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#Study Description
Brief Summary
Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.
Objectives:
* To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26.
* To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects.
* To describe the safety profile of a single dose of Menactra® vaccine in subjects.
Detailed Description
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.
#Intervention
- BIOLOGICAL : Meningococcal polysaccharide diphtheria toxoid conjugate
- 0.5 mL, IM
- Other Names :
- Menactra®
- BIOLOGICAL : Meningococcal polysaccharide diphtheria toxoid conjugate
- 0.5 mL, IM
- Other Names :
- Menactra®
- BIOLOGICAL : Meningococcal polysaccharide diphtheria toxoid conjugate
- 0.5 mL, IM
- Other Names :
- Menactra®
|
#Eligibility Criteria:
Inclusion Criteria :
* Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received
* At 3 to < 6 years and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine).
* Informed consent form signed and dated by the parent(s) or another legally acceptable representative.
* Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.
Exclusion Criteria :
* Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first study vaccination
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or to a product containing any of the substances present in the study vaccine.
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
* Received blood or blood-derived products in the past 3 months.
* Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first study vaccination.
* Planned receipt of any vaccine within the 4 weeks following the study vaccination.
* Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
* History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
* Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
* Personal or family history of Guillain-Barré Syndrome (GBS).
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00700713
|
{
"brief_title": "Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26",
"conditions": [
"Meningitis",
"Meningococcemia"
],
"interventions": [
"Biological: Meningococcal polysaccharide diphtheria toxoid conjugate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00700713",
"official_title": "Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-02",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-15",
"last_updated_that_met_qc_criteria": "2008-06-18",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-19",
"first_submitted": "2008-05-07",
"first_submitted_that_met_qc_criteria": "2016-01-16"
}
}
}
|
#Study Description
Brief Summary
Appropriate management reduces the mortality of severe trauma victims. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity. The objective of this research project is to show that the 28-day mortality after severe trauma is lower in a structured health system, compared to a non-structured system.
Detailed Description
Appropriate management reduces the mortality of severe trauma victims defined by an Injury Severity Score (ISS) greater than 15 or the need for specialized and/or urgent treatment. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity.
The trauma hospital organisation in France is of the 'exclusive' type. It contrasts trauma centres with other hospitals, only providing care for severe trauma victims in the former, which are most often confused with university hospitals. The choice of referral to this type of centre is made using a triage algorithm known as 'de Vittel'. In addition to an insufficient network within a region leading to longer hospital access time, this organisation leads to saturation of the referral centres by patients with few lesions. For this reason, this organisation has been rethought in an innovative way within the Auvergne-Rhône-Alpes region, in favour of an 'inclusive' system that takes the form of a network of hospitals with capacities to receive severely traumatised patients that vary according to their equipment and personnel. Patients are referred within this network according to their severity category (unstable, stabilized or stable).
The main objective is to show that the 28-day mortality of severely traumatized persons oriented according to their severity in an inclusive system is lower, at identical severity, than in a conventional exclusive system in which the orientation is guided by the Vittel algorithm.
Secondary objectives are to show that the management of severe traumatized persons oriented according to their severity in an inclusive system, compared to the management in an exclusive conventional system in which the orientation is guided by the Vittel/ASCOTT algorithm, is associated, at identical severity, with :
* Less under-triage;
* Less over-triage;
* A lower incidence of secondary transfers to a trauma center;
* A greater number of days living without mechanical ventilation (during the first 28 days);
* More days living without resuscitation (within the first 28 days);
* More frequent and rapid use of whole-body CT scans with contrast injection;
* More frequent and rapid use of specialized emergency therapies (laparotomy or hemostasis thoracotomy, embolization, craniectomy, intracranial pressure measurement, chest drainage).
#Intervention
- OTHER : Triage
- Experimental : Trauma patient orientation in a structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients cared for in the aftermath of a severe trauma, by a pre-hospital medical team regulated by the territorially competent SAMU, who arrived at the hospital alive.
Exclusion Criteria:
* Age < 18 years
* Patients with no signs of life on hospital arrival and reported deceased within 30 minutes of admission
* Patients with severe burns (>10% skin area burned)
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
|
NCT04275791
|
{
"brief_title": "Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients",
"conditions": [
"Wounds and Injuries"
],
"interventions": [
"Other: Triage"
],
"location_countries": [
"France"
],
"nct_id": "NCT04275791",
"official_title": "Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-23",
"study_completion_date(actual)": "2024-06-20",
"study_start_date(actual)": "2022-05-23"
},
"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)": "2024-07-30",
"last_updated_that_met_qc_criteria": "2020-02-17",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-19",
"first_submitted": "2020-01-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.
Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fasting conditions.
#Intervention
- DRUG : Clarithromycin
- Single-dose 500 mg immediate-release oral tablet
- DRUG : Clarithromycin
- Single-dose 500 mg immediate-release oral dose
- Other Names :
- Biaxin®; Biaxin® Filmtabs
|
#Eligibility Criteria:
Inclusion Criteria:
Subjects meeting all of the following criteria may be included in the study:
Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject
Males or females aged from 18 <= age <= 55 with a body mass index (BMI) greater than or equal to 19 and below 30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report
Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF (laboratory tests are presented in section 7.1.3)
Healthy according to the laboratory results and physical examination
Exclusion Criteria:
Significant history of hypersensitivity to clarithromycin, erythromycin, other macrolide antibacterial agents or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
Females who are pregnant, lactating or are likely to become pregnant during the study phases
Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study
Positive pregnancy test before or during the study
Use of the following products (astemizole, terfenadine, cisapride or pimozide) in the previous 14 days before day 1 of the study
Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease
Any clinically significant illness in the previous 28 days before day 1 of this study
Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)
Participation in another clinical trial in the previous 28 days before day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4)
Positive results to HIV, HBsAg or anti-HCV tests
History of fainting upon blood sampling
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
|
NCT00648960
|
{
"brief_title": "Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Clarithromycin"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00648960",
"official_title": "Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fasting State",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-07",
"study_completion_date(actual)": "2003-07",
"study_start_date(actual)": "2003-07"
},
"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)": "2008-04-01",
"last_updated_that_met_qc_criteria": "2008-03-31",
"last_verified": "2008-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-01",
"first_submitted": "2008-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the effects of Aubagio on changes in the brain using MRI.
Detailed Description
Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.
#Intervention
- OTHER : MRI
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 18 <= age <= 65
* Clinically definite MS according to the Polman criteria, 52
* Relapsing MS or Healthy Control (no neurological disorders)
* Expanded Disability Status Scale (EDSS) scores <=5.5
* Disease duration <30 years
* Normal kidney function (creatinine clearance >59 mL/min) (patients only)
* Signed informed consent
* None of the exclusion criteria
Exclusion Criteria:
* MS patients with hepatic impairment
* Nursing mothers or pregnant women who will need to undergo 12 months follow-up
* Women of childbearing potential not using reliable contraception
* Patients currently treated with leflunomide
* Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
* A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
* Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
* Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
* Other pathology related to MRI abnormalities
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
|
NCT01881191
|
{
"brief_title": "Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Other: MRI"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01881191",
"official_title": "Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2013-06"
},
"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)": "2016-02-12",
"last_updated_that_met_qc_criteria": "2013-06-18",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-19",
"first_submitted": "2013-06-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Detailed Description
Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).
#Intervention
- DEVICE : MammoSite Radiation Therapy System
- The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pre-Surgery:
* Unicentric pure DCIS
* Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
* Post-Surgery:
* Negative histological margins confirmed prior to beginning radiation therapy.
* Margins are positive if there is tumor at the inked margin.
* Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
* Clinically node negative
Exclusion Criteria:
* Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
* Distant metastases.
* Invasive or in-situ lobular carcinoma (post-surgery assessment).
* Nonepithelial breast malignancies such as sarcoma or lymphoma.
* DCIS that is multicentric in the ipsilateral breast.
* Pregnant or lactating.
* Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
* Collagen vascular diseases
* Coexisting medical conditions with life expectancy < 2 years.
* Serious psychiatric or addictive disorder
* Previously treated contralateral breast carcinoma
* Synchronous bilateral breast carcinoma.
* Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
* Patients with diffuse disease
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00586326
|
{
"brief_title": "MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ",
"conditions": [
"DCIS"
],
"interventions": [
"Device: MammoSite Radiation Therapy System"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00586326",
"official_title": "MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-01",
"study_completion_date(actual)": "2011-04",
"study_start_date(actual)": "2003-08"
},
"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)": "2012-11-06",
"last_updated_that_met_qc_criteria": "2007-12-21",
"last_verified": "2012-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-04",
"first_submitted": "2007-12-21",
"first_submitted_that_met_qc_criteria": "2012-09-20"
}
}
}
|
#Study Description
Brief Summary
This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.
Detailed Description
PRIMARY OBJECTIVES:
I. To pilot test a novel parenting intervention. II. To examine the feasibility and preliminary efficacy of the parenting intervention on child medication adherence among children who are experiencing an illness.
OUTLINE: Participants with poor medication adherence are randomized to 1 of 3 groups.
EARLY GROUP: Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
DELAYED GROUP: Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
LATE GROUP: Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.
#Intervention
- OTHER : Educational Activity
- Undergo parenting skills intervention
- PROCEDURE : Patient Monitoring
- Undergo medication adherence monitoring
- Other Names :
- monitor
- OTHER : Questionnaire Administration
- Ancillary studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Be a parent of a child (2 <= age <= 10 old) with any hematology or oncology diagnosis who is receiving treatment at Roswell Park Comprehensive Cancer Center. We define parents as biological parents, adoptive parents, foster parents, stepparents, and legal guardians
* Parent must have primary medication responsibility
* The child's treatment must include home-based daily oral medication
* Parent must have verbal English fluency
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Be a parent of a pediatric patient with any hematology or oncology diagnosis who is receiving treatment at Roswell Park and is < 2 or > 10 years
* Parent does not have primary medication responsibility
* Child's treatment does not include home-based daily oral medication
* Parent does not have verbal English fluency
* If unable to consent or a prisoner
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study intervention
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
|
NCT03895918
|
{
"brief_title": "Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients",
"conditions": [
"Guardian",
"Hematologic and Lymphocytic Disorder",
"Malignant Neoplasm",
"Parent"
],
"interventions": [
"Other: Questionnaire Administration",
"Other: Educational Activity",
"Procedure: Patient Monitoring"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03895918",
"official_title": "A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-25",
"study_completion_date(actual)": "2020-11-25",
"study_start_date(actual)": "2019-01-03"
},
"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)": "2021-09-16",
"last_updated_that_met_qc_criteria": "2019-03-28",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-29",
"first_submitted": "2019-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects.
Detailed Description
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization.
Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis).
Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia technique in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE).
The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia.
#Intervention
- PROCEDURE : erector spinae plane block
- the patient will be placed in the lateral position with the surgical side up for performing erector spinae plane block. After skin preparation, superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation 1-2cm lateral to the midline at the sacral level. The L2 level will be identified by counting upward from the sacrum. Following identification of the erector spinae muscle (ESM) and transverse process, a 21 G needle will be inserted deep to the erector spinae muscle (ESM) in a cranio-caudal direction. After negative aspiration, the correct needle position will be confirmed with the administration of 0.5-1ml LA. A total volume of 0.5 mL/kg local anesthetic solution will be injected interfascial plane between erector spinae muscle and transverse process for block performance.
- PROCEDURE : pericapsular nerve group block
- the patient will be in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 0.5 mL/kg local anesthetic solution will be injected.
|
#Eligibility Criteria:
Inclusion Criteria:
* Children of both genders
* American Society of Anaestheologists (ASA) physical activity I, II
* aged more than one year
* admitted for elective pediatric hip surgery
Exclusion Criteria:
* Children with severe systemic disease with American Society of Anaestheologists (ASA) III or IV,
* children with previous neurological or spinal disorders,
* coagulation disorder,
* infection at the block injection site,
* history of allergy to local anesthetics
* bilateral hip surgery.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04373577
|
{
"brief_title": "Comparison of Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Procedure: pericapsular nerve group block",
"Procedure: erector spinae plane block"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04373577",
"official_title": "Comparison of Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-01",
"study_completion_date(actual)": "2022-10-01",
"study_start_date(actual)": "2020-05-01"
},
"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)": "2022-11-25",
"last_updated_that_met_qc_criteria": "2020-05-01",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-04",
"first_submitted": "2020-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.
Detailed Description
At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.
The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA.
#Intervention
- DRUG : Ketamine Hydrochloride
- intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off
|
#Eligibility Criteria:
Inclusion Criteria:
* Age group 18 <= age <= 64 years
* ASA I-II
* BMI 20 <= age <= 29.9
* Patients accepting the study and consenting
* Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.
Exclusion Criteria:
* ketamine allergy
* Morphine allergy
* History of cardiac, neurological, or psychiatric disease, glaucoma,
* Patients with a body mass index of less than 20 or more than 30 kg/m2
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:
Yes
|
NCT05313659
|
{
"brief_title": "Intramuscular Ketamine Effect on Postnasal Surgery Agitation",
"conditions": [
"Agitation, Emergence"
],
"interventions": [
"Drug: Ketamine Hydrochloride"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT05313659",
"official_title": "Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-20",
"study_completion_date(actual)": "2022-10-20",
"study_start_date(actual)": "2022-05-11"
},
"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)": "2023-01-25",
"last_updated_that_met_qc_criteria": "2022-04-05",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-06",
"first_submitted": "2022-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this trial is to investigate the relative bioavailability of 100 mg nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg nintedanib.
#Intervention
- DRUG : nintedanib 25 mg
- soft gelatin capsule
- DRUG : nintedanib 100 mg
- soft gelatin capsule
- Other Names :
- Ofev®
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 <= age <= 55 (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04938453
|
{
"brief_title": "A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: nintedanib 100 mg",
"Drug: nintedanib 25 mg"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04938453",
"official_title": "Relative Bioavailability of 100 mg Nintedanib (Ofev®) Given as Four Capsules of 25 mg Compared to One Capsule of 100 mg Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)",
"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)": "2021-07-14"
},
"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)": "2023-07-17",
"last_updated_that_met_qc_criteria": "2021-06-23",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-24",
"first_submitted": "2021-06-23",
"first_submitted_that_met_qc_criteria": "2022-08-23"
}
}
}
|
#Study Description
Brief Summary
The study aims to identify whether stroke survivors can intentionally modulate their brain signals for controlling an FES device to produce arm movements for home based rehabilitation. The study also assess the participants acceptability of this new home-based rehabilitation.
Detailed Description
Movements of different parts of the body, including the arm, start when the brain produces specific electrical signals. Sometimes after a stroke, even though the person intends to move the arm, the arm will not move or will only move partly. The brain continues to produce electrical signals after stroke, but when the signals are weak the arm does not move. Brain-computer interface (BCI), is a method of utilising the brain signals to produce useful outputs via computers. One type of BCI is BCI Functional Electrical Stimulus (BCI-FES) which is a device that can detect these brain signals produced during the intention to move the weak arm after a stroke. It then uses these signals to trigger an electrical stimulator. The electrical stimulator then stimulates the muscles in the weak arm to produce the desired arm movement. Recent studies show that rehabilitation using this device has given better results when compared with conventional rehabilitation approaches. However, the BCI-FES devices currently available are bulky and participants need to come to the hospital or laboratory to receive the treatment. Our project aims to develop a BCI-FES device, called Tele BCI-FES that can be used at stroke participant's home. The investigators are using techniques like machine learning to make the Tele BCI-FES quick and simple to set up, easy to use and effective. This study aims to investigate if the proposed Tele BCI-FES device is a feasible and acceptable intervention for post-stroke rehabilitation.
#Intervention
- DEVICE : The BCI-FES Intervention
- To evaluate whether the participant can effectively control FES using the developed remote BCI system. Thus, participants will receive a three-week BCI-FES intervention at their home, including three sessions of intervention per week. Each session will last around 60 minutes, including 10 minutes of preparation, 40 minutes of intervention and 10 minutes interview on the user's experience with the device and any experienced side effects, if any.
|
#Eligibility Criteria:
Inclusion Criteria:
1) Age 18 and above.
(2) Experienced an ischaemic or haemorrhagic stroke more than 6 months ago.
(3) Arm weakness interfering with activities of daily living.
(4) Fugl-Meyer score of upper limb<45.
(5) Caregiver is willing to assist with trial by helping to deliver intervention.
(6) Cognitive and language abilities to understand and participate in the study protocol.
(7) Can maintain sitting with or without support for 1 hour continuously.
(8) Able to give consent and understand instructions.
Exclusion criteria:
* Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
* Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
* Pre-existing severe systemic disorders like cardiovascular disease; active cancer or renal disease; end stage pulmonary or cardiovascular disease; psychiatric illness including severe alcohol or drug abuse
* Inability to perform the baseline assessments;
* Severe tactile hypersensitivity;
* Participation in other, upper limb rehabilitation studies
* Within 12 weeks of receiving Botulinum toxin injections;
* History of epilepsy
* Pace maker or any other implanted devices
* Pregnancy
* Severe dystonia/spasm
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
|
NCT05215522
|
{
"brief_title": "Tele BCI-FES for Upper -Limb Stoke Rehabilitation",
"conditions": [
"Stroke"
],
"interventions": [
"Device: The BCI-FES Intervention"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05215522",
"official_title": "Upper Limb Telerehabilitation Using Brain -Controlled Functional Electrical Stimulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-30",
"study_completion_date(actual)": "2022-12-30",
"study_start_date(actual)": "2022-06-15"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DEVICE_FEASIBILITY",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-15",
"last_updated_that_met_qc_criteria": "2022-01-28",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-31",
"first_submitted": "2021-12-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To test the effects of exercise and weight loss on mobility disability of older overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.
Detailed Description
BACKGROUND:
Older adults make up the fastest growing segment of our population. It is estimated that by the year 2030, elderly people will make up 22% of the United States population. A large portion of older adults suffers from one or more chronic conditions that could be improved by regular physical activity. Therefore, research in this age group is needed.
DESIGN NARRATIVE:
The Cooperative Lifestyle Intervention Program (CLIP) will test the effects of a physical activity intervention and a weight loss intervention on mobility disability of overweight or obese men and women who have evidence of cardiovascular disease or the metabolic syndrome. The public health relevance of the trial lies in the fact that the interventions will be delivered in conjunction with four Cooperative Extension Centers in counties surrounding Winston-Salem, North Carolina. CLIP will be designed as a three arm, randomized, controlled trial. The three 18-month treatments will include: (1) a basic health education-based control condition, (2) a group treatment program for physical activity, and (3) a lifestyle intervention designed to reduce sedentary behavior and promote weight loss. The primary aim will be to compare the effects of the three treatment arms on the change in performance on a 400-meter walk test over the course of 18 months. Secondary aims will include changes in cardiovascular risk factors, adiposity, cardiovascular fitness, physical activity, and health-related quality of life. Analyses will also be conducted to determine whether changes in the primary outcome are mediated by changes in constructs from social cognitive theory.
#Intervention
- BEHAVIORAL : Exercise
- Increase Physical Activity to 150 min/wk
- Other Names :
- Physical activity
- BEHAVIORAL : Weight Loss
- Lose 7-10% of body weight and increase physical activity to 150 min/wk
- Other Names :
- Diet modification
- BEHAVIORAL : Health Education Control
- Lectures on information relevant to successful aging
- Other Names :
- Attention control
|
#Eligibility Criteria:
Inclusion Criteria:
* Currently living in one of the counties surrounding Winston-Salem, NC
* Sedentary (engages in fewer than 30 minutes of moderate structured physical activity for at least 10 minutes at a time each week)
* Overweight or obese, as defined by a body mass index (BMI) greater than 25
* Fasting glucose level less than 140
* Documented evidence of an MI, PCTA, chronic stable angina, or cardiovascular surgery (coronary artery or valvular heart disease) within the 6 months prior to study entry or an ATP III diagnosis of the metabolic syndrome
* Disability defined as self-reported difficulty with walking ¼ mile, climbing stairs, lifting and carrying groceries, or performing other household chores such as cleaning and yard work
* Does not plan to move out of the county of residence for the duration of the study
Exclusion Criteria:
* Diagnosis of bipolar depression or schizophrenia (defined as self-reported treatment for these conditions)
* Currently receiving lithium or neuroleptics
* Evidence of unstable angina, symptomatic congestive heart failure, or exercise-induced complex ventricular arrhythmias
* Resting blood pressure greater than 160/100 mmHg
* Diagnosis of any of the following: Parkinson's disease; chronic liver disease (cirrhosis, chronic hepatitis, etc.); systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.); end stage renal disease; or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study
* Actively being treated for cancer (other than non-melanotic skin cancer)
* Significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation
* Currently participating in or planning to participate in another medical intervention study
* Current alcohol abuse disorder or consumes more than 21 alcoholic drinks per week
* Unable to walk without assistance
* Unable to speak or read English
* Judged by the clinic staff to be unsuitable for the trial for any reason
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00119795
|
{
"brief_title": "Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese",
"conditions": [
"Cardiovascular Diseases",
"Heart Diseases",
"Metabolic Syndrome X",
"Obesity"
],
"interventions": [
"Behavioral: Health Education Control",
"Behavioral: Exercise",
"Behavioral: Weight Loss"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00119795",
"official_title": "Cooperative Lifestyle Intervention Program (CLIP)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-04",
"study_completion_date(actual)": "2011-04",
"study_start_date(actual)": "2005-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-15",
"last_updated_that_met_qc_criteria": "2005-07-06",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-07-14",
"first_submitted": "2005-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Purpose of the Pilot Trial:
To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients.
Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.
Detailed Description
Design:
This is a pilot interventional study to be conducted at 2 Canadian Centres. The Ottawa Hospital and Juravinski Hospital. It is an open label randomized controlled trial.
Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups.
Rivaroxaban 10mg by mouth daily x 90 (+/- 3) days OR Standard of Care
Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days or until CVC is removed. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days). Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days.
Outcomes The primary feasibility outcome for the pilot study is the number of participants recruited per centre per month. We will obtain baseline details of the patient's type, location and treatment of cancer, comorbidities and medications. Secondary feasibility outcomes of the pilot study will include, consent rates, loss to follow up, adherence to therapy defining 80% or greater medication taken as having good adherence to study drug, proportion of screened patients who meet eligibility criteria.
#Intervention
- DRUG : Rivaroxaban 10 MG
- Rivaroxaban 10mg po daily x 90 (+/- 3 days)
- Other Names :
- Xarelto 10mg tablet po daily
|
#Eligibility Criteria:
Inclusion Criteria:
*Patients 18 years or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.
Exclusion Criteria:
* CVC in place for >72 hours
* Patient requires anticoagulation for other indication
* Concomitant use of dual antiplatelet therapy
* Prior VTE
* Major bleeding event in the last 6 weeks
* Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
* Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
* Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)
* Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)
* Known thrombocytopenia < 50x 109/L (in the previous 3 months)
* Allergy to rivaroxaban
* Life expectancy <6 months
* History of condition at increased bleeding risk including, but not limited to:
1. Major surgical procedure or trauma within 30 days before the randomization visit
2. Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
3. History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
4. Chronic hemorrhagic disorder
5. Known intracranial neoplasm, arteriovenous malformation, or aneurysm
6. Sustained uncontrolled hypertension: systolic blood pressure >=180 mmHg or diastolic blood pressure >=100 mmHg
* Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
* Geographic inaccessibility
* Refused or unable to obtain 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
|
NCT03506815
|
{
"brief_title": "Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines",
"conditions": [
"Upper Extremity Deep Vein Thrombosis",
"Central Venous Catheter Thrombosis",
"Cancer"
],
"interventions": [
"Drug: Rivaroxaban 10 MG"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03506815",
"official_title": "A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-14",
"study_completion_date(actual)": "2020-06-14",
"study_start_date(actual)": "2019-03-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-05",
"last_updated_that_met_qc_criteria": "2018-04-13",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-24",
"first_submitted": "2018-03-19",
"first_submitted_that_met_qc_criteria": "2024-01-18"
}
}
}
|
#Study Description
Brief Summary
This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, add-on to standard of care study of NBP softgel capsules for the treatment of mild to moderate AIS in adults.
Detailed Description
This is a randomized, double-blind, placebo-controlled, add-on to standard-of-care study with a primary objective to assess the safety of NBP treatment in patients with mild to moderate acute ischemic stroke. The secondary objectives include determination of pharmacokinetic (PK) profile and exploratory evaluation for the efficacy of NBP treatment in stroke patients.
All randomized subjects will also receive standard supportive medical care for treatment of AIS throughout the study. The overall duration of the study will be approximately 90 days, including 30 days of treatment and an additional 60 days for follow up assessments. Subjects will be hospitalized long enough to receive the first four doses of study drug. After discharge from the hospital, subjects will continue to take study treatment daily through Day 30 and have scheduled assessments completed.
To maintain the blind, all subjects will take 4 softgel capsules BID, which will contain either 100 mg NBP or matching placebo. The first dose must be taken within 12 hours of the onset of the AIS defined as the last known normal.
#Intervention
- DRUG : NBP Softgel Capsules
- Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
- Other Names :
- NBP
- DRUG : Placebo
- Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
- Other Names :
- NBP Placebo Softgel Capsules
|
#Eligibility Criteria:
Inclusion Criteria
* Males or females aged >= 18 and <= 85 years.
* Women of childbearing potential (WOCBP) must have a negative urine human chorionic gonadotropin (HCG) pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% until the completion of the trial or 60 days after discontinuation of study treatment. Women are considered not childbearing if they are > 1 year postmenopausal or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy tubal ligation). If serum beta human chorionic gonadotropin (bHCG) is the standard of care, then this value can be used to determine eligibility.
* A clinical diagnosis of mild to moderate cortical or subcortical AIS.
* Able to swallow the softgel capsules as defined by the investigator.
* Completes screening procedures such that study treatment is first administered within 24 hours of stroke onset. The stroke onset time will be defined as the last known normal.
* If Tissue Plasminogen Activator (tPA) is given as part of standard of care, the first dose of NBP must be administered no sooner than 4 hours after the end of the tPA infusion.
* A standard NIHSS score of 4 to 17, inclusive. If patients receive tPA and/or endovascular treatment (EVT), the NIHSS score must be obtained after the infusion and/or procedure is completed. If sedation is used for EVT, then the NIHSS score must be obtained after sedation no longer confounds the assessment. All subjects must meet a NIHSS consciousness score of 0 <= age <= 1 in order to meet eligibility.
* Functionally independent, as defined by a Modified Rankin Scale (mRS) score of 0 to 1 before their present illness as determined by the subject or provided by a representative if the subject is unable to participate at the time of study entry (determined by retrospective assessment by the Investigator).
* Capable of understanding the purpose and risk of the study and has signed, in writing, the Informed Consent Form (ICF). If the subject is not capable of this at the time of enrollment, a legally authorized representative (LAR) will provide written informed consent in accordance with all regulations.
* Ability to comply with study requirements.
Exclusion Criteria:
* Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant within the next 3 months.
* Suspected diagnosis of stroke isolated to brainstem or brain areas other than cortical or subcortical AIS that may have caused the present symptoms, based on the opinion of the Investigator.
* Rapidly improving or resolving symptoms, suggesting a possible transient ischemic attack (TIA) rather than a qualifying stroke.
* Signs of acute intracranial hemorrhage or symptomatic hemorrhagic transformation of AIS defined by a 4-point worsening in NIHSS from presentation, or other cause of acute stroke symptoms (other than early ischemic findings) on cranial imaging at Screening.
* History of intracranial hemorrhage.
* Seizure at onset of stroke.
* A previous clinical diagnosis of stroke within 6 months of current AIS. A previously undiagnosed stroke evidenced on screening CT or MRI may be enrolled provided it does not affect neurological and functional assessments based on the opinion of the Investigator.
* Uncontrolled severe hypertension defined as a systolic blood pressure (SBP) >= 220 mm Hg or diastolic blood pressure (DBP) >= 110 mm Hg.
* Treatment with intensive antihypertensive therapy within 4 hours of randomization.
* SBP < 100 mm Hg, temperature > 38.0º C, or heart rate < 40 beats/minute or > 120 beats/minute at Screening or prior to randomization.
* A glucose level of < 50 mg/dL at Screening.
* An international normalized ratio (INR) >= 1.5 if not being treated with anticoagulant therapy, or an INR >= 3.5 if being treated with an acceptable anticoagulant therapy.
* A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 1.5 × Upper Limits of Normal (ULN), or bilirubin > 1.5 ULN (except in setting of known Gilbert's disease) at Screening.
* Clinically significant renal dysfunction (including serum creatinine level > 2.0 mg/dL or 177 µmol/L) at Screening.
* A hemoglobin level < 10 g/dL at Screening.
* Current or within the last 6 months prior to Screening, New York Heart Association Class III/IV heart failure, severe uncorrected valve disease, known or suspected infective/vegetative endocarditis, ventricular tachycardia, or torsade de pointes.
* Corrected QTcF (Fridericia) > 450 ms for male subjects or > 470 ms for female subjects (average of 3 ECG tracings) prior to randomization.
* Current diagnosis of cancer or is being treated or has received any treatments for cancer within the last 5 years except basal cell carcinoma or curatively resected squamous cell carcinoma.
* Known life expectancy < 6 months (for any reason).
* Known allergy or hypersensitivity to celery or soybeans.
* Received treatment with any other investigational drug within 30 days before Baseline, was previously treated with NBP, is currently taking celery seed extract, or is currently participating in another clinical study.
* Known or suspected history of alcohol or drug dependence within the past 6 months, or is known to have abused alcohol (eg, been intoxicated) within the last 24 hours.
* Known history of hepatitis B, hepatitis C, HIV, or tuberculous (TB).
* Any other reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.
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
|
NCT02905565
|
{
"brief_title": "NBP in Adult Patients With Acute Ischemic Stroke (AIS)",
"conditions": [
"AIS"
],
"interventions": [
"Drug: Placebo",
"Drug: NBP Softgel Capsules"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02905565",
"official_title": "A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard Of-Care Study of n Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke (AIS) in Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-07",
"study_completion_date(actual)": "2020-08-07",
"study_start_date(actual)": "2018-02-28"
},
"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)": "2020-09-17",
"last_updated_that_met_qc_criteria": "2016-09-14",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-19",
"first_submitted": "2016-08-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary objective:
Characterize the natural history of MoCD type A in terms of survival
Secondary objectives:
1. Evaluate blood and urine for biochemical markers
2. Evaluate head circumference, seizure activity and neurologic outcomes
3. To evaluate brain MRI
4. Compare blood and urine analysis, head circumference, seizure activity and neurologic outcomes to MRI findings
|
#Eligibility Criteria:
Inclusion Criteria:
* Both living and deceased patients of any age will be considered for study inclusion.
* Diagnosis of MoCD or isolated SOX deficiency
* Documented informed consent
Exclusion Criteria:
* MoCD Type A patient who was in Study ALX-MCD-501
* Deceased patients with unknown genotype (as of Amendment 4)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01735188
|
{
"brief_title": "A Natural History Study of Molybdenum Cofactor and Isolated Sulfite Oxidase Deficiencies",
"conditions": [
"Molybdenum Cofactor Deficiency",
"Isolated Sulfite Oxidase Deficiency"
],
"interventions": null,
"location_countries": [
"Japan",
"Israel",
"Saudi Arabia",
"Netherlands",
"United States",
"Poland",
"Germany",
"Canada",
"Malaysia",
"Spain",
"Tunisia",
"Italy",
"Turkey",
"United Kingdom"
],
"nct_id": "NCT01735188",
"official_title": "A Natural History Study Of Molybdenum Cofactor And Isolated Sulfite Oxidase Deficiencies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-19",
"last_updated_that_met_qc_criteria": "2012-11-26",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-28",
"first_submitted": "2012-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to determine the level of pain and anxiety in patients who present to the emergency department with acute pain, and to investigate the effect of the standard analgesic treatment and an additional anxiolytic treatment on pain and anxiety.
Detailed Description
After triage, each acute pain patient who qualified for the study was asked for consent. Written informed consent was obtained from all patients who were eligible for the study. After obtaining written informed consent, demographic and clinical data were collected and recorded by the attending physician. Our study consisted of two parallel groups. Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number. The control group was given only the analgesic drug dexketoprofen trometamol and the study group was given analgesic plus anxiolytic, the same dose of dexketoprofen trometamol plus midazolam . Both groups received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg, and the midazolam dose was 1 mg. The study was double-blind. Sequenced study medications were prepared by a nurse, and another nurse administered the medications. In patients with an insufficient improvement of pain after 60 minutes, fentanyl 1 mcg/kg ı.v. was administered as a rescue medication.
Pain and anxiety in patients was measured at 0, 30, 60 and 120 minutes using the standard 100 mm horizontal visual analogue scale (VAS). The patient's general anxiety states were measured with the Turkish adopted version of the Hospital Anxiety and Depression Scale (HADS). Patients who have greater than 10 points are assumed anxious (9). The HADS and VAS scores were measured and recorded to the database by the researcher. At the time of discharge, patient satisfaction with treatment was evaluated by asking two questions with the 5-step Likert scale. The questions were, 'I am satisfied with the applied treatment', and 'I would like the same treatment applied again'. Patient answers were, '1-I strongly disagree', '2-I disagree', '3-I am not sure', '4-I agree', and '5-I strongly agree'.
#Intervention
- DRUG : dexketoprofen trometamol
- DRUG : Midazolam
|
#Eligibility Criteria:
Inclusion Criteria:
* The patients who presented to the emergency department with acute pain
* Who accepted to include the study
* Who were older than 18 years
Exclusion Criteria:
* Patients who refused to participate to the study
* History of allergy to any of the study drugs
* Pregnancy
* Younger than 18 years
* Chronic pain
* Antidepressant or anxiolytic drug use
* Advanced kidney or liver failure
* Use of analgesics within 6 hours before presentation
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
|
NCT03420911
|
{
"brief_title": "Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department",
"conditions": [
"Pain, Acute",
"Anxiety"
],
"interventions": [
"Drug: dexketoprofen trometamol",
"Drug: Midazolam"
],
"location_countries": null,
"nct_id": "NCT03420911",
"official_title": "Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department Due to Acute Pain: a Double Blind, Randomized, Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2013-06"
},
"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)": "2018-02-05",
"last_updated_that_met_qc_criteria": "2018-02-01",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-05",
"first_submitted": "2018-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cavernous sinus syndrome (CSS) can be caused by a wide range of inflammatory, malignant, benign, vascular and miscellaneous disorders. Even after modern advances, reaching the final etiological diagnosis remains a challenge in CSS. This study is planned to determine the role and incremental value of 18F-FDG PET/CT in characterising different cavernous sinus pathologies based on their metabolic activity and detecting extracranial involvement.
