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#Study Description
Brief Summary
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.
#Intervention
- DRUG : BLI400 Laxative
- 21 gm BLI400 powder
- DRUG : Lubiprostone
- 24 mcg capsule bid
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects at least 18 years
* Constipated, defined by the following adapted ROME II definition:
A. Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
* Straining during > 25% of defecations
* Lumpy or hard stools in > 25% of defecations
* Sensation of incomplete evacuation for > 25% of defecations
B. Loose stools are rarely present without the use of laxatives
C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements
Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria:
* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
* Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
* Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
* Subjects who are pregnant or lactating, or intend to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any study medication component
* Subjects taking narcotic analgesics or other medications known to cause constipation
* Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Subjects with an active history of drug or alcohol abuse
* Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
* Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
* Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)
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
|
NCT02481947
|
{
"brief_title": "A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults",
"conditions": [
"Chronic Idiopathic Constipation"
],
"interventions": [
"Drug: Lubiprostone",
"Drug: BLI400 Laxative"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02481947",
"official_title": "A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2015-05"
},
"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)": "2020-07-27",
"last_updated_that_met_qc_criteria": "2015-06-23",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-25",
"first_submitted": "2015-06-23",
"first_submitted_that_met_qc_criteria": "2020-06-09"
}
}
}
|
#Study Description
Brief Summary
Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage.
They report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. Then data based on dairy will be analysis.
#Intervention
- OTHER : Massage
- Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
|
#Eligibility Criteria:
Inclusion Criteria:
* Chronic tension type headache according to IHS criteria
* Finding painful trigger point in physical examination
* no contraindication for massage
* no prophylactic treatment
* written inform consent
Exclusion Criteria:
* Dementia or severe cognitive impairment
* Under Treatment with drugs with prophylactic effect
* History of RA or Cervicocephalic fracture or other skeletal deformity
* Other complementary treatment
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
|
NCT04232046
|
{
"brief_title": "Trigger Point Massage in Chronic Tension Headache",
"conditions": [
"Tension-Type Headache"
],
"interventions": [
"Other: Massage"
],
"location_countries": null,
"nct_id": "NCT04232046",
"official_title": "Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-15",
"study_completion_date(actual)": "2019-03-15",
"study_start_date(actual)": "2016-02-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-18",
"last_updated_that_met_qc_criteria": "2020-01-15",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-18",
"first_submitted": "2020-01-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to investigate the effectiveness of manual therapy plus cervical stabilization exercise compared to manual therapy alone on balance, proprioception, and neck muscle morphology in chronic neck pain.
Detailed Description
Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP), defined as persistent pain lasting three or more mounts, causes disability and a reduction in life quality. Balance disorders or postural instability, a deficit in proprioception, changes in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual therapy and exercise have favorable effects on management with CNP. According to our knowledge, no study has investigated the effects of manual therapy plus cervical stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.
#Intervention
- OTHER : Manual Therapy
- Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.
- OTHER : Cervical Stabilazation Exercise (CSE)
- The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.
|
#Eligibility Criteria:
Inclusion Criteria:
* 20 <= age <= 55 of age,
* Having generalized neck pain for more than 3 months,
* Being volunteer
Exclusion Criteria:
* Being pregnant,
* Malignancy,
* Having cervical stenosis,
* Severe cervical spondylosis,
* Cervical fractures and tumor,
* Osteoporosis,
* Positive vertebrobasilar test
* Positive Babinski reflex
* Neurologic deficit related to compression of the spinal root or cord,
* Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
* Being an inability to fulfill the questionnaires,
* Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months
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
|
NCT04420403
|
{
"brief_title": "Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain",
"conditions": [
"Neck Pain"
],
"interventions": [
"Other: Manual Therapy",
"Other: Cervical Stabilazation Exercise (CSE)"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04420403",
"official_title": "Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise on Balance, Proprioception, and Neck Muscle Morphology in Chronic Neck Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-01",
"study_completion_date(actual)": "2021-06-24",
"study_start_date(actual)": "2020-05-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-04",
"last_updated_that_met_qc_criteria": "2020-06-04",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-09",
"first_submitted": "2020-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. For general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. Medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. In this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.
Detailed Description
Mask ventilation is a foundation of airway management after the initial induction of anesthesia. It allows for adequate oxygenation of the patient to buy enough time for intubation, during which the patient is not ventilated. However, in some patients mask ventilation may be difficult - older than 55 years, heavier (BMI \> 26 kg/m\^2), with no teeth, having a beard or sleep apnea. Inadequate ventilation, if not corrected, can result in decreasing oxygen saturation to dangerous levels - which could lead to devastating complications. As a result, the efficacy of mask ventilation is of critical importance to patient safety after the induction of anesthesia.
A recent study proposed that mask ventilation could be improved simply by turning a patient's head. The study showed that rotating a patient's head to a 45 degree angle significantly improved mask ventilation when compared with the head placed in a neutral position. However, this study was done in patients with a BMI lass than 35. As such, the effects of head rotation on the efficacy of mask ventilation has not been studied in patients with a BMI of 35 and greater.
Obesity (BMI ≥ 30 kg/m\^2) affects almost 40% of US adults and is one of the most prevalent health concerns in our society. It is a predictor of difficult mask ventilation because it is associated with increased upper airway obstruction, decreased airway patency, and decreased lung volumes such as functional residual capacity (FRC). If previous findings in regard to the effects of 45 degree head rotation on the efficacy of ventilation hold true in the obese patient, then this study will show that head rotation could be used as a simple way to improve the efficacy of mask ventilation for patients with a BMI of 35 and above.
#Intervention
- PROCEDURE : Head Rotation During Face Mask Ventilation
- Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle).
- DEVICE : Medline Top Valve Anesthesia Mask
- Face mask used per standard of care to provide oxygen to subjects before surgical procedures.
- Other Names :
- Face Mask
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* ASA Physical Status Classification I-III
* Body Mass Index (BMI) >= 35 kg/m^2
Exclusion Criteria:
* Inability to obtain written informed consent
* Pregnant or breastfeeding
* Limited head rotation or neck extension
* Subjects with expected or history difficult intubation
* Large beard
* Orogastric (OG)/nasogastric (NG) tube
* Gastroesophageal Reflux Disease (GERD)
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
|
NCT03876873
|
{
"brief_title": "Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults",
"conditions": [
"Noninvasive Ventilation"
],
"interventions": [
"Device: Medline Top Valve Anesthesia Mask",
"Procedure: Head Rotation During Face Mask Ventilation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03876873",
"official_title": "A Prospective, Randomized, Non-Blinded, Crossover Controlled Clinical Trial Evaluating the Efficacy of Face Mask Ventilation With 45 Degree Head Rotation in Anesthetized Obese (BMI ≥ 35) Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-01",
"study_completion_date(actual)": "2023-02-01",
"study_start_date(actual)": "2021-06-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-10",
"last_updated_that_met_qc_criteria": "2019-03-13",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-15",
"first_submitted": "2019-03-13",
"first_submitted_that_met_qc_criteria": "2024-07-02"
}
}
}
|
#Study Description
Brief Summary
Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer surveillance programs. However, it does not permit detection of early dysplastic lesions. Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa using laser-based endomicroscopy together with intravenous administration of fluorescein (FITC).
Detailed Description
Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscop is the new standard for cancer surveillance in patients with IBD . It gives the opportunity to identify suspected areas of dysplasia and to take targeted biopsies. The diagnostic accuracy improves and the chances for detecting dysplastic areas increase. In recent years new endoscopic techniques have been developed, including laser-based endomicroscopy. There is an increasing need for structured evaluation of the efficiency of these techniques. Laser-based endomicroscopy, taking in vivo confocal microscopy pictures during the colonoscopy examination, is the most promising new method. This method is established in highly rated centers for the early diagnosis of neoplasia in the bile ducts and the esophagus but its role for detection early malignancies in the colon is not known and studying this issue is of very high clinical value.
