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#Study Description
Brief Summary
According to the recommendations of French and international learned societies, respiratory rehabilitation is part of the care of patients with Chronic Obstructive Pulmonary Disease (COPD). Indeed, scientific work carried out for more than 10 years on the respiratory rehabilitation of patients suffering from COPD shows that respiratory rehabilitation allows a reduction of the handicap caused by the disease and an improvement in the quality of life of the patients.
A respiratory rehabilitation program (PRR) includes: individual exercise re-training, therapeutic education, respiratory physiotherapy, help with smoking cessation and nutritional and psychosocial care. Exercise retraining includes training the muscles of the lower limbs in endurance and strength combined with training the muscles of the upper limbs. Strengthening the upper limbs helps reduce dyspnea in patients with COPD. In order to determine a precise muscle building protocol, it is necessary to assess at the start of the program the maximum voluntary strength (FMV) of the different muscle groups of the upper limbs. Measuring FMV quantifies a possible frequent strength deficit in patients with COPD and the effects of the strengthening program. Currently, tests to assess FMV using isokinetic dynamometers are used as a benchmark. However, this material is little used in current practice. Portable dynamometers are used to perform simple tests and to obtain muscle strength measurements. However, the reliability of the maximum voluntary force measurements of the different muscle groups of the upper limb has not been evaluated. Studies seem necessary to determine the reproducibility of the measurement in intra and inter-examiner (Schrama 2014) and to assess its sensitivity to change during a respiratory rehabilitation program. The objectives of this study are to study the reproducibility, validity and sensitivity to change of the measurement of FMV using a portable dynamometer.
#Intervention
- OTHER : pulmonary rehabilitation
- the strength' measure of the deltoids, triceps and brachial biceps will be carried out by another technique: the 1-RM technique (with dumbbells);
- 2 other times, the strength' measure of the deltoids, triceps and brachial biceps will be carried out by handheld dynaometry. | #Eligibility Criteria:
Inclusion Criteria:
* Patient with COPD stages 2 to 4 (A to D) admitted to the pulmonary rehabilitation unit of Centre Hospitalier des Pays de Morlaix (4 weeks)
* Patient able to consent and having signed a consent form
* Patient 18 years or older
Exclusion Criteria:
* Patient with pain, arthritis, prosthetics, shoulder or elbow surgery.
* Patient with a history of pneumonectomy, lobectomy less than 6 months old
* Refusal to participate
* Patient with an inability to follow a full respiratory rehabilitation program
* Patient under guardianship or curatorship
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
| NCT04341753 | {
"brief_title": "Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures in Patients With COPD",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Other: pulmonary rehabilitation"
],
"location_countries": [
"France"
],
"nct_id": "NCT04341753",
"official_title": "Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures With Handheld Dynamometer, in Patients With COPD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-09",
"study_completion_date(actual)": "2021-09-09",
"study_start_date(actual)": "2020-09-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-16",
"last_updated_that_met_qc_criteria": "2020-04-09",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-10",
"first_submitted": "2020-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.
Detailed Description
Azithromycin is an antibiotic that has been shown to improve lung function in patients with cystic fibrosis (CF) whose lungs are infected with a bacterium called Pseudomonas aeruginosa. Scientists are not sure how azithromycin works in cystic fibrosis. It does not appear to work by killing the bacteria Pseudomonas aeruginosa, but it may make these bacteria and other bacteria less damaging to the lungs by reducing their ability to attach to the lining of the lung, or by reducing the bacteria's ability to make substances that damage the lungs of patients with cystic fibrosis. Azithromycin may also work directly on the cells in the lungs to improve lung function. This could occur by reducing inflammation (swelling) in the lungs, and/or making the mucus less sticky, or by affecting the salt channel that doesn't function correctly in CF. If azithromycin works in one or more of these ways; it may also be effective in improving lung function in cystic fibrosis patients who are not infected with Pseudomonas aeruginosa.
We are conducting this research study to examine the safety, effect on lung function and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin. This study is designed to determine if patients with cystic fibrosis whose lungs are not infected with the bacteria Pseudomonas aeruginosa will benefit from 24 weeks of treatment with the antibiotic azithromycin. Benefit will be determined as having better pulmonary function tests and getting sick less often compared to a placebo (sugar pill). This study is also designed to determine if azithromycin is safe when administered for 24 weeks to cystic fibrosis patients not infected with Pseudomonas aeruginosa. By doing this study, we hope to learn more about CF and improve the way in which we treat it.
Comparison: Three times weekly azithromycin tablets added to standard care, compared to three times weekly placebo tablets added to standard care.
#Intervention
- DRUG : azithromycin 250 mg tablets
- * One (1) tablet three times weekly for patients who weigh 40-79 lbs
* Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs
- Other Names :
- Zithromax
- DRUG : placebo tablets
- * One (1) tablet three times weekly for patients who weigh 40-79 lbs
* Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs
- Other Names :
- inactive pill | #Eligibility Criteria:
Inclusion Criteria:
* Male or female, 6 <= age <= 18 years at enrollment
* Confirmed diagnosis of CF
* Written informed consent (and assent when applicable)
* Clinically stable at enrollment as assessed by the site investigator
* FEV1 % predicted > 50%
* Ability to comply with medication use, study visits, and study procedures
* Ability to swallow a 250 mg tablet
Exclusion Criteria:
* Weight less than 18.0 kg
* Respiratory culture positive for P. aeruginosa, NTM, or B. cepacia complex within 1 year or at screening, or AFB positive at screening
* Allergy to macrolide antibiotics
* Use of macrolide antibiotics (e.g., azithromycin, clarithromycin) within 60 days of screening
* Use of systemic corticosteroids or intravenous or oral antibiotics within 14 days of screening
* Initiation of high dose ibuprofen, Pulmozyme®, hypertonic saline or aerosolized antibiotics within 30 days of screening
* Chronic therapy with drugs known to have rare but serious interactions with azithromycin: amiodarone, digoxin, disopyramide, lovastatin, pimozide, rifabutin, and nelfinavir
* Investigational drug use within 30 days of screening
* Laboratory abnormalities (creatinine, liver function or neutropenia) at screening and confirmed at follow-up testing prior to randomization
* History of biliary cirrhosis, portal hypertension, or splenomegaly, or splenomegaly on physical exam
* History of ventricular arrhythmia
* Other major organ dysfunction, excluding pancreatic dysfunction
* History of lung transplantation or currently on lung transplant list
* Relative decrease in FEV1 % predicted >= 20% between the screening and enrollment visit
* Positive serum pregnancy test at screening
* Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study
* History of alcohol, illicit drug or medication abuse within 1 year of screening in the judgment of the site investigator
* Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00431964 | {
"brief_title": "Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa",
"conditions": [
"Cystic Fibrosis"
],
"interventions": [
"Drug: azithromycin 250 mg tablets",
"Drug: placebo tablets"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00431964",
"official_title": "Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2007-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-19",
"last_updated_that_met_qc_criteria": "2007-02-02",
"last_verified": "2015-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-02-06",
"first_submitted": "2007-02-02",
"first_submitted_that_met_qc_criteria": "2015-07-24"
}
}
} |
#Study Description
Brief Summary
This phase II trial studies how well regorafenib works together with methotrexate in treating participants with metastatic non-squamous non-small cell lung cancer with tumors that harbor a KRAS mutation. Regorafenib is a targeted therapy that works on different cancer pathways to stop the growth of tumor cells and stop them from spreading. Methotrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving regorafenib and methotrexate together may work in treating participants with KRAS mutated non-small cell lung cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the progression free survival (PFS) of the combination of regorafenib and methotrexate for metastatic KRAS mutated non-small cell lung cancer (NSCLC) patients who have received at least 1 prior systemic therapy.
SECONDARY OBJECTIVES:
I. To determine the objective response rate (ORR) of the combination of regorafenib and methotrexate for metastatic KRAS mutated NSCLC patients who have received at least 1 prior systemic therapy.
II. To determine the disease control rate (DCR) at 8 weeks of the combination of regorafenib and methotrexate for metastatic KRAS mutated NSCLC patients who have received at least 1 prior systemic therapy.
III. To determine the safety of the combination of regorafenib and methotrexate in metastatic KRAS mutated NSCLC patients who have received at least 1 prior systemic therapy, assessed as the number of subjects that experience a treatment-emergent adverse event.
IV. To determine the safety of the combination of regorafenib and methotrexate in metastatic KRAS-mutated NSCLC patients who have received at least 1 prior systemic therapy, assessed as the number (percent) of participants experiencing any dose-limiting toxicity (DLT).
V. To determine the pharmacokinetic parameters of methotrexate when combined with regorafenib (i.e., trough and maximum serum concentration \[Cmax\]).
OUTLINE:
Participants receive regorafenib orally (PO) once daily (QD) and methotrexate PO twice weekly with 2-3 days apart on a 3 week on / 1 week off schedule. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants will come in for an end of study treatment visit.
#Intervention
- DRUG : Methotrexate
- Given PO
- Other Names :
- Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039
- OTHER : Pharmacokinetic Study
- Correlative studies
- Other Names :
- PHARMACOKINETIC, PK Study
- DRUG : Regorafenib
- Given PO
- Other Names :
- BAY 73-4506, Stivarga | #Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic confirmed diagnosis of non-squamous non-small cell lung cancer that is recurrent or metastatic.
* Documentation of pathogenic KRAS mutation
* Previous receipt of at least one systemic therapy for recurrent or metastatic disease OR previous receipt of adjuvant systemic therapy within 6 months of enrollment; there is no limit on number of prior therapies allowed
* Prior systemic therapy must be completed within 2 weeks of study treatment, with either improvement of clinically significant treatment-related toxicities to grade 0 <= age <= 1 OR stabilized to a new baseline
* Previously treated OR asymptomatic non-progressing < 1 cm untreated brain metastases are allowed
* Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
* Ability to understand and the willingness to sign a written informed consent document
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Absolute neutrophil count (ANC) >= 1500/mm^3
* Platelet count >= 100,000 /mm^3
* Hemoglobin (Hb) >= 9 g/dL
* Serum creatinine <= 1.5x upper limit of normal (ULN) OR calculated (Cockcroft Gault formula) or measured creatinine clearance >= 50 mL/min for patients with creatinine levels > 1.5x ULN
* Total bilirubin <= 1.5x ULN OR direct bilirubin <= ULN for patients with total bilirubin levels > 1.5x ULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3x ULN (<= 5x ULN for patients with liver involvement of their cancer)
* Must be able to swallow and retain oral medication
* Women patients of childbearing potential and men patients with women partners of childbearing potential must agree to use adequate contraception or agree to abstain from heterosexual activity beginning at the time of signing informed consent until at least 3 months after the last dose of study treatment; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not considered childbearing
Exclusion Criteria:
* Previously treated with regorafenib
* Known allergy to regorafenib or methotrexate
* Currently receiving another systemic standard or investigational anti-cancer therapy; prior investigational therapy must be completed within 4 half-lives (if known) or 2 weeks, whichever is longer; the maximal washout of investigational therapy will not exceed 4 weeks prior to study treatment; bone medications such as bisphosphonates and receptor activator of nuclear factor kappa-Β (RANK) ligand inhibitors permitted
* Leptomeningeal disease as documented by cerebrospinal fluid (CSF) cytology
* Clinically significant cardiovascular related disease including:
* Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mmHg on repeated measurements, i.e., 3 or more separate days within one week) despite optimal medical management
* Congestive heart failure - New York Heart Association (NYHA) class III or greater
* Active coronary artery disease (i.e., unstable or new onset angina within 3 months of study treatment; myocardial infarction within 6 months of study treatment)
* Clinically significant cardiac arrhythmias other than atrial flutter/fibrillation
* Stroke, including transient ischemic attacks, within 6 months of study treatment
* Other clinically significant arterial events, except for controlled asymptomatic pulmonary embolism, within 6 months of study treatment
* Clinically significant hemorrhage or bleeding event within 1 month of study treatment
* Uncontrolled symptomatic pleural effusion or ascites
* Known active additional malignancy that is undergoing or expected to undergo systemic treatment during duration of study participation
* Known history of human immunodeficiency virus (HIV) infection or known current active hepatitis B (i.e., hepatitis [Hep] B deoxyribonucleic acid [DNA] positive in prior 3 months) or hepatitis C infection (i.e., Hep C ribonucleic acid [RNA] positive in prior 3 months)
* Major surgical procedure (e.g., involving the opening of a major body cavity) within 4 weeks of study treatment; this does not apply to low risk procedures (i.e., thoracentesis; paracentesis; chest tube / PleurX catheter placement; line placement; needle biopsy of tumor; and bronchoscopy)
* Presence of a clinically significant non-healing wound, non-healing ulcer, or bone fracture
* Concomitant therapy required at time of first dose of study treatment, including:
* Strong CYP3A4 inhibitors and CYP3A4 inducers
* Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors, and probenecid
* Women who are pregnant or breast feeding
* Any condition which, in the investigator's opinion, including substance abuse, medical, psychological or social conditions that makes the patient unsuitable for trial participation or may interfere with the patient's participation in 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
| NCT03520842 | {
"brief_title": "Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer",
"conditions": [
"KRAS Gene Mutation",
"Metastatic Malignant Neoplasm in the Brain",
"Recurrent Non-Small Cell Lung Carcinoma",
"Stage IV Non-Small Cell Lung Cancer AJCC v7"
],
"interventions": [
"Drug: Regorafenib",
"Drug: Methotrexate",
"Other: Pharmacokinetic Study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03520842",
"official_title": "Study of Regorafenib in Combination With Oral Methotrexate for KRAS Mutated Non-Small Cell Lung Cancer (NSCLC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-15",
"study_completion_date(actual)": "2022-06-15",
"study_start_date(actual)": "2018-08-14"
},
"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)": "2023-08-01",
"last_updated_that_met_qc_criteria": "2018-04-26",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-11",
"first_submitted": "2018-04-18",
"first_submitted_that_met_qc_criteria": "2023-07-12"
}
}
} |
#Study Description
Brief Summary
The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.
Detailed Description
Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months
#Intervention
- DRUG : Autologous Bone Marrow Aspirate Concentrate
- Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees.
- DRUG : Sterile saline
- Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee. | #Eligibility Criteria:
Inclusion Criteria:
* Male and Female subjects are both eligible
* Subjects must be 18 years or older
* Subjects must have bilateral OA and pain in both knees.
* Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1 <= age <= 3.
* Subjects must have previously tried 6 weeks of one of the following conservative treatments Activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
* Patients can provide written informed consent after the nature of the study is fully explained
Exclusion Criteria:
* Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
* Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
* Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
* Patients receiving injections to the treated knee within 2 months prior to study entry.
* Patients who are pregnant or currently breast-feeding children.
* Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
* Patients with ongoing infectious disease, including HIV and hepatitis
* Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
* Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
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:
Yes
| NCT01931007 | {
"brief_title": "Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis",
"conditions": [
"Bilateral Primary Osteoarthritis of Knee"
],
"interventions": [
"Drug: Autologous Bone Marrow Aspirate Concentrate",
"Drug: Sterile saline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01931007",
"official_title": "Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study",
"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)": "2013-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-05",
"last_updated_that_met_qc_criteria": "2013-08-26",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-29",
"first_submitted": "2013-08-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.
Detailed Description
Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.
#Intervention
- PROCEDURE : Foraminal enlargement
- After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. | #Eligibility Criteria:
Inclusion Criteria:
* Mature permenent teeth having pulpal necrosis and apical periodontitis.
Exclusion Criteria:
* Systemic disorders
* Diabetes
* Pregnancy
* < 18 years
* Immunocompromised
* Patients who had taken antibiotics in the past 1 month
* Patients who had a positive history of analgesic use within the past 3 days
* Previously accessed teeth
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02770053 | {
"brief_title": "Foraminal Enlargement and Postoperative Pain.",
"conditions": [
"Pain Postoperative"
],
"interventions": [
"Procedure: Foraminal enlargement"
],
"location_countries": null,
"nct_id": "NCT02770053",
"official_title": "Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-31",
"last_updated_that_met_qc_criteria": "2016-05-11",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-12",
"first_submitted": "2016-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The etonogestrel subdermal implant has been available worldwide for more than 15 years. The action of etonogestrel subdermal implant is principal via suppression of ovulation, but it also has effects on cervical mucus and in some women induces suppression of endometrial proliferation. Several studies have confirmed its high efficacy and convenience. The uterine bleeding problems and in particular irregular bleeding and amenorrhea are major side effects of etonogestrel subdermal implant. A considerable number of patients request early removal due to bleeding changes. Amenorrhea occurs in about 22% in etonogestrel subdermal implant users. Despite the presence of many studies that reported the prevalence of etonogestrel subdermal implant-associated bleeding, little is known about the predictive factors affecting menstrual bleeding patterns especially amenorrhea after etonogestrel subdermal implant insertion. These predictive factors should be provided prior to the etonogestrel subdermal implant insertion which may improve acceptance and continuation of etonogestrel subdermal implant.
#Intervention
- DEVICE : Implanon NXT
- women will be subjected to etonogestrel 68 mg implant insertion. Participants will be trained on how to fill the menstrual diary. The menstrual diary includes information about days of bleeding and spotting days.
- Other Names :
- Etonogestrel subdermal implant | #Eligibility Criteria:
Inclusion Criteria:
* Women aged between 18 and 40 years.
* Women who are not lactating.
* Non-pregnant women
* Women have regular menstrual cycles every 21 <= age <= 35 days with a typical cycle length variation of no more than 5 days.
* Women who will ESI only for pregnancy prevention for at least 12 months.
* Have not any medical or gynecologic problems.
Exclusion Criteria:
* Women with any contraindications for progesterone-only contraception in accordance with WHO eligibility criteria.
* Refuse participation in the study.
Sex :
FEMALE
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
| NCT05040282 | {
"brief_title": "The Amenorrhea With Etonogestrel Implant",
"conditions": [
"Contraception"
],
"interventions": [
"Device: Implanon NXT"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05040282",
"official_title": "The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-01",
"study_completion_date(actual)": "2023-09-01",
"study_start_date(actual)": "2021-10-01"
},
"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)": "2023-10-16",
"last_updated_that_met_qc_criteria": "2021-09-03",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-09-10",
"first_submitted": "2021-08-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.
#Intervention
- DRUG : Deferasirox
- 10 mg/kg or 30 mg/kg orally daily
- DRUG : Deferasirox
- 5 mg/kg or 30 mg/kg orally daily | #Eligibility Criteria:
Inclusion Criteria:
* Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
* Patients currently participating in the food-effect sub-study, according to amendment 3.
* Ability to provide written informed consent prior to participation in this non-comparative extension study.
* Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
* Body weight of at least 35 kg.
Exclusion Criteria:
* Pregnant or breastfeeding patients.
* History of non-compliance to medical regimens and patients who are considered potentially unreliable.
* Proteinuria > 300 mg/L second void morning urine.
* Patients with serum creatinine above the upper limit normal.
Other protocol-defined inclusion/exclusion criteria may apply.
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
| NCT01033747 | {
"brief_title": "Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study",
"conditions": [
"Liver Iron Overload"
],
"interventions": [
"Drug: Deferasirox"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT01033747",
"official_title": "A 5-year Open Label, Non-comparative Extension to a Randomized, Open-label, Phase IIa Study to Evaluate Safety, Tolerability and the Effects on Liver Iron Concentration of Repeated Doses of 10 and 20 mg/kg/Day of Deferasirox in Comparison With 40 mg/kg/Day Deferoxamine in Patients With Transfusion-dependent Iron Overload",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-01",
"study_completion_date(actual)": "2008-01",
"study_start_date(actual)": "2003-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-08-11",
"last_updated_that_met_qc_criteria": "2009-12-15",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-12-16",
"first_submitted": "2009-10-16",
"first_submitted_that_met_qc_criteria": "2011-07-18"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
#Intervention
- DEVICE : DES Limus Carbostent
- DES Limus Carbostent Carbofilm Coated Coronary Stent
- DEVICE : Taxus Liberté Stent
- Taxus Liberté Coronary Stent | #Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Patient is eligible for percutaneous coronary intervention (PCI) and for surgical revascularization (CABG)
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site
* Patients with clinical evidence of ischemic heart disease and/or a positive functional study(e.g. stress test); documented stable (CCS I-IV) or unstable angina pectoris (Braunwald class I-II B and C) or documented silent ischemia
* LVEF>30%
* Requires treatment of a single de novo lesion in a native coronary artery in one or two different major epicardial vessels (LAD, LCX or RCA). The second lesion must fit with inclusion/exclusion criteria and must be treated with the same study stent as the first lesion
* Target lesion should be located in a target vessel with a diameter ranging from 3.0 to 3.75 mm
* Target lesion diameter stenosis > 50% and < 100% by visual estimate, with a TIMI flow of >= 1
* The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm). Any occurred dissection of the target vessel must be treated with an additional stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm)
* Patient that underwent BMS implantation more than 6 months before the enrolment or DES implantation more than 1 year before the enrolment in an other vessel.
Exclusion Criteria:
* Female with childbearing potential or lactating
* Known sensitivity to sirolimus, paclitaxel, the polymeric matrix, stainless steel or cobalt chromium
* Acute Q-wave or non Q-wave myocardial infarction within 72 hours, or presents with CK elevation greater than 2 times upper limit normal associated with elevated CK-MB
* Cardiogenic shock
* Cerebrovascular accident within the past 6 months
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl)
* Contraindication to aspirin or clopidogrel
* Thrombocytopenia (platelet count less than 100,000/mm³)
* Active gastrointestinal bleeding within the past 3 months
* Known bleeding or hypercoagulable disorder
* Prior anaphylactic reaction to contrast agents or contrast sensitivity that cannot be controlled with pre-medication
* Currently under immunosuppressant therapy
* Currently, or has been treated with either Rapamune or paclitaxel within 12 months of the procedure
* Active infection
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study
* Patient underwent coronary revascularization to any vessel within 30 days
* Patient underwent target vessel revascularization within 6 months
* Target vessel has had prior stent placement
* Presence of two lesions located in the same vascular territory (same major epicardial vessel)
* Prior coronary brachytherapy
* There is a planned target lesion treatment with any technique other than the pre-dilatation balloon angioplasty
* Treatment of more than two lesions is required at the time of enrolment, or is planned within 30 days following enrolment
* Any planned surgery within 6 months after index procedure
* Left main disease greater than 50% diameter stenosis
* Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off
* Heavily calcified vessel and/or lesion which cannot be successfully predilated
* Target lesion is located or supplied by an arterial or venous bypass graft
* Ostial target lesion or lesion located within 2 mm of a bifurcation
* Target lesion involves a side branch >2.0 mm in diameter with an ostial disease
* Target lesion has TIMI 0 flow
* Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.
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
| NCT01373502 | {
"brief_title": "International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions",
"conditions": [
"Stable Angina",
"Unstable Angina",
"Documented Silent Ischemia"
],
"interventions": [
"Device: Taxus Liberté Stent",
"Device: DES Limus Carbostent"
],
"location_countries": [
"France",
"Germany",
"Italy",
"Belgium"
],
"nct_id": "NCT01373502",
"official_title": "International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-04",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2009-10"
},
"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)": "2018-04-30",
"last_updated_that_met_qc_criteria": "2011-06-14",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-15",
"first_submitted": "2010-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary purpose of this study is to investigate whether audiovisual distraction can lead to a reduction in standard of care administered intraoperative propofol consumption compared to those who receive propofol sedation alone in adults having total hip or knee replacement surgery under spinal anesthesia.
Detailed Description
The perioperative period is often anxiety-provoking experience for many of our patients. Pain and awareness are the two primary concerns voiced most frequently. For total knee and hip replacement surgery, we offer our patients a spinal anesthetic which produces complete sensory blockade below the level of the waist. Despite a completely insensate knee or hip, patients still desire sedation during the surgery in order to remain unaware of their surgical surroundings. Propofol is commonly used in these monitored anesthesia care procedures because of its favorable drug profile. However, we have observed that anesthesia providers often use high infusion rates of propofol in order to achieve 'adequate patient comfort'. In this scenario, providers are often left with the dilemma of providing deeper levels of sedation for a pleasant patient experience and dealing with the potential cardiorespiratory complications that follow from oversedation. Unwanted side-effects include respiratory depression, airway obstruction and hypotension. Clinicians have began looking for other non-pharmacological ways to provide safe anxiolysis in the operating room while avoiding these undesirable side-effects.
Previous studies have shown that audiovisual distraction (AVD) can reduce stress and anxiety during the perioperative period. In 1997, Ganapathy et al. examined the use of sedative medications in elderly patients undergoing orthopedic procedures under spinal anesthesia. They compared patient-controlled propofol administration and anesthesiologist-controlled midazolam and fentanyl administration.This study found that there were no differences in patient satisfaction between the two groups. The secondary outcomes did show that propofol consumption was associated with significantly more episodes of brief respiratory rate depression but did not increase the need for emergency airway interventions.1
Ayoub et al studied propofol consumption in patients undergoing orthopedic procedures under spinal anesthesia using auditory distraction. This study demonstrated that auditory distraction decreased the amount of propofol consumed in patients using auditory distraction compared to those who had propofol sedation alone.2
Lee et al. began to shift the paradigm of medication induced anxiolysis and pain control during painful procedures through a series of studies examining different forms of distraction. An initial study conducted by this group confirmed that audio distraction during stimulating procedures (colonscopies) reduced the amount of propofol required. In 2003, they combined audio and visual distraction in patients undergoing and compared the dosages of propofol required to patients having only visual distraction or no distraction. This study found that patients with both audio and visual distraction required significantly less propofol than patients receiving visual distraction or patient-controlled sedation alone. Other key findings in the AVD group included reduced procedure time, a greater willingness by the patient to repeat the procedure under the same circumstances, and a statistically significant higher satisfaction score with the process.3
None of these studies has attempted to evaluate a possible reduction in propofol consumption for patients having a spinal anesthetic with both audio and visual distraction. We believe the next step to improving the perioperative experience for our patients is to incorporate AVD for patients having total knee and hip replacement surgery under a spinal anesthetic. Our hypothesis is that AVD will significantly reduce standard of care administered propofol consumption while still providing a pleasant experience for our patients and reducing unwanted side-effects associated with higher levels of propofol sedation.
#Intervention
- OTHER : Audiovisual Distraction
- The interventional group will be given audiovisual equipment. An Apple iPad will be attached to a Mayo stand and placed approximately 12-15 inches from the patient's face. Noise canceling headphones will be connected to the iPad. A movie of the subject's choosing will be shown on the iPad with a comfortable level of sound. | #Eligibility Criteria:
Inclusion Criteria:
* Adults >18 years having a
* Primary total hip or knee arthroplasty
* Surgery under a spinal anesthetic
Exclusion Criteria:
* ASA status >3
* parturients
* documented hearing or vision loss
* chronic opioid use (>30mg PO MEQ daily for >1 month)
* diagnosis of OSA, contraindications to spinal (coagulopathy, infection, spinal hardware)
* non-English speaking
* current history of substance abuse
* schizophrenia
* generalized anxiety disorder
* Alzheimer's disease
* other dementia
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
| NCT03191838 | {
"brief_title": "Audiovisual Distraction for Patients Undergoing Total Knee or Hip Replacement Surgery",
"conditions": [
"Anesthesia"
],
"interventions": [
"Other: Audiovisual Distraction"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03191838",
"official_title": "Audiovisual Distraction Versus Propofol Sedation for Patients Undergoing Total Knee or Hip Replacement Surgery Under Spinal Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-01",
"study_completion_date(actual)": "2020-06-01",
"study_start_date(actual)": "2017-11-01"
},
"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)": "2020-08-11",
"last_updated_that_met_qc_criteria": "2017-06-16",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-19",
"first_submitted": "2017-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Post diarrheal hemolytic and uremic syndrome (D+HUS) is the first etiology of acute renal failure in children less than 5 years old in France. Previous works highlighted a mortality rate of 2 % and a prevalence of renal sequelae at one year after D+HUS onset in 25 % of patients D+HUS is a consequence of a gastrointestinal infection with shiga toxin (Stx) producing E.coli (STEC). The most frequent straight is E.coli O157H7. The sequence of STEC induced HUS is now well known. Typically, digestive symptoms appear five days following STEC ingestion. STEC colonize the intestinal mucosa, adhere to the enterocyte and cause a typical attaching/effacing lesion and inflammation. Then, diarrhea and vomiting occurred. D+HUS occurs in about 10% of patients and is a consequence of Stx systemic absorption. Indeed, Stx are released in the gastrointestinal tract, then after transferred to the systemic circulation. At the cellular level, Stx binds the globotriosylceramide (Gb3Cer) localized at the surface of the endothelial and epithelial cells of target organs. Following binding to Gb3Cer, the A subunits of Stx are internalized and trigger the activation of the apoptotic program leading to cell death. In addition, Stx are also able to enhance the production and the release of pro inflammatory factor (IL-1, TNFα, IL-6). Cytokines locally produced by Stx-stimulated cells can amplify the inflammatory processes and the prothrombotic state leading to the constitution of the microangiopathic lesions of HUS. To this day, management of D+HUS involves supportive care mainly based on fluid management, dialysis and red blood cells transfusions. Specific therapies used in D+HUS (plasma infusion, antithrombotic and anti inflammatory agents) failed to improve the course of D+HUS. The use of antibiotics remains not recommended while meta-analysis clearly showed that the use of bactericidal antibiotics could worse the course of D+HUS. In vitro experimentations highlighted that some classes of antibiotics like fluoroquinolones dramatically increase the production and the release of Stx before bacterial lysis and worsen the outcome of D+HUS in animal models. By contrast, azythromycin, a bacteriostatic antibiotic of the macrolides family blocking the protein synthesis in bacteria, has a strong inhibitory effect on Stx production and release by STEC as well as it inhibits the in vitro growth of STEC strains. In addition, azithromycin is able to inhibit the Stx-induced production of inflammatory cytokines which are considered to be essential for the development of D+HUS. Consistently the use of azithromycin in animal models of D+HUS dramatically improved the survival rate. Preliminary data on humans with D+HUS treated with azithromycin highlighted a lower prevalence of severe gastrointestinal involvement than in control patients. All these data supported the hypothesis that azithromycin should have a beneficial effect on D+HUS and should improve the short and long term outcome and deserves to be formally demonstrated in human with D+HUS.
Detailed Description
Hemolytic uremic syndrome (HUS) is defined by the combination of microangiopathic hemolytic anemia, thrombocytopenia and acute renal failure. The underlying lesion is thrombotic microangiopathy (TMA) affecting arteriole and capillary walls, with endothelial cells swelling and detachment and thrombi obstructing vascular lumina. Post- diarrheal HUS (D+HUS) is induced by an infection due to E. coli (STEC) producing a Shiga -like toxin (Stx) which is responsible of TMA. Serotype O157:H7 represents 63-97 % of STEC causing D+HUS. Other serotypes frequently implicated in outbreaks are O26:H11, O103:H2, O111:H8, O145:H28 (Mariani - Kurkdjian P et al, 2001) (Espié et al, 2008).
The D+HUS mainly affects children under 3 years and occurs after a prodromal bloody diarrhea. The onset of HUS surrounds 3 to 5 days after the onset of diarrhea. D+HUS is the leading cause of acute renal failure in children under 5 years (Decludt et al. 2000).
In France, 100 to 120 pediatric cases of D+HUS are reported each year. STEC infection was demonstrated in 85 % of cases. In 50 % of cases, one or more persons of the same family have STEC diarrhea without HUS. The death rate in the acute phase is about 2% and 50% of D+HUS requires dialysis. The predictive factors of a poor outcome are an anuria for more than 8 days a neutrophil count\>20000/mm3, a severe bowel disease or central nervous system (CNS) involvement (Scheiring et al. 2008). In 65-80 % of cases, a seemingly ad integrum recovery of renal function was observed within the first year after D + HUS onset. However, D+HUS is responsible for a nephron loss that could lead to hypertension, proteinuria and chronic renal failure in the long term. A study performed on 218 patients undergoing D+HUS in the chidhood, highlighted the presence of renal sequelae in nearly 65 % of them with a median follow-up of nearly 20 years. (Fila et al, submitted).
Classically, humans are infected by contaminated food (minced meat undercooked products, unpasteurized milk and cheese...), by the animal environment (especially cattle) or by transmission from person to person. EHEC virulence is associated with the presence of toxins called Shigatoxins (Stx) and the presence of the eae gene, responsible for damage attachment - clearing in the colon and caecum. Two major types of Shigatoxin, Stx1 and Stx2, and many Stx1 or Stx2 variants were identified: three variants for Stx1 and at least, six variants for Stx2. The determination of different profiles variants Stx is considered as predictive of the severity of STEC infections with progression to HUS, especially Stx2d activated and Stx2c After ingestion of contaminated food, STEC are able to withstand the acidity of the stomach and colonize the digestive tract. Toxins produced by the bacteria go through the intestinal epithelium, join the circulatory system and reach their target organs, mainly kidneys and CNS. Indeed, toxins bind to a specific glycolipid receptor, globotriosylceramide (Gb3) on the surface of endothelial cells of target organs (digestive tract, kidney, CNS, pancreas) driving on the one hand, the release of pro-inflammatory factors (TNF- α, IL6, IL8) involved in the formation of lesions of microangiopathy and leading to apoptosis of the target cells (Hurley et al. 2001) (Thorpe et al, 1999) (Zoja et al.2010).
To this day, management of D+HUS requires only supportive care. All specific therapies (antithrombotic and anti inflammatory agents, specific antibodies against Shigatoxin, plasma transfusion and plasma exchange) did not show efficacy (Scheiring et al. 2008) (Loirat et al. 2012).
Several retrospective and prospective studies suggest that antibiotics increase the risk of HUS by release of Stx during bacterial lysis but also to certain types of antibiotics, increased synthesis of Shiga toxin. The meta-analysis performed by Wang et al on the use of antibiotics in patient with STEC diarrhea and D+HUS highlighted an increased risk of developing D+HUS in patients treated with antibiotics (Wang et al. 2000). A second meta-analysis bringing together 20 studies, that compared the risk of HUS occurrence in patients with STEC diarrhea treated or not with antibiotics, has not concluded (Panos et al. 2006). According to these results, antibiotherapy is actually not recommended for patients with diarrhea EHEC and patients with D+HUS (Scheiring et al. 2008). However, these studies did not distinguish between different classes of antibiotics, bringing together all the bacteriostatic antibiotics as well as bactericidal. But, in vitro studies have clearly shown that certain classes of antibiotics such as quinolones induced the production of Shigatoxin (multiplying production by a factor of 100 for ciprofloxacin) while others had a strong inhibitory action as the azithromycin (Ohara et al. 2002 ) .
Azithromycin, an antibiotic of the macrolide family, binds to the 50S subunit of the bacterial ribosome and inhibits protein synthesis by blocking transpeptidation. This mechanism inhibits the production and the release of Shiga toxin in STEC (Ohara et al. 2002). Studies on animal models of D+HUS (mice, piglet) showed a drastic reduction in mortality. Moreover, in addition to its inhibitory action on the synthesis of Stx, azithromycin has a modulating effect on the inflammatory reaction on the vascular endothelium induced by the Shigatoxin that contribute to thrombotic microangiopathy. Indeed, azithromycin dramatically decreased secretion of IL6, IL1 and TNFα (Gantzhorn et al. 2009) (Ohara et al. 2002) (Zhang Q et al. 2009).
Moreover, a recent work from Amran et al performed in a mouse model of D+HUS highlighted a protective effect of azithromycin on the occurrence of neurological inhibition of inflammatory mechanism induced by Shigatoxin in the vascular endothelium brain and neurons (Amran et al. 2013).
On the human being, the German outbreak of D+HUS in O104H4 helped highlight the importance of an early treatment with azithromycin on the eradication of carriage of the bacteria as well as the eradication of Stx in stool (Nitschke et al. 2012). In addition, preliminary data from a retrospective study of D+HUS in Robert Debré hospital showed a lower incidence of severe digestive tract impairment in patients with D+HUS who received treatment with azithromycin compared to the control group (unpublished data).
The objective of a prospective study on patients with D+HUS treated with azithromycin will be to prove its beneficial effects on renal, hematological, digestive tract and neurological impairment seen in D+HUS and to reduce the potential sequelae.
#Intervention
- DRUG : Azithromycin
- ZITHROMAX ® 40mg/ml solution. DCI : Azithromycin . Pfizer ® 20mg/kg dose with a maximum dose of 500mg per day for three days
- DRUG : Placebo (glucose solution 10%) | #Eligibility Criteria:
Inclusion Criteria:
* Patient aged from 6 months to 18 years, residing in France, with a D+HUS according to the definition used by the National Institute for Public Health Surveillance (InVS) :
* Renal impairment with a serum creatinine > 60μmol/l in children less than 2 years and > 75μmol/l > 2 years
* AND hemolytic anemia defined by hemoglobin < 10g/dl associated with schizocytes >= 2%
* Collection of free and informed consent of the holders of parental authority
Exclusion Criteria:
* Age < 6 months and > 18 years.
* Administration of antibiotics in the 15 days preceding the diagnosis of D+HUS.
* Personal or family history of atypical HUS .
* More than 15 days between the onset of diarrhea and the diagnosis of D+HUS.