#Intervention
- DIAGNOSTIC_TEST : FDG radiotracer
- Pilot study evaluating the role of FDG PET/CT in Cavernous sinus syndrome
- Other Names :
- FDG PET/CT
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with age greater than or equal to 18 years,
* with newly diagnosed CSS,
* lesion seen on MRI in the CS, and
* willing to give written informed consent.
Exclusion Criteria:
* Pregnant and lactating patients
* Patients already being treated (including steroids)
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
|
NCT06721130
|
{
"brief_title": "Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study",
"conditions": [
"Cavernous Sinus Syndrome",
"Cavernous Sinus Meningioma",
"Cavernous Sinus Lesions"
],
"interventions": [
"Diagnostic Test: FDG radiotracer"
],
"location_countries": [
"India"
],
"nct_id": "NCT06721130",
"official_title": "Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2024-06-30",
"study_start_date(actual)": "2022-07-01"
},
"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)": "2024-12-06",
"last_updated_that_met_qc_criteria": "2024-12-03",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-12-06",
"first_submitted": "2024-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).
#Intervention
- DRUG : Methotrexate
- MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs
- Other Names :
- MTX
- DRUG : 6-Thioguanine
- 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.
- Other Names :
- 6-TG
- DRUG : Leucovorin Calcium
- 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with histologic proof of LCH who have multifocal or multisystem disease involvement.
* Patients must have a life expectancy of at least 8 weeks.
* All patients must have ECOG performance level rating of-< 2.
* Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs.
* Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy.
* Patients must have adequate liver function (bilirubin _< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine <_ 1.5 mg/dl, creatinine clearance >_ 60 ml/min/1.73 m2) and normal electrolytes.
* Patients should have a granulocyte count > 500/uL and a platelet count >_ 100,000/uL (unless due to disease involvement of the bone marrow).
* Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.
Exclusion Criteria:
* Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00588536
|
{
"brief_title": "Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH",
"conditions": [
"Langerhans Cell Histiocytosis"
],
"interventions": [
"Drug: Methotrexate",
"Drug: 6-Thioguanine",
"Drug: Leucovorin Calcium"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00588536",
"official_title": "Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-07",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "1995-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-04",
"last_updated_that_met_qc_criteria": "2008-01-07",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-08",
"first_submitted": "2007-12-26",
"first_submitted_that_met_qc_criteria": "2015-04-16"
}
}
}
|
#Study Description
Brief Summary
Speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. Standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.).
The present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation.
Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage.
The principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback.
The progress will be regularly measured by means of standard batteries of speech articulation tests.
#Intervention
- DEVICE : Visual feedback
- Use of ultrasound echography for tongue articulatory visual feedback
|
#Eligibility Criteria:
Inclusion Criteria:
* Articulatory troubles needing speech therapy
* French mother tongue
* Adult patients [18 >= age < 80 years] who underwent buccopharyngeal surgery after cancer diagnostic OR children [8 >= age < 18 years] suffering from central nervous system damage
Exclusion Criteria:
* Incapacity to easily understand the speech therapist instructions
* People protected by the law
* People deprived from freedom by judiciary decision
* Potential allergy to the water-based conducting gel used to ensure good skin - probe contact
* Overweight if large fatty mass under chin
* Major edema under chin limiting echogenicity
* Non corrected vision or hearing problems
* For the adults: central or peripheral neural damage
* History of Ear, Nose, and Throat surgery or radiotherapy
* For the adults: isolated articulatory trouble, former articulatory trouble not treated, disfluency
* Massive orofacial dyspraxia
* Posture trouble
* Motor problem in upper limbs
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02752425
|
{
"brief_title": "Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation",
"conditions": [
"Speech Disorders"
],
"interventions": [
"Device: Visual feedback"
],
"location_countries": [
"France"
],
"nct_id": "NCT02752425",
"official_title": "Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-15",
"study_completion_date(actual)": "2018-05-15",
"study_start_date(actual)": "2016-05-30"
},
"study_design": {
"allocation": "NON_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)": "2019-01-24",
"last_updated_that_met_qc_criteria": "2016-04-22",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-27",
"first_submitted": "2016-04-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to patients. However, the diagnosis of this condition may sometimes be difficult. In pleural effusions undiagnosed by thoracocentesis, closed pleural biopsy increases the yield by ∼10% and 40%, respectively, in malignant and tuberculous pleural effusions, whereas the diagnostic yield of thoracoscopy is ∼93% in both malignant and tuberculous pleural effusions. Hence, medical thoracoscopy (MT) (pleuroscopy) is the gold standard in the diagnosis of pleural effusion and it is indicated when less invasive tests have failed. MT is a procedure in which the pleura is directly and visually examined. An endoscope is inserted into the intercostal space by creating a pneumothorax with an incision through the chest wall. The pleural space and its lining can be inspected and therapeutic interventions performed.
There are two different techniques that can be performed for diagnostic and therapeutic thoracoscopy. One method recommends a single-entry site, the use of a usually 9-mm rigid thoracoscope (or of a semi-rigid/semi-flexible 7-mm pleuroscope) with a working channel for accessory instruments and an optical biopsy forceps, both performed under local anaesthesia. The other method requires two entry sites: one for a 7-mm trocar for the examination telescope, and the other for a 5-mm trocar for accessory instruments including the biopsy forceps, and is usually performed with conscious sedation or general anaesthesia.
In the trained hands of a pulmonologist, MT is a safe and effective procedure for diagnosing and treating multiple pleural diseases. Valsecchi et al reported a pathological diagnostic yield of 71% over a span of 30 years in around 2000 patients. The unfamiliarity of the pulmonary physician with the rigid instrument and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy even with a fibreoptic bronchoscope.
The use of a flexible fibreoptic instrument to examine the pleural space was reported by Senno et al in the 1970s in the United States. Studies showed that flexible bronchoscope, when used as a thoracoscope, maintains a clear optical field by allowing concurrent suctioning, which is analogous to the suction techniques used during flexible bronchoscopy and better views at the apex and paravertebral gutters.This method is, therefore, considered to be useful for surgeons or physicians with experience in chest drainage and flexible bronchoscopy as well as safe and well tolerated with a minimal degree of discomfort and expense.
Detailed Description
RESEARCH QUESTION Can Medical thorascopy using a flexible bronchoscope be used as an alternative method to a semi-rigid pleuroscopy for diagnosis of pleural effusion with a comparable outcome?
RESEARCH HYPOTHESES
1. No difference in the diagnostic yield between flexible bronchoscopy and semi-rigid pleuroscopy
2. No difference in the complication rate between flexible bronchoscopy and semi-rigid pleuroscopy
3. Duration of procedure in flexible bronchoscopy is longer compared to semi-rigid pleuroscopy.
4. The predictors of diagnostic yield in flexible bronchoscopy are similar to semi-rigid pleroscopy.
5. No difeference in the specimen size taken from flexible bronchoscopy versus semi-rigid pleuroscopy
NOVELTY This is first study in Malaysia that we know of that has attempted to evaluate the diagnostic yield of medical thoracosopy using flexible bronchoscope and its complications. This study may be used to see whether there is a suitable alternative for respiratory physician to safely diagnosed pleural disease after a failed non-invasive procedure. While conventional medical thoracoscopy is the more expensive procedure, the true difference in procedure-related costs associated with flexible bronchoscope compared to semi-rigid pleuroscope is unknown due to the lack of cost-analysis study. Perhaps this study can provide the basis for future study to analyse the true cost-benefit of using flexible bronchoscope in medical thoracoscopy.
RESEARCH OBJECTIVES
GENERAL OBJECTIVE To compare the diagnostic yield, complication and duration of MT using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
SPECIFIC OBJECTIVES
1. To compare the type of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
2. To compare the rate of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
3. To compare the duration of procedure using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
4. To determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion.
5. To compare the size of biopsy samples from flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
SIGNIFICANCE OF RESEARCH This research proposal is important to improve the diagnosis of hospital patients presenting with pleural effusion in Malaysia. Semi-rigid pleuroscope is expensive and not widely available, whereas flexible bronchoscope is more readily available and can be used as an alternative for medical thoracoscopic pleural biopsy. There is no previous study looking at diagnostic yield comparison between flexible bronchoscope and semi-rigid pleuroscope. This study could potentially serve as a feasibility study that can help future investigators prepare for full-scale research leading to intervention.
#Intervention
- PROCEDURE : Flexible Bronchoscopy
- Subjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy
- PROCEDURE : Semi-Rigid Pleuroscopy
- Subjects with pleural effusion who underwent medical thorascopy using semi-rigid pleuroscopy
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and above
* Subjects admitted to Faculty of Medicine UKM during the study period and underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.
Exclusion Criteria:
* Age < 18 years.
* Patients with incomplete data
* Patients' medical record that cannot be retrieved.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06162429
|
{
"brief_title": "Medical Thoracoscopy With Flexible Bronchoscopy Versus Semi-Rigid Pleuroscope in Pleural Effusion (FLEXPLEUR)",
"conditions": [
"Pleural Effusion"
],
"interventions": [
"Procedure: Semi-Rigid Pleuroscopy",
"Procedure: Flexible Bronchoscopy"
],
"location_countries": [
"Malaysia"
],
"nct_id": "NCT06162429",
"official_title": "Comparison of Diagnostic Yield and Complication of Medical Thoracoscopy Using Flexible Bronchoscope Versus Semi-Rigid Pleuroscope Among Hospitalized Patients With Pleural Effusion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-11-01",
"study_completion_date(actual)": "2024-11-01",
"study_start_date(actual)": "2024-01-31"
},
"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)": "2024-11-07",
"last_updated_that_met_qc_criteria": "2023-11-29",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-12-08",
"first_submitted": "2023-11-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to compare the effectiveness of 2 intervention delivery strategies for increasing moderate physical activity (MPA), real-time group video conferencing (RGV) vs. enhanced usual care (EUC), in community dwelling adults with Alzheimer's diseases (AD) and their caregiver (dyads) over 18 mos. (6 mos. active, 6 mos. maintenance, 6 mos. no contact). The primary outcome is to compare total MPA (min/wk.), assessed using ActiGraph, in adults with AD from baseline to 6 mos. Secondary aims for the Adults with AD are to compare MPA (min/wk), sedentary time (min/wk.), percentage meeting 150 min/wk. goal, functional fitness, activities of daily living (basic/instrumental), quality of life, residential transitions, and cognitive function across 18 months between RGV and EUC. Secondary aims for the caregivers are to compare total MPA (min/wk.), sedentary time (min/wk.), functional fitness, quality of life, caregiver burden across 18 months between RGV and EUC. Additionally, as an exploratory aim, this study will evaluate the influence of process variables/participant characteristics on MPA in adults with AD and their caregiver across 6, 12 \& 18 mos.: age, sex, BMI, attendance (exercise/support sessions), use of recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers.
Detailed Description
This study will compare 2 strategies for the delivery of an intervention to increase moderate physical activity (MPA) in community dwelling adults with AD and their caregiver (dyads); real-time group video conferencing (RGV) vs. enchanced usual care (EUC). Adults (age ≥ 55 yrs.) with mild to moderate AD (n=100) and their caregiver (n=100) will be randomized (1:1) to one of the 2 intervention arms for an 18-mo. trial (6 mos. active intervention, 6 mos. maintenance, 6 mos no contact). Cohorts of \~20 dyads will be recruited and computer randomized. Dyads will be stratified by the sex of the person with AD, and sequentially randomized by the study statistician with equal allocation to the RGV or EUC arms. Participants in both arms will be provided with an iPad® for intervention delivery, Fitbit (Fitbit Inc., San Francisco, CA) for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home. Dyads in the EUC arm, will be given a recommended exercise plan to follow own their own. Dyads in both arms will be provided with written materials regarding exercise and physical activity from the National Institute on Aging and will be asked to complete brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, total MPA, will be assessed, in both individuals with AD and caregivers, by Actigraph at baseline, 3, 6, 12 \& 18 mos. All secondary/exploratory outcomes will be assessed at the individual with AD or caregivers' home at baselines, 6, 12, and 18 months. Secondary outcomes for the individual with AD are sedentary time, functional fitness, activities of daily living, quality of life, residential transition, and cognitive function. Secondary outcomes for the caregiver are sedentary time, functional fitness, quality of life, and caregiver burden. The exploratory outcomes are age, sex, BMI, attendance (exercise/support sessions), use of pre-recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers. This trial is powered to detect a between-arm difference (RGV vs. EUC) of 10 min./d. in MPA. This difference represents additional 70 mins. of MPA/wk. in the RGV arm. Power analysis shows that 84 participants (42/arm) would provide 81% power to test an overall between-arm difference across time, i.e., group effect. This sample size would also provide ≥ 80% power to detect a between-arm difference in change, i.e., group-by-time interaction, as small as f = 0.10. Thus, conservatively assuming a high attrition rate of 20%, the study team will recruit 100 dyads at baseline to assure the final sample size requirements are achieved, i.e., final N ≥ 84 (thus, power ≥ 80%) with attrition up to 20%. General mixed modeling for repeated measures will be utilized to evaluate the primary aim to compare total MPA (min/wk.) across the 6 mo. active intervention in adults with AD and their caregiver randomized to the RGV and EUC interventions. A similar mixed modeling analysis will be conducted to examine the secondary aim. General mixed models will be fitted for the two arms combined to examine the association for the process variables/participant characteristics with MPA. However, if there is a significant between-arm difference in MPA, the investigators will determine whether the process variables/participant characteristics amplify or attenuate the RGV effect, i.e., moderation, by testing a 2-way interaction with the group effect and/or a 3-way interaction with the group-by-time interaction term.
#Intervention
- BEHAVIORAL : Real-time Group Video
- Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
- BEHAVIORAL : Enhanced Usual Care
- Dyads in the EUC arm, will be given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
|
#Eligibility Criteria:
Inclusion Criteria:
Adults with AD -
* Very mild to moderate dementia
* Age >= 55 yrs
* Low-risk of falls
* Ability to participate in MPA, e.g., walk including with an assistive device, as verified PCP clearance.
* Ability to communicate verbally.
* Vision and hearing sufficient to safely comply with the intervention program as verified by PCP clearance.
* Reside at home and receive support from a caregiver.
* Internet access in the home.
Caregivers-
* Age >=18 yrs.
* Spends at least 20 hrs./wk. with the adult with AD.
Exclusion Criteria: Adults with AD-
* Current exercise, i.e., > 3, 30-min bouts of planned exercise/wk.
* Clinically significant psychiatric disorder; systemic illness or infection likely to affect safety; clinically-evident stroke; myocardial infarction or coronary artery disease in the last 2 yrs.; cancer in the last 5 yrs.; or significant pain or musculoskeletal symptoms that would prohibit exercise.
* Unwilling to be randomized.
Caregivers-
* Unable to participate in MPA, i.e., brisk walking.
* Unwilling to be randomized.
* Serious medical risk, such as cancer within the last 5 yrs. or cardiac event, i.e., heart attack, stroke, angioplasty within the last 2 yrs.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04102514
|
{
"brief_title": "A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers",
"conditions": [
"Alzheimer Disease"
],
"interventions": [
"Behavioral: Enhanced Usual Care",
"Behavioral: Real-time Group Video"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04102514",
"official_title": "A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-19",
"study_completion_date(actual)": "2024-08-19",
"study_start_date(actual)": "2020-07-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-23",
"last_updated_that_met_qc_criteria": "2019-09-23",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-25",
"first_submitted": "2019-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used to assess the sensitivity level.
#Intervention
- PROCEDURE : Colgate
- Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
- PROCEDURE : Sensodyne
- Digital application for 60 seconds.
- PROCEDURE : Nano P
- Slow-speed handpiece with a Robson brush for 10 seconds
- PROCEDURE : Cocorico
- Digital application for 60 seconds
|
#Eligibility Criteria:
Inclusion Criteria:
* subjects >= 18 years
* in good general and oral health; have complaint of CDH in teeth distributed in all 4 quadrants
* not making use of desensitizing agents
* not having undergone periodontal treatment over the past 3 months
* respond to evaporative stimulus with a score >= 1.5 cm on VAS
Exclusion Criteria:
* patients who presented restorations and caries near the exposed dentin of the hypersensitive teeth
* who made frequent use of painkillers, anti-inflammatory and antidepressants drugs
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 48 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02018783
|
{
"brief_title": "Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment",
"conditions": [
"Dentine Hypersensitivity"
],
"interventions": [
"Procedure: Colgate",
"Procedure: Cocorico",
"Procedure: Sensodyne",
"Procedure: Nano P"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02018783",
"official_title": "Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2013-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-12-23",
"last_updated_that_met_qc_criteria": "2013-12-17",
"last_verified": "2013-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-23",
"first_submitted": "2013-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to learn about how hearing loss impacts balance intervention outcomes and risk of falling in older adults. The main questions it aims to answer are:
* How does the evidence-based A Matter of Balance (AMOB) program affect older adults' falls risk and balance-related measures?
* Is the severity of someone's hearing loss related to their balance intervention (AMOB) outcomes?
Participants will:
* Complete a hearing and balance test
* Answer some questions about their background and health history, their thoughts about potential falls and how this impacts them, and their current physical activity level
* Participate in the A Matter of Balance Program, an evidence-based program that includes group discussion, activities, and exercises to reduce fall risk
#Intervention
- BEHAVIORAL : A Matter of Balance: Managing Concerns about Falls
- A Matter of Balance is an evidence-based program targeting physical activity and fall prevention for adults 60 years of age and older. This program incorporates active learning discussions and activities along with exercise training to reduce the fear of falling, improve fall efficacy and management, and increase physical activity levels in older adults.
|
#Eligibility Criteria:
Inclusion Criteria:
* age of 60 years or greater
* absence of any major physical or health condition that would prevent participation in the intervention sessions
* English speaking
Exclusion Criteria:
* severe balance disorder diagnosis
* uncorrected severe vision impairment
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05681078
|
{
"brief_title": "The Impact of Hearing Loss Severity on Balance Intervention Outcomes",
"conditions": [
"Hearing Loss",
"Fall",
"Postural Balance"
],
"interventions": [
"Behavioral: A Matter of Balance: Managing Concerns about Falls"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05681078",
"official_title": "The Impact of Hearing Loss Severity on Balance Intervention Outcomes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-15",
"study_completion_date(actual)": "2023-09-15",
"study_start_date(actual)": "2023-02-08"
},
"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)": "2024-11-04",
"last_updated_that_met_qc_criteria": "2023-01-08",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-12",
"first_submitted": "2022-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p\<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.
#Intervention
- OTHER : Questionnaire and polysomnography
- Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.
|
#Eligibility Criteria:
Inclusion Criteria:
* Charts of whose admission of patients was from October 2005 to July 2007
* Patients referred to the CESF for possible diagnosis of a sleep disorder
Exclusion Criteria:
* incomplete data
* patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients)
* patients undergoing uvulopalatopharyngoplasty
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00989885
|
{
"brief_title": "ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea",
"conditions": [
"Sleep Apnea",
"Mixed Central and Obstructive Sleep Apnea",
"Sleep-Disordered Breathing"
],
"interventions": [
"Other: Questionnaire and polysomnography"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT00989885",
"official_title": "The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-03",
"study_completion_date(actual)": "2007-07",
"study_start_date(actual)": "2007-01"
},
"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)": "2009-10-06",
"last_updated_that_met_qc_criteria": "2009-10-05",
"last_verified": "2009-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-06",
"first_submitted": "2009-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. The investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc.
Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.
Detailed Description
Background: Almost half of all newborns develops jaundice, due to elevated levels of bilirubin. If levels are high phototherapy is needed to reduce the levels of bilirubin. Presently most children with neonatal jaundice in Sweden receives phototherapy admitted to hospital. There is fiberoptic equipment available that can be used at home to treat the newborns.
Aim: Primary aim is to investigate if parent-child bonding is improved with home phototherapy compared to phototherapy performed at the hospital.
Method:The study is designed as a randomised controlled multicenter study. Eligible parents and newborns are randomised to either treatment at home or at the hospital. Demographic data about the newborn such as for example apgar score, gender, time of birth etc are registered. At time of discharge parents answers questionnaires such as for example the Postpartum Bonding Questionnaire (PBQ), the Edinburgh Postnatal Depression Scale (EDPS), the Swedish Parenthood Stress Questionnaire etc. Parents experiences from home phototherapy will also be investigated through semistructured interviews.
Parents will asked to answer questionnaires at the time of discharge as well as at 4-months after discharge.
Analysis of data will be performed by using conventional parametric and non-parametric statistical methods.
The results of the study will be reported as scientific articles and as part of a thesis.
#Intervention
- OTHER : home phototherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Gestational age w36 <= age <= 42.
* Age of newborn 48 hours or more.
* Level of bilirubin 300 <= age <= 400 µmol/l
Exclusion Criteria:
* Immunisation. Bilirubin >400 µmol/l. Asphyxia. Ongoing infection, weightloss > 10%, other severe disease, parents who don´t speak Swedish, parents that are not expected to be able to handle the home phototherapy equipment
Sex :
ALL
Ages :
- Minimum Age : 48 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03536078
|
{
"brief_title": "Home Phototherapy for Term Newborns With Icterus",
"conditions": [
"Neonatal Hyperbilirubinemia"
],
"interventions": [
"Other: home phototherapy"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT03536078",
"official_title": "Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-26",
"study_completion_date(actual)": "2019-06-26",
"study_start_date(actual)": "2016-06-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-11",
"last_updated_that_met_qc_criteria": "2018-05-23",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-24",
"first_submitted": "2018-03-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In people living with coronary heart disease (CHD), V̇O2 peak predicts all-cause mortality. V̇O2 peak increases with regular exercise training. Thus, in exercise-based cardiovascular rehabilitation programmes, V̇O2 peak is a useful marker of how effective the exercise training has been.
Maximal cardiopulmonary exercise testing (CPET) is the gold standard method of measuring V̇O2 peak. However, maximal CPET is expensive and requires trained staff to conduct the test and interpret the results. Furthermore, CPET is not routinely available in United Kingdom (UK) cardiovascular rehabilitation programmes. Field exercise tests, such as incremental cycle ergometer tests, are used in conjunction with predictive equations to estimate V̇O2 peak. However, this group has shown that estimating changes in V̇O2 peak in this way is inaccurate. Alternative solutions are required.
VentriJect Seismofit® uses a technique called seismocardiography (SCG); the measurement of vibrations in the chest wall, caused by each heartbeat, using accelerometers. SCG can be used to estimate V̇O2 peak from a SCG measurement taken at rest. This study will explore the validity of VentriJect Seismofit for estimating V̇O2 peak in people with CHD.
#Intervention
- DEVICE : VentriJect Seismofit validation
- All participants will have a resting and exercising electrocardiogram (ECG) trace and a lung function test, called spirometry, will be performed. They will take part in a maximal CPET to determine V̇O2 peak. Participants will also have their V̇O2 peak estimated twice, twenty minutes apart, using the VentriJect Seismofit device. A short questionnaire will be administered to explore the acceptability of completing a maximal CPET and having V̇O2 peak estimated using VentriJect Seismofit.
|
#Eligibility Criteria:
Inclusion Criteria:
* Stable coronary heart disease
* Able to lay fully supine for five minutes
* Capable of performing a maximum effort CPET on a stationary cycle ergometer
* Currently enrolled in a Phase IV cardiac rehabilitation programme
* A minimum of 12 weeks after a cardiac event
Exclusion Criteria:
* Awaiting any significant medical investigations relating to CPET absolute contraindications
* Hospitalisation within the last 4 weeks relating to CPET absolute contraindications
* Implantable cardiac devices e.g. pacemaker or implantable cardioverter defibrillator
* Unstable angina
* Unstable diabetes
* Left main coronary stenosis or its equivalent
* Known third degree heart block
* Unstable heart failure/New York Heart Association (NYHA) III or IV Heart Failure
* Acute aortic dissection, myocarditis, or pericarditis/endocarditis
* Suspected or known dissecting aneurysm
* Symptomatic severe aortic stenosis
* Acute deep vein thrombosis, pulmonary embolism or pulmonary infection
* Uncontrolled asthma
* Pulmonary oedema
* Respiratory failure
* Ambient O2 desaturation at rest <85%
* Resting tachycardia (>100bpm)
* Currently in atrial fibrillation
* Uncontrolled arrhythmia
* Resting systolic blood pressure >180 mmHg
* Resting diastolic blood pressure >100 mmHg
* Other conditions that prevent participants from completing study investigations (e.g. recent (last ~6 months) cardiac arrest)
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
|
NCT05505344
|
{
"brief_title": "Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease",
"conditions": [
"Coronary Heart Disease"
],
"interventions": [
"Device: VentriJect Seismofit validation"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05505344",
"official_title": "Exploring the Validity of Seismofit® for Estimating Peak Oxygen Uptake in People With Coronary Heart Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-20",
"study_completion_date(actual)": "2023-02-20",
"study_start_date(actual)": "2022-08-26"
},
"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)": "2023-12-01",
"last_updated_that_met_qc_criteria": "2022-08-16",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-17",
"first_submitted": "2022-08-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.
#Intervention
- DEVICE : Electromyogram
|
#Eligibility Criteria:
Inclusion criteria:
* patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements
* having signed a consent for study participation
No Inclusion Criteria:
Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...)
* Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months
* Ongoing neuroleptic treatment
* Pregnancy or breastfeeding
* Lack of insurance coverage
For patients, are added the following no inclusion criteria are added:
* Trembling cervical dystonia
* Injection of botulinum toxin in the past three months
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
|
NCT02834871
|
{
"brief_title": "Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia",
"conditions": [
"Cervical Dystonia"
],
"interventions": [
"Device: Electromyogram"
],
"location_countries": [
"France"
],
"nct_id": "NCT02834871",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2015-07",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "NON_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)": "2017-03-28",
"last_updated_that_met_qc_criteria": "2016-07-13",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-15",
"first_submitted": "2016-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam.
Detailed Description
The objective of this study is to conduct a cluster randomized controlled trial (RCT) to test the efficacy of a psychosocial intervention to support Alzheimer's family caregivers in Vietnam. The cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower psychological distress and lower caregiver burden compared with those in the control group (primary outcomes). In addition, we will conduct secondary analyses to examine whether the intervention group has lower perceived stress and somatic symptoms. Exploratory analyses will be conducted to determine if intervention effects are mediated by caregiver self-efficacy or knowledge gain.
#Intervention
- BEHAVIORAL : REACH VN
- 4-6 sessions delivered over the course of 2-3 months.
- BEHAVIORAL : Enhanced control
- A single session providing education about dementia
|
#Eligibility Criteria:
Inclusion Criteria:
* To be eligible for the cluster RCT, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. In the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible.
* Caregivers will need to score >= 6 on the Zarit Burden Inventory 4-item version.
* All participants will be living in designated clusters in Hai Duong, Vietnam.
* To be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. Clusters will be defined as geographic areas serving local health stations.
Exclusion Criteria:
* Significant cognitive impairment or sensory deficit.
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
|
NCT04542317
|
{
"brief_title": "Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam",
"conditions": [
"Dementia"
],
"interventions": [
"Behavioral: Enhanced control",
"Behavioral: REACH VN"
],
"location_countries": [
"Vietnam"
],
"nct_id": "NCT04542317",
"official_title": "Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-27",
"study_completion_date(actual)": "2024-02-27",
"study_start_date(actual)": "2020-10-15"
},
"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)": "2024-03-05",
"last_updated_that_met_qc_criteria": "2020-09-08",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-09",
"first_submitted": "2020-08-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.
Detailed Description
BACKGROUND \& RATIONALE Optimal postoperative analgesia is very important in the ambulatory arthroscopic shoulder surgery patient population; interscalene blocks are used for this surgery because they reduce acute pain and have opioid sparing effects postoperatively. While older patients, higher ASA grades and more complex arthroscopic procedures are risk factors for unplanned overnight admissions, in the ambulatory surgery setting, poor analgesia is one of the most common reasons a patient visits a health care provider after their surgery. Approximately 30 % of patients undergoing arthroscopic surgery globally experience significant postoperative pain within the first 24 hours post surgery. In light of this, interscalene brachial plexus blockade (ISB) has been found to be the most effective and preferred method of analgesia for arthroscopic shoulder surgeries when compared to subacromial/intra-articular injections, cryotherapy and oral pain medications. ISB usually consists of a single injection of local anesthetic, anywhere from 5 to 30 minutes prior to shoulder surgery. Although ISB reduces postoperative pain in arthroscopic shoulder surgeries, the length of analgesia from a single injection of local anesthetic is limited to 6 to 15 hours after surgery. Due to the limited duration of analgesia, interscalene catheters have been studied for prolongation of analgesia via continuous infusion of local anesthetics. Although continuous catheter infusions are effective and feasible, there exist several complications such as dyspnea, peripheral neuropathies, nausea, and practical challenges that limit their wider application in an ambulatory setting. Recently, different adjuncts given in combination with local anesthetics have been used to prolong the analgesic duration of a single injection ISB. These adjuncts have been given by both the intravenous and by the perineural routes, where perineural means the adjunct is injected with the local anesthetic around the brachial plexus.
Dexamethasone, a potent glucocorticoid, has been shown in multiple studies to prolong the duration of analgesia of the ISB compared to placebo when administered either perineurally or intravenously. A recently completed large trial (in press) at our centre showed that the duration of analgesia (mean (standard deviation), in hours (h)) with 4mg of intravenous dexamethasone (24.0 (4.6)h) is not significantly different from 8mg (24.8 (6.4)h) and only slightly shorter than perineural dexamethasone doses of 4mg (25.4 (6.6)h) or 8mg (27.2 (8.5)h). The 4mg intravenous dose was favored given the established safety of the intravenous route, its approximately equivalent effectiveness compared to the higher 8mg dose and the absence of differences in adverse effects between groups.
Dexmedetomidine, a highly selective α2 adrenergic agonist with sedative and analgesic properties, has also been shown to potentiate peripheral nerve blockade and prolong the duration of analgesia versus placebo when used as an adjunct to local anesthetic for regional anesthesia, including interscalene block. Most studies have compared perineural dexmedetomidine to placebo, as is the case for other adjuncts such as dexamethasone, even though there is less experience with the perineural route for dexmedetomidine compared to dexamethasone. Interestingly, a recent study found both intravenous and perineural dexmedetomidine reduced the 24 hour opioid consumption and comparably prolonged the duration of ISB analgesia compared to placebo. In a recent meta-analysis, a 50-60ug Dexmedetomidine perineural or intravenous dose maximized sensory block duration while minimizing hemodynamic side effects.
To our knowledge, there are no published studies comparing the analgesic duration of ISB between dexamethasone and dexmedetomidine, and no studies have evaluated whether there is additional benefit to administering these widely available medications in combination. Three ongoing studies are comparing dexamethasone and dexmedetomidine as single adjuncts, without a combination. All three of these studies are using the perineural route, despite the established safety and effectiveness of the intravenous route for both drugs. With this study we are seeking to improve our patients' postoperative experience with superior analgesia by better defining the relative analgesic effectiveness of dexamethasone and dexmedetomidine when given alone or in combination as intravenous adjuncts to ISB.
OBJECTIVES AND HYPOTHESES
In outpatients undergoing arthroscopic shoulder surgery with Interscalene Block:
I. To determine if there is a significant increase in duration of analgesia when combining intravenous dexamethasone and dexmedetomidine compared to administering each adjunct individually. We hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.
II. To compare the effect of Dexamethasone to Dexmedetomidine on duration of analgesia when given individually. We hypothesize that there will be no significant difference between the two adjuncts.
METHODS This single-centre, double-blinded, randomized controlled superiority trial has three parallel groups and 1:1:1 randomization. Consenting and eligible adult ambulatory patients undergoing arthroscopic shoulder surgery will receive preoperative, ultrasound guided ISB with 30 millilitres (mL) of 0.5% bupivacaine and 4mg of preservative free dexamethasone or 50mcg of dexmedetomidine or both intravenously. The remainder of the intraoperative and postoperative care is at the discretion of the attending anesthesiologist and surgeon. The primary outcome is analgesic block duration. The power analysis for this study was based on published results from previous studies, as well as our recent work. With a two-tailed alpha error of 0.05, and a standard deviation of 5.0 hours in each group, 180 total patients would provide greater than 90% power to detect a difference of 3.0 hours in block duration. To account for a 5% attrition rate we propose recruiting 63 patients per group (189 patient's total). Outcomes will be assessed by chart review and telephone follow up on postoperative day one, postoperative day 2 (if necessary), and postoperative day 14.
After collecting 102 primary outcomes, we will compare the primary outcome between the combination and each of the single adjuncts. At this point the study will be 90% powered to detect a difference of 6.0h in block duration, even if the standard deviations are higher than expected, at 7.5 hours. If the combination is superior to both of the single agents, the study will be terminated. The principle investigator cancelled this interim analysis on 18 December 2017 after consultation with the study statistician and research team. After reconsidering the original power calculations, the clinically plausible differences between groups, and the high level of statistical significance recommended for interim analyses, it was determined that this interim analysis would be very unlikely to convincingly demonstrate the superiority of the combination over the single agents. As of 18 December 2017 90 patients have participated in the study and recruitment is on schedule. The entire research team has been and will continue to be blinded to outcome data by group assignment until all 189 patients have participated, which is expected to occur in the second quarter of 2018.