Specific questions: Does the use of laser-based endomicroscopy increase the chances for early detection of dysplasia? What is the intraobserver variability? What is the learning curve for interpretation of confocal microscopy pictures? Material and methods: A laser-based endomicroscope (Cellvizio®, Mauna Kea Technologies) have been acquired and the examination procedure has been established at the Unit for Gastroenterology and Hepatology, Karolinska University Hospital Huddinge. Eighty patients with PSC and IBD included in annual surveillance with colonoscopy with routine biopsy regime will be included in the study. After informed consent, patients are investigated with laser-based endomicroscopy during surveillance colonoscopy. Each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein (FITC) injection, all macroscopically abnormal lesions will be examined by endomicroscopy. Intravenous administration of FITC makes it possible to obtain in vivo microscopic pictures with up to a 1000x magnification of the colon mucosa. The Cellvizio® technique allows for evaluation of epithelial and endothelial cell structures in areas with suspicious changes as well as for acquisition of directed biopsies. Confocal pictures from all sites where biopsies have been taken are saved for future blind re-evaluation. The biopsies are taken according to the routine standard with minimum of 2 biopsies from each 10 cm in the colon. For the immunological and microbiological (specific aim 2) parts of the study, additional 16 biopsies are gathered from left, transverse, and right colon. All the laser-based endomicroscopy pictures and sequences are saved for further evaluation and further application in arranging pedagogical sessions for evaluation of the learning curve of the technique.
#Intervention
- PROCEDURE : colonoscopy with endomicroscopy
- Examination will be performed in two steps. On the way from rectum to caecum, mucosa will be evaluated with white light endoscopy and random biopsies will be taken according to the routine standard with minimum of 2 biopsies from each 10 cm of colon. On the way back (from caecum to rectum) mucosa will be stained with indigo carmine and after intravenous fluorescein injection all macroscopically abnormal lesions will be examined by endomicroscopy and biopsied. Additionally, all places where random biopsies were taken will be also examined with endomicrosopy.
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of PSC-IBD
Exclusion Criteria:
* the lack of informed consent, allergy to fluorescein, B-blockers 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
|
NCT01880606
|
{
"brief_title": "Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance",
"conditions": [
"Primary Sclerosing Cholangitis",
"Inflammatory Bowel Disease"
],
"interventions": [
"Procedure: colonoscopy with endomicroscopy"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT01880606",
"official_title": "Probe-based Confocal Laser Endomicroscopy in Colonoscopic Surveillance of Patients With Primary Slerosing Cholangitis Related Inflammatory Bowel Disease (PSC-IBD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-27",
"last_updated_that_met_qc_criteria": "2013-06-14",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-19",
"first_submitted": "2013-06-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to analyze the applicability (usability) of a tele-health service as part of a potential disease management program for patients with peripheral arterial disease.
The following investigations will be conducted as part of the usability study. In the context of a tele-health service, knowledge, physical condition (including walking distance) will be documented during face-to-face and televisits, dislocated supervised gait training and education will be provided, and satisfaction with the tele-health service will be evaluated.
Detailed Description
Disease management programs (DMPs) are one of the methods used to optimize the care of patients with chronic diseases. DMPs are coordinated health care measures for patient populations with diseases in which active patient participation in treatment can lead to substantial effects. Specific treatment regimens, based on evidence-based treatment guidelines and structured patient information, are predominantly aimed at preventing disease exacerbations and complications. The World Health Organization (WHO) also recommends, among other things, forcing patient adherence through structured information and patient empowerment strategies to establish participatory treatment.
Peripheral arterial disease (PAD) causes oxygen and nutrient deprivation of tissues through narrowing of arterial vessels in the extremities. The cause of PAD is arteriosclerosis. The course of the disease begins asymptomatically and manifests itself over time with pain and cramps predominantly in the muscles of the lower extremity. The pain symptoms usually occur initially during physical exertion, and later at rest. As PAD progresses, chronic ulceration and necrosis occur.
Professional societies such as the European Society of Cardiology (ESC) and the European Society of Vascular Medicine (ESVM) regularly publish guidelines for the diagnosis and treatment of PAD. Therapy of PAD consists of drug therapy for the purpose of cardiovascular risk reduction (lipid and blood pressure lowering drugs and anticoagulant drugs as well as therapy of diabetes mellitus). Another aspect in the event of disease progression is interventional angioplasty, in which the affected constriction in the leg arteries is dilated and, if necessary, treated with stents. Another important pillar is also structured and supervised gait training and, in general, an improvement in lifestyle with cessation of nicotine abuse and a healthy diet.
In particular, structured gait training, which should be performed at least three times a week for 30 to 60 minutes, is strongly recommended in the current ESVM and ESV guidelines. Studies showed that structured gait training can increase walking distance by 200% in 12 weeks in patients with claudication. Daily individual interval training of 60 minutes with 5- to 15-minute intervals also proved effective in increasing walking distance. This is to overcome the pain threshold of claudication while walking. Furthermore, evidence showed that gait training may be equivalent to endovascular interventions in terms of long-term outcomes.
The aim of this study is to analyze the applicability (usability) of a telehealth service as part of a potential disease management program for patients with peripheral arterial disease.
A prospective monocentric pilot study will be conducted at the clinical department of angiology.
The study duration per participant is 90 (±14) days and is divided into 2 observation phases. In phase 1, there will be supervision by a certified nurse and the telehealth service app, and in phase 2, there will be only singular use of the app without contact by the certified nurse.
The Declaration of Helsinki (as amended from time to time) and the guidelines of 'Good Clinical Practice' were taken into account in the conduct and also the planning of the study.
Furthermore, the framework guideline for the 'IT infrastructure in the application of telemonitoring' was used for the planning of the study.
According to the manufacturer's manuals, the pedometers AS80/AS97/AS99 from the company Beurer are not medical devices. The app serves as a diary for patients and is not a Clinical Decision Support System. The 'User's Manual PAD Stepping' is included with the study material.
Reference Projects:
The DMS app system is also already being used in routine care in the 'Herzmobil' project in Styria and Tyrol. Here, patients with chronic heart failure are cared for.
The use of the DMS app is currently also being used in two other studies. These are observational studies that are not subject to the Medical Devices Act. Both projects have a positive ethics vote and are listed under the following titles:
* Telemedical follow-up of hospitalized patients with coronavirus disease-2019 (COVID-19) DRKS ID of the study: DRKS00022244.
* Building a training database of voice data recordings and body weight trajectories in hemodialysis patients for algorithm development.
|
#Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of 'peripheral arterial occlusive disease' in, IIa and IIb (according to Fontaine).
* Age between 18 and 80 years
* Written informed consent
* Smartphone with Android operating system
* Understanding of how to use the tele-health service
Exclusion Criteria:
* Patients with PAD stages I, III and IV (according to Fontaine)
* Lack of compliance
* Smartphone with non-Android operating system or incompatible software
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
|
NCT05619835
|
{
"brief_title": "A Usability Study of a Tele-health Service for Patients With Peripheral Arterial Disease.",
"conditions": [
"Peripheral Arterial Disease"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT05619835",
"official_title": "A Usability Study of a Tele-health Service for Patients With Peripheral Arterial Disease.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-30",
"study_completion_date(actual)": "2023-08-30",
"study_start_date(actual)": "2022-11-11"
},
"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)": "2023-11-01",
"last_updated_that_met_qc_criteria": "2022-11-11",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-11-17",
"first_submitted": "2022-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Based on data supporting the use of cyclophosphamide and etoposide both as single agents in combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we propose a Phase II clinical trial. This protocol establishes a model that will test the hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate cancer progression, when fewer tumor cells are present, will have greater anti-tumor activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and anti-tumor activity.