* Hypersensitivity to azithromycin, erythromycin, or any macrolide
* patient treated with dihydroergotamine, ergotamine or cisapride
* Severe hepatic impairment
* No affiliation to a social security scheme (beneficiary or legal)
* Pregnancy
* Breastfeeding
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02336516 | {
"brief_title": "Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome",
"conditions": [
"Haemolytic and Uremic Syndrome"
],
"interventions": [
"Drug: Azithromycin",
"Drug: Placebo (glucose solution 10%)"
],
"location_countries": [
"France"
],
"nct_id": "NCT02336516",
"official_title": "Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04",
"study_completion_date(actual)": "2021-04",
"study_start_date(actual)": "2015-07"
},
"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)": "2021-10-04",
"last_updated_that_met_qc_criteria": "2015-01-08",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-13",
"first_submitted": "2015-01-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two participant populations: healthy participants and participants with mild-to-moderate Alzheimer's disease. This study is a single dose, dose-escalation, and multiple dose study comprising approximately six single dose cohorts in healthy participants administered RO7105705, either intravenously (IV) or subcutaneously (SC), and comprising one or more multiple dose cohorts in healthy participants administered RO7105705 IV every week (QW), a total of 4 doses, and one or more multiple dose cohorts in participants with Alzheimer's disease administered RO7105705 IV QW, a total of 4 doses.
#Intervention
- DRUG : Placebo
- Participants will receive single or multiple doses of RO7105705 matching placebo IV.
- DRUG : RO7105705
- Participants will receive single or multiple doses of RO7105705 IV or SC. | #Eligibility Criteria:
Inclusion Criteria:
All participants
* Total body weight between 45 and 120 kilogram (kg), inclusive
* Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and vital signs
* Clinical laboratory evaluations (including chemistry panel fasted [fasted at least 8 hours], complete blood count (CBC), and urine analysis) within the reference range for the test laboratory, unless deemed not clinically significant by the investigator
* Negative test for selected drugs of abuse at screening and at check-in
* Agreement to use highly effective contraception measures
Healthy Participants
* Ages 18 <= age <= 80 years inclusive
* No history of symptomatic cognitive decline and no concern about clinically significant cognitive impairment by the participant or by the investigator
Participants who enroll into a cohort that requires lumbar puncture
* No contraindication to lumbar dural puncture, including coagulopathy, concomitant anticoagulation, thrombocytopenia, prior lumbar spinal surgery, or other factor that precludes safe lumbar puncture in the opinion of the investigator
Participants with Alzheimer's disease
* Ages 50 <= age <= 80 years, inclusive
* The participant should be capable of completing assessments either alone or with the help of the caregiver
* Availability of a person (caregiver) who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, which require partner input for scale completion, and signs the necessary consent form
* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing
* Clinical diagnosis of probable Alzheimer's disease dementia based on National Institute on Aging-Alzheimer's Association criteria
* Screening mini-mental state examination (MMSE) score of 16 <= age <= 28 points, inclusive
* Screening Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1.0, or 2.0
* Positive florbetapir amyloid positron emission tomography (PET) scan by qualitative read
* If already taking cholinesterase inhibitor and/or memantine therapy for Alzheimer's disease, on a stable dose for at least 4 weeks prior to screening. There should be no intent to, discontinue, or alter the dose of any Alzheimer's disease therapy for the duration of the study
Exclusion Criteria:
Any participants
* Pregnant or lactating, or intending to become pregnant within 16 weeks after last dose of study drug
* Participation in a clinical trial within 30 days before randomization; use of any experimental oral therapy within 30 days or 5 half-lives prior to Day 1, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to Day 1, whichever is greater
* Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks after the last dose
* Surgery or hospitalization during the 4 weeks prior to screening
* Planned procedure or surgery during the study
* Blood transfusion within 8 weeks prior to screening
* Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: 50 <= age <= 499 milliliters (mL) of blood within 30 days or greater than (>) 499 mL of blood within 56 days prior to study drug administration
* Poor peripheral venous access
* Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
* Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
* Administration of any herbal or nutritional supplements (with the exception of standard vitamins and calcium supplements) within 7 days prior to study dose
* Past history of seizures, prior traumatic brain injury, schizophrenia, schizoaffective disorder, or bipolar disorder
* At risk of suicide in the opinion of the investigator
* Serious infection requiring oral and IV antibiotics within 30 days prior to screening
* Any serious medical condition or abnormality in clinical laboratory tests; systemically, clinically immunocompromised because of continuing effects of immune-suppressing medication
Participants with Alzheimer's disease
* History or presence of clinically evident vascular disease potentially affecting the brain
* History or presence of stroke within the previous 2 years or documented history of transient ischemic attack within the previous 12 months
* History or presence of intracranial tumor that is clinically relevant in the opinion of the investigator
* Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
* History or presence of central nervous system (CNS) or systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
* History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
* Magnetic resonance imaging (MRI) evidence of 1) more than two lacunar infarcts, 2) any territorial infarct less than (>) 1 centimeters (cm), or 3) significant fluid attenuated inversion recovery (FLAIR) hyperintense lesions in the cerebral white matter that may, in the investigator's opinion, contribute to cognitive dysfunction
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
| NCT02820896 | {
"brief_title": "A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease",
"conditions": [
"Alzheimer's Disease"
],
"interventions": [
"Drug: Placebo",
"Drug: RO7105705"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02820896",
"official_title": "A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous and Subcutaneous RO7105705 Administered in Healthy Volunteers and Patients With Mild-to-Moderate Alzheimer's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06-26",
"study_completion_date(actual)": "2017-06-26",
"study_start_date(actual)": "2016-06-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-21",
"last_updated_that_met_qc_criteria": "2016-06-29",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-01",
"first_submitted": "2016-06-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
#Intervention
- DRUG : JNJ-55308942
- JNJ-55308942 capsules will be administered orally.
- DRUG : Placebo
- Matching placebo capsules will be administered orally. | #Eligibility Criteria:
Inclusion Criteria:
* Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI)
* Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
* Have a body mass index (BMI) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive (BMI = weight/height^2)
* A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test before the first dose of study intervention
Exclusion Criteria:
* Currently meets the DSM-5 criteria for Manic Episode (ME) on the MINI
* Received transcranial magnetic stimulation (TMS), any transcranial electrical stimulation, including transcranial direct current stimulation (tDCS), vagal nerve stimulation (VNS) and/or deep brain stimulation (DBS) within 6 weeks prior to randomization
* History of moderate to severe cannabis misuse according to DSM-5 criteria within 6 months before screening
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT05328297 | {
"brief_title": "A Study of JNJ-55308942 in the Treatment of Bipolar Depression",
"conditions": [
"Bipolar Disorder"
],
"interventions": [
"Drug: Placebo",
"Drug: JNJ-55308942"
],
"location_countries": [
"Poland",
"Canada",
"Spain",
"United States"
],
"nct_id": "NCT05328297",
"official_title": "A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-17",
"study_completion_date(actual)": "2024-05-17",
"study_start_date(actual)": "2022-06-03"
},
"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)": "2025-01-13",
"last_updated_that_met_qc_criteria": "2022-04-11",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-14",
"first_submitted": "2022-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Serenno Medical Automatic Urine Output measuring device is intended to measure volumetric flow rate (total volume and rate) of urine produced per minute over long periods by a patient with a urinary catheter as well as high resolution IAP via bladder pressure (IBP). The device comprises a control unit located near the bed, and a disposable unit connected between the catheter and the urine collection tube/bag. The disposable unit is connected to the control unit with a tube.
Frequent and accurate Intra-Abdominal Pressure measurements facilitate management of critical care patients, yet this parameter is normally measured manually, intermittently, and inaccurately. Automating IAP measurement will increase responsiveness, reduce workload, and potentially improve outcomes. The investigators goal is to validate the accuracy urinary catheter estimates of IAP compared to the gold standard during the application of a wide range of pressures controlled by a validated closed-loop insufflation reference.
Primary Objective:
The study objective is to evaluate the accuracy of the Serenno Medical IAP measurements in patients with indwelling urinary catheters vs. the gold standard - the Foley Manometer
Detailed Description
The system which is the subject of the current study comprises two connected parts, the controller and the disposable.The disposable is a special pressure sensing fluid pump connected serially between the catheter and urine bag. The pump is operated by controlled air pressures sent via three tubes from the controller. The pump operates in strokes, with each stroke passing exactly 1ml of fluid from the input port which is connected to the catheter in the patients' bladder, to the output port, which is connected via a long tube to the urine collection container (bag or other). Since each stroke of the pump is known and constant, and the monitor is counting and timing the strokes both current urine production rate, flow rate and cumulative urine volume over any period can be measured. The pump is also unique in that its design allows the controller to measure the fluid pressure at both the input port, as well as in the output port allowing automatic high resolution Intra-Abdominal pressure monitoring in parallel and without interrupting the Urine Output monitoring.
Ongoing pressure monitoring and supporting algorithm remove the need to manually fill and empty the bladder and avoid interrupting urine output monitoring. The method also delivers multiple per-hour IAP measurements and is able to show trends to correlate to patient angle and condition.
Urine pumping eliminates all problems associated with existing systems and methods for measuring urine output. The volume measurement is accurate since it is measured in a 'digital' format, by calculating of number of fixed bolus units transferred. Dependent loop and tube related accumulation are avoided since the pump passes a fixed volume of urine, no matter how it is distributed in the drain tube. Similarly, urine composition, temperature, production rate, specific weight are irrelevant to the pumping accuracy, as well as patient/bed motions and vibrations.
The controller operates the pump in a cyclic fashion. First, it measures the urine pressure inside the patients' bladder, as it is expressed as the pressure in the pump input port. A positive pressure of a few mmHg indicates that there is a minimal volume of urine in the bladder (and also indicate IAP). The controller then runs the pump for a single cycle, removing 1cc of urine from the bladder and repeating the pressure measurement and pump operation until the pressure at the input port drops back to zero - indicating an empty bladder, then stops. This process repeats for the duration of use. UO is calculated by the number of cycles and time of each divided by the relevant timeframe, normally cc/h.Providing a continuous fully automated and accurate method to measure IAP could be important in several clinical setups. Current reference methods for IAP measurement are intermittent and cumbersome. They are affected by body position, zero reference, and highly user dependent.
Study design allows a large range of pressure levels assessed simultaneously between the study device and the gold standard.
The study population is a good representation of the target population, being sedated in the supine position.
Subjects will be recruited in the pre-operative period by the study staff. b. Study Duration (per subject and total):
33 patients (3 pilot patients) Durations from study device connection to removal during the OR procedure. Estimated 15 minutes.
Total study duration is estimated as 12 months from its initiation. c. Study procedure: Screening Subjects will be screened according to eligibility criteria. The investigator will explain to the patient the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits involved and any discomfort it may entail. The patients will be informed that participation in the study is voluntary, that the participants may withdraw from the study at any time and that withdrawal of consent will not affect his/her subsequent medical treatment (if any) or relationship with the treating physician.
System set up, initiate data collection and follow up.
A sealed envelope containing a set of 5 computer-generated random pressure insufflation targets will be opened. This will be used for stage 9.
A new and sterile study device disposable pump will be used for each patient (study device).
A new and sterile IAP Foley Manometer will be used for each patient. The Foley Manometer will be positioned so it is visible, stationary and it's zero point is at the same level as required in the device installation requirements at the level of the bladder.
The study device Controller unit will be cleaned per OR procedures between uses (study device).
If catheter is installed in the OR (as part of the OR requirements) it should not be drained to a bag and immediately connected to the Foley Manometer The investigator or study staff in the OR will connect the study device and IAP Foley Manometer to the patient urine line, noting the date and time.
If needed for the IAP Foley Manometer reading and/or study device a fluid bolus of 25cc will be introduced and recorded.
If needed, the battery of the device will be replaced as needed. Data storage card from the device will be backed up between uses.
An investigator or study staff will perform a series of intermittent measurements using the Foley Manometer (manual IAP measurement) while the surgeon is changing the insufflation pressures to the preselected random targets, all between 8-25 mmHg. Each level will be maintained for a duration of 30 seconds.
The study device will measure and save ongoing IAP during the process, measurements gathered by the study device will not be visible once measurements have started and can only be retrieved from the device memory during analysis. Urine Output functions will be turned off.
After the set of measurements, the study device disposable unit and the manometer unit will be disconnectedNote: Disconnection of the patient from the study device control unit is considered as study termination.
The surgical procedure will resume as normal.
Study termination: system removal and documentation
1. The investigator in the OR will disconnect the study device and IAP Foley Manometer from the patient urine line.
2. The disconnected equipment will be sealed in a bio-hazard bag marked with the subject study number and returned to Serenno as soon as possible. After inspection it will be destroyed at the responsibility of Serenno.
3. The SD card carrying the patients' data will be removed from the controller, marked with the subject study number,. A new, blank SD card will be inserted in the controller in preparation for the next patient.
4. The controller can be used with the next patient after cleaning and disinfection per the OR normal operating procedures and IFU (instruction for use).
5. Patients' CRF will include information covering the study period will be extracted from the patient's medical files. The data included in the CRF shall include, at a minimum: i. Hospital records,, weight, BMI, ASA score or equivalent at admission. ii. The set of Foley Manometer IAP measurements and the set of insufflation levels and their timing preformed during the procedure (corresponding to the random values from the envelope).
iii. Record of any unusual events during the study period, made by the OR staff iv. Record of any unusual events during the study period, made by a technical representative.
v. Control unit and disposable units serial numbers used per session
#Intervention
- DEVICE : Serenno Sentinel, model Alpha 2.0, software version: 8.0
- intra-abdominal pressure measurements compared to a Foley Manometer at different insufflation pressures between 5 and 25 cmH20 at 30seconds intervals. | #Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 18 years or more.
* Patients scheduled for laparoscopic surgical procedure requiring an indwelling urinary catheter.
* Providing informed consent.
Exclusion Criteria:
* Known urological pathology
* Known pregnancy
* Cognitive and/or psychiatric impairment precluding informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05121454 | {
"brief_title": "Validation of Serenno CUO and IAP Measuring Device",
"conditions": [
"Urinary Catheter",
"Laparoscopic Surgery"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT05121454",
"official_title": "Validation of an Automatic Continuous Urine Output (CUO) and Intra-Abdominal Pressure (IAP) Measuring Device",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-07",
"study_completion_date(actual)": "2022-03-07",
"study_start_date(actual)": "2021-11-15"
},
"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)": "2023-04-12",
"last_updated_that_met_qc_criteria": "2021-11-14",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-16",
"first_submitted": "2021-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among cancer patients.
Detailed Description
Tightly controlled experimental laboratory studies (e.g., clinical trials with randomization) using Cannabis products available in state-regulated markets are simply, at this point, not possible owing largely to federal law and the University requirements related to the Controlled Substances Act and Drug Free Schools and Communities Act. Because a traditional clinical trial design is not possible given the current federal status of Cannabis products, this investigator will use a patient-oriented, prospective observational design. Specifically, individuals who have already decided to try Cannabis for their cancer treatment-related symptoms will initiate use of an orally administered product they have selected. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. The participants will then purchase the product and decide how often and how much to use. This approach is consistent with federal law and supported by our preliminary and ongoing studies(1R01AT009541-01, 1R01DA044131-01, CDPHE2902, R01DA039707). Patients will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks, at which time they will be scheduled for an acute administration session (Ta1-Tc1) so that we may examine the acute effects of the product. The final follow-up will be one month later via an online survey sent directly to the participant via email.
| #Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provision to sign and date the consent form.
* Stated willingness to comply with all study procedures and be available for the duration of the study.
* Be a female or male aged at least 21 years.
* Have a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment
* Have intent or interest to use cannabis to treat their symptoms.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Report of other non-prescription drug use, such as cocaine, heroin, methamphetamine in the past 60 days
* Actively seeking or in treatment for any substance use disorder
* Acute illness other than cancer that could affect cognition or compliance per the decision of the study M.D.
* Premenopausal females who are pregnant or trying to become pregnant. Note that pregnancy testing will not be required.
* A Telephone Interview for Cognitive Status (TICS) score indicating moderate or severe cognitive impairment at screening
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03617692 | {
"brief_title": "Cannabis Use in Cancer Patients",
"conditions": [
"Solid Tumor, Adult"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03617692",
"official_title": "Effects of Cannabis Use in Cancer Patients: A Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-12",
"study_completion_date(actual)": "2022-12-12",
"study_start_date(actual)": "2018-12-04"
},
"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)": "2024-06-11",
"last_updated_that_met_qc_criteria": "2018-07-31",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-06",
"first_submitted": "2018-07-23",
"first_submitted_that_met_qc_criteria": "2024-06-10"
}
}
} |
#Study Description
Brief Summary
To investigate and compare vertical gingival display (VGD) changes associated with upper premolars extraction during orthodontic treatment.
Detailed Description
Seventy-six subjects who met the inclusion criteria were divided into one of 3 groups according to their treatment modalities as follows: group 1: upper first premolars extraction (24 patients, aged 21.56±3.19 years); group 2: upper second premolars extraction (26 patients, aged 22.16±3.59 years) and group 3: no orthodontic intervention was performed (happy with their teeth) (26 subjects, aged 20.45±3.29 years).
Initial records (radiographs, study casts and clinical photographs) were taken for all subjects. The same records were taken post treatment for treated subjects only. The Pre- and post- treatment VGD and lip length in static and dynamic positions and the amount of upper teeth retractions were recorded.
The paired t-test and ANOVA test were used to detect treatment changes and differences between studied groups, respectively. Factors affecting VGD were investigated using backward stepwise linear regression analysis.
#Intervention
- PROCEDURE : Upper first premolars extractions
- Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
- PROCEDURE : Upper second premolars extraction
- Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain. | #Eligibility Criteria:
Inclusion Criteria:
* age 17 years or more
* skeletal class I or class II malocclusion
* upper premolars extraction treatment plan
* high smile line 2mm or more
* no previous orthodontic treatment.
Exclusion Criteria:
* poor oral hygiene
* lower arch extraction treatment plan
* smoking
* Any systemic or periodiontal disease.
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Maximum Age : 28 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT04375540 | {
"brief_title": "Vertical Gingival Display Changes Associated With Upper Premolars Extraction",
"conditions": [
"Gummy Smile",
"Orthodontic Treatment"
],
"interventions": [
"Procedure: Upper second premolars extraction",
"Procedure: Upper first premolars extractions"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT04375540",
"official_title": "Vertical Gingival Display Changes Associated With Upper Premolars Extraction Orthodontic Treatment in Gummy Smile Patients: A Prospective Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-01",
"study_completion_date(actual)": "2018-12-01",
"study_start_date(actual)": "2016-09-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-07",
"last_updated_that_met_qc_criteria": "2020-05-02",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-05",
"first_submitted": "2020-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Sanfilippo syndrome, or mucopolysaccharidosis type III (MPS III), is a disorder of metabolism, associated with insufficient production of a lysosomal enzyme needed for normal cell function. As a consequence of the cellular dysfunction, patients with this disorder develop progressive, irreversible neurodegeneration. Sadly, to date no evidence-based treatments are available.
Inflammation has been connected with disease pathogenesis in the MPS disorders. Therapies aimed at decreasing inflammation are currently being studied in many MPS disorders and benefits in both brain and other parts of the body have been reported.Decreasing interleukin-1 (IL-1) in an animal model of MPS III showed benefits in brain disease and behavior. Thus, we think that anakinra (Kineret), which decreases IL-1 levels in the body, will improve behavioral and other problems in children with MPS III.
Anakinra is approved by the FDA for treatment of rheumatoid arthritis (RA) and neonatal-onset multisystem inflammatory disease (NOMID). It is not approved for any MPS disorder.
The design of this study is an open-label, single center, pilot study of 20 participants with MPS III. There will be an initial screening visit, followed by an 8-week observational period, then a 36-week treatment period, and finally another 8-week observational period to determine any effects of withdrawal from the treatment.
During visits the participants will undergo a medical history, a physical examination, and anthropometric measurements. Blood, urine, and stool will be collected for biomarker levels and safety laboratory studies. Questionnaires will be completed with questions related to behavior, stooling, sleep, and activities of daily living. Seizure and movement disorders will be monitored as well.
The most common risks of receiving anakinra, based on RA and NOMID experience, include local injection site reactions, headache, nausea, vomiting, arthralgia, and flu-like symptoms. The most serious potential risk is a serious infection and neutropenia. However, because so few people with MPS have been treated with anakinra, all the risks related to MPS patients receiving anakinra are not currently known. Additional risks related to taking part in the study include some pain, bruising, and/or bleeding due to blood draws/peripheral IV placement, and discomfort with completing some of the questionnaires.
The expected potential direct benefits include, but are not limited to, improved behavior, sleep, stooling, communication, mood, and gait; as well as decreased seizure frequency, disordered movement and fatigue. However, there is no guarantee that participants will get any benefit from being in this study.
#Intervention
- BIOLOGICAL : anakinra
- anakinra single-use prefilled glass syringes
- Other Names :
- Kineret | #Eligibility Criteria:
Inclusion Criteria:
* MPS III
* >= 4 years
* Patient or parent/legal guardian is able and willing to provide informed consent. For patients 7 <= age <= 17 of age, assent must also be provided when cognitively possible.
* If on Genistein, must have been on a stable dose for 6 months prior to enrollment
* If on melatonin or other sleep medications, must have been on stable doses for the past 3 months
Exclusion Criteria:
* Currently enrolled in another ongoing clinical treatment trial
* Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor.
* Use of the following therapies prior to enrollment:
* Narcotic analgesics within 24 hours prior to enrollment.
* Tocilizumab, dapsone or mycophenolate mofetil within 3 weeks prior to enrollment.
* Etanercept, leflunomide, thalidomide, or cyclosporine or intraarticular, intramuscular, intravenous, or oral administration of glucocorticoids within 4 weeks prior to enrollment.
* Intravenous immunoglobulin (IVIG), adalimumab, or methotrexate within 8 weeks prior to enrollment.
* Infliximab, 6-mercaptopurine, azathioprine, cyclophosphamide or chlorambucil within 12 weeks prior to enrollment.
* Rituximab within 26 weeks prior to enrollment
* Live vaccines within 1 month prior to enrollment.
* Known presence or suspicion of active, chronic or recurrent serious bacterial, fungal or viral infections, including tuberculosis, HIV infection or hepatitis B or C infection.
* Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests:
* AST or ALT > 5 x ULN, or
* AST or ALT > 3 x ULN accompanied by elevated bilirubin >2 x ULN.
* Presence of severe renal function impairment (estimated creatinine clearance < 30 mL/min/1.73m2).
* Presence of neutropenia.
* History of malignancy.
* Known hypersensitivity to E coli-derived proteins, or any components of Kineret® (anakinra).
* Pregnant or lactating women.
* Current active infection;
* History of serious opportunistic infection (e.g., bacterial [Legionella and Listeria]; tuberculosis [TB]; invasive fungal infections; or viral, parasitic, and other opportunistic infections);
* Positive TB skin test, positive Quantiferon-TB Gold TB test, positive chest X-ray, or a recent exposure to TB
* Requirement for live vaccine exposure that would be expected to occur during the time frame of the study
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04018755 | {
"brief_title": "Open-label Study of Anakinra in MPS III",
"conditions": [
"Mucopolysaccharidosis III"
],
"interventions": [
"Biological: anakinra"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04018755",
"official_title": "Open-label Pilot Study of the Effects of Anakinra in Mucopolysaccharidosis (MPS) III",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-17",
"study_completion_date(actual)": "2023-03-08",
"study_start_date(actual)": "2020-01-30"
},
"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)": "2024-10-22",
"last_updated_that_met_qc_criteria": "2019-07-11",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-12",
"first_submitted": "2019-07-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
As medical cannabis use becomes more common in the United States, it is essential to understand the ways in which adults who use medical cannabis perceive the benefits of cannabis use and to identify effective strategies to help them cope with these problems. Emerging data indicate that insomnia and/or use of cannabis for sleep are very common in medical cannabis patients. The present study will adapt and gather pilot data on the impact of a Cognitive Behavioral Therapy for insomnia (CBTi-CB) intervention on sleep- and cannabis-related outcomes in adults who use medical cannabis.
Detailed Description
In recent years, the movement to promote the legalization of medical cannabis has grown in the United States and now 29 States and the District of Columbia have provisions that allow for the use of cannabis for medical reasons. Irrespective of the specific reasons for seeking medical cannabis, adults who have been evaluated for medical cannabis certification report significant sleep-related problems as well as frequent use of cannabis to address their sleep problems. Cannabis use for sleep is a key potential target for interventions given that prior research has found that, among individuals with cannabis use disorders, poor sleep is a barrier to sustained remission from cannabis use. Cognitive Behavioral Therapy (CBT) for insomnia is highly effective in individuals with insomnia comorbid with other health conditions, including substance use disorders; however, existing efficacy trials have not specifically evaluated its benefit in those who use cannabis for insomnia. The impact of CBT for insomnia on either sleep or cannabis use in medical cannabis users is, therefore, unknown. The objectives of this project are to adapt and tailor a telephone-delivered CBT for insomnia for adults who use medical cannabis (CBTi-CB) and to evaluate the acceptability and feasibility of this intervention. Qualitative and quantitative data will be collected to refine an existing CBTi-CB protocol and conduct a pilot test of the modified intervention in adults who use medical cannabis. Adults seeking certification for medical cannabis will be approached while waiting for their appointment and screened for insomnia as well as cannabis use for sleep. After initial qualitative interviews and beta testing, eligible participants (N = 60) will be randomized to CBTi-CB or Sleep Hygiene Education (SHE) control condition, delivered over the telephone. Participants will provide self-report data on sleep/insomnia, functioning and cannabis use and objective data on sleep quality will be measured by actigraphy. The study will evaluate changes in self-reported and objectively measured sleep, functioning and frequency/quantity of cannabis use during treatment and over the course of 18-weeks post-baseline. Completion of the study aims will provide all of the elements required for a future fully-powered randomized trial of the longer-term efficacy of CBTi-CB among those with medical cannabis. This line of research would be the first to evaluate a highly effective sleep-focused intervention and determine the effects on sleep-related and non-sleep-related cannabis use in a non-treatment seeking population.
#Intervention
- BEHAVIORAL : Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
- Each CBTi-CB therapy session will review the previous week of sleep/wake diaries and summarize key sleep parameters with participants. The treatment will address cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
- Other Names :
- Cognitive Behavioral Therapy
- BEHAVIORAL : Sleep Hygiene Education (SHE)
- The SHE condition will be matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements. | #Eligibility Criteria:
Inclusion Criteria:
* Age >= 21 years
* Insomnia Severity Index (ISI) score greater than 10 (indicating mild insomnia),
* Use of cannabis on average three times a week for the past three months,
* Self-reported use of cannabis to manage insomnia at least once a week over the past month,
* Positive drug screen for Tetrahydrocannabinol (THC),
* Consistent access to a telephone, smart phone, laptop, or tablet
Exclusion Criteria:
* Individuals who do not understand English,
* Individuals judged unable to provide informed consent (e.g. intoxication, mental incompetence),
* Diagnosis or high suspicion of a sleep disorder based on validated self-report questionnaires,
* Self-reported cancer,
* Self-reported pregnancy,
* Self-reported rotating or night (3rd) shift work.
* Participants taking medications for sleep will be included if they meet study criteria for insomnia, medications have been stable for at least 8 weeks, and they agree to maintain the same regimen throughout the study.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03964974 | {
"brief_title": "Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis",
"conditions": [
"Insomnia Chronic",
"Cannabis Use"
],
"interventions": [
"Behavioral: Sleep Hygiene Education (SHE)",
"Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03964974",
"official_title": "Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-13",
"study_completion_date(actual)": "2021-07-13",
"study_start_date(actual)": "2020-02-10"
},
"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)": "2022-09-14",
"last_updated_that_met_qc_criteria": "2019-05-23",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-28",
"first_submitted": "2019-05-17",
"first_submitted_that_met_qc_criteria": "2022-08-22"
}
}
} |
#Study Description
Brief Summary
Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units.
Detailed Description
Surgical intensive care units have high mortality and mobility rates and require 24-hour monitoring. Intensive care environments are stressful for working individuals, particularly nurses, due to health and safety concerns. In recent years, new health technologies and medical devices, as well as changing health environments, have increased work stress among nurses, leading to negative physical and mental health outcomes. The use of medical device alarms, including bedside monitors, pump devices, perfuser devices, patient heating-cooling devices, mechanical ventilators, computers, and nutrition devices, has increased over time. These alarms are used to monitor changes in the vital signs of patients and ensure continuity of care. However, alarm fatigue is a significant problem caused by medical devices. Noise pollution is a common issue in intensive care units due to the various sounds emitted by medical devices. Health professionals may experience alarm fatigue, which is defined as desensitisation to monitor alarms. Dealing with alarm fatigue requires objective and comprehensible solutions. Inappropriate techniques such as disabling alarms, delayed response, setting them between unsafe parameters, and turning down the volume so low that they cannot be heard, are cognitive stressors. The continuous exposure to these alarm sounds, coupled with the nature of nurses' work, can also cause stress. Occupational stress is a demanding profession that can have negative effects on performance. Therefore, it is important to address occupational stress in the nursing profession. It is quite common among nurses and can jeopardise both their quality of life and patient safety. Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units.
#Intervention
- BEHAVIORAL : Emotional Freedom Technique
- Emotional Freedom Technique (EFT) is a powerful and effective practice that enables individuals to release negative emotions and achieve mental and physical relaxation. EFT is a form of counselling based on acupuncture points, which are areas of low electrical and energy flow in the body. Stimulating these points causes the brain to secrete dopamine. EFT involves stimulating specific points on the body where energy flow is low. This is done by gently tapping on these areas with the fingers, which releases dopamine. The process is painless and can be performed by the individual themselves. | #Eligibility Criteria:
Inclusion Criteria:
* Being 18 years or older
* Working as a nurse in one of the surgical intensive care units
* Volunteering to participate in the study
Exclusion Criteria:
* Working in a unit other than surgical intensive care units
* Not volunteering to participate in the research
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
| NCT06271278 | {
"brief_title": "The Effect of Emotional Freedom Techniques Application on Nurses",
"conditions": [
"Occupational Stress",
"Alert Fatigue, Health Personnel"
],
"interventions": [
"Behavioral: Emotional Freedom Technique"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06271278",
"official_title": "The Effects of Emotional Freedom Technique on Work-Related Stress and Alarm Fatigue in Nurses Working in Surgical Intensive Care Units",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-28",
"study_completion_date(actual)": "2024-08-16",
"study_start_date(actual)": "2023-11-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-14",
"last_updated_that_met_qc_criteria": "2024-02-14",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-02-21",
"first_submitted": "2024-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Genetic association at the genomic level (genomewide association study - GWAS), requencing by NGS (whole exome sequencing) and gene expression studies to identify the main ones hereditary genetic determinants of predisposition to the development of SARS (symptomatic pathology associated with development of insufficiency respiratory disease of any degree) in Italian subjects affected by SARSCoV-2.
Detailed Description
Lombardy region in Northern Italy is now in the midst of an outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19) . The COVID-19 epidemic situation needs little introduction and represent a global world-wide emergency with mortality rates rapidly increasing in Europe and the US. Evidence is accumulating that the majority of individuals infected by SARS-CoV-2 are asymptomatic and the major source of viral spread 3, and that a considerable fraction of these has active viral replication 4,5. Furthermore, disease behavior is variable, with the majority of patients experiencing only mild symptoms or no symptoms at all. Some patients develop severe pulmonary affection, with aggressive and extensive inflammatory destruction of lung parenchyma and associated inflammatory responses and superinfections, driving large fractions of the COVID-19 related mortality. What exactly drives this development of severe lung disease remains unknown, but old age, obesity, diabetes and other co-morbidities increase the risk, while the role played by specific medications is still uncertain. Variation in virus genetics and patient immunology are also likely involved. As to the latter point, we hypothesize that host genetics may play a role in determining development of severe lung disease in SARS-CoV-2 infection. Genome-wide association studies (GWAS) have been applied to decipher the genetic predisposition in thousands of disease traits since the study design was invented in 2005. The genetic signals detected vary from very strong effects that can be detected in a few hundred individuals, to very weak effects requiring cohorts of tens of thousands for detection. By 2020, the study design is now a robust, off-the-shelf, easyto-perform industry-standard screening tool for genetic predisposition, even available through 'consumer genetics' online-based companies. The study design is simple: testing for genetic variants throughout the genome (single nucleotide polymorphisms, SNPs) using SNP microarrays, comparing their frequencies in patients versus controls (or across other variables). For inflammatory phenotypes in particular, GWAS has proven an efficient tool, delineating hundreds of susceptibility loci in many conditions, some of which has provided novel and surprising disease insights. GWAS serve two purposes. Most importantly they allow to determine biological factors involved in disease development, thus potentially guiding drug development and therapy. This would be particularly relevant during the current COVID-19 emergency, when hundreds of trials have begun and there is an urgent need to prioritize well-conducted collaborative studies based on robust pathophysiological data. Secondly, and increasingly popular, they allow for the calculation of a 'polygenic risk score' to predict disease development. Both aspects appear crucial to clarify for COVID-19 lung disease: (a) are there genetic signatures suggesting which biological mechanisms are involved that may suggest relevant therapeutic approaches, and (b) can we predict those at risk (or those with very low risk)?
#Intervention
- GENETIC : identify genetic determinants of the predisposition to develop respiratory failure
- To identify the main common genetic determinants of severe COVID-19 by conducting a GWAS: in first phase we will compare SARS-CoV-2 positive patients with severe lung affection to healthy controls from the same geographic area, in order to provide initial data informing the research in the field in a timely fashion. This will be conducted in close collaboration with the University of Kiel COVID-19 genomic initiative. Later on, we will proceed to assess objectives 1 and 2 in the full cohort, including also infected controls who did not developed clinically significant symptoms
- GENETIC : identify genetic determinants of the predisposition to develop respiratory failure
- To provide extensive genetic characterization of all patients managed at the Fondazione in order to facilitate other groups working on specific projects (e.g. on candidate genes such as SERPINA1 and ACE2 by the Intensive Care and Cardiology Units and other that may emerge from upcoming projects), in a large population and in a very timely fashion, and without incurring in any additional expenses for the Fondazione research network, and coordinate research efforts.
- GENETIC : identify genetic determinants of the predisposition to develop respiratory failure
- To provide a coordination to manage the collaboration with other research consortia in the field, e.g. the 'An anonymized GWAS to urgently query host genetic predisposition to severe COVID-19 (SARS-CoV-2 infection) lung disease, and the COVID-19 Host Genetic Initiative (https://www.covid19hg.org). Indeed, collaboration among large networks analyzing several thousand cases will be ultimately necessary to clarify the genetic basis of COVID-19 susceptibility, and large collaborative networks are essential instruments for conducting human genetic research. | #Eligibility Criteria:
Inclusion Criteria:
Cohort 1 inclusion criteria:
* SARS-CoV-2 positive patients (no age limit) with severe pulmonary compromise, hospitalized with failure respiratory that requires support of any kind
* Signature of informed consent
Cohort 2 inclusion criteria:
* Blood donors (18 <= age <= 70 years) who donated between 24/02/2020 and 31/12/2021
* exposure to the SARS-CoV-2 virus confirmed by viremia positive and presence of IgG/IgM
* Signature of informed consent
Cohort 3 inclusion criteria:
Healthy controls available from previous studies (n=5,000, ages 14 <= age <= 80 years), whose data are already available for genetic association analyses within the Kiel University database.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT06549712 | {
"brief_title": "The Fondazione Genomic SARS-CoV-2 Study (COVID-19)",
"conditions": [
"COVID-19",
"Genetic Predisposition"
],
"interventions": [
"Genetic: identify genetic determinants of the predisposition to develop respiratory failure"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT06549712",
"official_title": "The Fondazione Genomic SARS-CoV-2 Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31",
"study_completion_date(actual)": "2023-05-31",
"study_start_date(actual)": "2020-03-23"
},
"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)": "2024-08-12",
"last_updated_that_met_qc_criteria": "2024-08-09",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-08-12",
"first_submitted": "2024-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Hypothesis:
To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy has turn out relevant because of the exclusive dedication that it supposes to the therapist. To date, the evidence-base for MLD is very limited and only two studies analyze its relevance. The first study measured the effect of compression bandage with or without MLD. The group receiving compression and MLD had a significant reduction in limb volume and decreased pain, despite the fact the MLD was given only for one week (Johansson et al., 1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42 women with breast cancer-related lymphoedema, and the findings suggested that MLD do not contribute significantly to oedema reduction, although the MLD course was relatively short and the study group was limited to those with mild to moderate swelling (20-30 % of difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was gathered but the results were not considered in the final assessment (Andersen and Cabbage 2000).
Similar studies would provide comparative and enlightening information with regard to the previous results. The investigators could determine if the MLD, in spite of not obtaining an improvement in the volume of the lymphoedema, provides a benefit in the reduction of the symptoms related to it.
The investigators hypothesized that MLD does not contribute significantly in volume limb reduction but it provides a clinical improvement regarding the quality of life according to the questionnaire EORT QLQ-C30.
For the calculation of the sample size the investigators depart from the following assumptions:
The effect of the standard treatment on the control group control will produce an average volume limb reduction of 5 %.