The primary outcome analysis will analyze by intention to treat only those patients who were randomized and did receive an attempt at an interscalene block. A secondary analysis will exclude patients who had a 'failed' interscalene block in the post anesthesia care unit. A tertiary analysis will be a multivariable analysis adjusted for demographics, preoperative naproxen use, use of general anesthesia, cumulative analgesic use and failed interscalene block.
#Intervention
- DRUG : Dexamethasone
- 0.4 millilitres (mL) of 10 milligram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
- Other Names :
- Dexamethasone Omega Unidose (Omega Laboratories Limited), Dexamethasone Sodium Phosphate USP (1 millilitre vial)
- DRUG : Dexmedetomidine
- 0.5 millilitres (mL) of 100 microgram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
- Other Names :
- Precedex (Hospira Healthcare Corporation), Dexmedetomidine Hydrochloride for Injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery
* Including rotator cuff repair
* Stabilization procedures
* Acromioplasty
* Debridement and distal clavicle excision
Exclusion Criteria:
* Patient refusal
* Diabetes
* Pregnancy
* Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist
* Sensitivity to local anesthetics, dexamethasone or dexmedetomidine
* Severe chronic obstructive pulmonary disease
* Contralateral vocal cord paralysis
* Contralateral diaphragmatic paralysis
* Surgical limb brachial plexus neuropathy
* Interscalene block site infection
* Systemic glucocorticoids in the last 2 weeks
* Epidural or intraarticular steroid injection in the past 3 months
* Chronic opioid use defined as daily use for the last two weeks
* Active peptic ulcer disease
* End-stage renal disease
* Cirrhotic liver disease
* Ventricular dysfunction
* Advanced heart block
* Previous 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
|
NCT03270033
|
{
"brief_title": "Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery",
"conditions": [
"Pain, Postoperative",
"Shoulder Joint Disorder",
"Ambulatory Surgical Procedures",
"Brachial Plexus Block"
],
"interventions": [
"Drug: Dexmedetomidine",
"Drug: Dexamethasone"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03270033",
"official_title": "Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-14",
"study_completion_date(actual)": "2018-10-13",
"study_start_date(actual)": "2017-09-18"
},
"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)": "2019-04-16",
"last_updated_that_met_qc_criteria": "2017-08-30",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-01",
"first_submitted": "2017-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
Detailed Description
Currently available medications have proven to be useful for the treatment of depression, but also have limitations including low response rates, a significant number of treatment resistant patients, and time-lag for response, which emphasizes a major unmet need for more efficacious and faster-acting antidepressants. Recent studies have demonstrated that ketamine, a non-competitive glutamate-N-methyl-D-Aspartate (NMDA) receptor antagonist, produces rapid onset (2 hours) and long-lasting (7 days) antidepressant actions in treatment resistant patients. This rapid action, by a mechanism completely different from typical monoamine reuptake inhibitors, represents a significant finding in the field of depression.
Racemic methadone, the 50/50 combination of d-methadone and l-methadone, has been in widespread use for decades and has been studied extensively. Methadone is currently approved for use in the management of severe pain, detoxification treatment of opioid addiction, and maintenance treatment of opioid addiction.
The results of a study evaluating the receptor binding profiles of racemic methadone and its stereoisomers suggest that d-methadone does not essentially contribute to the opioid effect of racemic methadone and that it has a 10 times lower affinity for the mu1, mu2, and delta opioid receptors compared to l-methadone. Racemic methadone and its d- and l isomers exhibit similar affinities for the non-competitive binding site of the NMDA receptor and are non-competitive NMDA receptor antagonists.
In the forced swim test, a rodent behavioral model of antidepressant activity, both ketamine and d-methadone at all doses tested significantly decreased the immobility of the rats compared to the vehicle suggesting antidepressant like activity. Neither drug increased spontaneous locomotor activity.
Relmada has conducted 2 clinical studies to identify the dose levels of REL-1017 (d-methadone) that have little to no opioid effects and that are expected to possess NMDA antagonistic properties for the evaluation of oral REL-1017 in the treatment of MDD and neuropathic pain conditions. Initial Phase 1 single ascending dose and multiple ascending dose clinical studies of REL-1017 were designed to evaluate the safety and tolerance of the pure d methadone isomer in healthy opioid-naïve subjects and identify a safe and potentially effective dose range in this population. These studies showed that REL-1017 was safe and well-tolerated at single oral doses up to 150 mg (maximum tolerated dose) and up to 75 mg administered once daily for 10 days in healthy opioid-naïve subjects.
The pre-clinical and previous clinical experience with REL-1017 (d-methadone) provided the basis for the initiation of the present study, which will extend the evaluation of the safety, tolerability, and PK of REL-1017 at 2 doses with repeated administration to depressed patients. Since REL-1017 is proposed for use as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD), the patients will be male adults with MDD who are diagnosed with a current depressive episode who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication.
Based on the safety data from Protocol REL-1017-111, single doses of 5 mg, 20 mg, 60 mg, 100 mg, and 150 mg of REL-1017 or placebo were well tolerated. The results of Protocol REL-1017-112 evaluated 10 days of dosing with 25 mg, 50 mg and 75 mg of REL-1017 or placebo, and no impact on safety was observed. In spite of the confirmed dose proportionality, the comparison of concentration and exposure between the 50 mg and 75 mg REL-1017 treatment groups demonstrated only slight differences. Consequently, 25 mg and 50 mg doses were chosen for administration in Protocol REL-1017-202 as single daily doses over a period of 7 days.
Thus, as a single isomer of racemic methadone, d-methadone has been shown to possess NMDA antagonist properties with virtually no opioid activity or ketamine-like toxicities at the expected therapeutic doses.
In this study, adult male patients with MDD who are diagnosed with a current MDE and who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication will be randomized to study drug in a 1:1:1 ratio. Approximately 15 patients each will receive REL-1017 25 mg, REL-1017 50 mg, or placebo once daily for 7 days. Endpoints include assessments of safety, tolerability, efficacy and pharmacokinetics of REL-1017. Patients will be required to stay in the clinic for 10 days and will then be followed as an outpatient for 12 additional days.
#Intervention
- DRUG : REL-1017
- REL-1017 will be administered as an oral solution. Patients will continue to take the same, stabilized antidepressant medication that they were taking at screening throughout the course of the study.
- Other Names :
- d-Methadone
- DRUG : Placebo
- Placebo will be administered as an oral solution. Patients will continue to take the same, stabilized antidepressant medication that they were taking at screening throughout the course of the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Males between 18 and 65 years, inclusive; and females between 18 and 65 years, inclusive, who are >1 year postmenopausal.
* Diagnosed with recurrent MDD as defined by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview, Version 7.0.2 (MINI).
* Diagnosed with a current MDE lasting 8 weeks to 36 months as defined by the DSM-5 and confirmed by the MINI.
* Treated with an adequate dosage of a SSRI, SNRI, or bupropion during the current MDE for at least 8 weeks prior to Screening with the same, adequate dosage for the last 4 weeks. Minimum adequate doses are defined in the (ATRQ). The maximum dose allowed for paroxetine is 40 mg QD, for fluoxetine is 60 mg QD, and for sertraline is 200 mg QD.
* Have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication in the current episode, as defined as <50% improvement with an antidepressant medication at doses listed on the SAFER Interview Criteria: State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps (pervasive, persistent, and pathological).
* Hamilton Depression Rating Scale-17 (HAM-D-17) >=19 at Screening and Check-in (Day -1).
* BMI between 18.0 and 35.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
* Per the Investigator's judgment, able to meet all study requirements, including the confined/inpatient portion of the study, adherence with both approved ADT and study drug regimen, and completion of all assessments and all scheduled visits.
* Male patients of reproductive potential must be using and willing to continue using medically acceptable contraception, from Screening and for at least 2 months after the last study drug administration.
* Must be able to read, speak, and understand English and must provide written informed consent prior to the initiation of any protocol-specific procedures.
Exclusion Criteria:
* History or presence of clinically significant abnormality as assessed by physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, which in the opinion of the Investigator would jeopardize the safety of the patient or the validity of the study results, including torsades de pointes, any bradyarrhythmias, or uncompensated heart failure.
* Chronic use of prescribed opioids (i.e., >120 days in a 6-month period) up to 6 months prior to Screening or any recreational use of opioids.
* Evidence of clinically significant hepatic or renal impairment, including ALT or AST >1.5 x upper limit of normal (ULN), bilirubin >1 x ULN, or endocrine laboratory values (including clinically significant thyroid parameters, i.e., thyroid stimulating hormone [TSH], triiodothyronine [T3], and thyroxine [T4]).
* History or family history of sudden unexplained death or long QT syndrome (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle).
* Any 12-lead ECG with repeated demonstration of QTc >=450 msec or a QRS interval >120 msec at Screening.
* History of clinically diagnosed hypotension requiring treatment.
* History or presence of any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, bronchitis, or has/is suspected of having paralytic ileus).
* No more than 3 prescribed doses of an opioid within the 6 months prior to Screening and no use at all within the last month.
* Use of an antipsychotic, anticonvulsant, or mood stabilizer, regardless of indication, within the 3 months prior to Screening.
* History of allergy or hypersensitivity to methadone or related drugs (e.g., opioids).
* Positive test for hepatitis B or HIV. Patients with a positive hepatitis C test may be considered for inclusion with approval from the Medical Monitor.
* Any current and primary psychiatric disorder, as defined as a condition that is the primary focus of distress and/or treatment, other than MDD.
* Any lifetime history of bipolar I or II disorder, any psychotic disorder, post-traumatic stress disorder, borderline personality disorder, antisocial personality disorder, obsessive compulsive disorder, eating disorder, intellectual disability, or pervasive developmental disorder.
* History in the past 12 months of a primary diagnosis of anxiety disorder or panic disorder not related to the current MDE.
* Current diagnosis of alcohol or substance use disorder, as defined by DSM-5, at Screening or within the 12 months prior to Screening. Patients with the following diagnoses within the past 12 months, however, may be included at the Investigator's discretion: mild alcohol use disorder, mild cannabis use disorder, and any severity tobacco use disorder.
* A confirmed positive result on the urine drug/alcohol screen at Screening or Check-in. If the urine drug/alcohol screen is positive at Screening, retesting or rescreening may be scheduled with prior approval from the Medical Monitor.
* Patients who, in the Investigator's judgment, are at significant risk for suicide. A patient with a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation score of 4 or 5 within the last 6 months or any suicide attempt within the past year must be excluded, as should a patient with an ideation score of 4 or 5 or any suicide attempt at the Check-in or Baseline Visit.
* Patients with a 20% improvement between Screening and Check-in (Day -1) on the HAM-D-17.
* Patients who did not safely discontinue medications prohibited.
* Patients receiving new onset psychotherapy (individual, group, marriage, or family therapy) within 2 months prior to Screening or plans to start at any time during participation in the study.
* Patients who have received electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) or who have participated in a ketamine study within the last 6 months.
* Patients with any clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be permitted if they will not increase the safety risk to the patient or compromise interpretation of the safety or efficacy endpoints.
* Patients taking fluvoxamine or St. John's Wort.
* Patients who have participated in a clinical study with an investigational medication in the past 6 months, or who have participated in more than 4 clinical studies with investigational medications in the past 2 years.
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
|
NCT03051256
|
{
"brief_title": "Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD",
"conditions": [
"Depressive Disorder, Major",
"Depressive Disorder, Treatment-Resistant"
],
"interventions": [
"Drug: Placebo",
"Drug: REL-1017"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03051256",
"official_title": "Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing of REL-1017 as Adjunctive Therapy in the Treatment of Pts Diagnosed With MDD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-30",
"study_completion_date(actual)": "2019-09-30",
"study_start_date(actual)": "2018-05-11"
},
"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)": "2023-11-01",
"last_updated_that_met_qc_criteria": "2017-02-08",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-13",
"first_submitted": "2017-02-03",
"first_submitted_that_met_qc_criteria": "2021-03-16"
}
}
}
|
#Study Description
Brief Summary
Titanium elastic nails in the pediatric femoral fractures: A prospective randomized clinical trial of eliminating nail protrusion to decrease soft tissue complications
Detailed Description
This study will be conducted as a prospective cohort study of children and adolescents treated with TEN for a femoral shaft fracture. All children and adolescents presenting to the Emergency department of a participating center with a femur fracture will be approached for inclusion in the study. The primary outcome for this study will be functional recovery, as measured using a pediatric specific generic QOL measurement tool. The clinical outcome measure which will be used will be the performance version of the ASK (ASK-p) which has been previously tested and shown to be valid, reliable, and responsive in children and adolescents with acute and chronic Orthopaedic disorders. The first time point for data collection will be at four months. Clinical data which will be obtained over the course of follow-up will include clinical evaluation of hip and knee range of motion, limb rotation, clinical measurement of limb length, fracture union, and the presence of complications, including the need for nail removal in the group in which it was not planned. The second time point for data collection will be at one year. Again, the ASK-p will be mailed to all subjects in advance to allow completion at the desired time. The return of questionnaires and process for reminder notifications will proceed in a similar fashion to the four month time point. Clinical and radiographic data will be collected in a similar fashion to the four month time point. No subjects will be excluded on the basis of failure to return questionnaires at the one year time point since this represents a secondary outcome.
#Intervention
- PROCEDURE : Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ
- See Detailed Description.
|
#Eligibility Criteria:
Inclusion Criteria:
open femoral physes; closed midshaft femur fracture; no concomitant injuries to either lower extremity; no history of injury to either femur; no history of asymmetric femoral malalignment; agree to participate in 2 years of follow up; informed consent/assent.
Exclusion Criteria:
open midshaft femur fractures; other injuries to either lower extremity; a history of injury to either femur; unable to comply with 2 years of follow-up
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00175656
|
{
"brief_title": "Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures",
"conditions": [
"Femur Fracture"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00175656",
"official_title": "Titanium Elastic Nails in the Treatment of Paediatric Femoral Fractures: A Prospective Randomized Clinical Trial of Eliminating Nail Protrusion to Decrease Soft Tissue Complications",
"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)": "2007-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-04-14",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2011-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-15",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
#Intervention
- DRUG : IBI301
- IBI301 375mg/㎡
- DRUG : Rituximab
- Rituximab 375mg/㎡
|
#Eligibility Criteria:
Inclusion Criteria:
* CD20-positive B-cell lymphoma.
* 18 years to 65 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Signed an informed consent.
* Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.
Exclusion Criteria:
* Participation in another interventional clinical trial in the past 28 days.
* Known allergic reactions against monoclonal antibody or rituximab.
* Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
* Blood concentration of Rituximab>24ug/ml.
* HIV positive patients.
* HCV antigen and antibody positive.
* Acute and chronic hepatitis B virus infection.
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
|
NCT02945215
|
{
"brief_title": "A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients",
"conditions": [
"B-Cell Lymphoma"
],
"interventions": [
"Drug: Rituximab",
"Drug: IBI301"
],
"location_countries": [
"China"
],
"nct_id": "NCT02945215",
"official_title": "A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-21",
"study_completion_date(actual)": "2019-10-16",
"study_start_date(actual)": "2016-12-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-01",
"last_updated_that_met_qc_criteria": "2016-10-24",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-26",
"first_submitted": "2016-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under non-fasting conditions.
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
#Intervention
- DRUG : Mirtazapine 15 mg (Orally Disintegrating) Tablets
- 1 x 15 mg, single-dose non-fasting
- DRUG : REMERON SolTab® 15 mg Orally Disintegrating Tablets
- 1 x 15 mg, single-dose non-fasting
|
#Eligibility Criteria:
Inclusion Criteria:
* Screening Demographics: All subjects selected for this study will be healthy men or women 18 years or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
* Screening Procedures: Each subject will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before fill implementation of screening procedures.
* Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
* The screening clinical laboratory will include:
* Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
* Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
* HIV antibody, hepatitis B surface antigen, and hepatitis C antibody screens;
* Urinalysis: by dipstick; full microscopic examination of dipstick positive; and
* Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
* Serum Pregnancy Screen (female subjects only)
* If female and:
* of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
* is postmenopausal for at least 1 year; or
* is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Exclusion Criteria:
* Subjects with a recent history of drug or alcohol addiction or abuse.
* Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
* Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
* Subjects demonstrating a positive hepatitis B surface antigen screen, hepatitis C antibody screen, or a reactive HIV antibody screen.
* Subjects demonstrating a positive pregnancy screen.
* Subjects who are currently breastfeeding.
* Subjects with a history of clinically significant allergies including drug allergies.
* Subjects with a history of allergic response(s) to mirtazapine or related drugs.
* Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
* Subjects who currently use of have used tobacco products within 90 days of Period I dosing.
* Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
* Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
* Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
* Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
* Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
* Subjects who report an intolerance of direct venipuncture.
* Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
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
|
NCT00834197
|
{
"brief_title": "15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets",
"Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00834197",
"official_title": "A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Non-Fasting Conditions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-08",
"study_completion_date(actual)": "2003-08",
"study_start_date(actual)": "2003-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-20",
"last_updated_that_met_qc_criteria": "2009-02-02",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-03",
"first_submitted": "2009-01-30",
"first_submitted_that_met_qc_criteria": "2009-07-02"
}
}
}
|
#Study Description
Brief Summary
This study will:
* Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.
* Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.
* Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.
This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.
Detailed Description
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.
#Intervention
- DRUG : Copaxone
- 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
- Other Names :
- Glatiramer acetate
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with clinically definite MS according to the McDonald criteria
* Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse
* Age 18 <= age <= 65
* Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of >9 T2 lesions in addition to 1 Gd lesion)
* Have EDSS scores less than or equal to 5.5
* Have disease duration of 3 months to 30 years
* None of the exclusion criteria
Exclusion Criteria:
* Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
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
|
NCT00937157
|
{
"brief_title": "Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Drug: Copaxone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00937157",
"official_title": "Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2011-04",
"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)": "2021-03-19",
"last_updated_that_met_qc_criteria": "2009-07-09",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-10",
"first_submitted": "2009-07-09",
"first_submitted_that_met_qc_criteria": "2014-12-02"
}
}
}
|
#Study Description
Brief Summary
This study builds on the tested and refined HEART Camp intervention which has been shown to improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing access to hospital-based exercise facilities and online exercise programming. This study is a prospective, single-group, repeated measures feasibility study with 4 data collection points (baseline, 4, 8, and 12 weeks). Study variables including instruments will be collected at baseline, 4, and 8 weeks. Participants will also be asked to participate in a 30-45 minute interview at 12 weeks.
Detailed Description
At a rural health center in central Nebraska, potential participants will be identified, screened, and approached for participation. Study personnel will obtain informed consent in person in a private room or over the phone facilitated by the University of Nebraska Medical Center (UNMC) electronic consent process. Once consented, participants will complete cardiopulmonary exercise testing (CPET) to guide individual exercise prescriptions and protect against risks associated with exercise. CPET results that preclude safe exercise training (arrhythmia) or those with CPET results indicating cardio-respiratory fitness (females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.
Study personnel will complete baseline data collection (demographics, survey collection, and 6-minute-walk-test) on all participants at enrollment. The survey instruments have been validated and will be repeated at weeks 4 and 8. Participants will be given instruction on the use of the Actigraph, Polar Watch and chest strap, and Activity/Exercise Diary. The Actigraph will be worn for 7 consecutive days at baseline, week 4, and week 8. Participants will be asked to record daily activity/exercise in their diary for the entirety of the 12-week study and will be shared weekly with their coach. Participants will wear their Polar Watch and chest strap during exercise sessions for heart rate monitoring.
Prior to beginning exercise on their own, participants will complete 6 supervised, monitored sessions in cardiac rehabilitation. During these sessions, participants will be monitored by cardiac rehabilitation staff for adverse events during moderate-intensity aerobic exercise (40-80% of heart rate reserve) and resistance training (10-15 repetitions to volitional fatigue). During these sessions, participants will also receive educational training via videos on topics such as exercising with heart failure, how medications impact exercise, and nutrition. If a participant does not complete the sessions or is deemed unsafe to exercise, he/she will not be eligible to continue in the study.
Participants will be instructed to wear a heart rate monitor (Polar Watch and chest strap) during all exercise sessions and strive to meet a goal of 150 minutes of moderate-intensity exercise per week. Minutes toward adherence goals for the study will be calculated as time spent participating in a moderate-intensity activity and determined by their CPET results and personalized exercise prescription. Participants will be familiar with using heart rate and Rating of Perceived Exertion (RPE) to guide their exercise from their participation in the 6 supervised sessions. The heart rate monitor will be blue-tooth enabled and will require connection to the internet.
Participants will be given the choice to exercise at a hospital-based exercise facility, at home, or as a hybrid approach. If exercising at home, participants will be provided with training plans that will be available online or in hard-copy forms.
Each participant will be given access to an Omaha-based exercise coach that he/she will meet with weekly over Zoom for 30 minutes. Coaches will discuss exercise over the past week including problems, issues, concerns. Goals will be set, reviewed, assessed, and revised each week.
All participants will be given paid access to a hospital-based fitness facility for 8 weeks out of this 12-week study. Weeks 9-12 of the study, participants may elect to self-pay for membership or exercise at home. Exercise diaries will continue to be collected and Polar watch data will be monitored by exercise coaches until the end of this 12-week study. Participants will not meet with their exercise coach during the final 4 weeks. The rationale for this is that ultimately our goal is for participants to develop self-efficacy, knowledge, and positive attitudes toward exercise that will allow them to adhere to exercise without our intervention. The hope is that 8 weeks of exercise training and weekly coaching will get them started and they will continue on their own after that.
#Intervention
- BEHAVIORAL : HEART Camp Connect
- Once eligible and enrolled, participants will aim to complete 150 minutes of moderate-intensity exercise a week with the help of a virtual exercise coach
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of heart failure with preserved ejection fraction or heart failure (HF) with reduced ejection fraction (Stage C, chronic HF confirmed by echocardiography and clinical evaluation)
* 19 years or older
* Stable pharmacologic therapy per guidelines for preceding 30 days
* Able to read and understand English.
Exclusion Criteria:
* Clinical evidence of decompensated heart failure
* Unstable angina
* Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker less than 6 weeks prior
* Orthopedic or neuromuscular disorders preventing participating in aerobic exercise
* Pregnancy
* Participation in 3 times per week aerobic exercise during the past 6 months
* Plans to move more than 50 miles from the exercise facility in the next 12 weeks
* Cardiopulmonary stress test results that preclude safe exercise training (arrhythmia) or cardiorespiratory fitness indicated by females with maximum oxygen consumption >= 21ml/kg/min and males with maximum oxygen consumption >= 24 ml/kg/min.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05647759
|
{
"brief_title": "Rural HEART Camp Connect: A Feasibility Study",
"conditions": [
"Heart Failure"
],
"interventions": [
"Behavioral: HEART Camp Connect"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05647759",
"official_title": "Rural HEART Camp Connect: A Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-16",
"study_completion_date(actual)": "2023-09-05",
"study_start_date(actual)": "2022-06-01"
},
"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)": "2023-09-28",
"last_updated_that_met_qc_criteria": "2022-12-07",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-12-12",
"first_submitted": "2022-11-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of \> 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled.
Detailed Description
Recent evidence suggests that patients with concomitant chronic HCV infection and NASH or significant hepatic steatosis (\>33%) respond less well to standard antiviral therapy. As previously noted, up to 10% of patients with chronic HCV infection will have concomitant NASH and an even greater percentage will have associated hepatic steatosis. No prospective studies to date have evaluated the sustained viral response rates to standard antiviral therapy in this group of patients who were previously treated with a medication to eliminate or improve the underlying NASH and/or hepatic steatosis.
Primary Outcome: To determine if decreasing the amount of NASH or hepatic steatosis in overweight (BMI \>27 kg/m2) HCV patients results in improved overall SVR to PEGASYS and Copegus.
Secondary Outcome: 1.To determine the amount of steatosis, necroinflammatory activity, and fibrosis change in a group of participants with chronic hepatitis C and NASH or significant steatosis treated with Xenical vs. placebo for 36 weeks. 2. To assess for a difference in insulin resistance, as measured by the QUICKI score, before and after treatment with Xenical or Xenical placebo and diet and exercise.
#Intervention
- DRUG : Xenical, Pegasys, Copegus
- Xenical 120mg three times daily for 36 weeks or xenical placebo (Arm 1). Pegasys 180 mcg weekly for 48 weeks. Ribavirin daily for 48 weeks.
- Other Names :
- Xenical (orlistat), Pegasys (PEG-Interferon alpha-2a)
- BEHAVIORAL : Xenicare Program
- Xenicare program for 36 weeks.
- Other Names :
- Xenical placebo, Pegasys (Peg interferon alpha-2a)
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants must be willing to give written informed consent and be able to adhere to dose and visit schedules.
* HCV-Ab or HCV-RNA by PCR Positive for at least 6 months
* Serum positive for HCV-RNA by PCR assay
* Treatment naïve participants who have hepatitis C with genotype 1, 2, 3, or 4
* Body mass index >27
* Liver biopsy within 12 months with a pathology report confirming the histological diagnosis consistent with CHCand NASH or hepatic steatosis of >33%
* Compensated liver disease with minimum hematological, biochemical, and serologic criteria at the Enrollment Visit (WNL = within normal limits):
* Hemoglobin values of <12 gm/dL for females and <13 gm/dL for males
* WBC <3,000/ mm3
* Neutrophil count < 1,500/mm3
* Platelets <65,000/ mm3
* Direct bilirubin within 20% of ULN
* Indirect bilirubin WNL
* Albumin > 3 gm/dL
* creatinine < 20% of ULN
* TSH WNL
* Alpha fetoprotein value < 100 ng/mL
* Reconfirmation and documentation that sexually active female subjects of childbearing potential are practicing adequate contraception method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for six months following the last dose of study medication
* Reconfirmation that sexually active male subjects are practicing two acceptable methods of contraception
Exclusion Criteria:
* Women who are pregnant or breast-feeding
* Males whose female partner is pregnant
* No other Thiazolidinedione after liver biopsy and/or during the entire study
* Hepatitis C of non-genotype 1,2,3 or 4
* Previous anti-viral therapy for treatment of Hepatitis C
* Suspected hypersensitivity to interferon, PEG-interferon, ribavirin, Xenical
* Any other cause for liver disease other than chronic hepatitis C and NASH or steatosis, including but not limited to:
* Hemochromatosis
* Alpha-1 antitrypsin deficiency
* Co-infection with HBV
* Wilson's disease
* Autoimmune hepatitis
* Alcoholic liver disease
* Drug-related liver disease
* Any condition that would prevent the subject from having a liver biopsy
* Hemoglobinopathies (e.g., Beta Thalassemia)
* Evidence of advanced liver disease
* Patients with organ transplants other than cornea and hair transplant
* Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
* Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
* CNS trauma or preexisting/active seizure disorders uncontrolled with medication
* Significant cardiovascular dysfunction within the past 12 months
* Poorly controlled diabetes mellitus
* Chronic pulmonary disease with documented pulmonary hypertension
* Immunologically mediated disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis
* Any medical condition requiring, or likely to require chronic systemic administration of steroids
* Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is >= 20% within 2 years
* Active clinical gout
* Substance abuse
* Participants not willing to be counseled/abstain from alcohol
* Participants with clinically severe retinal abnormalities
* Any other condition that in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol
* Known positive HIV
* Inability/unwillingness to provide informed consent or abide by the requirements of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00207311
|
{
"brief_title": "Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus",
"conditions": [
"Fatty Liver",
"Hepatitis C"
],
"interventions": [
"Behavioral: Xenicare Program",
"Drug: Xenical, Pegasys, Copegus"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00207311",
"official_title": "A Multi-Centered, Prospective, Randomized, Placebo-Controlled Clinical Trial for the Treatment of Significant Steatosis or NASH With Xenical Followed by Treatment of Hepatitis C (HCV) With PEG-Interferon Alpha-2a/Copegus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-05",
"study_completion_date(actual)": "2009-05",
"study_start_date(actual)": "2005-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-14",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2012-02"
},
"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
Healthcare costs are a critical barrier to U.S. families' ability to access the preventive care needed to manage their children's asthma. Asthma specialty care teams are uniquely positioned to help families navigate these cost barriers, but lack structured approaches to discussing this sensitive and complex topic. This study will train asthma specialty care teams to identify families at risk for financial burden and engage in conversations about strategies to manage asthma care costs. The study team will evaluate the impact of a health care provider training on the frequency of cost navigation conversations. The investigators hypothesize that the health care provider training will increase the frequency of parent-reported cost conversations in the clinic.
#Intervention
- BEHAVIORAL : Health care provider cost navigation training
- Health care providers and asthma educators in a pediatric asthma clinic will receive an online training about the importance of cost of care conversations, how to start cost of care conversations with families, how to refer families to cost navigation resources, and how to lead asthma specialty care teams in cost navigation.
|
#Eligibility Criteria:
Inclusion Criteria:
Eligible caregivers will:
* attend a routine asthma care appointment for a 4 <= age <= 17 year old child
* screen positive for possible financial burden related to the cost of asthma care
Eligible healthcare providers will:
* be members of a pediatric asthma specialty care team
Exclusion Criteria:
Caregivers will not be eligible if they:
* attend an appointment for conditions other than routine asthma care
* do not screen positive for possible financial burden related to the cost of asthma care
Healthcare providers will not be eligible if they:
* are not part of the pediatric asthma specialty care team in the participating clinic
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
|
NCT04669080
|
{
"brief_title": "Asthma Clinics Helping Expand Cost Conversations",
"conditions": [
"Asthma in Children"
],
"interventions": [
"Behavioral: Health care provider cost navigation training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04669080",
"official_title": "Developing and Evaluating an Intervention to Enhance the Work of Asthma Specialty Care Teams in Helping Families in Cost Navigation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-21",
"study_completion_date(actual)": "2021-07-20",
"study_start_date(actual)": "2021-01-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-29",
"last_updated_that_met_qc_criteria": "2020-12-14",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-16",
"first_submitted": "2020-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.
#Intervention
- DEVICE : Glucosanol
- 2 tablets taken 3 times a day.
|
#Eligibility Criteria:
Inclusion Criteria:
* Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
* Age 18 <= age <= 60 at the time of inclusion into the INQ/K/003411 study
* BMI between 25 <= age <= 35 at the time of inclusion into the INQ/K/003411 study
* Expressed desire for weight maintenance
* Accustomed to 3 main meals per day
* Commitment to avoid the use of other weight loss products during study
* Females' agreement to use appropriate birth control methods during the active study period
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion Criteria:
* Known sensitivity to the ingredients of the device (Phaseolus vulgaris or members of the Fabaceae family)
* History of diabetes mellitus
* Fasting blood glucose more than 7 mmol/L
* History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
* Clinically relevant excursions of safety parameter
* Current use of anti-depressants
* Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
* Uncontrolled hypertension (more than 160/110 mm Hg)
* Stenosis in the GI tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to enrollment
* History of eating disorders like bulimia, anorexia nervosa within the past 12 months
* Other serious organ or systemic diseases such as cancer
* Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
* More than 3 hours strenuous sport activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within 6 months prior to enrolment
* Inability to comply due to language difficulties
* Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01435278
|
{
"brief_title": "Efficacy and Safety of Glucosanol in Maintaining Body Weight",
"conditions": [
"Overweight",
"Obesity"
],
"interventions": [
"Device: Glucosanol"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01435278",
"official_title": "Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2011-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-27",
"last_updated_that_met_qc_criteria": "2011-09-15",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-16",
"first_submitted": "2011-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.
#Intervention
- DRUG : Faster-acting insulin aspart
- Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
- DRUG : insulin aspart
- Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, age at least 18 years at the time of signing inform consent
* Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (Visit 1)
* Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1)
* Using an external CSII system for the previous 6 months prior to screening (Visit 1)
* HbA1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
* Body Mass Index (BMI) 20.0 <= age <= 35.0 kg/m^2
Exclusion Criteria:
* History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening (Visit 1)
* History of abscess at the infusion site within 6 months prior to screening (Visit 1)
* Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (Visit 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
|
NCT01999322
|
{
"brief_title": "A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 1"
],
"interventions": [
"Drug: insulin aspart",
"Drug: Faster-acting insulin aspart"
],
"location_countries": [
"Germany",
"United States"
],
"nct_id": "NCT01999322",
"official_title": "A 6-week Randomised, Double-blind, Parallel-group Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05-14",
"study_completion_date(actual)": "2014-05-14",
"study_start_date(actual)": "2013-11-19"
},
"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)": "2017-10-31",
"last_updated_that_met_qc_criteria": "2013-11-25",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-03",
"first_submitted": "2013-11-25",
"first_submitted_that_met_qc_criteria": "2017-10-02"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy
Detailed Description
In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study
#Intervention
- PROCEDURE : Laparoscopic internal gastric banding
- Laparoscopic internal gastric banding
- PROCEDURE : laparoscopic sleeve gastrectomy
- laparoscopic sleeve gastrectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* Approval to share in the study
* Patients fit for laparoscopic surgery
Exclusion Criteria:
* Patient age less than 18 or more than 50 years
* Refusal to share in the study
* Unfit for surgery
* patients with gastroesophageal reflux disease clinically or by investigation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02878525
|
{
"brief_title": "Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure",
"conditions": [
"Morbid Obesity"
],
"interventions": [
"Procedure: laparoscopic sleeve gastrectomy",
"Procedure: Laparoscopic internal gastric banding"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT02878525",
"official_title": "Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2016-10"
},
"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)": "2018-02-05",
"last_updated_that_met_qc_criteria": "2016-08-24",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-25",
"first_submitted": "2016-08-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice.
Prospective, Post market, Multi-center, Non-randomized Study
Detailed Description
Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites throughout China will participate in study. After SpyGlass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.
#Intervention
- DEVICE : SpyGlass
- The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age above 18 and not above 85.
* Willing and able to provide written informed consent to participate in the study.
* Willing and able to comply with the study procedures.
* Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.
Exclusion Criteria:
* Endoscopic techniques are contraindicated.