#Intervention
- DRUG : Etoposide
- 50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide.
- DRUG : Cyclophosphamide
- 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration of cyclophosphamide at this dose has been well tolerated
|
#Eligibility Criteria:
Inclusion Criteria
* Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesicle involvement, provided all visible disease was surgically removed) that have completed local therapy and have an rising PSA value, as defined in Section 5.1.5.
* Prior androgen ablation therapy is allowed as long as the patient completed therapy at least 1 year prior to entry into this study. The patient must be fully recovered from such therapy and must not have demonstrated progression while on androgen ablation therapy.
* Primary treatment to the prostate (surgery and/or radiation) must have been completed at least 3 months prior to entry into this study and the patient must be fully recovered from such therapy.
* Patients must have a negative CT of the chest, abdomen and pelvis and bone scan. The scans must be completed within 4 weeks prior to the date of starting therapy.
* PSA value for patients enrolled must be > 2 ng/ml with a doubling time of £ 12 months. PSA value > 2 ng/ml must be documented by two measurements at least four weeks apart. The final PSA measurement before study entry must be obtained within one week prior to therapy. This will be considered the baseline PSA. (Note: The website http://www.mskcc.org/mskcc/html/10088.cfm may be used to access a prostate normogram calculator.)
* The following lab values must be obtained within 4 weeks prior to therapy:
* ANC >=1500/mm³,
* Hemoglobin >= 10 g/dl
* Platelet count >= 100,000/mm³
* Serum creatinine <= 1.5 mg/dL
* Total bilirubin <= 1.5 mg/dL
* Liver function tests (SGOT, SGPT) <= 1.5 times the upper limit of the institution's normal range.
* Men >= 18 years.
* An estimated life expectancy of at least 6 months.
* ECOG performance status <= 2.
* Able to give informed, written consent.
* Men must consent to using effective contraception (barrier method- latex condom) while on treatment and for 4 weeks after discontinuation of treatment.
Exclusion Criteria
* Patients with active infections or known infection with HIV (HIV testing will not be performed as part of this study).
* Any coexisting medical condition including uncontrolled cardiac, hepatic, renal or psychiatric disease defined as ³ Grade 3 (CTCAE Version 3).
* Concurrent use of other investigational agent.
* Patients that have previously received more than 2 months of therapy with any of the agents used in this study.
* PSA value < 2 ng/ml.
* Prior chemotherapy in the past 5 years.
* Use of androgen ablation therapy within 1 year, or history of progression on androgen ablation therapy.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00176605
|
{
"brief_title": "Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Drug: Etoposide",
"Drug: Cyclophosphamide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00176605",
"official_title": "A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2008-10",
"study_start_date(actual)": "2005-05"
},
"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)": "2014-05-20",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2014-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-15",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": "2014-04-18"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent gastric cancer.
Detailed Description
URLC10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 are upregulated in esophageal cancer and gastric cancer and other cancer. The investigators identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro. According to these findings, in this trial, the investigators evaluate the safety, immunological and clinical response of URLC10 peptide vaccine in the patients with gastric cancer. Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection
#Intervention
- BIOLOGICAL : peptide vaccine
- peptides emulsified with Montanide ISA51
- Other Names :
- Peptides Drived From URLC10 emulsified with Montanide ISA51
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have Advanced or recurrent gastric cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
* WHO performance status of 0 to 2
* Age >= 20 years, <=80 years
* The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible
* Passing from previous treatment more than two weeks.
* Expected survival of at least 3 months
* WBC>= 1,500/mm³ WBC<= 15,000/mm³ Platelet count >= 50,000/mm³ Total bilirubin<= 3 x the institutional normal upper limits AST, ALT <= 3 x the institutional normal upper limits Creatinine <= 3 x the institutional normal upper limits
* Patients must be HLA-A2402
* Able and willing to give valid written informed consent
Exclusion Criteria:
* Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding
* Serious infections requiring antibiotics
* Concurrent treatment with steroids or immunosuppressing agent
* Decision of unsuitableness by principal investigator or physician-in-charge
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
|
NCT00845611
|
{
"brief_title": "Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Gastric Cancer",
"conditions": [
"Gastric Cancer"
],
"interventions": null,
"location_countries": [
"Japan"
],
"nct_id": "NCT00845611",
"official_title": "Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2010-09",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-06",
"last_updated_that_met_qc_criteria": "2009-02-17",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-18",
"first_submitted": "2009-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Transplantation remains the last resort to prolong life when the patient reaches the stage of terminal respiratory failure. Lung transplantation improves survival and quality of life compared to medical treatment, at acceptable costs. However, the burden of the lived reality and the direct consequences of the operation have considerable impact. The transplant patient faces extraordinary physical and psychological challenges.
While quality of life and long-term prognosis are significantly improved, psychopathological disorders are common, mainly anxiety disorders. A high prevalence of psychopathological disorders is reported in most retrospective and prospective studies. These are essentially adjustment disorders, with depressive mood and/or anxiety, reactive to the severity of the pre- and postoperative somatic reality.
The partial or total replacement of the respiratory 'bellows' leads to more anxiety disorders than in other transplants. Quality of life is a multidimensional concept that encompasses medical, social, cultural, psychological and economic factors. It is based on four dimensions: physical state, somatic sensations, psychological state, social status. Regarding the quality of psychic evolution after transplantation, among the criteria that are usually analysed we find adaptation to body changes and anxiety management.
Meta-analyses of clinical trials have shown that music therapy, which is based on the use of the properties of music and sound for therapeutic purposes, has an impact on the human being, reducing anxiety, depression and pain. Two clinical trials have shown that pulmonary rehabilitation with active music therapy improves lung function and reduces dyspnoea. The concept of active music therapy, which emphasises sound production and improvisation, is a controlled technique of musical practice for therapeutic purposes. Playing a wind instrument, using vocal techniques and respiratory rhythm modulation techniques, would provide additional benefits for respiratory function.
The use of recorders as an oscillating exhalation resistance device will provide conditions similar to the treatment provided by a flutter, a device that creates exhalation resistance and improves secretion clearance.
Investigators hypothesize that the combination of Respiratory Kinesitherapy and active breath music therapy (PPKRMA) will address anxiety, depression, and pain in lung.
#Intervention
- OTHER : Active music therapy
- Active music therapy is not a musical learning process. The restrictive character of classical respiratory rehabilitation will be alleviated by the playful aspect and the pleasure generated by the sessions, which will facilitate the commitment of the patients in their post-transplant respiratory rehabilitation.
The recorder was chosen among other wind instruments for several reasons:
* Its use is simple,
* It acts as an oscillating exhalation resistance device that generates a positive expiratory pressure (auto-PEP) produced by this wind instrument allows to obtain conditions similar to the treatment performed by a flutter (classical respiratory rehabilitation), a pressure on the expiratory flow with the obtaining of an oscillating effect during the trills, an increase of the respiratory capacities,
* The characteristics of the sound it produces (duration, intensity, timbre and frequency) will generate auditory feedback allowing patients to become aware of their breathing patterns.
- OTHER : Questionnaires
- We chose the HAD (Hospital Anxiety and Depression Scale) to assess anxiety and depression. This test is a reference test, often used in studies of transplant patients. The results obtained in previous studies allowed us to create our hypotheses.
