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#Study Description
Brief Summary
A randomized comparison clinical trial will be conducted in laparoscopic radical prostatectomy patients in the Weinberg PACU at the Johns Hopkins Hospital. 50 patients will be recruited and randomly assigned by a table of random numbers to either the music listening group (n=35) or the relaxation breathing group (n=35).
Detailed Description
Hypothesis:
Laparoscopic radical prostatectomy patients who experience music listening will report decreased anxiety scores and improved pain control scores compared with patients listening to relaxation and breathing.
Null Hypothesis:
There will be no difference in reported anxiety scores and pain control scores between laparoscopic radical prostatectomy patients listening to music versus listening to relaxation and breathing instructions.
Music listening participants who meet inclusion criteria will be consented in the PreOp Unit and asked to complete the Spielberg State Trait Anxiety Inventory (STAI) questionnaire. Patient vital signs will be taken and patient will be invited to listen to music study iPod for 15 minutes prior to changing into a hospital gown.
Intervention:
The music listening group will receive the standard care and a 15 minute patient-preferred music listening selection intervention in the Prep Room and unlimited music listening selection intervention in the PACU once cognitively ready until discharge criteria met. The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone music in the PACU once cognitively ready until discharge criteria met.
Results:
The experimental music listening group will reveal statistically significant decrease postanesthesia anxiety and pain, while lowering the blood pressure, heart rate and amount of opioids after laparoscopic radical prostatectomy surgery compared to the control group.
Conclusion:
The findings of the music listening intervention will provide further evidence to support the practice of music listening to decrease postanesthesia anxiety and pain, while lowering the blood pressure, heart rate and amount of opioids after laparoscopic radical prostatectomy surgery.
#Intervention
- BEHAVIORAL : Preferred music listening
- The preferred music listening group will receive 15 minute patient-preferred music listening selection intervention in the Prep Room and unlimited music listening selection intervention in the PACU once cognitively ready until discharge criteria met.
- BEHAVIORAL : Relaxation breathing narrative over hypnotic music listening
- The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone hypnotic music in the PreOp unit before surgery and then in the PACU once cognitively ready to listen to the hypnotic music until discharge criteria met.
|
#Eligibility Criteria:
Inclusion Criteria
* All adult male patients schedule to have a laparoscopic radical prostatectomy surgery who are ages 45 <= age <= 80 of age
* All ethnic backgrounds
* All religions
Exclusion Criteria:
* All patients who do not speak or understand the English language to the extent that it precludes their ability to provide informed consent for the study
Sex :
MALE
Ages :
- Minimum Age : 45 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04596917
|
{
"brief_title": "Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Behavioral: Relaxation breathing narrative over hypnotic music listening",
"Behavioral: Preferred music listening"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04596917",
"official_title": "Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-30",
"study_completion_date(actual)": "2020-12-30",
"study_start_date(actual)": "2020-10-06"
},
"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)": "2021-10-13",
"last_updated_that_met_qc_criteria": "2020-10-15",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-22",
"first_submitted": "2020-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
Detailed Description
Pharmacokinetic；Safety
#Intervention
- DRUG : IBI362 liquid formulation
- Administered by subcutaneous injection
- DRUG : IBI362 lyophilized powder
- Administered by subcutaneous injection
|
#Eligibility Criteria:
Inclusion Criteria:
* 20 years<= Healthy males<=45 years
* 19 kilograms per meter squared (kg/m²)<=Body Mass Index<=26 kg/m²
* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Exclusion Criteria:
* Subjects who have previously completed or discontinued from this study, or who have used IBI362.
* Abnormal vital signs and physical examination during the screening period;
* Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
* Have a previous or current mental illness.
* A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
* There are other factors judged by the investigators that are not suitable for inclusion in this study.
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04773977
|
{
"brief_title": "Clinical Study of IBI362 in Healthy Chinese Male Subjects",
"conditions": [
"Overweight/Obesity"
],
"interventions": [
"Drug: IBI362 liquid formulation",
"Drug: IBI362 lyophilized powder"
],
"location_countries": [
"China"
],
"nct_id": "NCT04773977",
"official_title": "Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-09",
"study_completion_date(actual)": "2021-06-17",
"study_start_date(actual)": "2021-03-03"
},
"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)": "2021-07-08",
"last_updated_that_met_qc_criteria": "2021-02-24",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-26",
"first_submitted": "2021-02-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device.
Detailed Description
There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a/LCI) to make light scattering measurements of retinal tissue structure. The objective of this device feasibility study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, we may use it in future studies to identify retinal structure changes that could be possible AD biomarkers.
For this study, the team will recruit healthy volunteers to attend one study visit that is about 30 minutes long. This visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system.
#Intervention
- DEVICE : retinal imaging with low-cost OCT device
- Retinal imaging with low-cost OCT device
- DEVICE : retinal imaging with commercial OCT device
- retinal imaging with commercial OCT device
|
#Eligibility Criteria:
Inclusion Criteria:
* able to provide informed consent
Exclusion Criteria:
* potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
* eyes that have had intraocular surgery, other than cataract surgery
If two eyes satisfy the inclusion / exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.
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:
Yes
|
NCT05530460
|
{
"brief_title": "Comparative Study of High Performance Low-Cost Optical Coherence Tomography",
"conditions": [
"Optical Coherence Tomography of Retina"
],
"interventions": [
"Device: retinal imaging with commercial OCT device",
"Device: retinal imaging with low-cost OCT device"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05530460",
"official_title": "Comparative Study of High Performance Low-Cost Optical Coherence Tomography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-17",
"study_completion_date(actual)": "2024-05-17",
"study_start_date(actual)": "2024-03-22"
},
"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)": "2024-10-17",
"last_updated_that_met_qc_criteria": "2022-09-06",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-07",
"first_submitted": "2022-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.
#Intervention
- OTHER : no intervention
- no intervention (observational study)
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy males and females aged 18 to 60
Exclusion Criteria:
* known disorders of the gastrointestinal tract which can lead to malabsorption
* intake of medication which could affect the absorption of any nutrients
* Pregnant or breast-feeding women
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
|
NCT03409445
|
{
"brief_title": "Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03409445",
"official_title": "Validation of a Food Frequency Questionnaire for the Assessment of Omega-3",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-25",
"study_completion_date(actual)": "2018-07-25",
"study_start_date(actual)": "2018-01-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-26",
"last_updated_that_met_qc_criteria": "2018-01-23",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-24",
"first_submitted": "2018-01-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.
Detailed Description
Weight gain is an important issue for young adults. Throughout the transition from adolescence to early adulthood, young adults encounter multiple stressors and influences that can contribute to weight gain. In turn, weight gain leads to increased risk of cardiovascular disease, diabetes, and other health issues. Thus, there is a critical need to advance our understanding of how to develop and deploy multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults.
The SMART 2.0 study is a 24-month (96 week) parallel-group randomized control trial designed to evaluate the impact of the interventions on objectively measured weight in kg over 24 months compared to a control group. The study will recruit 642 overweight/obese young adults aged 18-35 at universities in San Diego, CA. Participants will be randomly assigned to one of three groups for a 24-month study period. The three groups include: 1) SMART 2.0 with a consumer-level wearable and scale, text messaging, social media, and technology-based health coaching; 2) SMART 2.0 with a consumer-level wearable and scale, text messaging, and social media; and 3) a control group with a consumer-level wearable and scale alone. Theory- and evidence-based content will be framed around a minimum goal of 5-10% weight loss through increased energy expenditure, decreased energy intake, and adequate sleep. Additionally, participants will be encouraged to lose 1 to 2 pounds per week until they reach a body mass index (BMI) below 25 kg/m2. Once a participant reaches a BMI less than 25 kg/m2 the goal will be to maintain their weight loss.
SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable (e.g., Fitbit Charge 3), wireless scale (e.g., Aria Scale), and corresponding app (e.g., the Fitbit app); 2) a highly tailored and interactive text messaging system; 3) multiple social media streams (e.g., Facebook, Facebook Messenger, Instagram, and Twitter); and 4) social network mechanisms of influence. The consumer-level devices and app will be used to self-monitor behavior, and their data will be passively acquired in real-time. Algorithms will be used to automatically deliver text messages to support individually tailored goal setting, performance feedback, and goal review in a highly dynamic style that reflects participants' behavioral progress towards achieving a minimum goal of 5% weight loss. Participants will be encouraged to share their data and behavioral progress with others via social networking tools. Social network mechanisms of influence will be used both within the study-space, to elicit participant-to-participant and health coach-to-participant support, as well as outside the study-space, to invoke social support and accountability from strong ties known to be important for long-term behavior change. Additionally, one group will receive monthly technology-mediated and real-time personal health coaching that is theory- and evidence-based.
#Intervention
- BEHAVIORAL : SMART 2.0
- SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable, wireless scale, and corresponding app; 2) a highly tailored and interactive text messaging system; 3) multiple social media streams; 4) social network mechanisms of influence; and 5) technology-mediated health coaching.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 35
* Intending to be available for a 24 month intervention
* Affiliated with either University of California, San Diego (UCSD), San Diego State University (SDSU), or California State University, San Marcos (CSUSM) as a student, faculty, or staff
* Willing and able to use social media
* Willing and able to use a smartphone and text messaging
* Willing and able to use the wearable, scale, and corresponding app
* Willing and able to attend measurement visits over the 2 year intervention
* Willing and able to engage in moderate to vigorous physical activity
* Overweight or obese, but not severely obese (25 >= BMI < 40 kg/m2)
Exclusion Criteria:
* Any comorbidities of obesity that require a clinical referral including eating disorders, pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
* Psychiatric or medical conditions that prohibit compliance with the study protocol
* Had a cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
* Currently being treated for a malignancy (other than non-melanoma skin cancer)
* Currently being treated and/or have an eating disorder
* Planning to have a weight loss surgery in the next 24 months (e.g., liposuction, lap band, gastric bypass)
* Pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, or actively planning pregnancy within the next 24 months
* Prescribed physical activity and/or dietary changes
* Prescribed medications that alter weight
* Enrolled in or planning to enroll in a weight loss program during the study period
* Lost more than 15 pounds within the past 3 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03907462
|
{
"brief_title": "SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults",
"conditions": [
"Overweight and Obesity"
],
"interventions": [
"Behavioral: SMART 2.0"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03907462",
"official_title": "SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-01",
"study_completion_date(actual)": "2024-02-01",
"study_start_date(actual)": "2019-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-13",
"last_updated_that_met_qc_criteria": "2019-04-04",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-09",
"first_submitted": "2019-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study aims to evaluate whether the use of polypropylene and elastane Lupo ® masks can be considered as a significant causal agent in cases of respiratory and acid-base imbalances. For this, gas parameters such as lactate, bicarbonate, Sat02, pH, Sat02, P02 and PC02 of people before and after the practice of aerobic physical exercises will be measured. The control group will perform the exercise without wearing a mask and the study group will perform the exercise using a mask.
Detailed Description
The experimental phase was carried out at the Armação Atlética academy accredited by the Medical School of Pouso Alegre, following all sanitary recommendations in relation to covid-19.
The aerobic exercise performed by the participants consisted of 15 minutes of running on the treadmill without inclination, interspersing the speeds 10 km/h and 12km/h.
The evaluated clinical parameters of blood pressure, heart rate, pulse , O2 saturation and biochemical analyses of lactate, (partial oxygen pressure) PO2, (partial pressure of CO2 (carbon dioxide) PC02,(hydrogenic potential) pH ,- were collected just before exercise and shortly after that - with maximum interval between measurements of 2 minutes- through physical examination of the cardiovascular apparatus using littmann classic stetoscope iii®,Multilaser® sphygmomanometer and digital oximeter; and arterial blood collection for blood gas analysis.
The blood gas parameters were obtained before and after exercise from blood sample collection by arterial puncture of the Radial Artery performed by the nurses responsible for the blood gas service of the Samuel Libânio Clinic hospital in order to avoid errors regarding the technique. After collection, the samples were kept in a heparinized container and under cooling in an appropriate thermal box and were sent within 20 minutes to the laboratory to be analyzed by blood gas analysis.Such measures avoided the formation of microclots in the samples and the dissipation of blood gases to be analyzed as Co2 and O2 thus bypassing such possible random bias. The blood gas samples obtained were sent to the Hcsl Clinical Analysis laboratory where they underwent gas run in werfen's GEM Premier 3500® apparatus.
To perform the study, we defined a control group and study group based on the use of random sampling software that gave numbers to each participant, distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise.The specific use of this trademark mask made of 98% Polyamide and 2% Elastane ensures that there will be no variations within the study group regarding the composition of the mask, which could result in variable degrees of seals and, therefore, confounding bias to the study.
As an additional safety measure, especially for participants who have to perform the exercise without mask, since they can reinfect themselves, mobile transparent polymer plates for both groups will be temporarily installed around the treadmill. The appliance will be sanitized after each participant used it, with alcohol 70.
After performing the exercise, participants must complete the socio-demographic form sent via Forms in order to characterize such group regarding gender, weight age of participants.
The data acquired through the experiment received static treatments such as a. Classificationtest Signed by Wilcoxon by the statistician of the University of Vale do Sapucaí- Univás).
#Intervention
- DEVICE : Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
- The 26 participants allocated as G2 had to perform the physical exercise using the Zero Sewing Virus Bac-Off Virus® 98% Polyamide and 2% Elastane, in order to totally seal the nose and mouth.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy medical students who practice physical activity regularly, at least 3 times a week.
Exclusion Criteria:
* people who do not accept to participate in the study, refusing to sign the free and informed consent form.
* Sedentary people
* people with major cardiorespiratory diseases or comorbidity
* people tested positive for Covid-19 or other respiratory-infectious diseases in less that 15 days
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05270538
|
{
"brief_title": "Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask",
"conditions": [
"Acid-Base Imbalance",
"Respiration Disorders"
],
"interventions": [
"Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT05270538",
"official_title": "Cardiorespiratory and Acid-basic Imbalance Caused by Use of Face Mask, During Physical Exercices",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-12",
"study_completion_date(actual)": "2022-01-12",
"study_start_date(actual)": "2020-11-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-08",
"last_updated_that_met_qc_criteria": "2022-02-25",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-08",
"first_submitted": "2022-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to compare the pain score between the direct method and the conventional method in patients who have undergone copper or hormonal intrauterine devices (IUD) for contraception and to find an answer to the question of which method is better.
Detailed Description
The intrauterine device (IUD) is one of the commonly used methods of contraception due to its effectiveness in providing reliable contraception, its ease of application, non-obstruction of sexual life, affordability, minimal absolute contraindications, and reversibility. Despite this increasing preference, concerns regarding the use of both levonorgestrel-releasing and copper IUDs due to the potential pain and fear of pain during insertion, which has hindered the adoption of this method.
Although the conventional method is used for intrauterine device insertion, the authors defined the direct method, also known as the torpedo technique, in 2006. IUD practitioners have started to prefer this direct method because it is simpler, faster and has fewer insertion steps than the conventional technique. However, IUD practitioners should apply the most painless and tolerable method to women who choose an IUD for contraception. Therefore, in order to understand which method is less painful, patients will be divided into 2 groups as those who have IUD inserted with the conventional method and those who have IUD inserted with the direct method. At the end of the procedure, participants in both groups will be asked to rate the most severe pain they experienced during the procedure according to the Visual Analogue Scale (VAS) (from 0 to 10).
In the conventional method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD was inserted.
In the direct method: the anterior lip of the cervix was grasped and pulled with Pozzi forceps, and without using hysterometry the IUD was directly inserted.
#Intervention
- DEVICE : Intrauterine Device Insertion
- All womens will be placed in a gynecological position and underwent a bimanual examination to better determine whether the uterus was in the anteverted or retroverted position. Subsequently, a speculum will be inserted, and the cervix will be disinfected with betadine. In the conventional method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and after entering the uterine cavity with a hysterometry the IUD is inserted. In the direct method: the anterior lip of the cervix is grasped and pulled with Pozzi forceps, and without using hysterometry the IUD is directly inserted. The strings will be cut approximately 2-3 cm after the cervix, and the Pozzi forceps and speculum will be removed. The accuracy of the IUD placement will be confirmed using pelvic ultrasound. The process will take about five minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteer to participate in the study
* Preferring an intrauterine device for the contraceptive method
Exclusion Criteria:
* Patients with uterine leiomyoma
* Patients with endometriosis
* Patients with chronic pelvic pain
* Patients with familial mediterranean fever
* Patients who experienced complications during the procedure
* Patients who developed vasovagal reactions
* Patients who had previously used an IUD for any reason
* Patients with uterine anomalies
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05956184
|
{
"brief_title": "Intrauterine Device Insertion and Felt Pain",
"conditions": [
"Intrauterine Device Migration"
],
"interventions": [
"Device: Intrauterine Device Insertion"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05956184",
"official_title": "Intrauterine Device Insertion and Felt Pain: Which Method is Better?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-01",
"study_completion_date(actual)": "2023-09-01",
"study_start_date(actual)": "2023-07-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-05",
"last_updated_that_met_qc_criteria": "2023-07-13",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-21",
"first_submitted": "2023-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
Detailed Description
The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.
#Intervention
- DEVICE : DreamKit
- The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged >=18 years;
* Fluent in English;
* Able to provide informed consent.
Exclusion Criteria:
* Self-reported habitual sleep duration of <4 hours/night on average ('How many hours sleep do you usually get per night?');
* Circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study;
* History of allergic reactions to medical adhesives;
* Skin rash or other dermatological condition that would impact correct placement of the DreamKit device and/or PSG sensors, and/or would be exacerbated by the presence of the device or sensors;
* Presence of a pacemaker;
* Severe medical condition (controlled or uncontrolled) that would impede data collection in the opinion of the site investigator, including the requirement for oxygen therapy;
* [for those currently using overnight therapy]: Unwilling to withdraw from overnight therapy for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the site investigator, with overnight therapy including but not limited to any form of PAP or ventilation, oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator strips, and/or positional device;
* [for those currently using overnight therapy]: Considered by the site investigator to be at risk of an AE resulting from hypersomnolence the day after the overnight visit, such as a high-risk occupation including but not limited to a pilot or commercial driver;
* An employee, or family member of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips).
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
|
NCT04671342
|
{
"brief_title": "DreamKit Diagnostic Validation",
"conditions": [
"Sleep Apnea, Obstructive",
"Sleep Apnea, Central"
],
"interventions": [
"Device: DreamKit"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04671342",
"official_title": "Diagnostic Validation of the DreamKit Device Against Polysomnography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-18",
"study_completion_date(actual)": "2021-12-18",
"study_start_date(actual)": "2021-01-14"
},
"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)": "2023-01-31",
"last_updated_that_met_qc_criteria": "2020-12-15",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-17",
"first_submitted": "2020-12-09",
"first_submitted_that_met_qc_criteria": "2023-01-23"
}
}
}
|
#Study Description
Brief Summary
The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose of olanzapine will be studied.
In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the CYP1A2 and UGT metabolism of olanzapine.
Detailed Description
Psychosis and other mental illnesses are commonly described in patients infected with the human immunodeficiency virus (HIV). New-onset psychosis is estimated to occur in up to 15% of patients infected with HIV while 5 to 7% of patients with HIV-infection suffer from pre-existing mental illnesses including schizophrenia. Olanzapine could be an attractive antipsychotic in HIV/AIDS patients with schizophrenia.
Because olanzapine is a substrate for both UGT and CYP1A2, the pharmacokinetics of olanzapine might be influenced by low-dose ritonavir in combination with fosamprenavir. The current study is designed to test this hypothesis. Furthermore, in this study we evaluate the safety of such combination.
#Intervention
- DRUG : fosamprenavir/ritonavir
- 16 days 700mg/100mg RTV BID
- DRUG : olanzapine
- 15 mg olanzapine single dose
- DRUG : olanzapine
- 10 mg olanzapine single dose
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 and not older than 55 years at screening.
* Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition as established by medical history, physical examination, electro-cardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
* Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Exclusion Criteria:
* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Positive HIV test.
* Positive hepatitis B or C test.
* Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the trial.
* Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
* Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, glaucoma, gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose.
* Donation of blood within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose.
* History of narrow-angle glaucoma.
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
|
NCT00977301
|
{
"brief_title": "Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)",
"conditions": [
"HIV Infections"
],
"interventions": [
"Drug: olanzapine",
"Drug: fosamprenavir/ritonavir"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT00977301",
"official_title": "The Effect of FOsamprenavir/Ritonavir on the Pharmacokinetics of a Single-dose of the Antipsychotic Agent olanZApine (FORZA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-08",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2009-11"
},
"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)": "2020-11-30",
"last_updated_that_met_qc_criteria": "2009-09-14",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-15",
"first_submitted": "2009-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
Detailed Description
OsteoArthristis (OA) is the most frequent form of arthritis and a leading cause of pain and disability worldwide. OA can affect any synovial joint, although the hip, knee, hand, foot and spine are the most commonly affected sites.
The knee is the most commonly affected joint and knee OA (KOA) represents the leading joint disorder in the world. At present, there is no preventive or curative drug treatment available for KOA.
Physical therapy plays a significant role in treating patients with knee OA. Rehabilitation enables the patient to cope with their daily task independently and mainly focus on self-help and patient-driven treatments rather than on passive therapies delivered by clinicians.
A systemic review was conducted on Comparative Effect of Calisthenics and Proprioceptive Exercises on Pain, Proprioception, Balance and Function in Chronic Osteoarthritis of Knee. According to this study Light intensity Calisthenics exercises are effective and can be recommended as an adjunct to conventional physiotherapy for the patients with Osteoarthritis knee.
Another research was conducted on Efficacy of Neuromuscular Training on Pain, Balance and Function in Patients with Grade I and II Knee Osteoarthritis. The results shows that although conventional exercise program is effective in reducing knee pain, and increasing lower extremity muscle strength and range of motion, adding neuromuscular training (KBA) along with conventional exercise program in rehabilitation leads to higher improvement on balance and function in patient with knee grade I and II osteoarthritis.
A positive effect has been observed in treating patients with both the interventions.
The past research records are evident that therapists have determined individual effects of calisthenics and neuromuscular training for rehabilitation of Knee OA. The evidence for implementation of two protocols for rehabilitation of Knee OA is sparse. So the aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
#Intervention
- OTHER : Calisthenic Training
- Calisthenic Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises.
1. Abductor-Adductor leg raise
2. Alternate toe touch
3. Knee Bend
4. Prone leg extension
5. Forward Lunges
6. Toe Raise/ Calf raise Progressive training include following exercises.
1. Leg Lifts 2. Jack Twists 3. Side Lunges 4. Short bridge 5. Calf Raise with weight.
- Other Names :
- Group A
- OTHER : Neuromuscular Training
- Neuromuscular Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises.
1. Up and down step exercise in posterior and lateral directions.
2. Walking in anterior and posterior
3. Directions with eyes opened and eyes closed.
4. Walking in lateral direction with eyes opened and eyes closed.
5. Standing on one extremity
6. Inclination in anterior and lateral direction with eyes opened and closed. Progressive training includes following exercises.
1. Up and down on Bosu exercise. 2. Plantar flexion on minitrampoline. 3. Standing on one extremity on Bosu. 4. Standing on one extremity on minitrampoline
- Other Names :
- Group B
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with chronic OA (symptoms for more than 3 months).
* Subjects willing to participate and take treatment.
* Grade of 2 to 3 as per Kellegren and Lawrence radiographic classification.
Exclusion Criteria:
* Subjects having any systemic joint pathologies, inflammatory joint disease (e.g.
Rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
* Subjects who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy any mental illness (Dementia, Alzheimer's, Parkinson disease etc.) that can affect orientation and concentration.
* Subjects on medication like antidepressants, corticosteroid, and anti-inflammatory medications.
* Peripheral vascular diseases.
* Any history of surgery related to lower extremity.
* Subjects having metal implants in the lower limb
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05173649
|
{
"brief_title": "Calisthenic and Neuromuscular Training in Patients With Knee OA.",
"conditions": [
"Knee Osteoarthritis"
],
"interventions": [
"Other: Calisthenic Training",
"Other: Neuromuscular Training"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05173649",
"official_title": "Effect of Calisthenics and Neuromuscular Training in Patients With Knee Osteoarthritis.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-30",
"study_completion_date(actual)": "2022-01-30",
"study_start_date(actual)": "2021-11-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-18",
"last_updated_that_met_qc_criteria": "2021-12-29",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-30",
"first_submitted": "2021-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (QoL) and work productivity in patients with rheumatoid arthritis (RA) in Taiwan.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
* Male or female subjects >= 18 years (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
* Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C- Reactive Protein (CRP) >3.2
* Biologically treatment naïve and initiated adalimumab at baseline visit
* Availability of clinical data of the previous 12 weeks prior to baseline
* Ability to self-complete patient questionnaires
* Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Exclusion Criteria:
* Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
* Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline
* Patients, who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization
* Patients, who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.
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
|
NCT02616380
|
{
"brief_title": "Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02616380",
"official_title": "Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-23",
"study_completion_date(actual)": "2017-11-23",
"study_start_date(actual)": "2015-11-05"
},
"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)": "2019-03-14",
"last_updated_that_met_qc_criteria": "2015-11-25",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-26",
"first_submitted": "2015-11-25",
"first_submitted_that_met_qc_criteria": "2018-11-19"
}
}
}
|
#Study Description
Brief Summary
Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a transcatheter aortic value repair procedure began on December 2, 2014. Retrospective data was collected from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Aortic Valve Replacement Procedures (STS/ACC TVT, trademark) Registry - National database for Transcatherter Aortic Valve Replacement Procedures and included subjects from March 2012 through July 31, 2015. Patients included: s/p tAVR via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc); Exclusions: Major events including stroke, pacemaker placement, other cardiovascular (CV) repair or surgery required, etc). Future data analysis will extend subjects to December 31, 2015 and annually.
Detailed Description
Rationale: Frequency of transcatheter and other structural heart procedures increased dramatically from 2012 to 2014 and is trending even higher for 2015. Procedures increased from 15 in 2012 to 50 cases in 2013 (233% increase) and to 70 cases in 2014 (40% increase from 2013 to 2014.) -- PT and OT identified a gap in consults and need for specific education targeted for a new surgery population (tAVR) without sternotomy. Often consults were placed on day of discharge to rehab facility or not at all. -- Structural Heart division of CV institute identified increased length of stay (LOS) and decreased activity of their patients in the hospital. -- No literature on this subject found via Henry Ford Hospital Sladen Library PubMed literature review
Aim: • Create a standardized pathway for new transcatheter aortic valve replacement patients in the Structural Heart Division (SHD)
* Improve patient outcomes including increasing the percentage of patients returning to home rather than a rehab facility destination at discharge
* Decrease length of stay
Implementation:
* Plan: PT and OT identified a gap in consults and need for specific education targeted at a new surgeries population (tAVR); Structural Heart division of CV institute identified an increase LOS and decreased activity of their patients in the hospital. In October 2014 planning began to introduce a SHD tAVR pathway that would include post procedure day number 0 nursing requirements and training, post procedure day number 1-3 PT and OT assessment and interventions.
* Do: Implemented pathway in November 2014.
* Check: Order set revision; Patient handouts ; Cardiac Rehab; Weekend criteria; staff training
* Act: February 2015, order sets in place, patient handouts finalized and full pathway finalized for post op tAVR patients.
* Continued checks identified additional SHD procedures and team determined that Mitral Clips and LARIATs were not criteria for tAVR pathway but would receive routine PT and OT consults.
Intervention: • Added PT and OT to Structural Heart Order Set.
* PT and OT assessments completed on post procedure day number day 1.
* PT and OT follow up treatments post procedure day number 2, 3 and beyond as appropriate.
* Patient education handouts individualized for patient population
* Pre-op education handouts individualized for patient population
Outcome measures: Hospital Length of stay, discharge disposition. Data Analysis: Chi-square tests are used to compare proportions between groups, while Wilcoxon two-sample tests are used to compare distributions of continuous variables between groups. This nonparametric test was chosen due to non-Gaussian distribution of the continuous outcomes within groups. Statistical significance was set at p\<0.05. All analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, North Carolina, USA).
#Intervention
- OTHER : Post procedure daily PT and OT
- PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time
- OTHER : PT post procedure
- post procedure day one: PT and OT assessment, education and intervention.
- OTHER : OT post procedure
- PT and OT Daily until goals met or patient discharge.
- OTHER : Routine PT or OT
- Routine PT or OT consulted by physician when identified discharge disposition of home
|
#Eligibility Criteria:
Inclusion Criteria:
* admission to henry ford hospital after March 1, 2012
* status post transcatheter aortic valve replacement via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc)
Exclusion Criteria:
* Occurrence of major events including stroke, pacemaker placement, other CV repair or surgery required, etc)
* procedure via appropriate other than femoral access (transapical, transcaval)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03117296
|
{
"brief_title": "Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement",
"conditions": [
"Transcatheter Aortic Valve Implantation"
],
"interventions": [
"Other: PT post procedure",
"Other: Routine PT or OT",
"Other: Post procedure daily PT and OT",
"Other: OT post procedure"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03117296",
"official_title": "Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07-31",
"study_completion_date(actual)": "2017-12-31",
"study_start_date(actual)": "2014-12-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-20",
"last_updated_that_met_qc_criteria": "2017-04-14",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-17",
"first_submitted": "2017-04-07",
"first_submitted_that_met_qc_criteria": "2022-04-18"
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Primary Objective:
- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational Objectives:
* To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
* To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal Products (CPMP) - CHMP NfG CPMP/BWP/214/96.
Detailed Description
Adults age 18 to \< 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone Intradermal Quadrivalent vaccine and adults age ≥ 65 years will be randomly assigned to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. All subjects will receive a single dose of their randomly assigned vaccine.
They will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse reactions will be collected for 7 days after vaccination. Unsolicited non-serious adverse events (AEs) and serious adverse events (SAEs) will be collected from Visit 1 to Visit 2.
#Intervention
- BIOLOGICAL : Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
- 0.5 mL, Intramuscular (IM)
- Other Names :
- Fluzone® Quadrivalent, Influenza Vaccine
- BIOLOGICAL : Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
- 0.1 mL, Intradermal
- Other Names :
- Fluzone® Intradermal Quadrivalent, Influenza Vaccine
- BIOLOGICAL : Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
- 0.5 mL, Intramuscular
- Other Names :
- Fluzone® Quadrivalent, Influenza Vaccine
- BIOLOGICAL : Fluzone High-Dose vaccine, 2015-2016 formulation
- 0.5 mL, Intramuscular
- Other Names :
- Fluzone® High-Dose, Influenza Vaccine
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is >= 18 years on the day of inclusion
* Informed consent form has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
* History of serious adverse reaction to any influenza vaccine
* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2
* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
* Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
* Prior vaccination with any 2015 <= age <= 2016 formulation of influenza vaccine
* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
* Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine
* Personal history of Guillain-Barré syndrome
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
* Seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C, as reported by the subject.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
* Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature >= 100.4°F) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
* Identified as an Investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed 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:
Yes
|
NCT02563093
|
{
"brief_title": "Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation",
"Biological: Fluzone High-Dose vaccine, 2015-2016 formulation",
"Biological: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02563093",
"official_title": "Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2015-2016 Formulations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-12",
"last_updated_that_met_qc_criteria": "2015-09-28",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-29",
"first_submitted": "2015-09-28",
"first_submitted_that_met_qc_criteria": "2016-10-20"
}
}
}
|
#Study Description
Brief Summary
This study aims to determine whether a test, called the PET scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests.
The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. The study will compare pictures of the cancer from the PET scan to other x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery. If the study results show that the PET scan gives us a good idea of what is happening to the tumor, then it may be useful in deciding which patients with colorectal metastases to the liver should be operated on and what operation should be performed.
Additionally, by comparing the results of PET scans with the other studies that will be performed as part of your care, we will try to determine which test best tells us which patient is most likely to benefit from surgery.
|
#Eligibility Criteria:
Inclusion Criteria:
* initial diagnosis of colorectal carcinoma confirmed by the Pathology Department of Memorial Hospital or by diagnostic barium enema if the primary tumor is still in place.
* a candidate for liver resection for metastatic colorectal cancer as defined by members of the Department of Surgery of Memorial Hospital. Patients with metastatic colorectal cancer isolated to the colon, rectum, or liver are eligible. In addition, patients with limited, resectable pulmonary metastases are eligible.
Exclusion Criteria:
* Patients must not be pregnant; females of child bearing age must use an adequate form of contraception.
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
|
NCT00588549
|
{
"brief_title": "Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases",
"conditions": [
"Colorectal Carcinoma"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00588549",
"official_title": "Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "1998-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-03-19",
"last_updated_that_met_qc_criteria": "2007-12-24",
"last_verified": "2009-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-08",
"first_submitted": "2007-12-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants.