* ERCP is contraindicated
* A medical condition that warrants the use of the device outside of the indication for use.
* Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
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
|
NCT02287194
|
{
"brief_title": "SpyGlass Direct Visualization System Clinical Registry in China",
"conditions": [
"Biliary Tract Diseases"
],
"interventions": [
"Device: SpyGlass"
],
"location_countries": [
"China"
],
"nct_id": "NCT02287194",
"official_title": "Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04-30",
"study_completion_date(actual)": "2017-12-31",
"study_start_date(actual)": "2014-11-28"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-31",
"last_updated_that_met_qc_criteria": "2014-11-06",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-10",
"first_submitted": "2014-08-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Overview of Study Design:
This is an open phase II, single-arm, multi-center study to evaluate progression free survival in patients receiving ixazomib in combination with thalidomide and dexamethasone (ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months.
The patient population will consist of adult male and female patients with multiple myeloma (MM) with relapsed and/or refractory disease after at least one prior treatment line.
In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide 100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of treatment visit (EOT) will be performed within 14 days after the last dose of the last combination treatment cycle.
After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed less than 8 cycles of ITD treatment do not qualify for maintenance phase.
Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib maintenance therapy has concluded or discontinued the maintenance phase.
A safety analysis will be conducted after enrollment of the first 6 patients and completion of at least two cycles in every patient.
#Intervention
- DRUG : Ixazomib
- DRUG : Thalidomide
- DRUG : Dexamethasone
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients 18 yrs or older.
* Voluntary written consent
* Patients in need of therapy with a diagnosis of relapsed or refractory multiple myeloma who had at least one prior treatment line
* Patients must have measurable disease defined by at least 1 of the following criteria:
* Serum M-protein >= 10g/l
* Urine M-protein >= 200mg/24h
* Serum free light chain assay: involved serum light chain >= 10mg/dl provided that free light chain ration is abnormal
* Life expectancy > 3 months
* ECOG (Eastern Cooperative Oncology Group) <= 2
*
* ANC >= 1.000/mm3 and platelet count >= 50.000/mm3
* Total bilirubin <= 2 x ULN
* ALT and AST <= 3 x ULN
* GFR >= 15ml/min as calculated by cockroft-Gault equation
* Female patients who:
* Are older than 50 years and postmenopausal for at least 1 year before the screening visit, OR
* Are surgically sterile, OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time, from 4 weeks before starting study therapy through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
* Are informed and understand the possible consequences of the teratogenic potential of thalidomide
* Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
* Are informed and understand the possible consequences of the teratogenic potential of thalidomide
* Disease free of prior malignancies for >= 2 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma 'in situ' of the cervix or breast if they have undergone complete resection.
Exclusion Criteria:
* lactating females or have a positive serum pregnancy test
* Failure to have fully recovered (i.e., <= Grade 1 toxicity) from the reversible effects of prior chemotherapy
* Previous treatment with ixazomib
* Previous treatment with bortezomib or thalidomide within the last 3 months prior to baseline visit
* Primary refractory to, or relapsing during, or within <= 6 weeks after end of treatment with a proteasome inhibitor and/or thalidomide
* Previous anti-cancer treatment within the last 21 days prior to baseline visit (cycle 1 / day 1), except corticosteroid therapy (40 - 160mg dexamethasone or corticosteroid dose equivalent per month)
* Major surgery within 14 days before enrollment
* Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
* Central nervous system involvement
* Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
* Evidence of current uncontrolled cardiovascular conditions
* Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
* Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
* Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
* Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with basal cell, squamous cell carcinoma of the skin, or carcinoma 'in situ' of the cervix or breast with are not excluded if they have undergone complete resection
* Patient has >= Grade 3 peripheral neuropathy or Grade 2 with pain on clinical examination during the screening period
* Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
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
|
NCT02410694
|
{
"brief_title": "Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Drug: Dexamethasone",
"Drug: Thalidomide",
"Drug: Ixazomib"
],
"location_countries": [
"Austria",
"Germany",
"Czechia"
],
"nct_id": "NCT02410694",
"official_title": "Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-28",
"study_completion_date(actual)": "2019-05-02",
"study_start_date(actual)": "2015-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-13",
"last_updated_that_met_qc_criteria": "2015-04-02",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-08",
"first_submitted": "2015-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this observational study is to learn about the effect of steroid therapy in patients with COVID-19 ARDS. The main questions it aims to answer are:
* Differences between patients with COVID-19 ARDS before and after steroid treatment in BALF single cell landscape, as well as patients with different prognosis.
* Differences between COVID-19 and non COVID-19 ARDS patients in BALF single cell landscape.
Participants will Choose whether to use or not to utilize steroid treatment based on conditions.
Detailed Description
Collect BALF from COVID-19 and non-COVID-19 ARDS patients both before and during remission, then perform single-cell sequencing.
#Intervention
- DRUG : steroid
- Moderate- or high-dose steroids
|
#Eligibility Criteria:
Inclusion Criteria:
* Severe ARDS patients
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05933291
|
{
"brief_title": "Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS",
"conditions": [
"ARDS: Acute Respiratory Distress Syndrome",
"Covid19"
],
"interventions": [
"Drug: steroid"
],
"location_countries": [
"China"
],
"nct_id": "NCT05933291",
"official_title": "Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS: an Analysis of the Effectiveness of Steroid Therapy and a Comparison Between COVID-19 ARDS and ARDS From Other Etiologies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-09",
"study_completion_date(actual)": "2023-03-15",
"study_start_date(actual)": "2022-09-24"
},
"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)": "2023-07-06",
"last_updated_that_met_qc_criteria": "2023-07-05",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-06",
"first_submitted": "2023-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the safety and efficacy of 2 different dosing schedules of pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2 schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or metastatic melanoma. The primary hypotheses are that pembrolizumab is superior to ipilimumab with respect to progression-free survival (PFS) and overall survival (OS).
Detailed Description
Participants assigned to a primary course of pembrolizumab can receive up to 24 months of treatment. Participants with Stable Disease (SD) or better will then proceed to Post Treatment Follow-up. All efficacy and safety analyses will be based on the primary pembrolizumab course.
Participants who experience disease progression during the Post Treatment Follow-up will be eligible for a Second Course of pembrolizumab treatment for up to 1 additional year. With Amendment 05, all Second Course participants will be treated with a fixed dose of pembrolizumab 200 mg Q3W. With Amendment 06, after the study has achieved its key objectives or the study has ended, participants will be discontinued from this study and enrolled in an extension study to continue protocol-defined assessments and treatment.
#Intervention
- BIOLOGICAL : Pembrolizumab
- 10 mg/kg IV, administered Q2W or Q3W based upon randomization.
- Other Names :
- MK-3475
- BIOLOGICAL : Ipilimumab
- 3 mg/kg IV Q3W.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically-confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma)
* At least one measurable lesion
* No prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (first line) or one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (second line)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Archived tissue sample or new biopsy sample
* Female participants of childbearing potential must agree to use effective contraception from Visit 1 to 120 days after the last dose of study drug; male participants must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
Exclusion criteria:
* Prior treatment with ipilimumab or other anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) agent or any anti-programmed cell death (PD-1 or PD-L2) agent
* Chemotherapy, radioactive, or biological cancer therapy within four weeks prior to the first dose of study drug, or not recovered from adverse events caused by cancer therapeutics administered more than four weeks earlier
* Currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug
* Expected to require any other form of systemic or localized antineoplastic therapy while on study
* On any systemic steroid therapy within one week before the planned date for first dose of randomized treatment or on any other form of immunosuppressive medication
* History of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration, excluding adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other in situ cancers.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases are eligible
* Severe hypersensitivity reaction to treatment with another monoclonal antibody
* Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
* Active infection requiring systemic therapy
* Known history of Human Immunodeficiency Virus (HIV)
* Known history of or positive for Hepatitis B or C
* Known psychiatric or substance abuse disorder
* Regular user (including recreational use) of illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
* Pregnant or breastfeeding, or expecting to conceive, or father children within the projected duration of the study
* Received a live vaccine within 30 days prior to first dose of study drug
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
|
NCT01866319
|
{
"brief_title": "Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)",
"conditions": [
"Melanoma"
],
"interventions": [
"Biological: Ipilimumab",
"Biological: Pembrolizumab"
],
"location_countries": null,
"nct_id": "NCT01866319",
"official_title": "A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients With Advanced Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03-03",
"study_completion_date(actual)": "2019-06-03",
"study_start_date(actual)": "2013-08-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-02",
"last_updated_that_met_qc_criteria": "2013-05-28",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-31",
"first_submitted": "2013-05-28",
"first_submitted_that_met_qc_criteria": "2015-12-09"
}
}
}
|
#Study Description
Brief Summary
This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
#Intervention
- DEVICE : Test 8.5BC
- senofilcon A contact lenses with 8.5 base curve
- DEVICE : Test 9.0BC
- senofilcon A contact lenses with 9.0 base curve
- DEVICE : Control 8.5BC
- narafilcon A contact lenses with 8.5 base curve
- DEVICE : Control 9.0BC
- narafilcon A contact lenses with 9.0 base curve
|
#Eligibility Criteria:
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
* The subject must read and sign the Informed Consent form.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Healthy adult males or females aged 18 <= age <= 55 years.
* The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
* The subject's refractive cylinder must be <=1.00 D in each eye.
* The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
* The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
* Currently pregnant or lactating
* Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
* Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
* Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
* Extended wear contact lens correction.
* Any current use of ocular medication.
* Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
* Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
* Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
* Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
* Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
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
|
NCT03139578
|
{
"brief_title": "Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses",
"conditions": [
"Visual Acuity"
],
"interventions": [
"Device: Control 8.5BC",
"Device: Test 8.5BC",
"Device: Control 9.0BC",
"Device: Test 9.0BC"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03139578",
"official_title": "Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-22",
"study_completion_date(actual)": "2017-10-22",
"study_start_date(actual)": "2017-04-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-01",
"last_updated_that_met_qc_criteria": "2017-05-02",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-04",
"first_submitted": "2017-05-02",
"first_submitted_that_met_qc_criteria": "2018-12-10"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the safety and tolerability of ruxolitinib at different dose levels in combination with decitabine and the effectiveness of ruxolitinib in combination with decitabine in patients with accelerated or blast phase Myeloproliferative Neoplasm (MPN), which is a group of diseases of the bone marrow in which excess cells are produced. Ruxolitinib is a drug that is approved by the Federal Drug Administration (FDA) for the treatment of patients with advanced forms of myelofibrosis. It inhibits the Jak proteins that are often abnormal in MPN. A recent clinical study showed that ruxolitinib treatment could put some patients with this disease into remission. Decitabine is a chemotherapy, approved by the Federal Drug Administration (FDA), that has been used to treat acute leukemia. It works in some patients, but most patients with accelerated and blastic MPN do not respond to treatment. Ruxolitinib and decitabine will be combined in this study to find out what dose of the two medicines are safe together. Using Ruxolitinib in combination with Decitabine is experimental. The investigators want to find out what effects, good and/or bad it has on the patient and the disease.
Detailed Description
At this time, there is no standard medical treatment for MF-BP or MF-AP. The investigators believe that the combination of ruxolitinib and DEC is a candidate approach to the treatment of MF-BP/MF-AP that is worthy of exploration based on both the current understanding of the biology of disease and emerging preclinical data. The molecular pathogenesis of MPN and progression to blast phase is almost certainly due to a complex combination of gene mutations (JAK2V617F, MPL) and epigenetic alterations (IDH1/2, IKZF1, EZH2, TET2) that culminate in the emergence of leukemic clones. Recent evidence indicates that the JAK2V617F protein can localize in the nucleus and influence global DNA methylation patterns which may lead to genomic instability and disease progression. The inhibition of JAK-STAT mediated cell proliferation and survival in conjunction with the reversal of DNA hypermethylation of tumor suppressor genes would be predicted to have at least an additive if not synergistic effect in inducing apoptosis of cells belonging to the malignant myeloid clone. Correlative studies conducted within a trial of Private and Confidential MPD-RC 109 Ruxolitinib + Decitabine combination JAK2 inhibitor and DMNT1 inhibitor in patients with MPN-BP would explore the effect on methylation status of various gene promoters as well as the influence on gene expression of chromatin related proteins and ultimately leukemic cell survival. The sequential administration of a JAK2 inhibitor followed by a DNMT inhibitor would also potentially serve to overcome the JAK2-independent effects of epigenetic lesions that lead to MPN-BP. In addition, a murine model of leukemic transformation has been described. In this model, bone marrow obtained from Tp53 null mice is retrovirally transduced with Jak2V617F, and transplanted into donor C56BL/6 mice. The transplanted mice develop an MPN which progresses to AML. In vitro drug studies utilizing bone marrow from these leukemic mice have demonstrated that exposure to decitabine or ruxolitinib inhibits colony formation in a methylcellulose colony-forming assay. Importantly, the combination of decitabine and ruxolitinib in this assay significantly reduces colony formation when compared to either drug alone (Rampal et al. ASH 2012 oral abstract 808) thus providing pre-clinical evidence for the combination study proposed here.
#Intervention
- DRUG : Ruxolitinib
- Ruxolitinib will be administered at doses of 5mg, 10mg, 15mg, or 25 mg taken orally every 12 hours throughout the treatment cycle.
- DRUG : Decitabine
- Decitabine is administered intravenously at a dose of 20 mg/m2 daily for 5 days. Subsequent cycles of decitabine may be administered at 4 week intervals as clinically tolerated. Decitabine treatment may be deferred for up to 2 weeks to allow recovery from non-hematologic toxicity during the first 6 cycles and up to 2 weeks thereafter for hematologic toxicities as well. The first treatment cycle will last 35 days and will be the evaluable period for DLTs and RPTD determination for patients enrolled in the phase I portion only. Subsequent treatment cycles will be 4-6 weeks in duration as defined by decitabine administration.
|
#Eligibility Criteria:
Inclusion Criteria:
* Accelerated phase MPN as defined by 10%-19% blasts in the peripheral blood or bone marrow and evidence of dysplastic marrow features with a concomitant diagnosis of essential thrombocythemia (ET), polycythemia vera (PV) or primary myelofibrosis (PMF) or a diagnosis of acute myelogenous leukemia as defined by 20% blasts in the blood or bone marrow following a previous diagnosis of ET, PV or PMF.
* >18 years
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 <= age <= 2. Patients with ECOG performance status of 3 will be eligible if the lower performance status is deemed by the investigator to be due entirely to accelerated or blastic phase MPN and not due to another comorbidity.
* Acceptable pre-study organ function during screening as defined as: Total bilirubin < 1.5 times the upper limit of normal (ULN) unless due to Gilbert's disease or hemolysis, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times ULN, Serum creatinine <= 1.5 x ULN
* Women of childbearing potential and males must agree to use adequate contraception (i.e., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.
* Patients who are not candidates for or have declined an allograft.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Have had chemotherapy or investigational therapy, with the exception of hydroxyurea, within 4 weeks of study entry. Previous treatment with either ruxolitinib or decitabine as single agents will not exclude eligibility. Previous stem cell transplant will also not exclude eligibility as long as other inclusion/exclusion criteria have been met.
* Patients with acute myelofibrosis are excluded.
* Uncontrolled intercurrent illness including, but not limited to hepatitis, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Other medications, severe acute/chronic medical or psychiatric conditions, or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, that in the judgment of the Investigator would make the subject inappropriate for entry into this 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
|
NCT02076191
|
{
"brief_title": "Study of Combination Ruxolitinib and Decitabine Treatment for Accelerated Phase MPN or Post-MPN AML",
"conditions": [
"Myeloproliferative Neoplasms"
],
"interventions": [
"Drug: Ruxolitinib",
"Drug: Decitabine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02076191",
"official_title": "Multicenter Phase I/II Trial of Ruxolitinib in Combination With Decitabine in Patients With Accelerated Phase Myeloproliferative Neoplasm (MPN) or Post-MPN AML",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-20",
"study_completion_date(actual)": "2018-07-20",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-28",
"last_updated_that_met_qc_criteria": "2014-02-28",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-03",
"first_submitted": "2014-02-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).
Detailed Description
After enrollment, parents will be taught by the study team on the use of the Pediarity System which includes the placement of the Gabi Band and the use of the Gabi Wi-Fi monitor application for data transfer. This education by the study team will ensure uniform training and preliminary understanding with teach back on the use of the Gabi band and Gabi Wi-Fi monitoring application. Parents can ask the study team any use and/or technical questions during this time period. All clinical care questions from standard of care monitoring will go to the CHAMP healthcare team. If parents/LARs have a clinical concern from a value on the Pediarity System - they will be referred to use their standard of care pulse oximetry before any clinical intervention and care is recommended by the healthcare team. The study team will not make any healthcare or diagnostic recommendations during the monitoring period based on any Pediarity System data.
The study team will educate parents and LARs on the Pediarity System. This system does not replace any use of their standard of care pulse oximetry and CHAMP videos. Parents may place the Gabi band on their child and use the Pediarity System at any frequency they choose in the home setting for a length of approximately one month at home (to coordinate when they return to the study site for a care visit). Parents can email or Teams call the study team directly (during daytime hours M-F) for any technical questions during this the study period. The study team will evaluate clinical data only at the conclusion of the study period and qualitative feedback from the parents will be gathered.
#Intervention
- DEVICE : Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
- Gabi SmartCare has created a monitoring system named Pediarity System that obtains pediatric vitals data through non-invasive means through a Gabi band. When paired with a proprietary algorithm and software - Gabi Analytics - the cloud-based platform measures blood oxygen levels, pulse rate (and variability), respiratory rate, actigraphy, inter-beat interval, and tracking for the time the device is worn (or not worn by the child). Three LEDs on the monitor are used for capturing this information. Peak wavelengths for the red, infrared, and green LEDs operate at 660nm, 950nm, and 526nm respectively. The Gabi band features an optical front end coupled with an analog front end using 24 bits. Bluetooth data transmission is utilized on a mobile phone application with a tablet-based system in a CSV format for the purpose of offline data processing.
|
#Eligibility Criteria:
Inclusion Criteria:
* Study participants will be parent-child dyads - pediatric patients who have been diagnosed with congenital, arrhythmic, or acquired heart disease at Children's Mercy Kansas City.
* Age criteria for children: after birth and who are less than two years of age at the time of being approached.
* The child of the parent-child dyad must be planned from the clinical standpoint prior to approach for discharge home with standard of care oxygen saturation/heart rate/pulse oximeter for remote patient monitoring population - and followed with the CHAMP application in the home setting.
* CHAMP App CM IRB 15030113 - Pediatric patients may be followed by the CHAMP Clinical team or enrolled in the CHAMP App Cardiac Study
Exclusion Criteria:
* Over two years of age at the time of being approached for study participation.
* Families that do not speak English or Spanish (languages supported by the devices).
* Families that do not have access to a Wi-Fi network at home.
Sex :
ALL
Ages :
- Maximum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05975658
|
{
"brief_title": "WIReD: Wireless Interstage Remote Device Study",
"conditions": [
"Congenital Heart Disease in Children",
"Vital Signs",
"Pediatrics",
"Remote Monitoring"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05975658",
"official_title": "WIReD: Wireless Interstage Remote Device Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-03",
"study_completion_date(actual)": "2024-12-03",
"study_start_date(actual)": "2023-09-30"
},
"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)": "2024-12-05",
"last_updated_that_met_qc_criteria": "2023-07-27",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-04",
"first_submitted": "2023-07-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
#Intervention
- DIETARY_SUPPLEMENT : High dose group
- A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains
- DIETARY_SUPPLEMENT : Low dose group
- A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains
|
#Eligibility Criteria:
Inclusion Criteria:
* Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
* Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.
Exclusion Criteria:
* Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
* Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
* Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.
Sex :
ALL
Ages :
- Maximum Age : 72 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06501404
|
{
"brief_title": "PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis",
"conditions": [
"Premature Infants",
"Necrotizing Enterocolitis"
],
"interventions": [
"Dietary Supplement: Low dose group",
"Dietary Supplement: High dose group"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT06501404",
"official_title": "Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01-15",
"study_completion_date(actual)": "2020-03-20",
"study_start_date(actual)": "2015-01-10"
},
"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)": "2024-07-15",
"last_updated_that_met_qc_criteria": "2024-07-12",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-07-15",
"first_submitted": "2024-06-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
Detailed Description
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as adjunctive therapy (in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. In addition, participants may elect to receive adjunctive therapy (ie, double-blind supplemental oral analgesic medication or matching placebo) throughout the double-blind treatment period. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.
#Intervention
- DRUG : Placebo
- Placebo will be administered once every 4 weeks with or without adjunctive therapy for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
- DRUG : Fulranumab 1 mg
- Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.
- DRUG : Fulranumab 3 mg
- Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.
- DRUG : Celecoxib 100 mg
- Double-blind capsules taken twice daily for up to 16 weeks.
- DRUG : Celecoxib 100 mg Matching Placebo
- Double-blind capsules taken twice daily for up to 16 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class >=2) of the study joint
* Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
* Unsatisfactory response (inadequate efficacy or poor tolerability) on local standard of care that includes 3 medications from at least 2 of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid). For participants in the USA and Canada only: Unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products)
* Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
* During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child
Exclusion Criteria:
* Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
* Unstable or progressive neurologic disorders
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02301234
|
{
"brief_title": "Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007",
"conditions": [
"Osteoarthritis",
"Pain"
],
"interventions": [
"Drug: Fulranumab 3 mg",
"Drug: Celecoxib 100 mg",
"Drug: Celecoxib 100 mg Matching Placebo",
"Drug: Fulranumab 1 mg",
"Drug: Placebo"
],
"location_countries": [
"Sweden",
"United States",
"Poland",
"Germany",
"United Kingdom",
"Canada",
"Spain",
"Australia",
"Hungary",
"Czechia",
"Korea, Republic of"
],
"nct_id": "NCT02301234",
"official_title": "Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Fulranumab as Adjunctive Therapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09-19",
"study_completion_date(actual)": "2016-09-19",
"study_start_date(actual)": "2015-03-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-09-14",
"last_updated_that_met_qc_criteria": "2014-11-21",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-25",
"first_submitted": "2014-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized clinical trial. The population consisted of parents of children undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over 18 years, and the following were considered exclusion criteria: inability to understand and/or answer the questions for any reason, parents of children undergoing surgery for insertion of the pacemaker and defibrillator, surgical death and not take up the case. 22 parents in the intervention group were randomized and received standardized guidelines for nursing and 22 parents participated in the control group received the guidelines and routine of the institution. Anxiety was assessed using the STAI State-Trait Inventory in the preoperative period and 48 hours after surgery the child.
Detailed Description
anxiety
#Intervention
- OTHER : standardized guidelines for nursing
- Information was provided regarding the preoperative preparation of the child, the same conditions and in the postoperative period, as well as information relating to housing and food for the parents. The conventional orientation took about 15 minutes.
- Other Names :
- parents aged over 18 years
|
#Eligibility Criteria:
Inclusion Criteria:
* We included parents aged > 18 years
Exclusion Criteria:
* inability to understand and/or answer the questions for any reason,
* parents of children undergoing surgery for insertion of the pacemaker and defibrillator,
* surgical death and not take up the case
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
|
NCT01492452
|
{
"brief_title": "The Anxiety of Parents of Children Undergoing Cardiac Surgery",
"conditions": [
"Anxiety"
],
"interventions": [
"Other: standardized guidelines for nursing"
],
"location_countries": null,
"nct_id": "NCT01492452",
"official_title": "Standard Guidelines Impact of Nursing Anxiety of Parents of Children Undergoing Cardiac Surgery: Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2010-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-12-15",
"last_updated_that_met_qc_criteria": "2011-12-14",
"last_verified": "2011-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-15",
"first_submitted": "2011-12-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
Detailed Description
This study will be a single-center, open-label, 4-period, randomized,6-sequence study conducted with 24 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods1, 2, 3,and 4), and an End of Study (EOS) Phase. Screening must occur within 28 days before the first study drug administration. There will be a washout of at least 7days between 4 administrations of HMPL-523.Subjects in Periods 1, 2, and 3 will be randomized into 1 of 6 treatment sequences, with all subjects then receiving the same treatment in Period 4.
#Intervention
- DRUG : HMPL-523
- 700 mg HMPL-523 will be administered by mouth once daily on Day 1, Day 8, Day 15, and Day 26
- DRUG : Rabeprazole
- 40 mg of rabeprazole will be administered by mouth once daily in the morning from Day 20 to Day 26
|
#Eligibility Criteria:
Inclusion Criteria:
* The volunteer is male or female between the ages of 18 and 55 years (inclusive) at the time of informed consent.
* The volunteer has a body mass index (BMI)>18 and <=29.9 kg/m2at screening.
* Females must be postmenopausal (defined as absence of menses for at least 1year without alternative medical cause)or permanently sterile by total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
* Males, including those who have had a successful vasectomy, must use a condom during sexual intercourse with women of childbearing potential, starting from their first dose of study drug through 30 days after their last dose of study drug. Alternatively, abstinence is allowed if it is the normal and preferred lifestyle of the volunteer.
* The volunteer must provide written informed consent prior to any study specific screening procedures.
* The volunteer is willing and able to comply with all aspects of the protocol, as determined by the PI.
Exclusion Criteria:
* The volunteer has a known history of any gastrointestinal surgery or any condition possibly affecting drug absorption (eg, cholecystectomy, gastrectomy, achlorhydria, peptic ulcer disease, or history of stomach or intestinal surgery or resection). Note: Appendectomy and hernia repairs are allowed.
* The volunteer had a clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks prior to the first dose.
* The volunteer has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations at screening or at Day -1 check-in (baseline).
* The volunteer has systolic blood pressure >140 mmHg oradiastolic blood pressure >90mmHg.
* The volunteer has a clinically significant ECG abnormality, including a marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTcF interval >480msec), or hasa family history of prolonged QTc syndrome or sudden death.
* The volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or volunteer's verbal report and confirmed by cotinine test at check-in.
* The volunteer has a history of drug or alcohol misuse within 6 months prior to screening or a positive urine drug test at screening or at check-in.
* The volunteer has been diagnosed with acquired immune deficiency syndrome or has performed tests that are positive for human immunodeficiency virus (HIV), HepatitisBvirus (HBV), orHepatitis C virus (HCV).
* The volunteer has participated in a clinical trial of other study drug before screening, and the time since the last use of other study drug is less than 5 times the half-life or 4 weeks, whichever is longer, or the volunteer is currently enrolled in another clinical trial.1
* The volunteer has consumed grapefruit, starfruit, Seville oranges, or their products within 7 days prior to the first dose.
* The volunteer has consumed herbal preparations/medications, including, but not limited to, St. John's Wort, kava, ephedra (ma huang), Ginkgo biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng, within 7 days prior to the first dose (21days for St.John's Wort).
* The volunteer has experienced a weight loss or gain of >10% within 4 weeks prior to the first dose as noted by medical history and weight at screening and check-in.
* The volunteer has received blood or blood products within 4 weeks, donated blood or blood products within 8 weeks prior to the first dose or donated double red cell within 16weeks prior to first dose.
* The volunteer has used any over-the-counter (OTC) medications or prescription drugs (medications that can lower gastric acid in particular) within 2 weeks prior to the first dose.
* The volunteer is allergic to any of the study drugs (or its excipients) to be given in this study.
* A female participant is pregnant, lactating, or breastfeeding.
* A male volunteer who plans to donate sperm or father a child within 30 days after receiving the study drug.
* The volunteer has any condition that would make him or her, in the opinion of the PIor Sponsor, unsuitable for the study, or who, in the opinion of the PI, is not likely to complete the study for any reason.Note: One repeat of laboratory assessments, including vital signs and ECG,may be performed at screening and at -check-in(Day-1) at the discretion of the PI.
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
|
NCT05571787
|
{
"brief_title": "HMPL-523 Food Effect and Proton Pump Inhibitor Study",
"conditions": [
"Relapsed or Refractory Lymphoma"
],
"interventions": [
"Drug: Rabeprazole",
"Drug: HMPL-523"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05571787",
"official_title": "A Phase 1, Open-label, 4-period, Randomized 6-sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-22",
"study_completion_date(actual)": "2022-09-22",
"study_start_date(actual)": "2022-07-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-23",
"last_updated_that_met_qc_criteria": "2022-10-05",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-07",
"first_submitted": "2022-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Young gay, bisexual, and other men who have sex with men (MSM) are disproportionately affected by HIV. Despite this burden, most HIV prevention interventions target adult MSM (most of whom identify as gay) and heterosexual youth, creating an urgent need for interventions for gay and bisexual adolescents. Further, self-identified bisexual men, especially adolescents, have been neglected in research. Therefore, little is known about factors that drive engagement in risk behavior among self-identified bisexual adolescent men. The goals of this study are to: (1) examine factors that drive engagement in HIV risk behavior and substance use among self-identified bisexual adolescent men; and (2) develop and pilot test a tailored HIV and substance use prevention intervention for this population.
Detailed Description
Young gay, bisexual, and other men who have sex with men (MSM) are disproportionately affected by HIV. Despite this burden, most HIV prevention interventions target adult MSM (most of whom identify as gay) and heterosexual youth, creating an urgent need for interventions for gay and bisexual adolescents. Further, self-identified bisexual men, especially adolescents, have been neglected in research. This is a critical problem because: (1) there are as many, if not more, bisexual adolescent men than gay adolescent men; (2) bisexual adolescent men engage in several HIV risk behaviors more than their gay peers; (3) bisexual adolescent men are at increased risk for substance use-a robust risk factor for HIV; and (4) bisexual men face unique HIV prevention issues. Given that bisexual men are rarely included in research and most existing research on them focuses on 'behaviorally bisexual' adult men, little is known about factors that drive engagement in risk behavior among self-identified bisexual adolescent men. Attending to bisexual identity is critical to reducing HIV and substance use, because bisexuality is highly stigmatized and stigma-related stressors (e.g., concerns about disclosing one's bisexual identity) impact sexual behavior, substance use, and healthcare utilization. Interventions are also more effective when tailored to populations, underscoring the need for an intervention for self-identified bisexual adolescent men. The goals of this study are to: (1) examine factors that drive engagement in HIV risk behavior and substance use among self-identified bisexual adolescent men; and (2) develop and pilot test a tailored HIV and substance use prevention intervention for this population. In Phase 1, interviews will be conducted with 60 diverse self-identified bisexual adolescent men ages 14-17 focused on sexual identity, sexual decision-making, substance use motivations, and intervention preferences/barriers. In Phase 2, a tailored intervention will be developed using findings from Phase 1. In Phase 3, feasibility, acceptability, and preliminary efficacy will be tested in a pilot randomized trial (N = 60) with a waitlist control and one-month follow-up. In sum, self-identified bisexual adolescent men are at increased risk for HIV and substance use, but little is known about factors that drive their engagement in risk behavior. By focusing on self-identified bisexual adolescent men-an underrepresented, health disparity population-this study can identify prevention targets and reduce disparities in HIV and substance use.
#Intervention
- BEHAVIORAL : HIV and substance use prevention
- The intervention content will be developed through formative research during the initial phase of the study. However, the intervention will address: bisexual-inclusive sexual health education, unique influences of risk behavior among bisexual adolescents, and skills to cope with bisexual stigma and to increase acceptance of one's bisexual identity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 14 <= age <= 17
* Identifies as male
* Identifies as bisexual or another non-monosexual identity (e.g., pansexual)
* HIV-negative (self-report)
* Fluent in English
* Lives in United States
Exclusion Criteria:
* Does not meet inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03409328
|
{
"brief_title": "Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men",
"conditions": [
"HIV/AIDS",
"Substance Use",
"Bisexuality"
],
"interventions": [
"Behavioral: HIV and substance use prevention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03409328",
"official_title": "Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-31",
"study_completion_date(actual)": "2022-01-31",
"study_start_date(actual)": "2021-06-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-22",
"last_updated_that_met_qc_criteria": "2018-01-23",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-24",
"first_submitted": "2018-01-11",
"first_submitted_that_met_qc_criteria": "2024-08-16"
}
}
}
|
#Study Description
Brief Summary
Pharmaceutical and medical device manufacturers work closely with doctors and hospitals, and the companies often pay large sums for consulting and advising services. Recipients of these payments and companies have stated that these financial relationships contribute to innovation in health care. However, multiple studies have also found that such payments have the potential to bias prescribing and treatment behaviors, and thus may lead to increases in health care costs.
One way to address potential conflicts of interest in medicine is public disclosure. As part of the Affordable Care Act, the Physician Payment Sunshine Act (PPSA) will establish a national disclosure website that posts all payments from pharmaceutical, medical device, and biologics manufacturers to doctors and hospitals starting in 2014. Payments exceeding $10 must be reported, and they will be listed by category, such as speaking engagements, meals, travel, and consulting services.
The Centers for Medicare and Medicaid Services (CMS) explicitly state in their Final Regulations for the PPSA that the disclosure website 'will permit patients to make better informed decisions when choosing health care professionals and making treatment decisions,' but the ways in which patients will evaluate and interpret disclosure remain unclear. One prominent topic in the discussion of disclosure is patient trust in health care providers and how transparency will affect the patient-doctor relationship-and, consequently, how the new law may affect physicians and hospitals.
Detailed Description
Patient trust is associated with improved self-care among patients with conditions from diabetes mellitus to HIV, and patient trust has also been found to correlate with medication adherence and continuity with physician. Therefore, an exploration of how large-scale public disclosure of payments will affect patient trust in doctors and the medical profession can help predict the effect of the policy on patient care.
Past studies of patient responses to disclosure present contradictory findings: some patients may refuse to see doctors who accept payments, while others may see the potential for conflicts of interest as only a small factor in the choice of physician. In one literature review, both patients and participants believed that disclosure would lead to increased confidence in their providers' decisions. Yet another study found that while disclosure does not have much impact on a person's willingness to participate in research, 59% of participants said that disclosure did not change their trust in the researcher or institution and 36% of participants indicated that their trust decreased. Moreover, in a role-playing experiment, patients who heard a disclosure statement said they would feel uncomfortable turning down a doctor's recommendations for fear of suggesting that the doctor was corrupt. However, none of these studies explicitly measured trust in a clinical relationship in the context of large-scale disclosure, which will be the setting for the PPSA website.