To measure pain we chose the visual analogue scale (VAS). This reference test is often used in pain studies. It has the advantage of being simple to perform and easy to understand.
Quality of life will be assessed using the SF-12 (Short Form 12 Health Survey Questionary). We consider it to be simple and easy for patients to understand.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient aged at least 18 years and less than 70 years.
* Patient who has had a lung transplant for less than 5 weeks and who has been transferred to the participating department that provides post-transplant follow-up.
* Patient who has completed the pre-transplant assessment according to the practices of the receiving department.
* Clinically stable as judged by the investigator (pulmonologist).
* Patient who has been informed of the study and has given his agreement to participate.
Exclusion Criteria:
* Impaired perception of music as judged by the investigator: musicogenic epilepsy (i.e. seizures provoked by music), hyperacusis (i.e. an abnormally low threshold of tolerance to noise), dysmusia (music is perceived as an annoying noise), amusia (rhythm, melody, chords of music are not perceived) .
* Physical inability to perform the PPKRMA.
* Neurocognitive disorders that do not allow the PPKRMA, the questionnaires required by the protocol or the functional explorations to be carried out.
* Dependence on oxygen therapy with a flow rate of more than 5l of O2.
* Persons deprived of liberty by judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social institution for purposes other than research
* Persons of full age subject to a legal protection measure (guardianship, curatorship).
* Subjects participating in other interventional research with an exclusion period still in progress at pre-inclusion or which may interfere with the results of this research protocol.
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
|
NCT05219292
|
{
"brief_title": "Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients",
"conditions": [
"Lung Transplant; Pain"
],
"interventions": [
"Other: Questionnaires",
"Other: Active music therapy"
],
"location_countries": [
"France"
],
"nct_id": "NCT05219292",
"official_title": "Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients: PPKRMA",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-20",
"study_completion_date(actual)": "2024-08-20",
"study_start_date(actual)": "2022-03-22"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-18",
"last_updated_that_met_qc_criteria": "2022-01-21",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-02",
"first_submitted": "2022-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project is funded by Stiftelsen Dam and is a cooperation between The Norwegian Council for Mental Health (NCMH) and PROMENTA research group at the University of Oslo. Low-cost and evidence-based health promoting public health tools are urgently needed in Norwegian municipalities, to meet both current and future challenges with mental health and wellbeing. The aim in this randomized controlled trail is to test if a shorter, 10 week web-based version (The Five Ways to All, '5WaysA'), of an already established course (Five Ways to Wellbeing course), can promote wellbeing and mastery in the general population. The principal investigator will investigate to what extend the effects are short-term and long-term (i.e., 10 weeks, 18 weeks and 12 months after starting to receive the 5WaysA intervention).
Detailed Description
Background:
The need for effective, low-cost and evidence-based tools to prevent illness and promote health in the population is paramount. Norway, along with other countries in the Western world, is currently facing major health and welfare-related challenges. Demographic changes, lifestyle related diseases and work absence are threatening the sustainability of the Norwegian welfare state. Non-communicable diseases, including mental illness, currently account for 65% of the total disease burden in Norway and 50% of Norwegians are likely to meet diagnostic criteria for a mental disorder some time during their life span. Traditional treatment and care options tend to be costly and time consuming, and to depend on highly skilled specialist human resources. Systematic findings also indicate that population-based (i.e., universal, targeting the general population) measures often result in larger population health gains than selective and indicated measures targeting only those with excess risk. According to the paradox of prevention, when disease risk is common, universal interventions directed towards the whole population before illness occurs, are more effective than interventions targeting high risk groups after symptoms have emerged. The Covid-19 pandemic and associated social distancing measures have corroborated the need for digital solutions. Web-based interventions may reach a large number of participants, utilizing a very modest amount of both human and financial resources.
The aim:
This study aims to test a potentially effective low-cost health and wellbeing promotive web-based intervention targeting the general population in Norwegian municipalities. The intervention is based on the Five Ways to Wellbeing framework developed for British health authorities in 2008. This framework, and the intervention to be tested, provides participants with knowledge on simple, sustainable activities that may strengthen their subjective wellbeing (SWB), mastery, health and social relations, thereby also reducing the risk of common mental health problems such as depression and anxiety. The study will be conducted in close collaboration with municipal stakeholders and important user groups. Thus, the principal investigator (PI) will investigate effects of a low-cost health and wellbeing promotive public health tool based on the evidence-base of Five Ways to Wellbeing. To date, nobody has tested the Five Ways-concept in such a format. Proved effective, this web-based 5WaysA intervention, may have a significant impact on the public health of inhabitants in the municipalities.
Main hypothesis:
The web-based intervention 5WaysA will improve wellbeing and mastery and hence provide the municipalities with an effective measure for mental health promotion.
Research questions:
1. To what extent does participation in the web-based 5WaysA intervention lead to improved wellbeing, mental health and mastery in the general population?
2. To what extent are the effects short-term and long-term (i.e., 10 weeks, 18 weeks and 12 months after starting to receive the 5WaysA intervention)?
3. What mechanisms explain potential improvements in wellbeing?
1. For whom is this intervention effective (i.e., is the effect moderated by e.g. gender, age, education)?
2. What mechanisms (e.g., regular practicing of 5Ways actions, increased social activity or support) explain intervention effects?
Sample and recruitment:
The PI plan to recruit a minimum of 1500 participants from the general population in Norwegian municipalities. The participants will be randomized to either an intervention group (n=750), or to one of two wait-list control groups (active control, n=375) (inactive control, n =375). The wait-list control groups will receive the intervention three to five months later. The PI expect high drop-out (up to 50 %) since this has been the situation in other studies investigating online interventions in a general population. The PI is also unsure about how much time the municipalities have to help PI with the recruitment process, because of a high work load in the municipalities during the pandemic of Covid-19.
Note (June 19, 2021): PI was only able to recruit 226 participants in spring 2021. PI will continue the recruitment process and do another round of the intervention in fall 2021. This will not be registered as a new study, and is regarded as part of the current study
Procedures:
The web-based 10 week intervention consist of one main webinar (two hours at Zoom), a booster session webinar five weeks later and SMS messages twice a week in the the six following weeks. The webinars will be live lectures with an independent trained facilitator. The SMS messages will be sent out by the PI (via Nettskjema) to all participants while they are in the interventions period. Questionnaires will be administrated and distributed by the PI by using the Nettskjema and Services for sensitive data (TSD) tools. The measurements will also be conducted use of Nettskjema and TSD.
Power analysis:
The PI assume that we can recruit a minimum of 1500 participants, but high drop-out is expected. An a priori power analysis was conducted using G\*Power3 to test the interaction effect in a mixed ANOVA, using a two-tailed test, assuming a small effect size (f = .10), and an alpha of .05. The assumed effect size (f=0.1) was chosen as it is of the same magnitude (lower bound) as has been reported by other universal interventions with wellbeing as the outcome measure. The result showed that if PI attained a total sample of 750 participants at the second measurement point (attrition of 50%), PI would have power of .999 to detect a group by time interaction. The high level of statistical power will enable PI to investigate both moderators and mediators of the treatment effect.
#Intervention
- BEHAVIORAL : 5waysA Intervention
- Web-based 10 week intervention, encouraging participants engaging in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.
- BEHAVIORAL : 5waysA Active wait-list control
- Writing activity log in the waiting time. Then, after five months and the writing of activity log, the participants get the web-based intervention and SMS massages, which encourage the participants to engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.