The effect of the treatment in the experimental group will be an average of the 25 % (a minor difference of effects would indicate a discreet effect of the tested treatment). The investigators also assume that, the standard deviation will be similar in both groups and near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the calculation of the sample size is 20 patients in every group. Considering a rate of withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two groups of 29 patients.
Main aim:
To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of postmastectomy lymphoedema in order to reduce the volume of lymphoedema
Secondary aims:
To analyze the duration of the reduction of the lymphoedema in the time. To analyze the improvement in the concomitant symptomatology of the lymphoedema using the results of two quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and in which the higher the score the worse the result.
Methodology:
Researching Project with methodology of randomized, controlled clinical trial. Group A or Control: patients with standard treatment (care the skin, exercise and measures of compression -bandage for one month and later a sleeve of compression).
Group B or Experimental: patients with standard treatment (care of the skin, exercise and measures of compression (bandage for one month and later a sleeve for lymphoedema) and in addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected arm after the treatment expressed in percentage.
Number of patients: 58 women.
#Intervention
- OTHER : Compression Bandaging
- Group A or Control Group: ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied.
- OTHER : Manual Lymph Drainage (MLD) and Compression Bandaging
- Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied. | #Eligibility Criteria:
Inclusion Criteria:
* women older than 18 years, intervented of unilateral breast neoplasia with ipsilateral axillar lymphadenectomy
* Patients with ipsilateral lymphoedema with a volume difference of at least 200ml compared to the lateral limb
* Patients who have finished the treatment with Radiotherapy and / or chemotherapy at least six months before the study started
* Informed acceptance has to be signed
Exclusion Criteria:
* Bilateral affectation of both extremities.
* Malignant Active disease
* Acute Lymphoedema (in the first three months postintervention)
* Patients with previous paralysis or vascular alteration in the affected arm
* Patients with a major limitation of 30 º in any of the arches of movement of the ipsilateral shoulder
* Patients with contraindication for Lymphatic Manual Drainage (cellulite, deep venous thrombosis, heart failure, not controlled hypertension, renal failure and important radiodermatitis)
* Patients who have been managed with treatment of rehabilitation in three months previous to the recruitment.
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
| NCT01152099 | {
"brief_title": "A Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy",
"conditions": [
"Lymphoedema"
],
"interventions": [
"Other: Compression Bandaging",
"Other: Manual Lymph Drainage (MLD) and Compression Bandaging"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01152099",
"official_title": "A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-24",
"study_completion_date(actual)": "2017-04-24",
"study_start_date(actual)": "2007-09-11"
},
"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)": "2018-02-27",
"last_updated_that_met_qc_criteria": "2010-06-28",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-29",
"first_submitted": "2010-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Aim and hypothesis: This study was conducted to evaluate the effect of mobile information given to women before and after breast cancer surgery on anxiety, distress, and quality of life. E-mobile information given to women before and after breast cancer surgery reduces the level of anxiety (I) and the level of distress (II), and positively affects their quality of life (III).
Methods: This randomized controlled study was conducted between April and August 2021 in the surgical oncology clinic-outpatient clinics of a university hospital. Patients in the intervention group (n=42) used the mobile information application for one month with routine care. Patients in the control group (n=40) received their routine care. Data were collected with data collection forms one week before and three weeks after surgery.
#Intervention
- OTHER : Using mobile information application about before and after surgery
- The mobile application had three sections: Information forum (I), Personal forum (notebook and reminder) (II) and Ask the Researcher (messaging) (III). The information forum (Figure 2) is a section that enables patients to access related articles, pictures, and videos. The personal forum is a section that allows patients to create their notes and use the necessary reminders. Ask the researcher section allows patients to communicate with the researcher via messages.
The participants could download the mobile application with the name 'Breast Cancer Surgery Information Guide' from the Google Play Store and install it on their phones. Users who were authenticated by the researcher were able to access the content with an e-mail and password. | #Eligibility Criteria:
Inclusion Criteria:
* Scheduled for elective surgery due to breast cancer,
* Over 18 years,
* Read and understand Turkish,
* At least primary school graduates,
* Have internet access,
* Have a smartphone with an android operating system suitable for downloading the mobile application.
Exclusion Criteria:
* Diagnosed with active psychiatric disease,
* Using antidepressant medication,
* Vision problems that prevented them from using the mobile application,
* Scheduled for reconstructive surgery using their own tissue
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
| NCT05360407 | {
"brief_title": "The Effect of Mobile Application-based Information About Before and After Surgery",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Other: Using mobile information application about before and after surgery"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05360407",
"official_title": "The Effect of Mobile Application-based Information About Before and After Surgery on Anxiety, Distress and Quality of Life of Women With Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-30",
"study_completion_date(actual)": "2021-08-30",
"study_start_date(actual)": "2021-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-04",
"last_updated_that_met_qc_criteria": "2022-04-29",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-04",
"first_submitted": "2022-04-23",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This pilot clinical study evaluated the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV) in mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes syndrome (MELAS) volunteers and controls.
Detailed Description
This pilot clinical study evaluated the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV). This study will consist of two cohorts: MELAS syndrome volunteers (a specific identified disorder of mitochondrial dysfunction: mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) between 13-60 years OR adult control volunteers between 18-65 years of age. Both cohorts will receive the same treatment: a single vaccination with an FDA-licensed intramuscular seasonal trivalent inactivated influenza vaccine (TIV).
All participants will receive a single administration of a licensed influenza vaccine. Prior to vaccination, participants will provide information regarding health history and responses to health questionnaires. A blood sample and urine specimen were collected prior to vaccination, and at 6 hours, 5-7 days and 26-30 days post-immunization.
#Intervention
- BIOLOGICAL : Fluzone®
- This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate
- Other Names :
- trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccine | #Eligibility Criteria:
Inclusion Criteria:Inclusion criteria include:
* Age between 13 <= age <= 60 years for MELAS volunteers OR age between 18 <= age <= 65 years for adult control volunteers. Control volunteers will be age-matched +/-5 years to enrolled MELAS volunteers. If the MELAS volunteer has diabetes and uses insulin daily, their control will be an adult with diabetes who uses insulin daily.
* General good health at time of enrollment
* Willing and able to sign Informed Consent
* Available for follow-up for the planned duration of the study
* Acceptable medical history by screening evaluation and brief clinical assessment
* All female participants of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study (approximately 1 month to completion of Visit 4). (Acceptable contraception may include but is not limited to implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).
Exclusion Criteria:Exclusion criteria will include:
* Allergy to egg or egg products or allergy to vaccine components, including thimerosal
* Active systemic or serious concurrent illness, including febrile illness, within the 3 days prior to study vaccination
* History of immunodeficiency, known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
* Blood pressure >150 systolic or >95 diastolic at Visit 1.
* Hospitalization in the past year for congestive heart failure or emphysema.
* History of chronic Hepatitis B or C.
* Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
* Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
* Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
* History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
* Receipt of blood or blood products within the past 6 months
* Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
* Inactivated vaccine 14 days prior to vaccination or live, attenuated vaccine within 60 days of vaccination
* History of Guillain-Barré Syndrome
* Pregnant or lactating woman
* Use of investigational agents within 30 days prior to enrollment
* Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
* Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT01831934 | {
"brief_title": "Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)",
"conditions": [
"MELAS Syndrome"
],
"interventions": [
"Biological: Fluzone®"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01831934",
"official_title": "Metabolic and Immune Responses to TIV in Patients With Mitochondrial Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-30",
"last_updated_that_met_qc_criteria": "2013-04-10",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-15",
"first_submitted": "2013-03-19",
"first_submitted_that_met_qc_criteria": "2017-03-17"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in elderly volunteers following the combination of moderate physical activity and a standard meal.
#Intervention
- BEHAVIORAL : Walking test
- Walking test to increase cardiac output, maximum 12 minutes
- BEHAVIORAL : Standard Meal
- After the walking test, volunteers eat a standard warm meal | #Eligibility Criteria:
Inclusion Criteria:
* Age >= 75 years (both sexes)
* Participating in the Embrace project.
Exclusion Criteria:
* Previous gastrointestinal resections
* Chronic inflammatory gastrointestinal disease
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT02831400 | {
"brief_title": "Changes in Circulatory I-FABP in Elderly Persons in Daily Life",
"conditions": [
"Malnutrition",
"Intestinal Integrity",
"Intestinal Fatty Acid Binding Protein (IFABP)"
],
"interventions": [
"Behavioral: Walking test",
"Behavioral: Standard Meal"
],
"location_countries": null,
"nct_id": "NCT02831400",
"official_title": "Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2017-06",
"study_start_date(actual)": "2016-07"
},
"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)": "2017-06-08",
"last_updated_that_met_qc_criteria": "2016-07-10",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-13",
"first_submitted": "2016-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients
#Intervention
- DRUG : Danhong injection
- A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
- OTHER : Standard medical care
- Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
- DRUG : Placebo
- 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion. | #Eligibility Criteria:
Inclusion Criteria:
* Female or male inpatients.
* Age: 18 - 70 years.
* Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.
* Clinical diagnosis of 'Xueyu Zheng' (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of 'Xueyu Zheng' in angina >= 15. The Chinese medicine symptoms scales of 'Xueyu Zheng' is defined as following (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5.
* Patients with moderate angina pectoris (The definition of 'moderate angina pectoris ' is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.
* Patient is willing to participate voluntarily and to sign a written patient informed consent.
Exclusion Criteria:
* Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.
* Woman who disagree with contraception during treatment period
* Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .
* Patients who were angina-free during the run-in period without taking any drug.
* Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months
* Patients with chest pain caused by other disease (e.g., acute myocardial infarction，severe neurosis，menopausal syndrome，hyperthyroidism).
* Patients with history of drug-induced bleeding or history of bleeding caused by warfarin.
* Patients with history of hematopoietic system diseases.
* Patients who had surgery within the past 4 weeks and have hemorrhagic tendency.
* Patients who is participating in other trials or has been participated in other trials in recent 3 months.
* Patients with history of allergy or suspected allergic to the drug.
* Patients who were suspected addicted into alcohol or drug abuse in the past 2 years.
* Patients with mental disorder.
* Patients who were unable to participate in the study as judged by investigator.
* Patients who were family members or relatives of the research center staffs.
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
| NCT01681316 | {
"brief_title": "Danhong Injection in the Treatment of Chronic Stable Angina",
"conditions": [
"Chronic Stable Angina"
],
"interventions": [
"Other: Standard medical care",
"Drug: Placebo",
"Drug: Danhong injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT01681316",
"official_title": "A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2012-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-12",
"last_updated_that_met_qc_criteria": "2012-09-06",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-07",
"first_submitted": "2012-09-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.
Detailed Description
The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoint was the local control rate and the incidence of treatment-related side effects.
#Intervention
- DEVICE : 3DV+TPS/VARIAN
- Use imported 3DV+TPS to map targets and develop treatment plans
- DEVICE : TPS / VARIAN
- Use imported TPS to map targets and develop treatment plans
- DEVICE : 3DV + TPS / Domestic Accelerator
- Use domestic 3DV+TPS to delineate target areas and develop treatment plans
- DEVICE : TPS / Domestic Accelerator
- Use domestic TPS to map targets and develop treatment plans | #Eligibility Criteria:
Inclusion Criteria:
* Consolidate other serious diseases that affect quality of life or treatment;
* Reluctant to actively cooperate with the investigator;
* Mergers with distant transfers;
* Patients who have undergone head and neck surgery and radiotherapy;
* Subjects who are affected by the disease who sign a written informed consent or follow the study procedure; or who are unwilling or unable to comply with the research requirements.
* Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
* Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment;
* Pregnant or lactating women;
* The investigator judges other conditions that may affect the clinical study and the outcome of the study.
Exclusion Criteria:
* Those who did not follow the protocol.
* The subject is aggravated or has a serious adverse reaction.
* The subject himself requested to withdraw from the trial.
* The patient is lost to follow-up or died.
* The researcher believes that there is reason to withdraw
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
| NCT03791944 | {
"brief_title": "3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma",
"conditions": [
"Nasopharynx Cancer",
"Radiotherapy"
],
"interventions": [
"Device: TPS / Domestic Accelerator",
"Device: 3DV+TPS/VARIAN",
"Device: 3DV + TPS / Domestic Accelerator",
"Device: TPS / VARIAN"
],
"location_countries": [
"China"
],
"nct_id": "NCT03791944",
"official_title": "3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-31",
"study_completion_date(actual)": "2019-05-31",
"study_start_date(actual)": "2018-12-01"
},
"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)": "2024-02-23",
"last_updated_that_met_qc_criteria": "2018-12-31",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-03",
"first_submitted": "2018-12-31",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this research study is to determine if giving men with early stage (Grade 1-2) prostate cancer dietary supplement from soybeans called isoflavones, will change their blood hormone levels. Isoflavones are substances found in a high concentration in soybeans that are converted in the intestines to hormone-like compounds which are similar to estrogen. They are also thought to have cancer fighting properties. Clinical trials suggest that isoflavones can increase certain sex hormones, which results in the slower production of prostate cancer cells. This study will determine if adding isoflavones (supplied as Prevastein HC®) 80 mg/day in a pill form can change your risk factors that cause early stage prostate cancer to progress to more advanced disease.
Detailed Description
To prevent biasing the outcome of the study, this is a double-blind study design, where both the trialists and the participants are blinded to the specific nature of the product (isoflavones and placebo). Participants in both groups will be discouraged from increasing their intake of dietary isoflavones in the form of tofu, soy beans, soy milk, etc. In addition, the intervention does not include active counseling on dietary modification and supplementation of any one group. Monthly appointments will be made for all participants for data collection and toxicity assessment.
Schema:
This is a controlled, randomized, double blinded clinical trial, having one experimental and one control group (n - 75/arm). Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones and those in the control group will receive an identical placebo. The isoflavones supplement and the placebo tablets will be manufactured and packaged by Cognis Corporation.
1. Isoflavones will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as Prevastein HC®. Each Prevastein HC® tablet delivers 20 mg biologically active isoflavones, which is available for absorption. Participants will consume 2 tablets twice daily (with meals) in addition to their usual diet.
2. Placebo will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as an indistinguishable tablet. Participants will consume 2 tablets twice daily (with meals) in addition to their usual diet.
3. A standardized multivitamin will be supplied at no charge.
#Intervention
- DIETARY_SUPPLEMENT : Prevastein HC®
- Experimental Group - Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones.
- OTHER : Placebo
- Control Group - Control Group participants will receive an identical placebo. | #Eligibility Criteria:
Inclusion Criteria:
* Males, between the ages of 50 and 80
* Diagnosed with grade 1 <= age <= 2 prostate cancer (Gleason Score 2 to 6) Note: patients with a Gleason primary pattern 4 (4+1 or 4+2) are not eligible.
* No prior or current therapy for prostate cancer
* No other history of cancer except non-melanoma skin cancer
* No known history of hepatic and/or renal disease
* No evidence of prostatitis or urinary tract infection (men being treated with antibiotics may be enrolled 30 days after completion of therapy given that they still meet all other eligibility criteria)
* No antibiotic use within 30 days of registration
* Close to ideal body weight(Body Mass Index no greater than 32 Kg/m²)
* Omnivorous diet
* Able and willing to give written consent
Exclusion Criteria:
* Less than 50 years or > 80 years
* Prostate cancer beyond grade 2 (Gleason Score greater than 6)
* Gleason primary pattern 4 (4+1 or 4+2)
* Prior or planned treatment for prostate cancer of any stage
* Prior history of other cancer except non-melanoma skin cancer
* Current use of nutritional supplements, including modular supplements of other agents with antioxidant properties e.g. retinoids, beta-carotene, and isoflavones
* Allergy to study agent
* Known history of hepatic or renal disease
* Body Mass Index greater than 32 Kg/m²
* Vegetarian/vegan diet
* Diet high in soy products (men who routinely consume a diet high in soy products may be enrolled 30 days after eliminating soy product from the diet)
* Prostatitis or urinary tract infection
* Treatment with antibiotics within 30 days of registration
Sex :
MALE
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00617617 | {
"brief_title": "The Specific Role of Isoflavones in Reducing Prostate Cancer Risk",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Dietary Supplement: Prevastein HC®",
"Other: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00617617",
"official_title": "The Specific Role of Isoflavones in Reducing Prostate Cancer Risk",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-05",
"study_completion_date(actual)": "2007-05",
"study_start_date(actual)": "2002-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-24",
"last_updated_that_met_qc_criteria": "2008-02-05",
"last_verified": "2010-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-18",
"first_submitted": "2008-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction
Detailed Description
The primary objective of this post-market study is to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction using validated questionaires.
#Intervention
- DEVICE : Vivaer® ARC Stylus
- The Vivaer procedure will be performed in the study clinic using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering low-temperature bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nasal valves treated in a single study procedure session. Each nostril will be treated at up to 3 positions | #Eligibility Criteria:
Inclusion Criteria:
Eligible subject will meet all the following:
* 1. Age >= 18 years 2. Willing and able to provide informed consent 3. Willing and able to comply with the study protocol 4. Seeking treatment for nasal obstruction 5. NOSE score of >= 60 at Baseline 6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):
* Use of external nasal dilator strips (e.g., Breathe Right Strips)
* Q-Tip test (manual intranasal lateralization)
* Use of nasal stents
* Cottle Maneuver (manual lateral retraction of the cheek)
Exclusion Criteria:
Eligible subjects will NOT meet any of the following:
* Prior surgical treatment of the nasal valve
* Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
* Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
* Known or suspected to be pregnant or is lactating.
* Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.
* Current participation in any study or participation in any study less than 6 weeks before study date 1.
-
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
| NCT04717791 | {
"brief_title": "Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing",
"conditions": [
"Nasal Obstruction, Bilateral"
],
"interventions": [
"Device: Vivaer® ARC Stylus"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04717791",
"official_title": "Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-04",
"study_completion_date(actual)": "2022-10-04",
"study_start_date(actual)": "2020-09-08"
},
"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)": "2023-01-18",
"last_updated_that_met_qc_criteria": "2021-01-20",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-22",
"first_submitted": "2021-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.
Detailed Description
After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA.
48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale.
#Intervention
- DRUG : Ulipristal acetate
- Other Names :
- ESMYA®
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Not postmenopausal women aged 30 to 50,
* Accepting to give consent informed in writing,
* Suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated with pain)
* Diagnosis information, confirmed the adenomyosis (T2-weighted) MRI and/or transvaginal ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding (PBAC) > 100 from J1 to J8 of the menstruation before the visit of inclusion,
* With an index of body mass (IMC) >=18 and < 40,
* Using a reliable method of non-hormonal contraception (non-hormonal intrauterine device (IUDs), sexual abstinence, diaphragm, condoms or vasectomy by the partner, or having undergone a surgical sterilization),
* Willing and able to complete auto-questionnaires in french
* Had no difficulties to understand and communicate with the investigator and his representatives
* Affiliation to a social security or assign.
Exclusion Criteria:
* Patient with a hormonal oral contraceptive or with a hormonal intrauterine Device (IUD) contraceptive
* Patient with a history of surgery (other than a caesarean or a cervical conization) uterus, ablation endometrial or uterine artery embolization,
* With other than the endometriosis endometrial pathology,
* Suffering of myoma of type 0, 1, 2 or 3,
* Requiring a transfusion or having a <=6g/dL hemoglobin
* Existence of systemic coagulation,
* History of thromboembolism
* Progestagen taking severe disorders in the month preceding the tour selection, and corticosteroids and aspirin in the previous week,
* Existence of Pathology renal, respiratory or cardiac severe or progressive,
* Having a disturbed liver function (defined by the aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT), γGlutamylTranspeptidase, alkaline phosphatase or total bilirubin above 2 times the upper limit of normal),
* Existence or suspicion of malignancy,
* Considering pregnancy in the coming year,
* Pregnant patient or nursing
* Any clinical condition that the investigator considers incompatible with the conduct of the study in terms of acceptable security,
* Participation in courses at another clinical study
* Patient whose accession to the test procedures may be insufficient or for which a long term follow-up seems difficult to achieve
* Person under authorship or curators under safeguard of justice
* History of hypersensitivity to the ulipristal or any of the excipients of ESMYA ® 5 mg tablet.
Sex :
FEMALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT02587000 | {
"brief_title": "Adenomyosis and Ulipristal Acetate",
"conditions": [
"Adenomyosis"
],
"interventions": [
"Drug: Ulipristal acetate",
"Drug: Placebo"
],
"location_countries": [
"France"
],
"nct_id": "NCT02587000",
"official_title": "Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-02",
"study_completion_date(actual)": "2020-03-17",
"study_start_date(actual)": "2015-06-16"
},
"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)": "2022-09-27",
"last_updated_that_met_qc_criteria": "2015-10-23",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-27",
"first_submitted": "2015-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.
#Intervention
- PROCEDURE : LAL IOL lens
- Standard of care Cataract surgery with IOL placement | #Eligibility Criteria:
Inclusion Criteria:
* Patients able to sign informed consent
* Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.
Exclusion Criteria:
* Inability to sign informed consent
* Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
* Unable to return for light treatments
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 110 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04533191 | {
"brief_title": "Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)",
"conditions": [
"Cataract",
"Pseudophakia"
],
"interventions": [
"Procedure: LAL IOL lens"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04533191",
"official_title": "Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-01",
"study_completion_date(actual)": "2021-02-01",
"study_start_date(actual)": "2020-09-01"
},
"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)": "2024-05-20",
"last_updated_that_met_qc_criteria": "2020-08-25",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-31",
"first_submitted": "2020-08-25",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.
Detailed Description
This phase 1 first-in-human study was designed to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of EI1071 when administered to healthy adult volunteers. This was a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study was conducted in two phases: a single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. Approximately 58 healthy volunteers enrolled in SAD and MAD cohorts (34 in SAD; 24 in MAD). In SAD, participants in Cohorts 1 to 5 received one dose of EI-1071 or placebo. In MAD, participants in Cohorts 1 and 2 received multiple doses of EI-1071 or placebo for 14 consecutive days. Safety, tolerability, and PK profile of EI-1071 were assessed.
#Intervention
- DRUG : EI-1071
- EI-1071 Tablet(s)
- DRUG : Placebo
- Matching Placebo Tablet(s) | #Eligibility Criteria:
Inclusion Criteria:
Subjects were eligible for enrollment in the study only if they met all the following criteria:
* Healthy male and female subjects, 18 <= age <= 45 of age, inclusive. (Taiwan only: To be at least 20 years.)
* The subject had a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 50kg.
* The subject was in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator (as determined by medical history, physical examination, 12-lead electrocardiogram [ECG], vital signs, and clinical laboratory results at screening).
* The subject was able to understand the nature of the study and any potential hazards associated with participating in it.
* The subject was able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
* The subject was willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
* Negative pregnancy test for female subjects. Women of child bearing potential and Women not of child bearing potential were eligible to participate. Both women of child bearing potential and women of no child bearing potential used an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 90 days after taking the last dose of EI1071). Acceptable methods of contraception included abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method, female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner was surgically sterile or 2 years post-menopausal. All male subjects/partners must agree to consistently and correctly use a condom. In addition, subjects may not donate sperm for the duration of the study and for 90 days after taking study drug.
* Subject was currently not using strong inhibitors or inducers of CYP3A4 and was not anticipated to use these for the duration of the study
Exclusion Criteria:
Subjects were eligible for enrollment in the study only if they meet none of the following criteria:
* The subject had a history of severe allergic or anaphylactic reactions.
* The subject had a known allergy or hypersensitivity to any component of the formulation.
* The subject had a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
* The subject had a history of any malignant disease.
* The subject had a history of more than one herpes zoster episode or multidermatomal herpes zoster.
* The subject had a history of an opportunistic infection (e.g. cytomegalovirus, pneumocystis carinii, aspergillosis, clostridium difficile).
* The subject had a history of or ongoing chronic or recurrent infectious disease (e.g. infected indwelling prosthesis, osteomyelitis, chronic sinusitis).
* The subject had major trauma or surgery in the 2 months before screening or at any time between screening and check-in.
* The subject had an acute infection within 2 weeks before screening or at any time between screening and check-in including, but not limited to, history, signs, or symptoms of a common cold (eg, mild rhinorrhea), untreated oral/dental abnormalities (e.g. untreated dental caries as determined by examination of the mouth), or untreated disruption of the skin.
* The subject had clinically significant abnormal ECG findings at screening, check-in visits, or predose, as determined by the Investigator.
* The subject had a supine blood pressure measurement outside the ranges of 90 to 140 mm Hg systolic or 45 to 90 mm Hg diastolic (measured after a rest of at least 5 minutes) at screening, check-in, or predose. Note: If either value was out of the range, blood pressure measurements may be repeated in the supine position at intervals of 5 to 10 minutes up to 3 times. If the mean systolic or diastolic measurement continues to exceed the stated limits, the subject will be excluded.
* The subject had a pulse of fewer than 45 beats per minute (bpm) or greater than 100 bpm(measured after a rest of at least 5 minutes) at screening, check-in, or predose.
* The subject tests positive for tuberculosis (TB) at screening by the QuantiFERON-TB Gold Test, or has a history of latent, inadequately treated, or active TB.
* The subject had a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening.
* The subject had used prescription or over-the-counter (OTC) medication (other than <=2 g/day paracetamol [acetaminophen] or <=800 mg/day ibuprofen), vitamins, or herbal remedies, within 2 weeks or 5 half-lives before study drug administration, whichever was longer.
* The subject had participated in another clinical study of a new investigational drug or has received an investigational drug within the 3 months or 5 half-lives (if available) before study drug administration, whichever is longer.
* The subject had a loss of more than 400 mL of blood (e.g. a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before check-in, or plans to donate blood during the study or within 3 months after the study.
* The subject had a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 1 single shot of spirits. The subject will be required to abstain from alcohol consumption 48 hours prior to screening or check-in.
* The subject was a current smoker or has a history of smoking.
* The subject had a positive test for alcohol or drugs of abuse (barbiturates, methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines, tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone, and cotinine) at screening or check-in.
* The subject was unable to participate in, or successfully complete, the study, in the opinion of their general practitioner or the investigator, because the subject was any of the following:
1. mentally or legally incapacitated, or unable to give consent for any reason
2. in custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitarium or social institution
3. unable to be contacted in case of emergency
4. unlikely to cooperate or comply with the clinical study protocol or was unsuitable for any other reason
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
| NCT04238364 | {
"brief_title": "A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: EI-1071",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04238364",
"official_title": "A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EI1071 in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-16",
"study_completion_date(actual)": "2022-01-10",
"study_start_date(actual)": "2019-12-27"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-24",
"last_updated_that_met_qc_criteria": "2020-01-19",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-23",
"first_submitted": "2020-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.
#Intervention
- DEVICE : Epiceram(r)
- Topical barrier repair emulsion cream
- DRUG : Fluticasone Propionate 0.05%
- Topical mid-strength steroid | #Eligibility Criteria:
Inclusion Criteria:
* Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages > 7 <= age <= 18 and parental consent for ages 6 months to 7 years) to participate in the study
* Males or Females
* Age: 6 months to 18 years
* Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index
Exclusion Criteria:
* Subjects with mild AD as defined by the Rajka-Laneland Severity Index.
* Subjects having greater than 20% BSA as measured by SCORAD 'Extent' (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%)
* Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
* Subjects who require greater than 2mg per day of inhaled or intranasal steroids.
* Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month.
* Subjects with known allergy to or hypersensitivity to EpiCeram™ or Fluticasone or Cetaphil.
* Active infection of any type at the start of the study.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00616538 | {
"brief_title": "Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis",
"conditions": [
"Atopic Dermatitis"
],
"interventions": [
"Device: Epiceram(r)",
"Drug: Fluticasone Propionate 0.05%"
],
"location_countries": null,
"nct_id": "NCT00616538",
"official_title": "Prospective, Randomized, Investigator-Blind, Controlled, Pilot Study Comparing Effect of Epiceram™ Device vs Standard of Care Therapy of Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) in Treatment of Atopic Dermatitis in Pediatric Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-04",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-02-15",
"last_updated_that_met_qc_criteria": "2008-02-05",
"last_verified": "2008-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-15",
"first_submitted": "2008-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a study of the registration of tobacco, coffee and substance abuse among acutely admitted psychiatric patients.
Detailed Description
We will include all patients acutely admitted to Østmarka Psychiatric Hospital to register this population's use of coffee, tobacco and substances. We will determine whether this differs from other populations, between diagnoses, age, etc.
We will also compare results of substance in immunologic rapid urine tests taken by the nurse at the hospital with substance in urine tested in laboratory with LC/MS (liquid chromatography/mass spectrometry).
| #Eligibility Criteria:
Inclusion Criteria:
* All patients acutely admitted to Østmarka Psychiatric Hospital
Exclusion Criteria:
* Dementia
* Serious brain damage
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
| NCT00184184 | {
"brief_title": "Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients",
"conditions": [
"Substance Abuse",
"Tobacco Use Disorder"
],
"interventions": null,
"location_countries": [
"Norway"
],
"nct_id": "NCT00184184",
"official_title": "Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-06",
"study_completion_date(actual)": "2005-06",
"study_start_date(actual)": "2004-10"
},
"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)": "2017-03-14",
"last_updated_that_met_qc_criteria": "2005-09-15",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-16",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a non-randomized, multi-site, open-label trial of pembrolizumab and chemotherapy in subjects with gastric or gastroesophageal (GE) junction adenocarcinoma. The purpose of this study is to determine and evaluate the efficacy of combination therapy with immune checkpoint blockade and chemotherapy used in the perioperative period in eradicating micrometastatic disease; and to compare paired tissue and serum samples (pre-treatment and post-treatment) from individually treated patients to explore the immune effects of combination therapy and predictors of response.
Detailed Description
Gastric cancer is one of the most common cancers worldwide. Surgical resection is the primary treatment for gastric cancer but most patients present with locally advanced disease and recurrence is common after surgery. Many patients (35%) will have early recurrence within 6-9 months of surgery indicating the need for more aggressive upfront therapy in these subjects. In addition, the majority of patients will ultimately have recurrence and 5 year survival rates are 35-40% despite aggressive therapy.
The ability to combine immunotherapy with pembrolizumab gives the potential to increase therapeutic options while continuing standard of care chemotherapy. The particular use of maintenance therapy may delay or eliminate the growth of residual micrometastatic disease and lead to durable disease control. Additionally, this study provides the foundation for substantial correlative work to define tumor and patient characteristics that may predict for response to pembrolizumab in gastric cancer.
The initial primary outcome of Disease Free Survival (DFS) was changed to pathologic complete response rate (pCR) on November 24, 2020, at which time no formal data analysis had been preformed.
#Intervention
- DRUG : Pembrolizumab
- Pembrolizumab dosed IV at 200mg every 21 days per cycle.
- Other Names :
- KEYTRUDA, MK-3475
- DRUG : Standard of care chemotherapy regimen
- Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
- Other Names :
- Investigator's choice of of standard regimen | #Eligibility Criteria:
Inclusion Criteria:
* Have previously untreated localized gastric or GE junction adenocarcinoma as defined by T2 or greater primary lesion or the presence of any positive nodes- N+(clinical nodes) without evidence of metastatic disease.
* Plan to proceed to surgery following peri-operative chemotherapy based on standard staging studies per local practice.
* Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
* Be at least 18 years on day of signing informed consent.
* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1.
* Have a performance status of 0 or 1 on the ECOG Performance Scale.
* Demonstrate adequate organ function as defined below, all screening labs should be performed within 14 days of treatment initiation.
Adequate Organ Function Laboratory Values
* Absolute neutrophil count (ANC) >=1,500 /mcL
* Platelets >=100,000 / mcL
* Hemoglobin >=9 g/dL or >=5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
* Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <=1.5 X upper limit of normal (ULN) OR >=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
* Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN
* AST (SGOT) and ALT (SGPT) <= 2.5 X ULN OR <= 5 X ULN for subjects with liver metastases
* Albumin >2.5 mg/dL
* International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Activated Partial Thromboplastin Time (aPTT) <=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Creatinine clearance should be calculated per institutional standard.
* Have a 2D Echocardiogram with left ventricular ejection fraction = or > 45% in order to receive Epirubicin. Subjects with inadequate EF or other contraindication can proceed on study without the use of Epirubicin.
* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 120 days after the last dose of study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
* Male subjects of childbearing potential must agree to use an adequate method of contraception - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids (prednisone 10 mf or equivalent) may be approved after consultation.
* Has a known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had any prior chemotherapy, targeted small molecule therapy, or radiation therapy for their current diagnosis.
* Has a known additional malignancy that is progressing or requires active treatment within 3 years from registration. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Subjects with a history of prior malignancy diagnosed and treated greater than 3 years form registration may be considered with consultation of the primary investigator.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has known history of prior pneumonitis requiring treatment with steroids, or any evidence of active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy which is not expected to have resolved by Cycle 1 Day 1 dosing.
* Has a history or current evidence of any condition (e.g. known deficiency of the enzyme dihydropyrimidine dehydrogenase [DPD]),, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor-investigator staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
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
| NCT02918162 | {
"brief_title": "Perioperative Chemo and Pembrolizumab in Gastric Cancer",
"conditions": [
"Gastric Cancer",
"Adenocarcinoma of the Gastroesophageal Junction"
],
"interventions": [
"Drug: Standard of care chemotherapy regimen",
"Drug: Pembrolizumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02918162",
"official_title": "A Phase II Study of Chemotherapy and Immune Checkpoint Blockade With Pembrolizumab in the Perioperative and Maintenance Treatment of Locoregional Gastric or GE Junction Adenocarcinoma.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-28",
"study_completion_date(actual)": "2023-02-28",
"study_start_date(actual)": "2017-11-25"
},
"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)": "2024-02-15",
"last_updated_that_met_qc_criteria": "2016-09-27",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-28",
"first_submitted": "2016-09-27",
"first_submitted_that_met_qc_criteria": "2024-01-18"
}
}
} |
#Study Description
Brief Summary
Anxiety is a growing problem and has been steadily increasing, particularly in the adolescent and young adult populations in the past 24 years. Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been independently investigated in prior studies. Here, the anxiety-reducing potential of calm music combined with theta ABS was examined in a large sample of participants. Participants taking anxiolytics (n = 163) were randomly assigned to a single 24-minute session of sound-based treatment: combined (music \& ABS), music-alone, ABS-alone, or pink noise (control). Pre- and post-intervention somatic and cognitive state anxiety measures (STICSA State) were collected along with trait anxiety (STICSA Trait), personality measures (Short Form Eysenck Personality Inventory) and musical preferences (Short Test of Music Preferences).
Detailed Description
In this study, the investigators examined and compared the effectiveness of ABS in the theta range, calm music playlist curated by an affective music recommendation system, and the combination of ABS and the same music to reduce anxiety and stress levels (as measured by the State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)) compared to a control condition (pink noise). Prior work has demonstrated that ABS and music both reduce anxiety when presented on their own. It is hypothesized that music with ABS will lead to significantly lower anxiety levels and increased calmness compared to the other experimental conditions. Approximately 163 participants were recruited from the Prolific online participant pool (https://www.prolific.co). The experiment was conducted on the Qualtrics survey platform, and the experimental treatment was provided with the LUCID Research App. After reading and agreeing with the consent form, participants provided their Prolific ID and then filled out the Short Test of Music Preferences (STOMP), Queen's Music Questionnaire, Anxiety coping method's questionnaire, Positive and Negative Affect Scale (PANAS), Self-Assessment Manikin (SAM), Eysenck Personality Questionnaire, and the State Trait Inventory of Cognitive and Somatic Anxiety (STICSA). Participants were also asked to list any medications currently being taken (including cannabis). Participants were then randomly assigned to one of four treatment groups: (1) music; (2) music and auditory beat stimulation (ABS); (3) auditory beat stimulation (ABS) alone; or (4) pink noise for 24 minutes. Participants then received instructions on how to download the LUCID Research app on their iOS device or access the LUCID Research App through a virtual machine using their computer. Participants listened to their randomly assigned treatment for 24 minutes. Participants then completed their post-intervention questionnaires which included: the STICSA state version, SAM and PANAS. The investigators' hypotheses were that the combined, music alone and ABS alone conditions would experience a greater reduction in somatic and cognitive state anxiety compared to the pink noise control condition. These hypotheses were pre-registered using the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/VHCA5) and were based upon previous studies showing that ABS and music listening are capable of reducing anxiety. The investigators had no specific predictions for moderate and high trait anxiety participants, but their pre-registration noted their intention to recruit from both of these populations.
#Intervention
- BEHAVIORAL : Music & Auditory Beat Stimulation
- Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes
- BEHAVIORAL : Music Alone
- Listening to calm music Participants listened to calm music for 24 minutes
- BEHAVIORAL : Auditory Beat Stimulation
- Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes
- BEHAVIORAL : Pink Noise
- Listening to pink noise Participants listened to pink noise for 24 minutes | #Eligibility Criteria:
Inclusion Criteria:
* Adults (18+)
* Must be taking anxiety medication
* Self-identified normal hearing
* No known cardiac issues
* No known epilepsy/seizures
* Have access to an iOS device (iPhone or iPad) to run the Research Application
Exclusion Criteria:
* Adults younger than 18
* Not taking anxiety medication
* Have known cardiac issues
- Do not have access to an iOS device (iPhone or iPad) to run the Research Application
* Have known epilepsy/seizures
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
| NCT05171218 | {
"brief_title": "The Effects of Music & Auditory Beat Stimulation on Anxiety",
"conditions": [
"Anxiety"
],
"interventions": [
"Behavioral: Music Alone",
"Behavioral: Auditory Beat Stimulation",
"Behavioral: Pink Noise",
"Behavioral: Music & Auditory Beat Stimulation"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05171218",
"official_title": "The Effects of Music & Auditory Beat Stimulation on Anxiety",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-02",
"study_completion_date(actual)": "2021-02-02",
"study_start_date(actual)": "2020-07-09"
},
"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)": "2022-01-21",
"last_updated_that_met_qc_criteria": "2021-12-09",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-28",
"first_submitted": "2021-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.