Defining Trust Both in the medical context and beyond, many definitions of trust have been proposed, and multiple measurement tools have been developed. Trust is generally thought of as 'the willingness of a party to be vulnerable to the actions of another party based on the expectation that the other will perform a particular action important to the trustor, irrespective of the ability to monitor or control that other party.' One of the most comprehensive conceptual models for trust in physicians and medical institutions is based on 5 dimensions: 1) fidelity, pursuing a patient's best interests; 2) competence, avoiding mistakes and producing the best results; 3) honesty, or telling the truth, 4) confidentiality, protection of private information, and 5) global trust, a holistic aspect.
There are multiple predictions for how disclosure will influence patient-provider relations when considering these dimensions. For example, the increased transparency about ties to industry could increase patient perceptions of honesty. Physicians who receive payments for consulting may be viewed as experts in their fields, and therefore may be seen as more competent. Alternatively, patients may question the fidelity of a doctor who receives payments, wondering if she has the patient's best interests as her priority. Thus, the implications for a national disclosure website on patient trust in physicians and the institution of medicine are unclear, despite CMS' claims that the PPSA will aid consumer decision-making. This project sets out to explore the effects of disclosure on patient trust in doctors and the medical profession.
#Intervention
- BEHAVIORAL : Exposure to disclosure website
- Participants are exposed to a physician payment disclosure website.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants must be > 18 years, English-speaking, reside in Massachusetts, and have had an appointment with a physician within the last calendar year. These criteria will demonstrate a baseline level of interaction with the health care system. Our project uses data from health care professionals in Massachusetts, so we only wish to include people who live in Massachusetts.
Exclusion Criteria:
* Individuals under 18 years, non-English-speaking, who do not live in Massachusetts, and who have not had at least 1 appointment with a physician in the last calendar year.
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
|
NCT02179632
|
{
"brief_title": "Disclosure of Industry Payments to Physicians and the Patient-Doctor Relationship",
"conditions": [
"Patient Doctor Trust"
],
"interventions": [
"Behavioral: Exposure to disclosure website"
],
"location_countries": null,
"nct_id": "NCT02179632",
"official_title": "Disclosure of Industry Payments to Physicians and the Patient-Doctor Relationship",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-02",
"last_updated_that_met_qc_criteria": "2014-07-01",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-02",
"first_submitted": "2014-06-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Comparison of the combination of amlodipine with an angiotensin receptor blocker or an angiotensin converting inhibitor, on central arterial blood pressure in patients with hypertension and additional risk factors. This is a randomised, double-blind, double-dummy, multicenter study. The duration of active treatment 24 weeks.
Detailed Description
The study, multi-center balanced, parallel group (two treatment arms), randomized, double-blind (double-dummy), non-inferiority study is designed to show non-inferiority of Sevikar® (olmesartan(OM)/amlodipine (AM)) 40/10 mg compared to the combination of Perindopril (PER) 8 mg plus Amlodipine 10 mg with regard to central systolic blood pressure lowering effect, using the change from baseline (Week 0) to final examination (Week 24).
Male and female Caucasians aged ≥ 40 years and \<80 years with moderate to severe hypertension, defined by a systolic blood pressure (SBP) ≥ 160 and ≤ 200 or diastolic blood pressure (DBP) ≥ 100 and ≤ 115 mmHg for untreated patients, SBP ≥ 140 or DBP ≥ 90 mmHg for insufficiently pre-treated patients and SBP ≥ 130 mmHg or DBP ≥ 80 mmHg for insufficiently pretreated diabetics chronic kidney disease will be eligible for participation. In addition,three additional risk factors should be present.
During the course of the study three central blood pressure measurements (at randomization, at week 12 and at termination) will be performed with SphygmoCor ultrasound method. The conventional measurements with calibrated tensiometers (Omron) will be performed at each visit. Ambulatory blood pressure monitoring will be performed at randomisation.
The study starts with a 2-4 week run in phase. AM will be given as open-labelled 5 mg or 10 mg tablets, administered once daily. After randomization during the double-blind phase, study medication will comprise either OM/AM 40/10 mg or PER 8 mg (2x4 mg) plus AM 10 mg and will be administered once daily. Furthermore, open-label HCTZ 12.5 mg and 25.0 mg will be provided in tablets and administered once daily according to the treatment schedule.
The primary endpoint is the change in central SBP from baseline (Week 0, Visit 0) to final examination (Week 24, Visit 5) using Last Observation Carried Forward (LOCF) approach.
The study is conducted in approximately 15 centres in Spain. Depending on the previously administered drugs the run in phase is up to four weeks (Visits -2 and -1). Individual duration of active treatment (after randomization) will last 24 weeks (Visits 0-5). The total individual duration is 28 weeks.
A total of 518 patients (259 patients/arm) will be needed in the Per Protocol Set (PPS) for the confirmatory primary analysis using mean change from baseline (Week 0) to Final Examination assuming a drop out rate of 20% during Run-in Phase a total of 720 patients have to be screened in order to achieve 576 (288 patients/arm) randomised patients.
Assuming approximately 10% major protocol deviations, a total of 518 patients will remain in the PPS.
#Intervention
- DRUG : Perindopril + amlodipine + if necessary, hydrochlorothiazide
- Two perindopril 4 mg tablets + 1 amlodipine 10 mg tablet + placebo tablet matching the olmesartan/amlodipine tablet. All tablets are taken once daily. The duration of administration of perindopril tablets and placebo is 24 weeks. The duration of administration of amlodipine tablets is 24-26 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
- DRUG : olmesartan/amlodipine + hydrochlorothiazide, if necessary.
- olmesartan/amlodipine tablets 40 mg/10 mg, + placebo tablets matching the perindopril tablet and amlodipine tablet. All tablets are taken once daily for 24 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
|
#Eligibility Criteria:
Inclusion Criteria:
* moderate to severe hypertension
* 3 additional risk factors such as > 55 years(male), > 65 female, smoker, type 2 diabetes, obesity, cardiovascular disease, congestive heart failure, chronic kidney disease,
* ability to give informed consent
Exclusion Criteria:
* secondary or malignant hypertension
* contraindication to any of the study drugs
* Creatinine clearance level <40ml/min
* treatment with more than 3 antihypertensive drugs
* Myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac bypass surgery < 6 month prior to start of the study,
* unstable angina pectoris,
* stroke, transient ischemic attack < 3 months prior to start,
* Congestive heart failure NYHA II-IV,
* clinically relevant concomitant diseases,
* alcohol or drug abuse,
* pregnancy or women of childbearing potential without contraceptive precaution,
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01101009
|
{
"brief_title": "Comparison of Sevikar® and the Combination of Perindopril/Amlodipine on Central Blood Pressure",
"conditions": [
"Hypertension"
],
"interventions": [
"Drug: Perindopril + amlodipine + if necessary, hydrochlorothiazide",
"Drug: olmesartan/amlodipine + hydrochlorothiazide, if necessary."
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01101009",
"official_title": "Efficacy of Sevikar® Compared to the Combination of Perindopril/ Amlodipine on Central Arterial Blood Pressure in Patients With Moderate to Severe Hypertension-",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-24",
"last_updated_that_met_qc_criteria": "2010-04-07",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-09",
"first_submitted": "2010-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
Detailed Description
This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no placebo as control. All other healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and will be observed for 8 days.
#Intervention
- DRUG : Hepalatide
- There are seven cohorts as follows 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. Dose of 0.21mg is a pilot trial with no placebo. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
- Other Names :
- treatment drug
- DRUG : Placebo
- There are six cohorts as follows 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
- Other Names :
- control drug
|
#Eligibility Criteria:
Inclusion Criteria:
* Ages between 18 and 45 years
* BMI Index between 19 and 25 (BMI=weight/height2)
* Normal previous history and physical exam
* No drug and alcohol abuse
* No illness in 4 weeks and no drug therapy in 2 weeks
* No blood donation or subject not sampled in 3 months
* Consistent and correct use of recommended methods of birth control for men and women
* Good compliance with study protocol
* Understand and agree to sign a consent form
Exclusion Criteria:
* Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV
* Abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound of gallbladder, spleen and kidney, AFP ,and CEA
* Positive for anti-Pre-S1 antibody
* Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of ovaries/uterus proliferative diseases or breast mass
* Unable to quit smoking in trial
* Subject with little chance of enrollment (i.e. the weak)
* Subject not suitable to join the trial under other circumstances judged by investigator.
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
|
NCT02612506
|
{
"brief_title": "Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers",
"conditions": [
"Hepatitis B， Chronic"
],
"interventions": [
"Drug: Hepalatide",
"Drug: Placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT02612506",
"official_title": "A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-14",
"last_updated_that_met_qc_criteria": "2015-11-19",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-23",
"first_submitted": "2015-09-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced in the body when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and bone growth. Without sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D. Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D on the level of a harmful kind of cholesterol. Participants will have their cholesterol levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment, the investigators will measure their cholesterol levels again.
#Intervention
- DIETARY_SUPPLEMENT : Vitamin D3
- 50,000 units taken orally once a week for 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years and < 85 years
* Vitamin D 25-OH level <20 ng/ml
* One of the following risk factors:
* Known coronary artery disease (CAD) or a CAD equivalent (e.g. diabetes, chronic kidney disease, etc)
* BMI > 30 kg/m2
* Random Glucose Level > 200mg/dl
* Increased Waist Circumference (male: > 40in; Females: > 35in.)
* Decreased HDL (Male: < 40mg/dl; Female: < 50mf/dl)
* Framingham Risk Score > 10%
* hsCRP > 2 mg/L
Exclusion Criteria:
* Serum phosphorus level > 5.5 mg/dl
* Estimated GFR <30 ml/min/1.73m2
* Use of Vitamin D >400 IU/day within 1 month of most recent Vitamin D 25-OH determination
* Use of calcitriol or other 'activated' vitamin D
* Change in statin, ezetimibe, niacin, fibrate dose within 1 month
* Concurrent participation in an investigational drug study
* Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
* Serum calcium level >10.5 mg/dl
* anti-epileptic medication
* triglycerides > 400 mg/dL
* BMI > 40 kg/m2
* Evidence of cirrhosis as evidenced by AST > 3 x upper limit, ALT > 3 x upper limit, bilirubin > 1.5 mg/dL , albumin < 3.0 g/dL, PT > 14.5 sec
* Pregnant or Lactating Females
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
|
NCT01008384
|
{
"brief_title": "The Effect of Vitamin D Repletion on Small Low Density Lipoprotein (LDL) Particle Number in Subjects at Elevated Cardiovascular Risk",
"conditions": [
"Atherosclerosis"
],
"interventions": [
"Dietary Supplement: Vitamin D3"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01008384",
"official_title": "The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2011-10",
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-06-01",
"last_updated_that_met_qc_criteria": "2009-11-04",
"last_verified": "2012-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-05",
"first_submitted": "2009-10-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chest pain is a very common reason for resorting to the call center. The etiologies are very varied, ranging from benign pathologies to some that may involve, in the short term, the vital prognosis such as Acute Coronary Syndrome (ACS). ACS is a partial or complete occlusion of a coronary artery that causes potentially irreversible myocardial pain unless prompt treatment is undertaken. ACS represents 120 000 cases per year in France and causes about 18 000 deaths. There is currently no support score for the assessment of chest pain. However, reducing the duration of management of ACS is essential in order to hope to reduce the associated morbidity and mortality. In 2016, SAMU45's team established a predictive ACS score for the assessement of chest pain in SAMU 45 (France) based on the prospective study of 1367 patients. Seven items significantly associated with this risk of ACS could be highlighted: age, sex, smoking, typicality (potentially constrictive chest pain radiating potentially to the shoulders and / or jaw) pain, inaugural character of pain (ie first episode of this type), presence of sweats and the physician's belief to be in the presence of an ACS. These seven variables make up the SCARE score. This had good internal discrimination (AUC at 0.81) and excellent calibration ('p' of Hosmer-Lemeshow at 0.74). This score makes it possible to stratify the risk of ACS, by using epidemiological elements but also the physician's belief, whose Negative Predictive Value (VPN) proved excellent.
The objective of this new project is to confirm by an external validation via a multicentric study the robustness of this score and thus be able to consider its use in front of any chest pain regulated in France by a call center.
Detailed Description
The main objective is to validate the predictive SCARE score of acute coronary syndrome during the medical assessment of chest pain. The primary endpoint will be SCARE score analysis (pre-established in 2016) with assessment of its calibration (Hosmer Lemeshow) and discrimination (AUC) in a multicenter population of chest pain with a potential diagnosis of Acute Coronary Syndrome established according to the European Society of Cardiology criteria.
This is a multi-center study including any patient over 18 years of age calling call center for chest pain over a period of six months. It will exclude post-traumatic chest pain, patients under 18 years old, patients who do not speak French, patients refusing to participate in the study or refusing treatment, patients not affiliated to social security, patients incarcerated in a penitentiary center, patients under tutorship, curatorship or safeguard of justice.
The collection of data will be carried out thanks to files filled prospectively by the medical physician for each call for the reason of a chest pain. These cards will list the epidemiological data (age, sex, weight, height) and clinical data of each patient, as well as the decision and the resources committed by the regulating physician (hospital care via SMUR or ambulance, treatment in city medicine). For hospitalized patients, the diagnosis of ACS will be retained if the patient meets the criteria defined by the European Society of Cardiology. For patients managed in ambulatory medicine, a telephone call to the patient will be made at one month to obtain the diagnosis.
Then, the SCARE score will be analized in this multicenter population with evaluation of its calibration (Hosmer Lemeshow) and discrimination (AUC). The characteristic performances of the score (sensitivity, specificity, PPV, NPV, positive and negative likelihood ratios)will also be analized.
#Intervention
- OTHER : SCARE Score
- Predictive Score of acute coronary syndrome during the medical assessment of chest pain
|
#Eligibility Criteria:
Inclusion Criteria:
* Any patient over the age of 18 calling call center for chest pain
No-inclusion Criteria:
* Posttraumatic chest pain,
* Age under 18,
* Patient not speaking French,
* Patient refusing to participate in the study or refusing care
* Patient not affiliated with social security,
* Patients incarcerated in a penitentiary center,
* Patients under guardianship, curatorship or safeguard of justice.
Exclusion Criteria:
* Patient refusing to participate in the study or refusing care
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
|
NCT04000490
|
{
"brief_title": "External Validation of the SCARE Score",
"conditions": [
"Assessment",
"Chest Pain",
"ACS - Acute Coronary Syndrome"
],
"interventions": [
"Other: SCARE Score"
],
"location_countries": [
"France"
],
"nct_id": "NCT04000490",
"official_title": "Validation of the SCARE Score, Predictive Score of Acute Coronary Syndrome During the Assessment of Chest Pain in the Call Center.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-25",
"study_completion_date(actual)": "2020-03-25",
"study_start_date(actual)": "2019-10-01"
},
"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)": "2020-09-01",
"last_updated_that_met_qc_criteria": "2019-06-26",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-27",
"first_submitted": "2019-06-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research objective is to compare quadriceps strength by measuring maximal voluntary isometric contraction (MVIC) and risk of fall before and after subsartorial femoral triangle block (SSFTB)
#Intervention
- PROCEDURE : SSFTB
- Patients who underwent major knee surgery and had already planned to perform subsartorial femoral triangle block (SSFTB) were included in the study. They were measured the outcomes the night before surgery. The saphenous nerve and nerve to vastus medialis were blocked at the subsartorial femoral triangle level by experienced anesthesiologists. After standard monitor, the distal femoral triangle was identified 2 cm proximal to the opening of adductor canal by ultrasound guidance. At this level, The location of nerve to vastus medialis was confirmed by nerve stimulator and it was blocked with 0.5% levobupivacaine 5 ml. Then, 0.5% levobupivacaine 10 ml would be injected perifemoral artery. The outcomes were re-assessed 30 min after block.
- Other Names :
- nerve to vastus medialis and saphenous nerve block
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible patients are all ASA class I-III, age 18 <= age <= 80 years, and have plan to perform SSFTB at Thammasat University Hospital consecutively
Exclusion Criteria:
* Exclusion criteria are patients who refuse to participate the study, morbid obesity (BMI >= 35 kg.m2), lower extremity neurological dysfunction, performing other peripheral nerve blocks, patients who cannot cooperate or measure MVIC, difference of quadriceps strength between two side of knees more than 10 percent, and SSFTB is not finally performed or failed block.
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
|
NCT03845972
|
{
"brief_title": "Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength",
"conditions": [
"Saphenous Nerve Block",
"Regional Anesthesia Morbidity",
"Postoperative Pain"
],
"interventions": [
"Procedure: SSFTB"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT03845972",
"official_title": "Effect of Ultrasound-guided Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-04",
"study_completion_date(actual)": "2019-01-04",
"study_start_date(actual)": "2018-04-25"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-19",
"last_updated_that_met_qc_criteria": "2019-02-16",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-19",
"first_submitted": "2019-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Frailty is a state of vulnerability, characterized by a loss of mechanisms that maintain homeostasis, determining a lower capacity for recovery in the event of a stressful incident. It is one of the risk factors that increase postoperative adverse outcomes in the elderly population. It has been associated with worse results in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. Currently, there are several instruments for diagnosis and screening of frailty. All of them require time for their execution, an experienced evaluator and an adequate validation in the population in which they are intended to be used. The use of frontal electroencephalography during the intraoperative period has become increasingly popular. It allows the monitoring of brain activity during the administration of anesthetics. Various intraoperative electroencephalographic markers, such as alpha spectral power or total spectrum power, have been associated with factors such as preoperative physical activity, preoperative cognitive level, comorbidities, and postoperative delirium. The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in ≥ 65 years patients undergoing general anesthesia with Sevoflurane for non-cardiac surgery.
Detailed Description
The world health organization has estimated that the population over 60 years of age will increase exponentially between 2015 and 2050. This change will be more pronounced in developing countries, including Chile. Each year, the number of older people (≥ 65 years) undergoing surgical interventions raises. This is due to a sustained increase in life expectancy, demographic changes, and progress in surgical/anesthetic techniques that allow this population to undergo less invasive procedures. In addition, older patients have a higher risk of postoperative morbidity and mortality compared to younger people.
Frailty is one of the risk factors that increase adverse postoperative outcomes in the elderly population. It is defined as a state of vulnerability or lack of physiological reserve that is characterized by an inadequate resolution of homeostasis after a stressful event. Frailty determines that an event can generate changes in the postoperative state of dependence of these patients; causing a person who was independent prior to surgery to end up requiring assistance with their activities of daily living after it. Frailty has been associated with worse outcomes in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. In addition, preoperative frailty has also been associated with postoperative delirium.
Currently, there are several instruments for the diagnosis and screening of frailty that present good sensitivity and specificity. All of them require time for their execution, an experienced evaluator and adequate validation in the population in which they are intended to be used. Furthermore, with some instruments, specific elements may be required, for example the Handgrip dynamometer for the Fried phenotype. These conditions are not always easy to obtain in the local preoperative setting and the tools are not always adequately validated for non-English speaking populations. Moreover, there is uncertainty regarding which frailty instrument to choose among the dozens described in the literature, and there are time pressures that prevent the addition of more tests or evaluations in the preoperative clinic.
The use of frontal electroencephalography (EEG) during the intraoperative period has become increasingly popular. It is used to obtain a real-time record of brain electrical activity during administration of anesthetics. Interpreting the EEG in the time domain in real time in the operation room is challenging. Therefore, various processed EEG monitors (BIS®, SedLine®) currently clinically used, have incorporated the spectral analysis to their records. The spectrum presents the advantage to show the frequency decomposition of the EEG segment for all frequencies in a given range (usually \<30 Hz) by plotting the frequency on the X axis and power on the Y axis. The accumulation of spectra over time is called spectrogram and can be presented graphically on the monitor, where the X-axis represents time, Y axis the decomposition of frequencies, and the Z bar represents the amplitude or power of the different waves. With increasing age there is a decrease in spectral power and alpha wave coherence (8-12 Hz). In addition, decreased alpha spectral power during anesthetic administration has been correlated with preoperative cognitive dysfunction. Recently, preoperative physical activity, the spectral power of the alpha wave and the entire spectral band have been associated with postoperative delirium in the cardio-surgical population. In addition, the spectral power of the alpha wave and broadband power (baseline noise) has been correlated with changes in age and patient comorbidities.
The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in a population older than 65 years undergoing general anesthesia with sevoflurane for elective non-cardiac surgery. Our hypothesis is that frail patients (determined by the FRAIL, Clinical Frailty Scale and Fried scales) undergoing general anesthesia with sevofluorane for non-cardiac surgery have a lower alpha spectral power and lower entire spectral band power of the EEG compared to patients of similar age, who are robust, undergoing the same type of surgeries.
#Intervention
- DEVICE : Intraoperative frontal electroencephalogram
- Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 65 years
* Undergoing elective non-cardiac surgery requiring general anesthesia with Sevoflurane
* American Society of Anesthesiologists Physical Status I to III
Exclusion Criteria:
* Emergency surgery
* Neurosurgical patients
* History of alcohol
* History of recreational psychoactive drug use
* Allergy to anesthetic drugs.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04783662
|
{
"brief_title": "Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients",
"conditions": [
"Frailty"
],
"interventions": [
"Device: Intraoperative frontal electroencephalogram"
],
"location_countries": [
"Chile"
],
"nct_id": "NCT04783662",
"official_title": "Study of an Intraoperative Frontal Electroencephalographic Marker of Preoperative Frailty in Patients Over 65 Years of Age for Elective Non-cardiac Surgery.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-01",
"study_completion_date(actual)": "2022-03-28",
"study_start_date(actual)": "2021-05-13"
},
"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)": "2022-03-31",
"last_updated_that_met_qc_criteria": "2021-03-02",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-05",
"first_submitted": "2021-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.
#Intervention
- DRUG : Stavudine
|
#Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV positivity with CD4 count < 300 cells/mm3.
* Intolerance to or failure on approved antiretroviral therapy.
* Ability to provide informed consent (of parent or guardian if appropriate).
NOTE:
* Incarcerated persons may be eligible to participate.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Grade 2 or worse disease-related peripheral neuropathy.
* Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
* Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
* Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).
Strongly discouraged:
* AZT, ddI, ddC, and other antiretroviral agents.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00002308
|
{
"brief_title": "A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002308",
"official_title": "A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With HIV Infection Who Have Failed or Are Intolerant of Alternative Antiretroviral Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "1991-11",
"study_start_date(actual)": null
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-08-05",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "2011-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A study to compare maternal and perinatal outcome between 4 and 6 cm cervical dilatation at amniotomy.
Detailed Description
Low risk women with singleton pregnancy are recruited. There are two groups which are 4 and 6 cm cervical os dilatation. The intrapartum management and labour outcomes are documented.
#Intervention
- OTHER : oxytocin augmentation
- Only observation of the outcome
|
#Eligibility Criteria:
Inclusion Criteria:
* singleton pregnancy
* no medical disorders
* no antenatal complications such as hypertension and diabetes
Exclusion Criteria:
* fetal anomaly
* one previous caesarean section
* other uterine scars
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
|
NCT05339399
|
{
"brief_title": "4 Versus 6 cm Active Phase of Labour",
"conditions": [
"Labor Complication",
"Cervix; Open"
],
"interventions": [
"Other: oxytocin augmentation"
],
"location_countries": [
"Malaysia"
],
"nct_id": "NCT05339399",
"official_title": "4 Versus 6 cm Cervical os Dilatation to Demarcate Active Phase of Labour: Comparative Cross Ectional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-10",
"study_completion_date(actual)": "2022-02-10",
"study_start_date(actual)": "2021-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-29",
"last_updated_that_met_qc_criteria": "2022-04-14",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-21",
"first_submitted": "2022-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Literature shows the potential effectiveness of L. reuteri as an adjunct to non-surgical periodontal therapy in initial treatment of periodontitis, but also underlines the limits of the conclusions, and the heterogeneity and limited sample size of the available studies. Therefore, there is a need for longer-term, randomized, controlled studies. Moreover, only one study addresses the use of this probiotic during the supportive therapy, in particular in patients with severe forms of periodontitis, and only few patients were included.
Patients meeting the criteria of periodontitis stage III and IV, grade C are considered to be affected by severe and advanced forms of periodontitis with a rapid rate of progression. This group of patients could particularly benefit from supplements for the maintenance of periodontal health.
The hypothesis of the present randomized controlled trial is that the adjunctive use of probiotic treatment can bring clinical and microbiological advantages during the supportive therapy of periodontal disease, and reduce the number of residual pockets.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be prescribed one of the therapies below:
* PLACEBO: The patients of the control group will receive control lozenges without live bacteria;
* TEST: The patients of the probiotic group will receive probiotic lozenges containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB).
The probiotic and control lozenges will be identical in taste, texture and appearance. The lozenges will be given to all patients to consume at home. The patients will be instructed to dissolve them on their tongue twice a day, preferably after brushing, for 3 weeks.
Periodontal and microbiological parameters will be evaluated at 3 and 6 months after the initial therapy, and compared between the two groups.
Detailed Description
Probiotics are defined as 'live microorganisms which, when administered in adequate amounts, confer a health benefit on the host'. The influence of probiotics on pathogens flora can derive from three principal modes of action: innate and acquired host defense modulation, production of antibacterial substances and competitive exclusion mechanism. In particular, Lactobacillus reuteri has been studied for its antibacterial and anti-inflammatory properties.
It is a heterofermentative bacterium and the distinct strains have different characteristics. In particular it acts as an antibiotic, induces oxidative stress on pathogens, is resistant to proteolytic and lipolytic and present anti-inflammatory properties.
TRIAL DESIGN Parallel-arm, mono-center, statistician operator and examiner blinded RCT. The trial will have 6 months of duration.
STUDY POPULATION Forty-four (44) adults, aged 18-75 years, meeting the criteria of periodontitis stage III and IV, grade C, will be entered into study. It is expected that forty (40) subjects will complete the study.
PRIMARY OUTCOMES
- Change in (Pocket Probing Depth) PPD: change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
SECONDARY OUTCOMES
* Pocket closure
* Risk of progression of periodontitis
* Change in BoP: change in percentage of sites positive to bleeding on probing.
* Change in Plaque Index (PI): change in percentage of sites with presence of plaque. Baseline values will be compared to the values recorded at follow-up visits.
* Change in Periodontal Attachment Level (PAL): change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
* Change in Recession (REC): change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
* Changes in microbial composition and proportion of sequences identified as Lactobacillus reuteri in the deepest residual pockets
#Intervention
- DIETARY_SUPPLEMENT : Probiotic: Lactobacillus Reuteri
- Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
- DIETARY_SUPPLEMENT : Placebo
- Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form.
* Male and female subjects, aged 18 <= age <= 75 years, inclusive.
* Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
* History of periodontitis staging III or IV grading B or C
* At least 2 sites with probing depth >=6 mm or pockets of 5 mm with bleeding on probing in two different quadrants.
* Previous periodontal non-surgical treatment at least 3 months maximum 6 months.
* Availability for the 6-month duration of the study for an assigned subject.
Exclusion Criteria:
* Not willing to follow the agreed protocol.
* Presence of orthodontic appliances.
* Smokers (more than 10 cigarettes per day)
* Chronic obstructive pulmonary disease and asthma.
* Tumors or significant pathology of the soft or hard tissues of the oral cavity.
* Current radiotherapy or chemotherapy.
* Pregnant or lactating women.
* Current or past (within 3 months prior to enrolment) administration of medications that may influence periodontal conditions and/or interfere with healing following periodontal treatment (i.e., corticosteroids, calcium channel blockers, systemic antibiotics, ...).
* History of allergy to Erythritol or chlorexidine.
* Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner.
* Use of systemically administered antibacterial agents or probiotics 3 months prior to enrollment.
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
|
NCT04478643
|
{
"brief_title": "Lactobacillus Reuteri in the Supportive Therapy of Periodontitis",
"conditions": [
"Periodontal Diseases"
],
"interventions": [
"Dietary Supplement: Probiotic: Lactobacillus Reuteri",
"Dietary Supplement: Placebo"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04478643",
"official_title": "Clinical and Microbiological Efficacy of Lactobacillus Reuteri in the Supportive Therapy of Periodontitis: a 6 Months Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-12",
"study_completion_date(actual)": "2024-06-12",
"study_start_date(actual)": "2020-10-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-17",
"last_updated_that_met_qc_criteria": "2020-07-15",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-21",
"first_submitted": "2020-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.
#Intervention
- BEHAVIORAL : EWS Nursing Alerts
- An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.
- DEVICE : Wireless Remote Sensor
- A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.
Exclusion Criteria:
* Minors, patients younger than 18 years.
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
|
NCT01280942
|
{
"brief_title": "Early Warning System for Clinical Deterioration on General Hospital Wards",
"conditions": [
"Escalation of Care",
"Cardiopulmonary Arrest",
"Respiratory Arrest",
"Severe Sepsis",
"Septic Shock"
],
"interventions": [
"Behavioral: EWS Nursing Alerts",
"Device: Wireless Remote Sensor"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01280942",
"official_title": "Early Warning System for Clinical Deterioration on General Hospital Wards.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2011-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-14",
"last_updated_that_met_qc_criteria": "2011-01-20",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-21",
"first_submitted": "2011-01-19",
"first_submitted_that_met_qc_criteria": "2018-02-07"
}
}
}
|
#Study Description
Brief Summary
This study is a randomized clinical trial measuring outcomes up to 6-months post-intervention. The objective of this study is to evaluate outcomes of two different group interventions for Veterans with Chronic Multisymptom Illness (CMI). The interventions to be compared are Mindfulness-Based Stress Reduction and an adapted version of the Chronic Disease Self-Management Program (aCDSMP) for Veterans experiencing symptoms of Chronic Multi-Symptom Illness (CMI) - musculoskeletal pain, fatigue, and cognitive failures - especially those who were deployed to Gulf War I. Hypothesis One (re: Outcomes): Participants randomized to the adapted Chronic Disease Self-Management Program (aCDSMP) will derive benefit for the primary outcomes, but with smaller effects than the participants randomized to Mindfulness-Based Stress Reduction (MBSR). The investigators hypothesize that Veterans randomized to MBSR will report greater reductions in each of the three primary outcome measures (pain, fatigue, and cognitive failures) at 6-month follow-up as compared to aCDSMP. Hypothesis Two (re: Acceptability): MBSR will be an acceptable and satisfactory program for Veterans with CMI, as measured by attendance rates, a self-report measure of satisfaction, and qualitative interviews. The investigators hypothesize that Veterans with CMI randomized to MBSR will report greater satisfaction with care than their peers randomized to aCDSMP.
Detailed Description
The investigators will enroll 308 participants. Half of these will be Gulf War Veterans who meet criteria for CMI, and the other half will be Veterans from other periods of service who also meet criteria for CMI. Each participant will be randomized to either participate in MBSR or aCDSMP (stratified by Gulf War deployment status so there are \~7-8 Gulf War Veterans in each group for every cohort). Measures to collect primary outcome data (pain, fatigue, cognitive failures, patient satisfaction), secondary outcomes, and potential mediators will be administered at four assessments: (1) Baseline; (2) Post-Intervention; (3) at 3-months after the group ended; and (4) at 6-months after the group ended. Sample demographic data (age, gender, race, income, education, etc.) will be collected at baseline only. All study procedures will take place at VA Puget Sound Health Care System in Seattle, WA.
#Intervention
- BEHAVIORAL : Mindfulness-Based Stress Reduction
- An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions.
- Other Names :
- MBSR
- BEHAVIORAL : Chronic Disease Self-Management Program
- The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved).
- Other Names :
- CDSMP
|
#Eligibility Criteria:
Inclusion Criteria:
* Self-report all the criteria for Chronic Multi-Symptom Illness
* Fluent in English and able to provide informed consent
Exclusion Criteria:
* Currently drinking with past-year history of alcohol-related seizures or delirium tremens
* Current DMS-V substance use disorder other than cannabis or nicotine
* Moderate or high risk of suicide as assessed with MINI
* Current psychotic disorder
* Current manic episode
* Diagnosis of borderline personality disorder or antisocial personality disorder
* Inpatient admittance for psychiatric reasons in the past month
* Prior participation in MBSR or CDSMP (attended at least one session)
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
|
NCT03058952
|
{
"brief_title": "Groups for Regaining Our Wellbeing",
"conditions": [
"Gulf War",
"Fatigue",
"Pain",
"Depression"
],
"interventions": [
"Behavioral: Mindfulness-Based Stress Reduction",
"Behavioral: Chronic Disease Self-Management Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03058952",
"official_title": "Evaluation of a Mindfulness-Based Intervention for Gulf War Illness",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-31",
"study_completion_date(actual)": "2022-05-31",
"study_start_date(actual)": "2017-08-08"
},
"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)": "2024-06-21",
"last_updated_that_met_qc_criteria": "2017-02-16",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-23",
"first_submitted": "2017-02-07",
"first_submitted_that_met_qc_criteria": "2024-02-23"
}
}
}
|
#Study Description
Brief Summary
27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received subgingival instrumentation and rubber cup polishing with pumice. In addition test sites received a single application of PDT using Fotosan® and photosensitizer consisting of toludine blue O solution. The subjects were recalled three and six months later and re-examined. Site level analysis was performed.
#Intervention
- DEVICE : Fotosan 630, CMS Dental, Copenhagen, Denmark
- The PDT system consists of a hand-held rechargeable light-emitting diode (LED) light source (Fotosan® 630 device, CMS Dental, Copenhagen, Denmark) and 0.1 mg/mL toluidine blue photosensitiser. The LED light source has a wavelength between 620 to 640 nm and peak of 630 nm and a power density between 2000 to 4000 mW/cm2.