Detailed Description
This is a Phase I, open-label, single-arm, single dose PK study in healthy Chinese participants to be conducted at a single study centre in mainland China. In this study, approximately 10 participants (both females and males) will be assigned to the IMP. Each participant will receive a single dose of a capsule with balcinrenone/dapagliflozin 40 mg/10 mg on Day 1 under fasted condition. The study will comprise of the following:
* A screening period
* A treatment period
* A follow-up visit At the discretion of the investigator, the participant may remain in the study center until the completion of the follow-up visit
#Intervention
- DRUG : balcinrenone/dapagliflozin
- Each participant will receive a single dose of balcinrenone/dapagliflozin 40 mg/10 mg capsule on Day 1 under fasted condition.
Each participant will be involved in the study for up to 35 days.
|
#Eligibility Criteria:
Inclusion Criteria:
Age
* Participant aged 18 <= age <= 50.
Type of Participant and Disease Characteristics
* Chinese participants who are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
Weight
* Body weight within 50.0 <= age <= 100.0 kg and BMI within the range 19.0 <= age <= 28.0 kg/m2 (inclusive) at screening.
Exclusion Criteria:
Medical Conditions
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
* Any clinically significant abnormal findings in vital signs, as judged by the investigator.
* Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
* Any positive result on screening for serum HBsAg or anti-hepatitis B core antibody, hepatitis C antibody, and HIV antibody.
* Positive screen for drugs of abuse, alcohol or cotinine at screening or on admission to the study centre.
* Suspected or confirmed COVID-19 infection within the last 4 weeks prior to screening or admission. Or hospitalisation for COVID-19 within the last 12 weeks prior to screening or admission.
* Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
* Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone or dapagliflozin.
Prior/Concomitant Therapy
* Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), hormone replacement therapy, herbal remedies, megadose vitamins and minerals within 14 days or 5 half-lives (whichever is longer) before the start of IMP, unless, in the opinion of the investigator, the medication will not interfere with the study.
Prior/Concurrent another Clinical Study Experience
* Has received investigational product within 3 months (or 5 half-lives, whichever is longer) of administration of study intervention in this study.
Other Exclusions
* Involvement in the planning and/or conduct of this study.
* Judgment by the investigator that the participant should not participate in this study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
* Previous enrolment in the present 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:
Yes
|
NCT06651021
|
{
"brief_title": "A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: balcinrenone/dapagliflozin"
],
"location_countries": [
"China"
],
"nct_id": "NCT06651021",
"official_title": "A Phase I, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of a Single Dose of Balcinrenone/Dapagliflozin in Healthy Chinese Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-10-28",
"study_completion_date(actual)": "2024-10-28",
"study_start_date(actual)": "2024-10-21"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-15",
"last_updated_that_met_qc_criteria": "2024-10-17",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-21",
"first_submitted": "2024-09-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this single center, prospective, randomized, double blind clinical trial is to evaluate the effectiveness of anodal transcranial direct current stimulation (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine use for postoperative analgesia after thoracotomy. The intervention group will receive treatment with anodal tDCS, whereas the control group will receive sham stimulation.
Detailed Description
tDCS has been used for treatment of chronic pain states, but experience with the use of tDCS for treatment of acute postoperative pain is limited. tDCS has been used for postoperative analgesia after lumbar spine surgery, total knee arthroplasty and for post-procedural pain after endoscopic retrograde cholangiopancreatography.
This study investigates the effects of tDCS vs. sham stimulation combined with IV morphine PCA on postoperative morphine consumption for analgesia after thoracotomy for lung cancer.
Patients with malignant lung disease requiring thoracotomy will be randomly assigned to active stimulation or sham stimulation in a double-blind, sham-controlled, parallel design clinical trial. Each group will receive IV morphine PCA and tDCS vs. IV morphine PCA and sham stimulation daily, starting with arrival in the post-anesthesia care unit on the day of surgery and continuing for the first four postoperative days. Anodal tDCS with direct current at intensity 2 mA will be delivered for 20 minutes on five consecutive days, whereas sham stimulation will last for 30 seconds.
Morphine consumption, the number of analgesia demands, and pain intensity at rest, during movement and with cough will be recorded at predetermined time intervals as follows: After surgery, when VAS pain score at rest falls below 30 mm, tDCS will be applied. VAS pain will be measured immediately before the intervention (T0) and immediately after the intervention (T1), and then regularly every one hour for the four hours (Т2-Т5), and then every six hours (Т6-Т9) for five days.
#Intervention
- DEVICE : Transcranial direct current stimulation
- Transcranial direct current stimulation. All eligible patients will be treated with patient-controlled IV morphine analgesia by PCA (PCA pump (CADD-Legacy PCA Pump, Deltec, Inc.) IV morphine bolus 1 mg, lockout time 10 mins.).
Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 20 mins.
- Other Names :
- tDCS
- DRUG : Morphine
- In Sham comparator group All eligible patients will be treated with patient-controlled IV morphine analgesia (PCA) (PCA pump (CADD-Legacy PCA Pump (Deltec, Inc.) morphine IV bolus 1 mg, lockout time 10 mins).
Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 30s at the beginning.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is willing and able to provide written informed consent,
* Subject is 18 <= age <= 80 years,
* Subject needs thoracotomy for confirmed malignant lung disease,
* Subject is extubated in the operating room
Exclusion Criteria:
* Subject is pregnant
* Subject is in treatment for psychiatric disease
* Subject is in treatment for neurological disease
* Subject is in treatment for chronic pain
* Subject has history of current or past alcohol or Street Drug abuse
* Subject has received chemotherapy
* Subject has history of previous thoracic or cardiac surgery
* Subject is allergic to medications that will be used in the study
* Subject has pacemaker or automatic implantable cardioverter/defibrillator
* Subject has implants or any other devices in the head, the spinal cord or peripheral nerves
* Subject has confirmed brain lesion, including tumor or metastasis
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
|
NCT03005548
|
{
"brief_title": "Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation",
"conditions": [
"Pain, Postoperative"
],
"interventions": [
"Drug: Morphine",
"Device: Transcranial direct current stimulation"
],
"location_countries": [
"Serbia"
],
"nct_id": "NCT03005548",
"official_title": "Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2016-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-29",
"last_updated_that_met_qc_criteria": "2016-12-24",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-29",
"first_submitted": "2016-12-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this pilot study is to test the feasibility and preliminary efficacy of the repetitive negative thinking (RNT) focused web-based self-help program in college students. The main questions it aims to answer are:
* Does the program work without any help of a clinician?
* Does the program have any reducing effect on the participants' RNT, depression, anxiety, stress and cognitive fusion scores? - Does the program help participants to improve their psychological flexibility and committed actions? Participants will be administered a set of questionnaires before and after completing the 10-day long web-based self-help program, provided on a daily basis. Researchers will compare the intervention group with a waitlist control group to assess for any potential placebo effect.
Detailed Description
After obtaining informed consent, all participants will receive a set of questionnaires for baseline measurement. Participants will be randomized into two groups using block randomization: one as the intervention group and the other as the control group (waitlist condition). This method helps ensure an equal distribution of participants with similar characteristics in both groups, minimizing potential biases and increasing the validity of the study.
#Intervention
- BEHAVIORAL : RNT Focused Web- Based Self-Help Program
- This 10 day long intervention contains psychoeducational contents, experimental exercises, monitoring behavior and committed action strategies. Each step of the intervention aims to develop a specific psychological flexibility skill like cognitive defusion etc.
|
#Eligibility Criteria:
Inclusion Criteria:
* having internet connection and a working smart phone or computer
Exclusion Criteria:
* having thoughts of self-harm or suicide,
* diagnosed with psychotic disorder,
* substance abuse
* currently receiving psychological help
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06192056
|
{
"brief_title": "Feasibility and Preliminary Efficacy of a Web-Based Self-Help Program for College Students",
"conditions": [
"Repetitive Negative Thinking"
],
"interventions": [
"Behavioral: RNT Focused Web- Based Self-Help Program"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06192056",
"official_title": "Feasibility and Preliminary Efficacy of Web-Based Self-Help Program on Repetitive Negative Thinking for College Students: A Randomized Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-22",
"study_completion_date(actual)": "2023-12-22",
"study_start_date(actual)": "2023-12-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-13",
"last_updated_that_met_qc_criteria": "2024-01-04",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-05",
"first_submitted": "2023-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
We compared the effects of 8 weeks of aerobic exercise only, resistance exercise only, or a combination of both on blood pressure in overweight or obese middle-aged adults with elevated blood pressure. Participants engaged in supervised exercise sessions 3 times per week for 60 minutes each session. Outcomes were assessed at baseline and after the 8-week intervention. Extra-intervention physical activity and diet were also assessed.
#Intervention
- BEHAVIORAL : Aerobic Exercise
- 180 minutes of moderate-vigorous intensity aerobic exercise per week
- BEHAVIORAL : Resistance Exercise
- 180 minutes of resistance exercise per week
- BEHAVIORAL : Combined aerobic and resistance exercise
- 180 minutes of exercise per week with 90 minutes per week coming from moderate-vigorous intensity aerobic exercise and 90 minutes per week coming from resistance exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* Systolic/diastolic blood pressure of 120 <= age <= 159/80 <= age <= 99 mm Hg
* Non-smoking
* Overweight or obese, with a body mass index of 25 <= age <= 40 kg/m2
* Inactive--not meeting the aerobic or resistance physical activity guidelines, which means engaging in less than 150 minutes/wk of moderate intensity aerobic exercise and less than 2 days per week of resistance training over the past 3 months.
Exclusion Criteria:
* Unstable coronary heart disease or decompensated heart failure
* Severe pulmonary hypertension or aortic stenosis
* Acute myocarditis, endocarditis, pericarditis, or aortic dissection
* Other medical condition that is life-threatening or that can interfere or be aggravated by the exercise training such as cancer, uncontrolled diabetes, severe pain or mobility limitations.
* Premenopausal women or postmenopausal women taking hormonal replacement therapy
* Pregnant women or anticipated pregnancy via IVF or other medical procedures during the course of the intervention
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03734146
|
{
"brief_title": "Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure",
"conditions": [
"Cardiovascular Risk Factor"
],
"interventions": [
"Behavioral: Combined aerobic and resistance exercise",
"Behavioral: Aerobic Exercise",
"Behavioral: Resistance Exercise"
],
"location_countries": null,
"nct_id": "NCT03734146",
"official_title": "Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12-19",
"study_completion_date(actual)": "2014-12-19",
"study_start_date(actual)": "2014-07-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-07",
"last_updated_that_met_qc_criteria": "2018-11-05",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-07",
"first_submitted": "2018-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Given the heightened cardiovascular disease (CVD) risk in post-menopausal women, studies are needed to explore novel, feasible methods for reducing risk in this population. Based on prior data, primarily in other populations, progressive resistance training is a promising candidate. This project will test the effectiveness of a practical, progressive resistance training regimen for lowering numerous CVD risk factors compared to both aerobic training and no exercise in post-menopausal women.
Detailed Description
The number of women living with cardiovascular disease (CVD) is greater than for men and CVD is the leading cause of death for women. Post-menopausal women are a particularly vulnerable population in terms of adverse cardiovascular indicators and outcomes. Specifically, they exhibit greater visceral adipose tissue, fasting and postprandial glucose, total cholesterol (Total-C), fasting insulin, and systolic blood pressure, and are at increased risk for coronary heart disease compared to pre-menopausal women. There is also evidence that cardiovascular indicators (i.e., triglycerides, low high-density lipoprotein cholesterol (HDL-C), etc) are stronger risk predictors in women than men. Despite the staggering rates of CVD in post-menopausal women, as noted by the American Heart Association (AHA), CVD remains understudied in this population. Numerous studies have demonstrated the cardioprotective effects of exercise. However, these studies have largely featured younger individuals, primarily men, undergoing aerobic exercise training. Findings in recent years have indicated the potential benefits of resistance training beyond improving muscular size or strength, such as improved aerobic fitness, central adiposity, glycemic control, and cholesterol profiles. However, large clinical gaps have been noted for women with regard to the effects of resistance training on cardiovascular health. Thus, there is a clear need to assess the cardioprotective effects of progressive exercise training in post-menopausal women.
SPECIFIC AIMS:
1. To test the hypothesis that realistic full-body progressive resistance training improves markers of (a) cardiovascular health and (b) body composition and muscular health in post-menopausal women versus a low physical-activity control.
A. The primary markers of cardiovascular health to be assessed are aerobic capacity, fasting and postprandial metabolic and inflammatory responses, vascular function via flow-mediated dilation (FMD) and markers of angiogenesis.
B. The primary body composition and muscle function variables to be assessed are muscle size, isometric and dynamic muscle strength, lean body mass, percent body fat, and abdominal adiposity.
2. To compare the effects of realistic, full-body progressive resistance training in post-menopausal women versus moderate-intensity aerobic exercise, the standard exercise prescription for cardiovascular health, on the cardiovascular, body composition, and muscular health outcomes listed above in 1A. and B.
#Intervention
- BEHAVIORAL : Resistance Exercise
- Women assigned to the resistance exercise training group will complete progressive, full-body resistance exercise 3 times per week for 16 weeks.
- BEHAVIORAL : Aerobic Exercise
- Women assigned to the aerobic exercise training group will complete progressive, aerobic exercise 5 times per week for 16 weeks. The aerobic training will progress first in duration, and then in intensity.
|
#Eligibility Criteria:
Inclusion Criteria:
* provide written and dated informed consent to participate in the study; (2) be willing and able to comply with the protocol
* be willing and able to comply with the protocol
* be a female between the ages of 45 and 65, inclusive
* be postmenopausal for >= 1 year
* be in good health and free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire
* have a BMI between 18.5 and 40.0, inclusive; and
* answer no to all questions on the PAR-Q for people aged 15 to 69, which are as follows:
1. Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
2. Do you feel pain in your chest when you do physical activity?
3. In the past month, have you had chest pain when you were not doing physical activity?
4. Do you lose your balance because of dizziness or do you ever lose consciousness?
5. Do you have a bone or joint problem that could be made worse by a change in physical activity?
6. Is your doctor currently prescribing drugs for your blood pressure or heart condition? Do you know of any other reason why you should not do physical activity?
Exclusion Criteria:
* are currently prescribed and/or taking lipid-lowering medications
* are participating in another clinical trial within thirty days prior to enrollment
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03752060
|
{
"brief_title": "The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women",
"conditions": [
"Cardiovascular Risk Factor",
"Menopause Related Conditions",
"Neuromuscular Function",
"Aerobic Capacity",
"Inflammation"
],
"interventions": [
"Behavioral: Aerobic Exercise",
"Behavioral: Resistance Exercise"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03752060",
"official_title": "The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-15",
"study_completion_date(actual)": "2019-11-22",
"study_start_date(actual)": "2019-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-03",
"last_updated_that_met_qc_criteria": "2018-11-21",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-23",
"first_submitted": "2018-08-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with normal hepatic function, in male and female participants aged 18 to 79 years.
Detailed Description
The total duration of the study per participant is up to 41 days including:
* A screening period of up to 4 weeks (Days -28 to -2)
* A 5-day, open-label treatment period
* Up to 7 days post-treatment follow-up period
#Intervention
- DRUG : tolebrutinib
- Pharmaceutical form: Film-coated tablet Route of administration: oral
|
#Eligibility Criteria:
Inclusion Criteria:
For participants with mild hepatic impairment
* Stable chronic liver disease assessed by medical history, physical examination, and laboratory values
* Child-Pugh total score ranging from 5 to 6, inclusive.
* Laboratory parameters within the acceptable range for participants with hepatic impairment; however, estimated glomerular filtration rate (eGFR) should be above or equal to 60 mL/min
For all participants
* Body weight between 50.0 and 115.0 kg, inclusive, if male, between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) within the range 18 to 40 kg/m2, inclusive, at screening.
* Participant with platelet count >=150 000/μL at the screening visit and at Day -1
Exclusion Criteria:
For all participants :
* Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure >=30 mmHg within 3 minutes when changing from supine to standing position at screening and Day -1
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
* History of drug or alcohol abuse within 1 year before inclusion.
* Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization.
* Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
* Use of any herbal medicines 2 weeks before IMP administration
* Treatment with a strong or moderate CYP3A inhibitors, a strong, moderate or mild CYP2C8 inhibitors OR CYP3A, CYP2C8 inducers within 14 days before the study treatment administration or 5 half-lives, whichever is longer
Specific for participants with mild hepatic impairment:
* Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic, renal, infectious disease, moderate or severe hepatic impairment (Child-Pugh total score greater than or equal to 7), or signs of acute illness.
* Hepatocarcinoma.
* Acute liver disease.
* Hepatic encephalopathy Grade 2, 3, and 4.
* Esophageal bleeding which is caused by esophageal varices within 3 months before inclusion.
NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05283915
|
{
"brief_title": "Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function",
"conditions": [
"Hepatic Function Abnormal"
],
"interventions": [
"Drug: tolebrutinib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05283915",
"official_title": "An Open-label Phase 1, Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Dose in Adult Participants With Mild Hepatic Impairment, and in Matched Participants With Normal Hepatic Function",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-24",
"study_completion_date(actual)": "2022-05-24",
"study_start_date(actual)": "2022-03-18"
},
"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)": "2025-01-15",
"last_updated_that_met_qc_criteria": "2022-03-16",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-17",
"first_submitted": "2022-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.
#Intervention
- DEVICE : Sham tDCS device
- Sham tDCS
- DEVICE : Soterix tDCS device
- Active tDCS
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or above.
* Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
* Total score >= 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
Exclusion Criteria:
* Current episode duration greater than 3 years.
* Failed more than 3 adequate antidepressant trials in current episode.
* DSM-IV psychotic disorder.
* Drug or alcohol abuse or dependence (preceding 3 months).
* Inadequate response to ECT in the current episode of depression.
* Rapid clinical response required, e.g., high suicide risk.
* Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or >= 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
* Clinically defined neurological disorder or insult.
* Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Pregnancy.
* Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
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
|
NCT01562184
|
{
"brief_title": "Investigating tDCS as a Treatment for Unipolar and Bipolar Depression",
"conditions": [
"Unipolar Depression",
"Bipolar Depression"
],
"interventions": [
"Device: Sham tDCS device",
"Device: Soterix tDCS device"
],
"location_countries": [
"Australia",
"United States"
],
"nct_id": "NCT01562184",
"official_title": "A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression",
"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)": "2012-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-02",
"last_updated_that_met_qc_criteria": "2012-03-22",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-23",
"first_submitted": "2012-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to conduct a prospective, three-group study that randomly assigns 700 parolees, in a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, one-on-one coaching and the HAV/HBV vaccine.
Detailed Description
Homeless parolees pose a particular challenge for successful reentry into the community as they have underlying mental health issues combined with substance use and abuse and must contend with unstable housing situations, disorganized lives, unemployment, and limited access to health care and social services. Generally about 50% of all parolees scheduled to enroll in community-based drug treatment fail to enroll and less than 10% of enrollees actually complete treatment. Not surprisingly, about two-thirds of all individuals on parole are rearrested and return to custody within three years of release from prison. Recent data also revealed homeless persons who were least likely to complete a Hepatitis A/B (HAV/HBV) vaccine series were young (\< 40) men who had been discharged from prison. Therefore, it is critical to engage paroled adults in comprehensive intervention programs that not only protect them from hepatitis B, but also reduce risky behavior, promote access to health care, social and employment services, and enable positive coping and communication skills.
Building upon advice from community partners who have successfully treated parolees and the research team's experience with hepatitis vaccination work, this study is designed to conduct a prospective, three-group study that randomly assigns 700 ready-for-discharge parolees, scheduled to enter a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and referrals, the HAV/HBV vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, the HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, and the HAV/HBV vaccine. This study will advance the research team's knowledge about drug treatment and HBV vaccine completion and recidivism among homeless parolees. Findings from this study can inform targeted interventions and lay the groundwork for health policy decisions that may impact hepatitis and HIV risk reduction and recidivism in this group who are a reservoir for these viruses in the general population, and are returning to prison at unprecedented numbers.
#Intervention
- BEHAVIORAL : Parolee Comprehensive Care + Phone Coach
- A nurse case managed and specialized hepatitis education program with the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone).
- Other Names :
- PCPC
- BEHAVIORAL : Parolee Brief HBV Program + Phone Coach
- A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
- Other Names :
- PBPC
- BEHAVIORAL : Usual Care Group
- Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine
- Other Names :
- UC
|
#Eligibility Criteria:
Inclusion Criteria:
* Parolees enrolled in Amity's Amistad's program;
* Age 18 <= age <= 60;
* Discharged from prison or jail within the last six months;
* History of drug use 12 months prior to most recent incarceration;
* Previously homeless prior to most recent incarceration; and
* Willing to provide informed consent
Exclusion Criteria:
* Monolingual speakers of languages other than English; and
* Persons judged to be cognitively impaired by the research staff.
Sex :
MALE
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
|
NCT01844414
|
{
"brief_title": "UCLA-Amity Parolee Health Promotion Study",
"conditions": [
"Hepatitis B",
"Hepatitis C",
"HIV",
"Drug Addiction"
],
"interventions": [
"Behavioral: Parolee Brief HBV Program + Phone Coach",
"Behavioral: Usual Care Group",
"Behavioral: Parolee Comprehensive Care + Phone Coach"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01844414",
"official_title": "Health Promotion Coaching/Vaccine for Homeless Parolees",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2010-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-28",
"last_updated_that_met_qc_criteria": "2013-04-26",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-01",
"first_submitted": "2013-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.
#Intervention
- DEVICE : Implant placement
- Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
- Other Names :
- Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter), Locator® attachments (Zest Anchors: Escondido, CA, USA)
- PROCEDURE : Conventional reline
- conventional reline of the existing mandibular complete denture
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 75 years
* living institutionalized or receiving help for the ADL
* edentulous
* wearing complete dentures
* the lower denture had to cause discomfort to the degree that the patients were seeking treatment
Exclusion Criteria:
* severe clinical depression
* dementia
* poorly controlled diabetes
* immunosuppression
* treatment with bisphosphonates
* condition precluding the surgical intervention for implant placement
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01928004
|
{
"brief_title": "Mandibular Implants in Elderly Patients",
"conditions": [
"Edentulous Complete Denture Wearers"
],
"interventions": [
"Device: Implant placement",
"Procedure: Conventional reline"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01928004",
"official_title": "Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-04",
"study_completion_date(actual)": "2019-04",
"study_start_date(actual)": "2007-09"
},
"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)": "2021-04-30",
"last_updated_that_met_qc_criteria": "2013-08-20",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-23",
"first_submitted": "2013-08-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study in healthy men and women compares the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (sc, under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.
#Intervention
- DRUG : Semaglutide (administered by DV3396 pen)
- Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
- DRUG : Semaglutide (administered by PDS290 pen)
- Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female subjects, aged 18 <= age <= 75 (both inclusive) at the time of signing informed consent.
* BMI equal to or above 25.0 kg/m^2
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the Investigator.
Exclusion Criteria:
* Known or suspected hypersensitivity to the study product or related products.
* Previous participation in this study. Participation is defined as having received investigational product.
* Woman who is pregnant or breast-feeding or intends to become pregnant within 4 weeks after administration of the study drug, or is of childbearing potential and not using highly effective contraceptive methods with her fertile male sexual partner
* Participation in a drug study within 60 days prior to drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to drug administration in the current study.
* Any disorder that in the Investigator's opinion might jeopardize subject's safety, evaluation of results, or compliance with the protocol.
* Glycosylated haemoglobin (HbA1c) equal to or above 6.5% at screening.
* Supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90 to 160 mmHg for systolic or 45 to 89 mmHg for diastolic.
* Supine pulse rate (as part of vital signs) (after resting for at least 5 minutes) outside the range of 40 to 100 beats per minute.
* Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives, and occasional use of paracetamol (paracetamol not allowed within 24 hours prior to drug administration), within 14 days prior to drug administration.
* Diagnostic test results positive for human immunodeficiency virus (HIV)-1 or HIV-2 infection.
* Diagnostic test results positive for hepatitis B or hepatitis C infection.
* Mental incapacity, language barriers, or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the Investigator.
* Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
* Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center.
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 1 cigarette or the equivalent per day on average
* Not able or willing to refrain from smoking and the use of nicotine substitute products during the in-house period
* Blood donation, plasma donation or blood draw (as declared by the subject or reported in the medical records):
* In excess of 400 mL within the past 90 days prior to the day of screening
* In excess of 50 mL within the past 30 days prior to the day of screening
* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records)
* Subjects with a history of malignant neoplasms within the past 5 years prior to screening.
* Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records).
* Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the study requirements.
* Subject depends on the Sponsor, the Investigator, or the study center, or subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study.
* Vulnerable subject (eg, person kept in detention) who may have an increased likelihood of being wronged or of incurring additional harm.
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
|
NCT04007107
|
{
"brief_title": "A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity",
"conditions": [
"Healthy Volunteers Diabetes Mellitus, Type 2",
"Healthy Volunteers Overweight",
"Healthy Volunteers Obesity"
],
"interventions": [
"Drug: Semaglutide (administered by PDS290 pen)",
"Drug: Semaglutide (administered by DV3396 pen)"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT04007107",
"official_title": "A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide sc Administered by 2 Different Products",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-28",
"study_completion_date(actual)": "2019-09-04",
"study_start_date(actual)": "2019-06-27"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-04",
"last_updated_that_met_qc_criteria": "2019-07-02",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-05",
"first_submitted": "2019-06-25",
"first_submitted_that_met_qc_criteria": "2020-07-24"
}
}
}
|
#Study Description
Brief Summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
#Intervention
- DRUG : Telaprevir
- Tablet
- Other Names :
- VX-950
- DRUG : Ribavirin
- Tablet
- DRUG : Pegylated interferon alfa 2a
- Solution for Injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the control arm of Study VX06 <= age <= 950-106 (NCT00420784), VX05 <= age <= 950-104 (NCT00336479) or VX05 <= age <= 950-104EU (NCT00372385)
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
|
NCT00535847
|
{
"brief_title": "A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy",
"conditions": [
"Hepatitis C"
],
"interventions": [
"Drug: Telaprevir",
"Drug: Ribavirin",
"Drug: Pegylated interferon alfa 2a"
],
"location_countries": [
"France",
"Netherlands",
"United States",
"Germany",
"Canada",
"Austria",
"Puerto Rico",
"United Kingdom"
],
"nct_id": "NCT00535847",
"official_title": "A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02",
"study_completion_date(actual)": "2010-02",
"study_start_date(actual)": "2007-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-05",
"last_updated_that_met_qc_criteria": "2007-09-25",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-26",
"first_submitted": "2007-09-25",
"first_submitted_that_met_qc_criteria": "2011-06-22"
}
}
}
|
#Study Description
Brief Summary
Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP
Detailed Description
This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP
#Intervention
- DRUG : cyproterone acetate
- two weeks Cyproterone acetate administration before TURP
- DRUG : finasteride
- two weeks finasteride administration before TURP
- DRUG : no treatment received
- no treatment received before TURP
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with benign prostatic hyperplasia with prostate size (60 <= age <= 100) grams
* Lower urinary tract symptoms (LUTS) not responding to medical treatment
* Recurrent prostatic bleeding
* Recurrent acute urinary retention
* Chronic urinary retention
Exclusion Criteria:
* Patients with coagulation disorders
* Previous prostatic surgery
* Previous finasteride administration
* Bladder pathology (urinary bladder stones - bladder mass)
* Suspected or proved cancer prostate
* Hepatic or renal impairment
* Patients unfit for operation eg. Decompensated heart failure, poor chest condition
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04848181
|
{
"brief_title": "The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate",
"conditions": [
"Prostate Hyperplasia"
],
"interventions": [
"Drug: finasteride",
"Drug: no treatment received",
"Drug: cyproterone acetate"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04848181",
"official_title": "The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-01",
"study_completion_date(actual)": "2020-07-09",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-21",
"last_updated_that_met_qc_criteria": "2021-04-13",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-19",
"first_submitted": "2021-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate the effectiveness of a peer-led social skills training intervention compared to social activity (usual care) to improve social communication skills following severe brain injury.
Detailed Description
A pilot study first tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction. Following amendments to the pilot protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre in April 2015. An experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was trained separately to facilitate interaction in the peer-led group. The training took place in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.
#Intervention
- BEHAVIORAL : Peer facilitator training
- Peer facilitation of a project-based activity without staff present
- OTHER : Usual care
- Staff-led social activity
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults between 18 and 70 years
* A diagnosis of severe traumatic brain injury (TBI) or severe acquired brain injury (ABI) with similar cognitive presentation to TBI
* Minimum of six months post injury
* Evidence of a social communication impairment as a result of injury
* Ability to tolerate group activity
Exclusion Criteria:
* Significant aphasia
* Severe depression or psychiatric disorder
* Insufficient English to converse with peers
* Profound cognitive impairment
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
|
NCT02211339
|
{
"brief_title": "A New Intervention for Social Communication Skills Following Brain Injury",
"conditions": [
"Brain Injuries"
],
"interventions": [
"Behavioral: Peer facilitator training",
"Other: Usual care"
],
"location_countries": null,
"nct_id": "NCT02211339",
"official_title": "An Investigation Into the Effectiveness of a Social Communication Skills Training Programme for Adults Following Brain Injury Using a Peer Learning Model",
"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)": "2015-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-14",
"last_updated_that_met_qc_criteria": "2014-08-06",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-07",
"first_submitted": "2014-08-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost complete penetrance) that predisposes to many tumors including some associated with a poorer outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality.
The diagnosis of VHL disease may be challenging because tumors have an asynchronous and multi-organ development and there is often no apparent hereditary context. As it is admitted that VHL disease is underdiagnosed, some countries have decided to recall patients presenting one of the potentially VHL disease-associated tumors to screen them for VHL mutation. Screening is currently recommended in guidelines but many patients may have not been previously screened.
Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population enables the diagnosis of other tumor types at an early stage of development since HB is chronologically the second tumor occurring during the VHL disease history.
But it raises critical problems and questions: difficult announcement of a potentially severe disease and psychosocial dimension related to inheritance of the disease.
#Intervention
- OTHER : evaluation of anxiety with psychosocial scales
|
#Eligibility Criteria:
Inclusion Criteria:
* age >=18;
* Surgery for a CNS HB in the department of Neurosurgery of la Timone university hospital since 1999 ;
* Absence of prior screening for VHL
Exclusion Criteria:
* minor,
* incorrect French language
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
|
NCT02120040
|
{
"brief_title": "Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System",
"conditions": [
"Hemangioblastoma (HB) of the Central Nervous System (CNS)"
],
"interventions": [
"Other: evaluation of anxiety with psychosocial scales"
],
"location_countries": [
"France"
],
"nct_id": "NCT02120040",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10-09",
"study_completion_date(actual)": "2023-03-08",
"study_start_date(actual)": "2014-05-02"
},
"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)": "2023-04-06",
"last_updated_that_met_qc_criteria": "2014-04-18",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-22",
"first_submitted": "2014-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to compare the effectiveness of PNF (Proprioceptive Neuromuscular Facilitation) and Mulligan Mobilization techniques with classical physiotherapy modalities in individuals with neck pain.
Detailed Description
Forty individuals with neck pain aged between 18-55 years will be randomly divided into two groups, PNF and Mulligan group. Classical physiotherapy modalities will be applied to all individuals 5 days a week. PNF group will receive PNF techniques three days a week and Mulligan group will receive Mulligan mobilization techniques three days a week. Participants will be treated for 4 weeks. The pain level of the patients whose demographic data were recorded; Visual Analog Scale (VAS), pressure pain threshold; algometer, range of motion (ROM); universal goniometer, functionality; Neck Disability Index, kinesiophobia; Tampa Kinesiophobia Scale, quality of life; SF-36 Quality of Life Scale, mood; Beck Depression Inventory, cervical muscle performance level; cervical performance tests will be measured before and after treatment.
Post-treatment pain intensity, kinesiophobia and depression level; the effectiveness of pressure pain threshold, ROM, functionality, quality of life and cervical muscle performance level will be compared within and between groups.
#Intervention
- PROCEDURE : Mulligan Mobilization Technique
- NAGs (Natural Apophyseal Glides) involve passive oscillatory movements of a spinal facet joint in an anterocranial direction, performed with the patient seated. SNAGs (Sustained Natural Apophyseal Glides) maintain facet glides during active movements, aiming to reach the joint\'s end range. In SNAGs, the patient actively participates, and overpressure is applied at the end of movements to enhance the range of motion. Techniques include increasing rotation, lateral flexion, flexion, and extension. These were applied by a certified physiotherapist three times a week for four weeks, aiming to improve joint mobility without causing pain.
