non-childbearing potential female defined as: 1. Post-menopausal female (absence of menses for 12 months prior to the first study drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to the first study drug administration); or 2. Surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration). * Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for at least 90 days after the last study drug administration: 1. Simultaneous use of intra-uterine contraceptive device, without hormone release system placed at least 4 weeks prior to study drug administration, and condom for the male partner; 2. Simultaneous use of diaphragm or cervical cap with intravaginally applied spermicide and male condom for the male partner, started at least 21 days prior to study drug administration; * Male participants who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration: 1. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks or intra-uterine contraceptive device placed since at least 4 weeks; 2. Simultaneous use of a male condom and, for the female partner, a diaphragm or cervical cap with intravaginally applied spermicide. * Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration. * Male participants must be willing not to donate sperm until 90 days following the last study drug administration. * Female participants must be willing not to donate ovules until 90 days following the last study drug administration. * Participant's written informed consent obtained prior to any study-related procedure. * Willingness and capability to comply with the requirements of the study and ability to understand the study procedures and the risks involved. * Willing to take out dentures and mouth piercings for study procedures. Exclusion Criteria: * Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C found during medical screening. * Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 millimeter of mercury [mmHg], diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 40 or over 100 beats per minute [bpm]) at screening. For eligibility purposes, not the mean value, but the two single measurements will be considered. * Any of the following abnormalities on 12-lead ECG at screening. PR (PR interval) >210 millisecond (msec); QRS (QRS complex) >120 msec; QTcF >450 msec; any abnormality of cardiac rhythm other than sinus arrhythmia; abnormality of T-wave morphology that will impair the ability to measure the QT interval reliably. The averaged value of three ECGs 5 minutes apart from each other will be used; evaluations have to be used for the evaluation of the QTc interval requested by this exclusion criteria. * Participants with history of sustained and non-sustained cardiac arrhythmias (ECG demonstrated), participants with a family history of sudden cardiac death and participants with a history of additional risk factors for TdP, heart failure, hypokalemia, LQTS). * Any of the following abnormal laboratory test values at screening or at baseline (Day -1) of Period 1: 1. Platelet count <12510^9 per liter (/L) 2. Absolute neutrophil count <1.210^9/L * Participants who have cardiovascular condition such as, but not limited to unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, which may impact the safety of the participant or the evaluation of the result of the study according to the Investigator's judgment; cardiovascular conditions should be discarded based on the results obtained on the ECG, medical examination and routine lab test. * Positive urine drug screen, alcohol breath test or urine cotinine test at screening or at baseline (Day -1). * History of anaphylaxis reaction or clinically significant drug hypersensitivity reaction (e.g., angioedema, Stevens-Johnson syndrome, Acute Generalized Exanthematous Pustulosis, Drug-induced hypersensitivity syndrome, Drug-induced neutropenia). * History of allergic reactions to ITF2357, histone deacetylases (HDAC) inhibitors, or other related drugs, moxifloxacin, other quinolones, or to any excipient in the formulation. * Positive pregnancy test at screening or at baseline (Day -1). * Participants with a sorbitol intolerance or sorbitol malabsorption or have fructose intolerance. * Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease that can interfere with drug absorption. * Gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy) or gastric bands. * History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 milliliter [mL] of wine, 360 mL of beer, or 45 mL of 40 percent [%] alcohol]). * History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening. * Use of ITF2357 for a medical condition or in the context of another clinical trial within a period of 30 days prior to the first dosing. * Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration. * Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the pharmacokinetic profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption): 1. Prescription medications within 14 days prior to the first dosing; 2. OTC products (with the exception of the occasional use of acetaminophen [up to 2 grams [g] daily]) and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing; 3. Depot injection or implant of any drug within 3 months prior to the first dosing; 4. Any drugs known to induce or inhibit hepatic drug metabolism (including St. John's wort) within 30 days prior to the first dosing. * Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. * Breast-feeding participant. * Inability to be venipunctured and/or tolerate catheter venous access; * Inability or difficulty to swallow tablets or suspension. * Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study. * History or presence of other diseases, metabolic dysfunctions, physical examination findings, or any clinically relevant abnormal laboratory value at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the participant or the evaluation of the result of the study according to the Investigator's judgment. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT04821063	{ "brief_title": "Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval", "conditions": [ "Duchenne and Becker Muscular Dystrophy", "Polycytemia Vera" ], "interventions": [ "Drug: Moxifloxacin Hydrochloride", "Drug: ITF2357 10 mg/mL", "Drug: Placebo" ], "location_countries": [ "Canada" ], "nct_id": "NCT04821063", "official_title": "A Randomized, Partially Double-Blind, Four-Period, Four-Treatment, Crossover Study Investigating the Placebo-Corrected Effects of a Therapeutic Dose (100 mg) and a Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval in Healthy Male and Female Subjects", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-18", "study_completion_date(actual)": "2021-06-18", "study_start_date(actual)": "2021-04-13" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "QUADRUPLE", "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-01-11", "last_updated_that_met_qc_criteria": "2021-03-26", "last_verified": "2023-04" }, "study_registration_dates": { "first_posted(estimated)": "2021-03-29", "first_submitted": "2021-03-26", "first_submitted_that_met_qc_criteria": "2023-04-10" } } }
#Study Description Brief Summary The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL). Detailed Description Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date. #Intervention - DEVICE : Alcon Fluid Accommodating Intraocular Lens - Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near. - Other Names : - FAIOL, FluidVision MX Accommodating IOL - OTHER : Top Con Autorefractor - Device intended to automatically determine the focusing characteristics of the eye	#Eligibility Criteria: Inclusion Criteria: * Willing and able to attend all scheduled study visits as required per protocol * 22 years or older * Bilateral cataracts * Corneal astigmatism <= 1.25 D * Clear intraocular media other than cataract * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply: 1. are currently pregnant, 2. have a positive urine pregnancy test result at V0, 3. intend to become pregnant during the study period, 4. are breast-feeding. * Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject * Glaucoma * Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision * Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing * Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study * Systemic disease that could increase the operative risk or confound the outcome * Other protocol-specified exclusion criteria may apply Sex : ALL Ages : - Minimum Age : 22 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04330001	{ "brief_title": "Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL", "conditions": [ "Aphakia", "Presbyopia" ], "interventions": [ "Device: Alcon Fluid Accommodating Intraocular Lens", "Other: Top Con Autorefractor" ], "location_countries": [ "El Salvador", "Panama" ], "nct_id": "NCT04330001", "official_title": "Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-08", "study_completion_date(actual)": "2023-05-03", "study_start_date(actual)": "2020-12-28" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-05-06", "last_updated_that_met_qc_criteria": "2020-03-30", "last_verified": "2023-05" }, "study_registration_dates": { "first_posted(estimated)": "2020-04-01", "first_submitted": "2020-03-30", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial: * one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria. * a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria). Before the start of monitoring, an initial survey (Baseline) was carried out in the 'fokontany' (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms. As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods Detailed Description This study aims to compare the prevalence of malaria in the rural community of Mananjary after the Malaria Home Care Program (PECADOM Plus). The study will take place in fokontany rural communes of the district of Mananjary. This district was chosen for the following reasons: * High prevalence of malaria in this area (31% in subjects with fever and attending medical consultation in the CSB included in the sentinel IPM fever site) * presence of Peace Corps Volunteers (PCV) in this district. Mananjary District is situated in southeastern Madagascar, located in the central part of the Vatovavy Fitovinany Region, in the province of Fianarantsoa. It is located at 21°13'52' South and 48°20'31' East. The district is composed of one urban commune and 28 rural communes. After obtaining the agreement of the ethics committee for the realization of the study, the coordinator or the assistant coordinator of the project will make courtesy visits to all administrative and health officials in the Vatovavy Fitovinany and Mananjary District (Regional Directorate, District Chief ...).A random draw of fokontany meeting the inclusion criteria will be carried out later, to identify the distribution of fokontany in the intervention arm and control arm in the project. In addition to the 22 fokontany required, a draw of 8 reserve fokontany will be made (4 for each arm). A courtesy visit will be conducted in the fokontany raffled. The coordinator will check the number of inhabitants in these fokontany with the information gathered at the time of the preparation of the protocol (projection of the population according to the data of INSTAT, information from the Medical Inspector of Mananjary). If the fokontany will not be eligible, the reserve fokontany will replace them in the study. #Intervention - BEHAVIORAL : Proactive community case management - CHWs in the intervention arm conducted door-to-door fever screening for all inhabitants of all consenting households in their catchment area every fortnight. All individuals with temperature ≥ 37.5°C or history of self-reported fever in the previous two weeks were tested with an RDT; positive individuals who were not pregnant and did not have signs of severe disease were treated with artesunate-amodiaquine according to treatment guidelines. Individuals identified as requiring a referral during Pro-CCM visits were assisted with transfer to the healthcare center, with transportation handled by the project staff.	#Eligibility Criteria: Inclusion Criteria: * Inclusion criteria in community: * Fokontany in rural communes of Mananjary district (fokontany level of safety, accessibility by the study teams, and phone network availability was assessed). * Agreement of the chief of Fokontany for the participation of his fokontany in the study * Fokontany with at least 1,000 inhabitants * Individual inclusion criteria: * Resident in the relevant areas during the study period and consenting to participate Exclusion Criteria: * Exclusion criteria in community: * Fokontany with a total population of less than 1000 inhabitants * Fokontany in an urban commune * Fokontany in an area whose access is risky and perilous * Individual exclusion criteria: None (Non-resident present at the time of passage were tested in the study if they have suggestive signs of malaria but they were considered as visitors) Sex : ALL Ages : - Minimum Age : 2 Months - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT05223933	{ "brief_title": "Proactive Community Case Management (Pro-CCM) in Rural Madagascar", "conditions": [ "Malaria", "Case Management" ], "interventions": [ "Behavioral: Proactive community case management" ], "location_countries": [ "Madagascar" ], "nct_id": "NCT05223933", "official_title": "Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-12", "study_completion_date(actual)": "2018-12-29", "study_start_date(actual)": "2016-12-12" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "HEALTH_SERVICES_RESEARCH", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-02-04", "last_updated_that_met_qc_criteria": "2022-01-24", "last_verified": "2022-01" }, "study_registration_dates": { "first_posted(estimated)": "2022-02-04", "first_submitted": "2022-01-10", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This pilot research trial studies the use of a human prostate tissue model to maintain and study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was removed during surgery from patients with non-cancerous enlargement of the prostate (benign prostatic hyperplasia) and may create an environment similar to the natural environment of the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real tissue to create an environment to study stem cells may help doctors learn more about how they work and how they respond to treatments. Detailed Description PRIMARY OBJECTIVES: I. To optimize a decellularized prostate tissue model for the maintenance of prostate cancer stem cells. SECONDARY OBJECTIVES: I. To investigate the self-renewal and differentiation ability of human prostate cancer stem cells (CSCs) (tumor-associated calcium signal transducer 2 \[TROP2\]+ cells) in the above mentioned decellularized prostate tissue model. II. To compare the number of CSCs according to key patient characteristics, including race, age, Gleason, metastasis status, and previous cancer treatment(s). OUTLINE: Tissue samples are collected from patients with benign prostatic hyperplasia for decellularization and preparation as human extracellular matrix for growing human prostate CSCs. Tissue samples are also collected from patients with prostate cancer for the analysis of TROP2+ cells by flow cytometry. #Intervention - OTHER : Cytology Specimen Collection Procedure - Undergo collection of tissue samples - Other Names : - Cytologic Sampling - OTHER : Laboratory Biomarker Analysis - Correlative studies	#Eligibility Criteria: Inclusion Criteria: * Male patients scheduled for a prostatectomy * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: * Patients with prostate involvement secondary and as a result of metastasis or spread of cancerous cells from other organs Sex : MALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT02425800	{ "brief_title": "Human Prostate Tissue Model to Maintain and Study Prostate Cancer Stem Cells", "conditions": [ "Benign Prostatic Hyperplasia", "Prostate Carcinoma" ], "interventions": [ "Other: Laboratory Biomarker Analysis", "Other: Cytology Specimen Collection Procedure" ], "location_countries": [ "United States" ], "nct_id": "NCT02425800", "official_title": "Optimizing Human Prostate Extracellular Matrix as a Structure for Maintenance and Studying of Prostate Cancer Stem Cells", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-05", "study_completion_date(actual)": "2021-08-03", "study_start_date(actual)": "2015-07-28" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-09-01", "last_updated_that_met_qc_criteria": "2015-04-21", "last_verified": "2021-08" }, "study_registration_dates": { "first_posted(estimated)": "2015-04-24", "first_submitted": "2015-03-24", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded study to evaluate the effect of GSK1120212 on the electrical activity of the heart as compared to placebo in subjects with solid tumor cancers. All subjects will undergo Screening assessments within 21 days prior to the start of the study treatment to determine their eligibility for enrollment in the study. Eligible subjects will receive study treatment administered over a period of 15 days followed by a post-treatment follow-up visit. Study treatment (GSK1120212-matched placebo) will be blinded to subjects. Subjects will receive GSK1120212-matched placebo on one day during the first 14 days of dosing. On all other days the subject will receive a once-daily 2 mg dose of GSK1120212 except for Day 15 when the subject will receive 3mg dose of GSK1120212 12-lead ECG recordings will be obtained from continuous ECG recordings obtained via a 12-lead Holter monitor on Study Days 1 and 15 while subjects are in the clinical research unit. The effect of GSK1120212 on the electrical activity of the heart will be determined by time-matched ECGs obtained at the same time points relative to dosing on these days. Ambulatory blood pressure readings will be obtained from continuous 24-hour recordings via an ambulatory blood pressure monitor The effect of GSK1120212 on blood pressure parameters will be determined by blood pressure readings obtained at the same time points relative to dosing on Study Days 1 and 15. Serial blood samples to analyze the concentration of study drug in the subject's blood will be obtained at the same time points relative to dosing on Study Days 1 and 15. Subjects who are eligible for continued treatment with GSK1120212 may continue treatment under the rollover study MEK114375 (drug study number). A post-treatment follow-up visit will be conducted within 28 days of the last dose of study treatment for all subjects who do not continue treatment in the rollover study MEK114375. Detailed Description GSK1120212 is an orally administered, potent and highly selective small molecule inhibitor of MEK1(mitogen-activated extracellular signal-regulated kinase-1)/MEK2 (mitogen-activated extracellular signal-regulated kinase-2) activation and kinase activity. As monotherapy, GSK1120212 has shown an acceptable risk-benefit profile with encouraging efficacy in various oncologic settings. This Phase I, single-sequence, placebo-controlled, singleblind, multicenter study is designed to evaluate the effects of repeat oral dosing of GSK1120212 on electrocardiographic parameters with a particular focus on its effect on cardiac repolarization (Corrected QT interval \[QTc\] duration) as compared to placebo in subjects with solid tumor cancers. A single dose of placebo will be administered on Study Day 1 followed by administration of a once-daily 2 mg dose of GSK1120212 for 13 days (Study Days 2 through 14) and on Study Day 15 a dose of 3 mg of GSK1120212 will be given. Digital 12-lead electrocardiograms (ECGs) will be extracted from continuous ECG recordings obtained via Holter monitor on Study Days 1 and 2 after the administration of placebo and on Study Days 15 and 16 after the administration of GSK1120212. Pharmacokinetic samples will be time-matched with the Holter ECGs. This study will also assess the exposure-QTc relationship between plasma concentrations of GSK1120212 and its effect, if any, on cardiac repolarization, specifically on the QTc interval. Continuous 24-hour ambulatory blood pressure monitoring will be conducted to assess the effect of GSK1120212 on blood pressure parameters on Study Days 1 and 15. Safety assessments, including assessment of adverse events, clinical laboratory tests (hematology and clinical chemistry) and vital signs, will be performed throughout the study. Following completion of study treatment, eligible subjects may transition to the open-label, rollover study MEK114375 to continue treatment with GSK1120212. #Intervention - DRUG : GSK1120212 - GSK1120212 - placebo match oral dose on day 1 with GSK1120212 3 mg oral dose on day 15. GSK1120212 2mg and 2 tablets of GSK1120212 -placebo matched 0.5 mg oral dose daily from day 2 to day 14. 24 hour holter monitoring will be performed on day 1 and day 15 to compare the subjects cardiac repolarization while on placebo and after having received GSK1120212 for 14 days	#Eligibility Criteria: Inclusion Criteria * Has provided signed, written informed consent. * Male or female, age greater than and equal to 18 years at the time of signing the informed consent form. * Has histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapy(ies) or for which there is no approved therapy. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Able to swallow and retain oral medication. * Has adequate baseline organ function as follows: System: Hematologic - absolute neutrophil count, Laboratory values: greater than and equal to 1.2 × 109/L;System: Hematologic - Hemoglobin, laboratory values: greater than and equal to 9 g/dL; System: Hematologic-platelets, laboratory values: greater than and equal to 75 × 109/L; System: Hematologic - Prothrombin time (PT), INR (international normalizing ratio - a blood clotting test))and Partial thromboplastin time (PTT), laboratory values: less than and equal to 1.5 times ULN(Upper limit of normal); System - Hepatic - Total bilirubin, laboratory values: less than and equal to 1.5 times ULN; System: Hepatic-ALT(Alanine aminotransferase), laboratory values: less than and equal to 2.5 times ULN; System: Renal-Creatine, laboratory values: less than anad equal to 1.5 times ULN; or System: Renal-Calculated creatinine clearance, laboratory values: greater than and equal to 50 mL/min; or System: Renal-24hour urine creatine clearance, laboratory values: greater than and equal to 50 mL/min; System: Cardiac-LVEF, laboratory values: greater than and equal to LLN (Lower limit of normal) by ECHO or MUGA(Multigated acquisition scan). Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECHO, echocardiogram; INR; LLN,lower limit of normal; LVEF, left ventricular ejection fraction; MUGA; PT, prothrombin time; PTT, partial thromboplastin time; ULN, upper limit of normal. INR greater than 1.5 times ULN will be acceptable in case of subjects receiving therapeutic anticoagulants such as warfarin as long as INR is monitored during the study according to clinical practice; Calculated by the Cockcroft-Gault formula; If LLN is not defined for a given institution, then ejection fraction must be greater than and equal to 50%. NOTE: Subjects with aspartate aminotransferase (AST), ALT or bilirubin values outside the range(s) in the table due to Gilbert's syndrome or asymptomatic gallstones are not excluded. Laboratory results obtained during Screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may opt to retest the subject and the subsequent within-range screening result may be used to confirm eligibility. * Have serum potassium, serum magnesium, and total serum calcium levels within normal limits. NOTE: If total serum calcium is below the LLN, then it will be necessary to determine the albumin-corrected total serum calcium level. Use the following calculation: Calcium (mg/dL) = measured total Calcium (mg/dL) + 0.8 (4.0 - serum albumin [g/dL]) NOTE: If serum potassium or magnesium level is below the LLN, supplementation is permitted in order to meet the inclusion criterion. Subject should be retested following supplementation. In order to avoid a situation where the subject cannot be dosed during the study due to electrolyte levels falling below the LLN, it is strongly recommended to maintain serum potassium levels greater than 4 mEq(Milliequivalent )/L and serum magnesium levels greater than 2.2 mg/dL whenever possible. Slight elevations of potassium or magnesium above the upper limit of normal may be seen during supplementation and will not exclude subjects from study entry. * If a female subject of childbearing potential, must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in the protocol. during the study and for 4 months following the last dose of study treatment. Exclusion Criteria: * History of prior exposure to a MEK(activated extracellular signal-regulated kinase) inhibitor or disease progression while receiving treatment with a MEK inhibitor. * Any of the following ECG findings: QTcF (preferred) or QTcB(interval corrected for heart rate by Bazett's formula) interval greater than and equal to 480 msec; PR(Partial response) interval greater than 220 msec or less than and equal to 110 msec; Bradycardia defined as sinus rate less than 50 beats per minute (bpm) * Cardiac conduction abnormalities denoted by any of the following: Evidence of second-degree (type II) or third-degree atrioventricular block; Evidence of ventricular pre-excitation; Electrocardiographic evidence of complete left bundle branch block (LBBB) NOTE: Right bundle branch block (RBBB), incomplete LBBB or incomplete RBBB will be exclusionary ONLY if QRS(a name for the combination of the graphical deflections seen on a typical electrocardiogram) duration is greater than 120 msec; Intraventricular conduction delay with QRS duration greater than 120 msec; Evidence of atrial fibrillation or history of atrial fibrillation within the past 6 months; Presence of cardiac pacemaker * History or evidence of any one of the following cardiovascular conditions within the past 6 months: Class II, III, IV heart failure as defined by the New York Heart Association; Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; Symptomatic peripheral vascular disease or other clinically significant cardiac disease; Cardiac metastases * Left ventricular ejection fraction (LVEF), as measured by ECHO or MUGA scan, below the institutional LLN, or if a LLN does not exist at an institution, less than 50% * Personal or family history of long-QT syndrome. * Treatment-refractory hypertension defined as a blood pressure of SBP (Systolic blood pressure) greater than 140 mmHg and/or DBP(Diastolic blood pressure) greater than 90 mmHg which cannot be controlled by anti-hypertensive therapy or lifestyle modifications. * Anti-cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 21 days prior to enrollment; chemotherapy regimens without delayed toxicity within 14 days prior to enrollment; or use of an investigational anti-cancer drug within 28 days preceding the first dose of study treatment. NOTE: Subjects with a history of prior anthracycline exposure are excluded. * Current use of a prohibited medication(s) or requires any of these medications during treatment with study treatment. NOTE: This includes medications that are listed as drugs that are generally accepted by the QTdrug.org (Advisory Board of the Arizona Center for Education and Research on Therapeutics to have a risk of causing Torsade de pointes (available at: http://www.azcert.org/medical-pros/drug-lists/bycategory.cfm). * Current use of therapeutic warfarin. NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted. * Any unresolved toxicity of greater than and equal to Grade 2, except alopecia or Grade 2 anemia, (NCI-CTCAE), version 4.0, from previous anti-cancer therapy. * Pre-existing Grade 2 or greater peripheral neuropathy. * History or current evidence/risk of RVO or CSR: History of RVO (Retinal vein occlusion) or CSR (Central serous retinopathy), or predisposing factors to RVO or CSR (i.e., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension or diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes); Visible retinal pathology as assessed by ophthalmic examination that is considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping; Intraocular pressure >21 mmHg as measured by tonography * History of interstitial lung disease or pneumonitis. * Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. NOTE: Subjects previously treated for these conditions that have had stable central nervous system disease (verified with consecutive imaging studies) for greater than 3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 30 days prior to Study Day 1 are permitted. * Presence of clinically significant gastrointestinal (GI) abnormalities that may affect the absorption of study treatment(s) including, but not limited to: Active, uncontrolled GI disease; Malabsorption syndrome; Substantial resection of the stomach, small bowel or colon. If clarification is needed as to whether a condition will significantly affect the absorption of study treatment(s), contact the GSK Medical Monitor. * History or presence of hepatic insufficiency (excluding metastatic hepatic carcinoma). * Uncontrolled medical conditions (i.e., diabetes mellitus, hypertension), psychological,familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol. * Lactating or actively breastfeeding females. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to DMSO (Dimethyl Sulfoxide). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01658553	{ "brief_title": "A Study to Look at the Electrical Activity of the Heart in Subjects With Solid Tumor Cancers, Before and After Receiving the Study Treatment, GSK1120212", "conditions": [ "Cancer" ], "interventions": [ "Drug: GSK1120212" ], "location_countries": [ "United States" ], "nct_id": "NCT01658553", "official_title": "A Phase I, Single-Sequence, Placebo-Controlled, Single-Blind Study to Evaluate the Effect of Repeat Oral Dosing of GSK1120212 on Cardiac Repolarization in Subjects With Solid Tumors", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04-05", "study_completion_date(actual)": "2014-04-05", "study_start_date(actual)": "2012-09-19" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "SINGLE", "phase": [ "PHASE1" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2017-11-13", "last_updated_that_met_qc_criteria": "2012-08-02", "last_verified": "2017-11" }, "study_registration_dates": { "first_posted(estimated)": "2012-08-07", "first_submitted": "2012-06-28", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus. #Intervention - DRUG : SB-756050 immediate release capsule - SB-756050 immediate release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white drug layered pellets. Each capsule will contain 5, 25 or 100 milligrams of SB-756050. - DRUG : SB-756050 modified release capsule - SB-756050 modified release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white enteric coated drug layered pellets. Each capsule will contain either 25or 100 milligrams of SB-756050. - DRUG : Placebo - Subjects will also receive placebo capsules.	#Eligibility Criteria: Inclusion Criteria: Healthy Subjects * Healthy male or female subject as determined by a responsible physician, based on a medical evaluation including history, physical examination, vitals signs, laboratory tests, and cardiac monitoring. * Female subjects must be of non-childbearing potential including pre-menopausal women with documented (medical report verification) hysterectomy, tubal ligation, or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. * 18 - 60 years, inclusive, at the time of signing and dating the informed consent. * BMI (body mass index) within the range 20 <= age <= 30 kg/m2, inclusive. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Diabetic Subjects * Male or female subjects, 18 - 60 years, inclusive, at the time of signing the informed consent * Female subjects must be of non-childbearing potential including pre-menopausal women with documented (medical report verification) hysterectomy, tubal ligation, or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. * Subjects should have no significant known medical conditions other than T2DM. * BMI (body mass index) within the range 25 <= age <= 35 kg/m2, inclusive. * T2DM diagnosed at least 3 months prior to Screening with * Fasting plasma glucose (FPG) level <= 220mg/dL at the Screening visit, * FPG level <= 250 mg/dL on Day -1 of Period 1 * For subjects taking no antidiabetic medications: HbA1c between 7 and 10%, inclusive, at Screening visit * For subjects taking metformin or a sulfonylurea: HbA1c between 6.5 and 9.5%, inclusive, at Screening visit * Subjects must be taking either no anti-diabetic medication, or metformin as monotherapy, or a sulfonylurea as monotherapy. (Subjects taking BOTH metformin and a sulfonylurea are not qualified for the trial). If taking metformin or a sulfonylurea, the dose must have been stable for at least 3 months prior to screening, and the subject must be willing to wash out from metformin or sulfonylureas from Day -7 prior to Period 1, through discharge from Period 4. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: * As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study. * Has any of the following laboratory abnormalities: * Positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result. * History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH at Screening * A positive pre-study drug/urine screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. * A pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products. * Has a history of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound. * Has QTc at Screening > 450 msec. Note that if the initial QTc value is prolonged, the ECG should be repeated two more times (with 5 minutes between ECG readings) and the average of the 3 QTc values used to determine eligibility. * Has clinically significant rhythm abnormalities identified during 24-hour Screening Holter assessment. * History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. One drink is equivalent to 12 g alcohol (which equals 5 ounces (150 mL) of wine, 12 ounces (360 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening. * Smoked or used tobacco or nicotine-containing products within the previous 6 months. * Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Acetaminophen may be used as needed for adverse events; however, use should be restricted to 4 hours after dosing if possible with a preferred maximum dose of 2 grams in 24 hours. * Unwilling to abstain from * Caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level. * Use of illicit drugs * Alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level. * Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacodynamic blood samples. * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes sensitivity to heparin, if heparin will be used to maintain catheter patency. * Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period. * Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study. Healthy Subjects * As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study. * Has any of the following laboratory abnormalities: * Positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result. * History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH at Screening. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 3 months prior to Screening and who have a screening thyroid stimulating hormone (TSH) within the normal range may participate.) * ALT and/or AST > 2 times the upper limit of normal at screening or prior to the first dose. * Fasting triglycerides > 450mg/dL at screening or prior to the first dose. * Total Bilirubin > 1.5 times the upper limit of normal at screening or prior to the first dose * A positive pre-study drug/urine screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. * A pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products. * Significant renal disease or loss of a kidney * Significant ECG abnormalities, * Systolic pressure > 150 mmHg or <80 mmHg or diastolic blood pressure > 95 mmHg or <60 mmHg at screening. Blood pressure assessments may be repeated once if needed, allowing adequate time for subject to rest. * Previous use of insulin as a treatment within 3 months of Screening, or for >2 weeks when used for acute illness in the last 12 months prior to Screening, or if used for more than 1 year when associated with GDM. * Has a history of any of the following conditions: * Clinically significant symptoms of gastroparesis * Cholelithiasis or obstructive or inflammatory gallbladder disease within 3 months prior to Screening * Gastrointestinal disease that could affect fat or bile acid absorption, including inflammatory bowel disease, chronic diarrhea, Crohn's or malabsorption syndromes within the past year * Gastrointestinal surgery * Chronic or acute pancreatitis * History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. 1 drink is equivalent to (12 g alcohol) = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening. * Smoked or used tobacco or nicotine-containing products within the previous 6 months. * Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Is taking prohibited medications: * Acetaminophen may be used as needed for adverse events; however, use should be restricted to 4 hours after dosing if possible with a preferred maximum dose of 2 grams in 24 hours. * The use of anti-diabetic agents other than metformin or sulfonylureas is reason for exclusion and subjects will not be allowed to wash off of unapproved anti-diabetic medications in order to qualify for participation in this study. Subjects taking BOTH metformin and a sulfonylurea are not qualified for the trial. * Subjects must wash out from the following medications during the 7-day period prior to first dose, and must remain off these medications through discharge from period 4: metformin, sulfonylureas, statins, fat absorption blocking agents, bile acid sequestrants * All other prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) are prohibited within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication and through discharge from Period 4. * Unwilling to abstain from * Caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level * Use of illicit drugs * Alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level * Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacokinetic blood samples * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes sensitivity to heparin, if heparin will be used to maintain catheter patency. * Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period. * Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT00607906	{ "brief_title": "First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050", "conditions": [ "Diabetes Mellitus, Type 2" ], "interventions": [ "Drug: SB-756050 modified release capsule", "Drug: Placebo", "Drug: SB-756050 immediate release capsule" ], "location_countries": [ "United States" ], "nct_id": "NCT00607906", "official_title": "A Single-blinded, Randomized, Placebo-controlled, Staggered-parallel, Escalating Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered SB756050 in Healthy Volunteers and in Subjects With Type 2 Diabetes Mellitus", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-03-10", "study_completion_date(actual)": "2008-03-10", "study_start_date(actual)": "2007-11-16" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": null, "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2017-09-06", "last_updated_that_met_qc_criteria": "2008-01-23", "last_verified": "2017-09" }, "study_registration_dates": { "first_posted(estimated)": "2008-02-06", "first_submitted": "2008-01-23", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test. Detailed Description This study was a prospective, randomized controlled study. The enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. After initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group. #Intervention - DRUG : Ginkgo biloba & Methylprednisolone - Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. Methylprednisolone 48 mg/day(per oral, once a day for first 9 days. And then methylprednisolone tapering was started every 2 days. The entire duration of methylprednisolone treatment was 14 days. - Other Names : - Ginexin, Methylprednisolone - DRUG : Ginkgo biloba - Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. - Other Names : - Ginexin	#Eligibility Criteria: Inclusion Criteria: * Ages > 18 years * Acute vertigo that occurred within 7 days * The spontaneous nystagmus should be detected * Caloric weakness over 20% Exclusion Criteria: * Suspicious or verified a central nervous system lesion * If the patient has denied. * Other otologic disease (acute/chronic otitis media, otosclerosis, etc) * The patient with history of otologic surgery * The patient with history of brain surgery Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02098330	{ "brief_title": "The Efficacy of Steroid Therapy in Vestibular Neuritis", "conditions": [ "Vestibular Neuritis" ], "interventions": [ "Drug: Ginkgo biloba", "Drug: Ginkgo biloba & Methylprednisolone" ], "location_countries": [ "Korea, Republic of" ], "nct_id": "NCT02098330", "official_title": "The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12", "study_completion_date(actual)": "2015-06", "study_start_date(actual)": "2014-03" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE3" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-01-10", "last_updated_that_met_qc_criteria": "2014-03-25", "last_verified": "2019-01" }, "study_registration_dates": { "first_posted(estimated)": "2014-03-28", "first_submitted": "2014-03-21", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses. Detailed Description Setting: academic center designed as a referral center for patients with COVID-19 Design: single center observational autopsy study Participants: intensive care unit (ICU) adults who died from confirmed COVID-19 during the first wave of the pandemic in France. Oversight: As per legal health authority requirement only patients with suspected or confirmed severe acute respiratory syndrome (SARS)- related to coronavirus 2 infection were admitted to the ICU. The department of pathology and forensic medicine is allowed by legal authority to perform autopsy of non-survivors from COVID-19 to inform the cause of death as per ministerial decree of July 12 2017 and March 28, 2020. In this context, of autopsy for medical purpose and public interest there is no requirement for institutional review board submission. However, consent from patients legal representative or closest relatives is required for autopsy. #Intervention - PROCEDURE : autopsy - autopsy	#Eligibility Criteria: Inclusion Criteria: * Adults * admitted to the ICU * confirmed COVID-19 * died during ICU stay Exclusion Criteria: * refusal from patient's legal representative or closest relative Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04453670	{ "brief_title": "Neuropathology in Adults Intensive Care Unit Patients With COVID 19", "conditions": [ "COVID 19" ], "interventions": [ "Procedure: autopsy" ], "location_countries": [ "France" ], "nct_id": "NCT04453670", "official_title": "A Prospective Observational Autopsy Study of Neuropathology in Adults Intensive Care Unit Patients With COVID 19", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-11", "study_completion_date(actual)": "2020-05-15", "study_start_date(actual)": "2020-03-10" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-07-01", "last_updated_that_met_qc_criteria": "2020-06-30", "last_verified": "2020-06" }, "study_registration_dates": { "first_posted(estimated)": "2020-07-01", "first_submitted": "2020-05-15", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events \[MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke\] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed. #Intervention - BIOLOGICAL : Apolipoprotein A-I [human] (apoA-I) - Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma for intravenous administration - Other Names : - CSL112 - OTHER : Placebo - 25% albumin solution diluted to 4.4%	#Eligibility Criteria: Inclusion Criteria: * Male or female least 18 years * Evidence of myocardial necrosis, consistent with type I (spontaneous) MI * No suspicion of acute kidney injury * Evidence of multivessel coronary artery disease * Presence of established cardiovascular risk factor(s): 1. Diabetes mellitus on pharmacotherapy OR 2. 2 or more of the following: age >= 65 years, prior history of MI, peripheral arterial disease Exclusion Criteria: * Ongoing hemodynamic instability * Evidence of hepatobiliary disease * Evidence of severe chronic kidney disease * Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI * Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT03473223	{ "brief_title": "Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome", "conditions": [ "Acute Coronary Syndrome" ], "interventions": [ "Biological: Apolipoprotein A-I [human] (apoA-I)", "Other: Placebo" ], "location_countries": [ "Colombia", "United States", "Netherlands", "Germany", "Poland", "Singapore", "Romania", "Serbia", "Austria", "Estonia", "Switzerland", "Hong Kong", "Finland", "Czechia", "United Kingdom", "France", "Japan", "Israel", "Sweden", "Taiwan", "South Africa", "Thailand", "Russian Federation", "Australia", "Argentina", "Hungary", "Italy", "Turkey", "Croatia", "Denmark", "Slovakia", "Georgia", "Mexico", "New Zealand", "Norway", "Peru", "Brazil", "Korea, Republic of", "Latvia", "Lithuania", "Ukraine", "Chile", "Portugal", "Canada", "Malaysia", "Spain", "Bulgaria", "Belgium", "Greece" ], "nct_id": "NCT03473223", "official_title": "A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-16", "study_completion_date(actual)": "2023-11-17", "study_start_date(actual)": "2018-03-21" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "QUADRUPLE", "phase": [ "PHASE3" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2025-01-14", "last_updated_that_met_qc_criteria": "2018-03-20", "last_verified": "2024-12" }, "study_registration_dates": { "first_posted(estimated)": "2018-03-22", "first_submitted": "2018-03-14", "first_submitted_that_met_qc_criteria": "2024-12-19" } } }