- OTHER : Scaling and root planing
- Scaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste.
|
#Eligibility Criteria:
Inclusion Criteria:
* Good general health with no systemic diseases causing manifestation of periodontal diseases
* Age >= 21 years
* History of chronic periodontitis
* At least two residual PPD >= 5 mm with or without bleeding on probing
* Compliant with recalls, i.e. last SPT visit at most 6 months before start of trial
* Able to give written informed consent
Exclusion Criteria:
* Pregnant or lactating females
* Local or systemic antibiotics intake in the past 3 months
* Systemic conditions which could affect progression of periodontitis
* Long term use of NSAIDs or immunosuppressive medications
* Participation in other clinical trials
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02666573
|
{
"brief_title": "Photodynamic Therapy During Supportive Periodontal Therapy",
"conditions": [
"Periodontal Diseases",
"Chronic Periodontitis",
"Periodontal Attachment Loss"
],
"interventions": [
"Device: Fotosan 630, CMS Dental, Copenhagen, Denmark",
"Other: Scaling and root planing"
],
"location_countries": null,
"nct_id": "NCT02666573",
"official_title": "Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2013-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-28",
"last_updated_that_met_qc_criteria": "2016-01-27",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-28",
"first_submitted": "2016-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Shoulder pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed.
The aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (QOL) for stroke patients.
#Intervention
- PROCEDURE : acupuncture
- All participants were received regular rehabilitation program, and received different interventions.
treatment frequency: 20 minutes per session, once daily, 5 times a week for 2 weeks
- PROCEDURE : TENS
- PROCEDURE : sham acupuncture
|
#Eligibility Criteria:
Inclusion Criteria:
* Stroke within 6 months from onset
* Hemiplegia with shoulder pain (VAS > 2)
Exclusion Criteria:
* previous pathology of the shoulder or cardiac pacemaker, and cognition problems
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01650207
|
{
"brief_title": "Acupuncture for Hemiplegic Shoulder Pain",
"conditions": [
"Shoulder Pain in Hemiplegic Side After Stroke"
],
"interventions": [
"Procedure: TENS",
"Procedure: acupuncture",
"Procedure: sham acupuncture"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT01650207",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2011-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-26",
"last_updated_that_met_qc_criteria": "2012-07-25",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-26",
"first_submitted": "2012-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.
Detailed Description
Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.
#Intervention
- DRUG : Lidocaine,
- Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.
- DRUG : Ketamine
- Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.
- DRUG : association ketamine-lidocaine
- Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.
- DRUG : Placebo
- The control group (C) received an equal volume of saline 0.9 % during 48 h.
|
#Eligibility Criteria:
Inclusion Criteria:
* abdominal surgery by laparotomy
Exclusion Criteria:
* laparoscopy
* history of chronic pain
* opioid self-administration
* psychiatric disorders
* difficulties with communication
* renal or hepatic dysfunction
* ASA physical status > 3
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01439399
|
{
"brief_title": "Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Drug: Lidocaine,",
"Drug: association ketamine-lidocaine",
"Drug: Ketamine",
"Drug: Placebo"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01439399",
"official_title": "Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-07",
"study_completion_date(actual)": "2007-07",
"study_start_date(actual)": "2005-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-09-23",
"last_updated_that_met_qc_criteria": "2011-09-21",
"last_verified": "2011-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-23",
"first_submitted": "2011-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.
Detailed Description
Many treatments used for women with vulvodynia are based solely upon expert opinion. This randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT) and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects modeling was used to make use of all available data. Participants had statistically significant decreases in pain severity (p's\<.001) with 42% of the overall sample achieving clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at one-year follow-up in both groups. Participants in the CBT condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the SPT condition (p's\<.05). Findings from the present study suggest that psychosocial treatments for vulvodynia are effective. CBT, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.
#Intervention
- BEHAVIORAL : Cognitive-Behavioral Therapy
- Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.
- BEHAVIORAL : Supportive Psychotherapy
- Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
|
#Eligibility Criteria:
Inclusion Criteria:
* Independently diagnosed with vulvodynia by two study physicians
Exclusion Criteria:
* Any conditions known to better account for the vulvar pain
* Psychotic illness
* Actively suicidal
* Substance dependent
* Life-threatening illness
* Initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00607490
|
{
"brief_title": "A Randomized Clinical Trial for Women With Vulvodynia",
"conditions": [
"Vulvodynia"
],
"interventions": [
"Behavioral: Supportive Psychotherapy",
"Behavioral: Cognitive-Behavioral Therapy"
],
"location_countries": null,
"nct_id": "NCT00607490",
"official_title": "Cognitive-behavioral Therapy for Vulvodynia: a Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-03",
"study_completion_date(actual)": "2005-03",
"study_start_date(actual)": "2000-09"
},
"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)": "2016-05-23",
"last_updated_that_met_qc_criteria": "2008-02-04",
"last_verified": "2008-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-05",
"first_submitted": "2008-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several drugs with different ways of inhibiting the cell growth. In this trial, standard chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will be combined with a new drug called Selinexor.
Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus which control the cell growth.
#Intervention
- DRUG : Selinexor
- Patients receive Selinexor as specified in arm/group description (8 doses of 40 mg/m\^2 or 6 doses of 60 mg per induction cycle).
- Other Names :
- KPT-330
- DRUG : Idarubicin
- Infusion, iv, 10 mg/m\^2, on days 1,3,5 in cycle 1, on days 1,3 in cycle 2
- DRUG : Cytarabine
- Continuous infusion day 1 to 7, 100 mg/m\^2, iv,
- Other Names :
- Ara-C
|
#Eligibility Criteria:
Inclusion Criteria:
* Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3)
* Patients must have relapsed/refractory disease (relapse after stem cell transplantation is permitted) as defined as:
1. patients with <PR after first cycle of induction chemotherapy, or
2. patients with <CR(i) after second cycle of induction chemotherapy, or
3. patients who relapse after conventional chemotherapy or
4. patients who have undergone a single stem cell transplantation and who have relapse of their AML.
* Men and women aged >=18 years and eligible for standard dose of chemotherapy (7+3);
* A period of at least 3 weeks needs to have elapsed since last treatment (with the exception of hydroxyurea) before participating in this study. Hydroxyurea induction therapy to reduce peripheral blast counts is permitted prior to initiation of treatment on protocol. Treatment may begin in <3 weeks from last treatment if deemed in the best interest of the patient after discussion with the PI of the study;
* ECOG performance status <= 2
* Serum biochemical values with the following limits unless considered due to leukemia: creatinine <=2 mg/dl; total bilirubin <=2x ULN, unless increase is due to hemolysis or congenital disorder; transaminases (SGPT or SGOT) <=2.5x ULN.
* Ability to swallow and retain oral medication;
* Ability to understand and provide signed informed consent;
* Cardiac ejection fraction must be >=50% (by echocardiography).
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* Treatment with any investigational agent within four weeks.
* Cumulative anthracycline dose (daunorubicin or equivalent) >360 mg/m^2
* HIV infection
* Presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to:
* Presence of CNS leukemia
* Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery.
* For patients after SCT as part of prior treatment:
1. Necessity of immunosuppressive drugs
2. GvHD > grade 1
* Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
* Ongoing cardiac dysrhythmias of NCI CTCAE >= Grade 2.
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
* Clinically significant bleeding within 1 month
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
|
NCT02249091
|
{
"brief_title": "A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)",
"conditions": [
"Acute Myeloid Leukemia (Relapsed/Refractory)"
],
"interventions": [
"Drug: Cytarabine",
"Drug: Selinexor",
"Drug: Idarubicin"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02249091",
"official_title": "An Investigator-Initiated Study To Evaluate Ara-C and Idarubicin in Combination With the Selective Inhibitor Of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Relapsed Or Refractory AML",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-31",
"study_completion_date(actual)": "2018-07-31",
"study_start_date(actual)": "2014-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-25",
"last_updated_that_met_qc_criteria": "2014-09-23",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-25",
"first_submitted": "2014-09-16",
"first_submitted_that_met_qc_criteria": "2021-08-01"
}
}
}
|
#Study Description
Brief Summary
As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.
Detailed Description
This is a multicenter, open-label, single arm study designed to demonstrate durability of the treatment effect and to evaluate the short-term and longer-term safety profile of the Alair System in the United States in the intended use population (patients 18 years and older with severe persistent asthma).
#Intervention
- DEVICE : Alair System
- Treatment of airways with the Alair System
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is an adult between the ages of 18 <= age <= 65.
* Subject is able to read, understand, and sign a written Informed Consent to participate in the study and able to comply with the study protocol.
* Subject has asthma and is taking regular maintenance medication that includes:
1. Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting β2-agonist (LABA) at a dosage of >=80μg per day Salmeterol or equivalent.
2. Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
3. Oral corticosteroids (OCS) at a dosage of up to, but not greater than 10mg per day are acceptable.*
* Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.
* Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
* Subject is able to undergo outpatient (same day) bronchoscopy in the opinion of the investigator or per hospital guidelines.
* Subject has at least 2 days of asthma symptoms in the last 4 weeks.
* Subject has an AQLQ score during the baseline period of 6.25 or less.
* NOTE: Subjects on a dosage regimen of 20mg OCS every other day may be included as this is equivalent to an average daily dosage of 10mg.
Exclusion Criteria:
* Subject is participating in another clinical trial within 6 weeks of the Baseline Period involving respiratory intervention that could affect the outcome measures of this Study.
* Over the last 7 days of a 4 week medication stable period, subject requirement for rescue medication use other than for prophylactic use for exercise exceeds an average of:
1. 8 puffs per day of short-acting bronchodilator, or
2. 4 puffs per day of long-acting rescue bronchodilator, or
3. 2 nebulizer treatments per day. At the discretion of the Principal Investigator, subjects considered as unstable on baseline medications may have medications adjusted and re-evaluated after a 4 week medication stabilization period.
* Subject has a post-bronchodilator FEV1 of less than 65%.
* Subject has a history of life-threatening asthma, defined by past intubation for asthma, or ICU admission for asthma within the prior 2 years.
* Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year.
* Subject has had 4 or more infections of lower respiratory tract (LRTI) requiring antibiotics in the past 12 months.
* Subject has had 4 or more pulses of systemic corticosteroids (tablets, suspension or injection) for asthma symptoms in the past 12 months.
* Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
* Subject has other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (asthma, immediate cutaneous reactivity to A. fumigatus, total serum IgE of >1000ng/mL, elevated specific IgE and IgG to A. fumigatus with or without evidence of central bronchiectasis).
* Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
* Subject currently has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy, or stroke.
* Subject has a known aortic aneurysm.
* Subject has significant co-morbid illness such as cancer, renal failure, liver disease, or cerebral vascular disease.
* Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
* Subject has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
* Subject has coagulopathy (INR > 1.5).
* Subject has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.
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
|
NCT01350336
|
{
"brief_title": "Bronchial Thermoplasty in Severe Persistent Asthma",
"conditions": [
"Severe Asthma"
],
"interventions": [
"Device: Alair System"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT01350336",
"official_title": "Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-12",
"study_completion_date(actual)": "2020-03-17",
"study_start_date(actual)": "2011-04-07"
},
"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)": "2021-03-05",
"last_updated_that_met_qc_criteria": "2011-05-06",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-09",
"first_submitted": "2011-04-15",
"first_submitted_that_met_qc_criteria": "2021-02-13"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients
#Intervention
- DRUG : CCR2 Antagonist
- Tablets, Oral, 50 mg, once daily, 12 weeks
- Other Names :
- BMS-741672
- DRUG : Placebo
- Tablets, Oral, 0mg, once daily, 12 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Drug-naive Type 2 diabetics with a screening HbA1c of >= 7.5% and <= 10%
* Screening FPG >= 140 mg/dL and <= 220 mg/dL
* BMI <= 40 kg/m2
Exclusion Criteria:
* Active tuberculosis
* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis
* Significant cardiovascular history or gastrointestinal disorders
* History of unstable or rapidly progressing renal disease
* Active liver disease and/or significant abnormal liver function
* Abnormal chest x-ray at screening indicative of tuberculosis or other infection
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
|
NCT00699790
|
{
"brief_title": "Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance",
"conditions": [
"Type 2 Diabetes"
],
"interventions": [
"Drug: CCR2 Antagonist",
"Drug: Placebo"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT00699790",
"official_title": "A 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2009-02"
},
"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)": "2015-10-12",
"last_updated_that_met_qc_criteria": "2008-06-17",
"last_verified": "2015-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-18",
"first_submitted": "2008-06-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that participate in a Stress Reduction Intervention show a brain activation pattern (assessed by MRI) indicative of improved emotion regulation compared to an active control intervention.
#Intervention
- BEHAVIORAL : Stress Reduction Intervention
- eight week group program, plus daily homework practice
- BEHAVIORAL : Active Control intervention
- weekly group meetings for eight weeks, plus daily homework practice
|
#Eligibility Criteria:
Inclusion Criteria:
* participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects' by Dr. Elizabeth Hoge
Exclusion Criteria:
* metallic implants
* left handed
* epileptic seizures
* head trauma
* weight over 350 pounds
* claustrophobia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01128309
|
{
"brief_title": "Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain",
"conditions": [
"Generalized Anxiety Disorder"
],
"interventions": [
"Behavioral: Stress Reduction Intervention",
"Behavioral: Active Control intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01128309",
"official_title": "Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-04",
"study_completion_date(actual)": "2011-04",
"study_start_date(actual)": "2010-05"
},
"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)": "2012-05-07",
"last_updated_that_met_qc_criteria": "2010-05-20",
"last_verified": "2012-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-21",
"first_submitted": "2010-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The short term effects of TCC exercise are the significant increase in serum insulin and insulin resistance, and the significant decrease in serum TC, HDL-C, ET-1 and insulin sensitivity in TCC practitioners. TCC might be benefit the health of its practitioners through the regulation of lipid and glucose metabolism and endothelial function.
Detailed Description
Tai Chi Chuan (TCC) has been shown to be beneficial to the health. However, its effects on lipid and glucose metabolism are not fully understood. This study investigated the short term effect of TCC exercise on lipid and glucose metabolism and endothelial function in TCC practitioners. Twenty-one TCC practitioners and nineteen normal controls were included in this study. The hemodynamics, serum insulin, indices of insulin resistance/sensitivity, serum endothelin-1 (ET-1), blood lipids and aldosterone before and 30 min after a rest or a session of classical Yang's TCC exercise were compared.
#Intervention
- BEHAVIORAL : Classical Yang's TCC exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* TCC practitioners in a TCC training center in Taiwan > 50 years
* Healthy subjects without TCC experience > 50 years
Exclusion Criteria:
* Subjects who had major cardiopulmonary disease
* Subjects who have diabetes mellitus, renal or liver disease
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03503084
|
{
"brief_title": "Short-term Effects of Tai Chi Chuan Exercise on the Regulation of Lipid and Glucose Metabolisms and Endothelial Function",
"conditions": [
"Physiological Effect of TCC on Glucose Metabolism"
],
"interventions": [
"Behavioral: Classical Yang's TCC exercise"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03503084",
"official_title": "The Effect of Tai Chi Chuan on the Endothelin, Insulin, Blood Lipid, Blood Sugar, Aldosterone and Hemodynamics in the Elderly Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11-30",
"study_completion_date(actual)": "2009-12-31",
"study_start_date(actual)": "2009-05-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-04-19",
"last_updated_that_met_qc_criteria": "2018-04-11",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-19",
"first_submitted": "2018-03-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose is to establish chest auscultation data and related clinical data for diagnosing heart and lung diseases.
Detailed Description
The incidence of cardiovascular diseases worldwide is steadily increasing. According to the report of the American Heart Association, there were 271 million cardiovascular diseases in 1990, and 523 million cases in 2019, about doubling in 30 years. The number of deaths due to cardiovascular disease is also steadily increasing from 12.1 million in 1990 to 18.6 million in 2019.
Physical examination, which is the most basic skill in patient care, consists of inspection, auscultation, percussion, and palpation. Among them, auscultation is the most widely used test in all areas where a stethoscope is used, and it is a basic examination that is essential from primary medical institutions to tertiary medical institutions for non-invasive initial diagnosis in patients complaining of chest symptoms.
However, if a specialist in the field with a lot of experience does not interpret it carefully, it is difficult to make a decision, and the deviation of the test results is large, so a significant number of patients depend on expensive follow-up tests (ultrasound, CT, MRI, etc.) This leads to a vicious cycle of incurring costs and unnecessary treatment.
Recently, with the development of machine learning techniques, computing technologies, and artificial intelligence (AI) based on a lot of data, various learning technologies are applied as tools for disease diagnosis and prognosis prediction in medicine.
Through machine learning-based chest auscultation sound analysis, there is an expectation that disease diagnosis and prognosis prediction will be able to overcome differences and interpretations by examiners. It can be very helpful in preventing overuse of tests and reducing medical costs.
#Intervention
- DIAGNOSTIC_TEST : Chest auscultation
- Chest auscultation data
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults who are 20 years and older
Exclusion Criteria:
* Patient refusal
* Uncertain radiographs
* Uncertain tests results
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05320900
|
{
"brief_title": "Data Construction Project for Artificial Intelligence Learning: Chest Auscultation Sound Data",
"conditions": [
"Auscultation for Clinical Evaluation"
],
"interventions": [
"Diagnostic Test: Chest auscultation"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05320900",
"official_title": "Data Construction Project for Artificial Intelligence Learning: Chest Auscultation Sound Data",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-30",
"study_completion_date(actual)": "2022-12-31",
"study_start_date(actual)": "2022-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-26",
"last_updated_that_met_qc_criteria": "2022-04-07",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-11",
"first_submitted": "2022-03-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that Tadalafil treatment, by lowering Myeloid Derived Suppressor Cells (MDSCs) and regulatory T cells (Tregs), can prime an antitumor immune response and promote a permissive environment that should increase the efficacy of anti-tumor vaccine in a setting of minimal residual disease.
Detailed Description
This study is halting accrual at the end of the phase 1 portion of the study as data from the phase I study suggest that an alternative approach for the phase 2 portion of the study be undertaken. A newly designed Phase II trial is being developed and will be submitted as a new study protocol.
#Intervention
- DRUG : Tadalafil
- Tadalafil tablets administered by mouth. Dose will be between 10 to 20 mg adjusted depending on patient's body weight. On course 1, Tadalafil will be administered daily for 19 consecutive days. On Course 2 through 4, Tadalafil will be administered daily for 14 consecutive days. No Tadalafil will be provided on Course 5.
- Other Names :
- Cialis
- BIOLOGICAL : Anti-MUC1 Vaccine
- 300 uL Anti-MUC1 vaccine will be administered intramuscularly in the right upper limb. Anti-MUC1 vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5.
- Other Names :
- Hiltonol
- BIOLOGICAL : Anti-Influenza Vaccine
- 300 uL Anti-Influenza vaccine will be administered intramuscularly in the left upper limb. Anti-Influenza vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5.
- Other Names :
- Flublok
- OTHER : Tadalafil Placebo
- Placebo tablets mimicking Tadalafil administered by mouth. On course 1, Tadalafil Placebo will be administered daily for 19 consecutive days. On Course 2 through 4, Tadalafil placebo will be administered daily for 14 consecutive days. No Tadalafil Placebo will be provided on Course 5.
- OTHER : Anti-MUC1 Vaccine Placebo
- Placebo for Anti-MUC1 vaccine will be administered intramuscularly in the right upper limb. Placebo for Anti-MUC1 vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5..
- OTHER : Standard of Care Treatment
- Treatment according to prescribed standard of care regimen.
- OTHER : Anti-Influenza Vaccine Placebo
- Placebo for Anti-Influenza vaccine will be administered intramuscularly in the left upper limb. Placebo for Anti-Influenza vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5.
|
#Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven recurrent or second primary HNSCC of the oral cavity, oropharynx, hypopharynx or larynx (second primary includes unknown primary)
* Stage III or IV (AJCC, 7th ed., 2010) recurrent or second primary HNSCC (For recurrent tumors, staging is determined by the recurrent stage, not by the original pretreatment stage.)
* Surgically resectable, recurrent or second primary HNSCC
* Prior radiation, with or without prior surgery and/or chemotherapy, to the head and neck for definitive treatment of HNSCC of the oral cavity, oropharynx, hypopharynx or larynx with previously documented complete clinical or radiographic response to initial treatment
* a. Prior radiation and any chemotherapy, must have been completed >4 months prior to biopsy-proven recurrence or second primary site disease
* b. Recurrent or second primary HNSCC arises within the previously irradiated field
* Age >= 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 or equivalent scale score. See Appendix D for equivalent scale criteria.
* Acceptable organ function as defined by all of the following:
* Alkaline phosphatase < 4.0 x upper limit of normal (ULN)
* Aspartate transaminase (AST) <= 2.5 x ULN
* Alanine transaminase (ALT) <= 2.5 x ULN
* calculated Creatinine Clearance >= 51ml/min as determined by the Cockcroft-Gault Equation:
* [(140-age) * (Weight in kg) * (0.85, if female)] / (72 * Cr)
* Suitable venous access to allow for all study related blood sampling (safety and research)
* Ability to understand and willingness to sign the written informed consent and Health Insurance Portability and Accountability Act (HIPAA) document/s.
Inclusion Criteria (non-randomized control)
* Biopsy-proven recurrent or second primary HNSCC of the oral cavity, oropharynx, hypopharynx or larynx (second primary includes unknown primary)
* Stage III or IV (AJCC, 7th ed., 2010) recurrent or second primary HNSCC (For recurrent tumors, staging is determined by the recurrent stage, not by the original pretreatment stage.)
* Surgically resectable, recurrent or second primary HNSCC
* Prior radiation with or without prior surgery and/or chemotherapy, to the head and neck for definitive treatment of HNSCC of the oral cavity, oropharynx, hypopharynx or larynx with previously documented complete clinical or radiographic response to initial treatment
* a. Prior radiation and any chemotherapy, must have been completed >4 months prior to biopsy-proven recurrence or second primary site disease
* b. Recurrent or second primary HNSCC arises within the previously irradiated field
* Age >=18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 or equivalent scale score.
* Suitable venous access to allow for all study related blood sampling (safety and research)
* Ability to understand and willingness to sign the written informed consent and HIPAA document/s.
Exclusion Criteria:
* Salvage surgery is not recommended as per National Comprehensive Cancer Network (NCCN) guidelines, or after multidisciplinary treatment evaluation, including those with surgically unresectable disease at primary site or regional lymph nodes
* Recurrent or second primary AJCC Stage I or II HNSCC (for recurrent tumors, staging is determined by the recurrent stage, not by the original pretreatment stage).
* Distant metastatic disease
* Recurrent or second primary HNSCC of the nasopharynx, paranasal sinuses, or cervical esophagus
* Use of Phosphodiesterase Type 5 (PDE5) inhibitors such as vardenafil (Levitra®), Tadalafil (Cialis®), and sildenafil citrate (Viagra®) <=15-days prior to (intended) enrollment
* Patients who have the intention to receive non-study PDE5 inhibitors and flu vaccination(s) anytime during the study will be excluded.
* Prior or known adverse reactions to PDE5 inhibitors, poly-ICLC (Hiltonol®), and prior dose(s) of Influenza vaccine including but not limited to their components
* History of severe or unstable cardiac or cerebrovascular disease:
* a. Myocardial infarction within the last 90 days
* b. Unstable angina or angina occurring during sexual intercourse
* c. New York Heart Association (NYHA) Class 2 or greater heart failure in the last 3 months.
* d. Uncontrolled arrhythmias
* e. Sustained hypotension (<90/50 mmHg) or uncontrolled Hypertension (>170/100 mmHg)
* f. Stroke within the last 6 months
* Therapy with nitrates, alpha-blockers, or cytochrome P450 (CYP3A4) inhibitors within 7-days prior to study treatment initiation and for whom stopping is unsafe and/or a safe substitute is not medically recommended. Some examples are provided in Appendix A.
* Positive Antinuclear Antibody Test (ANA)
* Immunosuppression or immunocompromised for reasons not directly related to patient's malignancy (e.g. HIV or kidney transplant)
* History of severe or life threatening autoimmune diseases [Exceptions: Mild autoimmune diseases determined at the discretion of the Investigator(s), e.g. psoriasis.]
* Unilateral blindness, hereditary retinal disorders, or at an increased risk of blindness
* Unilateral deafness, or severe hearing loss dependent upon hearing aid(s) for serviceable communication
* Female patients who are pregnant or breastfeeding. (Females of childbearing potential are required to have a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women.)
* Females of childbearing potential who refuse to practice effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 30-days after the last vaccination.
* Serious medical or psychiatric illness/condition, including alcohol or drug abuse likely in the judgment of the Investigator(s) to interfere with compliance to protocol treatment/research.
* Patients of vulnerable populations such as children less than 18 years, prisoners, institutionalized individuals or others likely to be vulnerable are not eligible for participation in this study.
Exclusion Criteria (non-randomized control)
* Salvage surgery is not recommended as per NCCN guidelines, or after multidisciplinary treatment evaluation, including those with surgically unresectable disease at primary site or regional lymph nodes
* Recurrent or second primary AJCC Stage I or II HNSCC (for recurrent tumors, staging is determined by the recurrent stage, not by the original pretreatment stage).
* Distant metastatic disease
* Recurrent or second primary HNSCC of the nasopharynx, paranasal sinuses, or cervical esophagus
* Use of PDE5 inhibitors such as vardenafil (Levitra®), Tadalafil (Cialis®), and sildenafil citrate (Viagra®) <=15-days prior to (intended) enrollment
* Patients who have the intention to receive non-study PDE5 inhibitors and flu vaccination(s) anytime during the study will be excluded.
* Positive Antinuclear Antibody Test (ANA)
* Immunosuppression or immunocompromised for reasons not directly related to patient's malignancy (e.g. HIV or kidney transplant)
* History of severe or life threatening autoimmune diseases [Exceptions: Mild autoimmune diseases determined at the discretion of the Investigator(s), e.g. psoriasis.]
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
|
NCT02544880
|
{
"brief_title": "PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC",
"conditions": [
"Head and Neck Squamous Cell Carcinoma",
"Head and Neck Cancer"
],
"interventions": [
"Other: Standard of Care Treatment",
"Biological: Anti-Influenza Vaccine",
"Other: Anti-Influenza Vaccine Placebo",
"Biological: Anti-MUC1 Vaccine",
"Other: Tadalafil Placebo",
"Other: Anti-MUC1 Vaccine Placebo",
"Drug: Tadalafil"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02544880",
"official_title": "PDE5 Inhibition Via Tadalafil (Cialis®) to Enhance Anti-Tumor MUC1 Vaccine Efficacy in Patients With Resectable, and Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase I/II Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-02",
"study_completion_date(actual)": "2021-06-08",
"study_start_date(actual)": "2016-04-25"
},
"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)": "2021-06-15",
"last_updated_that_met_qc_criteria": "2015-09-04",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-09",
"first_submitted": "2015-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The prevalence of the Burnout Syndrome (BS) or symptoms among Primary Health Care (PHC) providers is high and can affect their quality of life and clinical results. Mindfulness-based interventions (MBI) have been tested as promising interventions to manage chronic stress and BS in PHC providers.
The main goal of this study was to compare the efficacy of an eight week MBI (Group 1 or G1) on burnout symptoms in Brazilian PHC providers, compared to a briefer, four-week relaxation-based intervention (Group 2 or G2) and to a waiting list control group (Group 3 or G3). The initial hypothesis was that the MBI is superior to relaxation and to the waiting list group. A non-randomized controlled trial was performed, with mixed-methods evaluation (qualitative and quantitative).
Detailed Description
Study Design: a non-randomized pragmatic controlled trial was performed, with mixed-methods investigation.
Population: The target population of the study were PHC professionals from the city of Porto Alegre in the southern region of Brazil.
Sample: PHC professionals from 50 health units. A sample size calculation was performed, considering an effect size of 0.5 (moderate), with a statistical power of 80% and a confidence interval of 95%. Thus, 65 individuals in each group would be necessary, totaling 195 people distributed in the three groups, estimating a drop-out rate of 10%.
Inclusion criteria: 18 years or over, complete primary education at least, be interested in the objectives of this study and have consented to volunteer to participate in one of the three groups of interventions proposed, being a primary health care worker for at least six months and experiencing any kind of stress in relation to work.
Exclusion criteria: Have been practicing mindfulness, meditation, yoga or similar (tai chi chuan, qi gong) in the last six months, presence of diagnosed clinical diseases that would not allow adherence to the study, being in treatment for psychological or psychiatric problems, in the phase of therapeutic adjustment (less than three months of psychological or pharmacological interventions), be on medical leave of absence from work, dependence or abusive use of alcohol or other drugs, except for tobacco.
Recruitment and procedures: The study was publicized among all PHC units using informative pamphlets, and PHC managers were informed personally by the first author (DS) about the goals of the project. The professionals were dismissed during working hours for the meetings that took place in places available and previously scheduled with the heads of health services. All the volunteers were previously submitted to the study´s criteria for participation. Those who were interested underwent a brief evaluation using the Beck´s Depression Inventory (BDI), Self Reported Questionnaire (SRQ-20) (common mental disorders) and Self Reported Questionnaire (SRQ-A) (alcohol use) scales to exclude severe symptoms (suicidal ideation and alcohol abuse). After inclusion, volunteers were able to choose between the three participant groups of the study (mindfulness, relaxation, or waiting list). We did not randomize the professionals in order to make the study more feasible and pragmatic. Specifically, in a pilot study we had observed that the professionals were highly resistant to being randomly allocated to the study groups.
Ethics: This study was conducted according to the Declaration of Helsinki and was submitted to three Research Ethics Committees, respecting all the criteria for the execution of research with human beings.
All participants agreed to participate in the study and signed the Free and Informed Consent prior to any study procedure.
A drop-out was defined as a participant who completed fewer than four sessions.
Measures:
Added to sociodemographic data, the Maslach Burnout Inventory - General Survey) (MBI-GS ) was used to identify symptoms of BS, The Positive and Negative Scale (PANAS) to evaluate affection, Five Facet Mindfulness Questionnaire (FFMQ) to measure mindfulness dimensions; the Experience Scale to measure decentering and rumination (ES), and the Self-Compassion Scale (SCS) to measure compassion.
#Intervention
- BEHAVIORAL : 1- Mindfulness Intervention
- An intervention program integrating elements of Mindfulness Breathworks Institute Mindfulness based approaches for Pain and illness (MBPI), (Burch , 2009) and Mindfulness Based Stress Reduction (MBSR), (Kabat Zinn, 2003), and Mindfulness based Cognitive Therapy (MBCT) shall be used. All programs are highly structured, lasting eight weeks, with a weekly meeting about two hours , and working with four main techniques during these meetings : mindfulness in breathing, body scan, walking meditation and mindfulness yoga. In order to facilitate the home practice of meditation by participants during and after the intervention protocol, all will receive a CD containing guided meditation sessions, covering the above techniques.
- Other Names :
- Mindfulness Based Stress Reduction
- BEHAVIORAL : 2- Relaxation Intervention
- Eight meetings where the participants will practice relaxation techniques.
- Other Names :
- Relaxation
- OTHER : 3- Wait List Control Group
- No intervention
- Other Names :
- Wait List
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteers > 18 years who consent to be randomized to one of two groups, and
* have available time to join the research
Exclusion Criteria:
* Practitioners of mindfulness, meditation yoga or similar in last year,
* presence of not controlled greater severity diseases, such as cancer, schizophrenia, epilepsy, or other psychiatric diseases,
* alcohol or other drugs addiction or abuse, except tobacco, and
* being in acute treatment for psychological or psychiatric problems. All volunteers will undergo a brief initial clinical evaluation to assess whether the conditions of mental and physical health permit participation in groups.
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
|
NCT02387528
|
{
"brief_title": "Efficacy of a Mindfulness-Based Intervention Versus Relaxation in Primary Care Burnout Providers.",
"conditions": [
"Burnout Syndrome"
],
"interventions": [
"Behavioral: 1- Mindfulness Intervention",
"Other: 3- Wait List Control Group",
"Behavioral: 2- Relaxation Intervention"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02387528",
"official_title": "Efficacy of a Mindfulness-Based Intervention ('Breathworks for Stress') Versus Relaxation in the Symptoms of Burnout in Primary Care Providers: A Mixed-Methods Pragmatic Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2018-10-09",
"study_start_date(actual)": "2014-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-29",
"last_updated_that_met_qc_criteria": "2015-03-12",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-13",
"first_submitted": "2015-03-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients have hypertension more than 3 year,whether well-controlled or uncontrolled,
* scheduled for major abdominal surgery for at least 2 h
* under general anesthesia
* American Society of Anesthesiologists（ASA）physical status : II ~ III
* Age > 30
Exclusion Criteria:
* pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;
* ASA physical status >IV
* hepatic failure
* renal failure
* preoperative Mini-Mental State Examination (MMSE) score less than 24
* a history of cardiovascular surgery or craniotomy
* cardiac failure
* respiratory failure
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02147275
|
{
"brief_title": "Monitoring Hypertensive Patients's Cerebral Oxygen Saturation",
"conditions": [
"Surgical Complications From General Anesthesia",
"Hypertension",
"Cerebral Ischemia",
"Cerebral Anoxia"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT02147275",
"official_title": "Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery",
"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)": "2014-05"
},
"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)": "2014-11-11",
"last_updated_that_met_qc_criteria": "2014-05-23",
"last_verified": "2014-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-26",
"first_submitted": "2014-05-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers. The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Detailed Description
The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers.
Objective: The primary objective is to investigate gastro-intestinal complaints during 11 day duckweed consumption. Secondary objectives are to assess blood based parameters related to general health and urine based biomarkers for kidney function and to investigate consumer acceptance.
Study design: The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
Study population: We aim to include 24 healthy volunteers aged 18-50 years. Intervention: A 11-day intervention in which subjects will receive a daily lunch with 150-180g wet weight duck weed or spinach. Products will be incorporated in food products such as pasta, curry, soup etc.