- PROCEDURE : Proprioceptive Neuromuscular Facilitation (PNF) Technique
- Proprioceptive Neuromuscular Facilitation (PNF) Technique: PNF consists of four movement patterns in two diagonals:
Flexion-left rotation and extension-right rotation Flexion-right rotation and extension-left rotation 3 PNF techniques were applied.
Combined Isotonic Contractions: This technique involves concentric, eccentric, and stabilizing contractions of a muscle group (agonist). The goal is to increase active range of motion (ROM), strength, and improve control and coordination.
Dynamic Stabilization (Stabilizing Reversal): This involves applying resistance in various directions to prevent movement, aiming to enhance dynamic stability, strength, and agonist-antagonist coordination.
Hold-Relax Technique: This relaxation method involves isometric contractions against maximum resistance without movement to increase passive ROM and reduce pain. These were applied by physiotherapist three times a week for four weeks, aiming to improve joint mobility without causing pain.
|
#Eligibility Criteria:
Inclusion Criteria:
* Complaint of neck pain for at least 3 months
* Volunteer between the ages of 18 <= age <= 55
* Receiving a diagnosis of chronic neck pain by a physician
Exclusion Criteria:
* Having undergone a surgical procedure for the spine
* Exercise therapy and/or physical therapy within the last 1 year
* History of fracture in the cervical region
* Radiculopathy, myelopathy (motor and sensory loss), or neurological impairment
* Presence of Cardiac Pacemaker
* Positive vertebrobasilar artery test
* Having a blood clotting disorder
* Presence of cancer
* Being diagnosed with rheumatoid arthritis
* Those with systemic diseases targeting the cervical region
* Presence of active infection
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:
No
|
NCT06620965
|
{
"brief_title": "A Comparison of the Effectiveness of PNF and Mulligan Mobilization Techniques with Neck Pain",
"conditions": [
"Neck Pain"
],
"interventions": [
"Procedure: Mulligan Mobilization Technique",
"Procedure: Proprioceptive Neuromuscular Facilitation (PNF) Technique"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06620965",
"official_title": "A Comparison of the Effectiveness of PNF and Mulligan Mobilization Techniques with Classic Physiotherapy Modalities in People with Neck Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-06",
"study_completion_date(actual)": "2024-06-14",
"study_start_date(actual)": "2022-09-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-02",
"last_updated_that_met_qc_criteria": "2024-09-27",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-01",
"first_submitted": "2024-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.
Detailed Description
CARISEPY3014 is the open-label extension study that follows the double-blind study CARISEPY3013 (NCT00740623). In an open label study such as CARISEPY3014, both the physician and the patient know the name of the assigned study medication. In a double blind study such as CARISEPY-3013, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the 14-week double-blind treatment phase of study CARISEPY3013 will be eligible to enter the open-label extension study during which patients will transition through a 1-week blinded period to open-label carisbamate. There will be a 1 week blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. Safety assessments include the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, the Physician Withdrawal Checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. Seizure counts will be obtained at every visit. The Quality of Life in Epilepsy-31 Patient Inventory questionnaire will be administered once during the study. A Medical Resource utilization questionnaire will be used to obtain cost-effectiveness information on carisbamate and will be administered twice during the study. There is no statistical testing hypothesis for this study. Carisbamate tablets taken twice daily in 2 equally divided doses, with or without food, and taken with noncarbonated water. During the first week on study, patients will take blinded transition study medication and thereafter will take a target dosage of 800 mg/day of unblinded, open-label study medication. The dosage of study medication will range from 400 to 1,200 mg/day. Patients will receive treatment for 1 year with the potential to receive treatment longer.
#Intervention
- DRUG : placebo
- placebo for 1 week
- DRUG : carisbamate
- 400 mg/day to 1,200 mg per day
|
#Eligibility Criteria:
Inclusion Criteria:
* Must have completed the 14-week double-blind treatment phase of study CARISEPY3013
* must be willing/able to follow the restrictions and prohibitions of the protocol
* must be able to complete the patient diaries correctly (patients or legally acceptable representatives)
* must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives)
* adolescents capable of understanding the nature of the study must provide assent to participate in the study
Exclusion Criteria:
* Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00744731
|
{
"brief_title": "An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures",
"conditions": [
"Epilepsy, Partial, Motor",
"Epilepsy, Complex Partial",
"Epilepsy, Simple Partial",
"Focal Motor Epilepsy"
],
"interventions": [
"Drug: placebo",
"Drug: carisbamate"
],
"location_countries": null,
"nct_id": "NCT00744731",
"official_title": "The Open Label Extension Portion of the Study Entitled A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-08",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-06-18",
"last_updated_that_met_qc_criteria": "2008-08-29",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-01",
"first_submitted": "2008-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
* Willingness to participate
Exclusion Criteria:
* Patient refusal
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02989441
|
{
"brief_title": "Perfusion Index in Anesthesia",
"conditions": [
"Monitoring, Physiological"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT02989441",
"official_title": "Peripheral Perfusion Index as Marker for Systemic Hemodynamics During Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03",
"study_completion_date(actual)": "2018-06",
"study_start_date(actual)": "2016-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-17",
"last_updated_that_met_qc_criteria": "2016-12-09",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-12",
"first_submitted": "2016-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators have designed a single site, Phase IV open label, prospective observational clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus standard postpartum contraceptive care (control) on consistent contraceptive use and rapid repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.
Detailed Description
Background: Opioid dependence in pregnancy has increased dramatically in the last decade. Over 86% of pregnancies conceived by OD women are unintended, compared to 31-43% of pregnancies in the general population. In evaluations of contraceptive use among sexually active women in opioid treatment programs, 40-75% of sexually active OD women report no contraceptive use. Even among women using contraception, 45-55% report using only condoms without more effective, hormonal contraception. Pregnancy and the postpartum period are unique opportunities to provide contraceptive education and services. Long-acting reversible contraception (LARC) has been shown to more effectively prevent rapid repeat, unintended pregnancies compared to other postpartum contraceptive options and does not incur the risk of venous thromboembolism associated with estrogen-containing methods (i.e. pills, ring, patch). No studies have evaluated the impact of immediate postpartum etonogestrel implant (Nexplanon) placement on reproductive health outcomes in OD women, a population at significant risk for rapid repeat, unintended pregnancy. In contrast to an intrauterine device (IUD), Nexplanon is safe to insert regardless of labor and delivery circumstances, does not incur an increased risk of postpartum expulsion and is long-acting, which makes it the ideal contraceptive for the immediate postpartum period.
Study site:This single site study will be conducted at Magee-Womens Hospital (MWH) of the University of Pittsburgh Medical Center.
Study Procedures: Recruitment - participants will be recruited during the third trimester of pregnancy (≥ 28 weeks gestation) during prenatal care visits.
Immediate postpartum Nexplanon placement (IPP) - participants who choose to enroll in the IPP Nexplanon arm will have Nexplanon placed in the immediate postpartum period (2-4 days following delivery), prior to hospital discharge.
Standard postpartum contraceptive care (control) - participants who choose to enroll in the control arm will receive a contraceptive method of their choice according to standard clinical protocols. Standard clinical protocols include condoms, Depo Provera (DMPA) or progestin-only pills initiated at any time after delivery, Nexplanon insertion at \> 4 weeks after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any time \> 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion any time \> 6 weeks after delivery.
Study Duration: 12 months
#Intervention
- DRUG : Nexplanon (etonogestrel contraceptive implant)
- Nexplanon is a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel indicated for postpartum contraceptive use by women to prevent pregnancy. Nexplanon is designed to be effective for 3 years.
- Other Names :
- Nexplanon
- DRUG : Standard postpartum contraceptive care
- Condoms, Depo Provera (DMPA) or progestin-only pills initiated at any time after delivery, Nexplanon insertion at \> 4 weeks after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any time \> 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion any time \> 6 weeks after delivery.
- Other Names :
- Postpartum contraception
|
#Eligibility Criteria:
Inclusion Criteria: Pregnant women, >= 18 years, who meet DSM-V criteria for opioid use disorder confirmed by diagnostic coding in the patient's medical record and/or urinary toxicology screen (UDS) and who plan to deliver at the study site hospital, Magee-Womens Hospital of UPMC (MWH-UPMC).
Exclusion Criteria: Women who have contraindications to etonogestrel use, intrauterine fetal demise or stillbirth, and/or who do not plan to deliver at MWH-UPMC.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02657148
|
{
"brief_title": "Immediate Postpartum Nexplanon Placement in Opioid Dependent Women",
"conditions": [
"Opiate Addiction",
"Pregnancy",
"Contraceptive Behavior",
"Sexual Behavior"
],
"interventions": [
"Drug: Standard postpartum contraceptive care",
"Drug: Nexplanon (etonogestrel contraceptive implant)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02657148",
"official_title": "A Prospective Observational Clinical Trial to Compare the Effect of Immediate Postpartum Nexplanon Placement Versus Standard Postpartum Contraceptive Care on Consistent Contraceptive Use and Rapid Repeat Pregnancy in Opioid Dependent Women.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08",
"study_completion_date(actual)": "2018-08",
"study_start_date(actual)": "2016-05"
},
"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)": "2018-08-31",
"last_updated_that_met_qc_criteria": "2016-01-13",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-15",
"first_submitted": "2015-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
Detailed Description
This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.
#Intervention
- BIOLOGICAL : GSK1024850A (Synflorix)
- 2, 3 or 4 intramuscular injection
- BIOLOGICAL : Tritanrix-HepB/Hib
- Intramuscular injection, 4 doses
- Other Names :
- DTPw-HBV/Hib
- BIOLOGICAL : Polio Sabin
- 4 oral doses
- Other Names :
- OPV
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
* A male or female between, and including:
* 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or
* 7 and 11 months at the time of the first vaccination for subjects in the 7 <= age <= 11S and 7 <= age <= 11NS groups or
* 12 and 23 months at the time of first vaccination for subjects in the 12 <= age <= 23S and 12 <= age <= 23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
* Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
Additional inclusion criteria for children with SCD (<6S, 7 <= age <= 11S and 12 <= age <= 23S groups):
* Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (<6S group) or electrophoresis (7 <= age <= 11S and 12 <= age <= 23S groups).
* Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context
Additional inclusion criteria for healthy children (<6NS, 7 <= age <= 11NS and 12 <= age <= 23NS groups):
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Children with negative diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.
Exclusion Criteria:
* Child in care
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital malformations.
* History of any neurological disorders or seizures.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Birth weight below 1500g.
* Serious chronic illness other than SCD.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Additional exclusion criteria for children with SCD (<6S, 7 <= age <= 11S and 12 <= age <= 23S groups):
* Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).
Additional exclusion criteria for healthy children (<6 NS, 7 <= age <= 11NS and 12 <= age <= 23NS groups):
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
Sex :
ALL
Ages :
- Minimum Age : 8 Weeks
- Maximum Age : 23 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01175083
|
{
"brief_title": "Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A",
"conditions": [
"Infections, Streptococcal"
],
"interventions": [
"Biological: Polio Sabin",
"Biological: GSK1024850A (Synflorix)",
"Biological: Tritanrix-HepB/Hib"
],
"location_countries": [
"Burkina Faso"
],
"nct_id": "NCT01175083",
"official_title": "Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01-17",
"study_completion_date(actual)": "2013-05-23",
"study_start_date(actual)": "2011-06-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-06",
"last_updated_that_met_qc_criteria": "2010-08-03",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-04",
"first_submitted": "2010-08-03",
"first_submitted_that_met_qc_criteria": "2019-02-26"
}
}
}
|
#Study Description
Brief Summary
This is a multi center, open label, parallel group, single administration, phase I trial, in subjects with mild, moderate or severe renal impairment and a control group with normal renal function.
Detailed Description
Current diabetes therapy does not stop progression of the disease and the development of diabetes mellitus (DM)-associated complications. A major concern in DM-patients is renal impairment due to nephropathy leading to a reduced glomerular filtration rate (GFR). It has been established that chronic (sub)clinical inflammation is crucial for the onset and progression of DM.
CCL2, also known as Monocyte chemoattractant protein 1 (MCP 1) is a chemokine from the cysteine-cysteine family, secreted by leukocytes or tissue cells. CCL2 promotes monocyte emigration from the bone marrow, activates monocytes and macrophages and directs their migration to sites of inflammation. Recent animal studies and clinical trials indicate a critical involvement of CCL2 in DM and diabetic nephropathy, suggesting that CCL2 may be a potential target for therapeutic intervention in DM. Finally, protein overload and oxidative challenge of the diseased kidney was suggested to stimulate CCL2 expression in renal tubuli, thereby accelerating the progression of diabetic nephropathy.
As NOX E36 is designed to specifically target human MCP-1/CCL2. This study is performed to evaluate the role of renal impairment for adequate dosing recommendations in the planned target population.
#Intervention
- DRUG : NOX-E36
- All subjects included in this study will receive the same dose of NOX E36. In previous clinical trials, single intravenous doses of NOX E36 up to 2 mg/kg body weight and single subcutaneous doses of up to 0.5 mg/kg body weight appeared to be safe and well tolerated in healthy volunteers. Pharmacokinetic analyses have shown dose linearity
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects (age 18 <= age <= 75 years, both inclusive)
* Male subjects who agree to sexual abstinence and/or use a highly effective method of birth control. Female partners of male subjects must be of non-child bearing potential or must practice an adequate non-hormonal contraceptive method to prevent pregnancies.
* Subjects will be categorized as follows based on creatinine clearance(mL/min/1.73m2): Normal renal function: CrCl > 80; mild renal impairment: 50 <= CrCl <= 80; moderate renal impairment: 30 <= CrCl <= 50; severe renal impairment: CrCl < 30
* Body Mass Index (BMI) between 22 and 40 kg/m², both inclusive.
Exclusion Criteria:
* Women of childbearing potential
* Patients who have received kidney transplantation.
* Patients receiving hemodialysis to control their disease.
* Any clinically significant abnormality other than related to the renal impairment following the investigator's review of the physical examination, ECG and clinical laboratory tests at screening.
* Not able to communicate meaningfully with the investigator and staff.
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
|
NCT01372124
|
{
"brief_title": "A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36",
"conditions": [
"Renal Impairment"
],
"interventions": [
"Drug: NOX-E36"
],
"location_countries": [
"Hungary",
"Moldova, Republic of"
],
"nct_id": "NCT01372124",
"official_title": "A Phase I, Open Label, Parallel Group, Multi-center Single Dose Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2011-06"
},
"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)": "2012-10-19",
"last_updated_that_met_qc_criteria": "2011-06-10",
"last_verified": "2012-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-13",
"first_submitted": "2011-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Evaluation of the effectiveness of a phlebology-oriented spa therapy at 6 months on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs
Detailed Description
NEYRAC is a:
* prospective, before/after, cohort follow-up study with repeated measurements
* monocentric study with the dispensation of a 3-week phlebology-oriented spa therapy in Neyrac-les-Bains
#Intervention
- OTHER : Spa therapy
- Thermal treatments among the following: pool, Kneipp pool, high pressure shower under immersion in a swimming pool, general jet shower, cataplasm in multiple local application, compress, massage under water or with thermal derivatives, walking corridor
- Other Names :
- spa treatment, spa care
|
#Eligibility Criteria:
Inclusion criteria:
* Age greater than 18 years
* Patient with chronic venous insufficiency of the lower limbs (CEAP category C4a, C4b and C4c)
* Patient presenting an indication for a phlebology-oriented spa treatment as the primary orientation. Patients with a dermatological or rheumatological pathology can benefit from a dual orientation spa treatment with a main phlebology orientation
* Patient affiliated to the social security system or such a system
* Available for an 18-day spa treatment and a 6-month follow-up
* For women of childbearing age: effective contraception
* Patient close to a study investigator (excluding teleconsultation) If not patient with access to the necessary equipment to perform a teleconsultation (smartphone, tablet or computer with an internet connection + taking and sending photos of the lower limbs)
Non inclusion criteria:
* Venous surgery or venous interventional therapy within 3 months prior to inclusion or scheduled within the next 3 months
* History of venous ulcer
* Contraindication to spa therapy (immune deficiency, evolving cardiopathy neoplasia, infection, pulmonary tuberculosis, severe renal insufficiency, alcoholic cirrhosis, advanced senility and severe mental disorders)
* Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.)
* Persons suffering from venous insufficiency of the varicose vein type (category CEAP C2) or edema alone (category CEAP C3) or open or healed ulcers (CEAP category C5 and C6)
* Patient who has already undergone a phlebology-oriented spa treatment within the current thermal season
* Subject already included in an interventional clinical research protocol
* Persons referred to in articles L1121 <= age <= 5 to L1121 <= age <= 8 of the 'Code de la Santé Publique' (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05449743
|
{
"brief_title": "Assessment of the Effect of Spa Therapy on the Quality of Life of Patients with Chronic Venous Insufficiency (NEYRAC)",
"conditions": [
"Chronic Venous Insufficiency"
],
"interventions": [
"Other: Spa therapy"
],
"location_countries": [
"France"
],
"nct_id": "NCT05449743",
"official_title": "Evaluation of the Effectiveness of a Phlebology-oriented Spa Treatment on the Quality of Life of Patients Suffering from Chronic Venous Insufficiency of the Lower Limbs, 6-month After the Spa Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-11-25",
"study_completion_date(actual)": "2024-11-25",
"study_start_date(actual)": "2022-07-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-19",
"last_updated_that_met_qc_criteria": "2022-07-04",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-08",
"first_submitted": "2022-06-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
#Intervention
- DRUG : LBS-008
- LBS-008 oral capsules
- DRUG : Placebos
- Oral capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* The subject is male or female, 18 <= age <= 65 of age, inclusive, at screening.
* The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
* The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
* Female subjects must be of nonchildbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening; FSH level >40 mIU/mL). Female subjects may also be considered of non-childbearing if they have a confirmed medical condition which would deem the subject as infertile. E.g. MRKH Syndrome (Mullerian Agenesis) or another applicable condition.
* Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or remain abstinent or agree to use a highly effective form of contraception when sexually active with a female partner for 90 days after study drug administration. Highly effective contraception requires use of a condom and appropriate contraceptive measures for your female partner (i.e. oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system). This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential.
* The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, and weighs 50 to 100 kg (110 to 220 pounds), inclusive, at screening and check-in.
* The subject is considered to be in stable health by the investigator.
* The subject agrees to comply with all protocol requirements.
Exclusion Criteria:
* Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
* Vitamin A deficiency.
* Any recent viral or bacterial infection.
* Participated in any clinical study in last 6 weeks.
* History of significant drug allergy
* History of significant vision, ocular or retinal disorder.
* Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations Other protocol-defined inclusion/exclusion criteria could apply.
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
|
NCT03735810
|
{
"brief_title": "Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: LBS-008",
"Drug: Placebos"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT03735810",
"official_title": "A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBS-008 in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-16",
"study_completion_date(actual)": "2019-09-16",
"study_start_date(actual)": "2018-11-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-07",
"last_updated_that_met_qc_criteria": "2018-11-07",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-08",
"first_submitted": "2018-11-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial or laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas (e.g. in the case of fire) or salts in the case of suicide attempts.
In fact, cyanide poisoning is considerably more common than is generally appreciated. Multiple clinical and post-mortal studies have demonstrated that HCN contributes to the toxicity of fire smoke.
Cyanide acts primarily through its strong affinity for the iron-containing heme moiety, binding to numerous critical enzyme systems in the body and rendering them inactive. Of late, increasing attention has been paid to the relationship of cyanide and nitric oxide. The interactions appear to be complex, with cyanide inducing nitric oxide production by binding to N-methyl-D-aspartate (NMDA) receptors, as well as binding to nitric oxide synthase. The latter may be overcome by the presence of nitric oxide synthase inhibitors.
Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in closed-space fires.
So far, there are no clear data available on the prevalence of cyanide poisoning in smoke inhalation.
This information would be of great interest for all emergency physicians since a proven or supposed cyanide poisoning does not only requires an intensive supportive care, including the administration of supplemental oxygen and artificial ventilation, blood pressure support, and anticonvulsants, but also a rapid administration of a cyanide antidote.
Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in smoke inhalation victims. Only the data of patients with a cyanide measurement before specific antidote treatment will be included
Detailed Description
Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial or laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas (e.g. in the case of fire) or salts in the case of suicide attempts.
In fact, cyanide poisoning is considerably more common than is generally appreciated. Multiple clinical \[1-4\] and post-mortal studies \[5-10\] have demonstrated that HCN contributes to the toxicity of fire smoke.
Cyanide acts primarily through its strong affinity for the iron-containing heme moiety, binding to numerous critical enzyme systems in the body and rendering them inactive \[11\]. Of late, increasing attention has been paid to the relationship of cyanide and nitric oxide. The interactions appear to be complex, with cyanide inducing nitric oxide production by binding to N-methyl-D-aspartate (NMDA) receptors \[12\], as well as binding to nitric oxide synthase. The latter may be overcome by the presence of nitric oxide synthase inhibitors.
Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in closed-space fires.
So far, there are no clear data available on the prevalence of cyanide poisoning in smoke inhalation.
This information would be of great interest for all emergency physicians since a proven or supposed cyanide poisoning does not only requires an intensive supportive care, including the administration of supplemental oxygen and artificial ventilation, blood pressure support, and anticonvulsants, but also a rapid administration of a cyanide antidote.
Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in smoke inhalation victims. Only the data of patients with a cyanide measurement before specific antidote treatment will be included.
#Intervention
- OTHER : There is no intervention planned (observational)
- No intervention foreseen
|
#Eligibility Criteria:
Inclusion Criteria:
* Closed space fire, Soot deposits, Altered mental status
* Blood specimen before intravenous antidote treatment (cyanide measurement)
* Known delay between end of smoke exposure and blood sampling
* Malaise and/or Headache and/or Altered mental status in fire workers
Exclusion Criteria:
* Pregnancy
* Multiple trauma, Blast
* Patient pronounced dead at scene without resuscitation attempt
* Patient in whom the time elapsed between the end of exposure and blood sampling is greater than 2 hours
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01386788
|
{
"brief_title": "European Survey: Risk of Cyanide Poisoning in Smoke Inhalation",
"conditions": [
"Smoke Inhalation Patients"
],
"interventions": [
"Other: There is no intervention planned (observational)"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01386788",
"official_title": "European Survey: Risk of Cyanide Poisoning in Smoke Inhalation, Symptoms, Key Treatment and Outcome (RISK)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2009-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-28",
"last_updated_that_met_qc_criteria": "2011-06-30",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-01",
"first_submitted": "2011-06-27",
"first_submitted_that_met_qc_criteria": "2016-08-05"
}
}
}
|
#Study Description
Brief Summary
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
Detailed Description
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome by 6 minute walking distance and oxygen consumption.
#Intervention
- DEVICE : CPAP therapy
- Continous positive airway pressure therapy
- OTHER : Control
- No CPAP
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis with COPD by GOLD guideline criteria (Post bronchodilator FEV1/FVC < 0.7 or < LLN) with post bronchodilator FEV1 = 30 <= age <= 80%
* Diagnosis with obstructive sleep apnea with AHI > 15 event/hr. (Moderate OSA or more)
* Age between 40 <= age <= 80 years
* Stable disease prior to inclusion.
Exclusion Criteria:
* Diagnosis with > 50% of central sleep apnea event
* History of COPD exacerbation during the past 8 week prior to inclusion.
* Subjects who cannot perform spirometry test or walking test
* Subjects with recording history of chronic heart failure, significant arrhythmias, acute myocardial infarction, moderate to severe mitral or aortic valve disease and pulmonary hypertension.
* Subjects with interstitial lung disease.
* Subjects with neuromuscular disease.
* Subjects with morbid obesity (BMI >=35)
* Subjects with chronic respiratory infection.
* Subjects with chronic CO2 retension (PaCO2 >= 45 from arterial blood gas analysis) or Transcutaneous CO2 during sleep test >= 45 or Serum bicarbonate level > 27
* Subjects with acute or active respiratory infecton during 2 week prior to inclusion.
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
|
NCT05857475
|
{
"brief_title": "Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome",
"conditions": [
"COPD",
"OSA",
"Lung Function Decreased"
],
"interventions": [
"Other: Control",
"Device: CPAP therapy"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT05857475",
"official_title": "Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-01",
"study_completion_date(actual)": "2024-01-01",
"study_start_date(actual)": "2023-06-01"
},
"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)": "2024-02-05",
"last_updated_that_met_qc_criteria": "2023-05-04",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-12",
"first_submitted": "2023-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (\> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.
The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.
#Intervention
- DRUG : Swallowed fluticasone
- 440 µg twice daily for 8 weeks
- DRUG : Esomeprazole
- 40 mg once daily for 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
* Males and females > 18 yearsyears of age.
* Ability to undergo ambulatory pH monitoring.
* DEERS (Defense Enrollment Eligibility Reporting System) eligible.
* Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
* Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.
Exclusion Criteria:
* Patients < 18 years.
* Inability to give consent.
* Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
* Contraindications to proton pump inhibitors or steroids.
* Inability to accurately fill out a short questionnaire.
* Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
* Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
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
|
NCT00895817
|
{
"brief_title": "Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis",
"conditions": [
"Eosinophilic Esophagitis"
],
"interventions": [
"Drug: Swallowed fluticasone",
"Drug: Esomeprazole"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00895817",
"official_title": "Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-12",
"last_updated_that_met_qc_criteria": "2009-05-06",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-08",
"first_submitted": "2009-05-06",
"first_submitted_that_met_qc_criteria": "2013-03-11"
}
}
}
|
#Study Description
Brief Summary
Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to this treatment (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. This project will test the effectiveness of improving family support for PE as a tool to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite congressional legislation and national mandates within VA/DoD for family involvement in PTSD care, there remains no proven strategies for how to routinely include family in traditional individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a model of family engagement that can be translated to other problems faced by Veterans, including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain management, contributing to a broader evolution towards evidence-based, family-inclusive care.
Detailed Description
Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD, through increasing family support for treatment. Improving retention rates in evidence-based PTSD treatment will positively impact Veterans' health and well-being, lower the cost of treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach could help resolve national calls for routine inclusion of family involvement in PTSD treatment. Once demonstrated for PTSD, these strategies could be utilized for other conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better routine and evidence-based involvement of families in care.
Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to these treatments (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. Engaging families in Veterans' treatment may provide a powerful method for promoting EBP adherence. The investigators data indicate that 70% of Veterans express some interest in involving their family in their care for PTSD; yet, only 17% of providers have had any contact with Veterans' families. The objective of the proposed study is to evaluate the effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This research agenda directly addresses two VA HSR\&D priorities:
* innovative mental health care;
* improving the quality of life for Veterans and their caregivers. The work aligns with the VHA Blueprint for Excellence and Strategic Plan through meeting the unique needs of military-service disabled Veterans, providing a novel treatment approach, and emphasizing patient- and family-centered care.
Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in care.
H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report greater homework compliance (H1b) than Veterans randomized to standard PE delivered in routine care.
Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in care.
H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and comorbid problems (depression, quality of life, relationship functioning) from baseline to posttreatment.
Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory Aim: To identify mechanisms underlying adherence differences between treatment conditions.
The investigators will explore if adherence differences are mediated by changes on key social influence variables (family perceptions of treatment credibility, family support for PE, and family symptom accommodation).
Methods. The investigators are proposing a practical randomized controlled trial to compare Veteran adherence, and to PE with and without family attendance at PE's educational sessions, with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators will use a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in PE within VA. Participants will include Veterans with clinically significant symptoms of PTSD across three sites, plus a family member or friend of the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim 2 outcomes include PTSD symptom severity, depression, quality of life, and relationship functioning, measured monthly over the course of treatment. Key social influences (Exploratory Aim) will be assessed through brief weekly self-reports.
#Intervention
- BEHAVIORAL : Family Supported Prolonged Exposure
- The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
- BEHAVIORAL : Standard Prolonged Exposure
- Standard Prolonged Exposure for PTSD as delivered in routine VA care.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female veterans at least 18 years. Recruitment is limited to Veterans enrolled in VHA care.
* Participant meets DSM-5 diagnostic criteria for PTSD or subthreshold PTSD. Consistent with recommendations, subthreshold PTSD will be defined as endorsement of criteria A (trauma), F (duration), and G (impairment), with at least one symptom from each of the remaining diagnostic criteria (Brancu et al., 2016).
* Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week
* Willing to allow this person to participate in the study.
* Provides informed consent.
* Speaks and reads English.
Exclusion Criteria:
* Current suicidal or homicidal ideation with intent and/or plan.
* Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.
* Meets DSM-5 diagnostic criteria for a severe substance use disorder in the past 3 months. Of note, subjects can be abusing or dependent upon nicotine or marijuana and still be included in the study.
* Moderate relationship violence between the identified support person and the Veteran, defined as one or more episodes of severe violence in the past year (e.g., punched, kicked, or beat up).
* Support person screens positive for PTSD on a self-report instrument (PCL).
* Having an ongoing medical condition that would interfere with ability to attend weekly treatment sessions.
* Having any planned upcoming major medical procedures over the next several months that would interfere with ability to attend weekly treatment sessions.
* Veteran and/or SP fails to complete baseline survey
* Episode of mania/psychosis in past 3 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03256227
|
{
"brief_title": "Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families",
"conditions": [
"Posttraumatic Stress Disorder"
],
"interventions": [
"Behavioral: Standard Prolonged Exposure",
"Behavioral: Family Supported Prolonged Exposure"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03256227",
"official_title": "Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-30",
"study_completion_date(actual)": "2022-06-30",
"study_start_date(actual)": "2018-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-14",
"last_updated_that_met_qc_criteria": "2017-08-16",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-21",
"first_submitted": "2017-08-09",
"first_submitted_that_met_qc_criteria": "2024-01-31"
}
}
}
|
#Study Description
Brief Summary
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
#Intervention
- DRUG : Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
- Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
- DRUG : Placebo
- Placebo and sham up-titration at weeks 2, 4, and 6
|
#Eligibility Criteria:
Inclusion Criteria:
* Previous diagnosis of chronic heart failure (HF)
* HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.
* N-terminal pro brain natriuretic peptide (NT-proBNP) >=300 or brain natriuretic peptide (BNP) >=100 pg/mL in sinus rhythm, or NT-proBNP
>=600 or BNP >=200 pg/mL in atrial fibrillation within 30 days prior to randomization
* Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)
* Left ventricular ejection fraction (LVEF) >=45% and
* Structural changes indicated by at least one of the following parameters:
* Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness >=1.1 cm, and/or LV mass index >=115 g/m*2 in male and >=95 g/m*2 in female), or
* Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index >=29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients)
* NYHA class II or III at randomization
Exclusion Criteria:
* Clinical instability at randomization, defined by
* Any IV treatment within 24h prior to randomization, and/or
* SBP >=160 mmHg
* SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
* Resting heart rate (HR) <50 or >=100 beats per minute (bpm)
* Use of IV inotropes at any time between qualifying HF event and randomization
* Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
* Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
* Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
* Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization
* Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
* Complex congenital heart disease
* Non-cardiac comorbidity (any of the following)
* Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by Modification of Diet in Renal Disease formula
* Hepatic insufficiency classified as Child-Pugh B or C
* Morbid obesity with a body mass index >45 kg/m*2
* Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
* Requires continuous home oxygen for severe pulmonary disease or has interstitial lung disease
* Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
* Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03547583
|
{
"brief_title": "Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF",
"conditions": [
"Chronic Heart Failure With Preserved Ejection Fraction"
],
"interventions": [
"Drug: Placebo",
"Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets"
],
"location_countries": [
"Colombia",
"United States",
"Poland",
"Germany",
"Singapore",
"Austria",
"Japan",
"Israel",
"Taiwan",
"South Africa",
"Russian Federation",
"Hungary",
"Argentina",
"Italy",
"Portugal",
"Canada",
"Malaysia",
"Spain",
"Bulgaria",
"Belgium",
"Greece"
],
"nct_id": "NCT03547583",
"official_title": "A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-15",
"study_completion_date(actual)": "2019-11-04",
"study_start_date(actual)": "2018-06-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-06",
"last_updated_that_met_qc_criteria": "2018-05-24",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-06",
"first_submitted": "2018-05-24",
"first_submitted_that_met_qc_criteria": "2020-11-11"
}
}
}
|
#Study Description
Brief Summary
This project aims to enhance AN university students' behavioral health by supporting their cultural identity development. While the connection between cultural identity and behavioral health is becoming clearer, comparably less research has explored methods of enhancing identity development. Consequently, the investigators will pilot a cultural identity development program for AN students at the University of Alaska Anchorage (UAA). This intervention is based on extant scientific literature, local findings from focus group with AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program incorporates storytelling, experiential learning, connection, exploration, and sharing of identity, cultural strengths, life paths, and rootedness in who they are in order to remain grounded when they face changes and challenges. Approximately 40 to 50 AN university students will be recruited for the intervention. Participants will be randomized, with half the participants receiving the intervention in the Fall 2020 semester and half the students receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this intervention will strengthen AN students' cultural identities, strengths, and sense of community; improve their behavioral health, as evidenced in higher self-reported wellbeing, and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support their academic persistence and achievement. Outcomes will be tested via mixed design analyses of covariance. Moreover, program feasibility will be examined through a process evaluation, which will entail thematic analyses of six focus groups with program participants (n=40-50) and with the Elders who facilitated the program (n=5).