#Study Description Brief Summary The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations. Detailed Description This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic). Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses. The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently. #Intervention - BIOLOGICAL : Botulinum toxin A 'BoNT/A-DP' - To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown. - BIOLOGICAL : Botulinum toxin A 'Botox Cosmetics' - To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.	#Eligibility Criteria: Inclusion Criteria: * Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on GLS-I/GLS-S) as determined by in clinic assessments by both the investigator and the subject (where: 0='none', 1='mild', 2='moderate', 3='severe'). * Subject has a stable medical condition with no uncontrolled systemic disease. * Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study. * Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the GLS-S), without glasses obstructing the forehead area. Exclusion Criteria: * Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to Screening, or any planned treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational treatment). * Known hypersensitivity to either study medication or its excipients. * Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy. * Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study. o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study. * Previous insertion of permanent material in the glabellar area, or planned insertion during the study. * Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line. * Active skin disease/infection or irritation at the treatment area. * Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart. * Use of a muscle relaxant within 2 weeks prior to Screening, or planned use during the study. * Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator. * Pregnant, breastfeeding or planning to become pregnant during the study. * Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to Screening or planned during the study. * Planned surgery with general anesthetic (use of local anesthetic outside the glabellar area is permitted). * Participation in another clinical study within one month of Screening and throughout the study. * Previous participation in another botulinum toxin aesthetic study, which involved the treatment of glabellar, lines in combination with canthal lines and/or forehead lines in the previous 18 months. * Chronic drug or alcohol abuse (as per investigator discretion). Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04763265	{ "brief_title": "Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines", "conditions": [ "Frown Lines" ], "interventions": [ "Biological: Botulinum toxin A 'BoNT/A-DP'", "Biological: Botulinum toxin A 'Botox Cosmetics'" ], "location_countries": [ "Austria", "Canada", "United States" ], "nct_id": "NCT04763265", "official_title": "A Double-Blinded, Randomized, Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-08", "study_completion_date(actual)": "2021-02-01", "study_start_date(actual)": "2019-12-18" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "TRIPLE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-02-21", "last_updated_that_met_qc_criteria": "2021-02-18", "last_verified": "2021-01" }, "study_registration_dates": { "first_posted(estimated)": "2021-02-21", "first_submitted": "2021-01-25", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a long-term, multi-center, longitudinal, observational study in children with achondroplasia (ACH). The aim is to study height velocity and comorbidities in children with ACH. This is a natural history study and no study medication will be administered.	#Eligibility Criteria: Inclusion Criteria: * Legally authorized representative is willing and able to provide written, signed informed consent (with a written assent from the child when appropriate per local requirements) * Willing and able to comply with study protocol per investigator judgement * Clinical diagnosis of achondroplasia (confirmed by the investigator) * Age between 0 <= age <= 8 old at enrollment * Able to stand without assistance (if the child is 24 months or older) Exclusion Criteria: * Have received chronic treatment (> 3 months) of human growth hormone (hGH) or other medicinal products intended to affect stature or body proportionality at any time * Have received any dose of medicinal products intended to affect stature or body proportionality within the previous 6 months of screening * Have received any investigational medicinal product or device intended to affect stature or body proportionality at any time * History or presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones * History of any bone-related surgery that affects growth potential of long bones, such as orthopedic reconstructive surgery and osteotomy (foramen magnum decompression, and laminectomy with full recovery are allowed with minimum of 6 months of bone healing. Limb-lengthening with full recovery is allowed with a minimum of 12 months of bone healing.) * Have forms of skeletal dysplasias other than achondroplasia or medical conditions that result in short stature or abnormal bone growth [such as severe achondroplasia with developmental delay and acanthosis nigricans (SADDAN), hypochondroplasia, growth hormone deficiency, Turner syndrome, pseudoachondroplasia. uncontrolled hypothyroidism, uncontrolled diabetes mellitus, autoimmune disease requiring corticosteroid therapy, inflammatory bowel disease, and chronic renal insufficiency] * History or presence of malignant disease, other than basal cell epithelioma/carcinoma or completely resected squamous skin cancer with no recurrence for 12 months per medical records Sex : ALL Ages : - Minimum Age : 0 Years - Maximum Age : 8 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No	NCT03875534	{ "brief_title": "A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia", "conditions": [ "Achondroplasia" ], "interventions": null, "location_countries": [ "France", "China", "United States", "Germany", "Portugal", "United Kingdom", "New Zealand", "Canada", "Austria", "Spain", "Australia", "Ireland", "Switzerland", "Italy", "Denmark" ], "nct_id": "NCT03875534", "official_title": "ACHieve: A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-12", "study_completion_date(actual)": "2024-01-12", "study_start_date(actual)": "2019-06-19" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-03-19", "last_updated_that_met_qc_criteria": "2019-03-13", "last_verified": "2024-03" }, "study_registration_dates": { "first_posted(estimated)": "2019-03-14", "first_submitted": "2019-03-07", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Even though the lower part of the body does receive some blood supply during Cardiopulmonary Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there are complications associated with CPB and clamping of the aorta. These include complications with the stomach, intestines and kidneys. The hypotheses of this study are that increased lower body perfusion during aortic arch reconstruction will decrease intestinal ischemia and the incidence of necrotizing enterocolitis, improve renal function in the postoperative period, and shorten both intensive care unit and hospital length of stay. The purpose of this research study is to provide the lower part of the body and its organs with possibly more blood supply with a modified form of cardiopulmonary bypass and see if this additional blood supply helps to decrease complications of the kidney, stomach and intestines. Detailed Description As the aorta is repaired, the child has no circulation to the body or brain. While short periods of circulatory arrest were well tolerated, a modified technique called selective cerebral perfusion was developed to maintain blood flow to the brain during aortic repairs so as to allow for less hurried repairs with less concern over brain ischemia and injury. Selective cerebral perfusion is designed to provide flow to the brain via the right carotid artery and collateral intracranial vessels while the aortic arch is isolated for repair. It is felt that collateral vessels also allow some perfusion of the lower body, but the adequacy of lower body perfusion during selective cerebral perfusion has not been well documented. While it is clear that some blood reaches the lower body, the incidence of renal and gastrointestinal complications following cardiac repairs involving aortic arch reconstructions remains significant. The goal of this proposal is to evaluate a simple modification of the standard selective cerebral perfusion protocol designed to increase perfusion to the lower body during aortic arch reconstructions. Essentially all children who undergo aortic arch reconstruction at Egleston hospital have either a femoral or umbilical artery catheter in place for routine monitoring. During selective cerebral perfusion, the descending thoracic aorta is clamped, so the lower body arterial line is not a useful monitor at that point. We propose to connect a pressure line from the cardiopulmonary bypass circuit to the lower body arterial catheter, allowing for increased perfusion of the lower body through the femoral/umbilical arterial catheter during selective cerebral perfusion We will monitor simultaneous near infra-red spectroscopy of the brain, flank, and thigh to determine the adequacy of oxygen delivery to the brain, kidney, and lower body musculature during the procedure. Near infra-red spectroscopy provides a measure of the oxygenation of hemoglobin in arterial, capillary, and venous blood within the path of an infra-red sensor. Blood samples will be collected before skin incision, at the end of the procedure, and at 3, 12, and 24 hours after arrival to the intensive care unit. Intestinal fatty acid binding protein (i-FABP) and c-reactive protein (CRP) serum levels will be measured at each timepoint as markers of intestinal ischemia and generalized inflammation respectively. The incidence of documented or suspected necrotizing enterocolitis prior to hospital discharge and the time required to achieve full enteral feeds will be recorded. Renal function will be assayed by the maximal change from preoperative to postoperative serum creatinine, normalized urine output per 12 hour period following surgery, total diuretic dose per day, and daily creatinine clearance for the first 3 days after surgery. #Intervention - PROCEDURE : Modified Selective Cerebral Perfusion - Modified Selective perfusion is a cardiopulmonary bypass circuit that has been modified to allow blood flow to the lower body as well as the upper body while the surgery is being performed.	#Eligibility Criteria: Inclusion Criteria: * Diagnosis including aortic coarctation, arch hypoplasia, or interrupted aortic arch which requires cardiopulmonary bypass for repair * age less than 1 year * parental consent for participation Exclusion Criteria: * prior aortic arch operations * emergency operation * operating surgeon decides that selective cerebral perfusion is not indicated * Documented renal insufficiency (creatinine > 2.0) or evidence of bowel ischemia prior to surgery Sex : ALL Ages : - Maximum Age : 1 Year - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No	NCT00490256	{ "brief_title": "Modified Perfusion for Neonatal Aortic Arch Reconstruction", "conditions": [ "Aortic Arch Hypoplasia or Atresia" ], "interventions": [ "Procedure: Modified Selective Cerebral Perfusion" ], "location_countries": [ "United States" ], "nct_id": "NCT00490256", "official_title": "Evaluation of a Modified Perfusion Strategy for Neonatal Aortic Arch Reconstruction: Does Perfusing the Lower Body During Arch Repair Help?", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-04", "study_completion_date(actual)": "2010-06", "study_start_date(actual)": "2007-06" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2014-06-03", "last_updated_that_met_qc_criteria": "2007-06-20", "last_verified": "2014-05" }, "study_registration_dates": { "first_posted(estimated)": "2007-06-22", "first_submitted": "2007-06-20", "first_submitted_that_met_qc_criteria": "2011-07-08" } } }
#Study Description Brief Summary The project seeks to test the integration of Interpersonal Psychotherapy for Groups within Care Group projects and investigate whether the treatment of maternal depression with Interpersonal Psychotherapy for Groups improves the adoption of nutrition-related behaviors that can reduce stunting in the Kitgum District in northern Uganda. A secondary aim is to examine whether the participation in the care groups will also result in remission of depression as a non-specific therapeutic effect although it may not be intended as an antidepressant treatment. Detailed Description Over the past two decades there has been a growing global momentum and commitment to address malnutrition. The most recent indication of this is reflected in goal #2 of the Sustainable Development Goals, 'end hunger, achieve food security and improved nutrition and promote sustainable agriculture.' However, great challenges remain. Today, over 165 million children under five are chronically malnourished or stunted, and once a child is stunted, it is nearly impossible to regain their cognitive and physical potential. In addition, it is estimated that malnutrition contributes to more than one-third of all child deaths under the age of five. Through research and fieldwork, key evidence-based interventions and target populations have been identified. It has been found that the most critical time to prevent chronic malnutrition is from conception up through the child's second birthday, known as the 'first 1,000 days.' Improving household behaviors related to maternal and child health and nutrition such as improved water, sanitation, and hygiene practices, proper infant and young child feeding practices, optimal maternal nutrition and antenatal care, and others can reduce child malnutrition and prevent up to 57% of deaths of children under five years of age. However, despite the gains in reducing stunting in children, there has been no program implemented at scale that has come close to normalizing child growth. There is a need for new tools and interventions that focus on other causes of malnutrition aside from poor water, sanitation, and hygiene, infant and young child feeding, home management/care seeking for sick children, maternal nutrition/antenatal care, and use of preventive services (e.g., immunizations). One promising new intervention is the treatment of maternal depression, an underlying cause of malnutrition. The potential global impact of adding community-based treatment of maternal depression to the investigator's toolbox of interventions to reduce child stunting could be significant: A recent meta-analysis found that stunting could be reduced globally by about 27% by eliminating maternal depression (Surkan, J, Kennedy C, Hurley, B, and Black, M., 2011). As such, the investigators believe that treatment of maternal depression could result in improved nutrition behavior change in mothers, leading to significant reductions in child stunting and helping to end hunger. An effective, low-cost, short-duration community-based method for decreasing depression has been established that was first rigorously tested in Uganda: Interpersonal Psychotherapy for Groups. Several Private Voluntary Organizations in Africa have used this low-cost, short-duration, community-based group psychosocial approach and found it to be a culturally-sensitive, acceptable, and feasible approach to address depression. A cluster randomized controlled trial of this approach in depressed adults in southern Ugandan rural communities yielded a 93% decline in diagnosable depression (vs. a 45% decline in controls), as well as significantly higher functionality in household tasks, including those associated with child nutrition and health (Bass et al, 2006). However, this study did not measure changes in maternal adoption of behaviors that affect child nutritional status and the possible effect of treatment of maternal depression on improved child growth. Demonstrating that Interpersonal Psychotherapy for Groups works for increasing maternal adoption of behaviors that affect child nutritional status could have a profound effect on how malnutrition is prevented worldwide, and save children and their mothers from a lot of unnecessary suffering. Therefore, Food for the Hungry in partnership with the team at the Global Mental Health Lab at Teachers College, Columbia University is proposing a 33 month project which will test how to integrate Interpersonal Psychotherapy for Groups within Care Group projects and whether the treatment of maternal depression with Interpersonal Psychotherapy for Groups improves the adoption of maternal behaviors that can reduce stunting in Kitgum District in northern Uganda. Using a cluster randomized controlled trial design, Food for the Hungry will test whether adding Interpersonal Psychotherapy for Groups for half of the women identified with depression improves the adoption of household health and nutrition behaviors known to improve child linear growth. Pregnant women and mothers with a child born after 3 April 2016 (who will be under 18 months of age by the time health promotion begins on 4 October 2017) will be assessed for depression, and half of those who meet a cutoff for depression will be randomly assigned to IPT-G. Following the three-month implementation of Interpersonal Psychotherapy for Groups, all pregnant women and women with children under two years of age in the project area will participate in Care Groups, an evidence-based community nutrition promotion model to improve maternal and child health and nutrition behaviors. A recent set of papers summarized the history of Care Groups and the outcomes achieved with the model on children under two years of age in many countries around the world (Perry et al, 2015), and how projects using Care Groups are achieving on average more than double the behavior change of other models on maternal behaviors that affect the growth of children 0-23m (George et al, 2015). Through Care Groups, women will learn about proper water, sanitation, and hygiene behaviors; Infant and Young Child Feeding practices; management of childhood illnesses; home management, referral and care seeking for sick children; family planning; and use of preventive services available at health facilities (e.g., growth monitoring, deworming, vitamin A supplementation). All children under five years of age will also be screened for acute malnutrition by the Care Group Volunteers, and receive deworming medication and vitamin A supplementation twice a year through the Ministry of Health and Community Health Workers as part of national campaigns. Care group experts report improvement of depression as a result of these focus groups, due to the connection, social support and problem-solving among the group members. At the conclusion of this project, a Lessons Learned conference will be held in Uganda and an online dissemination event will be held in order to facilitate the sharing of project results. Results will also be disseminated through peer-reviewed papers and communities of practice. #Intervention - OTHER : Care Groups - The Care Groups model has strong evidence of improvement of maternal and child health and maternal hygiene/nutrition behaviors.Through Care Groups, women will learn about proper water, sanitation, and hygiene behaviors; Infant and Young Child Feeding practices; management of childhood illnesses; home management, referral and care seeking for sick children; family planning; and use of preventive services available at health facilities (e.g., growth monitoring, deworming, vitamin A supplementation). All children under five years of age will also be screened for acute malnutrition by the Care Group Volunteers, and receive deworming medication and vitamin A supplementation twice a year through the Ministry of Health and Community Health Workers as part of national campaigns. - Other Names : - CG - BEHAVIORAL : IPT-G - IPT-G is an effective, low-cost, short-duration community-based method for decreasing depression has been established that was first rigorously tested in Uganda. Several Private Voluntary Organizations in Africa have used this low-cost, short-duration, community-based group psychosocial approach and found it to be a culturally-sensitive, acceptable, and feasible approach to address depression. IPT-G treatment spans 12 weeks of treatment, consisting of 3 phases (early, middle, and termination). Within this treatment, participants are also assessed for symptoms of depression every week. - Other Names : - Interpersonal Psychotherapy for Groups	#Eligibility Criteria: Inclusion Criteria: * Our study will only include depressed pregnant women and depressed mothers (ages 18 and up) with at least one child under 18 months of age (0 <= age <= 17.9 months) who consent and reside in selected communities in subcounties of Kitgum District of Uganda, as we are aiming to study the effects of the treatment of maternal depression on child care practices during the first few years of life. We will not exclude any classes of subject based on class, race, or ethnicity. Exclusion Criteria: * If a woman confirms current risk of suicide or another acute mental health condition (such as psychosis, mania, etc.), she will not be enrolled, but referred to the nearby Peter C. Alderman Kitgum Clinic (Director, Raymond Odonkonyero). Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT03573713	{ "brief_title": "Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes", "conditions": [ "Depression, Postpartum", "Malnutrition, Child" ], "interventions": [ "Behavioral: IPT-G", "Other: Care Groups" ], "location_countries": [ "Uganda" ], "nct_id": "NCT03573713", "official_title": "Decreasing Stunting by Reducing Maternal Depression in Uganda - A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-15", "study_completion_date(actual)": "2019-04-15", "study_start_date(actual)": "2017-09-11" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-02-07", "last_updated_that_met_qc_criteria": "2018-06-28", "last_verified": "2020-02" }, "study_registration_dates": { "first_posted(estimated)": "2018-06-29", "first_submitted": "2018-03-15", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The objective of this project is to evaluate the postprandial serum and plasma vitamin and mineral levels in healthy adult men and women between 18 and 32 years of age, following a single intake of a multivitamin and mineral supplement processed in two different ways. Detailed Description Serum or plasma levels of five vitamins and four minerals will be measured at baseline, and 1, 2, 4, and 6 hours after the intake of a multivitamin/mineral supplement processed by two different methods. The two methods involve using either conventional isolated vitamins and minerals blended together to provide approximately 100% of the Daily Value, or using the same amount of vitamins and minerals that have first been processing into liposomal forms before blending. Participants are required to come for two study visits which are 5 to 7 days apart. Health screening will also be done at Study Visit 1. The order of supplement assignment will be randomized, performed in a double-blind manner. #Intervention - DIETARY_SUPPLEMENT : Multivitamin/mineral supplement A - Oral administration of Supplement A - DIETARY_SUPPLEMENT : Multivitamin/mineral supplement B - Oral administration of Supplement B	#Eligibility Criteria: Inclusion Criteria: * Healthy males and females 18 <= age <= 32 years * BMI 18.5 <= age <= 32 kg/m2 * Free from disease * Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician * Normal blood pressure (individuals whose average blood pressure is greater than 140/90 will be excluded from the study) * Suitable vein structure and access for successful placement of an indwelling catheter, as determined by our nurse phlebotomist Exclusion Criteria: * Alcohol consumption > 3 drinks/week (i.e., 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor) * Smoking * Vaping or using cannabis in any form * Using multivitamin/mineral supplements in the past two months * Currently taking supplements including botanical supplements, probiotics or fiber * Fruit consumption >= 2 cups/day * Vegetable consumption >= 3 cups/day * Coffee/tea >= 3 cups/day * Chronic/routine high-intensity exercise * Any chronic health conditions * Self-reported malabsorption * Currently taking prescription drugs * Indications of substance or alcohol abuse within the last 3 years * Unable to consent Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 32 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT05336994	{ "brief_title": "Vitamin/Mineral Absorption From Two Different Supplements", "conditions": [ "Healthy Nutrition" ], "interventions": [ "Dietary Supplement: Multivitamin/mineral supplement A", "Dietary Supplement: Multivitamin/mineral supplement B" ], "location_countries": [ "United States" ], "nct_id": "NCT05336994", "official_title": "Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-30", "study_completion_date(actual)": "2022-07-30", "study_start_date(actual)": "2022-04-29" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "QUADRUPLE", "phase": [ "NA" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-09-02", "last_updated_that_met_qc_criteria": "2022-04-14", "last_verified": "2022-09" }, "study_registration_dates": { "first_posted(estimated)": "2022-04-20", "first_submitted": "2022-03-24", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods. Detailed Description