Main study parameters/endpoints: The main study parameter is frequency and severity of gastro-intestinal complaints. Secondary outcomes are intestinal health parameters derived from blood and urine samples taken before and after the intervention.
#Intervention
- OTHER : Duckweed
- various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
- OTHER : Spinach
- various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
|
#Eligibility Criteria:
Inclusion criteria
* Apparently healthy men and women
* Age between 18 and 50 years
* Body mass index (BMI) between 18.5 and 24.9 kg/m2
Exclusion criteria
* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Kidney dysfunction (self-reported)
* Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
* Reported slimming, medically prescribed or vegan/vegetarian diet
* Current smokers
* Alcohol intake >=4 glasses of alcoholic beverages per day
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
* Abuse of illicit drugs
* Food allergies for products that we use in the study
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science & Health group of Wageningen Food & Biobased Research
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03677583
|
{
"brief_title": "Duckweed Intake Study",
"conditions": [
"Gastrointestinal Complication"
],
"interventions": [
"Other: Duckweed",
"Other: Spinach"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT03677583",
"official_title": "Tolerance of Regular Intake of Duckweed Based Food Products",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-14",
"study_completion_date(actual)": "2018-10-15",
"study_start_date(actual)": "2018-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-22",
"last_updated_that_met_qc_criteria": "2018-09-18",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-19",
"first_submitted": "2018-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study represents the second Phase 1 study with GSK376501 and the goal is to further evaluate its safety and tolerability. The way the human body processes GSK376501 will also be determined.
#Intervention
- DRUG : GSK376501
- DRUG : Placebo
- Other Names :
- GSK376501
|
#Eligibility Criteria:
Inclusion Criteria:
* The subject is healthy and overweight/obese, defined as having a body mass index greater than 25 but less than 35kg/m2, inclusive.
* The subject is an adult male or a female of non-childbearing potential between the age of 18 and 65 years, inclusive, at the time of signing informed consent.
* The subject and their partner are willing to use double-barrier method of contraception from the first day of study drug administration until 5 half-lives of the drug have elapsed following the last day of study drug administration.
* The subject demonstrates an ECG with values within ranges specified in the protocol at screening or baseline.
* The subject is capable of giving written informed consent, which includes the ability to read, comprehend and comply with the protocol requirements and restrictions as described in the consent form.
Exclusion Criteria:
* Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to any medication that is chemically related to the study drug or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation in the study.
* Has a known allergy to any of the tablet formulation excipients of GSK376501 or pioglitazone (as applicable).
* Has sensitivity to heparin or history of heparin-induced thrombocytopenia.
* Has a history of alcohol abuse or dependence within 12 months prior to the study.
* Has a positive alcohol test at screening or baseline and/or is unwilling to abstain from alcohol for 72 hours prior to the start of dosing until discharged from the clinic and for 72 hours prior to the follow-up visit.
* Is unwilling to abstain from caffeine- or xanthine-containing products for 24 hours prior to each dose and throughout each in-house period, and for 24 hours prior to the follow-up visit.
* The subject smokes or has used tobacco or nicotine-containing products within the 6 months prior to the study, or is positive for urine cotinine at screening or at baseline.
* Is unwilling to refrain from the use of tobacco or illicit drugs during the trial, and/or tests positive for urine cotinine or drugs of abuse at screening or at baseline. At minimum, the list of drugs or classes of drugs that will be screened for include the following: amphetamines, barbiturates, benzoylecgonine, benzodiazepines, cannabinoids, cotinine, and opiates.
* Where participation in the study would result in donation of blood in excess of 500 ml within a 56 day period.
* Has a systolic blood pressure outside the range of 140 to 90mmHg, a diastolic blood pressure outside the range of 90 to 60mmHg and/or a heart rate outside the range of 90 to 45bpm, inclusive, at screening or at baseline.
* Experiencing clinically significant ECG abnormalities at screening or at baseline.
* Has a history or current evidence of a positive HIV test.
* Has a history of or a positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* Has laboratory safety screening tests outside of ranges specified in the protocol at screening or at baseline. T.
* Pregnant or lactating women, or woman of childbearing potential.
* Has a history of rhabdomyolysis.
* Has congestive heart failure or a history of congestive heart failure with New York Heart Association Class I-IV symptoms
* Has a history of thyroid dysfunction or an abnormal thyroid function test as assessed by TSH at screening.
* Has a history or current evidence of sleep apnea.
* Has had previous exposure to GSK376501, with the exception of subjects randomized into a previously completed study with GSK376501 may participate only in the cohort evaluating pioglitazone.
* Has had treatment with any other new molecular entity (investigational drug) during the previous 30 days or 5 half-lives, or twice the duration of the biological effect of the drug (whichever is longer), prior to the first dose of current study medication. For the purposes of this study, a new molecular entity is defined as any compound that has not yet reached Phase 3 development. The washout is defined from last dose of study medication in the previous study until the first dose of study drug.
* Has been exposed to more than four new molecular entities within 12 months prior to the first dosing day.
* Has used the following prescription or non-prescription medications within 14 days or 5 half lives, whichever is longer, prior to the first dose of study medication: vitamins (at a dose greater than the recommended daily allowance), or dietary or herbal supplements, including St. John's Wort.
* Is unable or unwilling to discontinue use of acetaminophen 72 hours prior to each dose and throughout each in-house period and no use within 72 hours of the follow-up visit.
* Requires the use of a prohibited medication .
* Is unable or unwilling to abstain from the consumption of grapefruit or grapefruit juice for 7 days prior to the first dose of study medication until the final pharmacokinetic sample has been collected.
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
|
NCT00495014
|
{
"brief_title": "Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00495014",
"official_title": "A Single-Blind, Randomized, Placebo-Controlled, Ascending Single Dose and Repeat Dose Study With Once Daily Dosing To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 in Healthy Overweight and Obese Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-12",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2007-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-10-15",
"last_updated_that_met_qc_criteria": "2007-06-28",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-07-02",
"first_submitted": "2007-06-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of Adolescent Impact is to develop and evaluate a developmentally targeted intervention designed to minimize secondary transmission risk behavior and enhance adherence to care and treatment. The intervention is delivered in 12 sessions (five one-to-one, 7 group) over a 3 month period of time. Intervention is delivered in addition to standard of care treatment at the participant's respective clinic. Participants are randomized to either an intervention or control arm; the control group receives standard of care treatment and control group participants are offered the Adolescent Impact intervention following the completion of the nine-month follow up. It is hypothesized that compared to control group participants, intervention group participants will evidence (1) improved or stable virologic and/or immunologic status, mediated by (a) adherence to prescribed antiretroviral medication and/or (b) adherence to HIV care appointments, and (2) reduction/minimization of secondary transmission risk behaviors to include (a) unprotected sex and/or needle sharing, and (b) sexual and drug use behaviors that increase risk for unprotected sex.
Detailed Description
The primary objective of Adolescent Impact is to develop and evaluate a developmentally targeted intervention designed to minimize secondary transmission risk behavior and enhance adherence to care and treatment. The intervention is delivered in 12 sessions (five one-to-one, 7 group) over a 3 month period of time. Intervention is delivered in addition to standard of care treatment at the participant's respective clinic. Participants are randomized to either an intervention or control arm; the control group receives standard of care treatment and control group participants are offered the Adolescent Impact intervention following the completion of the nine-month follow up. It is hypothesized that compared to control group participants, intervention group participants will evidence (1) improved or stable virologic and/or immunologic status, mediated by (a) adherence to prescribed antiretroviral medication and/or (b) adherence to HIV care appointments, and (2) reduction/minimization of secondary transmission risk behaviors to include (a) unprotected sex and/or needle sharing, and (b) sexual and drug use behaviors that increase risk for unprotected sex.
#Intervention
- BEHAVIORAL : Adolescent Impact
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV infection
* Followed at one of the participating clinics for HIV care
* Age 13 <= age <= 21 at enrollment (i.e., must be enrolled prior to 22nd birthday)
* Aware of HIV status and, for perinatally infected teens, the HIV status of one's biological mother
* Able to comprehend English well enough to participate in the study
* Able to understand and sign a written informed consent or assent
* Parental or legal guardian consent, if under the age of 18 -
Exclusion Criteria:
* Less than borderline intellectual functioning, as evidenced by clinician assessment or full scale IQ less than 65
* Acute and severe mental illness (including, but not limited to, psychosis, severe depression, or significant suicidal or homicidal ideation) -
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00164385
|
{
"brief_title": "Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00164385",
"official_title": "Adolescent Impact: A Behavioral Intervention for Adolescents Living With HIV/AIDS",
"recruitment_information": null,
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-10-21",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2005-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-14",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to determine the effect of group mindfulness based cognitive counseling on social anxiety, assertiveness and self-confidence in nursing students and the relationship of these variables to change over time.
Detailed Description
This is a randomized controlled and single-center study. The universe of the research consisted of nursing students who applied for counseling within the scope of the announcement made on the department web page. The research will be carried out in a state university, Faculty of Health Sciences, Department of Nursing between February 22, 2022 - December 23, 2022. In the study, the assignment of students to the intervention and control groups was made by simple randomization. Participant Information Form, Liebowitz Social Anxiety Scale, Self-Confidence Scale and Assertiveness Inventory will be used to collect the data of the study. Data collection tools will be applied three times simultaneously with the control group as a pre-test at the beginning of the study, as a post-test at the last session of the intervention group ( 2 month), and as a follow-up test 6 months after the last session of the intervention group.
#Intervention
- BEHAVIORAL : Mindfulness based cognitive counseling group
- Intervention: The sessions were conducted by the researchers who received training in the field of Mindfulness Based Cognitive Therapy. Sessions are structured as follows; 'Awareness and autopilot, living in our minds, tidying up the dispersed mind, recognizing the unpleasant/version, allowing, ways to take care of oneself, turning to face difficulties, being stuck in the past, living in the present?'
|
#Eligibility Criteria:
Inclusion Criteria:
* Liebowitz social anxiety scale score >50
* 18 years or older
* Volunteering to participate in the study
Exclusion Criteria:
* Diagnosed with a mental disorders
* History of participating in a counseling program
* Currently receiving individual or group counseling
* Unable to attend more than two sessions
* Diagnosed with a physical or mental disorder during group sessions
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
|
NCT05602012
|
{
"brief_title": "Mindfulness Based Cognitive Counseling on Social Anxiety",
"conditions": [
"Social Anxiety",
"Assertiveness",
"Self Confidence"
],
"interventions": [
"Behavioral: Mindfulness based cognitive counseling group"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05602012",
"official_title": "The Effect of Mindfulness Based Cognitive Counseling Group for Social Anxiety, Assertiveness and Self-Confidence in Nursing Students",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-17",
"study_completion_date(actual)": "2023-03-22",
"study_start_date(actual)": "2022-02-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-27",
"last_updated_that_met_qc_criteria": "2022-10-31",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-11-01",
"first_submitted": "2022-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex 'Milieu Intérieur' study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data from healthy individuals to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success.
Detailed Description
Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex 'Milieu Intérieur' study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success. Hence, it will give important insights for the individually adapted treatment of patients.
#Intervention
- OTHER : Human biological samples
- Blood samples collection
|
#Eligibility Criteria:
Inclusion Criteria:
* Allergic subjects having done either an allergic reaction at least of grade 3 according to Müller1 or a quincke edema in response to a wasp sting or penicillin intake, otherwise considered as healthy by the investigator based on medical history, clinical examination and laboratory results (blood sampling for laboratory assessments should be done at V0 and only after signed informed consent).
* Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
* Wasp or penicillin allergic but otherwise healthy male and female aged between 20 and 69 years.
* 18.5 <= BMI >= 32 kg/m2
* Ability to give their consent in writing
* Must understand spoken and written French
* Affiliated to the French social security or assimilated regimes
Exclusion Criteria:
* Subjects who cannot participate according to their status on the registry mentioned at Art L.1121 <= age <= 16 of the French Public Health Code
* Participation in another Clinical study in the last 3 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or medical device) or concurrent participation in another clinical study during the study period
* Travel in (sub-)tropical countries within the last 3 months
* For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal
* Any physical exercise within the last 8 hours before inclusion (V1) and before (V2)
* Presence of evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential patient unable/unlikely to participate in the study satisfactorily.
* Severe/chronic/recurrent pathological conditions,
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the V0, V1 or V2. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for > 2 weeks (inhaled and topical steroids allowed)
* Chronic administration of NSAIDs, including aspirin: prolonged intake (> 2 weeks) within 6 months before [exception for low dose aspirin: maximum 250mg/daily, see 5.1]
* Receipt of any vaccination 3 months before the inclusion or planning to receive any vaccination during the study
* Receipt of blood products or immunoglobulins within 3 months prior the inclusion or planning to receive blood products or immunoglobulins during the study
* Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
* Platelet count less than 120.000/mm3
* ALAT and/or ASAT > 3 times the upper limit of the norm (ULN)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03219827
|
{
"brief_title": "Pilot Study: Characterization of the Immune Phenotype of Patients Allergic to Wasp Venom or Penicillin",
"conditions": [
"Allergy"
],
"interventions": [
"Other: Human biological samples"
],
"location_countries": [
"France"
],
"nct_id": "NCT03219827",
"official_title": "Pilot Study: Characterization of the Immune Phenotype of Patients Allergic to Wasp Venom or Penicillin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-29",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2017-06-13"
},
"study_design": {
"allocation": "NON_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)": "2024-06-05",
"last_updated_that_met_qc_criteria": "2017-07-13",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-18",
"first_submitted": "2017-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aim of the current study was to evaluate the effect of Aloe vera gel as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
Detailed Description
The effect of Aloe vera on treatment of chronic periodontitis will be evaluated in a randomized, controlled clinical trial. Thirty patients with mild to moderate chronic periodontitis were divided into 2 groups: group 1 (test): will include 15 patients treated with SRP followed by application of Aloe vera gel in the periodontal pockets at day 1 and after 1 and 2 weeks, and group 2 (control) which includes 15 patients treated with SRP only.
#Intervention
- OTHER : Aloe vera after SRP
- Subgingival administration of Aloe vera gel was preceded by flushing the area with saline to wash away any debris. Aloe vera (1cc) gel was applied subgingivally using atraumatic needle. Patients were instructed not to rinse or drink any liquid for at least 30 minutes. The application was performed at baseline and after 1 and 2 weeks.
- PROCEDURE : Scaling and root planing (SRP)
- Removal of supragingival and sub-gingival calculus and debris was performed, followed by smoothing root surfaces and removing cementum or dentine that is impregnated with calculus and toxins.
|
#Eligibility Criteria:
Inclusion Criteria:
* Systemically healthy individuals.
* Patients with mild to moderate chronic periodontitis (CAL 1 <= age <= 4mm) according to the American Academy of Periodontology classification
Exclusion Criteria:
* Smoking and alcoholism.
* Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy, conditions leads to xerostomia).
* Patients on any medication affecting the periodontium.
* Lactating, pregnant or menopausal females.
* Patients with parafunctional habits.
* Patients with poor oral hygiene.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04615585
|
{
"brief_title": "Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis",
"conditions": [
"Chronic Periodontitis"
],
"interventions": [
"Procedure: Scaling and root planing (SRP)",
"Other: Aloe vera after SRP"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04615585",
"official_title": "Evaluation of Local Delivery of Aloe Vera Gel as an Adjunct to Non-surgical Treatment in Patients With Chronic Periodontitis (A Randomized, Clinical Trial)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-28",
"study_completion_date(actual)": "2020-07-30",
"study_start_date(actual)": "2018-07-15"
},
"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)": "2020-11-04",
"last_updated_that_met_qc_criteria": "2020-10-29",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-04",
"first_submitted": "2020-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. The availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. An online default option (i.e., prefilled grocery shopping cart) was previously shown to positively impact food selection in an online grocery shopping task.The present study provides preliminary evidence for the efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity.
Detailed Description
Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. The present study provides preliminary evidence for the efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity.
In behavioral economics, the default option refers to the option a consumer selects if no active choice is made. This study aims to determine whether the use of a default prefilled online grocery shopping cart results in the purchase of healthier food items in individuals with food insecurity, compared to nutrition education. The default approach, a non-monetary intervention that manipulates choice architecture, improves food choice behaviors in individuals facing significant financial constraints. The intervention is potentially broadly scalable via online platforms.
It was hypothesized that the default option effectively increases the nutritional quality of foods purchased online, compared to nutrition education.
Fifty participants recruited from food pantries in New York in 2018 were randomized to: (1) review nutrition information before selecting groceries for a week using a local grocery store's online shopping and delivery service (n = 23) or (2) modify a default prefilled online shopping cart containing groceries that meet nutritional guidelines according to their personal preferences (n = 27).
Primary outcome measures capture the nutritional quality of groceries purchased. Our primary nutritional outcomes include servings of whole grains fruits and vegetables, fiber, daily calories, fat, saturated fat, sodium and cholesterol content.
#Intervention
- BEHAVIORAL : Default Option While Online Grocery Shopping
- The 'default option' is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g. opt-out 401K plans, which significantly increase enrollment, compared to active sign up). Participants in the default condition were presented with a prefilled online shopping cart containing groceries that met nutritional requirements based on participants' gender and age.
- BEHAVIORAL : Nutrition Education
- The nutrition education materials were adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance ('Eat Smart New York').
|
#Eligibility Criteria:
Inclusion Criteria:
* age >= 18 years
* single person household
* fluent in written and spoken English
* able to provide informed consent
* food-insecure (verbal agreement that they consider themselves to be of that category) but not currently receiving SNAP benefits (as they would otherwise have access to twice the amount of benefits typically allocated; please note that all participants will be provided with information about enrollment in SNAP following study participation)
* current residence in a zip code served by Price Chopper's delivery program
Exclusion Criteria:
* None of the following dietary restrictions: vegetarian/vegan, gluten-free/celiacs disease, and lactose intolerant
* current residence outside of a zip code served by Price Chopper's delivery program
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
|
NCT03952949
|
{
"brief_title": "A Default Option to Enhance Dietary Quality in Participants With Food Insecurity",
"conditions": [
"Nutrition Poor"
],
"interventions": [
"Behavioral: Nutrition Education",
"Behavioral: Default Option While Online Grocery Shopping"
],
"location_countries": null,
"nct_id": "NCT03952949",
"official_title": "A Default Option to Enhance Dietary Quality in Participants With Food Insecurity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-28",
"study_completion_date(actual)": "2017-10-28",
"study_start_date(actual)": "2017-01-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-16",
"last_updated_that_met_qc_criteria": "2019-05-14",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-16",
"first_submitted": "2019-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.
#Intervention
- PROCEDURE : Regional pain control
- Regional pain catheter
- PROCEDURE : Local pain control
- Local intraarticular pain catheter
|
#Eligibility Criteria:
Inclusion Criteria:
* Indication to Total Knee Arthroplasty
* Signed informed consent
Exclusion Criteria:
* Chronic pain
* Allergy against local anaesthetics
* Not understanding study or questionnaires
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
|
NCT03032133
|
{
"brief_title": "Pain Control After Total Knee Arthroplasty",
"conditions": [
"Knee Osteoarthritis"
],
"interventions": [
"Procedure: Local pain control",
"Procedure: Regional pain control"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03032133",
"official_title": "Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-12",
"study_start_date(actual)": "2016-02"
},
"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)": "2019-02-12",
"last_updated_that_met_qc_criteria": "2017-01-24",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-26",
"first_submitted": "2017-01-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Purpose: To evaluate the performance of AKIpredictor, a computer-based algorithm that predicts the development of AKI in the 7 days following ICU admission, by comparing it with similar predictions made by attending physicians.
Primary objective: To compare the performances of AKIpredictor and physicians in predicting AKI stage 2 or 3 in the 7 days following ICU admission Secondary objective(s): To investigate the influence of the level of seniority of the physician on the accuracy of the predictions; feasibility of making predictions within a 3 hour window for physicians Trial Design: Monocentric, prospective, longitudinal, non-interventional Endpoints: Primary: comparing the area under the ROC curves of the AKIpredictor and physicians.
Secondary: estimation of PPV, NPV, sensitivity and specificity of both predictors at different thresholds; evaluation of alternative negative endpoints (ICU readmission after discharge, death); subgroup analyses.
Sample Size: This is a pilot study. Sample size calculations to obtain sufficient power are not feasible due to lack of previous studies. The investigation will be conducted with a preset end time on June 30th. The investigators expect to include approximately 150 patients.
Summary of eligibility criteria: All adult patients admitted to UZ Leuven's surgical ICU in the period of the study, with the exclusion of those with end-stage renal disease or AKI already present at the time of admission
Detailed Description
Inclusion and exclusion criteria:
All adult patients admitted to the UZ Leuven's ICU after the approval of the study by the local Ethical Committee and before June 30th 2018 will be included in the study. The only exclusion criteria will be the presence of end-stage renal disease before or of AKI on ICU admission.
Computer predictions:
Elements from laboratory reports, clinical history and physiological monitoring will be used both by clinicians and by the computer algorithm to estimate the risk of AKI. Such measurements are part of the routine standard care in the ICU: no additional exam will be required for this study. These values are regularly stored in the electronic health care system (KWS, Klinisch Werkstation and iMDsoft's MetaVision). They will be retrieved in read-only mode when needed for formulating the predictions. The retrieval will take place regularly on a weekly basis in order to limit the amount of time that patients' identification data will be stored for the study.
In detail, the following parameters will be used by the computer model:
* upon admission: age, baseline serum creatinine (lowest value of the previous 3 months; if not available, calculated using the Schwartz formula), surgical or medical category (transplant surgery / cardiovascular surgery / abdominal or pelvic surgery / thoracic surgery / other: medical, trauma, other surgery), planned admission (yes / no), history of diabetes (yes / no), blood glucose, suspected sepsis (yes / no), and hemodynamic support (none / mechanical / pharmacological / both);
* on the first morning after admission: serum creatinine (measured in the morning), APACHE II score, blood lactate (worst value since admission), total bilirubin, and hours of ICU stay;
* at 24h after admission: hourly urine output, doses of inotropes and vasopressors, and continuous arterial blood pressure values.
Physicians predictions:
Physicians' predictions will be collected alternatively through interviews conducted personally by one of the investigators or by means of a questionnaire compiled by the physicians themselves. To parallel the timing of AKIpredictor, clinicians' predictions will be gathered at three time-points:
* admission predictions: at the earliest after admission (up to 3h);
* morning predictions: on the first morning after admission, right before or after the handoffs that take place between 8.30 and 9.00 AM;
* 24h predictions: at 24h after admission (up to 24h+3h).
Interviews to multiple physicians about the same patient in the same time frame will be encouraged, as long as they are not influenced by one another (junior resident, senior resident, staff member).
In every prediction, both a continuous (on a 0-100 % scale) and a binary (yes / no) estimate of AKI risk will be inquired. A self-assessed degree of confidence about the prediction will also be tracked (very confident / medium confident / not confident at all). The exact time at which the human prediction is collected will be saved. Finally, data about the clinician expressing the prediction will be tracked: age, gender, seniority (see above), years of ICU experience.
Endpoint assessment The effective development of AKI will be diagnosed in agreement with the 2012 KDIGO guidelines \[1\]. To take into account AKI occurring outside the ICU where hourly measurements of urine output are not recorded, only the creatinine criterion will be used. Serum creatinine values will be collected from the electronic health record system KWS (Klinisch WerkStation) each day for 7 days following ICU admission. This biochemical exam is routinely performed on a daily basis in any hospitalized patient unless considered at low risk for complications, and it is always required if there's suspicion of an acute renal insult. For these reasons, potential missing creatinine values will be considered evidence of an improving patient and absence of AKI for that day.
ICU discharge and eventual readmission will also be tracked for secondary analyses. The death of the patient will also be recorded and included among the negative outcomes.
Assessment of efficacy The efficacy of both predictors will be evaluated with the construction of ROC curves. Due to the lack of previous studies on the subject, a current estimate of the accuracy of clinicians' prediction of AKI is not currently available. Appropriate sample size calculations to obtain sufficient power are therefore not feasible at the moment. Statistical analysis will be performed at the end of the data collection as follows. A ROC curve will be plotted both for the computer-based AKIpredictor and the continuous (%) estimate of AKI risk assessed by the clinicians at each of the three time-points (upon admission, on day 1 and at 24 hours). The area under the curve (AUC) of each plot will be calculated. The AUCs will then be compared in pairs by bootstrapping, and a significance value of the comparison will be derived. Subgroup analysis will be performed with the same approach.
Ethics and regulatory approvals:
The trial will be conducted in compliance with the principles of the Declaration of Helsinki (current version) and the principles of good clinical practice. This protocol will be submitted to the ethical committee of the UZ Leuven. Any eventual subsequent protocol amendment will also be submitted to the ethical committee and Regulatory Authorities for approval.
By virtue of its non-interventional nature and that all the data will be stored in anonymized fashion, informed consent will not be required from the subjects if this is deemed appropriate by the local Ethical Committee. The investigators shall treat all information and data relating to the study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the study. The collection, processing and disclosure of personal data, such as patient health and medical information is subject to compliance with applicable personal data protection and the processing of personal data (Directive 95/46/EC and Belgian law of December 8, 1992 on the Protection of the Privacy in relation to the Processing of Personal Data).
#Intervention
- OTHER : Computer model predictions of acute kidney injury
- Comparison of the performances of AKIpredictor and physicians in predicting AKI stage 2 or 3 in the 7 days following ICU admission
|
#Eligibility Criteria:
Inclusion Criteria:
* All adult patients admitted to UZ Leuven's surgical ICU in the period of the study
Exclusion Criteria:
* Patients with end-stage renal disease or AKI already present at the time of admission
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
|
NCT03574896
|
{
"brief_title": "Acute Kidney Injury Predictor Validation Study",
"conditions": [
"Critical Illness",
"Acute Kidney Injury"
],
"interventions": null,
"location_countries": [
"Belgium"
],
"nct_id": "NCT03574896",
"official_title": "Prospective Validation of the AKIpredictor Through Comparison With Predictions of Acute Kidney Injury by ICU Physicians",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-30",
"study_completion_date(actual)": "2018-09-01",
"study_start_date(actual)": "2018-05-02"
},
"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)": "2022-09-23",
"last_updated_that_met_qc_criteria": "2018-06-29",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-02",
"first_submitted": "2018-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
With the advancement in microprocessor technology and better understanding of pharmacodynamics and pharmacokinetics of anaesthetic agents, computer facilitated closed loop control of anaesthesia using propofol has been shown to be accurate with better performance than manual control. Literature on computer controlled administration of inhalational anaesthetics is few, as it requires the computer to control the dial setting on the vapouriser. The investigators intend to compare the computer controlled closed loop administration of isoflurane by infusing it into the anaesthetic circuit with conventional vaporiser control in elective open heart surgery.
40 patients (ASA (American Society of Anesthesiology) class II-IV; 18- 65 years) undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) will be randomly divided into manual or closed loop groups. Propofol will be used for induction of anaesthesia in both groups followed by isoflurane for maintenance. In the manual group, isoflurane will be administered through the Tech 7 vapouriser during pre and post CPB periods to target bispectral index (BIS) of 50. In closed loop group, isoflurane will be administered using infusion of liquid isoflurane into expiratory limb of the closed circuit. This rate of infusion though a conventional syringe pump will be controlled by algorithm termed 'Improvised Anaesthetic Agent Delivery System' (IAADS) to maintain BIS of 50. Patients in both groups will receive 500ml of 100 % oxygen as fresh gas flow. The % of time bispectral index (BIS) is within the 10 of set target BIS of 50 will be the primary outcome measure. The secondary outcome measures will be median performance error (MDPE)(2), median absolute performance error (MDAPE)(2), wobble(2), divergence(2), amount of isoflurane used and hemodynamic parameters will be secondary outcome measures.
Detailed Description
The basic components in a closed loop anesthesia delivery system are: (1) a system under control- patient; (2) a controlled variable that measures depth of anesthesia, (3) a set point for this variable specified by the user, (4) an actuator which comprises an algorithm to translate a measured value of the controlled variable to a particular action or the actuator to steer the controlled variable closer to the target variable.
In the proposed study, the controlled variable will be BIS. The control actuator is a patented (2158/DEL/2007) pharmacodynamic- pharmacokinetic model based adaptive infusion system termed 'Improved Anesthetic Agent Delivery System (IAADS'). An IBM compatible with PENTIUM 2 or higher processor personal computer (2 GHz) is used to implement the control algorithm, provide a user interface and control communication through serial ports (RS 232) with the infusion system (Pilot- C, Frasenius, France) and a Datex vital sign monitor. We will use Avance ventilator (Datex Ohmeda, software version 5.0) with carbon di oxide absorber and ascending bellows to provide constant volume ventilation. The amount of acceptable leak in the circuit will be reduced to ≤ 150 ml min-1 determined during ventilation of a test lung. Low fresh gas flows will be used during the study. Isoflurane will injected into the expiratory limb of circle system via 20 ml Plastipak (polyethylene BD) syringe with a 100 cm long polyethylene tubing (Vygon, India) using a Pilot C Infusion pump (Fresenius vial SA, France). The stated volumetric accuracy of the infusion pump is ±2 %.
After obtaining written informed consent, patients will be randomly allocated (by closed envelope technique using computer generated random numbers) to one of the two groups- manual and automatic. The investigator will be present during the procedure for data collection purpose only and will not be involved in the conduct of anaesthesia. All patients will receive 5- 10mg oral diazepam as per institutional protocol the night before and on the morning of surgery as pre-medication. After shifting the patient to the operation table, patients will be started on normal saline 100 ml/hr (1-2 ml/kg/hr). Routine physiological monitoring will be commenced (pulse oximetry, electrocardiography, non-invasive blood pressure monitoring). BIS (Bispectral index)will be obtained by disposable sensors (Aspect medical system Inc. MA USA) attached to the forehead of the patient. Patients will receive 0.15 mg/kg of morphine sulphate before induction in aliquots of 3-5mg, during which indwelling arterial cannula, central venous line and pulmonary artery catheters (if deemed to be necessary) will be inserted.
Before induction, patients shall receive fentanyl 3μg/kg over three minutes. In automatic mode, IAADS automatically will calculate and titrate the initial and subsequent propofol infusion rate according to the weight of the patient, risk status and target BIS value, which will be set at 50 for all cases with a range of 40-60. In manual group, the propofol infusion rate will be determined by the attending anaesthesiologist according to the weight of the patient, and the target BIS of 50, with the aim to maintain BIS within 40- 60. After loss of consciousness (LOC), patients will receive 0.1mg/kg vecuronium bromide and will be intubated after 4 minutes.
The circle system will be closed after ascertaining the correct position of the endotracheal tube. In the control group, isoflurane infusion will be started into the expiratory limb of the circle at predetermined rates. The isoflurane concentration in the circuit will be built gradually over a period of 10 minutes to attain a specified BIS value. During isoflurane anaesthesia, patients will be ventilated with 100% oxygen. Fresh gas flows will be started at 500ml/min, and the ventilation will be set so as to maintain an end tidal CO2 concentration of 30-35 mmHg. If the fresh gas flows are inadequate as determined by incomplete filling of bellows, the flows will be increased gradually by 100 ml/min till a maximum of 1000 ml/min. If still there is a leak, the study will be abandoned and patient ventilated with higher flows. Thus, patients will be maintained on isoflurane injected into the expiratory limb of the circuit. Analgesia will be maintained with fentanyl 1μg/kg/hr infusion with further boluses of 1μg/kg before skin incision, sternotomy and commencement of cardiopulmonary bypass (CPB). Muscular relaxation will be maintained with a continuous infusion of vecuronium bromide 50μg/kg/hr. After 30 minutes of induction, an arterial sample will be drawn to have baseline values for blood gases, activated clotting time (ACT), and blood glucose. Patients will receive a bolus of 3 mg/kg heparin to raise the ACT above 480s. In cases of lower values, further boluses of heparin will be infused as per bull and colleagues dose response curve for heparin.
In the manual group, after the confirmation of the placement of endotracheal tube, the circle system will be closed and fresh gas flows will be started at 1000ml/min. Inhalational anaesthetics will be delivered by Fluotech 7 vapouriser (Datex ohmeda) for isoflurane. The initial dial setting will be started at 3% and after 5 minutes, flows will be reduced to 500 ml/min and isoflurane concentration will be titrated by the anaesthesiologist to maintain BIS of 50. The dial setting will be increased or decreased to maintain BIS of 50 and the number of times the vapouriser dial setting is changed will be noted. Rest of the protocol will be similar to the computer control group described above.
After the initiation of CPB, arterial blood gases, ACT and blood glucose will be determined every half an hour. An arterial partial pressure of O2 of 300-400 mmHg, ACT \>480s and blood glucose \<180mg/dl will be maintained throughout the bypass period. After successful completion of cardiopulmonary bypass, heparin will be antagonised with protamine sulphate.
During episodes when the mean arterial pressure exceeds 25% of the baseline or heart rate exceeds 100 beats/ min or 25% of the baseline, analgesia will be supplemented with fentanyl 1μg/kg. In case of persistent hypertension or tachycardia with BIS \< 50, nitroglycerine infusion will be started and titrated to control blood pressure; Esmolol (upto 0.5mg/kg IV) will be administered to control the heart rate (HR). Similarly, in case of fall in mean arterial pressure to less than 25% of the baseline in the presence of normovolemia, initially phenylephrine will be used in boluses of 0.5μg/kg. For persistent hypotension after a cumulative Phenylephrine dose of 2μg/kg, dopamine infusion will be started and titrated to maintain MAP within 25% of the baseline. Likewise, in case of decrease in HR to \<45beats/min., atropine sulphate (10μg/kg IV boluses) will be administered after excluding other treatable causes.
During CPB, patients will be shifted to propofol infusion, as the equipment for delivering fresh gases during CPB requires large fresh gas flows and circle system is not possible presently. MAP will be maintained between 50- 80 mmHg and any deviation from theses limits shall be treated with Phenylephrine boluses or sodium nitroprusside infusion. Propofol will be administered as per IAADS in computer control group and manually in the manual group to maintain BIS of 50.