- BEHAVIORAL : 5waysA Inactive wait-list control
- No activity while the participants wait. After five months of waiting, the participants get the web-based intervention and SMS messages, which encourage participants engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 years
Exclusion Criteria:
* under 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 110 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04784871
|
{
"brief_title": "Promoting Wellbeing: The Five Ways to All Intervention",
"conditions": [
"Wellbeing",
"Health Attitude",
"Quality of Life"
],
"interventions": [
"Behavioral: 5waysA Active wait-list control",
"Behavioral: 5waysA Intervention",
"Behavioral: 5waysA Inactive wait-list control"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT04784871",
"official_title": "Promoting Wellbeing: A Randomized Controlled Trial of the Five Ways to All Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-24",
"study_completion_date(actual)": "2023-02-24",
"study_start_date(actual)": "2021-03-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-23",
"last_updated_that_met_qc_criteria": "2021-03-02",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-05",
"first_submitted": "2021-02-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the influence of dose selection of CPT-11 on toxicity, response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer patients.
Detailed Description
Genetic polymorphisms of UGTs result in reduced enzyme activity and increased toxicity. UGT1A1\*28 and UGT1A1\*6 are reported to increase CPT-11-related toxicity in Asian patients. Moreover, the area under concentration curve (AUC) ratio of SN-38G to SN-38 is decreased in Asian patients having UGT1A1 \*28 or UGT1A1\*6. This implicated that the current standard dose of CPT-11 would be overdosing for homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6 patients.
The study is designed to investigate the role of prospectively dose reduction of CPT-11 in toxicity, tumor response and pharmacokinetics for homozygous UGT1A1 patients, and compare these parameters to standard dose of CPT-11 for wild-type, heterozygous or homozygous UGT1A1 patients.
#Intervention
- DRUG : Irinotecan Injection [Camptosar]
- CPT-11 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
- Other Names :
- CPT-11, FOLFIRI regimen
- DRUG : 5-fluorouracil
- The 5-FU dosage will remain the standard.
- Other Names :
- 5-FU, FOLFIRI regimen
- DRUG : Leucovorin
- The LV dosage will remain the standard.
- Other Names :
- LV, FOLFIRI regimen
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed colorectal cancer patients who received no prior chemotherapy or failed to 1st line treatments
* At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Aged >= 18 years
* ECOG performance status of <= 2.
* Anticipated life expectancy of >= 3 months.
* UGT1A1 genotype tested. Categorized into Wild (UGT1A1*1/*1), Hetero (UGT1A1*1/ *28, UGT1A1*1/ *6), and Homo (UGT1A1*28/*28, UGT1A1*6/*6, UGT1A1*28/*6).
* Adequate organ function, including bone marrow, kidney and liver.
* ANC >= 1.5×109/L and hemoglobin >= 9g/dL and platelet count >= 100×109/L
* Serum total bilirubin <= 1.5 x ULN, alkaline phosphatase <= 2.5 x ULN, Serum ALT and AST <= 2.5 x ULN (Serum ALT and AST <= 5 x ULN, if liver metastases are present)
* Serum creatinine <= 1.5 x ULN or CLcr > 60 ml/min
* Written informed consent can be obtained prior to their participation in the trial.
Exclusion Criteria:
* Pregnant or breast feeding women.
* Subjects who have previously received CPT-11 treatment.
* Serious concurrent complication, severe active infection.
* Subjects with chronic diarrhea, acute or sub acute Intestinal obstruction.
* Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
* Subjects who are regarded to be unsuitable for this trial by the investigator.
* Subjects who are participating in other clinical trials.
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
|
NCT01523431
|
{
"brief_title": "Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients",
"conditions": [
"Metastatic Colorectal Cancer"
],
"interventions": [
"Drug: Leucovorin",
"Drug: Irinotecan Injection [Camptosar]",
"Drug: 5-fluorouracil"
],
"location_countries": [
"China"
],
"nct_id": "NCT01523431",
"official_title": "Influence of Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype on Clinical Outcomes and Pharmacokinetics in Chinese Patients With Metastatic Colorectal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11-23",
"study_completion_date(actual)": "2016-04-27",
"study_start_date(actual)": "2012-03-08"
},
"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)": "2017-03-30",
"last_updated_that_met_qc_criteria": "2012-01-29",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-01",
"first_submitted": "2012-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia.
Hypothesis: Percutaneous electrical stimulation on radial nerve plus in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation
Detailed Description
Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve.
Study Aims:
Aim #1: The primary aim of the study is to compare the immediate effect of a single session of PENS on pressure pain sensitivity as measured by pressure pain threshold in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS
Aim #2: The secondary aim of the study is to compare the immediate effect on pain free grip strength, on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS or Sham PENS.
#Intervention
- OTHER : Real PENS
- The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's
The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:
TENS Frequency 2 Hz TENS Pulse width - 250 microseconds Duration - 30 minutes. TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.
Administration - One single session.
- OTHER : Sham PENS
- The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's
The electrical current will not be working, and the needles will be placed during 30 minutes:
- Administration - One single session
|
#Eligibility Criteria:
Inclusion Criteria:
* Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:
1. pain during palpation of lateral epicondyle
2. pain on resisted wrist extension
3. pain on resisted middle finger extension
4. pain during hand-grip
Exclusion Criteria:
* History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.
* Neurological disorders, inflammatory and/or degenerative diseases.
* Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before.
* Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
* Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
* Contraindications of electrical current application
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04576195
|
{
"brief_title": "Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia",
"conditions": [
"Tennis Elbow"
],
"interventions": [
"Other: Real PENS",
"Other: Sham PENS"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT04576195",
"official_title": "Immediate Neurophysiological Effects of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-21",
"study_completion_date(actual)": "2023-03-21",
"study_start_date(actual)": "2020-10-09"
},
"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)": "2023-03-23",
"last_updated_that_met_qc_criteria": "2020-10-05",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-06",
"first_submitted": "2020-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.
Detailed Description
Epidural analgesia is the recommended perioperative analgesia in patients having major surgery in order to significantly reduced pain scores, minimize patient distress and can accelerate postoperative recovery especially with the major operation This technique has been reported to provide better pain control and less postoperative fatigue compared with patients receiving general anesthesia alone.Additionally, it is recommended in patients having major surgery to allow patients to mobilize quickly and have effective mobilization.This technique has been shown to be highly efficient at preventing postoperative ileus and various complications. Moreover, epidural analgesic technique is demonstrated to be safer and have fewer side effects than using intravenous opioids alone.
However, the epidural technique is not universally successful and the number of patients experiencing inadequate analgesia with this technique is approximately 12-32%. The failure of epidural analgesia is still a frequent clinical problem and needs active management including a new block or other analgesic medication in order to rescue postoperative pain. Previous study showed that the incidence of patients having epidural analgesia with postoperative moderate pain was 20.9% and that with severe pain was 7.8%. In Siriraj Hospital, recent study showed that 19.6% of patients having elective upper abdominal surgery under general anesthesia combined with epidural analgesia reported severe first pain scores in post anesthetic care unit.27 As a result of severe pain, patients needed a number of intervention and management from acute pain service, and finally spent longer time in post anesthetic care unit.
Inadequate pain control in patients receiving epidural analgesia frequently occurred in clinical practice but the number of the success rate or the failure rate have not been reported in our hospital. This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.
#Intervention
- PROCEDURE : Elective Thoracic and Abdominal Surgery Patients
- This is an observational audit, reviewing the implementation of a standard care practice and requiring de-identified data collection in Elective Thoracic and Abdominal Surgery Patients only. All collected data will be that which is routinely part of normal clinical practice. The Research staff will systematically collect data on each patient. Some information can be obtained from the medical record, intraoperative anesthetic record, acute pain service record, etc whereas other information has to be obtained from direct observation at the bedside.