#Intervention
- BEHAVIORAL : Knowing Who You Are (Becoming): Cultural Identity Intervention
- 8-week cultural identity development program led by Alaska Native Elders
|
#Eligibility Criteria:
Inclusion Criteria:
* self-identify as Alaska Native,
* are registered as an undergraduate student at UAA,
* are at least 18 years,
* speak English
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04561544
|
{
"brief_title": "Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health",
"conditions": [
"Depression",
"Anxiety",
"Suicidal Ideation",
"Substance Use"
],
"interventions": [
"Behavioral: Knowing Who You Are (Becoming): Cultural Identity Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04561544",
"official_title": "Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-05",
"study_completion_date(actual)": "2022-05-31",
"study_start_date(actual)": "2020-08-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-11",
"last_updated_that_met_qc_criteria": "2020-09-18",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-23",
"first_submitted": "2020-08-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
48-week open label randomized phase IV investigator initiated intervention study. The purpose of this study is to evaluate whether HIV-1 suppression can be maintained by DTG monotherapy in HIV-1 infected, virologically suppressed patients on cART.
104 adults fulfilling the in and exclusion criteria and on stable cART will be randomized over 2 investigational arms.
The first arm will contain the direct switch population. This population will switch directly from stable cART to Dolutegravir mono-therapy on baseline visit.
The second arm will contain the delayed-switch population. This group will switch from stable cART to Dolutegravir monotherapy 24 weeks after baseline visit.
The main goal is to investigate if Dolutegravir mono-therapy could be non-inferior to cART in virological suppressed HIV-1 infected adults.
If a interim analysis (performed when 40 patients on dolutegravir monotherapy have passed week 12) shows that it is safe to continue the study, an additional 30 patients will be included on top of the 104 patients needed for the primary endpoint analysis. In contrast to the primary endpoint population, these additional 30 patients will have a CD4 nadir \<200 but a CD4 \>350 at the time of the screening visit. Besides that, these 30 patients will have to fulfill all other in and exclusion criteria of the primary endpoint population (specifically a viral load never \>100.000). These 30 patients are part of a pilot study looking at the possibility to broaden the eligible population in a future larger randomized clinical trial.
Detailed Description
DTG Monotherapy will be considered non-inferior to cART if the lower bound of the one sided 97.5%CI for the difference in proportion of patients reaching the primary endpoint is not lower than -12%. For this purpose, a sample size of 52 per arm would provide 80% power at alpha 0.025 to establish non-inferiority of DTG monotherapy compared with cART when the primary endpoint success rate is 95% in both treatment arms.
#Intervention
- DRUG : Dolutegravir
- Switch from combination antiretroviral therapy to dolutegravir monotherapy
- Other Names :
- Tivicay, S/GSK1349572
|
#Eligibility Criteria:
Inclusion Criteria:
* Documented HIV-1 positive by ELISA or Western Blot or Plasma HIV-RNA >1000 c/ml.
* >= 18 years.
* HIV-RNA <=50 copies/mL for >=24 weeks.
* Historical baseline HIV-RNA plasma load <100.000 c/ml
* CD4 count nadir pre-cART >=200 cells/mm3
* Not on strong UGT1A1 or CYP3A4 inducing agents as stated in DTG SPC.
* General medical condition does not interfere with trial procedures (on investigators' discretion)
* Females should have no plans of becoming pregnant during the next 18 months after the baseline visit
* Females are eligible if:
1. They do not plan to become pregnant during the study
2. Negative screening pregnancy test and uses one of the following methods: 1.Abstinence from penile/vaginal intercourse during the study; 2.Double barrier contraceptive methods 1 of which must be condom.
Exclusion Criteria:
* Previous virological failure on any ART.
* Patient without documented anti-HBs antibodies.
* Subjects positive for hepatitis B at screening (HBsAg+).
* Any documented genotypic HIV-1 resistance with at least low-level resistance according to stanford HIV drug resistance database
* No record of the historical baseline plasma viral load available
* Subjects with concomitant CDC-C opportunistic infections within 90 days of screening.
* Subjects with history of allergy to INI.
* Subjects with creatinine clearance <50mL/min according to CKD-EPI.
* Subjects with hepatic impairment of at least Child-Pugh B.
* Exposure to experimental drug or experimental HIV-1 vaccine within 90 days of start of DTG.
* Screening ALT >5x ULN or ALT>3xULN and bilirubin >2 ULN.
* Patient (man or woman) planning or hoping to conceive a child/become pregnant during the study
* Patients who cannot take DTG 2 hours before or 6 hours after antacids, calciumcarbonate or iron supplements.
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
|
NCT02401828
|
{
"brief_title": "The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial",
"conditions": [
"Human Immunodeficiency Virus"
],
"interventions": [
"Drug: Dolutegravir"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT02401828",
"official_title": "The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-07",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-28",
"last_updated_that_met_qc_criteria": "2015-03-24",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-30",
"first_submitted": "2015-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.
#Intervention
- BEHAVIORAL : Behavioral Couples Therapy
- Behavioral Couples Therapy
- BEHAVIORAL : Individual Drug Counseling
- Individual Drug Counseling
|
#Eligibility Criteria:
Inclusion Criteria:
* female patients with primary drug abuse diagnosis & their relationship partners
* patient married or cohabiting with relationship partner
* partner without current alcohol or drug problem
Exclusion Criteria:
* both patient and partner without severe mental health disorders
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
|
NCT01189305
|
{
"brief_title": "Behavioral Couples Therapy for Female Drug-Abusing Patients",
"conditions": [
"Drug Abuse"
],
"interventions": [
"Behavioral: Individual Drug Counseling",
"Behavioral: Behavioral Couples Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01189305",
"official_title": "Behavioral Couples Therapy for Female Drug-Abusing Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-23",
"last_updated_that_met_qc_criteria": "2010-08-25",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-26",
"first_submitted": "2010-08-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.
This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:
* Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase,
* Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions,
* Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.
3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.
Patients will be followed during 4 weeks after the surgery.
#Intervention
- PROCEDURE : Fluobeam
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patient
* Affected of hepatic cancerous lesions whatever they are
* Requiring a one or two steps hepatectomy by laparotomy
* ECOG performance status (PS)<= 2
* Mandatory affiliation to health security insurance
* Written informed consent
Exclusion Criteria:
* With a contraindication or hypersensitivity to ICG administration in medical history
* Having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery)
* Unable to be followed during the duration of the study, for social, family, geographical or psychological reasons
* Pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate)
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
|
NCT01738217
|
{
"brief_title": "Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery",
"conditions": [
"Liver Neoplasms"
],
"interventions": [
"Procedure: Fluobeam"
],
"location_countries": [
"France"
],
"nct_id": "NCT01738217",
"official_title": "Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2013-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-08",
"last_updated_that_met_qc_criteria": "2012-11-28",
"last_verified": "2015-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-30",
"first_submitted": "2012-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.
|
#Eligibility Criteria:
Inclusion Criteria:
Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label
If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
none
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
|
NCT02582658
|
{
"brief_title": "Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)",
"conditions": [
"Chronic Hepatitis C"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02582658",
"official_title": "Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01-12",
"study_completion_date(actual)": "2017-01-12",
"study_start_date(actual)": "2015-10-06"
},
"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)": "2019-06-05",
"last_updated_that_met_qc_criteria": "2015-10-20",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-21",
"first_submitted": "2015-10-20",
"first_submitted_that_met_qc_criteria": "2019-02-28"
}
}
}
|
#Study Description
Brief Summary
This is a prospective, observational study, aimed to establish changes of bispectral bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.
#Intervention
- PROCEDURE : Surgery with general anaesthesia.
- PROCEDURE : Raw EEG
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged more than 18 years.
* Scheduled for general anaesthesia.
* Agree to participate(signed inform consent).
Exclusion Criteria:
* Neurological disease.
* Cognitive impairment.
* Egg allergy.
* Severe disease or condition that could potentially interfere with interpretation of tests.
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
|
NCT01993771
|
{
"brief_title": "Monitoring of Anaesthesic Depth in the Cerebral Cortex Using Bispectral Bilateral System.",
"conditions": [
"Breast Surgery"
],
"interventions": [
"Procedure: Raw EEG",
"Procedure: Surgery with general anaesthesia."
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01993771",
"official_title": "Monitoring of Anaesthetic Depth at Different Locations in the Cerebral Cortex Using Bispectral Bilateral System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2013-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-30",
"last_updated_that_met_qc_criteria": "2013-11-20",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-25",
"first_submitted": "2013-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the efficacy of two commonly used medications in the treatment of alcohol withdrawal, diazepam and lorazepam.
Detailed Description
Despite the frequent use of benzodiazepines for the treatment of alcohol withdrawal, studies comparing the efficacy of long and short half-life benzodiazepines in the treatment of alcohol withdrawal have shown mixed results. Due to the conflicting nature of published reports, clinicians have no clear indication as to which type of agent is preferable. The purpose of this study is to compare the efficacy of two commonly accepted medications in the treatment of alcohol withdrawal, diazepam and lorazepam, which are long and short half-life benzodiazepines, respectively.
#Intervention
- DRUG : Lorazepam
- Lorazepam 1 to 2 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
- Other Names :
- Ativan
- DRUG : Diazepam
- Diazepam 20 mg by mouth every two hours x 3 doses, or for parenteral treatment, diazepam 10 mg intravenously every one hour x 6 doses. Give additional diazepam 10 mg by mouth or intravenously every two hours as needed for alcohol withdrawal symptoms.
- Other Names :
- Valium
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of alcohol withdrawal
* History of alcohol use within 24 hours
* Ability to consent to participate in the study
Exclusion Criteria:
* Unwillingness to participate in the study
* Active abuse of other CNS depressants
* Acute intoxication with a CNS activating agent
* Severe hepatic dysfunction
* Pregnancy
* History of dementia
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
|
NCT00523185
|
{
"brief_title": "A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal",
"conditions": [
"Alcohol Withdrawal"
],
"interventions": [
"Drug: Diazepam",
"Drug: Lorazepam"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00523185",
"official_title": "A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-11",
"study_start_date(actual)": "2003-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-08-31",
"last_updated_that_met_qc_criteria": "2007-08-29",
"last_verified": "2007-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-08-31",
"first_submitted": "2007-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement.
Detailed Description
Participants will wear two different accelerometers (FitBit and Actigraph) to record normal, everyday movement. Data from each accelerometer will be compared to determine similarity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults with no upper extremity limitations
Exclusion Criteria:
* Upper extremity limitations
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03120039
|
{
"brief_title": "Measuring Upper Extremity Functional Movement with Accelerometry: FitBit® Vs Actigraph®",
"conditions": [
"Motor Activity"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03120039",
"official_title": "Measuring Upper Extremity Functional Movement with Accelerometry: FitBit Vs Actigraph",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05-01",
"study_completion_date(actual)": "2016-05-01",
"study_start_date(actual)": "2015-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-14",
"last_updated_that_met_qc_criteria": "2017-04-13",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-19",
"first_submitted": "2017-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure. Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus.
Objective: The study was set out to investigate the role of BNP on parameters of glucose metabolism in a placebo controlled cross-over study in healthy volunteers.
Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2 mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1 %BW vs. 11±1, P\<0.002), leading to an overall reduction of glucose concentration (P\<0.001) especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell function, insulin clearance or insulin sensitivity.
Discussion: Intravenous administration of BNP increases glucose initial distribution volume and lowers plasma glucose concentrations after a glucose load without affecting beta cell function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but improves the metabolic status in patients with heart failure. This opens new questions regarding BNP induced differences in glucose availability and signalling in several organs/tissues.
Detailed Description
In one of our recent studies we investigated insulin sensitivity (OGIS index) and insulin secretion (beta cell function with the insulinogenic index, IGI) in patients with heart insufficiency by frequently sampled oral glucose tolerance test (21). Insulin sensitivity was impaired in CHF compared to control (OGIS: 354±14 ml/min/m2 vs. 450±20; p\<0.003). Also beta cell function was reduced (IGI: 100±14 vs. 150±45 pmolINS/pmolGLUC). Interestingly a significant inverse correlation exists between BNP and IGI (r=0.41, p\<0.05) (21). The relationship between BNP and glucose metabolism has only been partially investigated. Plasma BNP rises in response to hyperglycemia, but is not influenced by hyperinsulinemia (22, 23). On the other side, the physiological role of BNP on beta cell function and insulin sensitivity has not been investigated to date. As BNP levels rise with the degree of heart insufficiency and insulin resistance correlates to the degree of cardiomyopathy, we hypothesize that BNP influences glucose metabolism in healthy men.
One gold standard investigation of both beta cell function and peripheral insulin sensitivity is the insulin-modified frequently sampled intravenous glucose tolerance test (FSIGT). The FSIGT consists in giving intravenously a glucose bolus at time point 0 followed by an intravenous administration of insulin at time point 20 minutes (18,19, 20). The determination of glucose, insulin and C-peptide at frequent intervals till time point 180 minutes allows the calculation of the acute insulin response, glucose effectiveness, insulin clearance and insulin sensitivity through the minimal model analysis (13) The intravenous administration of 3 pmol/kg/min BNP achieves a plateau of increased BNP plasma concentrations after 60 minutes. In previous publications, this infusion was administered during 4 hours, achieving a steady state plasma BNP between time points 60 minutes and 240 minutes (17). Using this already established protocol, we aim to maintain constantly high plasma BNP levels throughout the three hours of the FSIGT. The combination of both BNP (17) and FSIGT (13) protocols in an interventional study will be an adequate means of investigating the impact of BNP on glucose metabolism in healthy subjects.
The present study aims to investigate the effect of intravenous infusion of BNP-32 (American Peptide, Calif., US) on the beta cell function and insulin sensitivity during FSIGT in healthy volunteers.
-65, -60, -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 60, 70, 90, 100, 120, 140, 150 and 180 min for the measurement of glucose, insulin and C-peptide (8 ml per time point: time points -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 70, 100, 140 and 180 min), for the measurement of BNP and NT-proBNP (4 ml per time point: time points -65, -60, -30, 0, 30, 60, 90, 120, 150 and 180 min) and for the measurement of plasma sodium, potassium and creatinine (8 ml per time point: time points -60, 60 and 180 minutes).
Primary outcome parameter is area under the curve of insulin (AUCinsulin) from time point -30 to 180 min.
Secondary outcome parameters are AUCglucose and AUCc-peptide from time point -30 to 180 min, BNP- and NT-proBNP levels from time point -65 to 180, plasma sodium, potassium and creatinine from time point -60 to 180.
On study days volunteers will come to the study room at around 07:45 a.m. after an overnight fasting. After being weighed, they will remain in bed throughout the study, except when standing to pass urine. Two vein flow needles (Venflon, Helsingborg, Sweden) will be inserted in the antecubital veins of the right and left arm for the administration of infusions and blood sampling respectively. The subjects will rest for approximately 15 minutes before obtaining baseline blood samples (at time point - 65 minutes).
3.0 pmol/kg/min human BNP-32 (American Peptide, Calif., US) which is solved in Haemaccel (10 mL/h), or placebo (Haemaccel, 10 mL/h, alone) will be continuously administered for 4 hours, between time points -60 and 180 minutes, using a syringe pump (Treonic, Vickers Medical, Basingstoke, United Kingdom). A washout period of at least 2 weeks will be between the administration of BNP and placebo on the two different study days. This protocol has been used in the study of Lainchbury et al. (17).
330 mg/kg body weight glucose will be administered as a bolus during 30 seconds at time point 0-0.5 minutes.
0.03 IU/kg rapidly acting insulin (Actrapid, Novo-Nordisk, Denmark) will be infused intravenously for 5 minutes starting at time point 20.
Blood samples will be collected at time points: -65, -60, -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 60, 70, 90, 100, 120, 140, 150 and 180 min for the measurement of glucose, insulin and C-peptide (8 ml per time point: time points -30, 0, 3, 4, 5, 6, 8, 10, 14, 19, 22, 27, 30, 35, 40, 50, 70, 100, 140 and 180 min), for the measurement of BNP and NT-proBNP (4 ml per time point: time points -65, -60, -30, 0, 30, 60, 90, 120, 150 and 180 min) and for the measurement of plasma sodium, potassium and creatinine (8 ml per time point: time points -60, 60 and 180 minutes).
A final safety blood sample will be collected at time point 270 min for plasma sodium, potassium, creatinine and BNP, NT-proBNP, sodium, potassium, creatinine, GPT, gamma-GT, total bilirubin to ensure that (NT-pro)BNP levels returned to baseline and other parameters are within the normal range.
Total volume of blood withdrawal will be about 230 ml. When voiding, the subjects will be asked to collect the urine excreted during the study period (-65 till 180 minutes). for the measurement of sodium, potassium and creatinine excretion.
Heart rate and blood pressure will be continuously monitored during the whole study. If the systolic blood pressure is lower than 85 mmHg or the heart rate is less than 50 beats per minute BNP infusion will be stopped.
Data analysis for estimating insulin sensitivity, ß-cell secretion, insulin clearance, insulin hepatic extraction and insulin appearance rate will be done by minimal model computer analysis of the frequently sampled intravenous glucose tolerance test
#Intervention
- DRUG : human BNP-32
- 3pmol/kg/min infusion
- Other Names :
- human b-type natriuretic peptide
|
#Eligibility Criteria:
Inclusion Criteria:
written informed consent no disease history BNP level within the normal range Normal renal function (serum creatinine of more than 1.3 mg/dL and/or creatinin clearance greater than 80ml/min) Normal ECG
Exclusion Criteria:
systolic blood pressure < 90 mmHg subjects on any medication abnormal glucose metabolism history of anaphylaxis
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01324739
|
{
"brief_title": "B-type Natriuretic Peptide and Glucose Metabolism",
"conditions": [
"Diabetes Mellitus",
"Cardiomyopathy"
],
"interventions": [
"Drug: human BNP-32"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT01324739",
"official_title": "B-type Natriuretic Peptide Affects the Initial Response to Intravenous Glucose in a Placebo-controlled Cross-over Study in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2010-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-03-29",
"last_updated_that_met_qc_criteria": "2011-03-28",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-29",
"first_submitted": "2011-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.
Detailed Description
Specific objectives are:
1. To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program.
2. To compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools.
3. To evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias.
4. To compare change in family expenditures with sweetened beverages and sugar.
#Intervention
- BEHAVIORAL : lifestyle
- Based on beliefs and behaviors of children sections of education will be delivered via classroom activities.
Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
Children will also be stimulated to increase everyday activities such as walking and playing games at home and school. Also, activities with parents and family members such as walking around the neighborhood on weekends will be promoted.
|
#Eligibility Criteria:
Inclusion Criteria:
* 5th grades
Exclusion Criteria:
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01046474
|
{
"brief_title": "Reducing Beverages and Sugar and Increasing Physical Activity in Public School Adolescents From Brazil",
"conditions": [
"Sugar Intake",
"Beverage Intake",
"Fruit Intake",
"Beans Intake",
"Physical Activity"
],
"interventions": [
"Behavioral: lifestyle"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT01046474",
"official_title": "Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2010-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-07-20",
"last_updated_that_met_qc_criteria": "2010-01-11",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-12",
"first_submitted": "2010-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
Detailed Description
This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both.
This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs.
On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013 data cutoff date. According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Additionally, a suitable assay for the selection of participants for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not open Stage 2.
#Intervention
- DRUG : Lenalidomide
- Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance ≥ 30 mL/min but \< 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
- DRUG : Gemcitabine
- Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m\^2 intravenous (IV) administration on days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m\^2 IV days 1 and 15 every 28 days for 6 Cycles
- DRUG : Oxaliplatin
- Suggested starting dose and regimen for Oxaliplatin is 100 mg/m\^2 IV day 1 for 21 days for 6 Cycles
- DRUG : Rituximab
- Suggested starting dose for Rituximab is 375 mg/m\^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
- DRUG : Etoposide
- Suggested starting doses for Etoposide are:
100 mg/m\^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m\^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m\^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m\^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m\^2 oral days 1-10 every 28 days for 6 Cycles
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
* Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.
* Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Exclusion Criteria:
* Diagnosis of lymphoma histologies other than DLBCL.
* History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.
* Eligible for autologous stem cell transplant.
* Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)
* Neuropathy grade 4.
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
|
NCT01197560
|
{
"brief_title": "Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)",
"conditions": [
"Diffuse Large B-cell Lymphoma"
],
"interventions": [
"Drug: Rituximab",
"Drug: Oxaliplatin",
"Drug: Lenalidomide",
"Drug: Gemcitabine",
"Drug: Etoposide"
],
"location_countries": [
"France",
"Sweden",
"United States",
"Austria",
"Spain",
"Australia",
"Italy",
"Czechia",
"United Kingdom"
],
"nct_id": "NCT01197560",
"official_title": "A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07-04",
"study_completion_date(actual)": "2018-04-05",
"study_start_date(actual)": "2010-09-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-25",
"last_updated_that_met_qc_criteria": "2010-09-08",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-09",
"first_submitted": "2010-07-29",
"first_submitted_that_met_qc_criteria": "2014-07-31"
}
}
}
|
#Study Description
Brief Summary
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.
#Intervention
- DRUG : MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks
- DRUG : Comparator: Fluticasone / Duration of Treatment: 6 Weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
* Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
* Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
* Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value
Exclusion Criteria:
* Patient on combination therapy
* Patient on long acting beta2 agonists
* Patient on using moderate to high doses of ICS. (ICS >250 µ g/day flovent® or equivalent per day)
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
|
NCT00545324
|
{
"brief_title": "First Step With Singulair® Therapy (0476-323)",
"conditions": [
"Asthma"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00545324",
"official_title": "A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma 'To Low Dose' Inhaled Corticosteroid Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-12",
"study_completion_date(actual)": "2003-12",
"study_start_date(actual)": "2002-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-15",
"last_updated_that_met_qc_criteria": "2007-10-16",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-17",
"first_submitted": "2007-10-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI\>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week.
Detailed Description
Our study was conducted with participants, aged between 18-65 and with a BMI \>25 kg/m2, who consulted a family medicine clinic in Istanbul, accepted the terms and conditions of the study and signed the volunteer consent form. Sample analysis was performed by T.M. with G Power 3.1.9.7 (Franz Faul, Germany), using data from Sundfør et al.'s study, 'Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: a randomized 1-year trial'. The effect size was assumed to be d: 0.382 for the purposes of calculation. After the calculation made with the aforementioned effect size, with 80% power and 10% margin of error, it was concluded that a cohort of at least 126 samples, of which 63 would be in the patient group and 63 would be in the control group, should be used in this study.
People with a history of bariatric surgery, eating disorders, alcohol and drug addiction, anti-obesity medication use, diagnosed with diabetes and hypothyroidism, active cancer patients and people carrying infectious diseases were excluded from the study. At the beginning of the study, 88 people were included in the 16:8 time-restricted intermittent fasting (time-restricted eating) group, with an eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein); and 86 people were included in the energy-restricted six-meal group. Diet lists suitable for each group were prepared, and food substitution lists were handed out to the participants. Control measurements were performed after the 4th week. In order to keep the participants' motivation high throughout the study, an online chat group with the participation of a physician and dietitian, was set up. The study was concluded with 137 patients, because 37 people had left the study by the end of 8 weeks. Total daily energy expenditures were calculated using the Harris-Benedict formula. Participants in the time-restricted eating group were allowed to drink calorie-free soda, unsweetened tea, herbal tea and coffee during their 16-hour fast.
Anthropometric measurements, blood pressure measurements, as well as fasting blood glucose, ALT (alanine aminotransferase), AST (aspartate aminotransferase), lipid panel and HbA1c values in blood samples were checked at the start and the end of the study. Body composition was measured with the bioelectric impedance method with a Tanita Compacto CS 601. The bioelectrical impedance method is prone to error because of fluctuations in body water content. However, it is accepted as a valid method for assessing changes in weight loss studies when duly accompanied by X-ray absorptiometry and reference methods suitable for evaluating multi-compartment body composition under standard conditions \[14\]. Waist circumference, waist-to-hip ratio and waist-to-height ratio (WHtR), which is recently being recommended, correlate better than BMI in assessing the obesity-related health burden , including total mortality rate, type 2 diabetes, and CVD (cardiovascular disease) risk. The CBC (complete blood count) tests were performed with a Mindrat BC-6800 device, using the SF Cube technology; biochemical tests were performed with a Roche Cobas C702 device that works with photometry; and HbA1c tests were performed with an Arkray HA-8180V device that performs measurements based on the HPLC (High-Performance Liquid Chromatography) technique.
All statistical analyses were performed with the help of SPSS (Statistical Package for the Social Sciences) v. 25.0. The conformity of variables to the normal distribution pattern were checked with histogram graphics and Kolmogorov-Smirnov test. Average, standard deviation, median, IQR (Inter Quantile Range), min.-max. values were used while presenting defining analyses. Categorical variables were compared with Pearson Chi Square Test. Mann Whitney U Test was used in examining the nonparametric variants between groups. The Wilcoxon Test was used for assessing the change in the monitored values within a group, and Repeated Measures Analysis was used for the same purpose when the comparison was being made between the groups. Cases where the P value was under 0.05 were taken as statistically significant results.
#Intervention
- BEHAVIORAL : 16:8 Time-Restricted Intermittent Fasting Group
- Participants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have a feeding window 8 hours and eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). Participants in the time-restricted eating group were allowed to drink calorie-free. They were expected to follow their diet for two months during the study.
- BEHAVIORAL : Energy-Restricted Six-Meal Group
- Participants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have an eating plan three meals and three snacks of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). They were expected to follow their diet for two months during the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 <= age <= 65
* BMI >25 kg/m2
Exclusion Criteria:
* People with a history of bariatric surgery
* Eating disorders
* Alcohol and drug addiction
* Anti-obesity medication use
* Diagnosed with diabetes and hypothyroidism
* Active cancer patients
* People carrying infectious 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:
Yes
|
NCT06364475
|
{
"brief_title": "Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet?",
"conditions": [
"Overweight and Obesity"
],
"interventions": [
"Behavioral: Energy-Restricted Six-Meal Group",
"Behavioral: 16:8 Time-Restricted Intermittent Fasting Group"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06364475",
"official_title": "Comparing the Effects of Time-restricted Eating and Three Meals-three Snacks Diet on Body Composition and on Biochemical Parameters",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-01",
"study_completion_date(actual)": "2022-09-01",
"study_start_date(actual)": "2021-11-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-15",
"last_updated_that_met_qc_criteria": "2024-04-09",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-15",
"first_submitted": "2024-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.
#Intervention
- DRUG : Radium-223 (Xofigo, BAY88-8223)
- Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
- DRUG : Abiraterone
- Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
- DRUG : Enzalutamide
- Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with documented mCRPC receiving 1L NAHs.
* Initiation of Ra-223 after 1L NAH therapy, or
* Initiation of sequential NAH therapy after 1L NAH therapy
Exclusion criteria:
* Patients involved in clinical trials
* Patients who received combined therapies in 1L or 2L
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03896984
|
{
"brief_title": "Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).",
"conditions": [
"Metastatic Castration-resistant Prostate Cancer (mCRPC)"
],
"interventions": [
"Drug: Abiraterone",
"Drug: Radium-223 (Xofigo, BAY88-8223)",
"Drug: Enzalutamide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03896984",
"official_title": "DescriPtive Analysis of Real-world Clinical Outcomes of Second Line (2L) Novel Anti-HormonE Therapy (NAH) or RadIum-223 (Xofigo) in Patients With Metastatic Castration Resistance Prostate Cancer (mCRPC) After First Line (1L) NAH Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-08",
"study_completion_date(actual)": "2020-12-14",
"study_start_date(actual)": "2019-03-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-12-29",
"last_updated_that_met_qc_criteria": "2019-03-28",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-01",
"first_submitted": "2019-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine if measurement of urinary estrone glucuronide concentrations with an at-home device is correlated with superovulatory response during gonadotropin stimulated IVF cycles.
Detailed Description
Hypothesis
Urinary estradiol concentrations measured with an at-home device correlates with gonadotropin response during superovulation for IVF and can serve as an alternative to serum estradiol measurements.
Justification
The in vitro fertilization (IVF) process entails gonadotropin stimulation to obtain supernumerary oocytes. To ensure an adequate and safe administration, gonadotropin treatment requires monitoring with transvaginal sonography (TVS) to determine the quantity and size of ovarian follicles. In addition, serum estradiol (E2) concentration reflects bioactivity of the follicles and is used to modulate dosing. TVS and E2 are complementary modalities used synchronously to dynamically optimize the gonadotropin protocol. For the typical IVF stimulation cycle with an GnRH antagonist protocol, the patient will require 10-12 days of gonadotropin administration, during which time the 3-6 visits for TVS and blood tests will be needed.
Reducing the invasiveness of procedures can improve the patient experience. Repetitive phlebotomy, as is required for serum estradiol measurements during IVF, can be unpleasant and painful. Thus, a less invasive alternative with at-home urinary testing may be more desirable and convenient.
Estrone glucuronide (E3G) is a metabolite of E2 that can be measured in the urine. Urinary E3G with an FDA and CE registered home device called the Mira Fertility Tracker ('Mira'). Correlation between the serum hormones and their respective urinary metabolites has been established but the efficacy of monitoring urinary E3G has not been demonstrated in the context of IVF.
The purpose of the current observational study is to compare urinary E3G with traditional serum E2 monitoring during gonadotropin stimulation for IVF and correlate the levels with stimulation outcomes. If validated, urinary hormone monitoring could serve as a more patient-friendly alternative to repetitive phlebotomy required for serum hormone measurement during IVF.
Research Design
Patients will undergo IVF per clinical indication. Gonadotropin dosing will be determined at the discretion of the responsible physician using standard dosing criteria (age, ovarian reserve testing, prior history, etc). For consistency of comparison, the study population will focus on patients with a normal ovarian reserve (AMH 1-3.5ng/mL).
During stimulation, the monitoring schedule will be consistent with routine clinical protocols. In general, the initial E2 are determined on day 6 of stimulation from a single serum sample, and subsequent serum E2 and TVS are checked from day 8 onwards, as is clinically indicated by patient response to gonadotropin stimulation.
Urinary E3G will be monitored daily with first morning urine from the first day through the final day of gonadotropin stimulation. A Mira device and testing wands will be provided to each participating patient and urinary testing will be performed by the patient at home.
Primary outcomes will include correlation of E3G with the number of total and mature oocytes retrieved, and a comparison to the serum E2 correlation to the same parameters. Secondary outcomes will include correlation of urinary E3G and serum E2 levels throughout stimulation.
Additional details regarding laboratory study protocols are as follows:
Measurement of urine E3G: The Mira be used to measure urinary E3G via immunofluorescence method. First morning urine will be collected by the patient at home. A test wand will be dipped into the urine sample for ten seconds, then inserted into a palm-sized device.
All other protocols are consistent with routine clinical practice. Briefly, serum samples for E2 will be collected by venipuncture and processed using a commercially available E2 chemiluminescent assay on automated immunoanalyzer (Beckman-Coulter Access 2) in an accredited commercial laboratory (Novavita, Vancouver, BC). Sonography will be performed by licensed physicians with an endovaginal probe, consistent with standard clinical practice. IVF laboratory procedures will be performed by trained embryologists at the Olive Fertility Centre (Vancouver, BC).
#Intervention
- DEVICE : Mira Fertility Tracker
- Non-interventional: observational, documenting urine E3G levels during gonadotropin stimulation.
|
#Eligibility Criteria:
Inclusion Criteria:
Ages 21 <= age <= 45 AMH between 1 <= age <= 3.5 ng/mL (7.14 <= age <= 24.5 pmol/L) within 1 year of enrollment Gonadotropin stimulation with GnRH antagonist protocol Able to collect 1st morning urine
Exclusion Criteria:
Aversion to phlebotomy (as is normally required during IVF). Use of aromatase inhibitors during stimulation (which can affect serum E2 levels)
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05493202
|
{
"brief_title": "Superovulation And Urinary Concentration of Estrone",
"conditions": [
"in Vitro Fertilization",
"Hormone Testing"
],
"interventions": [
"Device: Mira Fertility Tracker"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05493202",
"official_title": "Correlation of Urinary Estrone Glucuronide With Superovulatory Response in IVF Cycles.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-13",
"study_completion_date(actual)": "2022-07-30",
"study_start_date(actual)": "2022-02-20"
},
"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)": "2022-08-09",
"last_updated_that_met_qc_criteria": "2022-08-02",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-09",
"first_submitted": "2022-08-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring.
Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the cardiovascular intensive care unit (CVICU), and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors.
Detailed Description
Maintaining tight blood glucose control following surgery is imperative to reducing infections and neurologic dysfunction. This requires frequent blood sampling while in the intensive care unit, leading to increased waste of blood and utilizing time and resources to collect samples and wait for results. Additionally, when on the regular floors, frequent point of care fingersticks for glucose levels are needed for therapeutic intervention.
Continuous glucose monitoring systems (CGMS) are now available for ambulatory use in patients with diabetes. The potential of using such a system in the hospital, including during the postoperative critical care setting and upon transfer to the regular floor, may reduce personnel burden, produce rapid results, and decrease blood waste. However, these systems have not yet been validated for hospital use.
This is a prospective longitudinal study to study the agreement between a novel continuous glucose monitoring system (CGMS) versus current blood glucose monitoring.
Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the CVICU, and by point of care glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems will be calculated, and error will be classified using the Surveillance Error grid. The proportion of errors of at least moderate risk will be calculated.
Subject characteristics including demographics, comorbidities and baseline disease severity will be summarized using means and standard deviations for continuous measures and frequencies and percentages for categorical factors. To evaluate agreement between methods, concordance correlation coefficients will be calculated, using the method that adjusts for repeated measures as described by King and implemented in software by Carrasco. Analysis will be performed overall, and then stratifying by type of current measure, if the type of measurement varies across settings. Correlations will be calculated using the methods described by Bland and Altman and implemented by Bakdash and Marusich. Differences will also be evaluated for errors according to the Surveillance Error Grid. Rates of moderate or more severe errors will be calculated. For each measure above, 95% confidence intervals will be calculated, accounting for the clustering within subject.. Analyses will be performed using SAS software (version 9.4; Cary, NC) and R software (version 3.5; Vienna Austria).
Glucose readings obtained from the CGMS will be compared with
1. blood glucose from the arterial blood gas (ABG) or peripheral/central venous catheter if arterial catheter not in use (standard of care in CVICU) while patients are in the CVICU
2. fingerstick point of care (POC) glucose when patients are on the regular floors
#Intervention
- DEVICE : Dexcom G6 continuous glucose monitor
- Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and above
* Planned cardiovascular surgery
* Planned admission to Cleveland Clinic Main Campus J5 or J6 or Q5 cardiovascular ICU (CVICU) post-operatively
* With or without known diabetes; if with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary
Exclusion Criteria:
* Allergy to the material of the CGMS or the adhesive to be used
* Skin conditions precluding the use of the CGMS
* Pregnancy
* Other conditions that investigators deem inappropriate for 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
|
NCT04569240
|
{
"brief_title": "Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery",
"conditions": [
"Surgery--Complications"
],
"interventions": [
"Device: Dexcom G6 continuous glucose monitor"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04569240",
"official_title": "Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-20",
"study_completion_date(actual)": "2024-07-01",
"study_start_date(actual)": "2021-05-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2020-09-24",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-29",
"first_submitted": "2020-09-08",
"first_submitted_that_met_qc_criteria": "2024-08-18"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .
|
#Eligibility Criteria:
Inclusion Criteria:
* all drug addict with chronic wound ( evolving at least since 1 month)
Exclusion Criteria:
* use following medication inductor of cutaneous ulcer: hydroxycarbamide, gefitinib, cetuximab, sunitinib, sorafenib, pazopanib, gemcitabine, sirolimus, methotrexate, nicorandil .
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03608384
|
{
"brief_title": "Characteristic of Drug Users Chronic Wound",
"conditions": [
"Wound",
"Drug Use"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT03608384",
"official_title": "Characteristic of Drug Users Chronic Wound",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-05",
"study_completion_date(actual)": "2019-02-05",
"study_start_date(actual)": "2018-08-01"
},
"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)": "2019-04-12",
"last_updated_that_met_qc_criteria": "2018-07-30",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-31",
"first_submitted": "2018-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart rate (HR), activity and breathing data, which will be integrated with weight, blood pressure and symptom data, in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.
Detailed Description
The elderly are facing an increasing prevalence of chronic disease and rapidly escalating healthcare costs threatening independent living. Congestive heart failure (CHF) is a growing health epidemic and is associated with significant morbidity, mortality and cost. Mayo Clinic and Preventice have developed a non-invasive, minimally obtrusive, interactive remote monitoring platform. It enables on-body monitoring and integration of ECG, heart rate, breathing, and activity, with measures of weight and blood pressure. It is designed as a platform for physician directed patient self-management. This technology may be useful in monitoring CHF patients. Our overall objective is to adapt, refine, test and validate this technology in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.
#Intervention
- DEVICE : BodyGuardian remote health monitoring system
- The remote health management system connects personal health sensors with secure mobile communication devices. It is also able to give immediate feedback to the user. The solution is a multi-tiered mobile health platform. The front-end includes an adhesive snap-strip body sensor (BodyGuardian) that can measure HR, ECG, respiration rate (RR), and activity which is FDA approved for detection of non-lethal cardiac arrhythmias. It can wirelessly communicate with off-body sensors such as a BP cuff and scale to incorporate BP and weight data based on automated algorithms and can solicit symptoms from the user. It can also be used as an event recorder inputting symptoms and recording simultaneous physiologic data.
|
#Eligibility Criteria:
Inclusion Criteria:
* Resident at independent living facility
* Adequate phone service
* Healthy with life anticipated survival >than one year
Exclusion Criteria:
* Skin reaction/allergies to adhesives
* Have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01808053
|
{
"brief_title": "Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects",
"conditions": [
"Congestive Heart Failure"
],
"interventions": [
"Device: BodyGuardian remote health monitoring system"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01808053",
"official_title": "Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects",
"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)": "2013-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-07",
"last_updated_that_met_qc_criteria": "2013-03-07",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-08",
"first_submitted": "2013-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this observational study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into the vein) itraconazole is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions.
Detailed Description
This is a prospective (study following patients forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) observational study to examine the correlation between a sufficient blood concentration of itraconazole and disappearance of a fever (defeverscence) when itraconazole injection is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions. The recommended dose of the drug will be 200 milligram (mg), which will be administered intravenously, twice daily for 2 days (a total of 4 doses) and then 200 mg once daily for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200 mg (which is equivalent to 20 ml) twice daily will be continued for a total of 14 days until clinically significant neutropenia is resolved.
#Intervention
- DRUG : Itraconazole
- Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered.
|
#Eligibility Criteria:
Inclusion Criteria:
* Immunocompromised participants with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis
* Female participants who are postmenopausal or received contraceptive operation or refrain from sexual relations and women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization) before participation and during the study
* Male participants who will not have a baby within 2 months after the completion of itraconazole therapy
Exclusion Criteria:
* Fever due to documented deep-seated fungal infection at the entry into the study, but documented candidemia will be included
* Participants with kidney function related abnormalities with calculated creatinine clearance of 30 milliliter per minute (mL/min) or lower
* Aminotransferase level 5 times or higher of normal limit and total bilirubin level 5 milliliter per deciliter (mL/dL) or higher due to hepatic dysfunction
* Participants with dementia (mental decline) related to head injury and hypoxic brain injury
* Participants with mental illness which may interfere with cooperation in treatment and monitoring condition of the clinical study
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01021683
|
{
"brief_title": "The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants",
"conditions": [
"Hematologic Neoplasms",
"Neutropenia",
"Fever"
],
"interventions": [
"Drug: Itraconazole"
],
"location_countries": null,
"nct_id": "NCT01021683",
"official_title": "The Relationship of Defeverscence and Itraconazole Plasma Level Using Sporanox IV as an Empiric Therapy in Immunocompromised Patients Who Have Been Treated With Sporanox Oral Solution as Prophylaxis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-08-12",
"last_updated_that_met_qc_criteria": "2009-11-27",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-30",
"first_submitted": "2009-11-25",
"first_submitted_that_met_qc_criteria": "2013-04-15"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.
#Intervention
- BEHAVIORAL : Double Trouble in Recovery
- Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment
- BEHAVIORAL : Standard psychiatric day treatment
- Individual counseling, groups, medication
|
#Eligibility Criteria:
Inclusion Criteria:
Admission to psychiatric day treatment program 18 <= age <= 64 years
Exclusion Criteria:
Did not understand or speak English, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00218582
|
{
"brief_title": "Effectiveness of Self-Help for Dually-Diagnosed Persons - 1",
"conditions": [
"Dual Diagnosis",
"Substance-Related Disorders",
"Mental Disorders"
],
"interventions": [
"Behavioral: Double Trouble in Recovery",
"Behavioral: Standard psychiatric day treatment"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00218582",
"official_title": "Effectiveness of Self-Help for Dually-Diagnosed Persons",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-03",
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2003-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-12",
"last_updated_that_met_qc_criteria": "2005-09-20",
"last_verified": "2008-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-22",
"first_submitted": "2005-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will investigate how repetitive transcranial magnetic stimulation (TMS) using intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of this study will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.
#Intervention
- DEVICE : Transcranial Magnetic Stimulation using iTBS Paradigm
- TMS is a non-invasive, painless method of stimulating the central and peripheral nervous system. ITBS is a form of TMS which is delivered for \~200sec and can promote changes in neural activity.
- Other Names :
- repetitive Transcranial Magnetic Stimulation
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 <= age <= 70 years inclusive
* Traumatic and non-traumatic tetraplegic patient following chronic incomplete (AIS C or D) SCI injury (sustained at least three months ago)
* Referred to the Sheffield Spinal Injuries Centre
* Be able to provide written informed consent or verbal consent in the presence of an independent witness
* Spasticity affecting upper limbs with a Modified Ashworth scale (MAS) 2 or above
* Stable medical treatment for at least 1 week before and 1 week after TMS application
* Stable medical condition
Exclusion Criteria:
* Aged less than 18 years
* Lack the mental capacity to consent
* Ventilated patients with sedation
* Very acute (<3 months) SCI patients
* Implanted electrical devices such as pacemakers, Concomitant neurological conditions, including any history of epilepsy
* Significant joint-related limitation of passive range of movement
* Unable to attend all TMS sessions
* Pregnancy
* Inability to tolerate TBS
* Significant upper limb contractures
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
|
NCT02914418
|
{
"brief_title": "Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study",
"conditions": [
"Spinal Cord Injuries"
],
"interventions": [
"Device: Transcranial Magnetic Stimulation using iTBS Paradigm"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02914418",
"official_title": "Feasibility Study to Investigate the Effects of Transcranial Magnetic Stimulation (TMS) Using Theta Burst Stimulation (TBS) to Treat Upper Limb Dysfunction and Spasticity in Patients With Spinal Cord Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-05",
"last_updated_that_met_qc_criteria": "2016-09-22",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-26",
"first_submitted": "2016-08-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the temporomandibular region.
1. Primary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in jaw pain.
2. Secondary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in function of the temporomandibular joint.
3. Exploratory Objectives To determine if there are any adverse effects that result from the consumption of CBD oil or placebo.
Detailed Description
The United States National Institute of Health Survey in 2001 conducted a self-reported survey of 30,978 people and determined the overall prevalence of temporomandibular joint and muscles disorders to be 4.6%, with 6.3% women and 1.8% men \[1\]. Temporomandibular joint arthralgia which is often caused by inflammatory joint arthropathy \[2\] and is commonly seen in conjunction with myofascial pain of the masticatory region. Myofascial pain syndrome is classically characterized by focal areas of exquisite tenderness caused by trigger points. Temporomandibular joint arthralgia and myofascial pain disorder pertaining to the temporomandibular joint region will be defined according to the research diagnostic criteria below \[3\].
The exact mechanism of action of CBD is not fully understood and several mechanisms of action have been proposed. Studies have indicated that CBD acts on a system in humans called the endocannabinoid system comprised of the CB1 and CB2 receptors. CB receptors were found throughout the human body: CB1 receptors in the brain and CNS and CB2 receptors are found throughout the gut, spleen, liver, heart, kidneys, blood vessels, lymph cells, and reproductive organs. CB1 receptors in the CNS help maintain core functions such as motor activity, pain perception, stress response, and memory. CB2 receptors widely distributed throughout the body in peripheral organs serve as core components of the immune system, muscular system, and cardiovascular system \[4\]. The endocannabinoid system has physiological and pathophysiological roles in modulation of pain \[5\]. Petitet et al. (1998) found CBD considerably reduced the receptor activation of a potent classical CB1 receptor agonist. CBD has a very low affinity for both known cannabinoid receptors. However, CBD antagonizes CB1 and CB2 receptor agonists at doses considerably lower than those of CBD needed to activate cannabis receptors \[6\]. Pertwee et al. (2002) found CBD was also shown to display inverse agonism at the human CB2 receptor, which may be a rational basis for its anti-inflammatory properties \[7\]. Pertwee (2002) proposes that CBD also functions outside of CB1 and CB2 receptors. An endogenous cannabinoid, anandamide, produced anti-nociception through mechanisms outside of the endocannabinoid system acting on the vanilloid receptors. The vanilloid receptors may regulate the release of inflammatory molecules (substance P) following exposure to noxious stimuli playing a role in the transmission of pain signals \[7\]. This pathway is well studied in capsaicin (an active component of chili peppers). Capasicin can produce an analgesic effect by desensitizing the TRPV1 receptor (a vanilloid receptor) inhibiting substance P. CBD inhibits the uptake and hydrolysis of the endocannabinoid anandamide, thus increasing its concentration \[8, 9\]. CBD stimulates the vanilloid receptor type 1 (VR1) with a maximum effect similar in efficacy to that of capsaicin \[8\] without the side effect of burning sensation. Not all cannabinoid effects can be explained through the CB1 and CB2 receptors and their endogenous ligand, anandamide. Researchers investigated the mechanisms, by which CBD reduces inflammatory and neuropathic pain in animals \[10\]. They found that the cannabinoid-induced analgesic effect is absent in mice lacking glycine receptors and concluded that this receptor mediates suppression of chronic pain. In other mouse models, CBD binds to the GPR55 receptor, a putative cannabinoid receptor \[11\]. This effect is involved in the anti-inflammatory action of CBD. In human clinical trials, Blake (2005) assessed the efficacy and safety of cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Sativex consists of a blend of plant extracts which delivers approximately equal amounts of THC and CBD. Statistically significant improvements in pain on movement, pain at rest, and quality of sleep \[12\]. The rationale for the starting dose is somewhat arbitrary, 600mg/2FL is the most popular with retail customers. It is the highest concentration available with the CBD PURE brand oil which allows study subjects to maximize on the possible benefits of CBD. Since there are little known side effects, the risk of a higher concentration of CBD causing more adverse side effects is minimal.
#Intervention
- OTHER : CBD Oil
- CBD PURE CBD OIL 20mg/1ml concentration
- Other Names :
- Cannabinoids
- OTHER : Hemp Oil
- CBD PURE HEMP OIL
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 <= age <= 70 years
* Ability to give informed consent
* Arthralgia of the temporomandibular joint as defined according to the RDC/TMD criteria (see below chart)[3] and/or Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria (see below chart)[3]
* Baseline pain must be greater than 3/10 as self-reported on the VAS
Exclusion Criteria:
* Allergy to study drug
* Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
* Mandibular fracture within last 12 months
* Pregnancy or breast feeding
* Initiation of additional treatment of MPD within the past 1 months
* Baseline pain less than 3/10 as self-reported on the VAS
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
|
NCT04298554
|
{
"brief_title": "Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region",
"conditions": [
"TMJ Disorder",
"Myofacial Pain",
"TMD"
],
"interventions": [
"Other: Hemp Oil",
"Other: CBD Oil"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04298554",
"official_title": "Comparison of Cannabinoids to Placebo in Management of Arthralgia and Myofascial Pain Disorder of the Temporomandibular Region: A Randomized Clinical Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-29",
"study_completion_date(actual)": "2022-05-29",
"study_start_date(actual)": "2020-08-06"
},
"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)": "2023-03-14",
"last_updated_that_met_qc_criteria": "2020-03-04",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-06",
"first_submitted": "2020-03-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease.
The awarded participating clinical centers are Emory University, University of Kansas, and Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington University to the University of Pittsburgh, the DCIAC for CRISP II is located at the University of Pittsburgh.
Detailed Description
The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time.
|
#Eligibility Criteria:
Inclusion Criteria:
* CRISP I participants will be invited to participate in CRISP II. At entry into CRISP I participants met a number of inclusion and exclusion criteria.
Exclusion Criteria:
* Current psychiatric or addiction or non-compliance disorder that in the discretion of the principal investigator indicates that the subject will not successfully complete the study;
* Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study;
* Inability to provide written informed consent
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01039987
|
{
"brief_title": "Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease",
"conditions": [
"Autosomal Dominant Polycystic Kidney Disease"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01039987",
"official_title": "Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-03",
"study_completion_date(actual)": "2011-03",
"study_start_date(actual)": "1999-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-17",
"last_updated_that_met_qc_criteria": "2009-12-24",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-12-25",
"first_submitted": "2009-12-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.
Detailed Description
In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.
We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.
#Intervention
- DRUG : Vitamin A
|
#Eligibility Criteria:
Inclusion Criteria:Between 6 mo and 5 years and thus eligible for vitamin A and OPV campaign -
Exclusion Criteria:Overt signs of vitamin A deficiency
*
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 5 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00168636
|
{
"brief_title": "Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality",
"conditions": [
"Mortality",
"Morbidity"
],
"interventions": null,
"location_countries": [
"Guinea-Bissau"
],
"nct_id": "NCT00168636",
"official_title": "The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2004-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-11-15",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-15",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Refractory ascites (fluid build up in the abdomen that can not bet managed by medications) occurs in at least 10% of patients with end stage liver disease (cirrhosis). Two major options for management include large volume paracentesis (LVP)-drainage with a needle through the abdominal wall) and placement of a transjugular intrahepatic portosystemic shunt (TIPS)-re-directs blood flow across the cirrhotic liver), Not all patients are candidates for TIPS or transplant, are left with LVP as the only long-term treatment option. Patients listed for transplant require LVP while they wait for transplant.
LVP can cause pain, bleeding, leakage from the drain site and frequent hospital visits which result in health care cost as well as patient and caregiver fatigue. In between the drains, living with ascites can negatively affect quality of life because of discomfort and limitations. Patients with ascites are more malnourished than those without.
Specialized drains tunnelled under the skin, are used in patents with ascites due to cancer (malignant). There are not many studies evaluating these drains in patients with cirrhosis, One of the reasons for the lack of studies is the potential for infection. As opposed to malignant ascites, cirrhotic ascites generally has a low protein content, a risk factor for development of spontaneous bacterial peritonitis (SBP). From available studies, infection rates in cirrhotic patients with tunnelled drains who are not on antibiotics are estimated at 10% (4/40). Infection rates on antibiotic prophylaxis would be expected to be lower.
This pilot study includes the evaluation of indwelling tunnelled PleurX catheters as an alternative option. The hypothesis is that with careful monitoring of kidney function and prevention of infection with antibiotics, PleurX catheters will be safe, cost-effective and improve quality of life and nutritional status compared to the standard of care.
Detailed Description
Ascites not manageable by diuretic therapy occurs in at least 10% of patients with cirrhosis. Two major options for management include intermittent large volume paracentesis (LVP) and placement of a transjugular intrahepatic portosystemic shunt (TIPS). Unfortunately, not all patients are candidates for TIPS. Those unable to receive TIPS or transplant are left with LVP as the only long-term treatment option. Non-TIPS candidates who are listed for transplant require LVP as a bridge to transplant.
LVP is performed by inserting a non-tunnelled drain, removing ascites fluid via, replacing ascites fluid losses \>5 litres(L) with albumin, removing the drain. It can be associated with pain, bleeding, leakage from the site and frequent hospital visits. In between the drains, living with ascites can negatively affect quality of life, particularly the physical discomfort and limitation component scales. In addition, patients with tense ascites have lower protein intake and are more malnourished than those without. Fluid removal improves gastric accommodation.
Indwelling ascites drains are routinely used in patents with malignant ascites. Data evaluating indwelling drains in patients with cirrhosis is limited. One of the reasons that this may not have been explored as a therapeutic option is the potential for infection. As opposed to malignant ascites, cirrhotic ascites generally has a low protein content, a known risk factor for development of spontaneous bacterial peritonitis (SBP). From available data, infection rates in cirrhotic patients with tunnelled drains, not on antibiotic prophylaxis are estimated at 10%. Infection rates on antibiotic prophylaxis would be expected to be lower, but this remains unstudied. Other concerns particular to the patient with cirrhosis are renal dysfunction and acute kidney injury. Limitation of the amount of ascites that is drained to \<5L per time and infusion of albumin 8grams(g)/L removed for amounts drained \>5L has shown benefit in preventing post paracentesis circulatory and renal dysfunction.
Therefore, as some patients with cirrhosis will be left with intermittent LVP as their only option for management, and as this therapy has implications for quality of life (QOL), worsening nutritional status and cost, we propose an evaluation of an indwelling tunnelled PleurX catheter as an alternative therapeutic option. In this prospective uncontrolled pilot study, the hypothesis is that use of indwelling drains with careful monitoring of renal function and prophylaxis with antibiotics, will be safe, cost-effective and improve quality of life and nutritional status compared to the standard of care.
METHODS:
Study design: Prospective uncontrolled interventional pilot study of 12 patients followed for 3 months.
Recruitment: Patients will be recruited from Hepatology departments at the University of Alberta hospital (UAH) and Royal Alexandra hospital (RAH) in Edmonton. All Hepatologists at these sites will be informed of the protocol. If a patient meets inclusion and exclusion criteria and is interested in hearing more about the study, the Hepatologist can contact the study personnel. Patients will be made aware that their decision to participate in the study will not influence their medical care.
Study Intervention:
PleurX drain insertion by interventional radiologist
Outpatient drainage protocol:
Ascites fluid drainage performed at participant's home via home care nurse 1-3 times per week (maximum 3L- with each drain) for 3months. PleurX drain bottles will be used instead of urinary drainage bags
Safety Measures:
Home care nurses are trained in the use of PleurX drains. Patients will be taught and given information about complication monitoring.
Albumin infusion at 1g/kilogram(kg) as an outpatient when: the serum creatinine increases from baseline \>26umol/L or by 1.5-2 times (Stage 1 Acute Kidney Injury), or the patient has clinical signs of hypovolemia Spontaneous bacterial peritonitis (SBP) prophylaxis with Norfloxacin 400mg daily Patient counselling on avoidance of non-steroidal anti-inflammatory drugs (NSAIDs), aminoglycosides, radiologic contrast, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, angiotensin receptor blockers (ARBs) where possible
PROCEDURE \& DATA COLLECTION:
Pre-Intervention (2 weeks prior to drain placement)
Continued standard of care LVP with albumin replacement, and recording of procedure related complications (shunt misplacement, insertion bleeding, pain-10 point scale) Pt to complete three-day food record (including 1 day pre-paracentesis, day of paracentesis, and 1 day post paracentesis), as well as Council on Nutrition appetite questionnaire (CNAQ, score range 8-40 where a lower score indicates more problems with appetite).
Nutritional assessment: Weight (kilograms), height (centimeters), calorie (kilocalories) and protein (grams) intake, mid-arm muscle circumference(centimeters), hand-grip strength by Jamar hand-grip dynamometer (kilograms) Labs pre-LVP including: urine electrolytes, serum complete blood cell (CBC) and differential, prothrombin time(PT), creatinine(Cr), electrolytes, alanine transaminase (ALT), aspartate transaminase (AST), Bilirubin, albumin, rennin, aldosterone
Quality of life and symptom questionnaires pre and post paracentesis: Chronic Liver Disease Questionnaire (CLDQ). The CLDQ includes 29 symptom questions, scored on a likert scale of 1-7 (where 1 is all of the time and 7 is none of time), and divided into 6 domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry). Edmonton Symptom Assessment System-revised version (ESAS-R). The ESAS-R includes 10 symptoms (9 pre-determined and 1 'other' free text scale), scored on a likert scale 0-10 (where 0 is 'No' and 10 is 'Worst possible'). Ascites Symptom Inventory-7 (ASI-7). The ASI-7 includes 7 symptom questions, scored on a likert scale of 0-4 where 0 is 'does not apply at all' and 4 is 'very strongly applies'.
History and physical examination: Demographics, Past Medical History, Medications, History of prior ascites fluid infections, other infections, and antibiotic use in the last 6 months, Liver disease severity-model for end stage liver disease (MELD, score range 6-40, where a higher score indicates higher mortality risk ) score \& Child Pugh score (score range 5-15, where a higher score indicates worse liver function), Resting blood pressure.
Day 1-90 (Day 1=drain placement day)
Adverse event monitoring and patient follow-up:
Pre-drain insertion abdominal wall ultrasound by the interventional radiologist who will be inserting the drain Drain placement associated safety outcomes will be recorded including: shunt misplacement, insertion bleeding, pain (10 point scale where 0 is 'no pain' and 10 is 'worst possible pain') Home care nurse visit assessment with each drain: vital signs, documentation of drain function, appearance, fluid drainage, fluid volume, fluid appearance, drain site description, patient symptoms.
Nurses will be asked to contact study personnel in the event of adverse outcomes or new patient symptoms Phone call to patient weekly and in person assessment monthly by primary investigator (PI): quality of life and symptom questionnaires-CLDQ, ESAS-R, ASI-7, changes in cognitive status, medication reassessment, documentation of hospitalizations, and Child Pugh/MELD calculation at monthly visit.
Monthly Nutritional assessment by dietitian-Weight, height, calorie and protein intake via 3-day food record (completed 1 day pre-drain, 1 day of a drain, and 1 day after a drain), mid-arm muscle circumference, hand-grip strength by the Jamar hand-grip dynamometer, CNAQ appetite screening tool
Diagnostic fluid analysis and septic work up if symptoms of SBP (abdominal pain, fever, elevated white blood cell count (WBC), sudden onset renal dysfunction or hepatic encephalopathy). Drain removal if SBP diagnosed using standard criteria (ascites fluid polymorphonuclear cell count ≥ 250 cells/millimetre3). Any removed drains with have the drain tip sent for culture and sensitivity
Labs: Weekly ascites fluid analysis for protein, cell count and diff, culture and sensitivity Weekly CBC and differential, PT, Cr, electrolytes, ALT, AST, Bilirubin, albumin via home collections or community based lab. Urine electrolytes, Plasma renin \& aldosterone monthly
STUDY EXTENSION OPTION
At 90 days, all patients that choose to continue with fluid drainage as per the study protocol, will be offered the option to continue contributing data to the study for the duration of time they have the drain inserted, or until they no longer wish to participate. Patients will be made aware that their decision to continue to participate in the study will not influence their medical care.
For patients that agree to continue participating, the initial protocol for drain frequency, volume, care, and safety measures will be followed. Data will be collected, including:
Every 4 weeks by PI or designate: quality of life and symptom questionnaires-CLDQ, ESAS-R, ASI-7, changes in cognitive status, medication reassessment, documentation of hospitalizations, and Child Pugh/MELD calculation, vital signs, documentation of drain function, appearance, drain site description, patient symptoms. Patients will be asked to bring in their home drain volume records for review at these visits. Nutritional assessment by dietitian-Weight, height, calorie and protein intake via 3-day food record (completed 1 day pre-drain, 1 day of a drain, and 1 day after a drain), mid-arm muscle circumference, hand-grip strength by the Jamar hand-grip dynamometer, CNAQ appetite screening tool.
Diagnostic fluid analysis and septic work up if symptoms of SBP (abdominal pain, fever, elevated WBC, sudden onset renal dysfunction or hepatic encephalopathy) Drain removal if SBP diagnosed using standard criteria (ascites fluid polymorphonuclear cell count ≥ 250 cells/mm3). Any removed drains with have the drain tip sent for culture and sensitivity.
Labs: Every 1-2 weeks-ascites fluid analysis for protein, cell count and diff, culture and sensitivity. Blood for CBC and differential, PT, Cr, electrolytes, AST, Bilirubin, albumin Every 4 weeks- blood rennin and aldosterone. Urine electrolytes.
#Intervention
- DEVICE : PleurX catheter
- Placement of PleurX catheter for refractory cirrhotic ascites, with follow up monitoring
|
#Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis (based on imaging, liver function test abnormalities, biopsy, or portal hypertension associated complications)
* Refractory or resistant ascites
* Not a candidate for TIPS (hospital admissions for encephalopathy, Model for End Stage Liver Disease (MELD) >=18, diastolic dysfunction (defined as E/A ratio <1 on echocardiogram), patient declined, advanced age, renal disease)
* Requiring large volume paracentesis >=twice/month
Exclusion Criteria:
* Malignant ascites due to peritoneal carcinomatosis (requires positive fluid cytology)
* Patient unwilling to let home care staff enter home
* Patient unwilling to have intravenous albumin
* Patient unwilling to have drain placed
* Patients post liver transplant
* multi-loculated ascites
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
|
NCT04569565
|
{
"brief_title": "Prospective Evaluation of PleurX Drain for Treatment of Cirrhotic Refractory Ascites",
"conditions": [
"Ascites Hepatic"
],
"interventions": [
"Device: PleurX catheter"
],
"location_countries": null,
"nct_id": "NCT04569565",
"official_title": "Prospective Evaluation of PleurX Drain for Treatment of Cirrhotic Refractory Ascites",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-20",
"study_completion_date(actual)": "2019-03-20",
"study_start_date(actual)": "2016-05-18"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-30",
"last_updated_that_met_qc_criteria": "2020-09-24",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-30",
"first_submitted": "2020-09-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Alopecia areata (AA) is a common disease of the immune system, known as an 'autoimmune' disease. In the disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat AA has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for AA.
Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid arthritis, another 'autoimmune' disease, by fighting inflammation. There are some genetic and chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA, suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed for testing drugs for the treatment of human alopecia areata, this medication worked to prevent the disease AA from starting in mice that would have otherwise developed the disease. To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a minimum of 3 months up to 6 months. This is an 'open-label' study, meaning that there will not be a placebo group; all patients enrolled in the study will receive the active medication. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 3 months off of the drug to see if the effects of treatment last and if there is delayed response. The safety of the medication, ruxolitinib, in patients with alopecia areata will also be evaluated.
Blood work will be collected before medication is started, during the treatment period, and after ruxolitinib is stopped, in order to monitor for adverse effects of the medication. Small scalp biopsies and peripheral blood will be taken at the beginning of the study before treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at additional time points based on clinical considerations. The chemical analysis of these skin samples and blood will help us to understand how the disease happens, how the treatment works, and may even guide us to better treatments in the future.
Detailed Description
Alopecia areata (AA) is a common autoimmune disease resulting from immune destruction of the hair follicle and subsequent hair loss. Despite its high prevalence, research into the pathogenesis and the development of innovative therapies in AA has lagged far behind other autoimmune diseases. Currently, there are no FDA approved drugs for AA. Ruxolitinib (Incyte) is an intervention known to effectively treat myelofibrosis and also rheumatoid arthritis by modulating the inflammatory response of the interferon response pathway by inhibition of Jak1/Jak2. Rheumatoid arthritis shares several susceptibility genes in common with AA. All three diseases share the central role of the interferon-gamma response pathway, which is the rationale for selecting Ruxolitinib for evaluation in this clinical trial. Both systemic and topical Ruxolitinib have been shown to prevent the onset of AA in the C3H-HeJ animal model of AA, demonstrating preclinical proof-of-concept data in AA. To test the safety and efficacy of Ruxolitinib in patients with moderate to severe AA, we propose this open-label, single arm pilot study with a total of 12 patients, treated for a minimum of 3 months up to 6 months. Efficacy will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician global evaluation scores. Patients will be followed for another 3 months to evaluate durability of response following the treatment phase. Punch biopsies and peripheral blood will be obtained at baseline prior to treatment and then after 12 and possibly 24 weeks for immune monitoring and for molecular studies.
#Intervention
- DRUG : Ruxolitinib
- A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
- Other Names :
- Jakavi
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 <= age <= 75 of age.
* Patients with a diagnosis of patch type alopecia areata.
* Patients will have >30% and <95% total scalp hair loss at baseline as measured using the SALT score. Two patients with current episodes of alopecia totalis/universalis may be included in this study.
* Duration of hair loss greater than 3 months.
* No evidence of regrowth present at baseline.
* Patients may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata.
Exclusion Criteria:
* Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.
* Patients in whom the diagnosis of alopecia areata is in question.
* Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.
* Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration.
* Women who are pregnant or nursing.
* Patients known to be HIV or hepatitis B or C positive.
* Patients with history or evidence of hematopoietic abnormality.
* Patients with <200K platelet count at baseline.
* Patients with history or evidence of renal or hepatic impairment.
* Patients with history of immunosuppression or history of recurrent serious infections.
* Patients unwilling or unable to discontinue treatments known to affect hair regrowth in AA.