Five minutes after the end of CPB, patients will be shifted back to isoflurane. In the computer control group, the concentration in the circuit for the set BIS will be achieved over 10 minutes. In the manual control group, the dial setting will be started at 3% and titrated according to the BIS. Fresh gas flows will be maintained at the same rate before the initiation of CPB.
At the end of skin closure, isoflurane, fentanyl and vecuronium will be stopped and the study protocol terminated. Patient will be shifted to propofol infusion for post operative sedation and will be shifted to post anaesthesia care unit without antagonizing muscle relaxants for elective mechanical ventilation. Patients will be extubated on meeting standard criteria for extubation. All patients will be continuously monitored for hemodynamic stability and maintenance of blood gases upto 24 hrs postoperatively. Patients will be subjected to a structured interview as modified from Brice and colleagues and described by Nordstrom for conscious awareness; on discharge from post anesthesia care unit, the day after surgery and approximately a week later.
#Intervention
- OTHER : Conventional control
- The isoflurane administration to deliver anesthesia will be done conventionally through a Tec 7 vaporiser to maintain the bispectral index at 50.
- Other Names :
- MANUAL CONTROL
- OTHER : Closed loop control
- The isoflurane administration to maintain anesthesia will be by infusion to the anesthesia circuit using syringe pump (injection technique). The rate of delivery of isoflurane will be regulated by computer that uses a control algorithm.
- Other Names :
- AUTOMATED CONTROL
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiology physical status 2- 4
* elective open heart surgery under general anaesthesia
* requiring Cardio Pulmonary Bypass (CPB)
Exclusion Criteria:
* body weight ±30% of the ideal body weight
* neurological disorder
* use of any psychoactive medication
* severe stenotic valve lesions
* severe pulmonary artery hypertension
* Tetrology of Fallot repair and other cyanotic heart diseases.
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
|
NCT01069562
|
{
"brief_title": "Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery",
"conditions": [
"Open Heart Surgery"
],
"interventions": [
"Other: Conventional control",
"Other: Closed loop control"
],
"location_countries": [
"India"
],
"nct_id": "NCT01069562",
"official_title": "Comparison of Isoflurane Anaesthesia by Closed Loop Controlled Administration Versus Manually Controlled Administration Using Bispectral Index in Open Heart Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-02-21",
"last_updated_that_met_qc_criteria": "2010-02-16",
"last_verified": "2010-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-17",
"first_submitted": "2010-02-01",
"first_submitted_that_met_qc_criteria": "2011-01-24"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector.
#Intervention
- DEVICE : Paclitaxel-eluting balloon
- Other Names :
- Luminor 14 & Luminor 35
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes aged at least 18
* Primary injuries and restenosis of the infrainguinal sector of AFS, AP and ATs, and intrastent restenosis or post-ATP prior in that sector.
* Stenosis >50% and occlusions. (image test)
* Length: 20 to 200 mm
* Artery diameter: 2 <= age <= 7 mm.
* Symptomatic patients (grades 2 <= age <= 5 Rutherford-Baker both included; Fontaine II-IV), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation).
Exclusion Criteria:
* Patients with acute or subacute ischemia will be excluded.
* Existence of flow-limiting lesions in arteries of the 'in flow' or the 'out flow' of the sector or artery under treatment (> 50 % of the arterial diameter).
* Aneurysmal dilatation in the ipsilateral arterial axis.
* Intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin.
* Hemorrhagic diathesis during the 3 months prior to inclusion.
* Patients with a life expectancy of less than 12 months.
* Serious allergy to contrasts or PTX.
* Inability to cross the lesion with the guide (these cases will be recorded for the analysis as 'intention to treat).
* Those participating simultaneously in another clinical trial.
* Pregnancy or lactation (pregnancy tests on fertiles).
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
|
NCT02458911
|
{
"brief_title": "Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.",
"conditions": [
"Peripheral Vascular Disease"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT02458911",
"official_title": "Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions (Superficial Femoral Artery (SFA), Popliteal Artery (PA) and Tibial Arteries (ATs)) and Restenosis From Prior Endovascular Procedures in This Sector.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2017-09",
"study_start_date(actual)": "2014-05"
},
"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)": "2017-11-22",
"last_updated_that_met_qc_criteria": "2015-05-28",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-01",
"first_submitted": "2015-05-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).
#Intervention
- DRUG : PF-05089771
- 450mg
- Other Names :
- no specified
- DRUG : PF-05089771
- 450mg
- Other Names :
- no specified
- DRUG : PF-05089771
- 450mg
- Other Names :
- no specified
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy)
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
|
NCT01854996
|
{
"brief_title": "Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: PF-05089771"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01854996",
"official_title": "A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2013-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-06-25",
"last_updated_that_met_qc_criteria": "2013-05-13",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-16",
"first_submitted": "2013-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects
Detailed Description
To healthy male subjects of thirty-two (32), Investigational products are administered following treatments in each period
#Intervention
- DRUG : D565
- Q.D. in both eye
- DRUG : D930
- T.I.D in both eye
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults volunteers aged between 19 and 55 years at the time of screening
* Weight >= 55 kg, Calculated Body Mass Index(BMI) of 18.0 to 30.0 kg/m2
* BMI = Weight(kg)/ Height(m)2
* Individuals who sign an informed consent form and decide to participate in the study after being fully informed of the study prior to participation
* Individuals who are suitable as a subject for this study at the discretion of the researcher as a result of screening tests such as examination, laboratory tests and questionnaires
Exclusion Criteria:
* Individuals who have other clinically significant cardiovascular system, respiratory system, liver, renal, nervous system, endocrine system, blood-oncology, psychiatric disorders, urinary system or ophthalmic diseases or have a history
* Individuals who satisfy the following items during the interview or examination
* Individuals with a history of or sign or symptoms of a disease of the visual system
* Individuals who had an ophthalmic surgery including for refractive correction surgery such as LASIK.
* Individuals with corrected visual acuity of 20/40 or less
* Individuals who have experienced side effects after wearing contact lenses or who have worn contact lenses within the last month
* Individuals who have more than 21mmHg or less than 10mmHg on either side of the intraocular pressure test
* Individuals who show abnormal findings in other ophthalmic examinations
* Individuals who have a history of hypersensitivity to the active ingredient and component of the investigational drug, or to the drug in the same class as the active ingredient
* Individuals with sitting systolic blood pressure >= 140 mmHg or <= 80 mmHg or sitting diastolic blood pressure >= 90 mmHg or <= 45 mmHg
* Individuals with the following results at screening test
* AST, ALT, γ-GT > 2x the upper limit of the normal range
* Total bilirubin > 2.0 mg/dL
* eGFR(CKD-EPI) < 60 mL/min/1.73m2
* Individuals who continue to drink(over 21 units/week) within 1 month or cannot abstain from alcohol during the clinical trial period
* Individuals who tested positive in an alcohol breath analysis
* Individuals who continuously smoke within one month(including e-cigarettes, over 10 fees/day) or who cannot quit smoking during the clinical trial period;
* Individuals who cannot restrict the intake of grapefruit or grapefruit-containing food from 3 days before administration of investigational drugs to the final pharmacokinetic blood sample collection
* Individuals who tested positive for urine cotinine at screening test
* Individuals who took ethical(ETC) or oriental medicine within 2 weeks or over the counter(OTC) within 1 week before the expected first dose
* Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 1 month before the expected first dose
* Individuals with a medical history of significant drug abuse or positive for abuse drug in urine test results at screening
* Individuals who had been administered investigational product(s) of other clinical study within the 6 months prior to the first dose of this study
* Individuals who donated whole blood within the 2 months, or donated blood components within 1 month, or received a blood transfusion with 1month prior to the first dose or plan to donate blood or transfusion during the clinical trial period
* Individuals who are unable to use an appropriate medically approved method of contraception for themselves, their spouses, or partners during the entire clinical trial period and for at least 90 days after the last investigational drug administration and cannot donate sperm during this period
* Individuals who were deemed to be inappropriate to participate in the study by the investigator
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
|
NCT05207761
|
{
"brief_title": "Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930",
"conditions": [
"Glaucoma"
],
"interventions": [
"Drug: D930",
"Drug: D565"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05207761",
"official_title": "A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930, in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-18",
"study_completion_date(actual)": "2022-11-02",
"study_start_date(actual)": "2022-01-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-05",
"last_updated_that_met_qc_criteria": "2022-01-24",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-26",
"first_submitted": "2022-01-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly developed treatment and education programme for diabetic patients with an insulin pump therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.
Detailed Description
INPUT is a self-management-based treatment and education program for diabetic patients with an insulin pump (CSII). It is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life.
INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for CSII exists.
This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of INPUT will take place at the respective practice.
Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of INPUT, follow-up measurements will be conducted at the respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary outcome measures will be assessed via psychometrically tested questionnaires, Case Reports Forms, or patient files.
#Intervention
- BEHAVIORAL : INPUT
- Treatment and education program based on the self-management theory of behavioral medicine.
The program is delivered by certified and specially trained diabetes educators.
- Other Names :
- treatment and education program for INsulin PUmp Therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Existing insulin pump therapy
* Prior participation in a structured diabetes education program
* HbA1c >= 7,5% but <= 13%
* Ability to understand, speak and write German language
* informed consent (if necessary, informed consent of the parents)
Exclusion Criteria:
* Diabetes duration < 1 year
* severe organic disease preventing a regular participation in the training course
* pregnancy
* severe cognitive impairment
* current treatment of psychiatric disorder
* renal disease requiring dialysis
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02868931
|
{
"brief_title": "Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT)",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Behavioral: INPUT"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02868931",
"official_title": "Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02",
"study_completion_date(actual)": "2017-03",
"study_start_date(actual)": "2016-04-01"
},
"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)": "2017-11-28",
"last_updated_that_met_qc_criteria": "2016-08-11",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-16",
"first_submitted": "2016-04-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).
#Intervention
- DIETARY_SUPPLEMENT : modified Atkins diet
- Modified Atkins Diet administration
1. Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
2. Fats (e.g. cream, butter, oils, ghee) encouraged.
3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
4. Clear carbohydrate-fluids not restricted.
5. Calcium and multivitamin supplementation will be provided.
- Other Names :
- Dietary treatment
- OTHER : modified Atkins diet
- Modified Atkins Diet administration
1. Carbohydrates intake restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
2. Fats (e.g. cream, butter, oils, ghee) encouraged.
3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
4. Clear carbohydrate-fluids not restricted.
5. Calcium and multivitamin supplementation will be provided.
- Other Names :
- Dietary treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: 6 months to 3 years.
* Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day.
* Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam).
Exclusion Criteria:
* Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycaemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
* Motivational or psychosocial issues in the family which would preclude compliance
* Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01006811
|
{
"brief_title": "Use of the Modified Atkins Diet in Infantile Spasms",
"conditions": [
"Infantile Spasms"
],
"interventions": [
"Other: modified Atkins diet",
"Dietary Supplement: modified Atkins diet"
],
"location_countries": [
"India"
],
"nct_id": "NCT01006811",
"official_title": "Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-11",
"study_start_date(actual)": "2009-10"
},
"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)": "2010-11-22",
"last_updated_that_met_qc_criteria": "2009-11-02",
"last_verified": "2010-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-03",
"first_submitted": "2009-11-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An observational study is designed to evaluate the clinical performance of VeriSee AMD for potential age-related macular degeneration (AMD) screening from color fundus photography images. The sensitivity and specificity of VeriSee AMD's automated image analysis for screening AMD will be determined through the comparison with the gold standard, which is the judgment of AMD by the ophthalmologists.
Detailed Description
This is a retrospective, single-center, observational study to assess the clinical performance of VeriSee AMD in screening for potential age-related macular degeneration (AMD).
Potential subjects with images of color fundus photography will be selected for eligibility, and then the ophthalmologist further confirms the images with legible quality. Three independent ophthalmologists (or evaluators) having more than 6 years of experience in retina will evaluate AMD from the color fundus photography images with different sequences of images independently. These three evaluators are different from the ophthalmologist who is responsible for deciding subject's eligibility. The evaluators determine the severity of AMD based on the four-level scale which is the AMD Severity Scale stated in Age-Related Eye Disease Study (AREDS) Report No. 6. Before the study, the training section is necessary to ensure the consensus of the AMD severity grading among three evaluators. The severity determined by the majority of the grade the three evaluators gave is considered the gold/reference standard in this study. Therefore, level 1 and level 2 are classified as non-mtl3AMD, while level 3 and advanced AMD (level 4) are classified as mtl3AMD. The clinical performance displayed as sensitivity and specificity will be determined by comparing the AMD results between VeriSee AMD and the gold standard.
VeriSee AMD is intended to screen AMD from the images taken by color fundus photography, which can assist the physicians to assess whether further examination for retinopathy by the ophthalmologist is needed. The screening result of AMD will be non-mtl3AMD or mtl3AMD for the physicians' reference and does not intend to diagnose AMD, detect concomitant diseases, or treat AMD.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject with age >= 50 years
* Subject with image taken by color fundus photography that meet the following requirement:
1. The resolution of image is 271x271 pixels or higher;
2. The angle view of image is 45 or 50 degree.
* Subject's image includes macula as judged by the ophthalmologist.
Exclusion Criteria:
* The color fundus photography image previously used by VeriSee AMD during the development process and pre-clinical test
* The macula or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.
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
|
NCT05593913
|
{
"brief_title": "Clinical Evaluation of VeriSee AMD in Screening for Age-Related Macular Degeneration",
"conditions": [
"Macular Degeneration, Age Related",
"Maculopathy, Age Related"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT05593913",
"official_title": "A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee AMD) for Screening of Age-Related Macular Degeneration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-03",
"study_completion_date(actual)": "2022-08-10",
"study_start_date(actual)": "2022-01-17"
},
"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)": "2024-01-22",
"last_updated_that_met_qc_criteria": "2022-10-23",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-26",
"first_submitted": "2022-10-18",
"first_submitted_that_met_qc_criteria": "2023-04-17"
}
}
}
|
#Study Description
Brief Summary
The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.
Detailed Description
Multinational, randomized, multicenter, open-label Phase 3 study of 633 participants with advanced, nonsquamous (Stage IV) NSCLC. Participants will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in Arm B.
Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization).
Participants will undergo radiographic assessment (computed tomography or magnetic resonance imaging) of disease status every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (Or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
After the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.
#Intervention
- DRUG : Pemetrexed
- 500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
- Other Names :
- Alimta®, LY231514
- DRUG : Cisplatin
- 75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
- BIOLOGICAL : Necitumumab
- 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
- Other Names :
- IMC-11F8, LY3012211, Portrazza®
|
#Eligibility Criteria:
Inclusion Criteria:
* Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer
* Has Stage IV disease at the time of study entry
* Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (participants with only truly nonmeasurable disease are not eligible)
* Has resolution to Grade <= 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
* Has an Eastern Cooperative Oncology Group performance status score of 0 <= age <= 2
* Has adequate hepatic function
* Has adequate renal function
* Has adequate hematologic function
* If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method). If male, the participants surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
* Female participants of childbearing potential must have a negative serum
Exclusion Criteria:
* Has squamous non small cell lung cancer
* Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the Epidermal Growth Factor Hormone (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
* Received previous chemotherapy for advanced NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization)
* Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization
* Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
* Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible
* Has superior vena cava syndrome contraindicating hydration
* Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
* Has experienced myocardial infarction within 6 months prior to randomization
* Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus
* Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance
* Has Grade >= 2 peripheral neuropathy
* Has significant third space fluid retention, requiring repeated drainage
* Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the participant's ability to complete the study or sign an informed consent document The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments
* Is pregnant or breastfeeding
* Has a known history of drug abuse
* Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for >= 3 years
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
|
NCT00982111
|
{
"brief_title": "First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin",
"conditions": [
"Non Small Cell Lung Cancer"
],
"interventions": [
"Biological: Necitumumab",
"Drug: Cisplatin",
"Drug: Pemetrexed"
],
"location_countries": [
"United States",
"Poland",
"Germany",
"Romania",
"Austria",
"United Kingdom",
"France",
"South Africa",
"Russian Federation",
"Australia",
"Hungary",
"Italy",
"Croatia",
"Slovakia",
"Brazil",
"Portugal",
"Canada",
"Spain",
"Belgium",
"Greece"
],
"nct_id": "NCT00982111",
"official_title": "A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11-14",
"study_completion_date(actual)": "2020-12-23",
"study_start_date(actual)": "2009-11-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-11",
"last_updated_that_met_qc_criteria": "2009-09-21",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-22",
"first_submitted": "2009-09-18",
"first_submitted_that_met_qc_criteria": "2016-05-20"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate which surgical protocol for treating Unilateral Cleft Lip and Palate (UCLP), a single or two stage repair ( with hard palate late closure) will have less impact in mid facial growth.
The study hypothesis states that a two stage cleft palate repair , with a late hard palate repair will reduce maxillary growth impairment.
Detailed Description
The study is being conducted at CADEFI- Centro de Atenção aos Defeitos da Face do IMIP (craniofacial center) in IMIP-Instituto de Medicina Integral Professor Fernando Figueira-, Recife PE- Pernambuco-, Brazil. All children were and will be operated by the same plastic surgeon in the operating room in IMIP. The sample size was calculated in 64 patients, 32 to GI ( one stage repair) and 32 to GII ( two stage repair, with a hard palate late closure), considering taking a statistical power of 90% with a 5% significance, determined with a difference of at least 25% between the two groups. Note : this sample was calculated for the dependent variable commonly present in patients with unilateral lip and palate cleft : atresia of the dental arches.
The groups are numbered in post op care attendance of the lip repair, according to randomization sequence done in computerized statistical program. The randomization is being held after the first month of the lip repair surgery. The surgeon, and parents or guardians (who have already signed the Informed Consent Form) will not have prior access to information on the type of allocation in each group. Subsequently it will be added in patients chart the record set for the patient group.
\>Study Variables Independent variables:. Group I (palate closure in two surgical times and GII (closure of the palate in a surgical time) also will be considered independent variables age, sex, birth weight and maternal education.
Dependent variables: the presence of postoperative infection, initial and intermediate cleft sizes, dimensional changes of the transverse arch, the evaluation indexes of dental arch relationship(Goslom,Atack Yardsticks) and speech outcomes evaluation grades
#Intervention
- PROCEDURE : two stage palate surgical repair
- two stage palate surgical repair with a hard palate closure at 3 to 4 years old
- PROCEDURE : One stage Palate Surgical repair
- One stage palate repair at the age of 9 to 24 months old
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with unilateral cleft lip and palate admitted consecutively in CADEFI-IMIP between August 1, 2011 and July 31, 2015
Exclusion Criteria:
* Patients with associated syndromes that retard the neuro-psycho-motor and speech development;
* Patients without clinical conditions for performing the surgical chronology protocol;
* Patients whose parents or guardians who are not in accordance with the Informed Consent Statement proposed by the researcher
Sex :
ALL
Ages :
- Maximum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02329509
|
{
"brief_title": "Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients",
"conditions": [
"Unilateral Cleft Lip and Palate",
"Cleft Lip",
"Cleft Palate",
"Developmental Disabilities",
"Restricted Language Development"
],
"interventions": [
"Procedure: One stage Palate Surgical repair",
"Procedure: two stage palate surgical repair"
],
"location_countries": null,
"nct_id": "NCT02329509",
"official_title": "Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients. A Prospective Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2010-01"
},
"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)": "2016-12-02",
"last_updated_that_met_qc_criteria": "2014-12-30",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-31",
"first_submitted": "2014-12-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.
Detailed Description
In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ('cervical or carotid or vertebral dissection') has been created in a data warehouse of the University Hospital of Nantes.
To determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.
#Intervention
- OTHER : questionnaries
- Study on questionnaries
|
#Eligibility Criteria:
Inclusion Criteria:
* Extracranial carotid or vertebral dissection
* Symptomatic dissection (with symptom onset within the last four weeks)
* Spontaneous dissection
* Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.
Exclusion Criteria:
* Minors or adults under guardianship
* Intracranial artery dissection
* Traumatic or iatrogenic dissection
* Patient refusal to participate
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
|
NCT04253535
|
{
"brief_title": "Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium",
"conditions": [
"Cervical Artery Dissection"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04253535",
"official_title": "A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-15",
"study_completion_date(actual)": "2020-06-15",
"study_start_date(actual)": "2020-02-14"
},
"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)": "2020-12-02",
"last_updated_that_met_qc_criteria": "2020-02-03",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-05",
"first_submitted": "2020-01-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.
#Intervention
- DRUG : Oral BMS-663068 (pro-drug)
- Oral BMS-663068 (pro-drug), metabolized to active BMS-626529
|
#Eligibility Criteria:
Inclusion Criteria (For renal impaired subjects):
* Classification by renal function based on eGFR
* Clinical, ECG, and laboratory findings consistent with renal dysfunction
* BMI of 18.0 to 38.0 kg/m2 inclusive
* Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
* Slightly different inclusion criteria are defined in the protocol for healthy subjects
Exclusion Criteria:
* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
* Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by >= 50% within the last 3 months
* Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
* Any major surgery within 4 weeks of study drug administration.
* Other protocol defined exclusion criteria could 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:
Yes
|
NCT02674581
|
{
"brief_title": "A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)",
"conditions": [
"HIV Infections"
],
"interventions": [
"Drug: Oral BMS-663068 (pro-drug)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02674581",
"official_title": "An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05-24",
"study_completion_date(actual)": "2016-05-24",
"study_start_date(actual)": "2016-02-26"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-15",
"last_updated_that_met_qc_criteria": "2016-02-02",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-02-04",
"first_submitted": "2015-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced cancer and kidney dysfunction. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
Detailed Description
PRIMARY OBJECTIVES:
I. To identify the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with advanced malignancy and mild, moderate or severe renal insufficiency.
II. Evaluate the safety, tolerability, and the maximum tolerated dose of PS-341 for patients with varying degrees of renal insufficiency.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to most recent creatinine clearance (greater than 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing renal dialysis).
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of up to 12 patients is treated at the MTD.
PROJECTED ACCRUAL: A total of 60-69 patients (at least 12 per stratum) will be accrued for this study.
#Intervention
- DRUG : bortezomib
- Given IV
- Other Names :
- LDP 341, MLN341, VELCADE
- OTHER : laboratory biomarker analysis
- Correlative studies
- OTHER : pharmacological study
- Correlative studies
- Other Names :
- pharmacological studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologic proof of malignancy (including non-Hodgkin's lymphoma and multiple myeloma)
* Patients must have measurable or evaluable disease; patients with reliable tumor markers (as determined by protocol chairman) are eligible for participation
* ANC >= 1000/uL
* PLT >= 50,000/uL
* Total bilirubin =< 1.5 x upper limit of normal (ULN)
* AST =< 2.5 x ULN or AST =< 5 x ULN if liver involvement
* Patients with abnormal kidney function will be allowed and will be grouped accordingly
* Willingness to return to treating institution for follow-up
* Life expectancy >= 12 weeks
* Willingness to provide all biologic specimens as required by the protocol
Exclusion Criteria:
* Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
* ECOG performance status (PS) 3 or 4
* Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any of the following prior therapies:
* Chemotherapy <= 4 weeks
* Mitomycin C/nitrosoureas <= 6 weeks
* Immunotherapy <= 4 weeks
* Biologic therapy <= 4 weeks
* Radiation therapy <= 2 weeks
* Radiation to > 50 % of bone marrow (excepting patients who have had total body irradiation incorporated into bone marrow or stem cell transplantation; all other eligibility criteria still apply)
* PS-341 treatment
* Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment (excludes renal function)
* New York Heart Association classification III or IV
* Symptomatic CNS metastases; patients who have received definitive treatment for brain metastases (radiation and/or surgery) and are stable for >= 8 weeks are eligible; eligible patients with brain metastases should not be taking enzyme-inducing anticonvulsants and should be receiving stable doses of steroids
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
* This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
* Other concurrent chemotherapy, immunotherapy, or radiotherapy
* HIV-positive patients receiving anti-retroviral therapy (HAART); there is a potential for pharmacokinetic interactions
* Concurrent use of other investigational agent (including thalidomide); bisphosphonate therapy (e.g. pamidronate or zoledronate) will not be considered investigational agents for the purpose of trial eligibility
* Pre-existing grade >= 2 neuropathy
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
|
NCT00054483
|
{
"brief_title": "Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction",
"conditions": [
"Adult Grade III Lymphomatoid Granulomatosis",
"Adult Nasal Type Extranodal NK/T-cell Lymphoma",
"Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue",
"Nodal Marginal Zone B-cell Lymphoma",
"Recurrent Adult Burkitt Lymphoma",
"Recurrent Adult Diffuse Large Cell Lymphoma",
"Recurrent Adult Diffuse Mixed Cell Lymphoma",
"Recurrent Adult Diffuse Small Cleaved Cell Lymphoma",
"Recurrent Adult Grade III Lymphomatoid Granulomatosis",
"Recurrent Adult Immunoblastic Large Cell Lymphoma",
"Recurrent Adult Lymphoblastic Lymphoma",
"Recurrent Grade 1 Follicular Lymphoma",
"Recurrent Grade 2 Follicular Lymphoma",
"Recurrent Grade 3 Follicular Lymphoma",
"Recurrent Mantle Cell Lymphoma",
"Recurrent Marginal Zone Lymphoma",
"Recurrent Small Lymphocytic Lymphoma",
"Refractory Multiple Myeloma",
"Splenic Marginal Zone Lymphoma",
"Stage III Multiple Myeloma",
"Stage IV Adult Burkitt Lymphoma",
"Stage IV Adult Diffuse Large Cell Lymphoma",
"Stage IV Adult Diffuse Mixed Cell Lymphoma",
"Stage IV Adult Diffuse Small Cleaved Cell Lymphoma",
"Stage IV Adult Immunoblastic Large Cell Lymphoma",
"Stage IV Adult Lymphoblastic Lymphoma",
"Stage IV Grade 1 Follicular Lymphoma",
"Stage IV Grade 2 Follicular Lymphoma",
"Stage IV Grade 3 Follicular Lymphoma",
"Stage IV Mantle Cell Lymphoma",
"Stage IV Marginal Zone Lymphoma",
"Stage IV Small Lymphocytic Lymphoma",
"Unspecified Adult Solid Tumor, Protocol Specific",
"Waldenström Macroglobulinemia"
],
"interventions": [
"Other: laboratory biomarker analysis",
"Other: pharmacological study",
"Drug: bortezomib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00054483",
"official_title": "A Phase I Pharmacokinetic Study of PS341 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2003-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-05-16",
"last_updated_that_met_qc_criteria": "2003-02-05",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-02-06",
"first_submitted": "2003-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary AML in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach
Detailed Description
To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases with the appropriate security.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients diagnosed with acute myeloid leukemia
Exclusion Criteria:
no 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:
No
|
NCT02006004
|
{
"brief_title": "Epidemiologic Registry PETHEMA LMA 2013",
"conditions": [
"AML"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT02006004",
"official_title": "Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2013)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2012-01"
},
"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)": "2015-10-14",
"last_updated_that_met_qc_criteria": "2013-12-04",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-09",
"first_submitted": "2013-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Randomized clinical trial with the objective of evaluating the effectiveness of operative groups to promote healthy habits in elderlies diabetics. The study was conducted in the Family Health Units of Microregion 4.2 Sanitary District IV of Recife, Pernambuco, Northeast Brazil. Participated in 202 elderlies diabetic randomly assigned to two groups: intervention and control, with similar characteristics in relation to age. Data collection occurred from August 2014 to August 2015 and elderlies were followed for 6 months (T0 to T6). Control group participated in the routine individual consultation with the staff of the Family Health Unit on a quarterly basis. Intervention group participated the routine individual consultation with the staff of the Family Health Unit on a quarterly basi and six operative groups of health education, with monthly frequency and duration of two hours, using the methodology of problematization (FREIRE, 2011), with themes identified from the needs of the participants.
Detailed Description
The study was conducted in the Family Health Units Microregion 4.2, Sanitary District IV, located in the city of Recife, Northeast Brazil. For the sample size was considered alpha error 5% (u), beta error of 20% (v). The standard deviation of glycated hemoglobin concentration distribution in both groups (Dp1 and Dp2) was equal to 1.9g/dL, and the difference between the intergroup glycated hemoglobin average was equal to 0.8%.
Initially a survey was conducted of elderlies diabetics interested in participating in the study. Then, an individual randomization of the sample was done using a table of random numbers generated by the software EPI INFO, version 6.04d. Two groups were formed, intervention and control, with similar characteristics in terms of age. Data collection occurred from August 2014 to August 2015 and the elderlies participants in the intervention group or control were followed for 6 months (T0 to T6).
Control Group: 101 elderlies diabetics who participated in the routine individual consultation with the staff of the Family Health Unit on a quarterly basis.
Group Intervention: 101 elderlies diabetics that in addition to individual routine consultation with the staff of the Family Health Unit on a quarterly basis participated in operative groups of health education. The groups had monthly frequency, duration of two hours and were conducted in close community spaces Health Units to facilitate the access of the elderlies.The operative groups with the methodology of problematization (FREIRE, 2011), included issues related to the promotion of healthy habits, identified from the needs of elderlies themselves.
In both groups, intervention and control the variables investigated were:
sociodemographic (T0) - Baseline; Knowledge about diabetes (T0 and T6) assessed by the Diabetes Knowledge Scale (DKN-A); Attitude for self-care (T0 and T6) measured by the ATT-19 - Baseline and Follow-up; healthy food consumption (T0 and T6) assessed by the Healthy Eating Index (HEI) - Baseline and Follow-up; Physical activity (T0 and T6) measured by the International Physical Activity Questionnaire (IPAQ) - Baseline and Follow-up; Anthropometric (T0 to T6) by weight measurement, height, waist circumference and body mass index - Baseline three months and follow-up; Biochemical assessment (T0, T3 and T6) by measuring glycated hemoglobin (A1C) - baseline, three months and follow-up.
#Intervention
- OTHER : Operative groups based on methodology of problematization
- The educational intervention based on the methodology of problematization consisted of the survey prior knowledge on the subject; planning; Implementation and Evaluation through verbalization solutions applicable to the reality of the elderlies.
Each operative group was composed of an average of 12 to 15 elderlies diabetics who participated in monthly activities lasting 2 hours, for six consecutive months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Elderlies people with diabetes mellitus diagnosis recorded in the medical record in the Family Health Units, located in the city of Recife, Northeast Brazil
Exclusion Criteria:
* Live in long-stay institutions
* Elderly hospitalized
* Wheelchair users
* Deficit communication and / or cognition recorded in the chart
* Presence of chronic complications of diabetes in advanced stages
* Locomotion difficulty restricting access to health facility
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02771821
|
{
"brief_title": "Promoting Healthy Habits With Elderlies Diabetics",
"conditions": [
"Diabetes Mellitus, Type 2",
"Aged",
"Health Behavior",
"Group Processes"
],
"interventions": [
"Other: Operative groups based on methodology of problematization"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02771821",
"official_title": "Promoting Healthy Habits With Elderlies Diabetics: Evaluation of Operative Groups as Therapeutic Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2014-08"
},
"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)": "2016-05-13",
"last_updated_that_met_qc_criteria": "2016-05-10",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-13",
"first_submitted": "2016-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the feasibility of using telepractice to provide Modified Interaction Guidance (MIG) to caregivers and their child with autism. MIG as an intervention to improve attachment for children with autism and their primary caregiver.
Detailed Description
The process objectives target focus on1) recruitment, 2) retention, 3) engagement with tools, 4) time demand on dyads, and 5) eligibility criteria.
The resource assessment objectives include: 1) equipment and internet accessibility 2) communication methods, and 3) timelines.
The management assessment objectives address: 1) ethical standards, 2) researcher qualifications and 3) data storage and collection.
Finally, when looking at the scientific assessment, the objectives relate to: 1) Is use of a concurrent multiple baseline single-subject design feasible with this population? 2)capturing dyad needs, 3) burden levels, and 4) safety protocols.
This study will evaluate the above listed dimensions of feasibility using a embedded mixed methods approach that incorporates both a single-subject design and qualitative data gathered throughout the research process and post intervention individual interviews.
#Intervention
- BEHAVIORAL : Modified Interaction Guidance
- The main steps in the procedure are to have the family identify the primary concern they are facing, highlight the strengths that the family already has in place and expand on those strengths, convey/impart caregiving and societal norms, and offer other perspectives (McDonough, 2004). The goal of this therapy is to engage the family to take an active role in the construction of their overall treatment. The individualized treatment approach focuses and builds on existing strengths.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of autism spectrum disorder
* Child between the ages of 24 <= age <= 60 months
* First born child
* No physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process
* Ability to follow simple verbal directions in English
* No current plan to initiate any treatment alternatives during the study period
* Willingness to participate in a -week intervention with a frequency of once a week
* Adults are primary caregiver
* Under age of 35
* Speak English
* Minimum grade 5 schooling
* Access to a computer and broadband wired or wireless (3G or 4G/LTE) internet connection?
Exclusion Criteria:
* Participants (both child and adult) will be excluded from the present study if they were deemed low functioning
* child is not the first-born child
* child already receiving ABA treatment
* parents have a history of mental illness
Sex :
ALL
Ages :
- Minimum Age : 10 Months
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03972254
|
{
"brief_title": "Feasibility of Using Telepractice to Provide Modified Interaction Guidance.",
"conditions": [
"Autism Spectrum Disorder"
],
"interventions": [
"Behavioral: Modified Interaction Guidance"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03972254",
"official_title": "Feasibility of Using Telepractice to Provide Modified Interaction Guidance as an Intervention Tool for Caregivers and Their Child With Autism",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-01",
"study_completion_date(actual)": "2021-12-01",
"study_start_date(actual)": "2020-11-01"
},
"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)": "2022-01-12",
"last_updated_that_met_qc_criteria": "2019-05-31",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-03",
"first_submitted": "2019-05-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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