- Other Names :
- Epidural Analgesia
|
#Eligibility Criteria:
Inclusion Criteria:
* patients aged more than 18 years scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Exclusion Criteria:
* inability to communicate or inform pain score
* cesarean section or labor analgesia
* additional analgesic techniques (spinal analgesia, paravertebral nerve block, intercostal block, transversus abdominis plane block, rectus sheath block, ilioinguinal block, iliohypogastric block
* emergency surgery
* fail epidural block after test dose of local anesthetics
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
|
NCT02315261
|
{
"brief_title": "Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery",
"conditions": [
"Analgesia Disorder",
"Anesthetic Complication Epidural",
"Adverse Reaction to Epidural Anesthesia"
],
"interventions": null,
"location_countries": [
"Thailand"
],
"nct_id": "NCT02315261",
"official_title": "Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery in Siriraj Hospital",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2014-12"
},
"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)": "2018-11-13",
"last_updated_that_met_qc_criteria": "2014-12-09",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-11",
"first_submitted": "2014-12-04",
"first_submitted_that_met_qc_criteria": "2018-04-16"
}
}
}
|
#Study Description
Brief Summary
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial
#Intervention
- DRUG : utidelone injection
- utidelone monotherapy in patients with advanced NSCLC by utidelone
- Other Names :
- UTD1 injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer
* NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC;
* NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy);
* Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment;
* Age 18 -70 years, ECOG performance status of 0 <= age <= 1; Life expectancy of 3 months or more;
* Patients must have measurable disease, defined as at least one target lesion that can be accurately measured by imaging techniques in at least one dimension as >=20 mm with conventional computed tomography (CT), >=10 mm with spiral CT scan (>=15mm for lymph node) within 3 weeks before enrolment;
* Patients with no brain metastases or with brain metastases but are stable for more than 4 weeks after treatment;
* Peripheral neuropathy (PN) <grade 2 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment;
* Patients must have normal haematology as defined below: HGB >=9 g/L, absolute neutrophil count >=1.5×109/L, platelets >=80×109/L, bilirubin <=1.5× the upper limit of normal (ULN) (patients with liver metastasis <=3xULN), aspartate transaminase (AST)/ alanine transaminase (ALT) <=2.5 ×ULN (patients with liver metastasis <=5xULN), and creatinine clearance >=45 mL/min;
* Patients with no major organ dysfunctions and heart disease;
* Patients who give written informed consent with good compliance.
Exclusion Criteria:
* Patients who are pregnant or breast feeding;
* Patients with active tuberculosis
* Patients with high possibility of interstitial lung disease ;
* Patients with comorbidities, such as carcinomatous meningitis, central nervous system (CNS) metastasis, other active malignancies requiring simultaneous treatment, but not including cervical cancer in situ or basal cell carcinoma of the skin, severe disorders of the heart, lung, liver, or kidneys, severe hypertension, uncontrolled diabetes, severe gastrointestinal ulceration, active infections in need of antibiotics, or with incontrollable psychiatric history;
* patients with HIV, untreated active hepatitis；
* Patients with poor compliance;
* Patients not fitted for this study determined by the investigators.
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
|
NCT03693547
|
{
"brief_title": "Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）",
"conditions": [
"Advanced Non-small Cell Lung Cancer"
],
"interventions": [
"Drug: utidelone injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT03693547",
"official_title": "Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer After Failure or Intolerability to Second-line Standard Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-25",
"study_completion_date(actual)": "2021-08-10",
"study_start_date(actual)": "2019-04-22"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-10",
"last_updated_that_met_qc_criteria": "2018-10-02",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-03",
"first_submitted": "2018-09-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of the study are:
1. Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance and cooperativity of children with ASD in dental examinations.
2. Analyzing the association between the predicting factors and compliance in the step of dental examination.
3. Analyzing the association between the predicting factors and cooperativity in dental examinations.
This study tested two hypotheses:
1. Evaluating the effectiveness of the structural-visual model of behavioral approach on the compliance
2. Evaluating the effectiveness of the structural-visual model of behavioral approach on cooperativity of children with ASD in dental examinations.
The participants will undergo the structural visual approach intervention, and the investigator will measure its effectiveness through four assessments: one pre-test and three post-tests.
Detailed Description
Autism Spectrum Disorder (ASD) is a brain development disorder marked by issues in two main areas: communication and interacting with others; as well as rigid, repetitive, and stereotypical behaviors, hobbies, or activities. Autism Spectrum Disorder (ASD) is becoming more common every year, making it a major concern for most parents around the world, including those in Indonesia. One of the areas in Indonesia, Yogyakarta, also has to deal with this problem.
Studies have shown that a lot of kids with autism are afraid of things that don't make sense. Sensory issues are common in kids with ASD, which makes it hard for them to handle the sounds and sights in the dentist's office. As a result, these kids often show more behavioral problems, too much worry, and bad behavior at the dentist's office, which makes it very hard for the dentists to do exams and provide oral care. Researchers also think that this refusal to cooperate makes parents hesitant to take their autistic children to the dentist for regular checkups or treatments. This means that these kids don't get the dental care they need and have bad mouth health. Also, many studies show that kids with ASD are more likely than kids in the general population to have cavities, bad oral health, and periodontal disease.
To help people with behavior problems, you need to know about their other health problems, the type of ASD they have, any previous treatment they've had, their behavior, their social and communication skills, the medicines they take to control their behavior, any learning disabilities or mental retardation they may have, their heightened sensory perceptions, and their inability to apply what they have learned in other situations.
Notably, visual pedagogy is a structural-visual behavior method that is often used with kids who have ASD. People in Indonesia have looked into how to help kids with autism understand dental checks by using visual aids. However, these tests were not done in real centers with lots of kids and long wait times. With this and other reasons in mind, this study used a visual-structural method to help Indonesian kids with autism during dental checks. What they learned about kids and their families led them to make changes. The information can help dentists handle kids with ASD and guess how they will act during dental exams.
The intervention comprised seven behavior approaches in this research defined as follows:
A successive approach: An approach to familiarization with the unfamiliar environment of the simulated dental office.
Tell-Feel-Show-Do (T-F-S-D): A dental approach explained to the patient's treatment by telling the patient what would happen, what he felt or did, and what had been done.
Visual pedagogy: Introduced dentistry to autistic children through visual media, such as pictures and photographs.
Audiovisual modeling: A learning process through audiovisual media, such as video and animation.
In-vivo modeling: Learning new activities by watching them in front of the model.
Behavioral trials: A learning strategy conducted through practicing the recent activity by him/herself.
Auto-modeling: A learning process following the activity of editing pictures during the prior visit of the patient.
#Intervention
- BEHAVIORAL : Structural visual approach
- The intervention comprised seven behavior approaches in this research defined as follows:
A successive approach: An approach to familiarization with the unfamiliar environment of the simulated dental office.
Tell-Feel-Show-Do (T-F-S-D): A dental approach explained to the patient's treatment by telling the patient what would happen, what he felt or did, and what had been done.
Visual pedagogy: Introduced dentistry to autistic children through visual media, such as pictures and photographs.
Audiovisual modeling: A learning process through audiovisual media, such as video and animation.
In-vivo modeling: Learning new activities by watching them in front of the model.
Behavioral trials: A learning strategy conducted through practicing the recent activity by him/herself.
Auto-modeling: A learning process following the activity of editing pictures during the prior visit of the patient.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged between 6 and 18 years (school-aged children in Indonesia).
* Good general health without physical disabilities.
* Cooperative parents/caregivers who provided informed consent to participate in the study.
* They reside in the same household as their parents/caregivers.
* Diagnosis of autism spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) by a psychiatrist.