Endoscopic retrograde endoscopic retrograde cholangiopancreatography (ERCP) is widely used for the diagnosis and treatment of pancreatic and biliary tract disease. However, post-ERCP pancreatitis (PEP) is the most common adverse event following the procedure, ranging from 2% to 10% in nonselective cases, and it can cause substantial morbidity, mortality, or high medical costs. Recent advances in cannulation technique and accessories for biliary cannulation have contributed to reduce the incidence of PEP, but biliary cannulation can fail in 5% to 20% of cases of ERCP. Suprapapillary needle-knife fistulotomy (NKF), with or without large-diameter balloon dilation, has been used as a rescue method in cases of difficult biliary cannulation, and NKF was recommended as an initial approach to selective biliary cannulation in cases of repetitive unintentional pancreatic cannulation.9 Moreover, difficult biliary cannulation is known to be a risk factor for PEP, and it has been reported that NKF is associated with a low risk of PEP. Thus, we hypothesized that NKF may reduce the risk of PEP in patients who are at increased risk for PEP. #Intervention - DEVICE : cannulation of ampulla of Vater - Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices	#Eligibility Criteria: Inclusion Criteria: * Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years * Patient who have naïve ampulla (no previous procedure was performed at ampulla) * Patient who is suspected to have biliary obstruction or biliary disease * Patient who is needed to have endoscopic retrograde cholangiopancreatography for treatment of biliary obstruction * Patient who have risks of post-endoscopic retrograde cholangiopancreatography pancreatitis among bellows (at least one more); 1. suspected biliary sphincter of Oddi dysfunction 2. young age (18~50 years) 3. female 4. normal common bile duct diameter (<=9mm) 5. normal serum bilirubin level 6. Obesity (body mass index > 30) 7. Past history of acute pancreatitis Exclusion Criteria: * Patient who is below 18 year old * Patient who is pregnant * Patient with mental retardation * Patient is sensitive to contrast agents * Patient who received sphincterotomy or pancreatobiliary operation previously * Patient who have ampulla of Vater cancer * Patient who have difficulty for approach to ampulla due to abdominal surgery including stomach cancer with Billroth II anastomosis * Patient who have pancreatic diseases as bellow (at least one more); 1. Patient who have acute pancreatitis within 30days before enrollment 2. Patient who have idiopathic acute recurrent pancreatitis 3. Patient who have pancreatic divisum 4. Patient who have obstructive chronic pancreatitis 5. Patient who pancreatic cancer * Patients who have improper ampulla shape as bellows; 1. Small ampulla (ampulla without oral protrusion) 2. Flat or crooked or asymmetric ampulla 3. Ampulla with peri-ampullary diverticulum type I or II Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02916199	{ "brief_title": "Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method", "conditions": [ "Common Bile Duct Stone", "Malignant Hepatobiliary Neoplasm", "Biliary Stricture", "Pancreatic Diseases", "Sphincter of Oddi Dysfunction" ], "interventions": [ "Device: cannulation of ampulla of Vater" ], "location_countries": [ "Korea, Republic of" ], "nct_id": "NCT02916199", "official_title": "Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-28", "study_completion_date(actual)": "2017-11-28", "study_start_date(actual)": "2016-10-04" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-01-30", "last_updated_that_met_qc_criteria": "2016-09-25", "last_verified": "2019-01" }, "study_registration_dates": { "first_posted(estimated)": "2016-09-27", "first_submitted": "2016-09-24", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study will assess absorption, distribution, metabolism, excretion and absolute bioavailability of AG-348 in healthy male participants. Potential participants will be screened within 29 days prior to dose administration to determine eligibility. Eligible Participants will be admitted into the Clinical Research Unit (CRU) one day prior to administration of AG-348 and will be confined to the CRU until at least Day 8. If participants are not eligible for discharge on Day 8, they may remain in the CRU up to Day 11. Radiolabelled analytes of AG-348 will be administered in a single oral and intravenous (IV) dose on Day 1. Participants will be required to fast pre-dose, remain in a supine position for 1 hour post-dose and avoid water for 2 hours post-dose. #Intervention - DRUG : AG-348 - 120 milligrams (mg) oral capsule, single dose, contains 100 microcuries (μCi) of radio labelled \[14C\]AG-348. - DRUG : [13C6]AG-348 - IV microdose of approximately 100 micrograms (mcg), single dose.	#Eligibility Criteria: Inclusion Criteria * Willing and able to provide voluntary written informed consent; * Males of any race between 18 and 55 years, inclusive; * Body mass index between 18.5 and 29.0 kilograms per meter squared (kg/m2), inclusive, and a total body weight between 50 and 100 kilograms (kg), inclusive; * In good health; * Participants will be surgically sterile for at least 90 days or, when sexually active with female partners of childbearing potential, will be required to use a male condom with spermicide from Check-in until 90 days after study drug administration. Sexual intercourse with female partners who are pregnant or breastfeeding should be avoided unless condoms are used from the time of study drug administration until 90 days after study drug administration. Male participants are required to refrain from donation of sperm from Check-in until 90 days after the last dose of study drug; * Participants who practice true abstinence, because of the participant's lifestyle choice (ie, the participant should not become abstinent just for the purpose of study participation), are exempt from contraceptive requirements. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. If a participant who is abstinent at the time of signing the informed consent form (ICF) becomes sexually active they must agree to use contraception as described previously; * Participants who are exclusively in same-sex relationships, contraceptive requirements do not apply. If a participant who is in a same-sex relationship at the time of signing the ICF becomes engaged in a heterosexual relationship, they must agree to use contraception as described previously; * Willing and able to communicate verbally and in writing with the Investigator and to participate in all scheduled study procedures (including Follow-up procedures) and abide by the study restrictions; * Agrees to abstain from any alcohol consumption, starting 48 hours before Check-in and continuing until Discharge; * History of a minimum of 1 bowel movement per day. Exclusion Criteria * History of a medical or surgical condition that, in the opinion of the Investigator, may potentially interfere with study drug absorption, distribution, metabolism, and/or excretion (eg, participant has undergone gastrectomy, appendectomy, or cholecystectomy); * Undergone any major surgical procedure within the past 3 months; * After 5 minutes of rest in the supine position at Screening, has a systolic blood pressure (BP) reading of >=140 mmHg (>=150 mmHg in participants >45 years) OR a diastolic BP reading of >=90 mmHg; * Experienced any serious adverse reaction or serious hypersensitivity to any drug or its formulation excipients; * History of a primary malignancy, with the exception of a malignancy that has been curatively treated and for which the participant has displayed no evidence of disease within the past 3 years; * History of alcoholism or drug/chemical abuse within the past 2 years; * Alcohol consumption of >21 units per week. One unit of alcohol equals 12 oz (360 mL) of beer, 1½ oz (45 mL) of liquor, or 5 oz (150 mL) of wine; * Positive urine drug screen at Screening or Check-in, or positive alcohol breath test at Check-in (confirmed by repeat); * Positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus; * Participation in a clinical study involving administration of an investigational product (IP) or new chemical entity (NCE) in the past 90 days, or 5 half-lives, if known, of the respective IP or NCE, whichever is longer; * Has taken, within the 14 days prior to Check-in, any of the following: prescription medication, over-the-counter medication, nonprescription preparation (including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations), or grapefruit products; * Has taken within the 28 days prior to Check-in, any restricted product known to strongly induce cytochrome P450 (CYP) 3A4 metabolism (eg, St. John's wort); * Is a current smoker or user of any other tobacco product, as confirmed by Screening and Check-in urine cotinine test OR has used any tobacco product within the past 3 months * Receipt of blood products within the past 2 months; * Donation of blood within the past 56 days, plasma within the past 2 weeks or platelets within the past 6 weeks; * Previously completed or withdrawn from this study or any other study investigating AG-348, and have previously received the IP; * Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures (eg, computed tomography scan, barium meal) exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years, or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; * Participants who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. * Is an employee of, or an immediate family member of an employee of, the study site or the Sponsor; * Participants who, in the opinion of the Investigator (or designee), should not participate in this study. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT03703505	{ "brief_title": "A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348", "conditions": [ "Healthy Volunteers" ], "interventions": [ "Drug: [13C6]AG-348", "Drug: AG-348" ], "location_countries": [ "United States" ], "nct_id": "NCT03703505", "official_title": "A Phase I, Open-label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion and to Assess the Absolute Bioavailability of AG-348 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-01", "study_completion_date(actual)": "2018-06-04", "study_start_date(actual)": "2018-05-24" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-10-12", "last_updated_that_met_qc_criteria": "2018-10-10", "last_verified": "2018-10" }, "study_registration_dates": { "first_posted(estimated)": "2018-10-12", "first_submitted": "2018-05-24", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Communication is a key health literacy educational competency in the professional training of health providers. However, students often have difficulty in applying theoretical communication models to the reality of clinical practice. Multimodal interventions based on simulation models emerge as an essential element to overcome this gap. During the simulation training, students must be aware of their communication errors and the needs that patients share in a clinical interaction. The aim is to evaluate the effectiveness of multimodal training, which incorporates a systematic feedback guide about the student's clinical interview simulation performance, as a training complement to classical education to improve health literacy competencies and clear communication practices in health sciences students. A randomized controlled trial will be conducted on 82 second-year nursing students recruited from the University of Cadiz. The experimental and control groups will receive the same communication multimodal training except for the inclusion of feedback on key aspects of communication for health literacy, which the experimental groups only used. Students will be assessed through clinical interview simulations by external observers. Bivariate and inferential statistical analyses will be carried out. #Intervention - BEHAVIORAL : Multimodal intervention (communication and education simulations) for EG1 - In summary, students in EG1 received the following multimodal intervention flow: 1) Health communication training, 2) Structured educational simulation using standardized patients (SPs), and 3) simulation feedback and self-assessment using a systematic guide that included the 'health literacy practices'.	#Eligibility Criteria: Inclusion Criteria: * Second-year nursing students at the University of Cadiz enrolled in the Interpersonal Communication Skills subject. Exclusion Criteria: * Absence in training. * Does not consent to participate in the study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 67 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT06490406	{ "brief_title": "Communication Practices to Develop the Health Literacy Competencies in Nursing Students", "conditions": [ "Health Literacy", "Competence", "Nursing Students" ], "interventions": [ "Behavioral: Multimodal intervention (communication and education simulations) for EG1" ], "location_countries": [ "Spain" ], "nct_id": "NCT06490406", "official_title": "Communication Practices to Develop the Health Literacy Competencies in Nursing Students: A Randomized Controlled Trial", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-30", "study_completion_date(actual)": "2020-06-30", "study_start_date(actual)": "2020-01-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "NA" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2024-07-08", "last_updated_that_met_qc_criteria": "2024-07-05", "last_verified": "2024-06" }, "study_registration_dates": { "first_posted(estimated)": "2024-07-08", "first_submitted": "2024-06-13", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study will consist of a randomized experimental group and a control group, In addition to the control and experimental group, there will also be a non-randomized motivated experimental group. Approximately 75 males and females from the ages of 18 to 80 will take part in this study. Subjects will be randomly divided into a Control and Experimental Group. Subjects for the control and experimental group will be recruited from a Tony Robbins Facebook page, and subjects in the experimental group (DWD Group) will be admitted to the Tony Robbins Date With Destiny Event (December 2019) in West Palm Beach for free, while the subjects randomly assigned to the control group, will not attend the event, but instead be required to a Gratitude Journaling experiment (Three Good Things Intervention). Psychological assessment surveys will be taken before the event, directly after the event, and one month following the event. The control group will take the psychological assessment before beginning journaling, directly after completing journaling, and one month following completion of journaling. Detailed Description Background: A Pubmed or Google Scholar search reveals zero peer-reviewed articles examining Robbins' events, techniques, or principles, despite Robbins' enormous impact on culture, psychology, and individual lives. Furthermore, only poorly conceptualized studies testing clinically irrelevant hypotheses were ever conducted on Neurolinguistic Programming (NLP), a constitutive framework for part of Robbins' methodologies. Due to the intimate link between beliefs, wellness, and disease, the investigators hypothesize that an intervention focused on belief-restructuring, trauma release, psychoeducation, hope, inspiration, \& social support like participation in a Tony Robbins' event (e.g. DWD) will demonstrate significant mental and physical health outcomes. The investigators hope to obtain a better understanding of: 1. Whether Tony Robbins' DWD improves affect, depression symptoms, and well-being. 2. Setup collaboration infrastructure and generate hypotheses for a future randomized controlled trial to determine short- and long-term physiological and health effects of Tony Robbins' interventions. Importance: Tony Robbins, inventor of the term, life coach, and a coach to leaders around the world, regularly sells out 14,000 person arenas worldwide to talk about psychology, mental health, and wellbeing, and his website alone averages 1,000,000 unique visitors per month. Yet, a literature search through PubMed \& Google Scholar reveals 0 empirical studies of Tony Robbins' work. Considering patients prefer psychotherapy over medication, there are a rich set of interventions to draw from Tony Robbins that could prove to be effective, accessible, and affordable in treating \& preventing mental health issues including depression and suicide. Understanding the science of Tony Robbins' work could provide new theoretical frameworks and clinical interventions to inform non-pharmacological approaches to mental health. Methodology: This study will consist of a randomized experimental group and a control group, In addition to the control and experimental group, there will also be a non-randomized motivated experimental group. Approximately 75 males and females from the ages of 18 to 80 will take part in this study. Subjects will be randomly divided into a Control and Experimental Group. Subjects for the control and experimental group will be recruited from a Tony Robbins Facebook page, and subjects in the experimental group (DWD Group) will be admitted to the Tony Robbins Date With Destiny Event (December 2019) in West Palm Beach for free, while the subjects randomly assigned to the control group, will not attend the event, but instead be required to a Gratitude Journaling experiment (Three Good Things Intervention). Subjects will be recruited by posting a Survey Monkey link on the DWD Facebook page as well as via email and direct referral. All participants will complete a consent form and take a brief eligibility survey administered digitally through Survey Monkey's secure system. Both groups will be given surveys before DWD, immediately after DWD to assess acute changes, and after 1 month after DWD to assess longitudinal changes. The experimental group will attend DWD. After attending DWD, the experimental group will be asked to continue practicing 'Priming ' daily for a month. A One-page 'priming' cheat sheet will be given to the subjects in the experimental group. The control group will be asked to engage in gratitude journaling (protocol below) every day for a month. The control group will NOT attend the event. A third group called the Motivated Experimental Group (M Experimental) will consist of participants who registered and paid for Tony Robbins Date with Destiny (DWD). They are chosen as the motivated experimental as they will be paying full price for the event. Subjects will be recruited at the event, as well as through the facebook group. Two investigators will follow up with subjects monthly by phone to assure consistency. All surveys will be administered electronically through survey monkey. Informed Consent forms will also be provided electronically to all subjects. All subjects that participate in this study will receive a free book and audiobook, regardless of the group they were in upon completion of the study. Study variables Primary variables: * Mental Health (depression, anxiety, stress) scores. IRBs will need to be Electronically Signed by all participants. All Variables will be collected electronically over Survey Monkey. All questions will be extracted and worded directly off of the physical copy of each questionnaire into Survey Monkey. #Intervention - BEHAVIORAL : Tony Robbins Date with Destiny - DWD is a 6-day immersive transformational experience led by Tony Robbins. It will be held at the PALM BEACH, FLORIDA Convention Center from December 5th through December 10th. Subjects will be exposed to a variety of mind-body exercises and psychoeducational content including neural linguistic programming, designed to motivate, inspire, and improve the quality of people's lives.	#Eligibility Criteria: Inclusion Criteria: * Ages 18+, male and female, English speaking, lives in the U.S. * Experimental group: must be a registered participant in Tony Robbins Palm Beach DWD (Dec 5th-10th) * Control group: PHQ 9 score > 4 (5 is the cutoff for mild depression). Exclusion Criteria: * Excluded from the experimental group if you DO NOT attend the event. * Excluded from the control group if you DO attend the event. * Excluded from the Motivated Experimental Group if they have been compensated for their admissions fee. * No confounding medical conditions. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT04172051	{ "brief_title": "The Effects of a Life Coaching Seminar on Gratitude and Psychological Well-Being", "conditions": [ "Psychological", "Depression, Anxiety", "Psychological Stress", "Mental Health Wellness 1", "Mental Stress", "Mental Depression" ], "interventions": [ "Behavioral: Tony Robbins Date with Destiny" ], "location_countries": [ "United States" ], "nct_id": "NCT04172051", "official_title": "The Effects of a Life Coaching Seminar on Gratitude and Psychological Well-Being", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-14", "study_completion_date(actual)": "2020-01-14", "study_start_date(actual)": "2019-11-25" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "OTHER", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-07-14", "last_updated_that_met_qc_criteria": "2019-11-19", "last_verified": "2020-07" }, "study_registration_dates": { "first_posted(estimated)": "2019-11-21", "first_submitted": "2019-11-18", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden, Denmark and Norway.	#Eligibility Criteria: Inclusion Criteria: * >= 18 years * diagnosed with cancer * subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates at the dose indicated for SRE prevention of less than 2 years duration (<= 24 IV infusions or <= 24 monthly oral prescriptions) Exclusion Criteria: * history of radiation treatment for head and neck cancer before a subject's potential index date * hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01967160	{ "brief_title": "Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid", "conditions": [ "Osteonecrosis of the Jaw", "Infection Leading to Hospitalization" ], "interventions": null, "location_countries": null, "nct_id": "NCT01967160", "official_title": "A Non-interventional Pharmacovigilance Study of Osteonecrosis of the Jaw and Infection Leading to Hospitalization Among Patients With Cancer Treated With XGEVA™ or Zoledronic Acid in Sweden, Denmark, and Norway", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-05", "study_completion_date(actual)": "2019-08-05", "study_start_date(actual)": "2012-01-02" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-06-22", "last_updated_that_met_qc_criteria": "2013-10-18", "last_verified": "2021-09" }, "study_registration_dates": { "first_posted(estimated)": "2013-10-22", "first_submitted": "2013-10-18", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy. Detailed Description This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209. #Intervention - DRUG : KBP-5209 - Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.	#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years; * Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists. * Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1 * Eastern Cooperative Oncology Group performance score 0 to 2; Exclusion Criteria: * Patients with symptomatic CNS metastases; * Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV * Any significant ophthalmologic abnormality * Patients who have any severe and/or uncontrolled medical conditions * Significant gastrointestinal abnormalities, * Patients who have impaired cardiac function or clinically significant cardiac diseases, * Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy; * Treatment with third generation EGFR inhibitors * Major surgery/surgical therapy for any cause within 4 weeks of Screening; Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02442414	{ "brief_title": "A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors", "conditions": [ "Advanced Solid Tumors" ], "interventions": [ "Drug: KBP-5209" ], "location_countries": [ "United States" ], "nct_id": "NCT02442414", "official_title": null, "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-26", "study_completion_date(actual)": "2019-11-26", "study_start_date(actual)": "2015-04-07" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-03-04", "last_updated_that_met_qc_criteria": "2015-05-08", "last_verified": "2022-02" }, "study_registration_dates": { "first_posted(estimated)": "2015-05-13", "first_submitted": "2015-04-29", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL). Detailed Description OBJECTIVES: Primary * To define the maximum tolerated dose (MTD) of Lenalidomide given in combination with FC.