Detailed Description
Prostate cancer (PCa) is the most common non-skin cancer effecting American males. Several reports suggest that physical activity after cancer diagnosis is associated with better cancer- specific and overall survival in individuals diagnosed with PCa. There is a growing body of evidence for lifestyle interventions that aim to promote physical activity as having the potential to counter some of the adverse effects of cancer treatments, disease progression and other health outcomes. Exercise performed 2-3 times a week has been shown to improve physical fitness, functional performance, and quality of life in men with PCa; however, few men with PCa exercise regularly and do not meet national physical activity guidelines. A potential explanation on the lack of exercise in men with PCa is the absence of a structured, home-based, exercise program. While studies have shown positive effects of exercise in men with PCa, little is known about how physical activity effects tumor physiology in men with PCa. The primary objective of this pilot study is to gather preliminary data regarding the impact of a novel, home-based exercise program on PCa biomarkers associated with recurrence and metastasis of PCa in men under active surveillance.
#Intervention
- OTHER : Home-Based Exercise Program
- The intervention will include a combination of both aerobic and body-weight based exercises. The aerobic portion of the intervention will include 5 days of light to moderate intensity walking for 30 mins. Intensity will be set at 40-60% of the individual's heart rate reserve. The body-weight based exercises will be done 3 times a week and will consist of 3 sets of 15 reps of bodyweight squats, incline push-ups, and hip thrusts. If these exercises cannot be performed, lower intensity exercises such as sit-to-stand, wall push up and pelvic tilt can be replaced. Individuals in this group will be given a pocket guide with instructions on how to safely perform the exercises and document their completion.
- Other Names :
- Exercise Group | #Eligibility Criteria:
Inclusion Criteria:
* Men aged >= 40 years
* Ambulating male
* Diagnosed with low grade prostate cancer
* Subjects willing and able to provide consent to participating in the study Exclusion Criteria
* prostatectomy
* severe cardiac disease (New York Heart Association class III or greater)
* angina
* severe osteoporosis
* uncontrolled hypertension (blood pressure > 160/95mm Hg)
* uncontrolled sinus tachycardia (> 120 beats per minute)
* uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness,
* severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation).
Sex :
MALE
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03397030 | {
"brief_title": "Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer",
"conditions": [
"Prostatic Neoplasm"
],
"interventions": [
"Other: Home-Based Exercise Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03397030",
"official_title": "Impact of a Home-based Exercise Program on Prognostic Biomarkers in Men With Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-09",
"study_completion_date(actual)": "2020-11-19",
"study_start_date(actual)": "2017-01-05"
},
"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)": "2021-08-10",
"last_updated_that_met_qc_criteria": "2018-01-04",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-11",
"first_submitted": "2018-01-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine, and lumbar puncture samples were collected whenever other specimens were obtained from participants for cultures. These samples are being tested using the new methods and compared with standard culture results. Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age.
Detailed Description
Candida species are a leading cause of infectious mortality in newborns with the incidence rates estimated at 4-18% in extremely low birth weight (ELBW) infants. 20-30% of these infants are likely to die. Because candida can invade virtually all body tissues (eyes, brain, heart, lung, liver, spleen, urinary tract, and joints), survivors of invasive Candida infections are at risk of blindness, developmental delays, and the need for surgical and other corrective procedures.
Time is of the essence in detecting and treating these infections, with infant mortality from candidiasis largely attributed to duration of time for cultures to become positive for Candida. Diagnosis of candidiasis is challenging - blood and urine tests are slow (taking up to 72 hours to complete) and inaccurate in many cases, showing negative results despite overwhelming disease in adults as well as children. These problems are likely made worse in neonates, with smaller amounts of blood available for testing and infections that often spread to tissues inaccessible for testing.
This observational study is evaluating the performance of new lab tests (beta-glucan assays, Gas Chromatography Mass Spectrometry for D-arabinitol, and polymerase chain reaction tests) compared to existing culture tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
In this study, 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g by 72 hours of life; more than 100 of these infants later tested positive for candidiasis. In the larger cohort, whenever cultures of blood or urine were obtained, or a lumbar puncture was done, additional samples and clinical data were collected. These additional samples are being tested using the new techniques under investigation. No additional blood specimens were taken once participants had a positive blood culture for candida. Note: Test procedure reagents are being provided the Duke University laboratory by Cape Cod Incorporated and Rockeby; the Thrasher Research Fund is also providing support to the Duke University laboratory.
Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age to evaluate potential early risk factors with long-term outcome.
| #Eligibility Criteria:
Inclusion Criteria:
* Infants born <=1,000g birth weight
* Infants >72 hours old and less than 120 days old
Exclusion Criteria:
* Prior positive blood culture for Candida
* Evidence of congenital candidiasis
* Parents/legal guardians refuse consent
Sex :
ALL
Ages :
- Minimum Age : 3 Days
- Maximum Age : 120 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT00109525 | {
"brief_title": "Early Diagnosis of Candidiasis in Premature Infants",
"conditions": [
"Infection",
"Candida",
"Candidiasis",
"Infant, Newborn",
"Infant, Low Birth Weight",
"Infant, Small for Gestational Age",
"Infant, Premature"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00109525",
"official_title": "Early Diagnosis of Nosocomial Candidiasis Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-07",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2004-03"
},
"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)": "2019-03-22",
"last_updated_that_met_qc_criteria": "2005-04-28",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-04-29",
"first_submitted": "2005-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the treatment of chronic heel pain arising from plantar fasciitis.
Detailed Description
Chronic heel pain is one of the most common forms of foot pain in adults. The heel bone (calcaneus) receives a lot of stress as it is the largest bone in the foot, and the heel is the first part of the foot to contact the ground during walking. Normally, as the foot absorbs the weight of the body during walking, the arch area joint locking mechanism provides about 80% of the stability of the foot. The other 20% of biomechanical stability is provided by the plantar fascia and muscles, tendons, and ligaments. Gait abnormalities can cause inflammation of the structures attached to the heel bone, resulting in heel pain.
Plantar fasciitis refers to syndromes of pain that occurs at the site of the attachment of the plantar fascia and the calcaneus, with or without accompanying pain along the medial band of the plantar fascia. Eighty per cent (80%) of heel pain is caused by plantar fasciitis, with 10% of the U.S. population likely to be afflicted over a lifetime. Two million Americans are treated for plantar fasciitis each year. It is more common in women than men and in people aged 40-60 years.
Plantar fasciitis results from small tears and inflammation in the wide band of tendons and ligaments that stretch from the heel to the ball of the foot. This band forms the arch of the foot and serves as a shock absorber for the body. Causes of plantar fasciitis include poor footwear, sedentary lifestyles, obesity and sports injuries. Plantar fasciitis is characterized by pain at the bottom of the heel on weight bearing, particularly when first arising in the morning, and after prolonged periods of rest.
Progressive conservative treatment options for plantar fasciitis include rest, stretching, strengthening, massage, physical therapy, orthotics and shoe inserts, heel cups, night splints, plantar strapping, non-steroidal anti-inflammatories (NSAIDs), steroid and corticosteroid injections and iontophoresis. When conservative treatments are unsuccessful, surgical release or removal of the plantar fascia may occur.
However, most conservative approaches are of limited effectiveness and there are potential significant complications from plantar fascia surgery.
Low level laser therapy (LLLT) offers a quick, painless, non-invasive, side-effect free alternative to relieve the debilitating pain of plantar fasciitis. When applied to injuries and lesions, low level laser light has been shown to stimulate healing and reduce pain by accelerating the speed, quality and strength of tissue repair and the reduction of inflammation. Laser therapy has been found to be particularly effective over other standard therapies in relieving pain and other symptoms associated with chronic problems and injuries as it impacts the complete system of targeted muscles, tendons, ligaments, connective tissue, bone, nerve, and dermal tissues. Additionally, Erchonia low level lasers have been shown through controlled clinical trials to be effective for pain reduction, as evidenced through several FDA 510(k) approvals for various indications.
#Intervention
- DEVICE : Erchonia HPS Laser
- The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
- DEVICE : Placebo Laser
- The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. | #Eligibility Criteria:
Inclusion Criteria:
* Unilateral mechanical plantar heel pain
* Chronic heel pain defined as at least 3 months of ongoing heel pain with no evidence of acute trauma to the heel
* Degree of heel pain rating on the 0 <= age <= 100 Visual Analog Scale (VAS) is at least 50 for heel pain experienced upon taking the first few steps of the day.
* Heel pain has been previously unresponsive to prescription non-steroidal anti-inflammatory drugs (NSAIDs) taken over a minimum period of 2 weeks; and any two or more of the following conservative treatments: rest, taping, stretching, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections
* Subject is willing and able to refrain from consuming non-study approved medications or partaking in other therapies for relief of heel pain throughout study participation
Exclusion Criteria:
* Inability to definitively rule out any one or more of the following potential etiologies of chronic heel pain: mechanical posterior; neurologic; arthritic; and traumatic heel pain
* Bilateral heel pain
* Evidence of acute trauma to the heel
* Loss of plantar foot sensation
* Foot deformity
* Previous surgery to the heel
* Foot trauma within the previous three months
* Skin ulceration (infection or wound) on the heel and surrounding area
* Sciatica
* Benign and malignant tumors
* Acute infection of soft tissue or bone such as osteomyelitis
* Diabetic neuropathic pain
* Type I Diabetes
* Sensory neuropathy
* Previous diagnosis of neuropathy affecting lower extremities
* Peripheral vascular disease or autoimmune disease
* Fibromyalgia
* Chronic fatigue syndrome
* Chronic pain disorders
* Metabolic disorders: Osteomalacia, Paget's disease, Sickle cell disease.
* Blood coagulation disorders
* Significant heart conditions including coronary heart failure (CHF) and implantable heart devices
* Non-ambulatory status
* Unable or unwilling to consume the study rescue medication of Tylenol
* Photosensitivity disorder
* Pregnant or lactating
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
* Developmental disability or cognitive impairment that would preclude adequate comprehension of the consent form or the ability to record the study measures
* Involvement in litigation or a worker's compensation claim or receiving disability benefits related to the heel pain
* Participation in other research in the past 30 days
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
| NCT01835743 | {
"brief_title": "Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis",
"conditions": [
"Plantar Fasciitis"
],
"interventions": [
"Device: Placebo Laser",
"Device: Erchonia HPS Laser"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01835743",
"official_title": "A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Chronic Heel Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2012-02"
},
"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)": "2014-06-03",
"last_updated_that_met_qc_criteria": "2013-04-17",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-19",
"first_submitted": "2013-04-17",
"first_submitted_that_met_qc_criteria": "2014-05-08"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.
#Intervention
- DRUG : Atorvastatin
- Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
(When not reach the LDL-C level of target in the Japan Atherosclerosis Society \[JAS\] Guidelines \[GL\] after 3 months, had the atorvastatin \[ATV\] dose of 20 mg.)
- Other Names :
- Lipitor
- DRUG : Rosuvastatin
- Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin \[RSV\] dose of 10 mg.)
- Other Names :
- Crestor | #Eligibility Criteria:
Inclusion Criteria:
* Hypercholesterolemia patients
* Patients who have not achieved the target control levels of LDL-C in the 'Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007'
* Type 2 diabetes patients
* Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication
* Patients who received constant therapy for three months before registration and have no plan for therapy change
* Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration
* Patients receiving or not receiving medication at present
* Patients giving voluntary written consent to participate in the study
* Male or female patients at >= 20 years
Exclusion Criteria:
* Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration
* Patients with severe hypertension (systolic blood pressure [SBP] >= 180 mmHg or diastolic blood pressure [DBP] >= 110 mmHg)
* Patients with type 1 diabetes
* Patients judged to have familial hypercholesterolemia
* Patients with a serum triglyceride level of >= 400 mg/dL
* Patients who had the onset of cardiovascular or cerebrovascular disease within three months
* Patients with serious heart failure (NYHA classification III - IV)
* Patients with a history of hypersensitivity to statins
* Patients with a history of drug-induced myopathy
* Patients with severe complication of diabetes
* Patients receiving insulin
* Patients with serious liver or kidney disease
* Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan
* Patients who are or may be pregnant
* Patients judged by the investigators to be ineligible for participation in the study for any other reason
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01544309 | {
"brief_title": "LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts",
"conditions": [
"Hypercholesterolemia With Concomitant Type 2 Diabetes"
],
"interventions": [
"Drug: Rosuvastatin",
"Drug: Atorvastatin"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01544309",
"official_title": "Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2012-03"
},
"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)": "2015-03-17",
"last_updated_that_met_qc_criteria": "2012-02-28",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-05",
"first_submitted": "2012-02-23",
"first_submitted_that_met_qc_criteria": "2015-03-04"
}
}
} |
#Study Description
Brief Summary
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods. Participants will receive a single dose of LY2624803 or placebo in each treatment period.
#Intervention
- DRUG : LY2624803 - Solution
- Administered orally as reconstituted solution
- DRUG : LY2624803 - Capsule
- Administered orally as a capsule
- DRUG : Placebo - Solution
- Administered orally as solution
- DRUG : Placebo - Capsule
- Administered orally as a capsule | #Eligibility Criteria:
Inclusion Criteria:
* Overtly healthy males or female Japanese
* Women of child-bearing potential, who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug
* Body mass index (BMI) of 17.6 to 26.4 kilogram per meter square (kg/m^2), inclusive
* Normal bedtime hours, with routine time spent in bed between 6.5 hours and 9 hours each night
* Clinical laboratory test results within normal reference range
* Venous access sufficient to allow blood sampling as per the protocol
* Are reliable and willing to make themselves available for the duration of the study and are willing and able to follow study procedures
* Have given written informed consent approved by Lilly and the ethical review board governing the site
Exclusion Criteria:
* Within 4 months of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
* Persons who have previously completed or withdrawn from this study or any other study investigating LY2624803 after receiving study drug
* Known allergies to LY2624803 or related compounds
* Women who are lactating
* Shift workers [those who shifted or plan to shift work within 7 days of any phase advance polysomnography (PSG) night] or any person who has crossed (or will have crossed) more than one time zone by aircraft within 3 days prior to entry
* Have an irregular or altered sleep/wake schedule that is likely to prevent from keeping a regular sleep/wake schedule during the study
* Regular napping (>= 2 daytime naps/week by history)
* Extreme morning type or evening type
* Rhinitis, conjunctivitis, urticaria or chronic pain severe enough to interfere with sleep
* Nocturia that would interfere with sleep assessment
* Symptoms consistent with a sleep disorder or history of same
* Evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months that could contribute to insomnia
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurocardiogenic or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* History or presence of orthostatic signs and symptoms within 2 years
* History of seizure or a close relative having a seizure disorder (such as epilepsy). History of a single febrile convulsion more than 10 years ago is acceptable. History of cranial trauma and loss of consciousness will be discussed prior to including any such participant
* Abnormal movements observed outside of normal sleep time
* Abnormal supine blood pressure and/or pulse rate
* Participants with orthostatic hypotension at screening
* An abnormality in the 12-lead electrocardiogram (ECG) that increases the risks associated with participating in the study
* Regular use of known drugs of abuse and/or positive findings on urinary drug screening
* Evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
* Evidence of hepatitis C and/or positive hepatitis C antibody
* Evidence of hepatitis B and/or positive hepatitis B surface antigen
* Evidence of syphilis infection and/or positive syphilis test
* Use or intended use of prescription (except oral contraceptives), over-the-counter or herbal medication, specifically antihistamines, anticholinergic medications or any medications that affect sleepiness, within 28 days prior to Period 1 dosing and/or during the study
* Participants who have donated more than 200 milliliters (mL) of blood or component blood within one month of screening, or those who have donated more than 400 mL of blood within 3 months of screening
* History of smoking within the previous 6 months of screening
* Participants who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or participants unwilling to stop alcohol consumption for the period
* Participants whose daily caffeine intake does not permit maintenance of usual sleep/wake schedule
* No response to phase advance or a placebo responder
* Sleep disorders detected during the PSG screening night
* History or presence of breast cancer
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01784614 | {
"brief_title": "A Study of LY2624803 in Japanese Participants With Transient Insomnia",
"conditions": [
"Sleep Initiation and Maintenance Disorders"
],
"interventions": [
"Drug: Placebo - Solution",
"Drug: LY2624803 - Capsule",
"Drug: LY2624803 - Solution",
"Drug: Placebo - Capsule"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01784614",
"official_title": "Pharmacodynamics and Pharmacokinetics of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Japanese Subjects",
"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)": "2009-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-28",
"last_updated_that_met_qc_criteria": "2013-02-04",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-06",
"first_submitted": "2013-02-04",
"first_submitted_that_met_qc_criteria": "2015-12-22"
}
}
} |
#Study Description
Brief Summary
In this regard, the present research project aims to compare dexamethasone PK in normal-weight versus obese patients treated for COVID-19.
This observational study will include patients hospitalized at HUG (Division of General Internal Medicine) with COVID-19 and treated with oral DEX. This study will include 2 groups of patients according to their body mass index (BMI) (normal weight with a BMI of 18.5-25.0 kg/m2; obese/ morbidly obese with a BMI ≥30). The primary outcome will be the assessment of the differential impact of weight on DEX PK. Finally, the data generated will be used to build a physiologically based PK (PBPK) model for DEX and in different sub-groups. The model will aim to predict the effect of BMI in virtual populations with different drugs and in different scenarios. This should allow prospective dose adjustment of DEX based on patient weight.
Detailed Description
Before starting the study, COVID-19 patients receiving dexamethasone as part of their hospital management and meeting the criteria of inclusion and non-exclusion will have an information session with an investigator as described above.
During the study session, capillary blood samples will be taken during a total of 8 hours, time starting just before DEX administration, and at the following times after the dose: time of the drug intake, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours. The capillary blood sample will be obtained by pricking the fingertip using contact-activated lancet (BD Microtainer). A total of five blood drops (10 μL each) will be collected by a micropipette and will be dropped off on the blotting paper 903 S\&S (Whatman). After a 45-minute drying time at room temperature, dried blood samples (DBS) samples will be packed in sealable plastic bags containing a desiccant and stored at - 80°C until analysis. Drugs will be extracted from DBS using methanol. DEX quantification in capillary DBS will be performed using reverse-phase- HPLC coupled to tandem mass spectrometer (MS/MS). In addition to this, an EDTA tube (3 ml) of blood will be collected and preserved in the biobank (-80°C) and will be used whether further analysis should be performed on the samples. In this aim an authorization to reuse the samples will be requested from each patient during the consent signature.
#Intervention
- OTHER : Capillary blood sampling
- The capillary blood sample will be obtained by pricking the fingertip using contact-activated lancet (BD Microtainer). A total of five blood drops (10 μL each) will be collected by a micropipette and will be dropped off on the blotting paper 903 S\&S (Whatman). | #Eligibility Criteria:
Inclusion Criteria:
* Male and female patients >= 18 years receiving DEX for COVID-19
* Stable dose of DEX for at least 24 hours
* BMI between 18.5 and 25 or >= 30 kg/m2
* Understanding of French orEnglish languages and ability to give a written inform consent
Exclusion Criteria:
* Medical history of cirrhosis (Child Pugh B and C) or/and nonalcoholic fatty liver disease.
* History of bariatric or other gastric surgery that may affect the drug absorption
* Patient already included in a clinical trial of an investigational drug
* Use of drugs that may affect CYP3A activity * *based on the 'drug interactions and cytochromes P450' table published by The Division of clinical Pharmacology and Toxicology [15], HUG and on the investigator's knowledge and on the drug interactions website from the University of Liverpool (https://www.covid19- druginteractions.org/checker).
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
| NCT04996784 | {
"brief_title": "Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients",
"conditions": [
"Obesity"
],
"interventions": [
"Other: Capillary blood sampling"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04996784",
"official_title": "Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-09",
"study_completion_date(actual)": "2021-04-16",
"study_start_date(actual)": "2021-02-02"
},
"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)": "2021-08-09",
"last_updated_that_met_qc_criteria": "2021-08-06",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-09",
"first_submitted": "2021-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit.
#Intervention
- BEHAVIORAL : Brief Advice (BA)
- Participants in this arm will receive a single session of brief advice. A counselor will briefly discuss the risks associated with smoking.
- BEHAVIORAL : Motivational Interviewing (MI)
- Subjects will receive 4 counseling sessions (over 18 weeks) in which their thoughts about their smoking will be discussed. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone(weeks 6 and 18).
- BEHAVIORAL : Health Education (HE)
- Subjects will receive 4 counseling sessions (over 18 weeks)in which they will receive educational information about the risks of smoking and the benefits of quitting. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone (weeks 6 and 18). | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Smoke at least once a day for the past 30 days
* Are willing to participate in all study components
* Sufficient language skills in English for counseling and assessments
* Has a home address
* Has a working phone number
Exclusion Criteria:
* Pregnant or planning to become pregnant in the next 6 months
* Currently using a smoking cessation medication
* Currently participating in smoking cessation program
* Motivated to quit smoking
* Planning to quit smoking in the next 2 weeks
* Lives in a home with someone currently enrolled in the study
* Minor
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
| NCT01188018 | {
"brief_title": "Testing Counseling Styles to Motivate Smokers to Quit",
"conditions": [
"Smoking",
"Tobacco Use",
"Nicotine Dependence"
],
"interventions": [
"Behavioral: Motivational Interviewing (MI)",
"Behavioral: Brief Advice (BA)",
"Behavioral: Health Education (HE)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01188018",
"official_title": "Can Motivational Interviewing be Effective for Smoking Cessation?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-04",
"last_updated_that_met_qc_criteria": "2010-08-24",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-25",
"first_submitted": "2010-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients.
The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.
Detailed Description
Infections are globally the biggest cause of mortality. In Denmark community acquired pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia has been stable high over the past 10 years. Therefore, it is relevant to look at improving the prognosis of these patients. After a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. Hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue.
This is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions.
Proteins are the body's building blocks. Thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. Protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients.
Methods:
Inclusion: 40 men and women \>60 years hospitalized with community acquired pneumonia Intervention: The patients will be randomized to either the control- or intervention group. They will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.
#Intervention
- DIETARY_SUPPLEMENT : Protein and vitamin supplementation
- The intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement | #Eligibility Criteria:
Inclusion Criteria:
* Hospitalized patients with community acquired pneumonia
* >60 years
* Patients who are able to speak and understand Danish
Exclusion Criteria:
* Patients with hospitalized acquired pneumonia
* Patients with septic shock
* Patients with an active cancer and in cancer treatment
* Patients in dialysis
* ICU patients
* Patients unable or unwilling to give informed consent
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03774953 | {
"brief_title": "The Effect of Protein Supplement on Lean Body Mass in Patients With Pneumonia",
"conditions": [
"Community-acquired Pneumonia"
],
"interventions": [
"Dietary Supplement: Protein and vitamin supplementation"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03774953",
"official_title": "A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-30",
"study_completion_date(actual)": "2019-06-30",
"study_start_date(actual)": "2019-01-15"
},
"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)": "2019-09-13",
"last_updated_that_met_qc_criteria": "2018-12-11",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-13",
"first_submitted": "2018-12-11",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.
Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.
#Intervention
- DRUG : Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
- Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel. | #Eligibility Criteria:
Inclusion Criteria:
* Patients must be at least 2 weeks status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed independently at MSKCC.
* Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below).
* Allergy to cisplatin
* Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade > or equal to 2)
* Baseline renal insufficiency (defined as a creatinine clearance of < than or equal to 60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
* Performance status 70% on the Karnofsky scale.
* Congestive heart failure with New York Heart Association functional classification > or equal to II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
* Patient refuses to take cisplatin.
* Age > than or equal 18
* Performance Status Karnofsky > than or equal to 70%
* Peripheral neuropathy must be < than grade 1
* Hematologic (minimal values)
* Absolute neutrophil count > than or equal to 1,500/mm3
* Hemoglobin > than or equal to 8.0 g/dl
* Platelet count > than or equal to 100,000/mm3 Hepatic
* Total Bilirubin < than or equal to 1.5 x ULN AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility
* Women of childbearing potential must have a negative pregnancy test.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* Patients being considered for treatment with bevacizumab must have a urine protein: creatinine (UPC) ratio < 1.0 at screening and an MRI of brain or CT brain with IV contrast showing no evidence of brain metastases within 3 months of study entry
Exclusion Criteria:
* > 16 weeks post-op
* Prior post-operative radiation
* > 1 cycle of prior adjuvant chemotherapy
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
* Women who are pregnant, or breast-feeding.
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
| NCT00675597 | {
"brief_title": "Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer",
"conditions": [
"Lung Cancer"
],
"interventions": [
"Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00675597",
"official_title": "A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-02",
"study_start_date(actual)": "2008-05"
},
"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)": "2015-11-20",
"last_updated_that_met_qc_criteria": "2008-05-08",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-09",
"first_submitted": "2008-05-07",
"first_submitted_that_met_qc_criteria": "2015-10-20"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause.
Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.
Detailed Description
The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health Initiative (WHI) findings indicate significant potential health risks associated with HT. This has prompted women to switch from HT to naturally occurring compounds similar to estrogen, such as those derived from soy, in the hope that estrogens from plant sources can provide benefits while sparing adverse effects caused by prescribed estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes associated with estrogen deficiency in young menopausal women. The 'Soy Phytoestrogens As Replacement Estrogen (SPARE)' study will provide a foundation of knowledge from which menopausal women and their doctors can begin to make more informed decisions regarding HT and other treatment options.
Enrollment into the study will occur over 3 years, with each participant taking part in the study for a total of 2 years. Participants will be randomly assigned to one of two groups; the first group will receive a 200 mg dose of soy isoflavones daily and the second group will receive placebo daily. There will be 10 study visits: screening, study entry, randomization at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end of active participation at Month 24. At each study visit, participants will have blood drawn, provide urine samples, answer questionnaires, and have mammograms and bone density tests.
#Intervention
- DIETARY_SUPPLEMENT : Soy isoflavones
- Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
- DIETARY_SUPPLEMENT : Placebo
- Placebo soy isoflavones | #Eligibility Criteria:
Inclusion Criteria
* Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L
Exclusion Criteria
* Treatment with estrogens, progesterone, raloxifene, or tamoxifen
* Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
* Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry
* Use of antibiotics in the month prior to study entry
* Use of prescription medication to treat hot flashes
* Chemical menopause, including post-chemotherapy
* Hyperthyroidism
* Hypothyroidism
* Uncontrolled diabetes
* Malabsorption syndromes or other chronic diseases
* Body mass index (BMI) less than 20 or greater than 32
* Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00076050 | {
"brief_title": "Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms",
"conditions": [
"Menopause",
"Osteoporosis",
"Osteopenia"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Soy isoflavones"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00076050",
"official_title": "Bone Sparing Effects of Soy Phytoestrogens in Menopause",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2003-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-06",
"last_updated_that_met_qc_criteria": "2004-01-13",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2004-01-14",
"first_submitted": "2004-01-13",
"first_submitted_that_met_qc_criteria": "2016-10-12"
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
Detailed Description
This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.
#Intervention
- DRUG : GMI-1359
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male or females, 19 <= age <= 60 years (inclusive).
* Medically healthy with no clinically significant screening results.
* Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
* Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
* Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.
Exclusion Criteria:
* Subject is mentally or legally incapacitated.
* History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
* Normal clinical laboratory values.
* Normal heart rate and blood pressure.
* Blood donation or significant blood loss within 56 days prior to dosing.
* Plasma donation within 7 days prior to dosing.
* Participation in another clinical trial within 28 days prior to dosing.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02931214 | {
"brief_title": "Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: GMI-1359",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02931214",
"official_title": "A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10",
"study_completion_date(actual)": "2018-11",
"study_start_date(actual)": "2016-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-04",
"last_updated_that_met_qc_criteria": "2016-10-10",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-12",
"first_submitted": "2016-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Constipation is a symptom based disorder with a prevalence of 15% in the adult population and its management remains challenging. Although not life threatening, constipation is associated with impaired quality of life, increased healthcare costs and excess work absenteeism. Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several risk factors have been suggested to lead to the condition and are divided in 3 main categories: a) physiological, b) environmental and c) demographic. To date, there is lack of large epidemiological studies on proposed aetiological factors of constipation, especially studies assessing all proposed risk factors of constipation together.
The overall aim of this study is to investigate the multidimensional (physiological, environmental and demographic) predictors of constipation with the use of a multivariate analysis statistical model.
This is a large single centre case control study comparing constipated adults with healthy individuals matched for age, gender and ethnicity.
The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in period and a baseline visit at the end of the run-in period. Transit time between constipated and healthy individuals is assessed at baseline visit. Differences in gastrointestinal symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and consistency) between constipated and healthy individuals are assessed over the baseline period (the week before the baseline visit). Differences in female sex hormone levels as well as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty acids) between constipated and healthy individuals are assessed at baseline visit. Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and differences in demographic measures (age, gender, body mass index) between patients suffering from constipation and healthy individuals are also assessed at baseline visit.
| #Eligibility Criteria:
Inclusion criteria for cases:
* Adult men or women (18 <= age <= 65 years)
* Symptoms of constipation for a minimum of 3 months
* Recruitment based on simplified core ROME III diagnostic criteria for functional constipation
* Average Bristol stool type of 1 <= age <= 4 AND frequency of 1 <= age <= 3 spontaneous bowel movements per week
* Cleveland Clinic constipation score (CCCS) of 8 <= age <= 15
Inclusion criteria for controls:
* Adult men or women (18 <= age <= 65 years)
* Healthy individuals without any coexisting acute or chronic disease
* Not meeting simplified core ROME III diagnostic criteria for functional constipation
* Average Bristol stool type of 2 <= age <= 5 AND frequency of 3 <= age <= 21 spontaneous bowel movements per week
* Cleveland Clinic constipation score (CCCS) of < 8
Exclusion criteria for both cases and controls:
* Pregnant or breastfeeding women
* Ongoing other diagnosed gastrointestinal disease or complication
* Alarm features such as sudden weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
* Prior GI surgery except cholecystectomy, appendicectomy and simple vaginal hysterectomy
* Neurologic diseases
* Ongoing therapy with drugs known to affect gut motility
* Subjects with comorbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions
* Self-reported symptoms of pelvic organ prolapse
* Moderate or severe active local anorectal problems
* Incapacity to consent
* Aged under 18 or > 65 years
* Any inclusion criteria listed above not met
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
| NCT02884167 | {
"brief_title": "Multidimensional Risk Factor Assessment in Constipation",
"conditions": [
"Constipation",
"Risk Factors"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02884167",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-06",
"study_start_date(actual)": "2016-06"
},
"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)": "2017-12-08",
"last_updated_that_met_qc_criteria": "2016-08-25",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-30",
"first_submitted": "2016-06-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United States population is not up-to-date with screening. Although 90% of colorectal cancer screening is done using colonoscopy, most other countries use fecal immunochemical tests, reserving colonoscopy for those with a positive fecal immunochemical test. This project will provide the foundation for a paradigm shift for colorectal cancer screening in the United States by identifying how well 5 different FITs work for detecting screening relevant neoplasia, thus reducing morbidity and mortality for colorectal cancer.
Detailed Description
Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC develops over a number of years from precursor lesions called polyps, it is largely detectable and preventable in early stages. As these polyps become larger, they, like most CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs) to detect both polyps and cancers early, while they are curable. However, early screening and detection is much less common than it could be, with about 43% of eligible individuals unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive, specific, and low cost alternative to colonoscopy for CRC screening. Modeling studies have shown that for population screening, a strategy of annual FIT testing from age of 50 to 75 years results in an equal number of life-years gained as compared with colonoscopy every 10 years. However, about 90% of screening in the U.S. is done with colonoscopy, the most expensive and invasive screening test. FITs are far less costly and largely replacing the guaiac test in CRC screening programs internationally, where only individuals with positive results are referred for a colonoscopy. Studies done on FITs in other countries often used FITs not available in the U.S. or studied high-risk populations; thus, results are not applicable in the U.S. It is critical to determine the FIT(s) with the best test characteristics in order to implement successful FIT-based screening programs in this country.
It is estimated that 24 million more individuals will need to be screened by 2018 to reach the '80% by 2018' goal set by the National Colorectal Cancer Roundtable. To address this knowledge gap, investigators propose to compare the test characteristics of three Clinical Laboratory Improvement Amendments (CLIA)-waived FITs and two automated FITs, using colonoscopy as the gold standard. The rationale for this proposed study is that, for almost all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed. Specific aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy as the gold standard.
Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and false negative FIT results for each device.
These findings will provide essential information about FITs with the best test characteristics for future expanded use of FIT, critically important to achieving the long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to patients, will allow higher screening rates, and will reduce costs as compared with a screening strategy based on colonoscopy as the primary initial screening method.
#Intervention
- DEVICE : Fecal immunochemical test (FIT)
- FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool. | #Eligibility Criteria:
Inclusion Criteria:
* scheduled for a screening or surveillance colonoscopy
Exclusion Criteria:
* familial polyposis syndromes: ulcerative colitis or Crohn's disease: or active rectal bleeding
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03264898 | {
"brief_title": "Comparative Effectiveness of FITs With Colonoscopy",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Device: Fecal immunochemical test (FIT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03264898",
"official_title": "Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy (R01 CA215034)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-07",
"study_completion_date(actual)": "2023-10-01",
"study_start_date(actual)": "2017-10-02"
},
"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)": "2024-08-02",
"last_updated_that_met_qc_criteria": "2017-08-24",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-29",
"first_submitted": "2017-08-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis.
Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.
Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.
The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.
#Intervention
- DRUG : BI 1291583
- BI 1291583
- DRUG : Placebo
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Male or female patients: Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information.
Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
* Age of patients when signing the informed consent >=18 (for Korea: >=19) and <=85 years.
* Clinical history consistent with bronchiectasis (e.g., cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose past chest radiographic image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years.
* History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:
* at least 2 exacerbations, or
* at least 1 exacerbation and a St. George´s Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1.
For patients on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics.
* Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1.
Exclusion Criteria:
Laboratory and medical examination
* Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment).
* Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1.
* An absolute blood neutrophil count <1,000/mm^3 at Visit 1 (equivalent to <1,000 cells/µL or <109 cells/L).
* Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the patient at risk by participating in the trial.
* Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status.
Concomitant diagnosis and therapy
* A current diagnosis of:
* Cystic Fibrosis
* Hypogammaglobulinemia
* Common variable immunodeficiency
* α1-antitrypsin deficiency being treated with augmentation therapy
* Allergic bronchopulmonary aspergillosis being treated or requiring treatment
* Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines
* Palmoplantar keratosis; or keratoderma climactericum
* Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial
* Psoriasis affecting palms and soles; or body surface area for psoriasis >= 10%
* Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum
* Pityriasis rubra pilaris
* Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis >= 10%
* Active extensive verruca vulgaris, as per investigator's discretion
* Active fungal infection of hand and/or feet not adequately treated, or not responsive to antifungal therapy, as per investigator's discretion.
* Any clinically relevant (at the discretion of the investigator) acute respiratory infection within 4 weeks prior Visit 2, or any other acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2.
* Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the study.
* Received any live attenuated vaccine within 4 weeks prior to Visit 2.
* Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist):
* Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis).
* Severe periodontal disease defined as with pocket depth measurements >= 6 mm on 2 or more teeth.
* Class-3 mobility or Class-3 furcation involvement.
* Scheduled tooth extraction during the study period.
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Further exclusion criteria apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05238675 | {
"brief_title": "A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis",
"conditions": [
"Bronchiectasis"
],
"interventions": [
"Drug: Placebo",
"Drug: BI 1291583"
],
"location_countries": [
"Netherlands",
"United States",
"Poland",
"Germany",
"Czechia",
"United Kingdom",
"France",
"Japan",
"Israel",
"Australia",
"Hungary",
"Italy",
"Turkey",
"Denmark",
"Mexico",
"Latvia",
"Korea, Republic of",
"Portugal",
"Canada",
"Spain",
"Bulgaria",
"Belgium",
"Greece"
],
"nct_id": "NCT05238675",
"official_title": "A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-01",
"study_completion_date(actual)": "2024-05-30",
"study_start_date(actual)": "2022-03-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2022-02-03",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-14",
"first_submitted": "2022-02-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
Detailed Description
This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.