Exclusion Criteria:
* a. Had undergone training for dental examination in a dental setting. b. The dental approach could not be provided due to a lack of non-pharmacological behavior management or cooperative behavior.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06470724
|
{
"brief_title": "Effectiveness of Visual-Behavioral Approach and Predictive Factors in Dental Exams for Children With Autism",
"conditions": [
"Autism Spectrum Disorder"
],
"interventions": [
"Behavioral: Structural visual approach"
],
"location_countries": [
"Indonesia"
],
"nct_id": "NCT06470724",
"official_title": "Effectiveness of Structural-Visual Model Behavioral Approach and Predictive Factors of Cooperativity and Compliance in Dental Examinations for Children With Autism Spectrum Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-23",
"study_completion_date(actual)": "2022-05-01",
"study_start_date(actual)": "2021-10-04"
},
"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)": "2024-06-24",
"last_updated_that_met_qc_criteria": "2024-06-18",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-24",
"first_submitted": "2024-06-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an observational and sample collection study involving patients (alive or deceased) from several clinical trials who had received the investigational drug, olaparib in other research studies. There is no intervention given for this study.
This research is being done to understand of the mechanisms involved in patients whose cancer responds well and whose cancer does not respond well to investigational drug, olaparib, to help better understand how olaparib works and to better identify patients who may benefit from this therapy.
Detailed Description
This is study will compare biomarker research with response in patients who have received olaparib.
Patients who have had a durable response to olaparib for at least 2 years will be approached for the study.
Patients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. Archival tumor tissue will also be collected for biomarker research.
A waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased.
If participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumor DNA, and the results of CT scans taken as part of their standard of care or as a part of another research study. If participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and BRCA testing (if not known). An optional tumor biopsy will also be requested.
Participants will continue to be followed by telephone for survival and any new treatments they are receiving.
|
#Eligibility Criteria:
Inclusion Criteria:
* Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer):
* single agent olaparib given for relapsed disease or
* single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or
* olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or
* olaparib combined with other types of therapy
* Had a durable response to Olaparib defined as patients who have benefited from olaparib for > 18 months. Patients who discontinued Olaparib due to toxicities but otherwise meet the definition of a durable response will be included or the control group is patients who had a short duration benefit with Olaparib of less than 6 months in any individual clinical trial/standard of care
* Ability to understand and the willingness to sign a written informed consent document.
* Patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Exclusion Criteria:
* Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
* Pregnant or breastfeeding women
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
|
NCT02489058
|
{
"brief_title": "A Study of Long-Term Responders on Olaparib",
"conditions": [
"Epithelial Ovarian Cancer",
"Fallopian Tube Cancer",
"Peritoneal Cancer"
],
"interventions": null,
"location_countries": [
"Canada",
"Spain",
"Australia",
"Italy",
"United Kingdom"
],
"nct_id": "NCT02489058",
"official_title": "A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-16",
"study_completion_date(actual)": "2022-08-31",
"study_start_date(actual)": "2016-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-10",
"last_updated_that_met_qc_criteria": "2015-07-01",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-02",
"first_submitted": "2015-04-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a storage mite extract would trigger symptoms and objective signs of rhinitis in bakery workers and a control group.
Detailed Description
The investigations include allergy testing with skin prick testing, and measuring of specific Immunoglobulin E (IgE) in sera, answering a questionnaire, and symptom scoring before and after provocations. The participants will be investigated one day with a placebo, and another day with the allergen extract of either Acarus Siro or Lepidoglyphus Destructor. As a measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical scoring of nasal secretion and blockage. Indices of inflammation (ECP and alfa-Macroglobulin) will be monitored in nasal lavage.
#Intervention
- BIOLOGICAL : Storage mite allergen extracts
- Nasal provocation with increasing doses of storage mite allergen extracts
- Other Names :
- Acarus Siro, Lepidoglyphus Destructor
|
#Eligibility Criteria:
Inclusion Criteria:
* bakery workers
* > 18 years
* sensitized to a storage mite (A.Siro or L. Destructor)
Exclusion Criteria:
* pregnant or breast-feeding
* infection in upper or lower airways the last month
* nasal polyposis
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
|
NCT01436851
|
{
"brief_title": "Nasal Provocation Testing in Occupational Rhinitis",
"conditions": [
"Allergic Rhinitis (Disorder)"
],
"interventions": [
"Biological: Storage mite allergen extracts"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01436851",
"official_title": "Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09-01",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2010-11-24"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-16",
"last_updated_that_met_qc_criteria": "2011-09-18",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-20",
"first_submitted": "2011-08-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.
#Intervention
- BEHAVIORAL : Gradual Cessation
- Other Names :
- Cigarette Reduction
- BEHAVIORAL : Gradual Cessation w/ Quitbit
- Other Names :
- Cigarette Reduction w/ Quitbit
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years
* cigarette smoker
* wanting to quit in the next 30 days
* preference to quit gradually (vs. abruptly) or having no preference
* access to an iPhone (iOS only)
* completion of a run-in period
Exclusion Criteria:
* no major change in number of cigarettes per day in the past month (+/- 20%)
* no major health diagnoses that could impact study attrition
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
|
NCT02515500
|
{
"brief_title": "Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial",
"conditions": [
"Smoking Cessation"
],
"interventions": [
"Behavioral: Gradual Cessation w/ Quitbit",
"Behavioral: Gradual Cessation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02515500",
"official_title": "Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06",
"study_completion_date(actual)": "2018-06",
"study_start_date(actual)": "2016-06"
},
"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)": "2020-01-13",
"last_updated_that_met_qc_criteria": "2015-07-31",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-04",
"first_submitted": "2015-07-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will provide the first rigorous integrative test of the hypothesis that rapid rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of alcohol and that such increased sensitivity correlates with increased alcohol use. Identification of the behavioral mechanisms by which estradiol surges can increase alcohol use would provide a critical advancement of neurobiological theory of alcohol abuse in women, an understudied area, as well as provide new directions for personalization of alcohol abuse treatment in women.
In this study, naturally-cycling women will be examined daily over their menstrual cycle using an integrative combination of daily ecological assessments of hormone fluctuations and alcohol use along with strategically-timed laboratory tests of their acute sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol.
#Intervention
- DRUG : Placebo
- Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol (or placebo) effects on disinhibition and impulsive choice. The placebo consists of 300 ml of lemon-flavored soda with a small amount (3 ml) of alcohol floated on top.
- DRUG : Alcohol
- Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol effects on disinhibition and impulsive choice. The alcohol dose consists of 0.60 g/kg absolute alcohol that produces a peak blood-alcohol concentration of 80 mg/dl. Doses will be mixed with a carbonated, non-caffeinated, lemon-flavored soda and consumed within 10 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* female
* regular menstrual cycle
* consume alcohol at least once per week
* no history of drug or alcohol dependence
Exclusion Criteria:
* use of hormone-based medications
* irregular menstrual cycle
* current pregnancy
* primary sensorimotor handicap
* frank neurological disorder
* pervasive developmental disorder
* frank psychosis
* diagnosed intellectual disability
* medical condition contraindicating alcohol use
* substance abuse history (except nicotine)
* body mass index (BMI) 30 or above
* alcohol abstainer
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04595682
|
{
"brief_title": "Estradiol Effects on Alcohol Across the Menstrual Cycle",
"conditions": [
"Alcohol Use, Unspecified"
],
"interventions": [
"Drug: Placebo",
"Drug: Alcohol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04595682",
"official_title": "Estradiol Effects on Behavioral and Reward Sensitivity to Alcohol Across the Menstrual Cycle",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-11-06",
"study_completion_date(actual)": "2024-11-06",
"study_start_date(actual)": "2021-03-15"
},
"study_design": {
"allocation": "NA",
"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)": "2025-01-10",
"last_updated_that_met_qc_criteria": "2020-10-14",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-20",
"first_submitted": "2020-10-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.