(Phase I) * To evaluate the complete remission (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL). (Phase II) Secondary * To define the toxicity and the infection rate of patients treated with FCL and the median number of delivered courses of FCL, overall response rate and the progression-free survival and the relationship between the response and the baseline biologic factors (IgVH, FISH, ZAP-70, CD38). * To evaluate the overall response rate (complete and partial responses). * To evaluate the progression-free survival. OUTLINE: This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL). All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). After completion of study treatment, patients are followed periodically for up to 18 months. #Intervention - DRUG : Cyclophosphamide - All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). - DRUG : Fludarabine phosphate - All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). - DRUG : Lenalidomide - All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). In the first phase of the study, the dose of Lenalidomide given with FC will be gradually escalated to reach the MTD. In the second phase of the study, FC will be given in combination with the Lenalidomide escalated to the MTD or the maximum planned dose.	#Eligibility Criteria: Inclusion criteria: * Age >=18 years. * Able to adhere to the study visit schedule and other protocol requirements. * Patients with advanced stage or progressive CLL (NCI criteria) and relapsed or refractory disease. * No more than 2 previous different treatment lines. * No treatment with Campath-1H in the previous 6 months. * Disease-free of prior malignancies for >=5 years, with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma 'in situ' of the cervix or breast. * All previous cancer therapy, including chemotherapy, immunotherapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. * ECOG performance status of <=2 at study entry. * Laboratory test results within these ranges: * Serum creatinine <=1.5 mg/dL and creatinine clearance >=60mL/min * Total bilirubin <=1.5 mg/dL * AST (SGOT) and ALT (SGPT) <=1.5 x ULN * Able to take low molecular weight heparin or in alternative, low- fixed-dose warfarin or, in alternative, low-dose aspirin. * Able to understand and voluntarily sign the informed consent form. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study. FCBP must agree to use two reliable forms of contraception for at least 28 days before starting study drug; while participating in the study; and for at least 4 weeks after discontinuation from the study. * Females must agree to abstain from breastfeeding during study participation and for at least 28 days after discontinuation from the study. * Males must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 4 weeks following discontinuation. * (Other details regarding pregnancy tests and contraception are reported in the chapter 'Eligibility Criteria' within the study protocol). Exclusion criteria: * Treatment with Campath-1H during the previous 6 months. * Concurrent use of other anti-cancer agents. * Positive DAT with clinical and laboratory signs of hemolysis, autoimmune thrombocytopenia. * Known positivity for HIV or active infectious hepatitis. * Active bacterial, viral, or fungal infection requiring systemic anti-viral, antibiotic or anti-fungal therapy. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breast feeding females (lactating females must agree not to breast feed while taking Lenalidomide). * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Prior history or presence of thrombosis, thromboembolism, hearth failure or arrhythmia, neurologic disease and renal insufficiency. * Use of any other experimental drug or therapy within 28 days of baseline. * Known hypersensitivity to thalidomide. * The development of erythema nodosum, desquamating rash while taking thalidomide or similar drugs. * Any prior use of Lenalidomide * Lactose intolerance Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT00727415	{ "brief_title": "Lenalidomide, Fludarabine & Cyclophosphamide in Advanced Chronic Lymphocytic Leukemia Not Responding to Therapy", "conditions": [ "Chronic Lymphocytic Leukemia" ], "interventions": null, "location_countries": [ "Italy" ], "nct_id": "NCT00727415", "official_title": "A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01", "study_completion_date(actual)": "2016-01", "study_start_date(actual)": "2008-02" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE1", "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-01-22", "last_updated_that_met_qc_criteria": "2008-08-01", "last_verified": "2018-08" }, "study_registration_dates": { "first_posted(estimated)": "2008-08-04", "first_submitted": "2008-08-01", "first_submitted_that_met_qc_criteria": "2018-08-10" } } }
#Study Description Brief Summary Tinnitus is perception of sound without the presence of an external acoustic stimulus. Approximately 50 million Americans experience chronic tinnitus and of these, 10 million have bothersome tinnitus. The tinnitus research literature suggests that NMDA receptor antagonists may prove to be useful in reducing tinnitus. Nitrous oxide, a member of the NMDA receptor antagonist class, is a widely-used general anesthetic and sedative with a proven safety profile. The investigators hypothesized that the administration of nitrous oxide, an NMDA receptor antagonist, may be effective in treatment of tinnitus. The study design was a randomized placebo-controlled crossover trial. Detailed Description Subjective, idiopathic, non-pulsatile tinnitus ('tinnitus') is perception of sound without the presence of an external acoustic stimulus. Approximately 50 million Americans experience chronic tinnitus and of these, 10 million have bothersome tinnitus. Bothersome tinnitus is associated with poorer working memory, slower processing speeds and reaction times, and deficiencies in selective attention. Currently, effective therapies for tinnitus remain limited. Examples of therapies include external sound therapy to mask the perceived sound, behavioral therapy to habituate the patient to the perceived sound, and counseling such as cognitive behavioral therapy to address the bother and impact that tinnitus has on people's lives. Surgical treatment such as nerve transection remains controversial given its lack of efficacy and adverse event profile. There are no drugs approved by the FDA for the treatment of tinnitus. Antidepressant and antianxiety medications are prescribed to patients with tinnitus with limited benefit. Nitrous oxide is an N-methyl-D-aspartate (NMDA) receptor antagonist, a class of drugs shown to have antidepressant effects. A previous trial examined the use of nitrous oxide as a treatment for major depressive disorder (MDD). Generally, NMDA receptors promote excitation at synapses throughout the auditory pathway and play diverse roles in synaptic development and auditory information processing. In the setting of chronic damage to the auditory system, overactivation of NMDA receptors leads to aberrant spontaneous neuronal firing in the cochlea and auditory brainstem structures, which can further perpetuate damage and disease in a feed-forward mechanism. Studies by Guitton et al. and Puel et al. showed that administration of NMDA receptor antagonists prior to the administration of salicylate was effective in preventing acute excitotoxic tinnitus, establishing that salicylate induces tinnitus through its action on NMDA receptors. Thus, NMDA receptors are thought to be implicated in the generation and perpetuation of several auditory diseases including tinnitus. The investigators hypothesized that the administration of nitrous oxide, an NMDA receptor antagonist, may be a therapeutic strategy in the treatment of tinnitus. The study was a randomized placebo-controlled crossover trial. Each participant attended two intervention sessions, one 'treatment' and one 'placebo'. Participants eligible to participate in the study were randomly assigned to receive either placebo followed by nitrous oxide or nitrous oxide followed by placebo, according to a computer-generated randomization sequence. Only the statistician and the anesthesiology team directly involved in administration of nitrous oxide and placebo had access to the group assignments. All participants and other study team members administering survey assessments remained blinded. The two intervention sessions were held at least two weeks apart and were indistinguishable in setting, setup, and monitoring in order to maintain blinding for the participants and study team members. All intervention sessions were performed at the Washington University Clinical Research Unit, a component of the Center for Applied Research Sciences. #Intervention - DRUG : Nitrous oxide gas for inhalation - Nitrous oxide gaseous mixture (50% nitrous oxide and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists. - DRUG : Placebo gas for inhalation - Placebo gaseous mixture (50% nitrogen and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.	#Eligibility Criteria: Inclusion Criteria: * Adult men and women 18 <= age <= 65 years * Subjective, unilateral or bilateral, non-pulsatile tinnitus scoring 'Bothered more than a little but not a lot', 'Bothered a lot', or 'Extremely bothered' on the Global Bothersome scale * Able to give informed consent * Must be able to read, write, and understand English Exclusion Criteria: * Bipolar disorder * Schizophrenia * Schizoaffective disorder * Substance abuse or dependence (except for remote substance abuse or dependence with remission at least 1 year prior to the study and except for nicotine use disorders) * Acute medical illness that may pose subject at risk during nitrous oxide administration * Active psychotic symptoms * Patients with significant pulmonary disease and/or requiring supplemental oxygen * Contraindication against the use of nitrous oxide: * Pneumothorax * Bowel obstruction * Middle ear occlusion * Elevated intracranial pressure * Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12 * Pregnant patients * Breastfeeding women * Previous administration of NMDA-receptor antagonists (e.g., ketamine) within the last 3 months * Tinnitus related to cochlear implantation, retrocochlear lesion, Meniere's Disease, or other known anatomic lesions of the ear or temporal bone * Tinnitus related to a Workman's Compensation claim or litigation-related event that is still pending. * Any medical condition, which, in the opinion of the PI, confounds study results or places the subject at greater risk Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT03365011	{ "brief_title": "Nitrous Oxide Treatment for Tinnitus", "conditions": [ "Tinnitus" ], "interventions": [ "Drug: Nitrous oxide gas for inhalation", "Drug: Placebo gas for inhalation" ], "location_countries": [ "United States" ], "nct_id": "NCT03365011", "official_title": "Nitrous Oxide as Treatment for Tinnitus: A Randomized Crossover Trial", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06", "study_completion_date(actual)": "2017-07", "study_start_date(actual)": "2016-10" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "DOUBLE", "phase": [ "PHASE4" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-12-14", "last_updated_that_met_qc_criteria": "2017-12-05", "last_verified": "2018-11" }, "study_registration_dates": { "first_posted(estimated)": "2017-12-07", "first_submitted": "2017-05-15", "first_submitted_that_met_qc_criteria": "2018-10-09" } } }
#Study Description Brief Summary This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2\<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University. Detailed Description After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet. #Intervention - OTHER : Gas exchanges at different PEEP - Gas exchanges measurement at different PEEP - OTHER : lung mechanics at different PEEP - lung mechanics measurement at different PEEP - OTHER : Hemodynamics changes at different PEEP - Hemodynamics changes measurement at different PEEP	#Eligibility Criteria: Inclusion Criteria: * COVID-19 patients with mechanical ventilation * PO2/FIO2<300mmHg * ages>18 years Exclusion Criteria: * pneumothorax * pregnant * hemodynamics is unstable Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04359251	{ "brief_title": "Different PEEP Settings of COVID-19 Induced ARDS", "conditions": [ "COVID-19", "Mechanical Ventilation Pressure High", "Acute Respiratory Distress Syndrome" ], "interventions": [ "Other: Hemodynamics changes at different PEEP", "Other: lung mechanics at different PEEP", "Other: Gas exchanges at different PEEP" ], "location_countries": [ "China" ], "nct_id": "NCT04359251", "official_title": "Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-25", "study_completion_date(actual)": "2020-03-25", "study_start_date(actual)": "2020-03-05" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "CROSSOVER", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-04-24", "last_updated_that_met_qc_criteria": "2020-04-21", "last_verified": "2020-04" }, "study_registration_dates": { "first_posted(estimated)": "2020-04-24", "first_submitted": "2020-04-13", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary 1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized double-blind trial. Detailed Description Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression. Previous studies of NF2 patients treated with bevacizumab suggested that inhibition of vascular endothelial growth factor (VEGF) could result in hearing improvement and reduction in tumor size.Recombinant human endostatin can inhibit the formation of blood vessels by inhibiting the migration of vascular endothelial cells .In this way, endostatin can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. In vitro tests, endostatin can inhibit the cell migration and Tube formation of the microvascular endothelial cell line HHEC. Besides, it can inhibit blood vessels' formation of the chicken embryo sac membrane. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of endostatin on NF2. #Intervention - DRUG : Endostatin - Method of drug administration:continuous intravenous pumping; Dosage: 7.5mg/m2/d; Course of treatment: 3 months;Total three treatment courses. - Other Names : - Recombinant Human Endostatin	#Eligibility Criteria: Inclusion Criteria: * 1)Patients must be at the age of 16 <= age <= 30 * 2)Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors * 3)Patients must not be treated with other drugs or radiation therapy recently * 4)Patients should live in Beijing or nearby and can be treated in hospital * 5)Patients must be healthy and not be seriously allergic with biological agents * 6)Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent. Exclusion Criteria: * 1)Treated with other drugs, surgery or radiation therapy recently * 2)Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time * 3)Being pregnant or try to get pregnant, lactating women * 4)With acute or chronic infectious diseases * 5)With heart diseases, cardiac dysfunction or abnormal ECG * 6)With uncontrolled neural or mental diseases, poor compliance * 7)Not available for enhanced MRI * 8)Take part in any other clinical trial * 9)With other conditions that are considered not suitable for this clinical trial. Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No	NCT02104323	{ "brief_title": "Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors", "conditions": [ "Vestibular Schwannoma", "Neurofibromatosis Type 2" ], "interventions": [ "Drug: Endostatin" ], "location_countries": [ "China" ], "nct_id": "NCT02104323", "official_title": "Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors by Continuous Intravenous Pumping", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04", "study_completion_date(actual)": "2016-04", "study_start_date(actual)": "2014-01" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2017-02-09", "last_updated_that_met_qc_criteria": "2014-04-02", "last_verified": "2017-02" }, "study_registration_dates": { "first_posted(estimated)": "2014-04-04", "first_submitted": "2014-03-26", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects. #Intervention - DRUG : GLPG3121 SAD - GLPG3121 oral suspension, single ascending doses - DRUG : Placebo SAD - Placebo oral suspension - DRUG : GLPG3121 MAD - GLPG3121 oral suspension, multiple ascending doses, daily for 13 days - DRUG : Placebo MAD - Placebo oral suspension, daily for 13 days	#Eligibility Criteria: Inclusion Criteria: * Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. * Male between 18 <= age <= 55 of age (extremes included), on the date of signing the ICF. * A Body Mass Index (BMI) between 18.0 to 30.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x the upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered nonclinically significant in the opinion of the investigator. Exclusion Criteria: * Known hypersensitivity to investigational medicinal product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator. * Known contraindication or hypersensitivity to interferon-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part). * Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP. * Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance <=80 mL/min using the Cockcroft-Gault formula: if calculated result is <=80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. * History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT03899909	{ "brief_title": "A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects", "conditions": [ "Healthy" ], "interventions": [ "Drug: Placebo MAD", "Drug: GLPG3121 MAD", "Drug: GLPG3121 SAD", "Drug: Placebo SAD" ], "location_countries": [ "Belgium" ], "nct_id": "NCT03899909", "official_title": "A First-in-human, Randomized, Double-blind, Placebo-controlled, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days in Adult, Healthy, Male Subjects.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-03", "study_completion_date(actual)": "2019-06-03", "study_start_date(actual)": "2019-03-29" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "SEQUENTIAL", "masking": "QUADRUPLE", "phase": [ "PHASE1" ], "primary_purpose": "BASIC_SCIENCE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-07-05", "last_updated_that_met_qc_criteria": "2019-04-01", "last_verified": "2019-07" }, "study_registration_dates": { "first_posted(estimated)": "2019-04-02", "first_submitted": "2019-04-01", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The transfer of frozen / thawed embryos has been routinely performed in the last 30 years as part of Assisted Reproduction treatment (ART). Currently, more than 50% of couples submitted to ART have surplus embryos eligible for freezing followed by transfer in subsequent cycles. Therefore the selection criteria for the thawed embryos to be transferred must be rigorous in order to maximize pregnancy and of live birth rates. Usually, the evaluation of the embryos before transfer can be performed based on blastomeres survival after a short culture period between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a prolonged period of culture (18h to 24h). Post-thaw embryo culture might have an impact on the recovery of mitosis and normal cellular functions. However, until now, there is no consensus in the literature on which post-thaw culture interval has a better impact on pregnancy and live birth rates. Also, blastocysts formation after freezing/thawing of embryos at cleavage stage may bring relevant information about post-thaw culture. Moreover, this strategy can be used as an alternative treatment. Therefore, the authors proposed this prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture on the pregnancy and live birth rates. #Intervention - PROCEDURE : embryo transfer after thaw and culture - embryos will be kept in culture after thawing for one day before transfer for the uterus - PROCEDURE : embryo transfer with no culture - embryos will be transfer with no culture after thaw	#Eligibility Criteria: Inclusion Criteria: * patients submitted to ART treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing Exclusion Criteria: * patients that does not reach criteria for frozen embryo transfer (thin endometrium, bleeding, inappropriate use of hormones) * difficult embryo transfer * embryos that were frozen twice Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No	NCT03381001	{ "brief_title": "Influence of Post-thaw Embryo Culture Interval on Assisted Reproduction Success Rates", "conditions": [ "Infertility" ], "interventions": [ "Procedure: embryo transfer with no culture", "Procedure: embryo transfer after thaw and culture" ], "location_countries": [ "Brazil" ], "nct_id": "NCT03381001", "official_title": "Influence of Post-thaw Embryo Culture Interval Before Embryo Transfer on Assisted Reproduction Success Rates", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-15", "study_completion_date(actual)": "2019-08-10", "study_start_date(actual)": "2017-06-15" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "TRIPLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2019-08-14", "last_updated_that_met_qc_criteria": "2017-12-20", "last_verified": "2019-08" }, "study_registration_dates": { "first_posted(estimated)": "2017-12-21", "first_submitted": "2017-12-11", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The study will test the tolerability and efficacy of the combination therapy Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic phase (CP1) newly diagnosted or failing interferon-based therapy. Detailed Description The protocol consists of a part 1, a phase I study that will enrol 20 patients, with the goal to determine the safety of the combination as well as the maximal tolerated dose. If the toxicity of the combination is acceptable, up to 200 more patients may be recruited and randomized to receive either Imatinib/HU or Imatinib alone (part 2). Patients who meet the inclusion criteria will be started on 400 mg Imatinib daily. In part 1 of the protocol, the dose of HU will be increased by 500 mg at 3-weekly intervals until the maximal tolerated dose has been reached. In part 2 of the study, patients will be randomized to receive either the combination or Imatinib monotherapy. Hematological and cytogenetic response will be evaluated at 3-months intervals during the first year, and at 6 months' intervals thereafter. Primary endpoints for part 1 are dose-limiting toxicity and maximal tolerated dose. Primary endpoints for part 2 are the rates of major and complete molecular response at 6, 12 and 18 months, respectively. #Intervention - DRUG : Imatinib - DRUG : Hydroxyurea	#Eligibility Criteria: Inclusion Criteria: * Ph-positive CML in CP1, newly diagnosed or resistant (hematologic or cytogenetic) or intolerant to interferon-based therapy * Age >= 18 years * Negative pregnancy test * Low- and intermediate risk patients younger than 45 with an HLA (Human Leukocyte Antigen) -matched sibling donor and medically fit to undergo allografting should be included only after they have been adequately counselled about the potential risk (of disease progression) associated with delaying the allograft * Informed consent Exclusion Criteria: * Objective signs of disease progression beyond CP1 defined as * bone marrow or peripheral blood blasts > 15% and/or * blasts + promyelocytes >= 30% and/or * peripheral blood basophils >= 20% and/or * platelets < 100/nl and/or * chromosomal abnormalities in addition to the Ph chromosome * Findings suggestive of extramedullary involvement * Any severe and uncontrolled medical condition * Previous treatment with Imatinib (only part 2 of the study) * History of non-compliance * Simultaneous inclusion in other studies Important note: previous treatment with Imatinib only is not an exclusion criterion for part 1 of the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02480608	{ "brief_title": "Treatment of CML Patients With Imatinib and Hydroxyurea (CML2004)", "conditions": [ "Leukemia, Myelogenous, Chronic, BCR-ABL Positive" ], "interventions": [ "Drug: Imatinib", "Drug: Hydroxyurea" ], "location_countries": null, "nct_id": "NCT02480608", "official_title": "Treatment of CML Patients With Imatinib and Hydroxyurea", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08", "study_completion_date(actual)": "2013-05", "study_start_date(actual)": "2004-04" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE1", "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2015-06-24", "last_updated_that_met_qc_criteria": "2015-06-23", "last_verified": "2015-06" }, "study_registration_dates": { "first_posted(estimated)": "2015-06-24", "first_submitted": "2015-06-10", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years. #Intervention - BIOLOGICAL : Meningococcal Vaccine - MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.	