#Intervention
- DRUG : Placebo
- Placebo tablet administered orally BID
- DRUG : Gefapixant 15 mg BID
- Gefapixant 15 mg tablet administered orally BID
- Other Names :
- MK-7264
- DRUG : Gefapixant 45 mg BID
- Gefapixant 45 mg tablet administered orally BID
- Other Names :
- MK-7264 | #Eligibility Criteria:
Inclusion Criteria:
* Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
* Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
* Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
* Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
Exclusion Criteria:
* Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
* Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
* Has a history of chronic bronchitis
* Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
* Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR an eGFR >=30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
* Has a history of malignancy <=5 years
* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
* Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
* Has a known allergy/sensitivity or contraindication to gefapixant
* Has donated or lost >=1 unit of blood within 8 weeks prior to the first dose of gefapixant
* Has previously received gefapixant
* Currently participating in or has participated in an interventional clinical study within 30 days 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
| NCT03449147 | {
"brief_title": "A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)",
"conditions": [
"Chronic Cough"
],
"interventions": [
"Drug: Gefapixant 45 mg BID",
"Drug: Placebo",
"Drug: Gefapixant 15 mg BID"
],
"location_countries": [
"Colombia",
"China",
"United States",
"Germany",
"Poland",
"Czechia",
"United Kingdom",
"Israel",
"Guatemala",
"South Africa",
"Australia",
"Hungary",
"Italy",
"Turkey",
"Denmark",
"New Zealand",
"Peru",
"Ukraine",
"Canada",
"Malaysia"
],
"nct_id": "NCT03449147",
"official_title": "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-20",
"study_completion_date(actual)": "2020-10-30",
"study_start_date(actual)": "2018-03-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-02",
"last_updated_that_met_qc_criteria": "2018-02-22",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-28",
"first_submitted": "2018-02-22",
"first_submitted_that_met_qc_criteria": "2021-08-09"
}
}
} |
#Study Description
Brief Summary
Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.
#Intervention
- PROCEDURE : Oral glucose tolerance test
- Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum. | #Eligibility Criteria:
Inclusion Criteria:
* Dx of gestational diabetes treated with insulin
* To be in post-partum
* Delivery of a baby of at least 37 weeks of gestation
* Have signed the consent form
Exclusion Criteria:
* History of glucose intolerance of diabetes before the pregnancy
* Obstetrical pathology during pregnancy
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:
No
| NCT00921882 | {
"brief_title": "Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?",
"conditions": [
"Gestational Diabetes Mellitus",
"Type 2 Diabetes"
],
"interventions": [
"Procedure: Oral glucose tolerance test"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00921882",
"official_title": "Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2008-06"
},
"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)": "2018-05-03",
"last_updated_that_met_qc_criteria": "2009-06-15",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-16",
"first_submitted": "2009-06-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Due to recent efforts to decrease antibiotic overuse, and reports of high rates of spontaneous resolution for clinically diagnosed Acute Otitis Media(AOM), most physicians now wait 48-72 hours before starting antibiotics for common ear infections. The investigators are interested to see if those patients with documented middle ear effusions, as determined by tympanometry, have higher rates of eventual antibiotic usage than those with normal tympanometry results. If there is a significant disparity between those with a positive tympanogram and those without the investigators may be able to identify a group that will benefit from antibiotics and a group that would not need treatment.
Detailed Description
INTRODUCTION Acute Otitis Media (AOM) is the most common childhood infection for which antibiotics are prescribed.{1-2} Several important factors have altered the prescription practices for AOM in the past decade. North America has seen an epidemic of microbial resistance, attributable in a large part to the over-prescription of antibiotics.{3-4} Evidence has shown that AOM is commonly over diagnosed and antibiotics are prescribed unnecessarily.{5-7} In addition a number of studies comparing antibiotic treatment to placebo, although proving superiority for antibiotic treatment, had very high rates of resolution with placebo. A meta analysis of 7 RCT's show a 73% success rate for Amoxicillin versus 60% for placebo.{8}
These results prompted interest in a watch and wait strategy for the treatment of AOM for children 6 months to 10 years of age. Three important studies were performed assessing the outcomes of delaying antibiotics for 48-72H, two in primary care{9-10} and one in a pediatric emergency department.{11} All three showed no difference in outcomes with 2-4 week follow-up. There was a significant reduction in antibiotic usage with the watch and wait approach, a reduction of about 70%. These studies led both the American Academy of Pediatrics and the Canadian Pediatric Society to recommend adopting a conservative non-antibiotic treatment strategy for AOM in the first 48-72H.{12} However in early 2011, 2 papers were published that suggested that antibiotic use in AOM was beneficial.{13, 14} What set both of these two papers apart from other papers was the definition of acute otitis media: in one study the children were enrolled by study clinicians who were otoscopists who had successfully completed an otoscopic validation program, in the second study middle ear fluid had to be present by means of pneumatic otoscopy. The question then arises, is the treatment of otitis media really a question that concerns the treatment, or is it a question of diagnosis? The published correspondence that these two papers generated, suggested that diagnosis of AOM is indeed a concern. A technique named tympanometry could prove to be useful.
Tympanometry is a well established technique for documentation of middle ear effusion. Tympanometry measures the compliance of the tympanic membrane over a range of pressures. A graphic curve is generated which can be compared to normals or examples of pathologic conditions. Primary care physicians have used this technique successfully among children with and without a diagnosis of AOM.{15} Two studies involving tympanometry and otitis media{16-17} have shown tympanograms consistent with clear middle ear effusion(Type B) in 50-60% of patients clinically diagnosed with AOM. This strongly suggests that AOM is being over diagnosed! Interestingly Spiro et al showed that rates of antibiotic prescription were not different in physicians who were aware of tympanogram results and those who were blinded. This indicates a lack of knowledge around the impact on outcome of the initial tympanogram.
Currently at the Stollery, (and as suggested by CPS and AMA) well children who are diagnosed with AOM are given a prescription for antibiotics, but told to wait 48 hours before filling them, in the expectation that many of these children will have a complete resolution of their symptoms. They are encouraged to take analgesics to keep them comfortable. However, the current state of knowledge indicates that antibiotics provide superior symptom control in the first 24-48H and provide superior resolution rates to placebo in clinically diagnosed AOM. The delayed antibiotic strategy has similar long term outcomes to immediate antibiotic treatment. It is not clear if patients with middle ear effusion documented by adjunctive tests, such as tympanometry represent a distinctly different group than those diagnosed by observation of the tympanic membrane only. Spiro's study indicates that physicians do not know and therefore are not changing their practice on the basis of tympanogram results.
This then brings us to the investigators' primary research question. Are those children aged 6 months to 16 years who attend the Stollery Emergency Department and are diagnosed with AOM (and sent home with conservative management) more likely to fill a prescription for antibiotics over the next 7 days if their tympanogram is type B rather than types A or C?
The investigators propose an observational study, within a watch and wait strategy, to determine if patients clinically diagnosed with AOM and having a type B tympanogram have higher rates of eventual antibiotic usage. Secondary outcome measures would include symptoms of pain, fever and impaired sleep than those without clear evidence of middle ear effusion.
If those patients with a B type tympanogram have a high rate of eventual antibiotic usage, delaying their treatment is not significantly reducing our overall antibiotic usage. Furthermore, the investigators could reduce the pain suffered by these patients in those first 48-72 hours. The corollary to this may be that those patients with other tympanogram patterns may have comparatively low need for antibiotics. This study would help to more accurately identify those patients likely to derive significant benefit from antibiotic treatment for AOM.
PROJECT DESIGN AND WORK PLAN
Design: The study is a non-interventional analysis of outcome. This is an observational cohort study.
Intervention and sampling method: All patients diagnosed with OM will be approached for study enrolment within the hours which an RA is available. Tympanometry will be conducted on every participant in both ears. The clinician will not be privy to the result of the tympanogram. The tympanograms will be assigned a B or A/C shape, upon review by the principle investigators. In cases of disagreement a third reviewer will review the tympanogram. Patients will be followed with a phone call in 3 days and again at 8 days. They will be asked to rate their symptoms (Acute Otitis Media-Severity of Symptom Scale){18}, in addition to specific scripted interview questions for the study (under development) including a determination of antibiotic usage for the infection. The investigators will also review the provincial pharmacy database to confirm if antibiotics prescriptions were filled.
Training: Research assistants will receive one-on-one training with the principal investigators on tympanography technique.
Recruitment: Updates regarding the study will occur at the monthly staff meetings, posters describing the study will also be placed throughout the ED. Research Assistants will be visible in the department and will remind staff of the study.
Primary Outcome: Are those children aged 6 months to 16 years who attend the Stollery Emergency Department and are diagnosed with AOM (and sent home with conservative management) more likely to fill a prescription for antibiotics over the next 7 days if their tympanogram is type B rather than types A or C? Secondary Outcomes: Does a type B tympanometry curve predict increases in (1)Reported Pain (2)Analgesic use (3)Fever (4)Sleep Disturbance (5)Oral intake versus type A/C tympanograms (6) Proportion of patients diagnosed with OM who have either type A or type A and C tympanograms.
Sample Size: A logistic regression will be performed using antibiotic use in 7 days as the dependent variable. Given 4 independent variables, the investigators need at least 40 (80 would be ideal) subjects who fill the antibiotic prescription. Enrolling 137 patients would give us an alpha and Beta each of 0.05, and would allow us to do Chi Squared test looking at a two by two table of Antibiotic (Yes or No) vs Tympanometry Graph (Type B vs other).
Analysis: Antibiotic use in the 7 days following enrolment will be analyzed by logistic regression. Independent variables will include age, Tympanogram type A/C, Viral upper respiratory symptoms for ≥ 5days prior to presentation to the ED, and pain requiring analgesia in the Emergency or at home within 6H of presentation. Quantitative and qualitative data will be described. Antibiotic drug data will be checked in NetCare to see if there is a discrepancy between verbal reports and NetCare.
Feasibility: Data from the investigators' emergency department indicates over 900 children per year present with AOM, and over the past 6 months of winter (Oct-Mar) there have been about 540. Based on previous results {9-11} the investigators predict an antibiotic usage rate of 30%. To collect 40 patients who fill a prescription for antibiotics the investigators will need 135 patients with otitis. If antibiotic usage rates are higher this number will decrease. Accounting for about a 15% drop out rate the investigators will need to enroll about 155 children. Conservatively assuming recruitment of 30% of children with AOM the investigators anticipate 24 weeks to reach the investigators' sample size.
#Intervention
- PROCEDURE : Tympanometry
- All patients enrolled with receive a tympanogram. There will be no difference between the follow up in the groups based on the tympanometry results. The study is simply observational | #Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Acute Otitis Media
* Clinician decision to adopt a delayed antibiotic treatment strategy
Exclusion Criteria:
* Antibiotics within previous 2 weeks
* Immunosuppressive Medication or Condition
* Perforated Otitis Media
* Previous complications secondary to Otitis Media
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT01941381 | {
"brief_title": "Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?",
"conditions": [
"Acute Otitis Media"
],
"interventions": [
"Procedure: Tympanometry"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01941381",
"official_title": "Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09",
"study_completion_date(actual)": "2018-09",
"study_start_date(actual)": "2013-10"
},
"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)": "2018-10-17",
"last_updated_that_met_qc_criteria": "2013-09-12",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-13",
"first_submitted": "2013-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.
Detailed Description
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.
#Intervention
- DEVICE : Xience alpine, ultimaster, resolute onyx, synergy
- PCI will be performed | #Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing PCI on unprotected left main or coronary bifurcation
Exclusion Criteria:
* PCI performed on other coronary vessels
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
| NCT03544294 | {
"brief_title": "veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study",
"conditions": [
"Stent Restenosis",
"Stent Thrombosis",
"Left Main Coronary Artery Disease",
"Coronary Bifurcations",
"Very Thin Stents"
],
"interventions": [
"Device: Xience alpine, ultimaster, resolute onyx, synergy"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03544294",
"official_title": "veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-30",
"study_completion_date(actual)": "2018-05-30",
"study_start_date(actual)": "2017-06-01"
},
"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)": "2018-06-06",
"last_updated_that_met_qc_criteria": "2018-05-31",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-01",
"first_submitted": "2018-05-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.
Detailed Description
Vertebral compression fractures secondary to osteoporosis can be treated with vertebral augmentation. Since intraprocedural pain is common during vertebral body endplate manipulation, these procedures are often carried out using conscious sedation or general anesthesia. Research has shown that the vertebral endplates are innervated by the basivertebral nerve, which has been successfully targeted via radiofrequency ablation to treat chronic vertebrogenic lower back pain. With this physiology in mind, the investigators will attempt to treated participants with vertebral compression using lidocaine-induced intraosseous basivertebral nerve block as the primary intraprocedural analgesia.
#Intervention
- PROCEDURE : Basivertebral nerve block
- Temporary intraosseous basivertebral nerve block using lidocaine
- Other Names :
- BVN block during vertebral augmentation
- DRUG : Lidocaine induced basivertebral nerve block
- Intraosseous lidocaine basivertebral nerve block
- Other Names :
- Lidocaine BVN block | #Eligibility Criteria:
Inclusion Criteria:
* Age >50 years
* Patient must have a diagnosis of osteoporosis on dual energy x-ray absorptiometry (DEXA),
* Patient must have an acute or subacute single level vertebral compression fracture between T10 - L3 as confirmed via magnetic resonance imaging (MRI) or nuclear medicine bone scan,
* Patient must have an initial pain score of greater than or equal to five using a standard 0 <= age <= 10 Visual Analog Scale subjective pain score upon initial consultation.
Exclusion Criteria:
* Pathologic compression fracture, such as due to metastatic disease
* Age >90 years or <50 years
* Pregnancy
* Diagnosed Anxiety Disorder
* Diagnosed Depression Disorder
* Diagnosed Psychotic Disorder
* Diagnosed Mental Disease Disorder
* Diagnosed Parkinson's disease/other movement disorders/or cerebellar dysfunction
* Eastern Cooperative Oncology Group (ECOG) score at baseline prior to compression fracture >1
* Back Pain scores at time of initial consult <5, using a standard Visual Analog Scale
* Illicit drug dependence or abuse
* Alcohol dependence or abuse
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04774029 | {
"brief_title": "Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management",
"conditions": [
"Vertebral Compression",
"Vertebra Compression Fracture",
"Vertebral Fracture"
],
"interventions": [
"Drug: Lidocaine induced basivertebral nerve block",
"Procedure: Basivertebral nerve block"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04774029",
"official_title": "Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-01",
"study_completion_date(actual)": "2020-05-01",
"study_start_date(actual)": "2020-01-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-26",
"last_updated_that_met_qc_criteria": "2021-02-25",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-26",
"first_submitted": "2021-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
Detailed Description
Natural history of tumors is a poorly studied subject, the clinical evidence of some tumors aggressiveness as opposed to some other's indolent behavior has never been formally assessed in daily practice or in clinical studies and remains largely unpredictable. The patient's populations are in fact a mix between different tumoral phenotypes that while carrying the same apparent disease evolve with different outcomes.
We hypothesize that,in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
If the hypothesis is verified, this finding could:
* Allow to define therapeutic strategies according to the tumoral metabolic progression index.
* Limit the need for randomization in the early drug development phases as each patient could be considered as his own control.
* To stratify patients according to their baseline metabolic growth rate in randomized controlled trials with overall survival as an endpoint.
#Intervention
- OTHER : FDG PET-CT
- All patients will undergo FDG PET-CT at inclusion and 2 weeks after
- Other Names :
- Metabolic Investigation
- OTHER : Diffusion MRI
- All patients will undergo Diffusion MRI at inclusion and 2 weeks later
- Other Names :
- Metabolic Investigation
- OTHER : Blood samples (plasma preparation and CTC) | #Eligibility Criteria:
Inclusion Criteria:
* Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
* The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type Kras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
* Participants should be candidate for a Phase I study
* Age equal or > 18 years.
* Life expectancy of greater than 12 weeks.
* ECOG performance status <= 1.
* Participants must have normal organ and marrow function as defined below:
Total bilirubin within 2 × normal institutional upper limits AST/ALT/Alk Phosphatase levels < 5 × normal institutional upper limits Creatinine within 2 × normal institutional upper limits or creatinine clearance > 35mL/min
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry during the assessment. For women of childbearing potential a pregnancy test (urinary or serum) must be performed within 7 days prior to inclusion and it must be negative. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately within one month.
* Signed written informed consent obtained prior to any study specific screening procedures).
Exclusion Criteria:
Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
* Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
* Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study.
* Patients receiving any experimental agents during the assessment time period.
* Patients with uncontrolled brain metastases.
* Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
* Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study
* Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or any significant disease which, in the investigator's opinion, would exclude the patient from the study.
* Pregnancy or breastfeeding before the FDG PET-CT scan examinations
* Uncontrolled Diabetes.
* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
* Contra-indications to the use of MRI: cardiac stimulator, implanted cardiac wires, any implanted electronic devices, intra-ocular metallic foreign bodies.
* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent.
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
| NCT01591590 | {
"brief_title": "Correlating the Tumoral Metabolic Progression Index to Patient's Outcome in Advanced Colorectal Cancer",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Other: Diffusion MRI",
"Other: Blood samples (plasma preparation and CTC)",
"Other: FDG PET-CT"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01591590",
"official_title": "Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07",
"study_completion_date(actual)": "2021-09-25",
"study_start_date(actual)": "2012-06"
},
"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)": "2021-10-26",
"last_updated_that_met_qc_criteria": "2012-05-02",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-04",
"first_submitted": "2012-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing.
Detailed Description
Prior to surgery, patient participants will receive a combined spinal-epidural per VCU total joint protocol; the following steps are considered standard of care and not considered study procedures. The combined spinal-epidural procedure creates complete numbness below the abdomen down to the feet, which negates the need for general anesthesia. For patient comfort during the combined-spinal epidural procedure, a one-time dose of 2 milligrams of intravenous midazolam will be given; this dose is adequate for reducing anxiety while allowing the patient to maintain conversation with health care providers if necessary. The standard intrathecal dose for total knee replacement at our institution is 15 mg bupivacaine and 0.2 mg preservative-free morphine; this dose will provide complete numbness to the lower extremities for approximately 3-6 hours. After this dose is administered, the patient will then be positioned appropriately in the operating room and vital signs will monitored per standard protocol.
Each patient participant will be randomized to one of two groups. Participants in the control group will receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. Participants in the experimental group will receive the same noise-cancelling wireless headphones but will be permitted to listen to the music of their choice while in the operating room. Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection. Participants will not be able to change the Spotify channel. We will be using the paid Spotify service with no commercials. If participants opt to have the music stopped, we will withdraw them from the study and continue standard of care. The participants will have the music playing for about two hours. If the participant has no music preference, the music will be chosen for them and it will be the same for all participants that have no preference. The volume will be adjusted in the operating room until the participant approves of the volume by saying 'yes, the volume is good' or giving another verbal cue of approval.The music will continue playing until the surgical procedure is complete and the patient has reached the post-anesthesia recovery unit.
As stated previously, spinal anesthesia provides numbness that negates the need for general anesthesia, but patients often times need additional sedation, which will be defined as anesthesia medication that is used to treat patient anxiety and discomfort in the operating room. Patient participants in both groups will receive sedation via the same protocol, which is outlined below.
Sedation will only be given as needed per patient request; the patient will be given a noise-making device (such as a rubber duckie that makes sound when squeezed) that will inform the anesthesia provider that the patient is uncomfortable and needs some sedation. A weight based dose of 0.3 micrograms per kilogram of intravenous propofol will be given for each patient request. This dose is expected to provide amnesia or light sleep for a few minutes. For patient safety, if the patient requests sedation more than once within a two minute window, the anesthesia provider will not administer any more medication during this two minute period. Additionally, the anesthesia provider may withhold sedation if he or she determines with physical exam and hemodynamic monitors that the patient is already over-sedated.
After five propofol boluses have been given to a patient, a propofol continuous infusion will be initiated at 25mcg/kg/min. The patient may still request additional sedation with the request instrument if he or she is still conscious enough to do so. If the anesthesia provider has given more than five boluses even with the baseline propofol infusion, the infusion will be increased to 50mcg/kg/min. In the highly unlikely scenario that five additional boluses are required with a propofol infusion rate of 50 mcg/kg/min, the anesthesia providers and investigators will make a clinical decision as to what is the safest next step.
There may be scenarios that warrant conversion to general anesthesia. These scenarios include, but are not limited to, hemodynamic instability, regurgitation of gastric content, obtundation, excessive agitation, and inadequate spinal anesthesia. The decision to convert to the general anesthesia will be made by the anesthesiologist and anesthesia provider in the operating room; implementation of this study should not prevent or delay this decision if it is necessary.
Documentation will be completed by the anesthesia provider per standard protocol for electronic anesthesia charting at VCU. This will allow for data acquisition by the investigators through the anesthesiology printed record in Cerner.
#Intervention
- OTHER : Music
- Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection.
- OTHER : Headphones
- All participants will receive noise-cancelling wireless headphones that they will wear in the operating room during the procedure.
- DRUG : Propofol
- All participants will receive intravenous doses of propofol; the timing and frequency of the doses will be given when the patient indicates (by squeezing a rubber duckie) that he/she wants sedation medication. | #Eligibility Criteria:
Inclusion Criteria:
* undergoing a primary elective total knee replacement by Dr. Gregory Golladay (VCU surgeon and co-investigator for this research study)
* 18 years or older
* eligible for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
* mentally capable of understanding instructions on how to request anesthesia medication
* mentally capable of understanding instructions on how to rate pain scores, anxiety level, and patient satisfaction
Exclusion Criteria:
* identified as a member of a regulated vulnerable population (one exception: limited English proficiency does not preclude them from this study; translation documents are available)
* ineligibility for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
* morbid obesity, BMI greater than 40
* allergy to propofol, midazolam, or morphine
* pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours
* hearing impaired individuals
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
| NCT03486106 | {
"brief_title": "Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery",
"conditions": [
"Anesthesia; Functional",
"Surgery"
],
"interventions": [
"Drug: Propofol",
"Other: Music",
"Other: Headphones"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03486106",
"official_title": "Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-12",
"study_completion_date(actual)": "2019-07-15",
"study_start_date(actual)": "2018-07-13"
},
"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)": "2023-05-25",
"last_updated_that_met_qc_criteria": "2018-03-26",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-03",
"first_submitted": "2018-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Patients affected with severe parenchymal pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD ), may experience dyspnea at rest due to increased work of breathing and reduced oxygenation. The delivery of high-flow humidified nasal oxygen (HFNC) has been shown to have a positive-end-expiratory pressure (PEEP) effect and is able to flush out CO2 from the upper airways, reducing dead space ventilation. Furthermore it has been proven to reduce the respiratory rate shortly after its initiation. These multiple actions offer the potential of changing the respiratory pattern and reducing work of breathing, improving the efficiency of breathing.
In this short-term, physiological, open, randomized, cross-over pilot study the investigator swill describe the effects of varying settings of high-flow nasal oxygen on respiratory rate, tidal volume, and diaphragmatic work of breathing in patients with severe COPD. The investigators will also describe changes in gas exchange and effects on the subjects' comfort and dyspnea and the breathing responses to varying setting of CPAP in the subject population.
Detailed Description
HFNC has been shown to have many advantages in the treatment of acutely hypoxemic patients, improving their clinical outcome. The exact mechanism underlying this beneficial effect is still not completely understood. Few studies have analyzed the effect of HFNC on ventilatory pattern and work of breathing. The majority of these studies have focused on the effects in healthy volunteers. Only one study from Braunlich et al. studied the effects of HFNC on COPD and interstitial lung disease (ILD) patients, showing that high-flow nasal oxygen reduces respiratory rate and increases the tidal volume in these patients.
In adults, a low flow range from 5 to 10 L/min is comparable to flow received by standard oxygen devices (nasal cannula or facial mask). Patients with underlying pulmonary diseases, as in our study population, have a higher inspiratory flow demands range (from 30 to 120 L/min during an acute respiratory failure episode) compared to healthy subjects.
We expect to observe physiological changes in our outcomes with the proposed Optiflow ™ settings of a minimal therapeutic flow of 30 L/min, intermediate of 45 L/min, and the maximal flow rate of 60 L/min. There is an extensive clinical experience using high flow rates in these ranges and they are generally very well tolerated. As mentioned above, HFNC generates a Positive End Expiratory Pressure (PEEP) comparable to CPAP range of 4 - 8 cmH2O (the minimal and the maximal PEEP generated by the HFNC).
Future studies, based on this pilot study, will differ from previous ones in the following ways:
1. We are testing a different technology. The Optiflow delivers substantially higher flow rates than in the previous Braunlich study13.That study used a single flow rate of 24 L/min whereas we are examining a range of flows that extend considerably higher (30 to 60L/min). We are interested in determining how the effects of higher flow rates compare to those in the range used in the Braunlich study, but we are not able to compare the devices directly because the latter device is not available in the US. It is important to understand whether there is any efficacy advantage to using the higher flow rates available with the Optiflow.
2. Future studies will aim to understand mechanisms of the effect of high flow nasal oxygen.
1. Are the effects that we anticipate seeing related to changes in inspiratory muscle effort as determined by measurement of transdiaphragmatic pressure and calculation of the pressure time product of the diaphragm?
2. Or does the flushing of dead space in the nasopharynx improve ventilatory efficiency so that gas exchange can remain stable or even improve (as determined by measurements of minute volume and transcutaneous PCO2 (PtcCO2)? This has implications for use of HFNC to treat patients with COPD exacerbations who are developing respiratory muscle fatigue.
1) Our focus will be on COPD patients for whom the use of HFNC has not been studied much to date. Most studies have focused on patients with hypoxemic respiratory failure. It is important to understand how HFNC affects breathing pattern and gas exchange in COPD patients because earlier reports suggest that excessive concentrations of oxygen administered to COPD patients retaining CO2 can actually worsen the CO2 retention by blunting respiratory drive. The reduction in respiratory rate and minute volume noted by Braunlich et al could represent a blunting effect of O2 on drive to breathe and could promote greater CO2 retention. By monitoring PCO2, something the Braunlich study didn't do, we can assess this possibility.
2) We wish to evaluate the effect of CPAP on the same breathing indices as with HFNC in our COPD patients. We plan to use the CPAP response as a 'positive control', to determine if our population responds as described by CPAP studies in the literature. Prior studies have demonstrated that in patients with severe COPD, using CPAP in the range we are proposing, lowers the diaphragmatic work of breathing and we wish to determine if our population manifests a similar effect.
Thus future studies, based on the data obtained from this pilot study, will extend the Braunlich et al study by evaluating the effects of higher flow rates using a different technology available in the US, determining effects on inspiratory muscle effort, and monitoring gas exchange which is important from both mechanistic and safety perspectives. We hypothesize that the higher flow rates will have a greater blunting effect on breathing pattern than a low flow rate and that there will be an improvement in ventilator efficiency that will be associated with decreased breathing work of the diaphragm.
#Intervention
- OTHER : Esophageal and gastric balloons
- Esophageal and gastric pressures will be measured with an esophageal ballon positioned at the lower third of the esophagus, filled with 0.5 mL of air and a gastric balloon filled with 1 mL of air. The proper position of balloons will be verified using the occlusion test as previously described. Transdiaphragmatic pressure (Pdi) is calculated as the difference between gastric (Pga) and esophageal (Pes) pressure. The pressure time integrals of the diaphragm and the other inspiratory muscles are calculated per breath (PTPdi/b and PTPes/b, respectively) and per minute (PTPdi/min and PTPes/min). Measurements will be collected at baseline, at each randomized HFNC and CPAP settings during the last 4 minutes of each 10 minutes session.
- OTHER : Respiratory Inductance Plethysmography (RIP) system
- Inspiratory tidal volume (VTi), respiratory rate (RR), breath duration (Ttot), inspiratory time (Ti) and fractional inspiratory time (Ti/Ttot) will be determined using a Respiratory Inductive Plethysmography (RIP) system. This will measure the thoracic and abdominal excursion of the subjects via two inductive wires which are sewn into the elastic bands that encircle the thorax and abdomen. The acquired signals represent changes in cross-sectional area and, following calibration to determine the relative contribution of each signal, and volume calibration using spirometry, their weighted sum will reflect VTi. The RIP companion software will be used to derive RR, Ttot, Ti and Ti/Ttot on a breath by breath basis.
- OTHER : Sentec transcutaneous monitoring system
- The oxygenation, the level of carbon dioxide, and the heart rate will be recorded using the Sentec transcutaneous monitoring system: a probe will be placed at the earlobe or on the forehead, and it will measure in a noninvasive way these parameters.
- DEVICE : High-flow humidified nasal oxygen delivery system
- DEVICE : CPAP (Positive Control)
- Other Names :
- Continuous Positive Airway Pressure | #Eligibility Criteria:
Inclusion Criteria:
* Subjects are 18 or more years of age
* Chronic respiratory failure, defined as indication for long-term oxygen therapy
* Underlying diagnosis of severe COPD (GOLD stage III or IV)
Exclusion Criteria:
* Recent (<1 month) exacerbation Acute exacerbation is defined as a sudden worsening of COPD symptoms (shortness of breath, quantity and color of phlegm) requiring a change in the baseline therapy.
* Respiratory rate at rest >28/min
* Subject requires > 6 L/min nasal O2 to maintain SpO2 >88% at rest
* Subject has severe dyspnea at rest
* Subject has swallowing disorder or chronic aspiration
* Prior esophageal surgery, known esophageal stricture or any other condition that would place the subject at risk during balloon placement
* Recent (< 1 month) abdominal and thoracic surgery
* Severe coagulopathy (defined as platelet count <5000/μL or international normalised ratio >4)
* Subject is too cognitively impaired to give subjective ratings for visual analogue scale.The PI and the Co-Investigators will assess the patient cognition using the Mini Mental State Examination (MMSE)
* Allergy or sensitivity to lidocaine
* Inability to obtain informed consent
* Pregnancy and breastfeeding
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
| NCT02514798 | {
"brief_title": "Pilot Study of Physiological Effect of High-Flow Nasal Cannula on Respiratory Pattern and Work of Breathing",
"conditions": [
"COPD"
],
"interventions": [
"Device: High-flow humidified nasal oxygen delivery system",
"Device: CPAP (Positive Control)",
"Other: Sentec transcutaneous monitoring system",
"Other: Respiratory Inductance Plethysmography (RIP) system",
"Other: Esophageal and gastric balloons"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02514798",
"official_title": "Pilot Study of Physiological Effect of High-Flow Nasal Cannula on Respiratory Pattern and Work of Breathing in Severe COPD Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-04-01",
"study_start_date(actual)": "2015-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-10",
"last_updated_that_met_qc_criteria": "2015-08-03",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-04",
"first_submitted": "2015-07-30",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Performing intravenous (IV) cannulation to pediatric patients might be much harder than adult ones according to their anxiety levels. However, managing adult patients during intravenous cannulation is also challenging if he or she had a noxious memory about the situation or has a low pain threshold. Therefore, it is essential to relieve the pain of an IV needle or an IV cannula insertion in the pediatric patient population. Lidocaine Hcl spray (Xylocaine 10% Oral ) will be utilized to the research group, and Serum Physiologic (Serum Fizyolojik %0,9 10 ml ampule, Biofarma İlaç San. ve Tic A.Ş., İstanbul, Turkey) will be utilized to the control group of the study. Both medications will be administrated by spraying the formula three times to an adhesive bandage and placing it to the skin that IV cannulation will be performed. After waiting for a minimum of 5 to a maximum of 15 minutes ( waiting time is closely associated with the patient's anxiety level), IV cannulation will be performed from the same area by an experienced pediatric nurse. The investigator hypothesizes that utilizing the spray form of the Lidocaine Hcl formula to the skin with an adhesive bandage before IV cannulation might lower the pain of the manipulation in pediatric patients, which might cause lower anxiety levels with stable vital signs.
Detailed Description
The G-Power 3.0.10. Computed required sample size (alpha:0.05, effect size:0.3 and power 0.8) related to t-test of the difference between two dependent means(matched pairs) according to the 5% change of before and after heartbeat outcome parameters with Standard derivations of ( -/+12 to +/-15). The total sample size of ninety participants is evaluated to be enough for the study. However, fifty participants are planned to be enrolled in each group (a total of 100 participants) to compensate for possible losses in this prospective, randomized clinical study. Six parameters will be evaluated, and three scales will be performed in each group. The six parameters are Heart Rate-1, Spo2-1, Body Temperature-1, Heart Rate-2, Spo2-2, Body Temperature-2. The three scales are 11 point Verbal Numeric Rating Scale-1, 11 point Verbal Numeric Rating Scale-2, and Visual Analog Scale. Those parameters will be measured non-invasively, without causing any pain.
The randomization is planned to be done with the sealed envelope modeling. One of the envelopes is planned to be chosen by each participant after the written consent form approval from the child and his/her parents. The envelopes have either a 'C' letter or 'L' letter inside representing C as {Group C: 'The Control Group'}, representing L as {Group L: 'The Lidocaine Group'} will be opened by the principal investigator. The bottle 1(Serum Physiologic inside) or bottle 2( Lidocaine inside) will be given to the ward nurse according to the letters in the envelope. The ward nurse will be blinded according to the ingredients in the bottles. The outcome parameters and the scales will be recorded by the nurse in the investigation. The nurse in the investigation will be blinded about the groups, the envelopes and the ingredients performed to the participants.
The study is planned to last in 4 months (16 weeks) time. However, in the middle of the study( 25 participants undertaken within each group), post-doc tests are planned to be done. If the power of the study according to the post-Hoc tests are more than 80%, the study will be stopped.
#Intervention
- DRUG : Xylocaine 10% Oral
- 50 ml of lidocaine solution maintained from xylocaine 10% oral that transferred to a bottle with a spray pump which pumps 0,1ml for each pump will be used for the experiment.
3 pumps of lidocaine will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted.
- Other Names :
- EJACERA%10 sprey, LINCAINE sprey %10, LOCANEST sprey %10, PRECOXIN %10 sprey, VEMCAINE pump sprey %10
- DRUG : Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul
- 50 ml of Serum physiologic in a bottle with a spray pump which pumps 0,1ml for each pump will be used for placebo.
3 pumps of placebo will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted.
- Other Names :
- Serum Fizyolojik Onfarma 10 Ml, 10 Ampul,, Serum Fizyolojik İzotonik %0,9 10 Ml, 100 Ampul, Serum Fizyolojik Biofarma % 0,9, 10 Ml 100 Ampul | #Eligibility Criteria:
Inclusion Criteria:
* The subject has to be treated with any drug submitted via intravenous cannula.
* The subject weighted more than 10 kg.
* The subject has a maximum ASA-2 score.
Exclusion Criteria:
* Allergic to amide group local anesthetics.
* The subject has a dermatological disease.
Sex :
ALL
Ages :
- Minimum Age : 72 Months
- Maximum Age : 215 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT04246255 | {
"brief_title": "Pain Relief During Intravenous Cannulation in Pediatric Patients",
"conditions": [
"Cannula Site Pain",
"Local Anesthesia"
],
"interventions": [
"Drug: Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul",
"Drug: Xylocaine 10% Oral"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04246255",
"official_title": "A New Method for Pain Relief, Intravenous Cannulation in Pediatric Patients; A Randomized Prospective Clinical Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-01",
"study_completion_date(actual)": "2020-08-24",
"study_start_date(actual)": "2020-02-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-25",
"last_updated_that_met_qc_criteria": "2020-01-27",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-29",
"first_submitted": "2020-01-27",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Given the paucity of pharmacological data on cefazolin treatment of Methicillin-susceptible S. aureus (MSSA) complicated S. aureus infection (CSAI), the primary purpose of this study is to investigate the probability of pharmacological target attainment (in the blood and infected tissue) with standard intermittent bolus administration of cefazolin in patients with CSAI caused by MSSA by determining plasma concentrations of cefazolin and exact Minimum inhibitory concentration (MICs) of the causative MSSA strains in patients with various disease severities (e.g. critically ill vs. noncritically ill patients).
* Sub-study quantitative measurement of Torque Teno virus (TTV): The primary purpose of this sub-study is to describe the viral kinetics of TTV in CSAI patients and to explore the association of TTV viremia with clinical outcomes and molecular markers of activation of the immune system.
* Sub-study investigating antibiotic concentrations in sweat as a non-invasive therapeutic drug monitoring
#Intervention
- OTHER : Blood samples for the measurement of the concentration of cefazolin
- Blood samples for the measurement of the concentration of cefazolin will be collected on the 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (usually within 4 weeks after inclusion; only in patients on outpatient continuous parenteral antibiotic treatment).
- OTHER : S. aureus culture isolate
- The S. aureus culture isolate will be subjected to exact cefazolin MIC determination and to measurement of the level of cefazolin tolerance.
- OTHER : structured telephone interview
- Structured telephone interview for Patient follow- up after 30 days
- OTHER : Sub-study quantitative measurement of Torque Teno virus
- An additional EDTA sample will be drawn for quantitative polymerase chain reaction (PCR) of TTV DNA and analyses of cytokines and other parameters of the activation state of the immune system.
- OTHER : Sub-study investigating cefazolin concentrations in sweat
- For each visit of included patients, a sweat sample will be collected via a CE certified Macroduct Sweat Collector. Eccrine sweat glands of the lower forearms are stimulated by pilocarpine (a parasympathomimetic) as well as a local current for 5min. Sweat is subsequently collected by capillary containers during 30min and transferred to small tubes on dry ice. Sweat sample analysis is conducted using mass spectrometry. | #Eligibility Criteria:
Inclusion Criteria:
* CSAI caused by MSSA. CSAI is defined as MSSA BSI with a positive follow-up blood culture result for MSSA or the presence of a site of infection remote from the primary focus caused by hematogenous seeding (e.g. endocarditis, vertebral osteomyelitis) or extension of the infection beyond the primary focus (e.g. septic thrombophlebitis or abscess); or deep-seated infections caused by MSSA (e.g. osteoarticular infections, deepseated abscesses).