* Patients taking any medication considered a strong CYP3A4 inhibitor who is unable or unwilling to stop this medication for the duration of the study.
* Patients receiving treatment deemed to affect alopecia areata within 2 weeks to one month of baseline visit depending on the specific treatment.
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
|
NCT01950780
|
{
"brief_title": "Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata",
"conditions": [
"Alopecia Areata"
],
"interventions": [
"Drug: Ruxolitinib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01950780",
"official_title": "An Open-Label Pilot Study to Evaluate the Efficacy of Ruxolitinib in Moderate to Severe Alopecia Areata",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-07",
"last_updated_that_met_qc_criteria": "2013-09-23",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-25",
"first_submitted": "2013-09-23",
"first_submitted_that_met_qc_criteria": "2019-04-15"
}
}
}
|
#Study Description
Brief Summary
This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).
Detailed Description
Primary Objective:
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).
Secondary Objectives:
The secondary objectives of this study are to compare iclaprim with linezolid regarding:
* Clinical efficacy at the end of study medication treatment;
* Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
* Clinical outcome in the microbiologically evaluable (ME) population;
* Bacteriologic outcome in the ME population;
* Bacteriologic eradication rates of Baseline (BL) pathogens;
* Clinical outcome in the modified intent-to-treat (MITT) population;
* Bacteriologic outcome in the MITT population;
* Baseline in vitro susceptibility of isolated pathogens in the ME population; and
* Safety and tolerability of iclaprim treatment.
#Intervention
- DRUG : intravenous iclaprim or intravenous linezolid
|
#Eligibility Criteria:
Inclusion Criteria -Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.
Exclusion Criteria: - Known or suspected hypersensitivity to any study medication or other related anti-infective medication - Any known or suspected condition or concurrent treatment contraindicated by the prescribing information - Previous enrollment in this study - Treatment with any investigational drug within 30 days before enrollment
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
|
NCT00299520
|
{
"brief_title": "Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)",
"conditions": [
"Complicated Skin and Skin Structure Infection"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00299520",
"official_title": "Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections.(ASSIST-1)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-07",
"study_start_date(actual)": "2005-06"
},
"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)": "2008-04-04",
"last_updated_that_met_qc_criteria": "2006-03-03",
"last_verified": "2008-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-03-07",
"first_submitted": "2006-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.
Detailed Description
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study was to consist of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA 9-1067 with a single-dose of racemic 25 mg warfarin. In the other period, a 25 mg warfarin single-dose was to be administered alone.
#Intervention
- DRUG : BIA 9-1067
- BIA 9-1067 25 mg
- Other Names :
- OPC, Opicapone
- DRUG : Warfarin
- Warfarin 25 mg
- Other Names :
- Varfine®
|
#Eligibility Criteria:
Inclusion Criteria:
* Able and willing to give written informed consent.
* Male or female subjects aged between 18 and 45 years, inclusive.
* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
* Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
* Non-smokers or ex-smokers for at least 3 months.
* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
* (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.
Exclusion Criteria:
* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* Clinically relevant surgical history.
* Personal or family history of haemostatic disorder.
* Personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
* Any abnormality in the coagulation tests.
* Any abnormality in the liver function tests.
* A history of relevant atopy or drug hypersensitivity.
* History of alcoholism or drug abuse.
* Consumed more than 14 units of alcohol a week.
* Significant infection or known inflammatory process at screening or admission to each treatment period.
* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
* Had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion.
* Had previously received BIA 9 <= age <= 1067.
* Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
* Had participated in more than 2 clinical trials within the 12 months prior to screening.
* Had donated or received any blood or blood products within the 3 months prior to screening.
* Vegetarians, vegans or had medical dietary restrictions.
* Cannot communicate reliably with the investigator.
* Unlikely to co-operate with the requirements of the study.
* Unwilling or unable to gave written informed consent.
* Employees at BIAL - Portela & Co, SA.
* (If female) She was pregnant or breast-feeding.
* (If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
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
|
NCT02169440
|
{
"brief_title": "Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin",
"conditions": [
"Parkinson's Disease (PD)"
],
"interventions": [
"Drug: BIA 9-1067",
"Drug: Warfarin"
],
"location_countries": [
"Portugal"
],
"nct_id": "NCT02169440",
"official_title": "Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-22",
"last_updated_that_met_qc_criteria": "2014-06-19",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-23",
"first_submitted": "2012-01-24",
"first_submitted_that_met_qc_criteria": "2015-11-18"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.
#Intervention
- DRUG : recombinant human erythropoietin
- 3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
- DRUG : recombinant human erythropoietin
- 36000IU(s.c.)/week for 12 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Cancer patients
Exclusion Criteria:
* a history of myocardial, cerebral or pulmonary infarction
* severe hypertension beyond control by drugs
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00144495
|
{
"brief_title": "A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy",
"conditions": [
"Chemotherapy Induced Anemia"
],
"interventions": [
"Drug: recombinant human erythropoietin"
],
"location_countries": null,
"nct_id": "NCT00144495",
"official_title": "A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-11",
"study_completion_date(actual)": "2005-05",
"study_start_date(actual)": "2004-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-02-02",
"last_updated_that_met_qc_criteria": "2005-09-02",
"last_verified": "2009-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-05",
"first_submitted": "2005-09-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.
#Intervention
- DRUG : Boceprevir (BOC)
- 200 mg capsules, 800 mg three times daily by mouth
- Other Names :
- SCH 503034, Victrelis
- DRUG : Placebo to boceprevir
- 200 mg placebo capsules, 800 mg three times daily by mouth
- DRUG : Peginterferon alfa-2b (PEG)
- 1.5 mcg/kg/week subcutaneously
- Other Names :
- PegIntron, SCH 054031, Redipen
- DRUG : Ribavirin (RBV)
- 200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
- Other Names :
- Rebetol, SCH 018908
- DRUG : Cross-Over Boceprevir Treatment
- At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.
- Other Names :
- SCH 503034, Victrelis
|
#Eligibility Criteria:
Inclusion Criteria:
* Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
* Liver biopsy with histology consistent with CHC and no other etiology.
* Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
* Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
* Weight between 40 kg and 125 kg, inclusive
* Of 'local' ancestral descent
* Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception
Exclusion Criteria:
* Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
* Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
* Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
* Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
* Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
* Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
* Diabetes and/or hypertension with clinically significant ocular examination findings.
* Any condition the could interfere with participation in and completion of the trial.
* Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
* Pregnant or breast-feeding.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01390844
|
{
"brief_title": "Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)",
"conditions": [
"Hepatitis C, Chronic"
],
"interventions": [
"Drug: Cross-Over Boceprevir Treatment",
"Drug: Ribavirin (RBV)",
"Drug: Peginterferon alfa-2b (PEG)",
"Drug: Placebo to boceprevir",
"Drug: Boceprevir (BOC)"
],
"location_countries": null,
"nct_id": "NCT01390844",
"official_title": "Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06-19",
"study_completion_date(actual)": "2015-06-19",
"study_start_date(actual)": "2011-10-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-11",
"last_updated_that_met_qc_criteria": "2011-07-07",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-11",
"first_submitted": "2011-07-07",
"first_submitted_that_met_qc_criteria": "2016-05-20"
}
}
}
|
#Study Description
Brief Summary
Induction and emergence from propofol can be a difficult process for patients and healthcare workers, and long recovery times in particular can limit the rate of care. A double-blinded randomized controlled trial with 220 patients undergoing elective colonoscopy or endoscopy is proposed to test the impact of perioperative music on patient experience and recovery from propofol anaesthesia. Patients will be assigned at random to hear either rhythmic auditory stimulation (music designed to drive neural oscillations) or spectrally-matched noise (sound that produces the same levels of activity at the cochlea but not expected to drive neural entrainment). Bone-conduction headphones will be administered in pre-operation waiting and will play music (or matched noise) until propofol administration ceases, at which time the music (or noise) will be switched: Pre- and post-operational music is designed to be sedative and stimulative, respectively, created with methods that drive auditory entrainment to promote those states. Outcome measures will be recovery time and the patient's subjective experience (taken via survey).
Detailed Description
INTRODUCTION
Can perioperative music improve the patient experience, and speed recovery from propofol anaesthesia?
Difficulties around induction and emergence from general anesthesia are a burden on healthcare workers, and central to a patient's experience. Anxiety prior to a procedure, and confusion upon regaining consciousness, are common experiences that negatively affect both patients and staff. Presurgical anxiety can result in difficulty with intubation and longer presurgical delay periods, burdening nurses and slowing the pace of care. Postsurgically, the duration and quality of a patient's recovery from anesthesia affects healthcare providers and patients, both of whom want to minimize the time spent in the recovery room. Lengthy recovery periods may involve amnesic episodes, delirium, agitation, cognitive dysfunction or other emergence phenomenon, which place strain on patients and staff. Longer recoveries also place strain on the patient's caretaker (e.g., relatives waiting to take them home) and burden the healthcare facility, which may be limited in how quickly procedures can occur based on space available in the recovery area.
Perioperative music has been used effectively to control anxiety and pain (Bringman et al. 2009, Gooding et al. 2012, Tan et al. 2012, Fu et al. 2019,. 2020, 2021), but in these studies the music is chosen to be either relaxing or familiar, with no regard for how it drives brain activity. Prior work has focused on the pre-operative period, and has not considered how stimulative music might be used to kickstart cognition following emergence from anaesthesia. Binaural beats (a type of sound therapy that drives neural entrainment) has been recommended for perioperative use (Padmanabhan et al. 2012), but for relaxation only rather than stimulation. Indeed, no work has been done to distinguish music for induction and emergence, or to provide stimulative music to aid recovery from the unconscious state.
Sound is a powerful neuromodulator, and the auditory system can be used to drive neural activity conducive to a variety of mental states. Part of this effect may be due to how sound (and some music in particular) affects neural oscillations (Will \& Berg 2007, Large 2010, Tierney et al. 2014), arousal systems (Thompson et al. 2001, Dillman et al. 2007, Gingras et al. 2014) and dopamine levels (Suttoo et al. 2004, Moraes et al. 2018). Propofol recovery is known to be accelerated by activating the brain's arousal systems via drugs (Chemali et al. 2012) or direct electrical stimulation (Bastos et al. 2021), and music targeting arousal is used to improve cognitive function in humans (Gupta et al. 2018, Woods et al. 2021). Auditory stimulation developed specifically to drive the brain in different ways (Brain.fm music) may be useful perioperatively, and different music may be useful for induction and emergence from anaesthesia.
LITERATURE REVIEW
Propofol recovery Propofol is a widely used general anesthetic agent for ambulatory procedures, but recovery from propofol is not well understood, and the time a patient spends in the recovery room following a procedure may vary widely (Gupta et al. 2004, Shraag et al. 2018). Following return to consciousness (usually characterized by opening the eyes), a patient may experience cognitive deficits or a variety of emergence phenomena such as delirium, aggravation, or amnesia, which are a burden on healthcare workers and likely to be a negative experience for the patient themselves (Lindqvist et al. 2014, Munk et al. 2016, Metterlein et al. 2021). Recovery from propofol can be sped up by activating arousal systems in the brain, for example with methylphenidate (Chemali et al. 2012) or direct thalamic stimulation (Bastos et al. 2021), and by stimuli that have particular arousal value: for example, speaking a patient's name as opposed to other words is more effective at waking patients from propofol, reducing wake-up times by \~20% and reducing time in PACU by \~8% (Jung et al. 2017). Somewhat surprisingly, rather than having negative effects, using arousing stimuli to speed emergence from anaesthesia has been associated with a reduction in emergence delirium in children (Byun et al. 2017). Auditory stimuli like music can also be used to modulate arousal (Husain et al. 2002, Hilz et al. 2014), and sound is commonly used in waking up from sleep. It thus seems likely that stimulating music could be used to speed recovery from general anaesthesia; this point has been noted by others recently but work in this area is still lacking (Seyedalshohadaei et al. 2021).
Perioperative music The role of music in a perioperative setting has largely been confined to anxiety and analgesia, where there is strong evidence for its effectiveness (Bringman et al. 2009, Gooding et al. 2012, Tan et al. 2012, Fu et al. 2019,. 2020, 2021). In a recent example of one such study, Muddanna et al. (2021) tested effects of relaxing music before and during cataract surgery in 165 patients, and found lowered postoperative BP in the test group, along with 48% of the test group reporting feeling 'not at all' or 'a little' anxious (lower ratings of anxiety), versus 30% of the control group. In another study, with 322 patients, Bringman et al. (2009) found that pre-surgical relaxing music was more effective at reducing anxiety than midazlolam (an orally-administered anxiolytic drug). Headsets to reduce anxiety have been tested in clinical settings (Johnson et al. 2012), but use only commercially-available (i.e., not purposely-designed) music, and focus only on relaxation.
Post-operative music has also been found beneficial: in a recent meta-analysis of more than 70 studies, Hole et al. (2015) found strong effects on anxiety, pain, and patient satisfaction, and highly recommended the use of music following surgeries. However, these studies again focus on relaxing music, often of the patient's choice, and in none of these studies was stimulative music used to reduce the duration and difficulty of a patient's emergence from anaesthesia. Studies involving both pre- and post-operative music (Billar et al. 2020, Kappen et al. 2021) use the same music on either side of the procedure, typically with the aim of reducing stress throughout the perioperative period, rather than aiding induction and emergence specifically.
One reason for a lack of interest thus far in stimulative 'wake-up' music may be that music is indeed so effective as an anxiolytic that work in the area has gravitated there. Another possibility is that the use of music to boost arousal or cognition is not widely appreciated, despite having been demonstrated in other contexts such as aiding attentive work (Thompson et al. 2001, Schellenberg et al. 2002, Cassidy et al. 2007), mitigating fatigue (Terry et al. 2020), or improving level-of-consciousness in patients with head trauma (Yekefallah et al. 2021). Finally, the way patients typically return to consciousness in practice may not appear to require external stimulation, since a nurse or doctor will come around to patients at intervals to rouse them (i.e., no 'alarm clock' is needed). However, whether the patient then is able to function cognitively and maintain consciousness (i.e., whether they do in fact wake up when roused), will depend on their neurological state at that time.
Auditory neuromodulation Sound stimuli can modulate brain activity by driving coordinated activity (i.e., entrainment) of neural populations well beyond auditory cortex (Will \& Berg 2007, Large 2010, Tierney et al. 2014). This effect is used to drive the brain into states conducive to activities such as sleep (Ngo et al. 2013) or attention (Calderone et al. 2014). Perhaps related to its effect on oscillations, music also can be used to modulate arousal levels bidirectionally (Thompson et al. 2001, Dillman et al. 2007, Gingras et al. 2014). During emergence from propofol, neural oscillations are returning from an altered dynamical state, and changes include increases in beta power (Breshears et al. 2010), an oscillatory band associated with wakefulness and focus (Zanos et al. 2018). Auditory stimuli can be used to shape oscillatory power and may be useful to drive the brain emerging from general anaesthesia. Hunt et al. 2021 used personalized entrainment music (designed to drive oscillations to inhibit pain) on patients with chronic pain, and found a greater improvement than when patients listened to music of their own choosing, demonstrating that the effects of music were due to entrainment rather than affect (emotion or familiarity). Similarly, music designed for sustained attention via entrainment particularly aids listeners with more ADHD-like symptoms (whose oscillatory activity is known to be different), and hightens activity in task-related functional networks (Woods et al. 2021).
In this study we will test music designed to be maximally effective for induction and emergence from propofol (Brain.fm music). The induction (pre-operative) music is designed to induce slow-wave activity and sleep, and has been shown to relax listeners significantly more than commercially-available relaxing music in a pilot study (unpublished). The emergence music (recovery; post-operative) has been shown to drive beta oscillations and improve focus, and as being rated higher in arousal than commercially-available focus music (Woods et al. 2021).
RATIONALE No study to date has explored the possibility of using stimulating music to shorten recovery times from general anaesthesia. One possible reason is that stimulating music is often jarring, which may produce a negative experience for the patient. It may perhaps have been unclear what this music should be, or how it can in practice be delivered during emergence from anaesthesia but not before that point (i.e., stimulating music would be counterproductive during induction). Another reason may be due to practical limitations around placing headphones on the unconscious patient and impacting their situational awareness upon waking. These limitations are overcome in this study, first by having developed a highly-arousing music that drives neural activity strongly, but which is not jarring (i.e., does not have negative emotional valence) by imposing rapid amplitude modulations on music, and secondly by administering this music via bone-conduction headphones which are convenient to place and do not obscure the ear canal. These innovations in content and delivery of music make it possible to test if music can ease a patient's induction and emergence from general anaesthesia, which is a point of concern for both patients and healthcare providers.
The main innovation of this study is to test stimulative music on recovery post-operatively, but we include relaxing music pre-operatively for three reasons: 1) The patient has a reason to apply the headphones themselves (in pre-op waiting), which stay on throughout their procedure. This familiarity with the device might be beneficial for their experience during emergence from anaesthesia. 2) To improve the perioperative experience with a unified music program for the patient; since stimulating music would be counterproductive pre-operatively, relaxing music is used instead. 3) There is some evidence that pre-operative music can reduce the level of anaesthetic agent required during a procedure by reducing anxiety and lowering arousal (LePage et al. 2001, IIkaya et al. 2014; with propofol: Koelsch et al. 2011). Such effects could lead to a faster trajectory of recovery and better patient experience.
The use of relaxing music pre-operatively is thus expected to improve outcome measures, in particular the patient experience more so than recovery times. In the case that the music condition improves patient satisfaction, further studies will be required to explore the contributions of the pre- or post-operative music. However, in the case of improved recovery times, the stimulative music during emergence is more likely to be responsible, and would constitute the first such use of music in a healthcare setting.
RESEARCH QUESTION
Can perioperative music improve the patient experience, and speed recovery from propofol anaesthesia?
OBJECTIVES AND HYPOTHESES
PRIMARY OBJECTIVE AND HYPOTHESIS
Primary Objective:
The primary objective of this study is to explore whether perioperative music-developed to aid induction and emergence from general anaesthesia-can speed recovery times, while maintaining or increasing patient satisfaction with the experience of induction and emergence.
Primary Hypothesis:
If rhythmic auditory stimulation (music developed to drive neural oscillations) improves patient satisfaction with induction and emergence, and speeds recovery from propofol, then these measures should be significantly improved compared to non-rhythmic auditory stimulation (spectrally-matched noise) delivered in the same manner (i.e., through bone-conduction headphones, presented as a recommended aid by a healthcare worker).
STUDY DESIGN
Blind study involving two hundred and twenty (220) participants undergoing elective upper endoscopy or colonoscopy, placed in one of two arms at random. Both groups will receive audio stimulation through bone conduction headphones, starting in the presurgical suite \< 2 minutes before application of IV, and ending in the PACU (recovery area) prior to discharge. One group (the test group) will hear Brain.fm music (music designed to be maximally effective for induction and emergence from propofol); the other group (the control group) will hear noise that has been spectrally matched to the Brain.fm music (i.e., contains the same energy at the same frequencies, but is not rhythmic). This control stimulus will be similar to pink noise, which is often used as an auditory stimulus in experiments and is also used by the public to relax and focus. Being spectrally matched to the test music, it will stimulate the cochlea to the same extent and have similar effects in terms of masking (degree of overlap with other sound in the environment).
Bone-conduction headphones will be wireless (bluetooth); audio will be transmitted from an iPad mini attached to the patient's bed (hung from an IV hook; in the clinic only one hook is used for an IV and several are unused); each patient has a given bed from presurgery to recovery. The bone-conduction headphones weigh 26 grams and are low-profile, suitable for lying down (AfterShokz 'Aeropex' model); the iPad mini device size is 5.3' x 7.7'.
Staff are required to interact with patients and study equipment with regard to this study at five timepoints:
Headphones applied, audio begins. In the presurgical waiting suite, after the patient has changed into their gown, and just prior to (\< 2 minutes) starting the IV. This timing is intended so that the audio will be maximally novel and effective while the IV is being started (a highly anxiety-inducing event for many patients). At this interaction point, the patient is given the bone-conduction device, shown how to wear it, and told it will be on throughout their procedure. They are told they may remove ask to have the device removed by staff at any time if the device or sound is causing discomfort (if they do so, the audio is stopped by staff upon removing the headphones; if this occurs in pre-op their data is excluded from analysis). If they choose to leave it on, they will wake up with it on, and upon waking should leave the device on until they are ready to leave the PACU (unless the device or sound are causing discomfort). They are told that when they take off the device they will be given a very short questionnaire.
Change of audio from sedative to stimulative. After the procedure, propofol is ceased and the attending nurse or anaesthesiologist presses a button on the iPad to switch the audio from sedative to stimulative. After this, the patient is wheeled into PACU.
When wakefulness is noted by staff in PACU, a button is pressed on the iPad. This may be staff confirming wakefulness after an attempt to rouse a patient, or may be staff noticing wakefulness in a patient who has been awake for some seconds or minutes already. As such this measure will not capture the exact wake-up time, but this noise in the data should be hypothesis-independent and non-biasing (i.e., staff will not be more frequently checking on patients with one experimental condition over another; conditions are blinded from the staff).
Headphones removed, audio stopped by staff. After return to consciousness the headphones should stay on until participants are ready to leave the PACU, but the patient may ask to remove them at any time When a patient's headphones are removed (either by request or prior to discharge), the staff will stop the audio, and the three-question survey which appears on the iPad (see Outcome Measures below) will be presented to patients at that point; they are given the option to take it at that pointor any time until they leave the PACU. In the event that a patient asks that their headphones are removed well in advance of leaving the PACU, staff can follow the same procedure, and the data will show that the audio was stopped well before the discharge/headphone-return time. If a patient removes their headphones unsupervised (i.e., staff find a patient with headphones off and do not know how long they have been off), then that patient will be excluded from the dataset.
At the time of discharge (i.e., when the patient leaves their bed), the headphones and iPad are recovered, and a button is pressed on the iPad closing that patient's session. This time is considered the patient's time of discharge.
Randomization between the control and test conditions is implemented by the experiment program on the iPad, which draws a condition at random for each new participant and logs the time of day at each interaction point (the start of audio, switch of audio, wakefulness, headphone removal / playback end, survey completion, and return of equipment). The experiment is double-blinded since the condition a given patient hears is unknown to staff or patient. Since pre-appointment (recruitment) materials do not refer to music but only to auditory stimulation, patients given the noise condition have no indication it is a control condition.
Volume levels are locked to a low, comfortable level, matched across conditions. The bone-conduction device does not obstruct the ear; this in conjunction with a low volume level will ensure patients retain situational awareness and can communicate easily with staff.
The headphones are wiped down with a sterilizing alcohol swab upon being returned to staff, and are placed onto a charging base station. iPads are returned to a charging base station accompanying the headphones. Headphones and iPads are uniquely paired by bluetooth, and so each pair will be labeled (e.g., the headphone set labeled '3' must be used with the iPad labeled '3').
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Sutoo, D. E., \& Akiyama, K. (2004). Music improves dopaminergic neurotransmission: demonstration based on the effect of music on blood pressure regulation. Brain research, 1016(2), 255-262.
Tan, D. J. A., Polascik, B. A., Kee, H. M., Hui Lee, A. C., Sultana, R., Kwan, M., ... \& Sng, B. L. (2020). The effect of perioperative music listening on patient satisfaction, anxiety, and depression: a Quasi-experimental study. Anesthesiology research and practice, 2020.
Terry, P. C., Karageorghis, C. I., Curran, M. L., Martin, O. V., \& Parsons-Smith, R. L. (2020). Effects of music in exercise and sport: A meta-analytic review. Psychological Bulletin, 146(2), 91.
Thompson, W. F., Schellenberg, E. G., \& Husain, G. (2001). Arousal, mood, and the Mozart effect. Psychological science, 12(3), 248-251.
Tierney, A., \& Kraus, N. (2014). Neural entrainment to the rhythmic structure of music. Journal of Cognitive Neuroscience, 27(2), 400-408.
Will, U., \& Berg, E. (2007). Brain wave synchronization and entrainment to periodic acoustic stimuli. Neuroscience letters, 424(1), 55-60.
Woods, K. J., Sempaio, G., James, T., Przysinda, E., Hewett, A., Spencer, A. E., ... \& Loui, P. (2021). Stimulating music supports attention in listeners with attentional difficulties. bioRxiv.
Yekefallah, L., Namdar, P., Azimian, J., Mohammadi, S. D., \& Mafi, M. (2021). The effects of musical stimulation on the level of consciousness among patients with head trauma hospitalized in intensive care units: A Randomized Control Trial. Complementary Therapies in Clinical Practice, 42, 101258.
Zanos, S., Rembado, I., Chen, D., \& Fetz, E. E. (2018). Phase-locked stimulation during cortical beta oscillations produces bidirectional synaptic plasticity in awake monkeys. Current Biology, 28(16), 2515-2526.
#Intervention
- OTHER : Brain.fm Music
- Experimental arm
- OTHER : Spectrally-matched Noise
- Active control arm
|
#Eligibility Criteria:
Inclusion Criteria:
* Opt-in based on recruitment materials.
* English speaking
* Able to consent
Exclusion Criteria:
* Adverse history to anaesthesia
* Cochlear implants
* Hearing aids
* Adverse/unexpected reaction to procedure/anesthesia (post-hoc)
* Headphones accidentally removed during the study period (post-hoc), for example: Data is excluded if playback is stopped before the audio is switched (indicating patient-initiated removal in pre-op); Data is excluded if playback is stopped before wakefulness is noted (indicating accidental removal of headphones)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05291832
|
{
"brief_title": "Perioperative Audio for Anaesthesia",
"conditions": [
"Anesthesia"
],
"interventions": [
"Other: Spectrally-matched Noise",
"Other: Brain.fm Music"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05291832",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled Study to Explore Perioperative Functional Audio for Anxiety and Cognitive Recovery From Propofol Anaesthesia in Patients Undergoing Endoscopic Procedures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-19",
"study_completion_date(actual)": "2022-07-19",
"study_start_date(actual)": "2022-02-22"
},
"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)": "2022-08-08",
"last_updated_that_met_qc_criteria": "2022-03-14",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-23",
"first_submitted": "2022-03-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.
#Intervention
- PROCEDURE : portal/superior vein resection
- portal/superior vein resection
|
#Eligibility Criteria:
Inclusion Criteria:
* Pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital
Exclusion Criteria:
* Metastatic unresectable and locally advanced pancreatic cancer
* Resectable pancreatic cancer without portal/superior mesenteric vein invasion
* Cancer aggravation after neoadjuvant treatment
* Portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment
* Patients who underwent palliative surgery
* Non-pancreatic ductal adenocarcinoma patients
* Patients who death within 30 days of surgery
* Loss of follow-up patients
* Patients who underwent resection for suspected main artery and adjacent organ invasion
Sex :
ALL
Ages :
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06372886
|
{
"brief_title": "Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment",
"conditions": [
"Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment"
],
"interventions": [
"Procedure: portal/superior vein resection"
],
"location_countries": null,
"nct_id": "NCT06372886",
"official_title": "Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-01",
"study_completion_date(actual)": "2024-03-01",
"study_start_date(actual)": "2012-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-18",
"last_updated_that_met_qc_criteria": "2024-04-15",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-18",
"first_submitted": "2024-04-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Introduction: Patellofemoral pain syndrome (PFPS) is related to the previous sore knee, change functionality and postural control deficits. One of the possibilities for pain control and better positioning of the patella is the rigid bandage patellar widely used by clinicians and researchers.
Objective: To evaluate the effect of rigid patellar bandage on postural control, pain and function in sedentary women with PFPS.
Methods: The sample will be composed of 30 volunteers, sedentary, between 18 and 55 years; randomized group Bandage Functional Rigid (n = 15) and Banding Placebo (n = 15). All fill the Personal Data Sheet, Visual analog scale Pain Questionnaire Previous Knee Pain Scale; and will be submitted to analysis of postural control (static and dynamic) and carry out the test and sit up in pre conditions and post application of the bandage.
Hypothesis: Expected to observe the effect of rigid patellar bandage in pain, function and postural control in sedentary women with PFPS.
Detailed Description
This is a randomized controlled trial and blind in the exercise area, postural control and biomechanics.
The subjects with a clinical diagnosis of PFPS will be allocated in two groups: PFPS group with rigid bandage patella (n = 15) and PFPS group with placebo (n = 15).
Procedures: The subjects with a clinical diagnosis of PFPS, will be forwarded to the evaluation protocols. The data collections will be held at University Hospital Physiotherapy Division of the State University of Londrina. Individuals respond to a questionnaire to characterize the sample, EVA and fill the patellofemoral disorders Scale (AKPS).
Data Collection Protocol: will be held to familiarize themselves with the equipment and tests to be used on the force platform and test sitting and standing, voluntary is inserted in one of the groups (PPS + B or PPS + P) through randomisation previously established by www.random.org and stored in opaque and sealed envelopes.
Following the participants carry out, random and drawn at the time way, the static and dynamic tests on the force platform:
Static: The volunteers will stay 30 seconds in one-leg position of the lower limb with pain with the knee flexed and contralateral suspended to about 90; the test will be performed three times, with one minute of sitting home. Participants will be instructed to keep aligned and torso upright during the test and stay as long as possible with most of the plantar region touching the ground. Will be targeted to fix the look upon in a pre-established and pasted on the wall point.
Dynamic Squat: The volunteers will perform three consecutive repetitions of squat exercise, controlled between about 0 ° to 45 ° of knee flexion in the lower limb with pain. The contralateral leg should be suspended and flexed to 90 °, the activity will be performed three times, with one minute rest in the sitting position between each repetition. Participants will be instructed to keep aligned and torso upright during the test and stay as long as possible with most of the plantar region touching the ground. Will be targeted to fix the look upon in a pre-established and pasted on the wall point.
Dynamic Up and Down Stairs: The force platform will be positioned at 20 cm from the ground on a wooden structure. The front is combined with a second step, also with 20 cm high from the first step, simulating a staircase with two steps of 20 cm each. Voluntary perform the functional activity of climbing the two steps, starting the first step with the leg with pain to support the platform. The activity will be carried out three consecutive times, with rest of a seated minute, and then the voluntary hold the decline in two steps, with lower limb support with pain on the platform, also performed by three consecutive times.
The average of the three repetitions of each activity (static and dynamic) will be used for postural control analysis (COP parameters) for each variable to be analyzed.
#Intervention
- OTHER : taping patellar McConnell
- Taping patellar McConnell: Lateralization correction of the patella with self-adhesive rigid bandage Johnson® positioned lateral border of the patella to the medial condyle of the femur, allowing the lifting of the medial border of the patella and stretching of the knee lateral structures.
- OTHER : Placebo taping
- Placebo taping through vertical application of patellar rigid taping, with the knee in flexion without medialization of the patella.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of patellofemoral dysfunction issued by a specialist orthopedic knee and provide anterior knee pain of 3 or more on the Visual Analogue Scale (VAS) for a minimum of 8 weeks prior to evaluation;
* Previous retropatellar pain or knee, for at least 3 of the following: up / down stairs, squatting, running, kneeling, sitting for long periods and insidious onset of symptoms unrelated to trauma.
Exclusion Criteria:
* History of severe / traumatic knee injury, surgery history in the locomotor system;
* Patellar luxation history; clinical evidence of meniscus injury; ligamentous instability; patellar tendinitis.
* Presence of neurological, cardiovascular or rheumatologic diseases; pregnancy; diabetes,
* Abnormal sensitivity in the plantar;
* Medication and / or therapy in the last six months and hypersensitivity or allergy to tape.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02841384
|
{
"brief_title": "McConnell Patellar Taping in Static and Dynamic Postural Control of Women With Patellofemoral Pain Syndrome",
"conditions": [
"Patellofemoral Pain Syndrome"
],
"interventions": [
"Other: taping patellar McConnell",
"Other: Placebo taping"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02841384",
"official_title": "McConnell Patellar Taping in Static and Dynamic Postural Control of Women With Patellofemoral Pain Syndrome: Randomized Clinical Trial and Blind",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-30",
"study_completion_date(actual)": "2017-05-03",
"study_start_date(actual)": "2016-07-01"
},
"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)": "2017-11-29",
"last_updated_that_met_qc_criteria": "2016-07-19",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-22",
"first_submitted": "2016-07-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.
The purpose of this project is to offer remote hearing aid adjustment as an additional support for experienced hearing aid users.