#Eligibility Criteria: Inclusion Criteria: Individuals eligible to be enrolled into this study are male and female subjects: * 11 <= age <= 18 years at the time of enrollment; * who have given their written consent/assent and whose parents or legal guardians have given written informed consent at the time of enrollment; * who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); * in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria: * History of any meningococcal vaccine administration; * Current or previous, confirmed or suspected disease caused by N. meningitidis; * Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; * Significant acute or chronic infection within the previous 7 days or fever (defined as temperature 38C) within the previous 3 days; * Antibiotics within 7 days prior to enrollment; * Pregnancy or nursing (breastfeeding) mothers; * Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; * Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); * Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants; * Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; * History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; * Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; * Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study; * Individuals who are part of study personnel or close family members conducting this study; * Individuals with medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; * Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. Sex : ALL Ages : - Minimum Age : 11 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes	NCT01210885	{ "brief_title": "Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents", "conditions": [ "Meningococcal Disease", "Meningococcal Meningitis" ], "interventions": [ "Biological: Meningococcal Vaccine" ], "location_countries": [ "Chile", "Colombia", "Panama" ], "nct_id": "NCT01210885", "official_title": "Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07", "study_completion_date(actual)": "2011-07", "study_start_date(actual)": "2010-12" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "PHASE2" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2011-10-24", "last_updated_that_met_qc_criteria": "2010-09-28", "last_verified": "2011-10" }, "study_registration_dates": { "first_posted(estimated)": "2010-09-29", "first_submitted": "2010-09-27", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery. #Intervention - PROCEDURE : Ultrasound -guided cannulation - radial artery cannulation using the ultrasound - PROCEDURE : Palpation -guided cannulation - radial artery cannulation using the palpation	#Eligibility Criteria: Inclusion Criteria: * American Society of Anesthesiologists 1, 2, 3 BMI >= 30 bariatic surgery Exclusion Criteria: * refusal infection or surgery history in wrist Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT03995264	{ "brief_title": "Ultrasound vs Palpation for Radial Artery Cannulation", "conditions": [ "Obese" ], "interventions": [ "Procedure: Palpation -guided cannulation", "Procedure: Ultrasound -guided cannulation" ], "location_countries": [ "Korea, Republic of" ], "nct_id": "NCT03995264", "official_title": "Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-07", "study_completion_date(actual)": "2022-01-07", "study_start_date(actual)": "2019-08-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "QUADRUPLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-01-11", "last_updated_that_met_qc_criteria": "2019-06-20", "last_verified": "2022-01" }, "study_registration_dates": { "first_posted(estimated)": "2019-06-24", "first_submitted": "2019-06-20", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records. Detailed Description After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon. Education Group: The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage. All Subjects: All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon. All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted, and then again at 6 months to ask history of prescription opioid utilization. #Intervention - BEHAVIORAL : Educational Video - The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long. - Other Names : - Best Advice for People Taking Opioid Medication	#Eligibility Criteria: Inclusion Criteria: * Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery. * Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic) * Between the age of 18 - 65 years * Read and speak English well enough to understand the education, provide informed consent and follow study instructions Exclusion Criteria: a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02674711	{ "brief_title": "Study of Opioid Use After Lumbar and Cervical Spine Surgery", "conditions": [ "Low Back Pain", "Opiate Addiction", "Neck Pain" ], "interventions": [ "Behavioral: Educational Video" ], "location_countries": [ "United States" ], "nct_id": "NCT02674711", "official_title": "The Effect of a Brief Pre-operative Pain Medication Educational Video on Post-operative Prescription Opioid Medication Use in Patients Undergoing Spine Surgery. A Randomized Controlled Trial", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02-28", "study_completion_date(actual)": "2018-06-01", "study_start_date(actual)": "2015-08" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-05-19", "last_updated_that_met_qc_criteria": "2016-02-03", "last_verified": "2022-07" }, "study_registration_dates": { "first_posted(estimated)": "2016-02-04", "first_submitted": "2016-02-02", "first_submitted_that_met_qc_criteria": "2022-07-13" } } }
#Study Description Brief Summary Peri-implant mucositis is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Non-surgical therapy of peri-implant mucositis appears to be partially effective in resolving the disease. In several cases, however, only limited improvements have been reported in the main clinical parameters (bleeding partial resolution and presence of pocket at follow-up visits) and there is a clear tendency to relapse of the disease. In these cases it is therefore recommended to consider adjunctive therapies. Numerous approaches have been used for implant surface decontamination including mechanical, chemical and treatments by means of air-powder or laser. The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of peri-implant mucositis. Detailed Description Peri-implant mucositis, defined as an inflammatory lesion of the surrounding peri-implant tissues without loss of supporting bone, is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implant mucositis affects 43% of the subjects. Numerous approaches have been used for implant surface decontamination, including mechanical, chemical and laser treatments. Using conventional mechanical means, eradication of pathogens on implant surfaces with threads and often with rough surface structures is difficult. Treatment models, such as debridement, effectively used to treat teeth with periodontitis, cannot be used in the same way on rough threaded implant surfaces. The implant rough surface structure also provides the bacteria with ''protected areas'', inaccessible to conventional mechanical removal. A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy. Data have shown that treatments with Er:YAG lasers have a bactericidal effect. Er:YAG laser treatment can debride the implant surface effectively and safely. Slightly better clinical results in terms of bleeding on probing and clinical attachment level have been reported by Er:YAG laser treatment as compared with traditional non-surgical mechanical debridement with curettes and chlorhexidine. The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of mucositis, demonstrating no relevant adverse effects. Until recently, air-polishing devices have used a slurry of water and sodium bicarbonate (NaHCO3) and pressurized air/water. A less abrasive method using an aminoacid glycine has been proven to be effective in removing bacterial biofilm structures in deep periodontal pockets and safe by not causing emphysema. Moreover the use of a glycine-based powder does not seem to cause titanium implant surface changes. The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of mucositis. #Intervention - PROCEDURE : Mechanical debridement with curettes - mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments - PROCEDURE : Er:YAG laser - mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Er:YAG laser will be used for the implant surface decontamination. - PROCEDURE : Air Powder - mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments. Furthermore, an Air-Powder treatment will be provided on the implant/abutment surface.	#Eligibility Criteria: Inclusion Criteria: * presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined without progressive radiographic bone loss (compared to crestal bone levels at the time of placement of the reconstruction)or <3mm bone level * single tooth and bridgework restorations without overhangings * no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment) * implant function time >= 1 year Exclusion Criteria: * Patients with uncontrolled diabetes * patients with osteoporosis or under bisphosphonate medication, * pregnant or lactating women, * patients with a history of radiotherapy to the head and neck region * patients with incapability to perform basal oral hygiene measures due to physical or mental disorders * hollow implants * implant mobility * implants at which no position could be identified where proper probing measurements could be performed; * previous surgical treatment of the peri-implantitis lesions Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT03951636	{ "brief_title": "Non Surgical Protocol for Treatment of Mucositis", "conditions": [ "Peri-implant Mucositis" ], "interventions": [ "Procedure: Er:YAG laser", "Procedure: Mechanical debridement with curettes", "Procedure: Air Powder" ], "location_countries": [ "Italy" ], "nct_id": "NCT03951636", "official_title": "Non Surgical Protocol for Treatment of Mucositis Using an Er:YAG Laser or an Air-abrasive Device: a Randomized Clinical Trial", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-16", "study_completion_date(actual)": "2022-07-27", "study_start_date(actual)": "2019-07-02" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-03-03", "last_updated_that_met_qc_criteria": "2019-05-14", "last_verified": "2023-02" }, "study_registration_dates": { "first_posted(estimated)": "2019-05-15", "first_submitted": "2019-05-14", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up. #Intervention - DRUG : peginterferon alfa-2a [Pegasys] - Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks	#Eligibility Criteria: Inclusion Criteria: * Adult patients, 18 <= age <= 65 years * HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve * Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL) Exclusion Criteria: * Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV) * Evidence of decompensated liver disease * A medical condition associated with chronic liver disease other than viral hepatitis Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01519921	{ "brief_title": "A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.", "conditions": [ "Hepatitis B, Chronic" ], "interventions": [ "Drug: peginterferon alfa-2a [Pegasys]" ], "location_countries": [ "Korea, Republic of" ], "nct_id": "NCT01519921", "official_title": "An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06", "study_completion_date(actual)": "2008-06", "study_start_date(actual)": "2005-10" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE4" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-04-21", "last_updated_that_met_qc_criteria": "2012-01-24", "last_verified": "2016-03" }, "study_registration_dates": { "first_posted(estimated)": "2012-01-27", "first_submitted": "2012-01-05", "first_submitted_that_met_qc_criteria": "2015-12-17" } } }
#Study Description Brief Summary The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development. #Intervention - DRUG : BI 655064 dose 1 - DRUG : BI 655064 dose 2 - DRUG : BI 655064 dose 3 - DRUG : Placebo	#Eligibility Criteria: Inclusion criteria: * Males and females 18 <= age <= 70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly. * Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy * Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started * Active renal disease evidenced by proteinuria >= 1.0 g/day [(Uprot/Ucrea) >= 1] * Signed and dated written informed consent Exclusion criteria: * Clinically significant current other renal disease * Glomerular Filtration Rate <30ml/min/1.73m² * Dialysis within 12m of screening * Antiphospholipid syndrome * Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy * Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data * Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation * Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation * Treatment with abatacept within 12 months prior to randomisation * Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation * Treatment with cyclophosphamid within 6 months prior to randomisation * Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation * Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug. * Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test * Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma. * Live vaccination within 6 weeks before randomisation * Patients unable to comply with the protocol in the investigator's opinion. * Alcohol abuse in the opinion of the investigator or active drug abuse . * Women who are pregnant, nursing, or who plan to become pregnant while in the trial * Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal * Further exclusion criteria apply. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02770170	{ "brief_title": "Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis", "conditions": [ "Lupus Nephritis" ], "interventions": [ "Drug: BI 655064 dose 2", "Drug: Placebo", "Drug: BI 655064 dose 1", "Drug: BI 655064 dose 3" ], "location_countries": [ "United States", "Poland", "Germany", "Serbia", "Hong Kong", "Czechia", "United Kingdom", "France", "Japan", "Thailand", "Australia", "Philippines", "Italy", "Mexico", "Korea, Republic of", "Portugal", "Canada", "Malaysia", "Spain", "Greece" ], "nct_id": "NCT02770170", "official_title": "A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-23", "study_completion_date(actual)": "2020-08-18", "study_start_date(actual)": "2016-05-16" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-07-12", "last_updated_that_met_qc_criteria": "2016-05-11", "last_verified": "2021-06" }, "study_registration_dates": { "first_posted(estimated)": "2016-05-12", "first_submitted": "2016-05-11", "first_submitted_that_met_qc_criteria": "2021-06-18" } } }
#Study Description Brief Summary A randomized control trial was conducted to test the effect of umbilical cord clamping distance on cord separation time and umbilical cord microbial colonization in neonates. Detailed Description Among the indicators of a country's level of development is the neonatal mortality rate. This rate reveals the extent of a country's economic development and how this affects health. One of the main causes of neonatal mortality is infection-related fatalities. Every year, approximately 700,000 neonatal deaths occur from bacterial infections.Navel cord infections comprise a large part of neonatal infections. The umbilical cord is clamped and cut off at a distance of 2-3 cm from the newborn's abdominal wall after birth, after which its function is terminated. The necrotic tissue remaining in the newborn's umbilical cord provides an ideal environment for bacterial growth. The umbilical cord dries out and falls in the interval between postpartum 5-15 day. The prolongation of the umbilical cord falling time increases the possibility of developing bacterial infection. The umbilical cord microbial colonization was usually detected on 5th and 7th days after birth. Since the time the umbilical cord falls off directly affects the health of the newborn, it is important to understand the factors that can affect this time. The literature reveals studies on umbilical cord separation times, most of which are devoted to comparing various techniques of caring for the cord. No study however has been discovered that has examined the effect of the distance between the abdominal wall of the newborn and the cord clamping site. It is believed that the clamping distance of the umbilical cord may be among the factors that have an impact on the separation time of the cord. Also, although midwives are responsible for the clamping and cutting of the umbilical cord, it is observed that there is no measuring instrument that is used in this procedure and the cord is clamped by eyeball estimation. There is no standard practice and there are also differences between the practices of midwives. This situation and the lack of adequate information in the literature on cord clamping distance pointed to the need for conducting a study in this context. This study was intended to determine the effect of umbilical cord clamping distance on the cord separation time and on microbial colonization in the umbilical cord. It was tested the hypotheses that there is no difference between the intervention and control groups of newborns after the umbilical cord clambing distance intervention, the cord separation time and on microbial colonization outcomes. #Intervention - PROCEDURE : Umbilical cord clamping distance - Intervention group I: Umbilical cord clamped at a distance of 2cm Intervention group II: Umbilical cord clamped at a distance of 3cm Control group: Usual care (clamped without measurement).	#Eligibility Criteria: Inclusion Criteria: * Being at 38 <= age <= 42 weeks of gestation, being 18 years and over, having primary school education, being able to speak and understand Turkish, having no communication problems, not having a history of active or previous vaginal infection, living in the metropolitan area of Kahramanmaras, accepting home visits during the research process, and agreeing to participate in the research. Exclusion Criteria: * Cesarean delivery, premature membrane rupture, newborns with severe congenital anomalies, severely ill infants requiring hospitalization immediately after birth, and babies born with a birth weight of less than 1500 g. Sex : ALL Ages : - Minimum Age : 37 Weeks - Maximum Age : 42 Weeks - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes	NCT04862403	{ "brief_title": "The Effect of Umbilical Cord Clamping Distance", "conditions": [ "Newborn; Infection", "Umbilical Cord Infection" ], "interventions": [ "Procedure: Umbilical cord clamping distance" ], "location_countries": [ "Turkey" ], "nct_id": "NCT04862403", "official_title": "The Effect of Umbilical Cord Clamping Distance on Cord Separation Time and Microbial Colonization: Randomized Controlled Study", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-01", "study_completion_date(actual)": "2019-03-30", "study_start_date(actual)": "2018-06-01" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "DOUBLE", "phase": [ "NA" ], "primary_purpose": "SUPPORTIVE_CARE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2021-04-28", "last_updated_that_met_qc_criteria": "2021-04-26", "last_verified": "2021-04" }, "study_registration_dates": { "first_posted(estimated)": "2021-04-28", "first_submitted": "2021-03-29", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The electronic medical record (EMR) offers a new method to provide patients with information about their visits with a clinician. The EMR can generate personalized and patient specific handouts at the end of the visit that can recap the topics covered during that visit. These After Visit Summaries (AVS) can be automatically generated with information contained in the patient's chart. The AVS has the potential to improve patient retention of information needed for adherence to treatment plans, and follow-up instructions, and to facilitate information transfer between healthcare settings. However, the content and formatting of the AVS to optimize patients' information retention and satisfaction with the visit is not known. In this study, we will develop and test in a randomized trial three different versions of an AVS to determine the AVS content that maximizes patient satisfaction and retention of information on the AVS,and adherence to physician instructions. The three versions of the AVS developed from patient and physician input will be compared to a control condition which consists of current practice in each setting. Detailed Description We will conduct an experiment in the four selected primary care clinics to test objectively the effect of three levels of AVS content on patient recall of personal visit information, satisfaction with the information received from their providers, and uses of the information after their visits. The four clinics were selected to provide a diverse patient sample with regard to socioeconomic status, race/ethnicity and language preference. The study is planned to have a total of 68 patients in each AVS form group (272 total), and 136 patients in each language group. In our previous research in these SPUR-Net clinics, we found that it is very difficult to recruit Spanish-language preference individuals in private practice settings. The great majority of persons of Hispanic ethnicity who attend private practice clinics prefer to communicate in English. For this reason, we will not attempt to recruit Spanish-speakers from the Baylor Family Medicine Clinic. Patients will be approached, and if they agree to participate they will be consented for the study. At the end of the visit, each study patient will be randomized either to the control group or one of the three experimental groups. The RA will accomplish this by opening a sealed envelope that contains the randomly generated group assignment. For the experimental AVS's, the RA will select and generate the appropriate study AVS in Epic. For the control group, the AVS that is currently being used in that clinic will be printed and distributed to the patient. All research subjects will then be contacted in 24 hours, and then again in 2-3 weeks to study the following outcomes. We are not able to test a control condition that withholds an AVS altogether, in as much as JACHO standards governing some of the participating clinics require an AVS of some kind. Primary Outcome: The primary outcome measure will be the amount of information recalled by