* Current or intended treatment with cefazolin
Exclusion Criteria:
* Previous enrolment into the current study within 30 days
* Hemodialysis (patients on hemofiltration are eligible)
* Patients who are very likely to stop treatment with cefazolin in the next 48 hours as per treating physician (because of treatment failure, switch to oral medication, palliative care, allergy etc.) or who are very likely to be discharged in the next 48 hours as per treating physician.
* Outpatients
* Women who are pregnant (special pharmacokinetic)
* Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Propionibacterium acnes) or an anaerobic pathogen. If an additional pathogen is identified after inclusion of the patient into the study, the patient will remain in the study.
* Not-complicated S. aureus infections: non-bacteremic skin- and soft tissue or small Joint infections without deep-seated abscesses (as these patients will be quickly switched to oral antibiotics)
* CSAI caused by methicillin-resistant S. aureus (MRSA)
Additional exclusion criteria for the sub-study investigating cefazolin concentrations in sweat:
* Allergic to pilocarpine
* Continuous oxygen therapy without the possibility to interrupt oxygen administration for 10min
* Pacemaker
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
| NCT04503252 | {
"brief_title": "Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus",
"conditions": [
"Staphylococcus Aureus Infection"
],
"interventions": [
"Other: Blood samples for the measurement of the concentration of cefazolin",
"Other: Sub-study quantitative measurement of Torque Teno virus",
"Other: structured telephone interview",
"Other: S. aureus culture isolate",
"Other: Sub-study investigating cefazolin concentrations in sweat"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04503252",
"official_title": "Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus: A Prospective Single-center Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-28",
"study_completion_date(actual)": "2022-03-28",
"study_start_date(actual)": "2020-01-14"
},
"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)": "2022-03-29",
"last_updated_that_met_qc_criteria": "2020-08-03",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-07",
"first_submitted": "2020-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objectives of this study are to assess the safety of azficel-T treatment for dysphonia related to vocal fold function and to evaluate the efficacy of azficel-T for the treatment of dysphonia related to vocal fold function.
Detailed Description
Twenty subjects with dysphonia caused by vocal fold scarring or age-related dysphonia will be randomized for treatment with autologous cultured fibroblasts (azficel-T, n=14) or placebo (saline, n=6). Subjects will receive treatment to the vocal fold(s) in the lamina propria compartment.
Subjects with both unilateral and bilateral vocal fold scarring will be treated in this study. Only one vocal fold will be treated at each treatment session alternating to the opposite vocal fold (if applicable) at the next treatment. Subjects are to receive a total of three treatments with study drug (azficel-T or placebo) if one vocal fold is to be treated and up to a total of six treatments with study drug (azficel-T or placebo) if two vocal folds are to be treated at approximately 2-week intervals. Follow-up examinations will be performed at 1, 4, 8, and 12 months after the final treatment. If there are any evident safety issues, follow-up treatments will be delayed or withheld.
In the Blinded Phase of the study, subjects will be followed for safety and efficacy for 4 months after the final treatment. After all subjects have completed the 4-month follow-up visit, the study will be unblinded and subjects will continue to be followed for safety for 12 months after the final treatment. Efficacy assessments will be made through the 12-month follow-up visit in order to document any duration of effect. All AEs that have an onset date from biopsy through the 4-month follow-up visit will be recorded.
#Intervention
- BIOLOGICAL : Azficel-T (autologous fibroblasts)
- Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.
Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
- Other Names :
- LAVIV™
- DRUG : Placebo
- Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
- Other Names :
- Sterile saline for injection | #Eligibility Criteria:
Inclusion Criteria:
* Subject has read and signed the Institutional Review Board (IRB)-approved informed consent form (ICF) before treatment
* Subject is at least 18 years
* Subject has presence of unilateral or bilateral vocal fold scarring or age-related dysphonia, as diagnosed by medical history and physical examination
* Subject must have Grade 1 <= age <= 2 mucosal waves as determined by videostroboscopy
* Subject has failed any one or more of the following treatments including, but not limited to, anti-reflux regimen, speech therapy, or vocal fold injection augmentation prior to screening
* Subject feels that their voice quality is a major handicap
* Subject must have a blood sample tested and found to be non-reactive for human immunodeficiency virus-1 (HIV-1) antibody, hepatitis B surface antigen and hepatitis C virus (HCV) antibody
* If the subject is female and of childbearing potential, she must agree to use a medically acceptable means of birth control, and test negative on a urine pregnancy test
* Subject must be willing and able to follow study procedures and instructions
Exclusion Criteria:
* Subject is pregnant or lactating
* Subject is a smoker
* Subject has an upper respiratory infection at baseline (subject can be rescheduled after four weeks)
* Subject is already participating, or has participated in another clinical trial involving therapeutic intervention within 30 days prior to enrollment
* Subject plans to begin or continue other vocal fold therapies during the course of this study
* Subject has other concurrent laryngeal pathology including lesions that would require removal
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
| NCT02120781 | {
"brief_title": "Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia",
"conditions": [
"Dysphonia Resulting From Vocal Fold Scarring",
"Age-related Dysphonia"
],
"interventions": [
"Drug: Placebo",
"Biological: Azficel-T (autologous fibroblasts)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02120781",
"official_title": "A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for the Treatment of Vocal Fold Scarring and Age-Related Dysphonia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-12-21",
"study_start_date(actual)": "2014-03"
},
"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)": "2021-06-03",
"last_updated_that_met_qc_criteria": "2014-04-21",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-23",
"first_submitted": "2014-03-21",
"first_submitted_that_met_qc_criteria": "2021-05-10"
}
}
} |
#Study Description
Brief Summary
This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
#Intervention
- DRUG : bevacizumab [Avastin]
- 7.5mg/kg iv or 15mg/kg iv every 3 weeks
- DRUG : cisplatin
- 75mg/m2 iv according to a standard chemotherapy treatment protocol
- DRUG : vinorelbine
- 15mg/m2 iv according to a standard chemotherapy treatment protocol | #Eligibility Criteria:
Inclusion Criteria:
* patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;
* ECOG performance status of 0 or 1;
* no prior thoracic head and neck irradiation or surgical resection for current lung cancer.
Exclusion Criteria:
* mixed, non-small cell and small cell tumors;
* mixed adeno-squamous carcinomas with a predominant squamous component;
* evidence of tumor invasion or encasement of major vessels;
* history of grade >=2 hemoptysis;
* presence of cavitations in lung lesions at baseline.
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
| NCT00773188 | {
"brief_title": "A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.",
"conditions": [
"Non-Squamous Non-Small Cell Lung Cancer"
],
"interventions": [
"Drug: bevacizumab [Avastin]",
"Drug: vinorelbine",
"Drug: cisplatin"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00773188",
"official_title": "A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2008-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-02",
"last_updated_that_met_qc_criteria": "2008-10-15",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-16",
"first_submitted": "2008-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.
#Intervention
- DRUG : ABT-869 .25 mg/kg
- Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
- DRUG : ABT-869 0.10 mg/kg
- Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight. | #Eligibility Criteria:
Inclusion Criteria:
* Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC
* Subjects must have at least one lesion measurable by CT scan as defined by RECIST
* The measurable lesion may have not received radiation therapy
* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 <= age <= 2
* Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC
* Adequate organ function
Exclusion Criteria:
* Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed.
* Subject has untreated brain or meningeal metastases.
* History of greater than 10% weight loss
* Subject has clinically relevant hemoptysis
* The subject has proteinuria CTC Grade > 1
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
* The subject has a documented left ventricular ejection fraction < 50%
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
| NCT00517790 | {
"brief_title": "Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)",
"conditions": [
"Non-Small Cell Lung Cancer (NSCLC)"
],
"interventions": [
"Drug: ABT-869 .25 mg/kg",
"Drug: ABT-869 0.10 mg/kg"
],
"location_countries": [
"France",
"United States",
"Singapore",
"Taiwan",
"Canada"
],
"nct_id": "NCT00517790",
"official_title": "An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2007-08"
},
"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)": "2013-04-05",
"last_updated_that_met_qc_criteria": "2007-08-16",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-08-17",
"first_submitted": "2007-08-16",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
Detailed Description
A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating the feasibility and performance of the implantation and the safety at 30-Day follow-up.
#Intervention
- DEVICE : ACURATE TA™
- ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement surgery.
- Other Names :
- ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System | #Eligibility Criteria:
Inclusion Criteria:
* Patients older than 75 years;
* Additive EuroSCORE > 9 and/or STS > 9%;
* Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient > 40mmHg,and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²;
* NYHA Functional Class > II;
* Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm <= AAn <=27mm) by transoesophageal echocardiography;
* Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) [STJ>1.1xAAn] AND STJ<45mm by transoesophageal echocardiography;
* Patient understands the implications of participating in the study and provides signed informed consent
Exclusion Criteria:
* Congenital unicuspid or bicuspid aortic valve;
* Severe eccentricity of calcification;
* Severe mitral regurgitation (> 2°);
* Pre-existing prosthetic heart valve in any position and /or prosthetic ring;
* Severe transapical access problem, non-reachable LV apex;
* Previous surgery of the LV using a patch, such as the Dor procedure;
* Presence of apical LV thrombus;
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
* Acute Myocardial Infarction (AMI) within 1 month prior to the procedure;
* PCI within 1 month prior to the procedure;
* Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months;
* Untreated clinically significant CAD requiring revascularization;
* Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump;
* Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) < 25% by echocardiography;
* Calcified pericardium;
* Septal hypertrophy;
* Primary Hypertrophic Obstructive Cardiomyopathy (HOCM);
* Active infection, endocarditis or pyrexia;
* Active peptic ulcer or Gastrointestinal (GI) bleeding within the past 3 months;
* Significant hepatic involvement (Child > B);
* Major lung disease (FEV < 0.8 or FEV1% < 30% of normal);
* Pulmonary hypertension;
* History of bleeding diathesis or coagulopathy;
* Hematologic disorder (WBC<3000mm3, Hb<9g/dL, platelet count <50000 cells/ mm3);
* Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis;
* Neurological disease severely affecting ambulation or daily functioning, including dementia;
* Other procedure scheduled at the same time, whether surgery or percutaneous approach;
* Emergency procedure;
* Life expectancy < 12 months due to non-cardiac co-morbid conditions;
* Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol;
* Currently participating in an investigational drug or another device study
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT03567278 | {
"brief_title": "Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)",
"conditions": [
"Aortic Stenosis Symptomatic"
],
"interventions": [
"Device: ACURATE TA™"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03567278",
"official_title": "Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2009-11"
},
"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)": "2018-06-25",
"last_updated_that_met_qc_criteria": "2018-06-15",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-25",
"first_submitted": "2014-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
Detailed Description
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.
The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).
The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
#Intervention
- DEVICE : CardioMEMS™ HF System
- The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
- Other Names :
- CardioMEMS, CardioMEMS PA Sensor, CardioMEMS HF System | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:
a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
* GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
* GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
* HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
1. Subjects with LVEF <= 40%: NT-proBNP >= 1000 pg/mL (or BNP >= 250 pg/mL).
2. Subjects with LVEF > 40%: NT-proBNP >= 700 pg/mL (or BNP >= 175 pg/mL).
3. Thresholds for NT-proBNP and BNP (for both LVEF <= 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
* >= 18 years
* Chest circumference of < 65 inches, if BMI is > 35 kg/m2
* Written informed consent obtained from subject
* Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements
Exclusion Criteria:
* Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
* ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
* Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
* NYHA Class IV HF patients with:
1. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of <= 4, OR
2. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
* Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
* Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
* Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
* Implanted with mechanical right heart valve(s)
* Unrepaired severe valvular disease
* Pregnant or planning to become pregnant in the next 12 months
* An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
* History of current or recurrent (>= 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
* Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
* Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
* Enrollment into another trial with an active treatment arm
* Anticipated life expectancy of < 12 months
* Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation
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
| NCT03387813 | {
"brief_title": "Hemodynamic-GUIDEd Management of Heart Failure",
"conditions": [
"Heart Failure",
"Heart Failure, Systolic",
"Heart Failure, Diastolic",
"Heart Failure NYHA Class II",
"Heart Failure NYHA Class III",
"Heart Failure NYHA Class IV",
"Heart Failure，Congestive",
"Heart Failure With Reduced Ejection Fraction",
"Heart Failure With Normal Ejection Fraction",
"Heart Failure; With Decompensation"
],
"interventions": [
"Device: CardioMEMS™ HF System"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT03387813",
"official_title": "Hemodynamic-GUIDEd Management of Heart Failure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-17",
"study_completion_date(actual)": "2023-05-17",
"study_start_date(actual)": "2018-03-15"
},
"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)": "2023-08-09",
"last_updated_that_met_qc_criteria": "2017-12-22",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-02",
"first_submitted": "2017-12-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program.
Detailed Description
The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information learned about barriers into a novel immunization registry training program with strategies specific to individual subsets of pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term goal which is to increase the use of immunization registries in community pharmacies in Alabama.
The specific aims are to
1. identify barriers and best practices of immunization registry implementation,
2. use a participatory design approach to develop an immunization registry training program, and
3. disseminate and assess the impact of the immunization registry training program among community pharmacies' registry participation rates.
The impact of the training program on registry participation rates will be assessed using a randomized controlled trial design comparing Alabama community pharmacies' registry data as well as intention to participate.
#Intervention
- BEHAVIORAL : Immunization Registry Training
- Education highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow.
- BEHAVIORAL : Informational flyer
- Informational flyer with ImmPRINT contact information | #Eligibility Criteria:
Inclusion Criteria:
* not currently enrolled in ImmPRINT
* currently provide at least one type of vaccination in addition to influenza
* independently owned
* agree to provide requested data for assessment
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03796585 | {
"brief_title": "Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies",
"conditions": [
"Immunization"
],
"interventions": [
"Behavioral: Informational flyer",
"Behavioral: Immunization Registry Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03796585",
"official_title": "Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-15",
"study_completion_date(actual)": "2019-09-15",
"study_start_date(actual)": "2019-01-10"
},
"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)": "2019-10-30",
"last_updated_that_met_qc_criteria": "2019-01-04",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-08",
"first_submitted": "2019-01-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.
Detailed Description
The study is constructed to help inform which vaccine regimen, likely in combination with enhanced HIV care, could serve as a public health model for an effective and cost-efficient approach to preventing SARS-CoV-2 disease, prolonged viral shedding, and the emergence of VOCs within this population. Moreover, we will evaluate whether immune responses postvaccination can be correlated to these clinically important outcomes.
The study will enroll 15,600 adults from many clinics in Eastern and Southern Africa. All participants in the study will get the study vaccine. There are 4 primary groups in this study. The groups differ in the number of doses of the study vaccine administered. The groups are organized by whether or not people are living with HIV and whether or not people have evidence of prior SARS-CoV-2 infection in their blood.
Group 1 includes people living with HIV and Group 3 includes people who are not living with HIV. All people in groups 1 and 3 will have no evidence of prior SARS-CoV-2 infection in their blood. Participants in Group 1 or Group 3 will get three doses of the study vaccine.
Group 2 includes people living with HIV and Group 4 includes people who are not living with HIV. All people in groups 2 and 4 will have evidence of prior SARS-CoV-2 infection in their blood. Participants in Group 2 or Group 4 will get two doses of the study vaccine.
There are 8 scheduled clinic visits over 18 months. Study visits may include physical examinations, medical history, vaccine injections, HIV testing, blood collection, nasal swabs, and questionnaires.
#Intervention
- BIOLOGICAL : Moderna mRNA-1273
- COVID-19 vaccine (mRNA-1273) developed by Moderna, Inc. is a lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available).
- BIOLOGICAL : Vaccine 3 Dose
- COVID-19 mRNA vaccine in 100 mcg dose given as IM injection into the deltoid muscle on Day 1, Day 29, and Day 169.
- BIOLOGICAL : Vaccine 2 Dose
- COVID-19 mRNA vaccine is to be administered as IM injection into the deltoid muscle on Day 1 and Day 169. | #Eligibility Criteria:
Inclusion Criteria:
General and Demographic Criteria
* Age >= 18 years if participant self-reports living with HIV or another comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list):
* Hypertension
* Type 2 diabetes mellitus
* Overweight, obese, or severely obese (ie, body mass index [BMI] >= 25 kg/m2)
* Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
* Chronic kidney disease
* COPD (chronic obstructive pulmonary disease)
* Cancer
* Non-HIV immunocompromised state (weakened immune system) or solid organ transplant
* Pregnancy
* Sickle cell disease
* Smoking
* Willingness to be followed and remain in the catchment area for the planned duration of the study.
* Ability and willingness to provide informed consent.
* Willingness to discuss HIV infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize HIV acquisition/improve HIV care as appropriate based on their infection status.
* Assessment of Understanding (AoU): Participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly.
* Agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease.
Exclusion Criteria:
General
* Acutely ill 72 hours prior to or at screening. Participants meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.
* History of angioedema or anaphylaxis.
Vaccines and other injections
* Prior receipt of a SARS-CoV-2 vaccine.
* History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose).
* Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine).
* Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B).
* Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.
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
| NCT05168813 | {
"brief_title": "Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern",
"conditions": [
"SARS-CoV-2 Infection",
"HIV Infections",
"COVID-19"
],
"interventions": [
"Biological: Vaccine 2 Dose",
"Biological: Vaccine 3 Dose",
"Biological: Moderna mRNA-1273"
],
"location_countries": [
"Zambia",
"Botswana",
"Kenya",
"Swaziland",
"South Africa",
"Uganda",
"Malawi"
],
"nct_id": "NCT05168813",
"official_title": "Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-19",
"study_completion_date(actual)": "2024-04-19",
"study_start_date(actual)": "2021-12-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-09",
"last_updated_that_met_qc_criteria": "2021-12-21",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-23",
"first_submitted": "2021-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million people in Canada (13% of Canadians). OA symptoms include joint pain, stiffness, range of motion loss, and inflammation, resulting in a significant decrease in quality of life. Current evidence-based guidelines for OA management recommend weight loss, patient education, exercise therapy, bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines and focus largely on joint replacement. Recently, research from a group in Denmark has shown a reduction in the progression of knee OA symptoms, joint related painkiller use, individuals on sick leave, and higher physical activity levels 12 months after a combined patient education and standardized group exercise therapy program (GLA:D®). Based on the Danish success, the GLA:D® program has been made available in Canada. To date it is unclear if the GLA:DTM Canada program will result in outcomes similar to those seen in Denmark, or how the GLA:DTM program compares to existing individualized OA care programs (i.e. JointEffort). This research will answer the following three questions;
1. Is the GLA:DTM standardized education and exercise program associated with improvements in functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients in Calgary, Alberta?
2. Is the JointEffort individualized exercise and education program associated with improved functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients in Calgary, Alberta?
3. Do the improvements in functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients differ between those enrolled in the GLA:DTM and the JointEffort education and exercise programs?
Detailed Description
BACKGROUND:
Osteoarthritis (OA) is the leading cause of disability worldwide and affects more than 4.4 million people in Canada (13% of Canadians). OA symptoms include joint pain, stiffness, range of motion loss, and inflammation, resulting in a significant decrease in quality of life. Current evidence-based guidelines for OA management recommend weight loss, patient education, exercise therapy, bracing, viscosupplementation, and anti-inflammatory/pain medications prior to joint replacement surgery. Unfortunately, current practice trends are not consistent with these guidelines and focus largely on joint replacement. Recently, research from a group in Denmark has shown a reduction in the progression of knee OA symptoms, joint related painkiller use, individuals on sick leave, and higher physical activity levels 12 months after a combined patient education and standardized group exercise therapy program (GLA:D®). Based on the Danish success, the GLA:D® program has been made available in Canada. To date it is unclear if the GLA:D® Canada program will result in outcomes similar to those seen in Denmark, or how the GLA:D® program compares to existing individualized OA care programs (i.e. JointEffort).
RESEARCH QUESTIONS:
1. Is the GLA:D® standardized education and exercise program associated with improvements in functional mobility, quality of life, pain management, and biomarkers in knee OA patients in Alberta?
2. Is the JointEffort individualized exercise and education program associated with improved functional mobility, quality of life, pain management, and biomarkers in knee OA patients in Alberta?
3. Do the improvements in functional mobility, quality of life, pain management, and biomarkers in knee OA patients differ between those enrolled in the GLA:D® and the JointEffort education and exercise programs?
OBJECTIVES:
The objectives of this pre-experimental intervention study are to 1) assess the association between participation in the GLA:D® standardized program and functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients, 2) assess the association between participation in the JointEffort individualized program and functional mobility, quality of life, pain management, and inflammatory biomarkers in knee OA patients, and 3) assess if there are any differences in outcomes between the standardized (GLA:D®) and individualized (JointEffort) exercise programs.
METHODOLOGY:
Study Participants: A convenience sample of 60 participants ≥50 years of age with a primary care physician or orthopedic surgeon knee OA diagnosis will be included in the study. Specifically, 30 individuals will participate in 1) the GLA:D® program and 30 sex- and age-matched individuals will participate in 2) the JointEffort program. 60 participants is a conservative estimate based on the ability to detect a moderate effect between study groups (1-β=0.8, α=0.05).
Exercise Programs: The GLA:D® program consists of 1) pre- and post-program outcome measurement (self-reported and functional outcomes); 2) 2, 1-1.5 hour education sessions including information on OA disease characteristics, treatments and self-help strategies; and 3) a neuromuscular exercise (warm-up, circuit training, and cool down) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks. The goal of the exercises is to restore neutral, functional alignment of the legs by building compensatory functional stability and improving sensorimotor control. The JointEffort program consists of: 1) one appointment aimed at individualized program design; 2) a nutritional seminar taught by a registered dietician explaining dietary recommendations for OA patients and inflammatory conditions, including weight loss and/or management; and 3) an individualized exercise (strength and neuromuscular training, balance training, and range of motion exercises) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks.
Study Outcomes:
1. Demographic (age, sex, height, weight, and body mass index), comorbidity, attendance, exercise log, and medication use details will be recorded at each visit. Adherence will be measured by exercise program attendance (number of sessions).
2. The following self-report questionnaires will be completed at baseline, 2, and 12 months: the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and Constant Osteoarthritis Pain (ICOAP) Score, and the EuroQOL-5 Dimensions-5 Levels (EQ-5D-5L) Score.
3. The patient knowledge questionnaire on OA (PKQ-OA) and the arthritis self-efficacy questionnaire will be completed at baseline, 2, and 12 months.
4. All participants will complete the 40m Face-Paced Walk Test and the 30s Chair Stand Test at baseline, 2, and 12 months.
5. A blood serum sample, collected at baseline, 2, and 12 months will be analyzed to assess for biomarkers (cytokines, chemokines, adipokines, mytokines) using a Discovery Assay (42 Custom-Plex human assay) with Luminex-xMAP technology (Eve Technologies).
STATISTICAL ANALYSIS:
Descriptive statistics (mean (95% CI), proportion (95% CI) or median (range) will be used report the baseline, 2, and 12 month change in self-report, functional and biomarker outcomes, as appropriate. To account for the matched design, mean within-pair difference (95% CI) will be used to compare treatment groups across outcomes. Finally, conditional logistic regression will be used to assess the relationship between attendance (number of sessions) and 12-month change in each outcome.
SIGNIFICANCE:
This project will contribute to the understanding of exercise programming prescription for knee OA patients. If GLA:D® and/or JointEffort support improvements in functional mobility, quality of life, pain management, and biomarkers, it could play a role in the implementation strategy for OA patients within the province. Exercise programming has the potential to be implemented in several sites across Alberta, and thus potentially modifying disease progression and possibly delaying total joint replacement.
#Intervention
- OTHER : GLA:D Canada Program
- The GLA:D® program consists of 1) pre- and post-program outcome measurement (self-reported and functional outcomes); 2) 2, 1-1.5 hour education sessions including information on OA disease characteristics, treatments and self-help strategies; and 3) a neuromuscular exercise (warm-up, circuit training, and cool down) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks. The goal of the exercises is to restore neutral, functional alignment of the legs by building compensatory functional stability and improving sensorimotor control.
- OTHER : JointEffort Program
- The JointEffort program consists of: 1) one appointment aimed at individualized program design (1-1.5 hours); 2) a nutritional seminar taught by a registered dietician explaining dietary recommendations for OA patients and inflammatory conditions, including weight loss and/or management (1 hours); and 3) an individualized exercise (strength and neuromuscular training, balance training, and range of motion exercises) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks. | #Eligibility Criteria:
Inclusion Criteria:
* have been diagnosed with OA by a primary care physician or orthopedic surgeon;
* >=50 years;
* are able read, understand, and provide informed consent in English; and
* can attend exercise programming classes at the University of Calgary.
Exclusion Criteria:
* have physical or neurological impairments or pre-existing medical conditions where physical activity is contraindicated;
* have inflammatory arthritis, a fracture, tumor, or acute trauma; and
* participated in the JointEffort or GLA:D program previously.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03406767 | {
"brief_title": "A Comparison Between GLA:D Canada and an Individualized JointEffort Exercise Program in Knee Osteoarthritis Patients",
"conditions": [
"Osteoarthritis, Knee"
],
"interventions": [
"Other: JointEffort Program",
"Other: GLA:D Canada Program"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03406767",
"official_title": "A Comparison Between a Standardized (GLA:D Canada) and an Individualized (JointEffort) Exercise Program on Functional Mobility, Quality of Life, Pain Management, and Inflammatory Biomarkers in Knee Osteoarthritis Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-15",
"study_completion_date(actual)": "2020-03-15",
"study_start_date(actual)": "2018-05-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-21",
"last_updated_that_met_qc_criteria": "2018-01-15",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-23",
"first_submitted": "2018-01-05",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The investigators' goal is to incorporate advanced imaging information into the treatment planning process and assess response in tumor, nodes and non-cancerous tissues in head and neck cancer patients during and after concurrent chemotherapy and radiation therapy (chemoRT) via biophysical, biochemical and vascular imaging using magnetic resonance imaging (MRI). The investigators will recruit 30 patients with locally advanced head and neck cancer into the study. All patients will obtain an advanced MRI study at three time points: 1) before the start of chemoRT, 2) 4 weeks following the start of chemoRT, and 3) 3-4 months following completion of chemoRT. MRI scans will include a) T1, T2 and T2\* imaging, b) vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. The subject's response (tumor, nodes and salivary and mucosal tissues) will be evaluated using clinical outcomes. Correlations will be generated between the parameters obtained from MR images and from clinical response assessments.
The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function (salivary gland and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Detailed Description
MRI scans will be performed at three time points. The time points will be 1-2 weeks prior to the start of treatment, between 4 and 5 weeks after the start of treatment (i.e., after the 20th radiation treatment fraction and before the start of the 25th radiation treatment fraction), and 3-4 months after the completion of chemoRT. Scans acquired at the first and third time points will be clinically indicated (except for the spectroscopy scan) and ordered by the treating physician. The scan session corresponding to the second time point will be for research purposes. The investigators chose 4-5 weeks as the time point for predicting early response to chemoRT for the following reason. In a 7-week treatment regimen, an indicator tested at \> 5 weeks would have limited predictive utility in the consideration of an alternative therapy, i.e., surgical intervention. However, an indicator measured at \<= 5 weeks (i.e., with enough time remaining to the end of therapy) might potentially inform the therapeutic course of action in future studies. If this pilot study demonstrates utility of advanced MR imaging techniques identified at 4-5 weeks, future studies could focus on the optimal timing for assessment of early response. The time point of 3-4 months is selected for assessing post-therapy response because it coincides with the clinical follow-up schedule (at which an image-based assessment of response is performed via a clinical exam and/or PET imaging) that determines the standard of care response.
T1, T2, and T2\* MRI scans will be performed to delineate head and neck tissues. DCE MRI scans will provide quantitative assessment of contrast uptake in tissues and tissue vasculature both during and at follow-up after completion of chemoRT. Contrast on images will be provided by a gadolinium-based contrast agent (GBCA). GBCA is FDA-approved and is routinely used in dynamic contrast-enhanced MRI scans. Further, contrast enhanced MRI is typically obtained on all cancer patients including head and neck cancer as part of routine clinical care. Diffusion MRI scans will provide information on the diffusion of water molecules in tumor, nodes and other head and neck tissues. MR spectroscopy scans will provide information on tissue metabolites. All scans acquired prior to the start of chemoRT will provide baseline maps against which functional maps acquired during and after completion of chemoRT will be compared to determine the relative change in anatomical, biophysical and biochemical parameters.
Image anatomy and parameter maps will be correlated with dose maps derived from CT images by registering (fusing) MRI images with CT images acquired as part of standard of care and used for treatment planning of the subject's radiation treatment.
| #Eligibility Criteria:
Inclusion Criteria:
* 1 Subjects must be >= 18 years.
* 2 Subjects must have Stage III or IV head and neck cancer.
* 3 Subjects must be undergoing concurrent chemotherapy and radiation with or without induction chemotherapy for head and neck cancers.
* 4 Subjects must be capable of giving informed consent.
* 5 Subjects must not be claustrophobic.
* 6 Patients with conditions or using medications that may contribute to xerostomia will not be excluded in this pilot study, but medical conditions and medications will be documented.
* 7 Macroscopic disease at presentation (at least T2 and/or >2cm lymph node) based on radiographic imaging.
Exclusion Criteria:
* 1 Subjects with pacemakers.
* 2 Subjects who have metallic ferromagnetic implants or pumps.
* 3 Subjects who are pregnant. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'), intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam.
* 5 Subjects with kidney disease of any severity or on hemodialysis.
* 6 Subjects with known allergies to gadolinium-based contrast agents.
* 7 Subjects incapable of lying on their backs for up to an hour at a time.
* 8 Subjects who have a tracheostomy.
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
| NCT01768442 | {
"brief_title": "MRI for Eval Tumor & Node Response & Normal Tissue Function to Concurrent Chemo & Radiation Therapy in H&N Cancer (GCC1043)",
"conditions": [
"Head and Neck Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01768442",
"official_title": "GCC1043: Magnetic Resonance Imaging for Evaluating Tumor and Node Response and Normal Tissue Function to Concurrent Chemotherapy and Radiation Therapy in Head and Neck Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09",
"study_completion_date(actual)": "2019-01",
"study_start_date(actual)": "2011-09"
},
"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)": "2019-09-12",
"last_updated_that_met_qc_criteria": "2013-01-11",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-15",
"first_submitted": "2013-01-09",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to examine whether patients who participate in cognitive remediation prior to a skills training program learn and perform the skills better than patients who do not participate in cognitive remediation.
Detailed Description
Subjects are 40 stable outpatients with schizophrenia or schizoaffective disorder who are receiving medication and routine follow-up care at community clinics in San Antonio, Texas.
Patients receive baseline assessments and then are randomly assigned to either Cognitive Remediation (CR) or Keyboarding Skills (KS) for a period of 8 weeks. Following 8 weeks of treatment in either CR or KS, all patients participated in Social Skills Training (SST) for a period of 8 weeks. Assessments conducted by raters blinded to treatment condition are repeated following either remediation or control treatment, and again following SST.
Treatment groups Cognitive Remediation (CR) -- The CR program is based upon teaching techniques developed within educational psychology that promote intrinsic motivation and task engagement. The program uses existing computer software packages (e.g., Oregon Trail) with engaging story lines or activities, and built-in reinforcement of correct responses to help patients with schizophrenia develop attention, memory, planning, and problem-solving skills. CR is delivered in a computer lab setting with a facilitator present to assist patients.
Keyboarding Skills (KS) -- Control Treatment: The control treatment is an engaging self-paced software program designed to teach typing skills. KS is delivered in a computer lab setting with a facilitator present.
Both the KS and CR are administered in small groups of three to five patients each.
Social Skills Training (SST) -- SST is a manual-driven, behavioral rehabilitation program teaching basic conversation and social problem-solving skills (Bellack et al., 1997). SST runs for 8 weeks and is conducted in small groups that meet twice weekly.
#Intervention
- BEHAVIORAL : Cognitive Remediation
- BEHAVIORAL : Social Skills Training | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia/schizoaffective disorder
* currently receiving treatment with an atypical antipsychotic medication
* between the ages of 18 and 60 years
* speak English as their primary language
* has at least a 6th grade level of reading (WRAT) Exclusion Criteria
* no current diagnosis of substance abuse or dependence
* no documented history of head injury, epilepsy or mental retardation.
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:
No
| NCT00223535 | {
"brief_title": "Cognitive Remediation and Social Skills Training in Schizophrenia",
"conditions": [
"Schizophrenia",
"Schizoaffective"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00223535",
"official_title": "Cognitive Remediation and Social Skills Training in Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-03",
"study_start_date(actual)": "2003-02"
},
"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)": "2005-09-22",
"last_updated_that_met_qc_criteria": "2005-09-14",
"last_verified": "2005-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-22",
"first_submitted": "2005-09-14",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and weekly questionnaires. Nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.
#Intervention
- OTHER : Standard of care + Mediterranean diet (intervention)
- Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.
Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consume ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fruits; d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish/seafood; f) ≥3 weekly serving of nuts/seeds; g) select white instead of red or processed meats; h) cook at least twice a week with sofrito. Limit consumption of cream, butter, processed meat, sugared beverages, industrial bakery products and desserts, and French fries or chips. For usual drinkers, the main source of alcohol should be wine.
- OTHER : Standard of care (control)
- Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included. | #Eligibility Criteria:
Inclusion Criteria:
* Physician-diagnosed Parkinson's disease aged 40 <= age <= 85 years
* Drug naïve or on stable dosage of Parkinson's medications with no plans to change for the duration of the study protocol
* Hoehn & Yahr stage =<2.5 in the clinical 'ON' state
* Constipation syndrome scores >=2.0 based on the GSRS
* Consume <20 grams of fiber daily based on the Block Fruit/Vegetable/Fiber screener
* Able to complete informed consent in English
* Willing to maintain habitual diet through the pre-baseline period.
* Willing to make dietary changes to follow a Mediterranean diet and/or receive standard of care for constipation during the intervention period.
* Willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks.
* Able to provide stool samples during the study collection periods.
* Willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits.
* Able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit
* Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
Exclusion Criteria:
* Atypical or secondary Parkinsonism
* Underweight (BMI <18.5)
* History of deep brain stimulation (DBS) surgery
* Regular use of enemas or suppositories to alleviate constipation (e.g., >1 time per week)
* Use of another investigational product within 3 months of the screening visit
* Antibiotic or probiotic supplement use within 2 months from the day of stool collection
* Currently being treated for a physician-diagnosed GI disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04683900 | {
"brief_title": "Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial",
"conditions": [
"Parkinson Disease"
],
"interventions": [
"Other: Standard of care + Mediterranean diet (intervention)",
"Other: Standard of care (control)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04683900",
"official_title": "Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-07",
"study_completion_date(actual)": "2022-06-07",
"study_start_date(actual)": "2021-02-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-12",
"last_updated_that_met_qc_criteria": "2020-12-23",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-24",
"first_submitted": "2020-12-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this clinical trial is to assess the feasibility and the security of the intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.
Detailed Description
Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. Moreover, the clinical trial (Study NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis in humans, found that this procedure is feasible and safe. Continuing with that study, we have designed a phase I/II clinical trial to check the feasibility of the intraspinal and intrathecal infusion of autologous bone marrow stem cells.
#Intervention
- PROCEDURE : Laminectomy and bone marrow stem cells transplantation
- Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
- PROCEDURE : Intrathecal infusion of autologous bone marrow stem cells
- Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.
Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.
- PROCEDURE : Intrathecal infusion of placebo (saline solution).
- Patients were infused 2 ml of saline solution | #Eligibility Criteria:
Inclusion Criteria:
* Diagnose established following the World Federation of Neurology criteria
* More than 6 and less than 36 months of evolution of the disease
* Medullar onset of the disease
* More than 18 and less than 70 years
* Forced Vital Capacity >= 50%
* Total time of oxygen saturation <90% inferior to 5% of the sleeping time
* Signed informed consent
Exclusion Criteria:
* Neurological or psychiatric concomitant disease
* Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
* Concomitant systemic disease
* Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
* Inclusion in other clinical trials
* Unability to understand the informed consent
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
| NCT01254539 | {
"brief_title": "Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)",
"conditions": [
"Amyotrophic Lateral Sclerosis"
],
"interventions": [
"Procedure: Intrathecal infusion of placebo (saline solution).",
"Procedure: Laminectomy and bone marrow stem cells transplantation",
"Procedure: Intrathecal infusion of autologous bone marrow stem cells"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01254539",
"official_title": "Phase I/II Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11-20",
"study_completion_date(actual)": "2015-11-20",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-30",
"last_updated_that_met_qc_criteria": "2010-12-03",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-12-06",
"first_submitted": "2010-12-03",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and ambulatory blood pressure in obese participants. The study is designed to evaluate the efficacy and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion.
#Intervention
- DRUG : Setmelanotide
- Daily subcutaneous infusion
- Other Names :
- RM-493
- DRUG : Placebo
- Daily subcutaneous infusion | #Eligibility Criteria:
Inclusion Criteria:
* Be between the age of 18 and 65.
* Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.
* In good general health, without significant medical history, physical examination findings, or clinical laboratory abnormalities.
* Body Mass Index: 35 <= age <= 50 Kg/m^2, inclusive. It is planned that approximately 20 (but no more than 50% of the total participants enrolled) of these participants will have a BMI >= 40 Kg/m^2
* Stable body weight (+/- 5 Kg) during previous 6 months.
* Blood pressure (<150/95 mmHg); may include stable dose (>= 30 days of use) of up to two anti-hypertensive medications to achieve control that are intended to remain on a stable dose during the protocol.
* Willingness and demonstrates ability to self-administer study medication subcutaneously via an infusion pump during the placebo practice period.
* Willing to maintain a healthy diet and exercise regime throughout study as recommended by counseling at study start.
* Females of childbearing potential must agree to be abstinent or else use any two of the following medically acceptable forms of contraception from the Screening Period through the completion of study treatment: hormonal, condom with spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intrauterine device (IUD). Hormonal contraception must have started at least 3 months prior to screening. A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. Participants must agree to practice the above birth control methods for 30 days after completion of study treatment as a safety precaution.
* Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months (and confirmed with a screening follicle stimulating hormone (FSH) level in the post-menopausal range), do not require contraception during the study.
* Males with female partners of childbearing potential must agree to use two medically acceptable forms of contraception as described above, with one of the two forms being condom with spermicide, from the Screening Period through 90 days after completion of study treatment. Males with female partners of childbearing potential who themselves are surgically sterile (status post vasectomy) must agree to use condoms with spermicide over the same period of time.
Exclusion Criteria:
* Fasting blood glucose > than 140 mg/dL.
* Haemoglobin A1c (HbA1c) >=6.5%.
* Thyroid stimulating hormone (TSH) level outside the normal range.
* Creatinine > 1.5 times the upper limit of normal.
* Liver function tests > 2 times the upper limit of normal.
* Active or history of any significant medical condition including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.
* Participants with a history of the following:
1. Uncontrolled hypertension;
2. Diabetes requiring medical treatment, presently or in the past;
3. Major depressive disorder within the last 2 years;
4. Any lifetime history of a suicide attempt;
5. Any suicidal behavior in the last month;
6. Other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder, severe eating disorders including bulimia).
* A patient health questionnaire - 9 (PHQ-9) score of >=15.
* Any suicidal ideation of type 4 or 5 on the columbia suicide severity rating scale (C-SSRS).
* Prior bariatric surgery.
* Treated with anorectic agents or drugs with anorexia as a frequent side event.
* Taking 3 or more anti-hypertensive medications.
* Acute illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the participant or obscure interpretation of laboratory test results or interpretation of study data.
* History of human immunodeficiency virus (HIV) infection.
* History of significant drug hypersensitivity or anaphylaxis.
* History of hypersensitivity to proteins (e.g., allergy shots).
* Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
* Abnormal 12-lead electrocardiogram (ECG) at screening or pre-dose (Day 1), except minor deviations deemed to be of no clinical significance by the Investigator. QTc must be < 450 ms.
* Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to dosing.
* Hospitalization for surgery within the 3 months prior to screening except for minor outpatient procedures, or any planned hospitalizations during the study period.
* Poor venous access or inability to tolerate venipuncture.
* Inability to attend all study visits or comply with protocol requirements including fasting and restrictions on concomitant medication intake.
* Participation in weight loss programs during the study period, including nutritional supplements/ replacements other than as recommended by nutritional counseling provided at study start.
* Use of prescription medications on a regular basis with the following exceptions:
1. Contraceptives (must be on for >=3 months);
2. Hormone replacement therapy (must be on stable dose for >=3 months);
3. Antihypertensives (<3 medications on a stable dose for >= 30 days);
4. Statins (dose must be <= half the maximum dose; must be on a stable dose >=3 months);
5. Fibrates (must be on stable dose for >=3 months);
6. Niacin (must be on stable dose for >=3 months);
7. Thyroxin (stable dose for >= 30 days);
8. The last use of any other prescription medication must have been greater than 5 half-lives for the specific medication or at least 14 days prior to randomization, whichever is longer.
* Women who are pregnant or are breast feeding.
* Previously randomized and dosed in this study or previously exposed to RM-493.
* History of alcohol or drug abuse within 5 years of Screening Visit.
* Any other reason, which in the opinion of the Investigator would confound proper evaluation of the study.
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
| NCT01749137 | {
"brief_title": "Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants",
"conditions": [
"Overweight"
],
"interventions": [
"Drug: Placebo",
"Drug: Setmelanotide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01749137",
"official_title": "A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09-28",
"study_completion_date(actual)": "2013-09-28",
"study_start_date(actual)": "2013-01-14"
},
"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)": "2023-08-14",
"last_updated_that_met_qc_criteria": "2012-12-11",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-13",
"first_submitted": "2012-12-11",
"first_submitted_that_met_qc_criteria": "2023-07-19"
}
}
} |
#Study Description
Brief Summary
This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.
| #Eligibility Criteria:
Inclusion Criteria:
* All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.
Exclusion Criteria:
* Presence of a know opposition to participation to research projects
* Patient tracheostomized specifically for ENT (ear-nose-throat) reason
* Burn victim
* Patient tracheostomized before his/her admission to the Lausanne ICU
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
| NCT04987398 | {
"brief_title": "Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU",
"conditions": [
"Respiratory Failure",
"Tracheostomy Complication"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04987398",
"official_title": "Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-15",
"study_completion_date(actual)": "2022-05-15",
"study_start_date(actual)": "2021-06-10"
},
"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)": "2022-06-03",
"last_updated_that_met_qc_criteria": "2021-08-02",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-03",
"first_submitted": "2021-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density and functional status.
Detailed Description
Anterior cruciate ligament (ACL) reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100,000 cases performed per year in the United States. A large amount of sports injuries were related to ACL problem. As such, ACL injuries and treatment is still widely under intensive study.
Traditionally, ACL surgery has been focused on using bone patella bone graft and single bundle hamstring graft. Problems of knee pain, unstable fixation, rotational instability and degenerative changes were reported. Recently, the use of double bundle hamstring graft to reconstruct the ACL according its anatomy aiming to improve the rotational stability was proposed. However, results about the clinical, functional and radiological outcomes are limited.
The objective of this prospective pilot study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, skin sensation, bone mineral density and functional status.
Subjects to be operated for ACL reconstruction and meeting the inclusion and exclusion criteria will be recruited. Subjects will be randomly assigned to the three surgical groups by block randomization. Demographic information, parameters in recovery domain, functional domain and stability domain, isokinetic test, motion analysis domain, proprioception and radiographical measurements will be made at baseline and at day 1, week 2, week 4, week 8, month 3, month 5, 1 year and 2 years post-surgery. The effect of different surgical techniques and time on the different outcomes will be analysed by 2-way ANOVA.
#Intervention
- PROCEDURE : Single bundle hamstring
- Single bundle hamstring
- PROCEDURE : Double bundle hamstring
- Double bundle hamstring
- PROCEDURE : Bone patellar tendon bone
- Bone patellar tendon bone | #Eligibility Criteria:
Inclusion Criteria:
* Men above age 18 <= age <= 40 years
* First ACL reconstruction surgery
* Single leg involvement
Exclusion Criteria:
* ACL injury less than 6 weeks as deleterious effect of the injury may affect the extension range
* Injury on Duty (IOD) cases
* Other associated injuries (Fractures, other ligaments involvement, neurovascular bundles injury),Chondral lesion with co-commitment intervention
* Concomitant meniscus repair in same operation, or within 3 months before the operation
* Significant OA changes
* Known chronic disease or receiving long term medications affecting bone metabolism, including anabolic steroids, medication for thyroid hormone therapy or osteoporosis
* Neurological deficit
Sex :
MALE
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
| NCT00418964 | {
"brief_title": "Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures",
"conditions": [
"Knee Injuries"
],
"interventions": [
"Procedure: Bone patellar tendon bone",
"Procedure: Double bundle hamstring",
"Procedure: Single bundle hamstring"
],
"location_countries": [
"China"
],
"nct_id": "NCT00418964",
"official_title": "Functional, Clinical & Radiological Outcome of Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Control Clinical Trial Studies Comparing Bone Patella Bone, Single Bundle and Double Bundle Method.",
"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)": "2006-12"
},
"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)": "2012-03-27",
"last_updated_that_met_qc_criteria": "2007-01-04",
"last_verified": "2012-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-05",
"first_submitted": "2007-01-04",
"first_submitted_that_met_qc_criteria": "2012-02-16"
}
}
} |
#Study Description
Brief Summary
The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely measurement of AMH values in blood samples.
Detailed Description
An important requirement for the use of the new measurement to determine the AMH concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased AMH concentration is the most important argument to manage this parameter.
There are several studies, which give different professional opinions of the AMH concentration depending on the phase of the menstrual cycle. Some authors came to the conclusion that the AMH concentration over the menstrual cycle is constant, others described significant fluctuations. It is unclear, if the described fluctuation is relevant for the interpretation of the ovarian reserve. Recently it could be shown, that intraindividual fluctuations of joung women during the menstrual cycle is stronger, which means that the measurement of AMH in this age is less secure.
The primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys method delivers stable values over the menstrual cycle.
The secondary goal of the study is to determine whether there are any fluctuations in the number of antral follicles as given by 3D ultrasound.
For this reason we are recruiting a group of 50 women within two categories of age to measure eventually changes in AMH- concentration during their menstrual cycle.
#Intervention
- PROCEDURE : blood sample and ultrasound
- When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion. | #Eligibility Criteria:
Inclusion Criteria:
* Regular natural menstrual cycle between 24 and 32 days
* Body Mass Index (BMI) between 19 and 26 kg/m2
* Negative serum titer for HIV, Hepatitis B and Hepatitis C
* Non-smoker
* Willingness to visit the clinic every second day of two non-consecutive menstrual cycles.
Exclusion Criteria:
* Intake of hormonal medication like contraceptives
* Pregnancy/breast feeding
* Known infertility
* Known former or actual hormonal disorder
* Polycystic ovarial syndrom (PCOS)
* Participation on another clinical trial during the last 3 months.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03398603 | {
"brief_title": "Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?",
"conditions": [
"Ovarian Failure"
],
"interventions": [
"Procedure: blood sample and ultrasound"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03398603",
"official_title": "Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-31",
"study_completion_date(actual)": "2019-10-13",
"study_start_date(actual)": "2016-11-01"
},
"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)": "2020-01-28",
"last_updated_that_met_qc_criteria": "2018-01-07",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-12",
"first_submitted": "2017-12-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Patients with craniofacial defects caused by oncologic resection, traumatic events or congenital etiologies suffer from esthetic, functional and psychological problems. Auricular, nasal and orbital defects can be reconstructed with implant retained extra-oral prosthesis. The goal of this study is to evaluate implant survival in temporal, maxillary and orbital bone, and peri-implant tissue reactions using a new implant system developed by BioComp Industries.
Detailed Description
Protocol:
1. Planning The ideal size and location of the implants is based on pre-operative CT or CBCT scan followed by analysis using romexis planning software.
In normal circumstances, without bone limitations, the number and location of the implants will be planned as mentioned below:
* Left auricular region: 2 implants placed on position 4h and 1h30 in the temporal/mastoid bone. If necessary, 3 implants are placed on positions 1h30, 3h and 4h30. The inter implant distance is 20mm.
* Right auricular region: 2 implants placed on position 8h and 10h30 in the temporal/mastoid bone. If necessary, 3 implants are placed on positions 10h30, 9h and 7h30. The inter implant distance is 20mm.
* Nasal region: 2 implants placed in the lateral parts of the piriform aperture of the maxilla, as far away from the spina nasalis anterior as possible. If necessary a third implant will be placed in the glabella.
* Left orbital region: 2-4 implants are placed in the supra-orbital, lateral and/or infra-orbital rim on positions 1h, 2h, 3h en 5h.
* Right orbital region: 2-4 implants are placed in the supra-orbital, lateral and/or infra-orbital rim on positions 11h, 10h, 9h en 7h.
If for some reason there is insufficient bone in the above mentioned areas, the position of the implants will be minimally adjusted in order to secure good osseointegration. Neuronavigation will be used for cases with limited bone volume.
2. Flap design During surgery the first step is the creation of a skin flap or resection of a tumor, exposing the area for implantation.
3. Implantation The implantation protocol as described by BioComp Industries will be used. Each drilling procedure is executed by 1800-2000rpm with water cooling.
* Defining the implant location with the 2,45mm diameter round bur.
* Preparation of the implant site with the implant drills, length and diameter of the drill is dependent on the length and diameter of the implant. Drilling protocol will always start with the smallest and shortest drill and gradually expanded, corresponding to the size of the implants.
* Placement of the implant without water cooling at 15rpm and maximal torque of 52Ncm. If necessary the implant will be inserted manually.
For auricular, orbital and nasal defects with sufficient bone volume (\>=3mm) and good bone quality, a percutaneous healing abutment with torque 20-25 ncm will be placed immediately after insertion of the implant (=one-stage protocol). Soft tissues in an area of 15-20mm surrounding the implant will be reduced to 1mm thickness.
In all other circumstances, the implant will be protected by means of a cover screw and reburied under the skin for a 3 month osseointegration period (=two-stage protocol). After 3 months the implants are exposed, percutaneous healing abutments placed and the surrounding soft tissues reduced to 1mm thickness.
In the case of large resections where no viable skin is left, a split thickness skin graft from the upper thigh will be used.
Finally, a healing cap surrounding the healing abutments is placed to ensure strong bone-skin contact around the implant. This healing cap will be fixated by a fixation screw, torqued at 15 Ncm.
4. Clinical measurements:
The stability of the implants will be measured at the time of abutment placement, 1 or 2 weeks, 1 month, 3 months, 6 months and yearly until the end of the study by resonance frequency analysis (RFA), using the Osstell idx system.
At the same time periods the peri-abutment tissue will be evaluated according to the Holgers criteria.
Once all implants have reached a stability measurement of 50 ISQ, the patient will be sent to the anaplastologist for prosthesis treatment.
In case one or more of the implants fail during the study period, the implant will be removed and replaced by a new implant. The protocol will restart for the newly placed implant.
5. Radiological measurements:
The bone level around the implants will be measured at 1 or 2 weeks after implant placement and 1 year after implant placement. Radiological imaging will be performed using a cone beam computed tomography device (planmeca promax 3d max) or CT scan, dependent on primary imaging in order to allow comparison between both images.
#Intervention
- DEVICE : Implantation of BioComp Industries cranio-maxillo-facial (CMF) screw implants
- Placement of BioComp Industries extraoral screw implants with diameters 3.4mm or 4mm and lengths 3.4mm or 4mm in temporal, nasal or orbital bone
- Other Names :
- EO-1110-34VD04, EO-1110-40VD03, EO-1110-40VD04 | #Eligibility Criteria:
Inclusion Criteria:
* All patients with auricular, nasal, orbital defects caused by congenital, traumatic, oncologic or infectious etiologies
* Adults (>18yr)
Exclusion Criteria:
* Children
* Implant placement for bone anchored hearing aid (BAHA)
* Implant placement for oral rehabilitation
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
| NCT03182361 | {
"brief_title": "Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants.",
"conditions": [
"Maxillofacial Prosthesis Implantation",
"Extra-oral Implants",
"Extra-oral Prosthesis",
"Prostheses and Implants"
],
"interventions": [
"Device: Implantation of BioComp Industries cranio-maxillo-facial (CMF) screw implants"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT03182361",
"official_title": "Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants: An Interventional Study of 10 Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-17",
"study_completion_date(actual)": "2019-10-17",
"study_start_date(actual)": "2017-06-20"
},
"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)": "2022-12-23",
"last_updated_that_met_qc_criteria": "2017-06-07",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-09",
"first_submitted": "2017-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.
This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.
Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.
Detailed Description
Thirty patients will be enrolled and followed for 1 year after their inclusion.
Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.
Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.
Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.
The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).
#Intervention
- PROCEDURE : Magnetic resonance imaging (MRI)
- MRI cardiac and pulmonary with gadolinium | #Eligibility Criteria:
Inclusion Criteria:
* Adults patients with pulmonary hypertension without specific treatment at inclusion
* Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
* informed consent
* affiliated to medical insurance.
Exclusion Criteria:
* Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
* Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
* Child
* pregnancy
* contraindications to MRI
* without informed consent
* without insurance
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
| NCT01100008 | {
"brief_title": "Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion",
"conditions": [
"Pulmonary Hypertension"
],
"interventions": [
"Procedure: Magnetic resonance imaging (MRI)"
],
"location_countries": [
"France"
],
"nct_id": "NCT01100008",
"official_title": "Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2007-09"
},
"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)": "2016-03-14",
"last_updated_that_met_qc_criteria": "2010-04-07",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-08",
"first_submitted": "2010-03-01",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.
#Intervention
- PROCEDURE : 5 ml arterial blood
- A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg). | #Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires 'Fagerstrom test for nicotine dependence' 1 day prior to the surgery.
Exclusion Criteria:
* the patients undergoing major thoracic cardiovascular surgery
* the patients with significant lung lesion
* the patients with conscious disturbance
* the patients with allergic history to morphine
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02266212 | {
"brief_title": "A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking",
"conditions": [
"Current Smokers",
"Past Smokers",
"Never Smokers"
],
"interventions": [
"Procedure: 5 ml arterial blood"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT02266212",
"official_title": "The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-09",
"study_completion_date(actual)": "2012-09",
"study_start_date(actual)": "2011-09"
},
"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)": "2023-10-27",
"last_updated_that_met_qc_criteria": "2014-10-12",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-16",
"first_submitted": "2014-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Background: Hand osteoarthritis (OA) is highly prevalent, affecting 55-70% of the population over 55 years with an age-related progressive increase. The OA of interphalangeal (IF) and carpometacarpal joints may have varying degrees of deformity associated with pain, decreased of grip and pinch strength, decreased range of motion and functional impairment. Systematic reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb OA, however for hand OA exercise is still used based on recommendations based on clinical experience and low quality studies, not allowing a conclusion about the effects of exercise in pain, function and strength in hand OA patients.
Objective: assess the effectiveness of progressive resistance strength training program on pain, function and strength in hand OA patients.
Methods: diagnostic of hand OA according to American College of Rheumatology of at least 1year, age over 50 years, both genders, pain in IF joints between 3-8 cm on a 10-cm numerical pain scale (NPS). Sixty patients who meet the eligibility criteria were randomized into exercise group (EG) and control group (CG). Both groups performed a session regarding joint protection and energy conservation before randomization. The EG performed a progressive resistance strength training program for intrinsic muscles of the hand for 12 weeks. The outcome measures were NPS; Australian/Canadian (AUSCAN) Hand Osteoarthritis Index and Cochin Hand Functional Scale for hand function; grip and pinch strengthening using the Hydraulic Hand Dynamometer and a pinch gauge dynamometer and satisfaction with the treatment using a Likert scale. A blinded evaluator performed the evaluations at baseline, 6 and 12 weeks after treatment baseline.
#Intervention
- OTHER : Progressive resistance strength training program
- Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.
- OTHER : Joint protection and energy conservation advice
- A session regarding joint protection and energy conservation for hands was done before randomization. | #Eligibility Criteria:
Inclusion Criteria:
* diagnostic of hand OA according to american college of rheumatology of at least 1year;
* age > 50 years;
* both genders;
* pain in interphalangeal joints between 3 <= age <= 8 cm on a 10-cm numerical pain scale
Exclusion Criteria:
* other joint disease in hands;
* other rheumatic systemic disease;
* surgery in hands or writs;
* exercise or joint injection in hands in the previous 3 months;
* disability to perform the exercises.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02528630 | {
"brief_title": "Progressive Strength in Hand Osteoarthritis",
"conditions": [
"Hand Osteoarthritis"
],
"interventions": [
"Other: Joint protection and energy conservation advice",
"Other: Progressive resistance strength training program"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02528630",
"official_title": "Effectiveness of a Progressive Resistance Strength Program on Hand Osteoarthritis: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2013-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-23",
"last_updated_that_met_qc_criteria": "2015-08-18",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-19",
"first_submitted": "2015-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic properties of tadalafil
Detailed Description
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tamsulosin(0.2mg) on tadalafil(5mg) in healthy male subjects. Subjects will receive repeated dose of tadalafil (5mg\*1t/day) or tadalafil (5mg\*1t/day) / tamsulosin (0.2mg\*1t/day) for 5days. Each treatment period was separated by a washout period of at least 10 days.
Each period of study will enroll 8 healthy male subjects. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events.
#Intervention
- DRUG : Cialis Tab. 5mg
- Other Names :
- Tadalafil 5mg
- DRUG : Harnal-D Cap. 0.2mg
- Other Names :
- Tamsulosin 0.2mg | #Eligibility Criteria:
Inclusion Criteria:
* Healthy man age 19 years or more and less than 55 years at the time of screening.
* BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
* Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
* Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
* Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
* Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Exclusion Criteria:
* Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
* Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
* Showing the value that corresponds to following laboratory parameters: AST or AST > 2* upper limit of normal range.
* Alcohol > 210g/week, within 6 months prior to the screening.
* Taking the medication involved in other clinical trials within two months before the first dose medication characters.
* Sitting Systolic Blood Pressure >= 140 mmHg, Diastolic Blood Pressure >= 90 mmHg at the time of screening.
* History of alcohol or drug abuse, within 1 year
* Positive result in urine drug test(Amphetamines, Cocaine, Opioid, Benzodiazepines, Cannabinoid)
* Positive result in Serology test(Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus), TPPA(qual)).
* Subject who takes an abnormal meal which can affect the ADME of drug.
* Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
* Smoker (> 20cigarettes/day)
* Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
* Subject who done the whole blood donation within two months or component blood donation within 1 month prior to the first dosing.
* Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
* Subject with taking any forms of organic nitrate periodically and/or intermittently.
* Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
* Subject with serious history of hypersensitivity or allergy to investigational product.
* Subject who Lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy (NAION).
* Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
* Orthostatic hypotension
* Subjects who is not able to comply with guidelines described in the protocol.
* Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02247518 | {
"brief_title": "CKD-397 Drug-drug Interaction Study (A)",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Harnal-D Cap. 0.2mg",
"Drug: Cialis Tab. 5mg"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02247518",
"official_title": "A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tamsulosin on Tadalafil in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2014-09"
},
"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)": "2015-08-20",
"last_updated_that_met_qc_criteria": "2014-09-21",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-25",
"first_submitted": "2014-09-15",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level, the durability of the response, the practicality and the possible toxicity.
Detailed Description
Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune disease in animals that is used as a model of MS.
Recently, emerging data from epidemiologic studies suggest that vitamin D may play an important role in the progression of the development of MS. A longitudinal study in pediatric MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher vitamin D levels have also been shown to be associated with less subsequent inflammatory MS activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that patients have lower vitamin D levels during MS relapses.
#Intervention
- DIETARY_SUPPLEMENT : Vitamin D3
- two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
- Other Names :
- cholecalciferol | #Eligibility Criteria:
Inclusion Criteria:
* with serum 25(OH)D3 concentration <= 20 ng/ml
Exclusion Criteria:
* hypercalcaemia, primary hyperparathyroidism, Paget disease, thyrotoxicosis, pregnancy, active malignancy, hypercalciuria, history of liver disease, renal insufficiency, clinically apparent malabsorption syndrome, using drugs containing vitamin D products, calcium, estrogen and drugs known to affect vitamin D metabolism (anticonvulsants, glucocorticoids) or receiving any form of supplements containing vitamin D during last 6 months.
* Participants with serum 25(OH)D concentration>= 20 ng/ml
Sex :
ALL
Ages :
- Minimum Age : 23 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02696590 | {
"brief_title": "High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients",
"conditions": [
"Relapsing Remitting Multiple Sclerosis"
],
"interventions": [
"Dietary Supplement: Vitamin D3"
],
"location_countries": [
"Iran, Islamic Republic of"
],
"nct_id": "NCT02696590",
"official_title": "Isfahan University of Medical Sciences",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2015-07"
},
"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)": "2016-03-02",
"last_updated_that_met_qc_criteria": "2016-03-01",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-02",
"first_submitted": "2016-02-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).
#Intervention
- DRUG : FOLFIRI regimen
- Intravenous repeating dose
- DRUG : bevacizumab
- Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
- DRUG : cetuximab
- Intravenous repeating dose
- DRUG : dulanermin
- Intravenous repeating dose
- DRUG : irinotecan
- Intravenous repeating dose | #Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form
* Age >= 18 years
* Histologically confirmed CRC with evidence of metastases and measurable tumor lesion(s)
* Progression of disease following, or intolerance to, treatment with 5-fluorouracil-based therapy
* Progression of disease during or within =< 6 months following the last dose of a prior first-line treatment with a fluoropyrimidine and oxaliplatin-based chemotherapy plus bevacizumab for metastatic disease
* Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential (use per institutional standard)
* Life expectancy of > 3 months
* Willingness and capability to be accessible for study follow-up
Exclusion Criteria:
* Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
* Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal or pelvic field within 28 days prior to Day 1
* Chemotherapy, hormonal therapy, or immunology within 4 weeks prior to Day 1
* Previous exposure to DR4-targeted therapy or DR5-targeted therapy
* Evidence of clinically detectable ascites on Day
* Other invasive malignancies within 5 years prior to Day 1 (other than basal cell carcinoma of the skin or in situ carcinoma of the cervix)
* History or evidence upon physical examination of CNS disease
* Active infection requiring parenteral antibiotics on Day 1
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study and fine needle aspirations within 7 days prior to Day 1
* Pregnancy or lactation
* Serious nonhealing wound, ulcer, or bone fracture
* Current or recent participation in another experimental drug study
* Clinically significant cardiovascular disease
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
* Cohort 5 only: Subjects who have a Kras mutation will be excluded from enrollment
* The following exclusion criteria apply only to subjects who have received prior bevacizumab and are enrolled in Cohort 6: four or more prior doses of bevacizumab therapy, inadequately controlled hypertension, history of hypertensive crisis or hypertensive encephalopathy, history of arterial thromboembolic event 6 months prior to Day 1, proteinuria, history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
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
| NCT00671372 | {
"brief_title": "A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Drug: irinotecan",
"Drug: bevacizumab",
"Drug: cetuximab",
"Drug: dulanermin",
"Drug: FOLFIRI regimen"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00671372",
"official_title": "A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Multiple Doses of Dulanermin Administered Intravenously in Combination With Camptosar®/Erbitux® Chemotherapy or the Folfiri Regimen With or Without Bevacizumab in Subjects With Previously Treated Metastatic Colorectal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-02",
"last_updated_that_met_qc_criteria": "2008-04-30",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-05",
"first_submitted": "2008-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.
Detailed Description
The study is designed to determine the effects of Tai Chi training on balance and other functional outcomes in persons with Parkinson's disease.
#Intervention
- BEHAVIORAL : Tai Chi
- a set of pre-designed Tai Chi Movements
- BEHAVIORAL : Strength training
- Lower-extremity strength training exercises
- BEHAVIORAL : Low-Impact Exercise Control
- a set of chair-based low-impact exercises | #Eligibility Criteria:
Inclusion Criteria:
Patients who have:
* A diagnosis of idiopathic PD, with a disease severity rating of stage I to IV on the Hoehn and Yahr scale (Hoehn & Yahr, 1967)
* At least 1 score of 2 or more for at least 1 limb for either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
* Stable medication usage
* Not participated in a structured exercise program (i.e., not involved in any routine, organized physical activity program lasting 30 minutes or more per day, such as a gym program or regularly scheduled instructor-led exercise class) in the previous 2 months
* Ability to stand unaided or walk independently; had a personal physician's or neurologist's clearance for participation; and had a willingness to be assigned to intervention conditions.
Exclusion Criteria:
Patients who:
* Participate in any other behavioral or pharmacological research study
* Have cognitive decline (Mini-Mental State Examination score, <= 24) (Folstein et al., 1975)
* Have self-reported diagnosis of Alzheimer disease or other severe neurological (stage III and IV PD)
* Have evidence of progressive or debilitating conditions (metastatic cancer, severe heart or lung disease, crippling arthritis) or severe losses in vision and hearing that would limit their tolerance to testing and training procedures, that would interfere with study participation
* Are unavailable during the study period.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00611481 | {
"brief_title": "Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease",
"conditions": [
"Parkinson's Disease"
],
"interventions": [
"Behavioral: Low-Impact Exercise Control",
"Behavioral: Strength training",
"Behavioral: Tai Chi"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00611481",
"official_title": "Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2011-08",
"study_start_date(actual)": "2008-10"
},
"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)": "2011-10-12",
"last_updated_that_met_qc_criteria": "2008-02-06",
"last_verified": "2011-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-11",
"first_submitted": "2008-02-06",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
Detailed Description
A phase 2 trial evaluating the safety and tolerability of a one time subcutaneous (SC) administration of L9LS, as well its protective efficacy against naturally occurring Pf infection over a 6-month malaria season. The primary study hypotheses is that L9LS will be safe and protective against malaria infection. As a secondary objective, the efficacy of L9LS within three body weight strata among female participants will each be compared to placebo. Before study agent administration, all subjects will be given artemether lumefantrine to clear any preexisting Pf blood stage infection.
The study is a randomized, double-blind, placebo-controlled, sex-stratified (2:1 female to male ratio) and weight-stratified trial (N=288 total) with 2 treatment arms: L9LS 900 mg SC (n=216) and placebo (n=72) to assess safety and protective efficacy of L9LS compared to placebo.
Subjects will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examination and blood collection for identification of Pf infection and other research laboratory evaluations.
#Intervention
- BIOLOGICAL : L9LS (VRC-MALMAB0114-00-AB)
- Administered one time via subcutaneous route.
- OTHER : Normal Saline
- Administered one time via subcutaneous route. | #Eligibility Criteria:
Inclusion Criteria:
* Females aged >=18 and <=49 years and weighing >= 45.0 and <= 90.0 kg.
* Males aged >=18 and <=55 years and weighing >= 50.0 and <= 100.0 kg.
* Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
* In good general health and without clinically significant medical history.
* Able to provide informed consent.
* Willing to have blood samples and data stored for future research.
* Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study.
* Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study day 0 through the final study visit as described below.
1. Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device.
2. Nonchildbearing women will be required to report date of last menstrual period, history of surgical sterility (i.e., tubal ligation, hysterectomy) or premature ovarian insufficiency, and will have urine or serum pregnancy tests performed per protocol.
Exclusion Criteria:
* Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female).
* Currently breastfeeding.
* Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol.
* Study comprehension examination score of <80% correct or per investigator discretion.
* Hemoglobin, white blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Subjects may be included at the investigator's discretion for 'not clinically significant' values.)
* Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator's discretion for 'not clinically significant' values.)
* Infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
* Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)
* Clinically significant abnormal electrocardiogram (ECG; QTc >460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
* Receipt of any investigational product within the past 30 days.
* Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. [Note: Past, current, or planned participation in observational studies is NOT exclusionary; participation in the placebo arm of the Mali adult CIS43LS MAb trial (ClinicalTrials.gov Identifier: NCT04329104) is NOT exclusionary.]
* Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
* History of a severe allergic reaction or anaphylaxis.
* Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).
* Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
* Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors).
* Known immunodeficiency syndrome.
* Known asplenia or functional asplenia.
* Use of chronic (>=14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of day 0.
* Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.
* Receipt of immunoglobulins and/or blood products within the past 6 months.
* Previous receipt of an investigational malaria vaccine or monoclonal antibody in the last 5 years.
* Known allergies or contraindication against artemether lumefantrine.
* Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.
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
| NCT05816330 | {
"brief_title": "L9LS MAb in Malian Adults",
"conditions": [
"Plasmodium Falciparum Infection",
"Malaria"
],
"interventions": [
"Other: Normal Saline",
"Biological: L9LS (VRC-MALMAB0114-00-AB)"
],
"location_countries": [
"Mali"
],
"nct_id": "NCT05816330",
"official_title": "Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Adults in Mali",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-11",
"study_completion_date(actual)": "2024-02-11",
"study_start_date(actual)": "2023-05-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-17",
"last_updated_that_met_qc_criteria": "2023-03-31",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-18",
"first_submitted": "2023-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Patients suffering from migraine will be randomly allocated to one of two different behavioral interventions:
* mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation \& yoga techniques and teaching information regarding the relationship between stress and health.
* into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigators will measure the frequency and intensity of migraine attacks before during and after the intervention as well as secondary variables on quality of life and psychological functioning. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.
Detailed Description
Sixty patients suffering from migraine will be randomly allocated to one of two different behavioral interventions: (i) mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation \& yoga techniques and teaching information regarding the relationship between stress and health. or (ii) into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigator will measure the frequency and intensity of migraine attacks before during and after the intervention by headache diaries as well as secondary variables on pain sensation, psychological well being, generic quality of life, pain regulation, pain acceptance, mindfulness, compliance and satisfaction with the intervention. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.
#Intervention
- BEHAVIORAL : Mindfulness Based Stress Reduction MBSR
- Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills
- BEHAVIORAL : Psychoeducation
- Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work | #Eligibility Criteria:
Inclusion Criteria:
* migraine for at least 6 months
* commandment of German language
* 3 <= age <= 8 migraine attacks per month
* willingness to participate in a behavioral intervention and to conduct the daily homework
* if patients take a drug as prophylaxis for migraine no change of drug for at least three months and no change of dose for at least one month prior to enrollment
Exclusion Criteria:
* psychiatric disorders at the time of enrollment
* addiction
* participation in other trials
* prior experience with mbsr
* migraine related to the ovary cycle
* abuse of acute medication for migraine
* other psychological disorders which impair the communication and interaction with the patient
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
| NCT00826475 | {
"brief_title": "Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine",
"conditions": [
"Migraine"
],
"interventions": [
"Behavioral: Mindfulness Based Stress Reduction MBSR",
"Behavioral: Psychoeducation"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00826475",
"official_title": "Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-04",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2009-01"
},
"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)": "2011-08-15",
"last_updated_that_met_qc_criteria": "2009-01-20",
"last_verified": "2009-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-22",
"first_submitted": "2009-01-20",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages.1-3 The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients 5, 6 and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.
The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced atelectasis using intraoperative lung ultrasound.
Objectives
* To determine the effect of recruitment on anesthesia induced atelectasis using lung ultrasound.
* To Estimate the change of Pao2 with anesthesia induced lung atelectasis.
* To Estimate the change of Pao2 with lung recruitment.
* To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung recruitment.
Detailed Description
This a randomized control trial is designed to include 40 children aged from one to four years presented for major abdominal surgery.
Forty patients meeting the inclusion criteria will be randomly assigned into to two equal groups:
Group C (n= 20): Without recruitment maneuver (control group)
Group REC (n= 20): recruitment group
All children will be premedicated with oral midazolam 0.5mg/kg half hour before procedure and atropine at a dose of 0.01-0.02 mg/kg( IM). Continuous electrocardiogram (ECG) , pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring will be applied and all patients will be induced with inhalational anesthetic using Sevoflurane+ oxygen(O2) with mac 2%. After deepening of the anesthesia, intravenous (I.V.) line will be inserted and fentanyl 2μg/kg, muscle relaxant will be given in the form of atracurium 0.5mg/kg and patients will be intubated by appropriate size of endotracheal tube.
After induction of anesthesia all patients will be ventilated using pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5, and Fio2 1, baseline arterial blood gas will be withdrawn. Patients will be divided into two groups. Group (REC) recruitment group; in this group, lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O22,23. In next assessment time, if still there are atelectatic areas recruitment will be repeated and patient will be maintained at PEEP 10 cm H2O till the end of surgery. In group (C) non recruitment group, patient ventilation will be maintained on aforementioned tidal volume without recruitment but with PEEP 5cm H2O.
Lung ultrasound (LUS) LUS will be performed with the portable echograph MicroMax (SonoSite, M-turbo) using a linear probe of 3 to 6 MHz. Each hemithorax will be divided into six sections using three longitudinal lines (parasternal, anterior, and posterior axillary) and two axial lines, one above the diaphragm and another one 1 cm above the nipples.
As LUS provides regional information, we will repeat the following examination sequence in each hemithorax and in all patients: (1) anterior, (2) lateral, and (3) posterior regions starting from the diaphragm (caudal lung) and moving toward the apex (cranial lung).13,14 Each hemithorax will be assessed using the two-dimensional classical view placing the probe parallel to the ribs .24 (fig. 1).The LUS of a normal lung shows a lung sliding (caused by the respiratory movement of the visceral pleura relative to the fixed parietal pleura) and A lines (repetitive horizontal reverberation artifacts generated by air within the lungs separated by regular intervals, the distances of which being equal that between the skin and the pleural line.
Patients demographic data will be collected; age, gender, weight, height, type of surgery and duration of surgery.
Lung ultrasound examinations will be performed at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia, before extubation and after extubation at recovery room to detect and monitor atelectasis. Arterial blood samples will be collected simultaneously to measure Pao2.
Atelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0.
The sum of surface area of atelectatic regions and the number of recruitment attempts to recruit atelectatic areas will be recorded.
Other data as heart rate, systolic, diastolic and mean arterial blood pressure will be recorded at same measuring points and during recruitment.