#Intervention
- DEVICE : Remote hearing aid adjustment
- The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.
|
#Eligibility Criteria:
Inclusion Criteria:
* >18 yr of age
* experienced hearing aid user
Exclusion Criteria:
* <18 yr of age
* new hearing aid users
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
|
NCT04840277
|
{
"brief_title": "Remote Hearing Aid Adjustment for Experienced Hearing Aid Users",
"conditions": [
"Hearing Aids"
],
"interventions": [
"Device: Remote hearing aid adjustment"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT04840277",
"official_title": "Remote Hearing Aid Adjustment for Experienced Hearing Aid Users; a Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-31",
"study_completion_date(actual)": "2022-05-31",
"study_start_date(actual)": "2020-03-01"
},
"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)": "2022-11-03",
"last_updated_that_met_qc_criteria": "2021-04-08",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-09",
"first_submitted": "2021-03-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to find the dose of rapidly administered ketamine in 3 different pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction.
Ketamine is the most common drug administered to children to facilitate painful procedures in the emergency setting because it achieves potent sedation, pain relief and amnesia with minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6) associated with standard ketamine administration guidelines(7) strains work flow because it requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation despite more frequent respiratory depression, apnea and hypotension caused by this technique.(2,4,8,9)
The investigators believe recovery associated with our novel method for administering ketamine is significantly shorter than with the standard larger dose more slowly administered ketamine technique(7). Through the investigators clinical experience, the investigators have found rapid infusion of smaller than standard doses of ketamine safely achieves the drug's sedative effect, with the benefit of more rapid recovery due to the use of a smaller dose. However, this novel technique challenges published beliefs that time of recovery from ketamine sedation does not differ significantly with the dose administered, within the usual dose ranges, and that rapid infusion may cause respiratory depression, similar to that seen with other classes of sedative-analgesic drugs.(7,10) the investigators believe the slow infusion recommended by standard guidelines(7) requires a larger ketamine dose necessary to achieve effective sedation, and, consequently, prolongs recovery. It is the prolonged recovery that has prompted increased use of other less safe but briefer sedatives, such as propofol/fentanyl. By demonstrating patients recover rapidly with new ketamine technique, without increased adverse cardiopulmonary effects, the investigators will provide clinicians with an important new method for ketamine procedural sedation. The investigators believe clinicians will prefer more rapid recovery ketamine technique because it is safer and reduces pain and distress better than the propofol/fentanyl combination for sedation.
The investigators complete proposal requires two steps. In Step One, this proposal, the investigators will determine the minimum effective dose of rapidly infused ketamine that achieves deep sedation for at least 5 minutes in 95% of children (ED95). Two groups of patients will be studied: one group is patients undergoing abscess incision and drainage and the other group is patients undergoing fracture reduction in our Emergency Department. The investigators believe that the ED95 is different for both the groups as the severity of pain is different. The investigators will compare the safety and recovery times to published standard ketamine techniques. In the following study, Step Two, the investigators will compare this novel technique, in a blinded randomized trial using the ED95 ketamine dose determined in Step One to the standard ketamine technique to determine if the novel technique results in significantly shorter recovery without an increase in the frequency of adverse effects. The study the investigators are proposing in this submission is Step One only.
Detailed Description
During fracture reduction in children, the investigators found less distress using ketamine+midazolam (K/M) sedation (P\<0.0001) and less hypoxia (5% vs. 25%) compared to sedation with fentanyl+midazolam (F/M)(1). Others also found less hypoxia with K/M (4%) compared to propofol+fentanyl (P/F) (18-31%)(2,4). Because of the greater safety and efficacy determined in these and similar studies, ketamine is now the most common drug administered for procedural sedation of children undergoing painful procedures in the ED.(7) For the past 15 years, the investigators have sedated about 2,500 children each year with ketamine in the St. Louis Children's Emergency Department for setting broken bones, debriding burns, draining abscesses, and other very painful procedures. Midazolam was co-administered with ketamine in early studies to reduce dysphoria during recovery, but this practice has since been shown not to be beneficial. For the past 5-10 years the investigators have used ketamine without midazolam and have seen no change in how children wake up from ketamine sedation.(6,11)
Ketamine administration in the investigators previous studies (1,3) was similar to recent recommendations (1.5-2 mg/kg I.V. infused over 30-60 sec)(7). Problematically, while most of these ED procedures such as fracture reduction, burn debridement, or abscess incision and drainage, require only 5-10 minutes of deep sedation, this standard ketamine technique results in recovery periods of 60-120 minutes(1,3,6). During recovery, patients remain in treatment rooms to be monitored one-on-one by nurses for respiratory depression, airway obstruction, vomiting and other potentially life-threatening adverse events, thus tying up these limited resources(10). This long recovery has led to increased use of propofol based techniques which have more rapid recovery (20-30 minutes) but cause increased respiratory depression and hypotension and less effective sedation(2-6,9). Because of ketamine's greater safety and efficacy profile, the investigators have been interested in developing alternative ketamine administration regimens that result in more rapid recovery, similar to propofol. If successful in hastening recovery, the investigators believe that the relative lack of respiratory depression and greater analgesia with ketamine will improve patient safety by encouraging continued use of ketamine as the preferred technique for procedural sedation in children undergoing painful procedures in the ED.
To explore new techniques for hastening recovery from sedation, the investigators took advantage of the uniqueness of ketamine. Rapid administration of opioid and gabaergic drugs such as fentanyl and propofol significantly augments the drugs' beneficial effects, but it also markedly increases respiratory depression, apnea and hypotension.(13) Cautions that rapid infusion of ketamine may cause brief respiratory depression stem from early anesthesia trials using doses larger than those typically used for sedation.(7) Although not formally studied, for the past 5 years the investigators have observed no adverse effects with rapid administration of 0.5-1.5 mg/kg ketamine doses for brief painful procedures like fracture reduction and abscess incision \& drainage in children in the Emergency Unit of St. Louis Children's Hospital.
Lipophilic drugs used for procedural sedation-analgesia, such as ketamine, fentanyl, and propofol rapidly diffuse from the bloodstream into the brain. A disproportionately high percentage of the cardiac output goes to the brain, thus a large portion of a drug injected intravenously initially goes into the brain's circulation on first pass through the heart and exerts clinical effects within a single circulation time, usually \< 60 seconds. The drug remaining in the bloodstream circulates throughout the body and diffuses into muscle, bone and fat, causing the blood concentration to fall. The blood-brain concentration gradient then favors drug diffusion out of the brain and the patient awakens.
Rapid infusion of sedative drugs increases central nervous system clinical effects by directing a larger portion of the drug into the brain. A rapidly injected dose of drug travels as a more concentrated bolus into the brain circulation than a slowly injected dose that is diluted by the passing blood. With rapid injection, therefore, the initial blood-brain concentration gradient is greater and a larger portion of the dose initially enters the brain, causing deeper sedation. Smaller doses, rapidly injected, therefore can be used to achieve deep sedation similar to that of larger doses injected more slowly. With the smaller dose, the blood-brain concentration gradient subsequently reverses more rapidly and 'wake up time' is shorter. Because rapid increases in brain concentration of ketamine does not cause respiratory depression, unlike that seen with fentanyl or propofol, this rapid infusion technique can be used with ketamine.
The purpose of this research project is to determine formally the minimum dose of ketamine that, when rapidly infused, achieves 5 minutes of deep sedation in 95% of patients (ED95). The investigators will use the up and down method (15) which is a standard method in anesthesiology to find the mean effective dose. Five minutes is typically enough time to perform these brief painful procedures. The investigators anticipate the ED95 will be smaller than the standard recommended ketamine dose and thus patients will wake up faster.
Of special note, determination of the 'standard dose and rate of administration of ketamine'(7) has been based upon our and others' studies in which the dose and rate of infusion of ketamine were not carefully controlled and, in fact, varied widely(1,3,4,7). Thus, the 'standard recommendation for administration of ketamine' is somewhat anecdotal and has not been precisely determined. Our proposed study will be the first to precisely determine a minimum effective ketamine dose.
#Intervention
- DRUG : Ketamine
- participants who need ketamine sedation for abscess drainage or fracture reduction will be approached for enrollment. there is no comparison group. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
- Other Names :
- Ketalar
|
#Eligibility Criteria:
Inclusion Criteria:
Healthy children (ASA Physical Status I and II) 2 <= age <= 17 yrs old who require deep sedation for abscess incision and drainage in the St. Louis Children's Hospital Emergency Unit
Exclusion Criteria:
* Fever (temperature >= 38 0Celcius) due to upper respiratory infection.
* Obesity (BMI > 2SD for age and sex) or undernourishment (BMI < 2SD for age and sex)
* Children with psychosis/psychiatric diagnosis (currently under the care of psychiatrist and/or taking psychiatric medication. ADHD is not an exclusion criterion)
* Previous adverse reactions with ketamine sedation
* Receipt of opioid analgesic in the ED (oxycodone/morphine etc) prior to sedation
* Multiple abscesses (2 or more) requiring I & D
* Non -English speaking families
* Children under foster care.
* Previous participation in current research study
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01669642
|
{
"brief_title": "Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children",
"conditions": [
"Abscess",
"Fracture"
],
"interventions": [
"Drug: Ketamine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01669642",
"official_title": "Mean Effective Dose of Rapidly Administered Ketamine for Brief Pediatric Procedural Sedation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2012-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-25",
"last_updated_that_met_qc_criteria": "2012-08-20",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-21",
"first_submitted": "2012-08-08",
"first_submitted_that_met_qc_criteria": "2018-02-12"
}
}
}
|
#Study Description
Brief Summary
Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still remain controversial. Therefore, the aims of this study were to investigate the efficacy of PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult Subjects (From 16 <= age <= 85 old)
* The participants with GERD symptoms were treated a PPI therapy.
* The participants completed a questionnaire. The questionnaire consisted of demographic data, GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).
Exclusion Criteria:
* Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, peptic ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) were excluded.
* Patients who took the PPI therapy less than 4 weeks were excluded.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01797939
|
{
"brief_title": "Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients",
"conditions": [
"Erosive Reflux Disease",
"Non-erosive Reflux Disease",
"Functional Heartburn"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01797939",
"official_title": "Predictive Factors of Response to Proton Pump Inhibitor Treatment in Patients With Gastroesophageal Reflux Disease Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2008-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-25",
"last_updated_that_met_qc_criteria": "2013-02-22",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-25",
"first_submitted": "2013-02-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This will be a single centre, open label, randomised, two-way crossover study in healthy volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in this study to establish at what time point a therapeutic concentration of paracetamol in the blood is reached. Subjects will attend a screening visit to check if they are eligible for study participation then within 15 days they will check-in to the unit for a stay of approximately 48 hours (hrs). They will be given a single dose of one of the preparations on the first day and then the other preparation on the next day. Regular blood samples will be taken along with other assessments for safety.
#Intervention
- DRUG : Paracetamol formulation 1
- formulation 1
- DRUG : Paracetamol formulation 2
- Formulation 2
|
#Eligibility Criteria:
Inclusion Criteria:
* Males in good general heatlh and Body Mass Index between 19 <= age <= 28 kg/m2
Exclusion Criteria:
* Disease
1. Current liver impairment, renal impairment, history of or active gastrointestinal ulcers, uncontrolled hypertension, haemophilia or other bleeding disorders.
2. Current or recurrent disease, within 12 months of the screening, that could affect the action, absorption or disposition of the study formulations or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure).
3. Current or relevant previous history, within 12 months of the screening visit, of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatments or procedures.
* Medications
1. Current or regular use at screening of any prescription, herbal or Over the Counter (OTC) medication including paracetamol, aspirin, metaclopramide, domperidone, cholestyramine, angiotensin -converting enzyme (ACE) inhibitors, acetazolamide, anticonvulsants, diuretics, methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and oral hypoglycemics within the past 48 hrs and monoamine oxidase inhibitors, tricyclic antidepressants, beta blockers and anticoagulants such as warfarin and heparin within the past 2 weeks.
2. Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to the screening visit (some examples of inducers: barbiturates, theophylline; inhibitors: cimetidine, erythromycin).
3. Subjects for whom the use of any of the study drugs is contraindicated.
* Virology Screening Positive screening for serum Hepatitis B surface antigen, Hepatitis C antibodies or human immunodeficiency virus (HIV).
* Drug Screen
1. Positive urine screen for drugs of abuse at screening and/or Day-1.
2. Positive alcohol breath test on Day-1.
* Smoking
1. Smoking more than five cigarettes a day.
2. Prior (within 7 days of dosing on Day 1) or current use of any other nicotine containing products, other than cigarettes/pipes/cigars.
* Blood donation Has donated blood or plasma or any other blood product within 3 months of the screening visit. Subjects for whom participation in this study would result in having donated more than 1500 ml of blood within the previous 12 months.
* Nutrition
1. Is a vegetarian or is under a sodium restricted diet.
2. Has consumed poppy seed containing foods within 3 days prior to the screening visit and admission on Day -1.
3. Has consumed food and beverages containing grapefruit, Seville oranges or marmalade within 24 hrs prior to admission on Day -1.
4. Has consumed caffeine containing drinks or food (e.g. tea, coffee, chocolate and cola) 24 hrs prior to admission on Day -1.
5. Has consumed alcohol 36 hrs prior to admission on Day -1.
* Has undertaken any unusually strenuous physical activity 24 hrs prior to the screening visit or check-in on Day 1.
* Weight Weight below 50 kg.
* Haemoglobin Subjects with haemoglobin level below 12.0 gram /decilitre (dl).
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
|
NCT01551836
|
{
"brief_title": "At What Time Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: Paracetamol formulation 2",
"Drug: Paracetamol formulation 1"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01551836",
"official_title": "A Randomised, Two Way Crossover Study to Determine the Time at Which Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-03-13",
"last_updated_that_met_qc_criteria": "2012-03-08",
"last_verified": "2012-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-13",
"first_submitted": "2011-06-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
#Intervention
- DRUG : Polyphenon E (Veregen) 15% ointment
- 3 times daily application on genital and perianal warts over 7 days
- OTHER : Green Tea Beverage with defined catechin content
- 3 times daily oral intake over 7 days
|
#Eligibility Criteria:
Inclusion Criteria:
For both subject groups (treatment arms 1 + 2):
* Male and female subjects, 18 years or older at the time of enrollment. Subjects will be stratified by gender.
* Written informed consent.
* Ability to comply with the requirements of the study.
For patients (treatment arm 1, additionally):
* Clinical diagnosis of external genital and perianal warts which can be located: in men: over the glans penis, foreskin, penis shaft, and scrotum; in women: on the vulva; in both gender: in the inguinal, perineal, and perianal areas.
* A total wart area of at least 100 mm² and a maximum of 2500 mm².
* For women of child-bearing potential: negative pregnancy test and willingness to use two effective methods of contraception throughout their study participation is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection). For male patients and partners of male patients who are of childbearing potential: use of two methods of effective contraception during the treatment period is mandatory (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant, or sterilization (for contraception) plus condom (for prevention of reinfection).
Exclusion Criteria:
For both subject groups (treatment arms 1 + 2):
* Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration.
* Any current uncontrolled infection.
* Current known acute or chronic infection with Hepatitis virus B or C.
* Known Human immunodeficiency virus infection.
* Subjects with known history of chronic (diabetes, hypertension, gastritis, etc.) or consuming diseases (cancer, multiple sclerosis, etc.), chronic inflammation, or liver or renal insufficiency.
* Any chronic or acute condition including the skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect.
* Laboratory data above the upper normal range.
* Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration, with the exception of acyclovir and the related drugs famciclovir and valaciclovir.
* Systemic intake of immunosuppressive or immuno-modulatory medication or vaccination within 30 days prior to enrollment and for the whole study duration.
* Organ allograft recipient.
* Medication intake, including over the counter products and dietary supplements such as iodine, fluoride, or vitamins, which would interfere with study results, except paracetamol and oral contraceptives, within one week before and during the study course. Subjects are not allowed to consume green, black or Oolong tea as well as red wine or any other beverages or foods containing green tea extract within three days before each blood sampling visit.
* For female patients: pregnancy or lactation.
* Blood transfusion within 30 days prior to enrollment.
* Subjects who are placed in an institution due to a judicial or official directive.
For patients (treatment arm 1, additionally):
* Previous participation in a trial investigating sinecatechins in the treatment of external genital and perianal warts.
* Treatment of external genital warts within 30 days prior to enrollment and for the whole study duration.
* Current infection with Herpes genitalis or history of Herpes genitalis infection within the last 3 months prior to enrollment.
* Any current and/or recurrent pathologically relevant genital infections other than genital warts.
* Known allergies against any of the ingredients of the ointment.
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
|
NCT01082302
|
{
"brief_title": "Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage",
"conditions": [
"Genital Warts",
"Perianal Warts"
],
"interventions": [
"Other: Green Tea Beverage with defined catechin content",
"Drug: Polyphenon E (Veregen) 15% ointment"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01082302",
"official_title": "An Open-Label, Single-Center Phase I (Phase IV/ USA) Study to Assess the Pharmacokinetic Profile of Topically Applied Veregen® 15% in Patients With External Genital and Perianal Warts Compared With Oral Intake of a Green Tea Beverage",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-08",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2010-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-09-08",
"last_updated_that_met_qc_criteria": "2010-03-05",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-08",
"first_submitted": "2010-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Oseltamivir dosing in infants \< 3 months of age is based on a single pharmacokinetic study in 20 infants from a single center. This dataset is limited by a lack of robustness, because only 1 sample was collected from each participant. The investigators obtained two blood samples each from infants receiving oseltamivir after obtaining informed consent from the infant's parents. The investigators propose to analyze the blood samples to determine the amount of oseltamivir in the infant's blood. Measurement of these values will increase the understanding of the absorption and elimination of oseltamivir in preterm and term infants, and improve our ability to provide the correct doses to this high risk population.
#Intervention
- DRUG : Oseltamivir
- Treatment dose was oseltamivir 3 mg/kg/dose by mouth (PO) twice daily. Prophylactic dose was oseltamivir 1 mg/kg/dose PO once daily to infants \< 28 weeks postmenstrual age (PMA), 1 mg/kg/dose PO twice daily to infants 28 - 38 weeks PMA, and 3 mg/kg/dose PO once daily to infants \> 38 weeks PMA. Dosing in infants \< 28 weeks PMA was chosen based on unpublished data from Acosta et al. This data was obtained from phone contact with Dr. Peter Gal, co-author of the study. Dosing in infants 28 - 38 weeks PMA was chosen based on published data from Acosta et al.1 Dosing in infants \> 38 weeks PMA and less than 3 months postnatal age was chosen based on data from Kimberlin et al. Dosing in infants \> 38 weeks PMA and greater than 3 months postnatal age was per the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services.
|
#Eligibility Criteria:
Inclusion Criteria:
* All neonates and infants in the NICU at St. Louis Children's Hospital who received oseltamivir for treatment of or exposure to influenza virus type A were considered eligible for this study.
Sex :
ALL
Ages :
- Maximum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01388439
|
{
"brief_title": "Pharmacokinetics of Oseltamivir in Newborns and Infants",
"conditions": [
"Prematurity of Fetus"
],
"interventions": [
"Drug: Oseltamivir"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01388439",
"official_title": "Pharmacokinetics of Oseltamivir in Newborns and Infants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01",
"study_completion_date(actual)": "2011-01",
"study_start_date(actual)": "2011-01"
},
"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)": "2011-07-06",
"last_updated_that_met_qc_criteria": "2011-07-05",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-06",
"first_submitted": "2011-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase I trial studies how well vismodegib after stem cell transplant works in treating patients with high-risk first remission or relapsed multiple myeloma. Vismodegib may slow the growth of cancer cells. Giving vismodegib after autologous stem cell transplant may kill more multiple myeloma cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if GDC-0449 (vismodegib) is able to reduce myeloma cancer stem cells (CSC) when given to patients with multiple myeloma (MM) following autologous stem cell transplantation.
SECONDARY OBJECTIVES:
I. To determine whether GDC-0449 is inhibiting the hedgehog (Hh) pathway in patients with MM following autologous transplantation by measuring downstream targets of Hh using quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) on plasma cells and MM CSC obtained from blood and bone marrow of patients undergoing treatment.
II. To determine whether changes in MM CSC as measured by clonogenic assays on bone marrow are seen in response to GDC-0449 and whether these changes predict recurrence.
III. To determine whether changes in MM CSC can be measured with similar or better accuracy using peripheral blood flow cytometry as compared to bone marrow clonogenic assays.
IV. To determine the safety and toxicity profile for treatment with GDC-0449 following autologous transplantation in patients with high risk or relapsed MM.
V. To characterize the pharmacokinetics (PK) of GDC-0449 (total and unbound) at steady-state and correlate this with pharmacodynamic (PD) endpoints.
VI. To determine the one year progression free survival for patients given GDC-0449 following autologous transplantation.
OUTLINE:
Patients receive vismodegib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.
After completion of treatment, patients are followed up for 4 weeks.
#Intervention
- DRUG : Vismodegib
- Given PO
- Other Names :
- Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449
- OTHER : Pharmacological Study
- Correlative studies
- Other Names :
- pharmacological studies
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed multiple myeloma meeting criteria with symptomatic disease requiring treatment; patients considered to have high risk disease (defined as chromosome 13 deletion by cytogenetics; t(4;14), t(14;16) or 17p deletion by fluorescence in situ hybridization [FISH], B2-M > 5.5 g/dL, immunoglobulin A [IgA] phenotype) in first remission (>= partial remission [PR]) or patients with relapsed myeloma responding to salvage therapy (>= PR) based on the International Uniform Response Criteria are eligible
* Patients must have measurable disease utilizing serum or urine protein electrophoresis or serum kappa / lambda light chain assay
* Patients must be planning to proceed to single autologous transplantation according to institutional standards and must receive this transplantation prior to implementation of GDC-0449
* Concomitant bisphosphonate use is allowed as clinically indicated
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
* Life expectancy of greater than 6 months
* Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to GDC-0449 treatment, for the duration of study participation, and for at least 12 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10 <= age <= 14 days and within 24 hours prior to the first dose of GDC-0449 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient understands of GDC-0449 cause serious or life-threatening birth defects
* Women of childbearing potential are defined as follows:
* Patients with regular menses
* Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding
* Women who have had a tubal ligation
* Women are considered not to be of childbearing potential for the following reasons:
* The patient has undergone hysterectomy and/or bilateral oophorectomy
* The patient is post-menopausal defined by amenorrhea for at least 1 year in a women
* Human immunodeficiency virus (HIV)-positive patients without a prior acquired immune deficiency syndrome (AIDS)-defining illness and a CD4 count 400/millimeter^3 and either do not require anti-HIV therapy or are taking anti-HIV therapy that would not interfere with GDC-0449 (e.g. not taking zidovudine, protease inhibitors or non-nucleoside reverse transcriptase inhibitors) are eligible
* Ability to understand and the willingness to sign a written informed consent document
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
|
NCT01330173
|
{
"brief_title": "Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma",
"conditions": [
"DS Stage I Plasma Cell Myeloma",
"DS Stage II Plasma Cell Myeloma",
"DS Stage III Plasma Cell Myeloma",
"Refractory Plasma Cell Myeloma"
],
"interventions": [
"Other: Laboratory Biomarker Analysis",
"Drug: Vismodegib",
"Other: Pharmacological Study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01330173",
"official_title": "A Phase 1b Study of GDC-0449 Following Autologous Transplantation in Patients With High Risk First Remission or Relapsed Multiple Myeloma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2010-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-23",
"last_updated_that_met_qc_criteria": "2011-04-05",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-06",
"first_submitted": "2011-04-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients
Detailed Description
dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic stability for operative procedure. It had been already reported that dexmedetomidine reduce the impairment of renal functon after cardiac operation in adult. we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients
#Intervention
- DRUG : Dexmedetomidine
- administration of dexmedetomidine on dexemedetomidine group
- Other Names :
- administration of dexmedetomidine
- DRUG : no dexmedetomidine
- no administration of dexmedetomidine on control group
- Other Names :
- no administration of dexmedetomidine
|
#Eligibility Criteria:
Inclusion Criteria:
* 1 <= age <= 6yr pediatric cardiac patients
Exclusion Criteria:
* previous renal dysfunction
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
|
NCT01920542
|
{
"brief_title": "Dexmedetomidine on Pediatric Heart Operation",
"conditions": [
"Acute Renal Injury"
],
"interventions": [
"Drug: no dexmedetomidine",
"Drug: Dexmedetomidine"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01920542",
"official_title": "Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2013-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-10",
"last_updated_that_met_qc_criteria": "2013-08-09",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-12",
"first_submitted": "2013-08-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.
#Intervention
- DRUG : Peginterferon alfa-2a
- 180 uG in 0.5 mL solution administered once weekly for 48 weeks
- Other Names :
- Pegasys
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult participants 18 <= age <= 70 years
* Positive test result for HBsAg for >6 months
* Naive to treatment for HBV
* On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis
Exclusion Criteria:
* Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
* Decompensated liver disease
* Hepatocellular cancer
* Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
* Medical condition associated with chronic liver disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02570191
|
{
"brief_title": "A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)",
"conditions": [
"Hepatitis B, Chronic"
],
"interventions": [
"Drug: Peginterferon alfa-2a"
],
"location_countries": [
"Bulgaria"
],
"nct_id": "NCT02570191",
"official_title": "An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-02",
"study_completion_date(actual)": "2007-02",
"study_start_date(actual)": "2004-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-02",
"last_updated_that_met_qc_criteria": "2015-10-05",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-07",
"first_submitted": "2015-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate the pharmacokinetic (PK) of JNJ-440 in healthy participants and in CHB participants following single and multiple dose regimens, administered alone (healthy participants and CHB participants).
#Intervention
- DRUG : JNJ-440
- JNJ-440 will be administered as oral tablets in Parts 1, 2 and 3. JNJ-440 may be provided as oral solution in a cohort in Part 1.
- Other Names :
- JNJ-64530440 or ALS-003440
- DRUG : Placebo
- Matching placebo as oral tablets will be administered in Parts 1, 2 and 3.
|
#Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria for Healthy Participants:
* Female participants (except for postmenopausal women) must have a negative pregnancy test at screening and on Day -1
* Participants must have a body mass index (BMI; weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included
* Participants must agree not to donate blood during the study and for at least 1 month after the completion of study drug administration
Inclusion Criteria for Participants with Chronic Hepatitis B (CHB):
* Participant must have CHB infection documented by: (a) Serum hepatitis B surface antigen (HBsAg) positive at screening and at least 6 months prior to screening; (b) Serum antibody immunoglobulin M (IgM) anti-HBc antibody negative at screening
* Participants must currently not be receiving any CHB treatment at screening, that is, have never received treatment with hepatitis B virus (HBV) antiviral medicines, nucleos(t)ide analog (NAs), interferon (IFN) products, or investigational anti-HBV agents, OR Have not been on treatment with HBV antiviral medicines, NAs, or IFN products within 6 months prior to baseline (first intake of study drugs)
Exclusion Criteria:
Exclusion Criteria for Healthy Participants:
* Participants with a past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant electrocardiogram [ECG] abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening. Any evidence of heart block or bundle branch block is also exclusionary
* Participants with any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticarial
* Participants with a history of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Exclusion Criteria for Participants with CHB:
* Participant with positivity of anti-HBs antibodies
* Participants with current hepatitis D virus (HDV) infection (confirmed by HDV antibody) at screening
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
|
NCT03439488
|
{
"brief_title": "A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B",
"conditions": [
"Chronic Hepatitis B"
],
"interventions": [
"Drug: Placebo",
"Drug: JNJ-440"
],
"location_countries": [
"Ukraine",
"Thailand",
"New Zealand",
"Moldova, Republic of",
"Korea, Republic of"
],
"nct_id": "NCT03439488",
"official_title": "A Multipart Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human, Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation (Part 1); After Multi-Day Dosing (Part 2) in Healthy Subjects; and After Multiple (Ascending) Doses in Subjects With Chronic Hepatitis B (Part 3)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-10",
"study_completion_date(actual)": "2019-10-10",
"study_start_date(actual)": "2018-03-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-10",
"last_updated_that_met_qc_criteria": "2018-02-13",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-20",
"first_submitted": "2018-01-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced. The subject will then be returned to breathing room air.
#Intervention
- DEVICE : INVSENSOR00039
- Noninvasive pulse oximeter sensor
|
#Eligibility Criteria:
Inclusion Criteria
* Subject is 18 <= age <= 50 years.
* Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
* Hemoglobin value is greater than or equal to 11 g/dL.
* Baseline heart rate >= 45 bpm and <= 85 bpm.
* Carbon monoxide (CO value) <= 2.0% fraction of carboxyhemoglobin (FCOHb)
* Subject has a physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
* Blood pressure: Systolic Blood Pressure <= 140 mmHg and >= 90 mmHg, Diastolic Blood Pressure <= 90 mmHg and >= 50 mmHg, and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test.
* Subject is able to read and communicate in English and understands the study and risks involved.
Exclusion Criteria (* = per physician discretion)
* Subject is pregnant.
* Subject has a Body Mass Index (BMI) > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
* Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after blood draw, or has a fear of blood draws.
* Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e- cigarette liquid, and smokers are not being recruited as indicated in the Case Study Report Form (CSRF).
* Subject has open wounds, inflamed tattoos or piercings, and/or any visible healing wounds that a medical professional renders them at an increased risk for participation.*
* Subject has known drug or alcohol abuse and/or use of recreational drugs.
* Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
* Subject has experienced a concussion or head injury with loss of consciousness within the last 12 months.
* Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
* Subject has a chronic bleeding disorder (i.e. hemophilia).
* Subject who has taken anticoagulant medication within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)).
* Subject has donated blood within the past 4 weeks.
* Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
* Subject has any symptomatic cardiac dysrhythmia (i.e. atrial fibrillation) and has not received clearance by their physician to participate.
* Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's Disease) that interferes with the subject's level of consciousness.
* Subject has taken opioid pain medication 24 hours before the study.
* Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
* Subject is taking medications known to treat any type of infectious disease.*
* Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
* Subject has had invasive surgery within the past year- including but not limited to major dental surgery*, appendix*, plastic surgery*.
* Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ears, nose, and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
* Subject has symptoms of congestion, head cold, flu or other illnesses.
* Subject experiences claustrophobia or has generalized anxiety disorder.
* Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
* Subject has any cancer or history of cancer (not including skin cancer).*
* Subject has chronic unresolved asthma, lung disease (including chronic obstructive pulmonary disease (COPD)) or respiratory disease.
* Subject is allergic to lidocaine, latex, adhesives, or plastic.
* Subject has heart conditions, insulin-dependent Diabetes or uncontrolled hypertension.
* Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
* Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
* Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
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
|
NCT04112784
|
{
"brief_title": "Desaturation Validation of INVSENSOR00039",
"conditions": [
"Healthy"
],
"interventions": [
"Device: INVSENSOR00039"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04112784",
"official_title": "Desaturation Validation of INVSENSOR00039",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-09",
"study_completion_date(actual)": "2019-10-09",
"study_start_date(actual)": "2019-09-17"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": null,
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-06",
"last_updated_that_met_qc_criteria": "2019-09-30",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-02",
"first_submitted": "2019-09-30",
"first_submitted_that_met_qc_criteria": "2022-09-08"
}
}
}
|
#Study Description
Brief Summary
Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)
Detailed Description
This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium).
The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.
The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens.
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.
#Intervention
- DEVICE : IOL implantation experimental
- Implantation of trifocal IOL POD F GF consisting of hydrophobic material
|
#Eligibility Criteria:
Inclusion Criteria:
* Cataractous eyes with no comorbidity
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent
Exclusion Criteria:
* Irregular astigmatism
* Age of patient < 45 years
* Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* AMD suspicious eyes (determined by OCT)
* Complicated surgery
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03306342
|
{
"brief_title": "Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL",
"conditions": [
"Cataract",
"Lens Opacities",
"Presbyopia"
],
"interventions": [
"Device: IOL implantation experimental"
],
"location_countries": [
"France"
],
"nct_id": "NCT03306342",
"official_title": "Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-10",
"study_completion_date(actual)": "2020-11-11",
"study_start_date(actual)": "2018-02-02"
},
"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)": "2022-01-11",
"last_updated_that_met_qc_criteria": "2017-10-04",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-11",
"first_submitted": "2017-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label study to evaluate the performance of a novel tau imaging ligand in up to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV). Subjects will be recruited from the patient population and healthy volunteers of Taiwan residents. This study protocol requires each subject to complete the following components: screening evaluation, brain MRI and 18F-PM-PBB3 PET imaging up to two sessions. The screening procedures will include neuropsychological assessments, vital signs, ECG, physical examinations and laboratory tests. In addition, 18F-AV-45 PET imaging result will be as a part of inclusion criteria to confirm presence of amyloid deposition in patients with clinically diagnosed probable AD or absence of amyloid deposition in FTD, VCI and HV subjects. Furthermore, 18F-AV-133 PET imaging data will also be as a part of inclusion criteria to confirm the diagnosis of PSP and CBS. All subjects will complete clinical assessments and clinical safety tests to ensure the subject is medically stable to complete the study protocol. The screening procedures will occur within 30 days prior to 18F-PMPBB3 PET imaging.