patients at two time points: 2 days after the primary care visit, and 2-3 weeks after the visit. The recall test will consist of two parts. Part 1 will involve recall of the general categories of information contained on the AVS. Sample questions are: * Did the form have information about your blood pressure? * Did the form have information about your medications? * Did the form have a list of your health problems? The responses will be scored as correct or incorrect, depending on the version of the AVS randomly assigned to the patient. The final version of the recall test will be developed after the focus group analysis, when a final determination of the content of the three forms of the AVS is completed. Part 2 of the recall test will ask the patient to generate the list of medications prescribed and instructions given. This represents the content of the minimum information AVS (Form 3), which can be answered by all study participants. The patients' answers will be recorded in the data base verbatim, and at the completion of data collection, the investigators will develop scoring rules to assign a score to each item. These rules will account for informal names for medications (such as 'water pill,' 'sugar pill,' etc.). The score on this part will be the percent of medication information correctly recalled, including name of pill (formal or informal), number of doses to be taken per day, and timing of dose. The total test score will be the percent of items correctly recalled. The two parts can be analyzed separately and as a total score. Secondary Outcomes Patient Satisfaction with the AVS will be assessed with a 9-item questionnaire adapted from a longer patient satisfaction scale developed by researchers in Baylor's Department of Family and Community Medicine for evaluating patient responses to educational materials. Response options to a series of questions regarding satisfaction with various characteristics of the AVS range from 'strongly agree' to 'strongly disagree.' Two open ended questions will provide patients the opportunity to mention elements of the AVS, or their reaction to it, that might not have been anticipated by the research team. The form will be available in both English and Spanish versions. Adherence to Treatment will be assessed to examine whether the different AVS formats influence patients' self-reported adherence to the provider's recommendations. We will use a general measure of adherence that summarizes information about the patient's tendency to adhere to medical recommendations, regardless of type of treatment recommended. The items in this measure are: 1. I had a hard time doing what the doctor suggested I do; 2. I found it easy to do the things my doctor suggested I do; 3. I was unable to do what was necessary to follow my doctor's treatment plans; 4. I followed my doctor's suggestions exactly; and 5. Generally speaking, how often during the past 4 weeks were you able to do what the doctor told you? Response options for each item range from 'none of the time' to 'all of the time.' The general adherence scale was constructed by averaging responses to the five items and transforming the result linearly to a 0-100 distribution. This scale, developed in conjunction with the Health Outcomes Study, has demonstrated good internal reliability approaching .80, and acceptable stability over time. Standard back translation procedures have been used to construct an equivalent Spanish version. Other Study Variables Health Literacy will be assessed with the Short Test of Functional Health Literacy in Adults (S-TOFHLA)in order to account for the effect of functional health literacy on response to the AVS. Patients' health literacy skills are increasingly recognized as a critical variable in primary care research. The S-TOFHLA is a timed reading comprehension test that measures patients' ability to read and understand passages describing common medical instructions. It is available in English and Spanish versions, takes approximately 7 minutes for patients to complete, and is scored on a scale of 0 to 36. Patients are categorized as having adequate health literacy if the S-TOFHLA score is 23-36, marginal health literacy if it is 17-22, and inadequate health literacy if the score is 0-16. Demographic and Health variables will be collected, including such standard variables as age, sex, race/ethnicity, and number of years of education completed. In order to adjust analyses for disease severity, we will document the total number of health problems included in the patient's problem list on the day of their study visit. In addition, because the salience of the AVS may be related to the presence or absence of an acute condition, we will classify each visit as to whether the problem list for the visit includes chronic conditions only, and acute condition only, or a combination of acute and chronic problems. This categorical variable will be included as a covariate in the outcomes analysis. Analysis If the potential confounders are evenly distributed across the study groups, the differences among groups on the primary and secondary outcome measures will be tested by one-way ANOVA or Chi-square analysis as appropriate for continuous or discrete variables. #Intervention - OTHER : Maximum After Visit Summary Content - OTHER : Intermediate After Visit Summary Content - OTHER : Minimum After Visit Summary Content - OTHER : Usual AVS	#Eligibility Criteria: Inclusion Criteria * Adult 21 or over * At least one previous visit to the clinic * Has one chronic condition require medications * Willing to participate and answer questionnaires by phone Exclusion Criteria: * No previous visits to the clinic * Unwilling to participate Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01685541	{ "brief_title": "Evaluation of Computer Generated After Visit Summaries", "conditions": [ "Primary Care Patients With Chronic Conditions" ], "interventions": [ "Other: Maximum After Visit Summary Content", "Other: Minimum After Visit Summary Content", "Other: Usual AVS", "Other: Intermediate After Visit Summary Content" ], "location_countries": null, "nct_id": "NCT01685541", "official_title": "Evaluation of Computer Generated After Visit Summaries to Support Patient-Centered Care", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01", "study_completion_date(actual)": "2012-06", "study_start_date(actual)": "2010-12" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE3" ], "primary_purpose": "HEALTH_SERVICES_RESEARCH", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-11-18", "last_updated_that_met_qc_criteria": "2012-09-13", "last_verified": "2023-11" }, "study_registration_dates": { "first_posted(estimated)": "2012-09-14", "first_submitted": "2012-09-12", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months. Detailed Description Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months. #Intervention - DRUG : eletriptan - oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days - Other Names : - Relpax	#Eligibility Criteria: Inclusion Criteria: * age 18 <= age <= 45 healthy menstruating female Exclusion Criteria: * cardiac or other conditions precluding use of eletriptan Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT00259649	{ "brief_title": "Prospective Survey of Menstrual Migraine & Prevention With Eletriptan", "conditions": [ "Migraine" ], "interventions": null, "location_countries": [ "United States" ], "nct_id": "NCT00259649", "official_title": "Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08", "study_completion_date(actual)": null, "study_start_date(actual)": "2004-08" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE4" ], "primary_purpose": "PREVENTION", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2011-07-04", "last_updated_that_met_qc_criteria": "2005-11-26", "last_verified": "2011-06" }, "study_registration_dates": { "first_posted(estimated)": "2005-11-29", "first_submitted": "2005-11-26", "first_submitted_that_met_qc_criteria": "2011-07-01" } } }
#Study Description Brief Summary A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it.	#Eligibility Criteria: Inclusion Criteria: For Radiologists: American Board of Radiology Certification and live within the Baltimore, MD-Washington, DC Metropolitan areas For chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality * Exclusion Criteria: Radiologists who assisted by providing cases for review For chest radiographs: poor image quality Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01261507	{ "brief_title": "Reader Study of DeltaView™ Chest Radiograph Software", "conditions": [ "Lung Neoplasm" ], "interventions": null, "location_countries": [ "United States" ], "nct_id": "NCT01261507", "official_title": "Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current Antero/Posterior (AP/PA) X-ray Image Pair", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12", "study_completion_date(actual)": "2012-12", "study_start_date(actual)": "2010-11" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2015-12-01", "last_updated_that_met_qc_criteria": "2010-12-15", "last_verified": "2015-11" }, "study_registration_dates": { "first_posted(estimated)": "2010-12-16", "first_submitted": "2010-12-14", "first_submitted_that_met_qc_criteria": "2014-06-18" } } }
#Study Description Brief Summary The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease. Detailed Description Among several symptoms in patients with multiple myeloma, the bone disease is one of the most common symptoms that approximately 80 percent of the patients experience. Multiple myeloma is different from other tumors in that several osteoclast activating factors (OAF) released from multiple myeloma cells resorb bone and, at the same time, activation of osteoblast is inhibited, leading to unbalance of breakdown and formation of bone. Activation of osteoclast and inhibition of osteoblast brings about bone fractures, osteoporosis, hypercalcemia, bone pain and spinal cord compression. Those symptoms are directly related to patients' quality of life. Therefore, they are the important therapeutic targets for multiple myeloma. Various types of bisphosphonate agents are used for the treatment of the bone disease in patients with multiple myeloma. This is a prospective (a study where the participants are identified and then followed forward in time), multi-center, Phase 4, observational study (studies that record specific events occurring without any intervention from the researcher) in order to analyze the change in bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) before and after the use of bortezomib injection by using an enzyme-linked immunosorbent assay (ELISA) in serum. The adverse events will be assessed through the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE V3). The patients will receive bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days under usual clinical practice. #Intervention - DRUG : bortezomib - injection into a vein 1.3 mg/m2 twice a week for 21 days	#Eligibility Criteria: Inclusion Criteria: * Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included. Exclusion Criteria: * Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity * Patients with severe hepatic impairment * Women who are pregnant Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01026701	{ "brief_title": "Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.", "conditions": [ "Multiple Myeloma" ], "interventions": [ "Drug: bortezomib" ], "location_countries": null, "nct_id": "NCT01026701", "official_title": "Observational Study of Osteoblast Activity in Velcade�(Bortezomib) IV Treated Multiple Myeloma Patients.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11", "study_completion_date(actual)": "2009-11", "study_start_date(actual)": "2008-03" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2014-04-28", "last_updated_that_met_qc_criteria": "2009-12-03", "last_verified": "2014-04" }, "study_registration_dates": { "first_posted(estimated)": "2009-12-04", "first_submitted": "2009-12-03", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect. #Intervention - DRUG : Ruxolitinib plus simvastatin - Ruxolitinib 5 mg orally every 12 hours for 7 days, which will be increased to 10 mg every 12 hours for a total of 14 days. Simvastatin 40 mg orally every 24 hours for 14 days - OTHER : Standard of Care - Patients will receive treatment according to usual clinical practice in the participant site.	#Eligibility Criteria: Inclusion Criteria: * Patients who have given their written informed consent. If it is considered that obtaining written consent could constitute a factor for the transmission of the disease (given the high contagiousness of the SARS-Cov-2 virus), it will be permitted to obtain duly justified verbal consent in the patient's medical history. * Clinical diagnosis or confirmed by analytical tests (PCR of viral RNA or detection of antiSARS-Cov-2 antibodies) that requires care in hospital and that are grade 3 or 4 of the WHO 7-point ordinal scale of severity categorization for COVID. * Platelets> 50,000 / uL, neutrophils> 500 / ul * Kidney or liver failure is not a contraindication, dose adjustment will be made according to the SmPC * Women of childbearing potential who are sexually active, not undergoing a hysterectomy or double adnexectomy, should follow the following indications for contraception: * Negative serum or urine pregnancy test in the 72 hours prior to the start of treatment. * Use of a medically accepted contraceptive method during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment. Exclusion Criteria: * Documented concomitant severe bacterial or fungal infection * Infection with HIV, HCV, HBV * Age <18 years * Thrombocytopenia <50,000 / uL, Neutropenia <500 / uL * Women of childbearing age who do not use an effective contraceptive method. * Pregnant or lactating women. * Patients who do not want or cannot comply with the protocol. * Patients with impaired gastrointestinal function or gastric disease that significantly impairs the absorption of ruxolitinib or simvastatin, such as: severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small intestine or inability to swallow oral medication. Previous partial or total gastrectomy is not an exclusion criterion Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04348695	{ "brief_title": "Study of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.", "conditions": [ "Coronavirus Infection" ], "interventions": [ "Drug: Ruxolitinib plus simvastatin", "Other: Standard of Care" ], "location_countries": [ "Spain" ], "nct_id": "NCT04348695", "official_title": "Randomized Phase II Clinical Trial of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.Ruxo-Sim-20 Clinical Trial.", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31", "study_completion_date(actual)": "2021-01-31", "study_start_date(actual)": "2020-04-12" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-06-06", "last_updated_that_met_qc_criteria": "2020-04-13", "last_verified": "2022-06" }, "study_registration_dates": { "first_posted(estimated)": "2020-04-16", "first_submitted": "2020-04-13", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen is proposed to help in finding the causative insect. Detailed Description Insect sting allergy from insects in Hymenoptera is not uncommon. The reaction maybe very severe and life threatening. To find the cause of insect sting allergy is important in prevention and specific treatment such as immunotherapy. The skin prick test and sIgE of these insects may have cross reactions so it is difficult to be interpreted. The usage of sIgE recombinant venom allergen can benefit in separate cross reaction and dual allergy reaction. #Intervention - OTHER : Skin prick test - Skin prick tests to local and imported insect sting allergen with different concentration are performed. - OTHER : sIgE measurement - sIgE levels to stinging insect allergen and their recombinant venom allergen are measured	#Eligibility Criteria: Inclusion Criteria: * Cases with severe insect sting allergy reactions Exclusion Criteria: * Without other severe systemic diseases * Not pregnant or lactation Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT02764242	{ "brief_title": "The Causative Insects in Severe Insect Sting Allergy", "conditions": [ "Insect Sting Allergy" ], "interventions": [ "Other: sIgE measurement", "Other: Skin prick test" ], "location_countries": null, "nct_id": "NCT02764242", "official_title": "Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03", "study_completion_date(actual)": "2016-04", "study_start_date(actual)": "2015-02" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "DIAGNOSTIC", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2016-05-06", "last_updated_that_met_qc_criteria": "2016-05-04", "last_verified": "2016-05" }, "study_registration_dates": { "first_posted(estimated)": "2016-05-06", "first_submitted": "2016-05-04", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Diabetes is a common chronic disease in most parts of the world. Diabetes-related complications are harmful to the human body. Different types of diabetes have different levels of harm to the human body. There are also fewer studies on the relationship between specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism. Therefore, clarifying the differences in the clinical characteristics of adult men with late-onset autoimmune diabetes (LADA) ,Classical type 1 diabetes (T1DM) and type 2 diabetes (T2DM) will help to further understand the effects of diabetes on bone metabolism and sex hormones. Detailed Description Diabetes is a common chronic disease in most parts of the world. Diabetes-related complications are harmful to the human body. There are also fewer studies on the relationship between specific types of diabetes and clinical diseases such as osteoporosis and Hypogonadism. This study aimed to compare the prevalence of hypogonadism and osteoporosis among male patients with latent autoimmune diabetes (LADA), type 1 diabetes (T1DM) and type 2 diabetes (T2DM) and investigate the protective factors for hypogonadism and osteoporosis in these patients. This cross-sectional study evaluated male patients with LADA, T1DM, and T2DM who visited the endocrinology department of Shanghai Tenth People's Hospital for diabetes management. Sex hormones, lipid profiles, sex hormone-binding globulin (SHBG), glycosylated hemoglobin A1c, beta-cell function, uric acid, and osteocalcin were determined in serum samples. Therefor，clarifying the differences in the clinical characteristics of adult men with LADA, T1DM and T2DM will help to further understand the effects of diabetes on bone metabolism and sex hormones. #Intervention - OTHER : No interventions - This clinical study is a retrospective study, and no interventions have been implemented for patients.	#Eligibility Criteria: Inclusion Criteria: * 30 ~ 80 years male; * Meet the American Diabetes Association (ADA) definition and standards for diabetes Exclusion Criteria: * having diseases that affect bone and calcium metabolism, such as hyperthyroidism, hyperparathyroidism, hypogonadism, cushing syndrome, rheumatoid arthritis, cirrhosis, or malignant tumor; * the use in the past 6 months of drugs that interfere with bone and calcium metabolism, such as sex steroids, vitamin D metabolites, calcitonin, bisphosphonates, and thyroid hormone; * moderate or severe liver and renal dysfunction, including serum alanine aminotransferase of 120 IU/L, aspartate aminotransferase of 80 IU/L, and serum creatinine of 120 μmol/L. 4）a history of congenital/hypogonadotropic hypogonadism or hyperthyroidism, or those who received testosterone replacement therapy in the past 6 months were excluded. Sex : MALE Ages : - Minimum Age : 30 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT04618354	{ "brief_title": "Comparing the Clinical Characteristics of Male LADA, T1DM and T2DM Patients", "conditions": [ "Diabetes" ], "interventions": [ "Other: No interventions" ], "location_countries": [ "China" ], "nct_id": "NCT04618354", "official_title": "Comparing the Clinical Characteristics of Male Patients With Latent Autoimmune Diabetes ,Classic Type 2 Diabetes and Classic Type 2 Diabetes", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-30", "study_completion_date(actual)": "2020-12-30", "study_start_date(actual)": "2019-01-01" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2022-09-13", "last_updated_that_met_qc_criteria": "2020-10-31", "last_verified": "2022-09" }, "study_registration_dates": { "first_posted(estimated)": "2020-11-05", "first_submitted": "2020-10-31", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with breast cancer. Detailed Description This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial using non-inferior design. A total of 188 patients with breast cancer who are suitable for endocrine therapy will be enrolled into the screening period from D-28 to D-1 before administration. Eligible subjects will be randomized in a 1:1 ratio to receive LY01005 3.6 mg intramuscularly or ZOLADEX ® 3.6 mg subcutaneously once every 28 days for three doses until intolerable toxicity, disease progression requiring other anti-tumor treatments, withdrawal of consent, loss to follow-up, death or the end of the whole study, and stratified according to history of chemotherapy (yes vs. no) and age (\<45 vs. ≥45 years old). And all subjects will be also treated with tamoxifen orally twice per day (10 mg/tablet, 1 tablet/time). Blood samples will be collected at the specified time points of the study to detect serum E2, LH and FSH. Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) will be conducted as required in the protocol. Additional blood samples will be collected from 12 subjects (PK subgroup) who are randomized to LY01005 group to assess the PK and PD characteristics of LY01005 in patients with breast cancer. #Intervention - DRUG : LY01005 - LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period. - Other Names : - Goserelin Acetate Sustained-Release Microspheres for Injection - DRUG : ZOLADEX® 3.6 mg - ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period. - Other Names : - Goserelin Acetate Implant 3.6 mg	#Eligibility Criteria: Inclusion Criteria: * Women aged >=18 and <60 at screening, in pre-menopausal status defined as: (1) Menses within 1 year before enrolment; (2) Serum E2 >30 pg/mL and FSH <=40 mIU/mL within 4 weeks before enrollment. (If patients received hysterectomy, they should only meet the second item.) * Histologically confirmed ER+ primary breast cancer (ER+ defined as at least 10% of the cells examined by immunohistochemistry testing have estrogen receptors), TNM stage (according to the 8th edition of the AJCC Cancer Staging Manual): T1-T3, any N stage, M0 or Tis/T0, lymph node positive, M0. * Patients who have previously received breast cancer-related surgery, have no known clinical residual local regional lesions after surgery (adjuvant radiotherapy was allowed after surgery), and are suitable for treatment with the combination of the study drug and tamoxifen as judged by the investigator (patients who have received neoadjuvant/adjuvant chemotherapy were allowed); * Life expectancy of more than 9 months. * ECOG score of <= 2. * Female patients of child bearing potential who have a negative pregnancy test and their partners must agree to the use of non-hormonal contraception throughout the study period for at least 3 months after last dose. * Patients who voluntarily sign an IRB-approved informed consent form before any trial-related activities, are willing to abide by the restrictions of the study, and complete the prescribed examinations. Exclusion Criteria: * Any evidence of distant metastatic lesions. * Have received any neoadjuvant /adjuvant endocrine therapy for breast cancer previously. * Have received a bilateral oophorectomy, ovarian radiotherapy, hypophysectomy or adrenalectomy, or who have pituitary lesions. * Have received major surgery within 4 weeks prior to randomization. * History or presence of another malignancy, other than surgically removed squamous/basal cell carcinoma of the skin or radically resected in situ cervical carcinoma, within the last 5 years. * Presence of infectious diseases requiring intramuscular or intravenous drug therapy at the screening visit. * Suffering from serious diseases within 6 months before the screening visit, including but not limited to: acute coronary syndrome, coronary revascularization, New York Heart Association (NYHA) class >= II cardiac insufficiency, severe unstable arrhythmia; Or the presence of fundus disease, severe osteoporosis, uncontrolled seizures, extensive bilateral lung disease diagnosed by high-resolution computed tomography, mental diseases that prevent the signing of informed consent at the screening visit. * History of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC] or clotting factor deficiency) or long-term anti-coagulant therapy (other than anti-platelet therapy). * History of deep venous thrombosis, pulmonary embolism or stroke. * Total bilirubin >1.5xULN, ALT or AST >2.5xULN, platelets <90 × 10^9/L, QTc interval >460ms, creatinine clearance < 30 mL/min (calculated according to Cockcroft-Gault formula) at the screening visit. * Patients who are seropositive for hepatitis B surface antigen (HBsAg) must meet the following 2 conditions at the same time: 1. HBV DNA level: HBeAg-positive patients, HBV DNA >= 20,000 IU/ml [equivalent to 10^5 copies/mL]; HBeAg-negative patients, HBV DNA >= 2,000 IU/ml [equivalent to 10^4 copies/mL]; 2. ALT >= 2 x ULN). * Patients who are seropositive for any one of hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) or anti-treponema pallidum antibody (TP-Ab). * Known to be allergic to the active ingredients or any excipients of GnRH analogues or tamoxifen. * Unwilling to stop taking any drug that affects sex hormonal status. * Have received any investigational drug, any investigational biological product or any investigational medical device, and discontinued within 1 month or 5 half-lives of the corresponding drug before the screening visit, whichever is longer. * Female patients who are pregnant or breast-feeding. * Other conditions considered unsuitable for enrollment by the investigator. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 59 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No	NCT05110170	{ "brief_title": "Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX®", "conditions": [ "Breast Cancer" ], "interventions": [ "Drug: LY01005", "Drug: ZOLADEX® 3.6 mg" ], "location_countries": [ "China" ], "nct_id": "NCT05110170", "official_title": "A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Breast Cancer", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-05", "study_completion_date(actual)": "2022-06-24", "study_start_date(actual)": "2020-10-15" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE3" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2023-05-16", "last_updated_that_met_qc_criteria": "2021-11-03", "last_verified": "2023-05" }, "study_registration_dates": { "first_posted(estimated)": "2021-11-05", "first_submitted": "2021-11-03", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation. Detailed Description Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.	#Eligibility Criteria: Inclusion Criteria: * atrial fibrillation Exclusion Criteria: * follow-up not possible, poor prognosis within 3 months Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT01224574	{ "brief_title": "To Assess the Predictive Value of D-dimer Level on the Occurrence of Cardiovascular Events", "conditions": [ "Atrial Fibrillation" ], "interventions": null, "location_countries": [ "France" ], "nct_id": "NCT01224574", "official_title": "Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07", "study_completion_date(actual)": "2007-07", "study_start_date(actual)": "2001-01" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2010-10-20", "last_updated_that_met_qc_criteria": "2010-10-19", "last_verified": "2010-09" }, "study_registration_dates": { "first_posted(estimated)": "2010-10-20", "first_submitted": "2010-09-13", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Detailed Description Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT. #Intervention - DRUG : Fecal Microbiota suspension - The prepared microbiota suspension was infused into mid-gut.	#Eligibility Criteria: Inclusion Criteria: * age between 14 <= age <= 80 years; * difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation). Exclusion Criteria: * difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders); * with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD); * pregnant or breast-feeding women; * infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks. Sex : ALL Ages : - Minimum Age : 14 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT03308461	{ "brief_title": "Fecal Microbiota Transplantation for Constipation", "conditions": [ "Gut Microbiota", "Constipation" ], "interventions": [ "Drug: Fecal Microbiota suspension" ], "location_countries": [ "China" ], "nct_id": "NCT03308461", "official_title": "Fecal Microbiota Transplantation for Constipation With Difficult Defecation", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-01", "study_completion_date(actual)": "2017-05-01", "study_start_date(actual)": "2013-05-01" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2017-10-12", "last_updated_that_met_qc_criteria": "2017-10-11", "last_verified": "2016-05" }, "study_registration_dates": { "first_posted(estimated)": "2017-10-12", "first_submitted": "2017-10-07", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients. Detailed Description Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients. Participants were randomly assigned to an experimental group which received problem-solving therapy, or to a control group which relied on their standard methods of coping (e.g. their normal therapist, family and friends). Participants completed baseline surveys regarding their distress and coping prior to randomization. They then completed these surveys again at post-intervention (approximately 2-3 months post-baseline) and 6 months post-baseline to determine lasting effects of the intervention. #Intervention - BEHAVIORAL : Problem-Solving Therapy - Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.	#Eligibility Criteria: Inclusion Criteria: * Diagnosed with prostate cancer within 18 months of study enrollment. * The patient and significant other cohabited * Couples resided in San Diego County * Both patient and significant other were sufficiently proficient in English Exclusion Criteria: * Sex : ALL Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes	NCT02085096	{ "brief_title": "Problem Solving Therapy for Prostate Cancer Spousal Caregivers", "conditions": [ "Prostate Cancer" ], "interventions": [ "Behavioral: Problem-Solving Therapy" ], "location_countries": [ "United States" ], "nct_id": "NCT02085096", "official_title": "Problem-Solving Therapy for Prostate Cancer Patient's Spousal Caregivers", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-12", "study_completion_date(actual)": "2005-09", "study_start_date(actual)": "1997-07" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "FACTORIAL", "masking": "QUADRUPLE", "phase": [ "NA" ], "primary_purpose": "SUPPORTIVE_CARE", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-03-05", "last_updated_that_met_qc_criteria": "2014-03-10", "last_verified": "2020-03" }, "study_registration_dates": { "first_posted(estimated)": "2014-03-12", "first_submitted": "2014-03-10", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration. Detailed Description Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (\~\<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain. #Intervention - DRUG : combined spinal epidural - Combined Spinal Epidural	#Eligibility Criteria: Inclusion Criteria: * >= 18 years not allergic to medications used to treat labor pain <= 6cm cervical dilation visual pain score >=3 Exclusion Criteria: * <18 years of > 6 yearscm cervical dilation non-English speaking subjects Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No	NCT02020304	{ "brief_title": "Combined Spinal-Epidural Temperature and Duration of Action", "conditions": [ "Pain" ], "interventions": [ "Drug: combined spinal epidural" ], "location_countries": [ "United States" ], "nct_id": "NCT02020304", "official_title": "Effect of Temperature of Combined Spinal Epidural Dosing on Duration", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05-04", "study_completion_date(actual)": "2014-05-04", "study_start_date(actual)": "2013-08-29" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "SINGLE", "phase": [ "PHASE2" ], "primary_purpose": "DIAGNOSTIC", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2018-09-10", "last_updated_that_met_qc_criteria": "2013-12-18", "last_verified": "2018-09" }, "study_registration_dates": { "first_posted(estimated)": "2013-12-24", "first_submitted": "2013-11-21", "first_submitted_that_met_qc_criteria": "2017-07-25" } } }
#Study Description Brief Summary The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents. Detailed Description The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss. #Intervention - DEVICE : Placement of an adjustable gastric band - Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.	#Eligibility Criteria: Inclusion Criteria: * Ages 14 through 17 * BMI greater than 40 * BMI 35 to 40 and also having an obesity related comorbidity * Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training Exclusion Criteria: * Subject history of congenital or acquired anomalies fo the gastrointestinal tract * Severe cardiopulmonary or other serious organic disease * Severe coagulopathy * Hepatic insufficiency or cirrhosis * History of bariatric gastric or esophageal surgery * History of intestinal obstruction or adhesive peritonitis * History of esophageal motility disorders * Type I diabetes Sex : ALL Ages : - Minimum Age : 14 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No	NCT00592202	{ "brief_title": "Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents", "conditions": [ "Morbid Obesity" ], "interventions": [ "Device: Placement of an adjustable gastric band" ], "location_countries": [ "United States" ], "nct_id": "NCT00592202", "official_title": "Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-02", "study_completion_date(actual)": "2013-02", "study_start_date(actual)": "2004-12" }, "study_design": { "allocation": "NA", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "NA" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2014-04-02", "last_updated_that_met_qc_criteria": "2007-12-27", "last_verified": "2014-03" }, "study_registration_dates": { "first_posted(estimated)": "2008-01-11", "first_submitted": "2007-12-27", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients will be enrolled in the Phase II part to determine whether the combination of LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447. This trial never made it to the Phase II part of the this trial. #Intervention - DRUG : LGH447 - pan-PIM inhibitor - DRUG : BYL719 - PI3K-alpha inhibitor	#Eligibility Criteria: Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Patients with a confirmed diagnosis of multiple myeloma who have received two or more lines of therapy and are refractory to their most recent line of therapy, as defined as relapse while on therapy or within 60 days from their last line of therapy. If patient has not received either an immunomodulatory drug (IMID) or proteasome inhibitor as a prior therapy then Investigator must notify Novartis prior to the patient enrollment. Patients who have received a prior bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study * For patients in the Phase II portion of the study, must have measurable disease defined by at least 1 of the following 3 measurements: * Serum M-protein >= 0.5 g/dL * Urine M-protein >= 200 mg/24 hours OR * Serum free light chain (FLC) > 100 mg/L of involved FLC * All patients must be willing to undergo a mandatory bone marrow aspirate and/or biopsy at baseline for the assessment of biomarker/pharmacodynamics and disease status Exclusion Criteria: * Systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of either study drug * Radiotherapy within 14 days before the first dose of either study drug except localized radiation therapy for lytic bone lesions and plasmacytomas * Major surgery within 2 weeks before the first dose of either study drug * Ongoing therapy with chronic or high dose corticosteroids. Low dose steroids (i.e. prednisone <= 10 mg or an equivalent steroid dose), inhaled and topical steroids are permitted * Patients who are currently receiving treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment: * Narrow Therapeutic index substrates, strong inhibitors and strong inducers of CYP3A4 * Strong Inhibitors of CYP2D6 * Narrow therapeutic index substrates of CYP2C8, CYP2C9, CYP2C19 and CYP2D6 * Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of either study drug): * Absolute neutrophil count (ANC) < 1,000/mm3 without growth factor support within 7 days prior to testing * Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing * Bilirubin > 1.5 times the upper limit of the normal range (ULN). * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN. * Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation * Corrected QT interval (QTc) of > 450 milliseconds (ms) in males and > 470 milliseconds (ms) in females on baseline electrocardiogram (ECG) (using Fridericia [QTcF] corrected QT interval Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT02144038	{ "brief_title": "Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma", "conditions": [ "Relapsed and Refractory Multiple Myeloma" ], "interventions": [ "Drug: BYL719", "Drug: LGH447" ], "location_countries": [ "United States", "Germany", "Singapore", "Australia", "Italy" ], "nct_id": "NCT02144038", "official_title": "A Phase Ib/II, Multi-center, Study of Oral LGH447 in Combination With Oral BYL719 in Patients With Relapsed and Refractory Multiple Myeloma", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10-28", "study_completion_date(actual)": "2015-10-28", "study_start_date(actual)": "2014-07-23" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE1" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2020-12-17", "last_updated_that_met_qc_criteria": "2014-05-19", "last_verified": "2018-04" }, "study_registration_dates": { "first_posted(estimated)": "2014-05-21", "first_submitted": "2014-05-01", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Motor imagery is the mental representation of movement without any body movement. According to recent studies motor imagery contains three strategies to mentally simulate the movements: internal visual, external visual and kinesthetic imagery. Motor imagery is associated with cortical reorganization and functional improvements and it does not only related with motor performance, it also influces cognitions. Movement Imagery Questionnaire-3 (MIQ-3) is the recent, modified version of the Movement Imagery Questionnaire-Revised, Second Edition and measures imagery ability in terms of ease of imagery. The aim of this study is to translate MIQ-3 into Turkish and evaluate its test-retest reliability for Turkish-speaking population. #Intervention - BEHAVIORAL : Determining Imaginary levels - Determining the motor imaginary: internal visual, external visual and kinesthetic imagery	#Eligibility Criteria: Inclusion Criteria: * age above 18, consenting, with no limitation in mobility or movement disorder Exclusion Criteria: * refuse to attend to the study Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes	NCT03129516	{ "brief_title": "Turkish Version of the Movement Imagery Questionnaire-3", "conditions": [ "Image, Body" ], "interventions": null, "location_countries": [ "Turkey" ], "nct_id": "NCT03129516", "official_title": "Reliability and Validity of the Turkish Version of the Movement Imagery Questionnaire-3", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05", "study_completion_date(actual)": "2017-01", "study_start_date(actual)": "2015-09" }, "study_design": { "allocation": null, "interventional_model": null, "masking": null, "phase": null, "primary_purpose": null, "study_type": "OBSERVATIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2017-04-26", "last_updated_that_met_qc_criteria": "2017-04-22", "last_verified": "2017-04" }, "study_registration_dates": { "first_posted(estimated)": "2017-04-26", "first_submitted": "2017-04-16", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies: * Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion * Elective referral for 'facilitated' PTCA after early administration of Abciximab and half dose of Reteplase Detailed Description All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry. #Intervention - DEVICE : Coronary Angioplasty (PTCA)	#Eligibility Criteria: Inclusion Criteria: * ECG with ST-elevation (>= 1mm in at least 2 ECG limb leads or >= 2 mm in 2 contiguous precordial leads) AMI within <12 hours from symptoms onset fulfilling 1 or more of the following criteria of 'high risk': * Summation of ST-segment elevation or depression >= 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block; * Previous myocardial infarction (Q- and non Q-wave); * Killip Class 2 or 3; * LV ejection fraction at transthoracic ultrasound < 40%. Exclusion Criteria: * Inability to provide informed consent; * Age > 75 years * CABG or PCI procedure in past history involving the infarct-related artery; * Participation in another study with any investigational drug or device within the previous 30 days; * Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer); * Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) < 90 mmHg and tachycardia > 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation); * Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc); * Severe hepatic disease; * Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min); * Transmural MI in different location within the previous week; * Previous administration of thrombolytics within 7 days; * Intolerance or contraindications to ASA or Clopidogrel; * Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml * Known neutropenia, defined as < 1000 neutrophils / ml; * Known thrombocytopenia (< 100.000 platelets / ml ); * Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months; * Previous hemorrhagic stroke; * Previous ischemic cerebrovascular event within 3 months; * Intracranial neoplasm; * Recent major surgery at risk of bleeding; * Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years; * Administration of oral anticoagulants within the previous 7 days unless INR <= 1.2; * Severe recent trauma; * Known or possible pregnancy; * Absence of suitable vascular access (diffuse peripheral arterial disease); * Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.). Sex : ALL Ages : - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No	NCT00220571	{ "brief_title": "CARESS in Acute Myocardial Infarction", "conditions": [ "Myocardial Infarction" ], "interventions": null, "location_countries": [ "France", "Italy", "Poland" ], "nct_id": "NCT00220571", "official_title": "Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null, "study_completion_date(actual)": "2007-03", "study_start_date(actual)": "2003-05" }, "study_design": { "allocation": "RANDOMIZED", "interventional_model": "PARALLEL", "masking": "NONE", "phase": [ "PHASE3" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2007-07-03", "last_updated_that_met_qc_criteria": "2005-09-20", "last_verified": "2005-09" }, "study_registration_dates": { "first_posted(estimated)": "2005-09-22", "first_submitted": "2005-09-13", "first_submitted_that_met_qc_criteria": null } } }
#Study Description Brief Summary Ph+ leukemias (i.e.Chronic Myelogenous Leukemia (CML) and (Ph+) Acute Lymphoblastic Leukemia are malignant clonal disorder of the hemopoietic stem cell due to reciprocal translocation of genetic material between chromosome 9 and 22 giving rise to the translocation t(9;22) (q2.2; q2.1). The translocation causes the formation of a new hybrid gene (bcr-abl) that codes for a 185 kb or 210 kb cytoplasmic protein (P185 and P210 respectively) that by autophosphorylation activates a number of signaling pathways involved in cell proliferation, maturation, apoptosis and adhesion, leading to the malignant cell transformation1-3. The course of the disease goes on through a chronic phase (CP), usually lasting some years, that is characterized by a massive myeloid hyperplasia with hyperleukocytosis and splenomegaly. The CP is almost always followed by an accelerated or blastic phase (ABP) where the leukemic process acquires the characteristics of acute leukemia. The ABP usually lasts some months and terminates with the death of the patient3. The frequency of CML in western countries ranges between 10 and 15 per million persons (age - standardized). It is rare in children. The median age is 55 years. Current treatment of CML includes conventional chemotherapy, allogeneic bone marrow transplantation (allo BMT), alpha-interferon (alpha-IFN)and imatinib. #Intervention - DRUG : Bortezomib	#Eligibility Criteria: Inclusion Criteria for chronic phase patients : * Age >=18 years * Ph positive * Absence of a CHR after 3 months on imatinib * Loss of a previously obtained CHR on imatinib alone * Absence of a CCgR within 12 months on imatinib alone * Loss of a previously obtained CCgR on imatinib alone * Written informed consent Exclusion Criteria for chronic phase patients : * Age <18 * Performance status (ECOG/WHO) > 2 (see Appendix 2) * Inability to provide written informed consent * Pregnancy * Accelerated or blastic phase * Formal refusal of any recommendation of a safe contraception * Alcohol or drug addiction * Altered hepatic or renal function as defined by AST/ALT or bilirubin > 3 times upper normal limits (UNL) * Serum creatinine > 265 umol/l or >3.0 mg/dl * Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems. Inclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients: * Age >=18 years * Ph positive * Loss of a previous hematological response to imatinib alone, with further progression to ABP (see section 14 for definitions) * Performance status (ECOG/WHO) * Written informed consent Exclusion criteria for accelerated and blastic phase or acute lymphoblastic leukemia Ph+ patients: * Age <18 * Performance status (ECOG/WHO) > 2 (see Appendix 2) * Inability to provide written informed consent * Pregnancy * Chronic Phase disease * Formal refusal of any recommendation of a safe contraception * Alcohol or drug addiction * Altered hepatic or renal function as defined by AST/ALT or bilirubin > 3 times upper normal limits (UNL) * Serum creatinine > 265 umol/l or >3.0 mg/dl * Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No	NCT00511069	{ "brief_title": "Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia", "conditions": [ "Leukemia" ], "interventions": null, "location_countries": [ "Italy" ], "nct_id": "NCT00511069", "official_title": "A Phase II Study of Velcade (Bortezomib - PS341) in the Treatment of Patients Over 18 Years With Ph+ Leukemia", "recruitment_information": { "primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-02", "study_completion_date(actual)": "2008-02", "study_start_date(actual)": "2006-07" }, "study_design": { "allocation": "NON_RANDOMIZED", "interventional_model": "SINGLE_GROUP", "masking": "NONE", "phase": [ "PHASE2" ], "primary_purpose": "TREATMENT", "study_type": "INTERVENTIONAL" }, "study_record_dates": { "study_record_updates": { "last_update_posted(estimated)": "2008-11-24", "last_updated_that_met_qc_criteria": "2007-08-02", "last_verified": "2008-11" }, "study_registration_dates": { "first_posted(estimated)": "2007-08-03", "first_submitted": "2007-08-02", "first_submitted_that_met_qc_criteria": null } } }

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