Assessment for incidence of pneumothorax and postoperative pulmonary complications like; postoperative lung collapse and postoperative pneumonia.
Assessment the duration of postoperative hospital stay.
#Intervention
- PROCEDURE : lung recruitment maneuver
- lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O | #Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I-II.
* Age (1 <= age <= 4) years.
* Patients undergoing major abdominal surgery in supine position (eg. Splenectomy, exploration, kasai etc.,).
Exclusion Criteria:
* Parents' refusal.
* Patients with congenital heart disease.
* Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,)
* Patients with respiratory tract infection.
* Patients with chest wall deformities
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 4 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT03069157 | {
"brief_title": "Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound",
"conditions": [
"Anesthesia Induced Atelectasis"
],
"interventions": [
"Procedure: lung recruitment maneuver"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03069157",
"official_title": "Evaluation of the Effect of Lung Recruitment and Positive End- Expiratory Pressure (PEEP) on Anesthesia Induced Atelectasis Using Lung Ultrasound in Children Undergoing Major Abdominal Surgery.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-15",
"study_completion_date(actual)": "2017-11-15",
"study_start_date(actual)": "2017-03-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-25",
"last_updated_that_met_qc_criteria": "2017-03-01",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-03",
"first_submitted": "2017-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study is a randomized trial of interventions to improve parent-child relationships of drug-dependent mothers.
Detailed Description
In this Stage II study, we will conduct a randomized clinical trial of the Relational Parenting Mothers' Group (RPMG), an intervention designed for opioid abusing mothers with children between the ages of 7 and 14 which was manualized and tested as part of a Stage I study (NIDA # P50-DA09241; September 1, 1994- August 31, 1997). This intervention was developed in recognition of the substantial psychosocial risks faced by substance abusing mothers and their offspring, and the notable lack of parenting interventions currently available for addicted mothers with children past the preschool years. Based on developmental psychopathology perspectives on resilience, this integrative treatment addresses multiple levels of adversity (individual, family, and community) faced by addicted mothers: risks that typically result in negative parenting behaviors and psychosocial distress among the mothers and concomitantly, psychiatric disturbance among their offspring. Designed as a supplement to standard drug counseling, RPMG is a structured and time-limited treatment, entailing 24 weekly group sessions of 1½ hours each.
Preliminary data collected in the Stage I pilot study have attested to the promise of RPMG in terms of diverse parenting behaviors and psychiatric outcomes among both mothers and their children. In the proposed study, we will conduct a randomized clinical trial in which mothers receiving RPMG as a supplement to Recovery Training (RT, a manualized group intervention representing standard drug counseling offered in methadone clinics) will be compared with those who receive RT alone. The RPMG clinical team will include one masters/doctoral level therapist and one assistant therapist and RT groups will be conducted by drug counselors; all therapists (RPMG \& RT) will be trained and supervised by our research team. One hundred sixty mothers will be randomized to one of the two treatment conditions. Multiple-method, multiple-informant assessments will be used to measure salient outcomes; these will include reports from mothers and their children, and from the mothers' clinicians and their children's teachers.
We will address the following specific aims in this study:
1. We will evaluate the effectiveness of the Relational Parenting Mother's Group (RPMG) as a supplement to Recovery Training (RT) vs. Recovery Training alone in terms of a) mothers' parenting behaviors, b) their psychosocial adjustment, c) their children's psychosocial adjustment, and d) mothers' treatment compliance.
2. We will evaluate the comparative durability of RPMG+RT vs. RT in terms of the outcomes in Aim #1, and in terms of delayed improvement in frequency of illicit drug use, HIV-risk behaviors, and other problems related to drug use.
3. We will examine how specific maternal characteristics interact with treatment to affect outcomes. Guided by previous research, these characteristics will include mothers' intelligence, readiness for change, and sensation seeking.
#Intervention
- BEHAVIORAL : Parenting Intervention | #Eligibility Criteria:
Inclusion criteria:
* female adult humans
* enrollment in methadone treatment for opioid addiction
* caring for a child between the ages of 7 and 14 years
Exclusion Criteria:
* suicidality/homicidality requiring more intensive level of care
* serious cognitive impairment (AIDS-related dementia or schizophrenia)
Sex :
FEMALE
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
| NCT00319241 | {
"brief_title": "Relational Parenting Group for Opioid-addicted Mothers",
"conditions": [
"Substance Abuse",
"Child Abuse"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00319241",
"official_title": "Relational Parenting Group for Opioid-addicted Mothers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-10",
"study_completion_date(actual)": "2003-11",
"study_start_date(actual)": "1998-01"
},
"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)": "2020-03-31",
"last_updated_that_met_qc_criteria": "2006-04-26",
"last_verified": "2008-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-04-27",
"first_submitted": "2006-04-26",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement
Detailed Description
Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.
#Intervention
- DRUG : Hylase
- median nerve hydro-dissection using Hyalase + 10 cc saline injection
- Other Names :
- ( group I )
- DRUG : Saline
- median nerve hydro-dissection using 10 cc saline injection
- Other Names :
- (group II) | #Eligibility Criteria:
Inclusion Criteria:
* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study
Exclusion Criteria:
* patient refusal infection at the site of intervention
* local anesthetic allergy
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:
No
| NCT03177915 | {
"brief_title": "Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome",
"conditions": [
"Carpal Tunnel Syndrome",
"Pain, Chronic"
],
"interventions": [
"Drug: Hylase",
"Drug: Saline"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03177915",
"official_title": "Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2017-02",
"study_start_date(actual)": "2016-03"
},
"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)": "2018-09-20",
"last_updated_that_met_qc_criteria": "2017-06-05",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-06",
"first_submitted": "2017-05-31",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Nutritional formula drinks are widely consumed in Asia especially by those having chronic illnesses such as diabetes. Therefore, gauging the impact of nutritional formulas on blood glucose levels is very important. Asia is home to three predominant ethnic groups- Chinese, Malay and Indians. It is still unknown if the blood glucose response to nutritional formulas differs between ethnic groups. Therefore the aim of this study is to observe if there are ethnic differences in the blood glucose response to nutritional formula drinks.
Detailed Description
Nutritional formulas are commonly consumed by individuals both to supplement their food intake and as total meal replacers. Consumption rates of nutritional formulas are increasing also in Asia. Very little is known about differences in the glycaemic response to nutritional formulas between different ethnic groups. The aim of the current study is to determine the glycaemic response (GR) and glycaemic index (GI) to three nutrition formulas in Chinese, Indian and Malay subjects.
The study will have a randomised, non-blind, between-subjects, crossover design. The subjects will return for six test sessions. At three random sessions subjects will test the reference food and on the remaining three sessions they will consume the test foods (Diasip, Isocal, Protinex). The first test session will be a glucose test session (for subjects requiring glucose tests). The reference food will be anhydrous glucose (50 g) dissolved in 250 ml of water. The test foods will be portions of the nutritional formulas containing 50 g of available carbohydrates. Subjects who have previously taken part in GI studies at the CNRC and who have already completed three reference glucose tests will have to complete only the three test food sessions. However, they may be asked to do one, two or all three of the glucose tests if their previous test results are old (\> 3 months) or are not within the required precision (CV \<30%). This aspect will be at the discretion of the investigator and communicated to the participant at the time of briefing (before consenting).
The primary measurement in the study will be the glycaemic response. This will be measured using finger-prick blood samples. The fingers in the non-dominant hand will be used. To encourage blood flow the hand will be warmed using warm water or a hot towel beforehand if required. The finger will then be disinfected using a sterile wipe. Blood will be obtained by finger prick using a single-use lancing device. To minimise plasma dilution fingertips will not be squeezed to extract blood but gently massaged starting from the base of the hand moving towards the tips. The first two drops of expressed blood will be discarded and the next drop (5 μL) will be used for testing. Blood glucose in the sample will be measured using the HemoCue® 201+ Glucose analyser (HemoCue Ltd, Dronfield, UK).
The participants will arrive at the laboratory between 8:30-9 am following a 10 hour overnight fast. They will be instructed not to partake in intense level sports and avoid alcohol consumption on the evening prior to a test session. Following a 10 minute rest two blood samples will be obtained five minutes apart for determining baseline blood glucose levels. If the two baseline blood glucose values are far apart a further 1-2 blood samples may be taken until two stable values are obtained. The study session will be terminated if stable values cannot be obtained or if baseline blood glucose levels are above 6 mmol/L. After obtaining acceptable baseline blood glucose values they will be given either the standard or test food to consume. They will be asked to consume the drink at a comfortable pace within 10 minutes. Further blood samples will be obtained at 15, 30, 45, 60, 90, 120, 150 and 180 minutes for blood glucose measurements. Mandatory sampling will be carried out up to 120 minutes. If the blood glucose level has not reached baseline levels by the end of 120 minutes further samples may be taken at 150 and 180 minutes. During the entire testing period the participants will be instructed to remain rested and in the laboratory.
#Intervention
- DIETARY_SUPPLEMENT : Liquid-based Nutritional Formulae and liquid glucose
- Other Names :
- Diasip, Protinex, Isocal, liquid glucose | #Eligibility Criteria:
Inclusion Criteria:
* Age between 21 <= age <= 40 years
* Be of Chinese, Malay or Indian ethnic origin
* Do not partake in sports at the competitive and/or endurance levels
* Body mass index between 18 to 24 kg/m2
* Normal blood pressure range (120/80 mmHg)
Exclusion Criteria:
* Those having a fasting blood glucose concentration above 6.0 mmol/l
* Those having metabolic or chronic diseases (Diabetes, hypertension etc)
* Having allergies/intolerances to the foods provided in the study
* Smoking
* Those having medical conditions and/or taking medications known to affect glycaemia or major effects on body fat distribution (glucocorticoids, thyroid hormones, thiazide diuretics)
* Those having gastrointestinal diseases that may interfere with digestion or nutrient absorption
* Those who had medical or surgical events requiring hospitalization within the preceding three months
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01889628 | {
"brief_title": "Study to Determine Ethnic Differences in the Glycaemic Response to Nutritional Formula Drinks",
"conditions": [
"Diabetes",
"Impaired Glucose Tolerence"
],
"interventions": [
"Dietary Supplement: Liquid-based Nutritional Formulae and liquid glucose"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT01889628",
"official_title": "Ethnic Differences in the Glycaemic Response and Glycaemic Index to Liquid-based Nutritional Formulas Between Chinese, Malays and Indians in Singapore",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2013-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-02",
"last_updated_that_met_qc_criteria": "2013-06-27",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-28",
"first_submitted": "2013-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.
Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.
#Intervention
- OTHER : alcohol-free experimental mouth rinse
- OTHER : alcohol-containing mouth rinsing | #Eligibility Criteria:
Inclusion Criteria:
* participants between 18 and 65 years
* no severe periodontitis
* informed consent
Exclusion Criteria:
* handicapped participants
* allergies against mouth rinses
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
| NCT01811615 | {
"brief_title": "Efficacy of New Alcohol Free Mouthrinses",
"conditions": [
"Gum Disease"
],
"interventions": [
"Other: alcohol-free experimental mouth rinse",
"Other: alcohol-containing mouth rinsing"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01811615",
"official_title": "A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-02",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2010-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-14",
"last_updated_that_met_qc_criteria": "2013-03-13",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-14",
"first_submitted": "2013-01-18",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.
Detailed Description
The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld controllers in a motion-tracked three-dimensional space called 'room scale' of the mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users with \>90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology.
First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. Horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 \* maximum reaching distance, 0.9 \* (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. A falling object disappeared at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. By thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training.
The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation programs will be personalized.
#Intervention
- DEVICE : mediVR KAGURA
- Approximately 20 min mediVR KAGURA-guided rehabilitation | #Eligibility Criteria:
Inclusion Criteria:
* Patients with physical and/or cognitive dysfunctions
* Agreed to the participation of this study with written informed consent by themselves or guardians
Exclusion Criteria:
* Inappropriate candidates at attending physician's discretion
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 110 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04562662 | {
"brief_title": "Evaluation of mediVR-KAGURA Guided Therapy",
"conditions": [
"Physical Disability",
"Cognitive Dysfunction"
],
"interventions": [
"Device: mediVR KAGURA"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT04562662",
"official_title": "Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-31",
"study_completion_date(actual)": "2022-03-31",
"study_start_date(actual)": "2020-09-01"
},
"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)": "2022-08-16",
"last_updated_that_met_qc_criteria": "2020-09-18",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-24",
"first_submitted": "2020-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
While there are a variety of arthritis education materials available, the evidence-base on most of them is slim, so it i impossible to know what benefits they may have for the people who participate. The purpose of this project is to evaluate the effectiveness of the mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and to evaluate the appropriateness, usefulness, and readibility of the program. This project will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for helping people with arthritis improve their quality of life.
#Intervention
- BEHAVIORAL : Arthritis Basics for Change Education program | #Eligibility Criteria:
Inclusion Criteria:
adults with arthritis
Exclusion Criteria:
*
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
| NCT00207623 | {
"brief_title": "Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program",
"conditions": [
"Arthritis"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00207623",
"official_title": "Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2003-07",
"study_start_date(actual)": "2002-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "ECT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-09-21",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2005-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-21",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.
| #Eligibility Criteria:
Inclusion Criteria:
* Cardiac surgery patients who sign the informed consent
Exclusion Criteria:
* Chronic renal failure (Cr>1.5mg/dL), Dialysis patients
* Previous stroke
* Left ventricular dysfunction (EF <50%)
* ASO with claudication
* < 40 years
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02014012 | {
"brief_title": "PWV for Cardiovascular Complication After Cardiac Surgery",
"conditions": [
"C.Surgical Procedure; Cardiac"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02014012",
"official_title": "Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2013-04"
},
"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)": "2015-04-13",
"last_updated_that_met_qc_criteria": "2013-12-11",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-17",
"first_submitted": "2013-07-31",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.
In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.
Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.
Study duration per subject in the Booster Phase is a maximum of approximately 13 months.
Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.
Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.
Detailed Description
This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.
In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).
Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.
#Intervention
- BIOLOGICAL : VLA15
- a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
- BIOLOGICAL : Placebo
- PBS (Phosphate Buffered Saline) | #Eligibility Criteria:
Inclusion Criteria - Main Study Phase:
* Subject is aged 18 <= age <= 65 at the day of screening
* Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
* Subject has an understanding of the study and its procedures, agrees to its provisions,and gives written informed consent prior to any study-related procedures;
* If subject is of childbearing potential:
* Subject has a negative serum pregnancy test at screening;
* Subject agrees to employ adequate birth control measures for the duration of the study.
Inclusion Criteria - Booster Phase:
* Randomization into higher dose group in the Main Study Phase
* No relevant protocol deviation in the Main Study Phase, i.e., included in the Per-Protocol population for the Day 208 interim analysis of the Main Study;
* Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
* Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
* If subject is of childbearing potential:
1. Subject has a negative Urine pregnancy test before booster vaccination;
2. Subject agrees to employ adequate birth control measures for the duration of the study
Exclusion Criteria - Main Study Phase:
* Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to screening;
* Subject received previous vaccination against LB.;
* Subject had a tick bite within 4 weeks prior to vaccination visit;
* Subject has a medical history of or currently has a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
* Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
* Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the three weeks prior to each study vaccination, contraindicating I.M. vaccination as judged by the investigator;
* Subject has received an active or passive immunization within 28 days before or after any vaccination; except for influenza (seasonal or pandemic) vaccines which may be administered outside a 7-days interval before or after any trial vaccination;
* Subject has received any other non-registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and throughout the entire study period or has received a registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and up to Day 208;
* Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), Status post organ transplantation or immuno-suppressive therapy within 30 days prior to first vaccination. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >=0.05 mg/kg/day. Topical and inhaled steroids are allowed;
* Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine; Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled;
* Subject had acute febrile infections within 10 days prior to first vaccination;
* Subject is pregnant (positive serum pregnancy test at screening), has plans to become pregnant during the course of the study or is lactating at the time of enrollment. Women of childbearing potential that are unwilling or unable to employ an adequate birth Control measure for the duration of the study.
* Subject has donated blood or blood-derived products (e.g. plasma) within 30 days or received blood or blood-derived products (e.g. plasma) within 90 days prior to first vaccination in this study or plans to donate or use blood or blood products during the course of the study;
* Subject has any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would Limit the subject's ability to complete the study;
* Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
* Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel.
Exclusion Criteria - Booster Phase:
* Subject met an individual stopping criterion during the Main Study Phase;
* Subject has developed a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to vaccination visit;
* Subject has developed a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for further participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment;
* Subject has developed a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
* Subject has developed an immunodeficiency, including known infection with human immunodeficiency virus (HIV), status post organ transplantation, or immuno-suppressive therapy within 30 days prior to vaccination visit. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >= 0.05 mg/kg/day. Topical and inhaled steroids are allowed;
* Subject has developed anaphylaxis or severe allergic reactions;
* Subject has developed allergic reactions to one of the components of the vaccine;
* Subject has developed a malignancy;
* Subject has developed thrombocytopenia or received anticoagulants in the 3 weeks prior to the booster vaccination contraindicating I.M. vaccination as judged by the investigator;
* Subject has received any other non-registered medicinal product in another clinical trial within 28 days prior to VLA15 booster vaccination at Month 18 or plans to participate in another clinical trial with a non-registered medicinal product until Month 24;
* Subject is pregnant, or plans to become pregnant prior to Month 24, or is lactating. Women of childbearing potential that are unwilling or unable to employ an adequate birth control measure for the duration of the study;
* Subject has developed any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
* Subject has been committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
* Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, sibling).
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
| NCT03970733 | {
"brief_title": "Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis",
"conditions": [
"Lyme Borreliosis"
],
"interventions": [
"Biological: VLA15",
"Biological: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03970733",
"official_title": "ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-07",
"study_completion_date(actual)": "2022-03-28",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-21",
"last_updated_that_met_qc_criteria": "2019-05-30",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-31",
"first_submitted": "2019-05-29",
"first_submitted_that_met_qc_criteria": "2021-07-06"
}
}
} |
#Study Description
Brief Summary
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
#Intervention
- DRUG : Sorafenib (Nexavar, BAY43-9006)
- Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
- DRUG : Placebo
- Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
- DRUG : Dacarbazine
- Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1 | #Eligibility Criteria:
Inclusion Criteria:
* Patients who have a life expectancy of at least 12 weeks
* Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
* Patients who have an ECOG PS of 0, or 1
* Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion Criteria:
* Primary ocular or mucosal melanoma
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: 'flat tumor'] & T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 3 years prior to study entry
* History of cardiac disease
* Known history of human immunodeficiency virus (HIV) infection
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
| NCT00110994 | {
"brief_title": "Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma",
"conditions": [
"Cancer",
"Melanoma"
],
"interventions": [
"Drug: Dacarbazine",
"Drug: Sorafenib (Nexavar, BAY43-9006)",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00110994",
"official_title": "Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-10",
"study_completion_date(actual)": "2008-03",
"study_start_date(actual)": "2005-04"
},
"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)": "2015-06-08",
"last_updated_that_met_qc_criteria": "2005-05-16",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-05-17",
"first_submitted": "2005-05-16",
"first_submitted_that_met_qc_criteria": "2011-04-29"
}
}
} |
#Study Description
Brief Summary
Overweight and obesity are well established risk factors for breast cancer that develop after menopause. The increased postmenopausal breast cancer risk in women who are overweight or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly used medication in diabetics to stabilize blood sugar. Association studies and laboratory studies have shown its potential to reduce the risk for development of cancer, including breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin may only be effective in overweight or obese women with metabolic disturbances. We propose to conduct a clinical study of metformin in overweight or obese premenopausal women with metabolic disturbances. Study participants will be randomly assigned to receive metformin or placebo for 12 months. The study will evaluate whether metformin can result in favorable changes in risk features that have been associated with increased breast cancer risk. The risk features that will be examined in our study include breast density, certain proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases.
Detailed Description
High adiposity is a major risk factor for a number of chronic diseases, including type 2 diabetes, cardiovascular diseases, and certain types of cancer, including postmenopausal breast cancer. The increased postmenopausal breast cancer risk in women with high adiposity is likely to be attributed to multiple metabolic disturbances including altered circulating sex steroid hormones, hyperinsulinemic insulin resistance, altered expression and secretion of adipokines from adipose tissue, increased production of pro-inflammatory cytokines, and increased oxidative stress.
Metformin, a widely used antidiabetic drug, exerts favorable effects on multiple metabolic disturbances which may lead to reduction of breast cancer risk in women with high adiposity. In addition, metformin may exert a direct effect in mammary tissue through the activation of the AMP-activated protein kinase signaling pathway, leading to an antiproliferative effect and induction of apoptosis. Recent case control and cohort studies found that treatment with metformin appears to substantially reduce the risk for development of cancer in diabetics, including breast cancer. There are a number of ongoing clinical trials of metformin in breast cancer patients. However, applicability of these trials to at risk healthy women requires further research and the concurrent or prior cancer treatments in these trials hinder the evaluation of metformin as a single agent for breast cancer risk reduction. In addition, recent clinical and animal studies suggest that metformin may only exert tumor suppressive effects in metabolic phenotypes of high adiposity and metabolic disturbances.
A Phase II randomized, double-blind, placebo-controlled trial of metformin in overweight/obese premenopausal women who have metabolic syndrome will be conducted. This study population is at increased risk for postmenopausal breast cancer and has a high prevalence of metabolic disturbances. The overall objective of this study is to determine its potential effects on reduction of obesity-associated breast cancer risk.
#Intervention
- DRUG : Metformin
- metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
- Other Names :
- Glucophage, Glumetza, Fortamet
- DRUG : Placebo
- 1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months) | #Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women
* 21 <= age <= 54 years
* Have a BMI of 25 kg/m2 or greater
* No change in menstrual patterns for the past 6 months preceding the time of registration
* Waist circumference >= 35 inches or >= 31 inches for Asian Americans, individuals with polycystic ovary syndrome, or individuals with non-alcoholic fatty liver disease.
* Have at least one other component of metabolic syndrome (103) reported below:
* Elevated triglycerides (>= 150 mg/dL (1.7 mmol/L) or on drug treatment for elevated triglycerides
* Reduced HDL-C (< 50 mg/dL (1.3 mmol/L) or on drug treatment for reduced HDL-C
* Elevated blood pressure (>= 130 Hg systolic blood pressure or >=85 mm Hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension
* Elevated fasting glucose (>=100 mg/dL)
* Mammogram negative for breast cancer within the 12 months preceding the time of registration for women >= 50 years
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Postmenopausal women
* Amenorrhea for at least 12 months (preceding the time of registration), or
* History of hysterectomy and bilateral salpingo-oophorectomy, or
* At least 55 years with prior hysterectomy with or without oophorectomy, or
* Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
* Women who are pregnant, planning pregnancy within the next year, or breastfeeding
* On treatment with any drug for diabetes
* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any illness that would limit compliance with study requirements
* Have received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years (preceding the time of registration)
* Have received other investigational agents within the past 3 months (preceding the time of registration)
* Have a history of lactic acidosis or risk factors for lactic acidosis
* Have significant renal disease or dysfunction (creatinine >= 1.4 mg/dL)
* Have significant hepatic dysfunction (bilirubin >= 1.5 x ULN unless with Gilberts syndrome or AST/ALT >= 3 x ULN)
* Have a history of alcoholism or high alcohol consumption (average of > 3 standard drinks/day)
* Have a history of allergic reactions to metformin or similar drugs
* Have a history of severe claustrophobia
* Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses
* Have breast implants
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 54 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT02028221 | {
"brief_title": "Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk",
"conditions": [
"Breast Cancer Prevention"
],
"interventions": [
"Drug: Placebo",
"Drug: Metformin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02028221",
"official_title": "Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-30",
"study_completion_date(actual)": "2022-06-14",
"study_start_date(actual)": "2014-03-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-27",
"last_updated_that_met_qc_criteria": "2014-01-03",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-07",
"first_submitted": "2014-01-02",
"first_submitted_that_met_qc_criteria": "2021-02-17"
}
}
} |
#Study Description
Brief Summary
This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.
| #Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged >=18 years at index date.
* Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
* Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
* Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).
Exclusion Criteria:
* Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
* Patients known to be participating in an interventional study at any point of the one-year study period.
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
| NCT06666114 | {
"brief_title": "Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment",
"conditions": [
"Psoriasis (PsO)",
"Psoriatic Arthritis (PsA)"
],
"interventions": null,
"location_countries": [
"Brazil"
],
"nct_id": "NCT06666114",
"official_title": "Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-10",
"study_completion_date(actual)": "2023-10-10",
"study_start_date(actual)": "2021-08-03"
},
"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)": "2024-10-30",
"last_updated_that_met_qc_criteria": "2024-10-29",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-30",
"first_submitted": "2024-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolism in subject with type 2 diabetes.
Detailed Description
During the past two decades, there has been a steady increase in the incidence of diabetes mellitus, such that nearly 17 million people are now afflicted. The vast majority of these have type 2 diabetes. Over the next 40 years, the type 2 diabetic population in the United States is expected to increase to nearly 30 million.
Diabetes substantially increases the risk of atherosclerosis, and thereby, cardiovascular morbidity and mortality. Indeed, cardiovascular disease causes more than 50% of the mortality in patients with diabetes. People with type 2 diabetes manifest two cardinal signs of dysmetabolism: hyperglycemia and insulin resistance. Insulin resistance is a progressive phenomenon that occurs well before the onset of frank diabetes, and results in alterations in insulin signaling. Experimental studies suggest that insulin signaling is required for vascular homeostasis, and its impairment is associated with endothelial dysfunction. In the clinical setting, insulin resistance is associated with atherosclerosis and predicts cardiovascular events independent of hyperglycemia. Therefore, we will study the importance of insulin signaling in endothelial biology in humans and the effects of free fatty acids on endothelial function in people with type 2 diabetes.
#Intervention
- DRUG : acipimox
- subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit
- Other Names :
- Olbetam
- DRUG : placebo
- matching placebo | #Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetes mellitus (as defined by the National Diabetes Data Group)
* normal cardiovascular exam
* non smoker (for 1 year prior to entry)
* Healthy volunteers
* no known medical problems
* normal cardiovascular exam
* fasting glucose < 110 mg/dL
* non-smoker (for 1 year prior to entry)
Exclusion Criteria:
Type 2 Diabetics
* untreated hypertension (>140/90 mmHg)
* untreated hypercholesterolemia (LDL > 75th percentile for age)
* cigarette smoking within 1 year
* neuropathy requiring medication
* nephropathy (> 300mg/24 hour urinary albumin, or serum creatinine > 1.4 mg/dL
* abnormal cardiovascular exam
* treatment with thiazolidinedione within 1 year
* post-menopausal women taking hormone replacement therapy
(Note: subjects taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) must stop these medications for 2 weeks prior to taking study drug. If blood pressure rises to >140/90, subjects will be prescribed an alternative medication or be withdrawn from the study.
Healthy Volunteers
* abnormal cardiovascular exam
* use of prescription medications
* fasting glucose > 110mg/dL
* cigarette smoking within 1 year
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:
Yes
| NCT00153179 | {
"brief_title": "Free Fatty Acids and Vascular Function in Subjects With Diabetes",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: placebo",
"Drug: acipimox"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00153179",
"official_title": "The Impact of Free Fatty Acid Reduction on Vascular Function and Skeletal Muscle Glucose Utilization in Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2005-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-25",
"last_updated_that_met_qc_criteria": "2005-09-08",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-12",
"first_submitted": "2005-09-08",
"first_submitted_that_met_qc_criteria": "2013-05-30"
}
}
} |
#Study Description
Brief Summary
New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery stenting (CAS). The aim was to assess correlation between selected laboratory markers and occurrence of new brain infarctions after CAS.
Detailed Description
Methods: All consecutive patients 1) with internal carotid artery stenosis \>70%, 2) indicated to CAS, 3) with signed informed consent were enrolled to the prospective study during 16 months. All patients used dual antiplatelet therapy (acetylsalicylic acid \[ASA\] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS. Neurological examination and brain magnetic resonance imaging (MRI) were performed before and 24 hours after CAS in all patients. Venous blood samples were collected within 24 hours before CAS in all patients: hematology + reticulocytes, coagulation markers (PT, APTT, INR, Fbg, Clauss), vWF antigen, PAI-1 activity, PAI-1 polymorphism 4G/g, Multiplate (ASA and clopidogrel resistance test). Blood samples for the assessment of anti Xa activity were collected during CAS. T-test was used for statistical evaluation.
#Intervention
- PROCEDURE : Carotid stenting
- Procedures will be carried out via the femoral approach following a Seldinger technique. All patients will be on long-term aspirin (100 mg/day) and a 525-mg loading dose of clopidogrel. A dose of 10 000 units unfractionated heparin will be administered at the beginning of the intervention. A cerebral protection device (FilterWire EZ™; Boston Scientific, Natick, Massachusetts, USA) will be use in all patients if possible. The type of covered stent and other specific intervention strategies will be left to the discretion of the interventional radiologists. After predilatation of the stenosis (if needed), an appropriate stent for each stenosis will be implanted and then dilated using a balloon catheter. | #Eligibility Criteria:
Inclusion Criteria:
patients
* With internal carotid artery stenosis >70%
* Indicated to CAS
* With signed informed consent. Able to use (acetylsalicylic acid [ASA] 100 mg + clopidogrel 75 mg per day) at least 7 days before CAS
Exclusion Criteria:
* Contraindication for magnetic resonance imaging
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
| NCT02310191 | {
"brief_title": "Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting",
"conditions": [
"Carotid Stenosis",
"Brain Ischemia",
"Laboratory Problem"
],
"interventions": [
"Procedure: Carotid stenting"
],
"location_countries": [
"Czech Republic"
],
"nct_id": "NCT02310191",
"official_title": "Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2012-07"
},
"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)": "2014-12-08",
"last_updated_that_met_qc_criteria": "2014-12-03",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-08",
"first_submitted": "2014-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
} |
#Study Description
Brief Summary
This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an effective treatment for ovarian cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the activity of the study regimen as measured by the proportion of patients who are alive and progression-free for at least 12 months after study entry in patients with newly diagnosed stage III or IV clear cell ovarian cancer in the following populations: patients in the United States (U.S.) and worldwide (outside of Japan) and patients in Japan.
II. To compare progression-free survival in newly diagnosed stage III or IV clear cell ovarian cancer patients in patients in the U.S. and worldwide (outside of Japan) versus patients in Japan.
SECONDARY OBJECTIVES:
I. To characterize the duration of overall survival and progression-free survival in each population.
II. To examine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4 in each population.
III. To estimate the rate of objective tumor response in patients with measurable disease.
TERTIARY OBJECTIVES:
I. To explore whether immunohistochemical (IHC) expression of components of the mammalian target of rapamycin (mTOR) signaling pathway (phosphatase and tensin homolog \[PTEN\], total and phosphorylated protein kinase B \[Akt\], as well as, ATP-binding cassette, sub-family C \[CFTR/MRP\], member 3 \[ABCC3\] \[MRP3\], ATPase, H+ transporting, lysosomal accessory protein 1 \[AB CF2\], cyclin E, and vascular endothelial growth factor \[VEGF\]) are associated with outcome, nationality or clinical characteristics.
II. To explore whether there is any differences in differential gene expression profiles between U.S. and worldwide (outside of Japan) versus Japanese patients.
OUTLINE:
Patients receive paclitaxel\* intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV on days 1 and 8. Treatment repeats every 3 weeks for 6 courses. Patients then receive consolidation therapy comprising temsirolimus IV on days 1, 8, and 15. Treatment repeats every 3 weeks for 11 courses in the absence of disease progression or unacceptable toxicity.
NOTE: \* For circumstances in which docetaxel should be substituted for paclitaxel, docetaxel is given IV over 1 hour.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
#Intervention
- DRUG : Carboplatin
- Given IV
- Other Names :
- Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
- DRUG : Docetaxel
- Given IV
- Other Names :
- RP56976, Taxotere, Taxotere Injection Concentrate
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Paclitaxel
- Given IV
- Other Names :
- Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
- DRUG : Temsirolimus
- Given IV
- Other Names :
- CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, Torisel | #Eligibility Criteria:
Inclusion Criteria:
* Patients must have stage III or IV clear cell ovarian cancer; primary tumors must be at least 50% clear cell histomorphology in order to be eligible; in addition, the tumors should be negative for expression of Wilms tumor 1 (WT-1) antigen and estrogen receptor (ER) antigen by immunohistochemistry; appropriate tissue sections to confirm stage and histologic classification of cell type must be sent to Gynecologic Oncology Group (GOG) for central pathology review; immunohistochemical stained slides for ER and WT-1 antigen must be also be submitted to GOG for pathology review
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
* Patients with a GOG performance status of 0, 1, or 2
* Patients must be entered between 2 and 12 weeks after initial surgery; performed for the combined purpose of diagnosis, staging and cytoreduction
* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
* Absolute neutrophil count >= 1,500/mcl
* Platelets >= 100,000/mcl
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 times institutional upper limit of normal (< 5 times upper limit of normal [ULN] for subjects with liver metastases)
* Alkaline phosphatase =< 2.5 times institutional upper limit of normal (< 5 times ULN for subjects with liver metastases)
* Creatinine =< 1.5 x institutional upper limit of normal, grade 1 per CTCAE v. 4.0
* Cholesterol =< 350 mg/dL (fasting)
* Triglycerides =< 400 mg/dL (fasting)
* Albumin >= 3.0 g/dL
* Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus)
* Partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
* Neurologic function (sensory and motor) =< CTCAE grade 1
Exclusion Criteria:
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than five years prior to registration, and the patient remains free of recurrent or metastatic disease
* Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their clear cell ovarian cancer
* Patients with primary peritoneal and fallopian tube carcinoma are not eligible
* Previous treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin
* Patients cannot be receiving enzyme-inducing antiepileptic drugs (enzyme-inducing antiepileptic drugs [EIAEDs]; e.g., phenytoin, carbamazepine, phenobarbital) nor any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's Wort; use of agents that potently inhibit CYP3A4 (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited; the appropriateness of use of such agents is left to physician discretion; strong CYP3A4 inhibitors are prohibited
* Patients receiving any investigational agents
* Patients with severely impaired lung function defined as a diffusion lung capacity for carbon monoxide (DLCO) =< 50% of the normal predicted value and/or oxygen (O2) saturation =< 88% at rest on room air
* Patients with symptomatic congestive heart failure of New York Heart Association class III or IV, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant disease
* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
* Patients on maintenance corticosteroids are ineligible with the exception of short term use (fewer than 5 days)
* Patients with baseline requirement for oxygen
* Patients with serious concomitant illness which, in the opinion of the treating physician, will place patient at unreasonable risk from therapy on this protocol
* Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of study therapies
* Patients with poorly controlled diabetes
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
| NCT01196429 | {
"brief_title": "Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer",
"conditions": [
"Ovarian Clear Cell Cystadenocarcinoma",
"Stage III Ovarian Cancer",
"Stage IV Ovarian Cancer"
],
"interventions": [
"Drug: Docetaxel",
"Drug: Temsirolimus",
"Drug: Paclitaxel",
"Other: Laboratory Biomarker Analysis",
"Drug: Carboplatin"
],
"location_countries": [
"Japan",
"Korea, Republic of",
"United States"
],
"nct_id": "NCT01196429",
"official_title": "A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC# 683864,) in Combination With Carboplatin and Paclitaxel Followed by Temsirolimus Consolidation as First-Line Therapy in the Treatment of Clear Cell Carcinoma of the Ovary",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2010-08"
},
"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)": "2019-08-08",
"last_updated_that_met_qc_criteria": "2010-09-04",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-08",
"first_submitted": "2010-09-04",
"first_submitted_that_met_qc_criteria": "2017-03-22"
}
}
} |
#Study Description
Brief Summary
The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.
#Intervention
- DRUG : PLX3397
- 1000 mg/day (400 mg in the morning and 600 mg in the evening)
- Other Names :
- Pexidartinib | #Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
* Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
* Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 <= age <= 2
* Life expectancy >= 3 months
* Adequate organ and bone marrow function
* Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for >= 1 year or surgically sterile.
* Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
* Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
Exclusion Criteria:
* Prior treatment with a KIT inhibitor for melanoma
* Presence of NRAS or BRAF mutation
* Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
* Symptomatic brain metastases.
* Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
* Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
* Uncontrolled intercurrent or infectious illness
* Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
* Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
* Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
* Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease [myocardial infarction (MI) more than 6 months prior to study entry is permitted] or serious cardiac arrhythmia
* Baseline QT interval corrected using Fridericia equation (QTcF) >= 450 msec (for males) or >= 470 msec (for females) at Screening
* Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
* Known chronic liver disease
* Women who are breast-feeding or 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
| NCT02975700 | {
"brief_title": "A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma",
"conditions": [
"Melanoma"
],
"interventions": [
"Drug: PLX3397"
],
"location_countries": [
"Korea, Republic of",
"China"
],
"nct_id": "NCT02975700",
"official_title": "A Phase I/II Open Label, Multicenter Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-31",
"study_completion_date(actual)": "2024-10-14",
"study_start_date(actual)": "2017-01-31"
},
"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)": "2024-11-19",
"last_updated_that_met_qc_criteria": "2016-11-23",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-29",
"first_submitted": "2016-11-21",
"first_submitted_that_met_qc_criteria": "2020-03-25"
}
}
} |
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