#Intervention
- DRUG : F-18
- This is an open-label study to evaluate the performance of a novel tau imaging ligand in up to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV).
- Other Names :
- F-18 PMPBB3
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained before any assessment is performed.
* Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
* Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
* Male subjects must not donate sperm for the study duration.
* Willing and able to cooperate with study procedures
Exclusion Criteria:
* Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
* Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes (except for patients with VCI), acute myocardial infarction, poorly controlled diabetes, previous head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases.
* Current or prior history of major psychiatric disorders, epilepsy and major depression.
* History of severe allergic or anaphylactic reactions particularly to the tested drugs.
* History of positive test for human immunodeficiency virus (HIV).
* Life expectancy less than 1 year.
* Pregnant women, lactating or breast-feeding women.
* Clinically significant abnormal laboratory values and/or clinically significant or unstable medical or psychiatric illness.
* Substance abuse or alcoholism for at least 3 months.
* Cognitive impairment resulting from trauma brain injury.
* Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv.
* Subject has received an investigational drug or device within 30 days of screening
* Patients in whom MRI was contraindicated and with history of claustrophobia in MRI
* General MRI, and / or PET exclusion criteria. MRI exclusion criteria include: Findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the FLAIR sequence that is >=20 mm in any dimension, except for patients with VCI), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS disease.
* Severe language impairment precluding cognitive assessments, defined as a score of 3 points in the language score of the National Institute of Health Stroke Scale.
* Subjects having high risks for the study according to the PI discretion.
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:
Yes
|
NCT03625128
|
{
"brief_title": "18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls",
"conditions": [
"Alzheimer's Disease",
"Cortical Basal Syndrome",
"Frontotemporal Dementia",
"Progressive Supranuclear Palsy",
"Vascular Cognitive Impairment"
],
"interventions": [
"Drug: F-18"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03625128",
"official_title": "Phase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-03",
"study_completion_date(actual)": "2018-12-03",
"study_start_date(actual)": "2018-01-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-21",
"last_updated_that_met_qc_criteria": "2018-08-07",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-10",
"first_submitted": "2018-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To assess in patients with CAD \[coronary artery disease\] and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation requiring ICD \[implantable cardioverter defibrillator\] intervention) within one year after randomization.
#Intervention
- DRUG : Atorvastatin 80mg
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible subjects were male or female subjects, age >18 years, with clinically documented coronary artery disease and life-threatening ventricular arrhythmias who met the following criteria:
* Were scheduled for an ICD implantation or had an ICD implantation within 1 month, according to the class I American College of Cardiology/American Heart Association (ACC/AHA) practice guidelines for ICD therapy
OR
* Were already treated with an ICD for a class I ACC/AHA indication for more than one month, provided they received at least one appropriate ICD intervention (shock or antitachycardia pacing (ATP) for ventricular tachycardia or ventricular fibrillation) during the preceding six months
Exclusion Criteria:
* Patients with ventricular arrhythmias in the acute phase of myocardial infarction (first 48 hours).
* Patients with incessant ventricular tachycardia.
* Patients with ventricular arrhythmias without underlying coronary artery disease.
* Patients with a transient or reversible cause of ventricular arrhythmias (including significant electrolyte disturbances or drug induced proarrhythmia).
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
|
NCT00457340
|
{
"brief_title": "Atorvastatin For The Reduction Of Ventricular Arrhythmias",
"conditions": [
"Arrhythmia"
],
"interventions": null,
"location_countries": [
"Belgium",
"Greece"
],
"nct_id": "NCT00457340",
"official_title": "Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-09",
"study_start_date(actual)": "2000-02"
},
"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)": "2021-02-18",
"last_updated_that_met_qc_criteria": "2007-04-05",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-04-06",
"first_submitted": "2007-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and sometimes result in lasting psychological effects. Shoes are our direct link between the ground and our feet. Wearing shoes plays a major role in postural control. The characteristics of shoes usually worn by elderly people are identified with those of shoes known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the elderly, Axis-Comfort Development® has developed 'experimental balance shoes'. Their shoes have technical characteristics presented in the scientific literature as beneficial for postural stability.
Therefore, the aim of this study was to investigate the effects of wearing experimental balance shoes on postural balance compared with the people's own shoes. We assumed that postural balance would be improved by experimental balance shoes in an acute way and improved by a familiarization phase.
This was a controlled, randomized, blind and cross-over study. three sessions were held in our center, each time interspersed with a phase of familiarization at home (7 to 10 days) during which the people had to wear either the experimental balance shoes or their own personal shoes. 21 volunteers in total participated in this study, all between 65 and 75 years old. Five tests were presented randomly for each session and all tests were carried out on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were stride frequency during the walk on the spot and stability limits.
An improvement of these multiple criteria during the different sessions would be proof of the positive effect of experimental balance shoes on postural balance in the elderly.
#Intervention
- DEVICE : Balance Shoe
- Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases
- Other Names :
- Axis Comfort Development® Experimental Balance shoes
- DEVICE : Personal Shoe
- Use of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases
- Other Names :
- Own personal shoes of subjects
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects from 65 <= age <= 75 old
* Healthy subjects
* Having given their written informed consent
Exclusion Criteria:
* Subject who has fallen during the six months prior to the study.
* Subject who moves with walking aids.
* Subject with severe balance problems or unable to stand up without help
* Subject who takes sedatives or sleeping pills
* Subject with neurological disease (dizziness including turning dizziness, multiple sclerosis, Parkinson's, etc.)
* Subject with history of heart attack
* Subject who is short of breath when inactive.
* Subject who has pains limiting walking and standing
* Subject who takes neuroleptics except Anti-depressors if the treatment is long-standing and well-balanced.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04344223
|
{
"brief_title": "Effect of Stabilization Shoes on Balance in Elderly",
"conditions": [
"Elderly"
],
"interventions": [
"Device: Personal Shoe",
"Device: Balance Shoe"
],
"location_countries": [
"France"
],
"nct_id": "NCT04344223",
"official_title": "Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-15",
"study_completion_date(actual)": "2020-02-29",
"study_start_date(actual)": "2019-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-14",
"last_updated_that_met_qc_criteria": "2020-04-10",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-14",
"first_submitted": "2020-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study we will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. In this study we hypothesize that oral glucose intake and consequently the endogenous induced hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular dilatation, resulting from this physiological induced hyperinsulinemia, will be less in hypertensive and obese subjects compared to healthy controls.
#Intervention
- DIETARY_SUPPLEMENT : Glucose solution
- single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)
- DIETARY_SUPPLEMENT : Placebo
- single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally
|
#Eligibility Criteria:
Inclusion Criteria:
healthy normotensive subjects:
* 18 <= age <= 60 years
* Caucasian
* Blood pressure <140/90 mmHg
obese normotensive subjects:
* 18 <= age <= 60 years
* Caucasian
* Blood pressure <140/90 mmHg
* BMI 30 <= age <= 38kg/m2
hypertensive subjects:
* 18 <= age <= 60 years
* Caucasian
* Untreated hypertension >140/90mmHg.
Exclusion Criteria for healthy normotensive and hypertensive subjects:
* Obesity (BMI>27kg/m2)
* Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
* Diabetes mellitus according to the criteria of the ADA
* Smoking
* Alcohol use >4U/day
* Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
* Pregnancy
* Wearing contact lenses
for normotensive obese subjects:
* Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
* Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
* Smoking
* Alcohol use >4U/day
* Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
* Pregnancy
* Wearing contact lenses
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
|
NCT00742456
|
{
"brief_title": "Microvascular Dilatation After Endogenous Induced Hyperinsulinemia",
"conditions": [
"Hypertension",
"Obesity"
],
"interventions": [
"Dietary Supplement: Glucose solution",
"Dietary Supplement: Placebo"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT00742456",
"official_title": "Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-08",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-02-23",
"last_updated_that_met_qc_criteria": "2008-08-26",
"last_verified": "2011-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-27",
"first_submitted": "2008-08-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
Detailed Description
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.
#Intervention
- DEVICE : T-Piece Nebulizer
- Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
- DEVICE : Breath-Enhanced Nebulizer
- Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)
- DRUG : Albuterol
- One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
- Other Names :
- albuterol sulfate
- PROCEDURE : Pre-Treatment Spirometry Measurement
- Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.
- PROCEDURE : Post-Treatment Spirometry Measurement
- Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 6 years and < 18 years
* History of physician diagnosed asthma
* Presenting to ED with breathing difficulty or cough
* Initial FEV1 25%-70% predicted
* Parent or guardian speaks English or Spanish.
Exclusion Criteria:
* Pediatric Asthma Score of 0
* Pregnancy or breast-feeding
* Immediate resuscitation required
* Chronic lung disease (other than asthma)
* Congenital heart disease
* Neuromuscular disease
* Suspected intrathoracic foreign body
* Allergy or other contraindication to study medication
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02566902
|
{
"brief_title": "Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma",
"conditions": [
"Asthma"
],
"interventions": [
"Procedure: Post-Treatment Spirometry Measurement",
"Device: Breath-Enhanced Nebulizer",
"Drug: Albuterol",
"Procedure: Pre-Treatment Spirometry Measurement",
"Device: T-Piece Nebulizer"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02566902",
"official_title": "Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06-30",
"study_completion_date(actual)": "2017-06-30",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-05-06",
"last_updated_that_met_qc_criteria": "2015-09-30",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-02",
"first_submitted": "2015-09-24",
"first_submitted_that_met_qc_criteria": "2021-04-13"
}
}
}
|
#Study Description
Brief Summary
This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.
#Intervention
- OTHER : Supportive care
- Information, guidance, supportive care, and psychological intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a first-time ICD or CRT-D
* >=18 years
Exclusion Criteria:
* Subcutaneous ICD
* Upgrade from a pacemaker to ICD or CRT
* History of psychiatric illness other than affective/anxiety disorders
* Cognitive impairments (e.g. dementia)
* Left ventricular assist device (LVAD) or upcoming LVAD implant
* Under evaluation or on the waiting list for heart transplantation
* No e-mail address
* Inability to manage or cope with computer technology
* Insufficient knowledge of the Danish language
* Participation in other randomized controlled trials unless of a technical nature
* Irresponsible to ask patient to participate according to GCP
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
|
NCT02976961
|
{
"brief_title": "A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care",
"conditions": [
"Implantable Defibrillator User",
"Distress"
],
"interventions": [
"Other: Supportive care"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02976961",
"official_title": "A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-05-08",
"study_start_date(actual)": "2017-02-06"
},
"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)": "2024-12-06",
"last_updated_that_met_qc_criteria": "2016-11-29",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-30",
"first_submitted": "2016-11-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
If the patients's teeth are weak or the mouth dose not open well, the lightwand is a useful device when endotracheal intubation is necessary.
Therefore, if the appropriate position of the light beam is determined and the distance of the light source suitable for intubation using the lightwand is obtained from anatomical structures such as thyroid cartilage and cricoid cartilage, it is clinically useful. Because it can prevent unnecessary deep insertion or shallow insertion that can cause damage to anatomical structures during intubation.
Detailed Description
Studies have been reported on the proper position to bend the lightwand and the appropriate angle to bend when performing endotracheal intubation with lightwand. For ease of procedure, the assistant has to lift the patient's lower jaw or perform a neck extension.
However, there is no report on the position of the lightbulb when the light passes through the front of the airway and neck and appears bright in the midpoint.
The prodcedure is as follows.
1. FOB examination and check position of light below 1cm from vocal cord
2. lightwand intubation aimed at checkpoint
3. measurement of distance from thyroid cartilage/cricoid cartilage to light point
#Intervention
- PROCEDURE : lightwand intubation
- intubation using lightwand
|
#Eligibility Criteria:
Inclusion Criteria:
* impossibility of neck extension
* trismus
* weak teeth
Exclusion Criteria:
* previous history of larynx or neck surgery
* no informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03480035
|
{
"brief_title": "Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand",
"conditions": [
"Neck Disease",
"Trismus",
"Tooth Abnormalities"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03480035",
"official_title": "Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-27",
"study_completion_date(actual)": "2018-07-27",
"study_start_date(actual)": "2018-03-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-21",
"last_updated_that_met_qc_criteria": "2018-03-21",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-27",
"first_submitted": "2018-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
Detailed Description
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.
#Intervention
- DRUG : Nicotrol Inhaler
- 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
|
#Eligibility Criteria:
Inclusion Criteria:
* 13 <= age <= 26 weeks pregnant
* Smoking at least 5 cigarettes per day the preceding 7 days
* Motivated to quit smoking (at least 7 on a 10 pt. scale)
* Able to speak English
* Intend to carry pregnancy to term
* Stable residence
Exclusion Criteria:
* Current drug or alcohol abuse or dependence (other than methadone maintenance
* Twins or multiple gestation
* Unstable psychiatric disorder
* Unstable medical problems
* Known congenital abnormality
* High risk pregnancy
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00888979
|
{
"brief_title": "Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy",
"conditions": [
"Tobacco Use Disorder"
],
"interventions": [
"Drug: Nicotrol Inhaler"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00888979",
"official_title": "Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2009-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-09",
"last_updated_that_met_qc_criteria": "2009-04-27",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-28",
"first_submitted": "2009-04-24",
"first_submitted_that_met_qc_criteria": "2016-11-10"
}
}
}
|
#Study Description
Brief Summary
Despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (HFrEF) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for HFrEF. The autonomic nervous system (ANS), particularly the sympathetic nervous system (SNS), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. This is critical given the huge unmet need for novel treatment strategies for HFrEF.
Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. However, it is unclear whether TEA could positively impact the clinical outcomes of patients with HFrEF.
#Intervention
- COMBINATION_PRODUCT : TEA plus GDMT
- Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. All the patients received maximally tolerated guideline-directed medical therapy (GDMT).
- DRUG : GDMT
- All the patients received maximally tolerated guideline-directed medical therapy (GDMT) alone.
|
#Eligibility Criteria:
Inclusion Criteria:
* The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) <=40%, who were hospitalized from July 2013 to August 2019.
Exclusion Criteria:
* Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.
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
|
NCT06068166
|
{
"brief_title": "Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction",
"conditions": [
"Heart Failure With Reduced Ejection Fraction",
"Thoracic Epidural Anesthesia"
],
"interventions": [
"Drug: GDMT",
"Combination Product: TEA plus GDMT"
],
"location_countries": null,
"nct_id": "NCT06068166",
"official_title": "Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction：a Retrospective Matched Case-control Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-31",
"study_completion_date(actual)": "2023-08-31",
"study_start_date(actual)": "2013-07-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-13",
"last_updated_that_met_qc_criteria": "2023-09-28",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-05",
"first_submitted": "2023-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will investigate the brain areas that are activated by vocal and motor tics in patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive movements similar to voluntary movements. They may be simple, involving only a few muscles or simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and snorting.
Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or vocal tics may be eligible for this study.
Participants will have a brief medical history and physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images. For the procedure, the subject lies on a table that is moved into a cylindrical chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made by electrical switching of the radio frequency circuits and protect against temporary hearing impairment.
During the scan, normal volunteers will be asked to make simple movements or sounds designed to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders will have two parts to the scanning session. First they will relax and allow tics to occur spontaneously, then they will be asked to imitate a specific tic when there is no urge to tic.
Patients and healthy subjects will have electromyography (EMG) to record the timing of the voluntary movements and tics. For this procedure, several pairs of small, saucer-like electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes are amplified and recorded on a computer. A microphone may be placed near patients to record any vocal tics. A video camera may also be used to record the tics.
Detailed Description
The purpose of this study is to determine the areas of the brain responsible for motor tics in patients with tic disorders including Tourette's Syndrome and Chronic Motor or Vocal Tic Disorder. Previous studies have been done looking at brain activity during tics using electroencephalography (EEG) and positron emission tomography (PET). 16 adult patients with DSM-IV-TR (American Psychiatric Association 2000) diagnosis of a tic disorder and frequent tics will be studied. We will utilize blood oxygenation level dependent functional magnetic resonance imaging (BOLD fMRI) on patients with tics while they are experiencing spontaneous tics and while they are voluntarily imitating those tics. The differential activation between the tics and the voluntary movements may shed light on the regions of the brain responsible for generation of tics.
|
#Eligibility Criteria:
INCLUSION CRITERIA
Patients will have a clinically documented tic disorder as defined by DSM-IV-TR and evaluation of tics severity using Yale Tic Sale. This criterion will be established by the preliminary screening in the NINDS Movement Disorders Outpatient Clinic.
Patients will be in age range 14 to 65.
Patients may be male or female.
Patients will be asked to stop any medications that can influence central nervous system for at least 24 hours prior to exam also they will be asked to abstain from alcohol for 24 hours before the study.
10 normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examination.
Controls with chronic illnesses, taking any medication that affects the CNS will be excluded.
Controls will be asked to abstain from alcohol for 24 hours before the study.
All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.
EXCLUSION CRITERIA
Patients younger than 14 years will be excluded from the study.
Patients with MRI findings consistent with brain tumors, strokes, trauma or AVMs will be excluded.
Patients with progressive neurological disorders other than a tic disorder will be excluded.
Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs, which cannot be stopped, will be excluded.
Patients with cancer will be excluded.
Pregnant women will be excluded.
Patients not capable of giving informed consent will be excluded.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00026000
|
{
"brief_title": "Brain Activation in Vocal and Motor Tics",
"conditions": [
"Tourette's Syndrome",
"Chronic Motor Tic Disorder",
"Chronic Motor Vocal Disorder"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00026000",
"official_title": "Brain Activation in Motor and Vocal Tics in Patients With Tourette's Syndrome or Chronic Motor or Vocal Tic Disorder Using Blood Oxygenation Level Dependent Functional MRI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-01",
"study_start_date(actual)": "2001-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-03-04",
"last_updated_that_met_qc_criteria": "2001-11-02",
"last_verified": "2005-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-11-05",
"first_submitted": "2001-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease globally, with an estimated prevalence of approximately 15 to 30%. The incidence of NAFLD is even higher, reaching up to 58%, in individuals who are overweight or obese. The pathogenesis of NAFLD is complex and not fully understood. The metabolism of carbohydrates contributes to the development of NAFLD, as it increases the enzymatic activity of lipid synthesis in the liver, depleting adenosine triphosphate (ATP) rapidly and causing stress on mitochondria and endoplasmic reticulum. The multifunctional protein Glycine N-methyltransferase (GNMT) plays a regulatory role in liver carbohydrate metabolism, and its expression is downregulated in the liver tissues of NAFLD.
While weight loss and lifestyle adjustments are helpful in controlling NAFLD, effective pharmacological or healthcare interventions for NAFLD patients are currently lacking. Insulin resistance is crucial in the pathogenesis of NAFLD, suggesting that drugs improving insulin sensitivity, such as metformin, might have therapeutic effects. However, recent large-scale clinical trial results have not supported this hypothesis. Investigators propose that the mitochondrial inhibitory effects of metformin may be related to this discrepancy, and the negative effects may be reversed through food containing substances promoting GNMT gene expression, such as Ganwei (as know as 'HepatoKeeper'). Preliminary animal experiments also show that the combined use of metformin and GNMT enhancers effectively eliminates liver lipid droplet accumulation and improves liver inflammation in a NAFLD mouse model, surpassing the effects of either drug used alone.
Based on these findings, our team designed the medication treatment group for this clinical trial, aiming to investigate whether the combination of Ganwei and metformin produces a synergistic effect in humans. Ganwei compound herbal extract capsules contain extracts from natural foods such as Schisandra chinensis, Paeonia lactiflora, and Punica granatum. Among them, Paeonia lactiflora is known to contain components that enhance GNMT expression. Animal and cell experiments have demonstrated its potential for repairing liver damage and inflammation. This trial aims to assess the impact of orally administering Ganwei compound herbal extract capsules on participants and evaluate its effects on fatty liver, liver fibrosis, and metabolic indicators.
Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease globally, with an estimated prevalence of approximately 15 to 30%. The incidence of NAFLD is even higher, reaching up to 58%, in individuals who are overweight or obese (Schwenger, 2014). With the Westernization of diets and insufficient physical activity, the prevalence of obesity, diabetes, and hyperlipidemia has been increasing in Taiwan in recent years, contributing to the gradual rise in the prevalence of NAFLD. NAFLD is strongly associated with metabolic syndrome, cardiovascular diseases, insulin resistance, and may progress to hepatitis, liver fibrosis, and even cirrhosis (Fazel, 2016; Amr, 2020).
The pathogenesis of NAFLD is complex and not fully understood. Current understanding suggests that environmental factors such as diet, exercise, obesity, gut microbiota, and genetics play a role in the development of NAFLD. The liver, responsible for metabolizing major substances including carbohydrates and fatty acids, becomes overwhelmed, leading to the production of toxic lipids. Disruptions in lipid metabolism, inhibition of mitochondrial function, and impaired export of triglycerides from liver cells contribute to the accumulation of lipids within the liver. Insulin resistance further exacerbates this process. Additionally, lipid alterations in liver cells increase oxidative stress and activate cell signaling, triggering immune responses that damage liver cells and contribute to the development of fatty liver inflammation, fibrosis, and potentially liver cancer (Fazel, 2016; Amr, 2020).
The metabolism of carbohydrates also contributes to NAFLD, as it increases the enzymatic activity of lipid synthesis in the liver, depleting adenosine triphosphate (ATP) rapidly and causing stress on mitochondria and endoplasmic reticulum. This results in liver cell necrosis, contributing to the development of NAFLD. The multifunctional protein Glycine N-methyltransferase (GNMT) plays a regulatory role in liver carbohydrate metabolism, and its expression is downregulated in the liver tissues of NAFLD (Liao, 2012).
While weight loss and lifestyle adjustments are helpful in controlling NAFLD, effective pharmacological or healthcare interventions for NAFLD patients are currently lacking (Julien et al., 2019; Mary et al., 2020). Insulin resistance is crucial in the pathogenesis of NAFLD, suggesting that drugs improving insulin sensitivity, such as metformin, might have therapeutic effects. However, recent large-scale clinical trial results have not supported this hypothesis. Investigators propose that the mitochondrial inhibitory effects of metformin may be related to this discrepancy, and the negative effects may be reversed through food containing substances promoting GNMT gene expression, such as Ganwei (as know as 'HepatoKeeper'). Preliminary animal experiments also show that the combined use of metformin and GNMT enhancers effectively eliminates liver lipid droplet accumulation and improves liver inflammation in a NAFLD mouse model, surpassing the effects of either drug used alone.
Based on these findings, our team designed the medication treatment group for this clinical trial, aiming to investigate whether the combination of Ganwei and metformin produces a synergistic effect in humans. Ganwei compound herbal extract capsules contain extracts from natural foods such as Schisandra chinensis, Paeonia lactiflora, and Punica granatum. Among them, Paeonia lactiflora is known to contain components that enhance GNMT expression (Kyu-Han et al., 2020; Rajni et al., 2019). Animal and cell experiments have demonstrated its potential for repairing liver damage and inflammation. This trial aims to assess the impact of orally administering Ganwei compound herbal extract capsules on participants and evaluate its effects on fatty liver, liver fibrosis, and metabolic indicators.
#Intervention
- DRUG : Ganwei
- Capsules
- Other Names :
- HepatoKeeper
- DRUG : Metformin
- Tablets
- Other Names :
- A10BA02
- DRUG : Placebo
- Matching capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be willing to participate in the study and provide written informed consent.
* Male and female adults >=20 and <80 years.
* Suspected or confirmed diagnosis of NAFLD:
* Fibroscan with CAP >=220 dB/m
* Criteria for diagnosing fatty liver: Abdominal ultrasound reveals differences in liver and kidney parenchyma due to wave reflection, liver parenchymal ultrasound attenuation, and blurred imaging of liver vessels and diaphragm, indicating fatty liver.
Exclusion Criteria:
* Female patients who are pregnant or breastfeeding.
* Diabetic patients undergoing medication treatment.
* Patients clinically diagnosed with alcoholic hepatitis, autoimmune hepatitis, or biliary liver disease.
* Excessive alcohol consumption (more than 15 grams/day for females, more than 30 grams/day for males).
* Users of weight-loss products and vitamin E supplements.
* Individuals with an estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73m².
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06244550
|
{
"brief_title": "Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors",
"conditions": [
"Non-alcoholic Fatty Liver Disease",
"Liver Fibrosis",
"Liver Injury"
],
"interventions": [
"Drug: Ganwei",
"Drug: Placebo",
"Drug: Metformin"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT06244550",
"official_title": "A Clinical Trial Using Ganwei (HepatoKeeper) Herbal Essentials to Treat Non-Alcoholic Fatty Liver Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-14",
"study_completion_date(actual)": "2023-06-13",
"study_start_date(actual)": "2021-09-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-20",
"last_updated_that_met_qc_criteria": "2024-01-29",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-02-06",
"first_submitted": "2024-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial is studying how well cognitive behavioral therapy with or without armodafinil works in treating cancer survivors with insomnia and fatigue after chemotherapy.
Detailed Description
Detailed DescriptionOBJECTIVES:
I. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, reduce insomnia in cancer patients following the conclusion of chemotherapy and/or radiation therapy.
II. To determine if one or more of the intervention strategies (i.e, CBT-I, armodafinil, or both), when compared to a placebo only group, reduce fatigue in cancer patients following the conclusion of chemotherapy and/or radiation therapy.
III. To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, improve QOL in cancer patients following the conclusion of chemotherapy and/or radiation therapy.
OUTLINE: Patients are randomized to 1 of 4 treatment arms (cognitive behavioral therapy, armodafinil, both, or neither).
After completion of study treatment, patients are followed for 30 days.
#Intervention
- PROCEDURE : Quality-of-Life Assessment
- Ancillary Studies
- OTHER : Questionnaire Administration
- Ancillary Studies
- OTHER : Placebo
- Given orally
- Other Names :
- PLCB
- PROCEDURE : Fatigue Assessment and Management
- Other Names :
- Fatigue Assessment/Management
- PROCEDURE : Sleep Disorder Therapy
- Other Names :
- Sleep disorders therapy
- DRUG : Armodafinil
- Given orally
- Other Names :
- Nuvigil
- PROCEDURE : Quality-of-life assessment
- Ancillary studies
- Other Names :
- Quality of Life assessment
- OTHER : Questionnaire Administration
- Ancillary Studies
- PROCEDURE : Fatigue Assessment and Management
- Other Names :
- Fatigue Assessment and Mangement
- PROCEDURE : Management of Therapy
- Other Names :
- Complications of therapy management
- PROCEDURE : Sleep disorder therapy
- PROCEDURE : cognitive assessment
- PROCEDURE : Quality of Life assessment
- Ancillary Studies
- OTHER : Questionnaire Administration
- Ancillary studies
- OTHER : Placebo
- Given orally
- Other Names :
- PLCB
- PROCEDURE : Fatigue assessment and management
- PROCEDURE : Management of therapy and complications
- Other Names :
- Compllications of therapy management
- PROCEDURE : Sleep disorder therapy
- Other Names :
- sleep disorders therapy
- DRUG : Armodafinil
- Given orally
- Other Names :
- Nuvigil
- PROCEDURE : Cognitive Assessment
- PROCEDURE : Quality of Life Assessment
- Quality of Life Assessment
- Other Names :
- Ancillary studies
- OTHER : Questionnaire Administration
- Ancillary Studies
- PROCEDURE : Fatifue assessment and management
- Other Names :
- Fatigue Assessment/management
|
#Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of cancer
* Be able to understand written and spoken English
* Be able to swallow medication
* Have preferred sleep phase between 7:30 pm and 11:00 am
* Be willing to discontinue any medications /OTCs/Herbals for sleep for the 11-week study period
* Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
* Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
* At least one month must have passed since completion of chemotherapy and/or radiation treatment
* Report insomnia on the SDS-CL at a frequency of at least 3 days a week
Exclusion Criteria:
* Have ever taken modafinil or armodafinil had CBT-I therapy (CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component)
* Have an unstable medical or psychiatric illness (Axis I- current or within the last 5 years)
* Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
* Be presently taking an anticoagulant or a corticosteroid
* Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert] or similar psycho stimulants) within the past 30 days
* Be currently pregnant or nursing
* Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >= 2 or an Alcohol Use Disorders Identification Test (AUDIT) score >= 13
* Have surgery planned within the study period
* Have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the 'Often' or 'Frequently' level
* Have serious RLS/PLMs indicated by endorsing two or more items associated with RLS/PLMs on the Sleep Disorders Symptom Check at the 'Frequently' level
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01019187
|
{
"brief_title": "Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy",
"conditions": [
"Unspecified Adult Solid Tumor, Protocol Specific"
],
"interventions": [
"Procedure: Quality of Life Assessment",
"Other: Placebo",
"Procedure: Fatigue Assessment and Management",
"Procedure: Sleep Disorder Therapy",
"Procedure: Cognitive Assessment",
"Procedure: Fatigue assessment and management",
"Procedure: cognitive assessment",
"Procedure: Management of Therapy",
"Drug: Armodafinil",
"Other: Questionnaire Administration",
"Procedure: Quality-of-life assessment",
"Procedure: Quality of Life assessment",
"Procedure: Management of therapy and complications",
"Procedure: Sleep disorder therapy",
"Procedure: Fatifue assessment and management",
"Procedure: Quality-of-Life Assessment"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01019187",
"official_title": "Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-09",
"last_updated_that_met_qc_criteria": "2009-11-23",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-24",
"first_submitted": "2009-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a retrospective comparative evaluation of six main periodontal pathogens and total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes mellitus by polymerase chain reaction analysis.
Detailed Description
The aim of this study was to compare prevalence and bacterial load of six main periodontal pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus. Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also investigated.
The recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test.
For each subject, the following data have been collected: age, gender, smoking habits, type of metabolic control of diabetes, duration of diabetes, number of missing teeth.
For each subject, four periodontal sites were studied. Probing pocket depth, sites with bleeding on probing, sites with suppuration and microbiological data were evaluated.
An individual matching on the basis of severity and extension of periodontitis was performed by pairing a diabetic patient with another non-diabetic one with the same degree of severity and extension of the periodontal disease.
Microbiological data of subgingival biofilm were analysed and compared for the examined pathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, Fusobacterium nucleatum, Tannerella forsythia.
Differences in genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.
#Intervention
- DIAGNOSTIC_TEST : Analysis of microbiological tests
- Collection and comparison of microbiological data
|
#Eligibility Criteria:
Inclusion Criteria:
* diagnosis of chronic periodontitis
* diagnosis of type 2 diabetes mellitus (only in the test group)
* the presence of at least 12 teeth (except for the third molar)
* belonging to caucasian ethnic group
* age greater than 18 years.
Exclusion Criteria:
* pregnant or lactating
* history of systemic antibiotics within 3 months prior to the microbiological testing or anti-inflammatory therapy in the month before the visit
* if they were suffering from any other systemic disease except diabetes mellitus (arthritis, ulcerative colitis, Crohn's disease, osteoporosis or osteopenia, HIV infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or pathologies that could potentially interfere with the periodontitis and/or with diabetes)
* mental disorders
* if they had received periodontal treatment in the 6 months before the microbiological test.
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
|
NCT03786133
|
{
"brief_title": "Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients",
"conditions": [
"Chronic Periodontitis",
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Diagnostic Test: Analysis of microbiological tests"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03786133",
"official_title": "The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07-26",
"study_completion_date(actual)": "2016-11-16",
"study_start_date(actual)": "2016-06-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-24",
"last_updated_that_met_qc_criteria": "2018-12-21",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-24",
"first_submitted": "2018-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
#Intervention
- DRUG : CP-690,550
- Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
- DRUG : CP-690,550
- Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
- DRUG : Placebo
- Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
- Other Names :
- double-blind, placebo-controlled phase
- DRUG : CP-690,550
- Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
- Other Names :
- double-blind, extension phase
- DRUG : Placebo
- Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
- Other Names :
- double-blind, placebo-controlled phase
- DRUG : CP-690,550
- Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
- Other Names :
- double-blind, extension phase
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.
Exclusion Criteria:
* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
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
|
NCT00960440
|
{
"brief_title": "Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors",
"conditions": [
"Arthritis, Rheumatoid"
],
"interventions": [
"Drug: CP-690,550",
"Drug: Placebo"
],
"location_countries": [
"France",
"United States",
"Germany",
"Taiwan",
"Canada",
"Austria",
"Puerto Rico",
"Spain",
"Australia",
"Ireland",
"Brazil",
"Italy",
"Belgium",
"Korea, Republic of"
],
"nct_id": "NCT00960440",
"official_title": "Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-03",
"study_completion_date(actual)": "2011-03",
"study_start_date(actual)": "2009-10"
},
"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)": "2018-12-19",
"last_updated_that_met_qc_criteria": "2009-08-14",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-08-17",
"first_submitted": "2009-08-14",
"first_submitted_that_met_qc_criteria": "2012-12-06"
}
}
}
|
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