Detailed Description
This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.
Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.
Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.
Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:
Regimen A
* Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
* Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.
Regimen B
* Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
* Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle
TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.
#Intervention
- DRUG : TXA127
- Once daily subcutaneous injection of 100 ug/kg
- Other Names :
- Angiotensin 1-7
- DRUG : TXA127
- Once daily subcutaneous injection of 300 ug/kg
- Other Names :
- Angiotensin 1-7
- DRUG : Placebo
- Once daily subcutaneous injection of placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Females at least 18 years with ovarian carcinoma who are one of the following:
* Newly diagnosed with ovarian cancer and chemotherapy naïve, or
* Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
* Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
* Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
* Adequate blood coagulation parameters as measured by standard blood tests for coagulation
Exclusion Criteria:
* Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
* Significant unstable cardiovascular disease
* Uncontrolled high blood pressure
* Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
* Evidence of metastatic disease to the bone
* Metastatic disease to the CNS requiring treatment or radiation therapy
* Uncontrolled infection(s)
* Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
* Concurrent use of hematopoietic or erythropoietic agents
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
|
NCT00771810
|
{
"brief_title": "Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer",
"conditions": [
"Thrombocytopenia",
"Neutropenia",
"Lymphopenia",
"Anemia"
],
"interventions": [
"Drug: Placebo",
"Drug: TXA127"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00771810",
"official_title": "Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2008-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-13",
"last_updated_that_met_qc_criteria": "2008-10-09",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-13",
"first_submitted": "2008-10-09",
"first_submitted_that_met_qc_criteria": "2013-04-30"
}
}
}
|
#Study Description
Brief Summary
Clofazimine (CFZ) is a promising drug for the treatment of NTM diseases. CFZ is highly active in vitro against M. abscessus and M. avium, the most common NTM pathogens, and shows synergy with macrolides and amikacin. The results from limited clinical studies with CFZ-based treatment regimens are promising. CFZ is currently considered an alternative drug for patients with M. avium complex infections, who are intolerant of first-line drugs. CFZ is a first-line oral drug for treatment of M. abscessus infections.
CFZ might prove to be a cornerstone in NTM treatment, but its optimal dosage is not known. The current dose for adults is 100 mg oncedaily. However, due to the complex pharmacokinetics (PK) of CFZ - it is highly protein bound, extremely lipophilic and accumulates in fatty tissues resulting in a long elimination half-life of \~30 days - it takes several months before steady state, and presumably effective, concentrations are achieved. With the use of a loading dose regimen concentrations similar to those at steady state could be reached faster, possibly leading to improved early treatment efficacy.
The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases. It will be an explorative, single-center, one-arm, open label, pharmacokinetic study. A number of 10 patients with pulmonary or extrapulmonary NTM disease will be included. Patients will receive a loading dose regimen of 300 mg once daily for 4 weeks and will then continue with a standard dose of 100 mg once daily until a total 4 months of treatment with CFZ.
The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once daily, in adult patients with pulmonary or extrapulmonary NTM disease
#Intervention
- DRUG : Clofazimine
- All participants will receive an (experimental) oral loading dose regimen of 300 mg clofazimine once daily (= 3 capsules of 100 mg) for 4 weeks. Afterwards, all participants will continue with a standard oral dose of 100 mg clofazimine once daily (= 1 capsule of 100 mg) until a total 4 months of treatment with CFZ.
Blood samples will be taken at Day 28 (+/- 2 days), Day 29 (Day 28 +1) and after 4 months of treatment to assess the pharmacokinetics of CFZ, both with the loading dose and the standard dose. In addition, the safety/tolerability of CFZ will monitored.
- Other Names :
- Lamprene
|
#Eligibility Criteria:
Inclusion Criteria:
* The participant is diagnosed with pulmonary or extrapulmonary NTM disease and is eligible for treatment with CFZ
* The participant is at least 18 years
* The participant has a body weight (in light clothing and with no shoes) of at least 45 kg
* The participant is able and willing to provide written, informed consent
Exclusion Criteria:
* The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
* There is evidence showing the participant has clinically significant metabolic, gastrointestinal, or other abnormalities that could possibly alter the PK of CFZ
* The participant is diagnosed with cystic fibrosis
* The participant has a prolongation of the QTc interval, > 450 milliseconds for males and > 460 milliseconds for females, on the screening ECG
* The participant has abnormal alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels of > 3 times the upper limit of the laboratory reference range at screening
* The participant is pregnant or is using inadequate contraceptive measures (if applicable)
* The participant is breastfeeding (if applicable)
* The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
* The participant has as history of allergy/hypersensitivity to CFZ
* The participant has received clofazimine in the past 3 months before inclusion with the exception of short-term use of no more than 7 days in the period of 1 to 3 months before inclusion
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
|
NCT05294146
|
{
"brief_title": "Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease",
"conditions": [
"Nontuberculous Mycobacterial Diseases"
],
"interventions": [
"Drug: Clofazimine"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT05294146",
"official_title": "Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-01",
"study_completion_date(actual)": "2023-08-08",
"study_start_date(actual)": "2022-02-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-16",
"last_updated_that_met_qc_criteria": "2022-03-15",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-24",
"first_submitted": "2022-03-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to identify whether specific clinical practices-including attention to body-mass-index (BMI) screening/overweight/obesity, medical risk (from conditions associated with overweight/obesity such as high blood pressure), and following up to reassess progress-will improve the weight status of overweight school-age children.
Detailed Description
The aim of this study is to identify specific clinical practice elements in pediatric primary care that predict improvement in weight status among overweight school-age children. Pediatricians are well-suited to regularly assess and treat school-age children who are overweight. Well-child visits present an important opportunity to assess and treat overweight children. Strategies are needed to maximize the effectiveness of this opportunity. Although the American Academy of Pediatrics endorses recommendations by the United States Preventive Services Task Force that clinicians screen for overweight, assess medical/behavior risk, and use a staged treatment approach that includes frequent reassessment, it is unclear whether these practices, when used in primary care, impact whether children make lifestyle changes or improve their weight status. It is essential to identify specific clinical practice elements and communication strategies associated with weight-status improvement in overweight children, to maximize the effectiveness of primary-care weight-management interventions. The investigators hypothesize that, during primary-care visits with overweight 6-12-year-old children, attention to high BMI, medical risk (from weight-related comorbidities such as high blood pressure), and reassessing progress (defined as having a primary-care visit with evidence of attention to BMI or completing a referral to a weight-management specialist or nutritionist) will be associated with improvement in weight status (assessed as decrease in percent overweight (percentage above the age/sex-specific 95th BMI percentile) at follow-up.
#Intervention
- OTHER : Attention to BMI
- Evidence (using electronic health record data) denoting provider attention to about high BMI.
- Other Names :
- BMI
- OTHER : Attention to high-BMI-related Medical Risk
- Evidence (using electronic health record data) denoting provider attention to high-BMI-related medical risk, including from high blood pressure/hypertension, cholesterol/dyslipidemia, blood sugar/diabetes, liver enzymes/fatty liver, and low vitamin D/vitamin-D deficiency.
- Other Names :
- Medical Risk
- OTHER : No attention to high BMI or high-BMI-related medical risk
- Lack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk.
- Other Names :
- No BMI/Medical-Risk Attention
|
#Eligibility Criteria:
Inclusion Criteria:
* 6 <= age <= 12 year-old children with >=2 visits
* valid height and weight data at each visit
* BMI >=85th percentile at the first visit
Exclusion Criteria:
* children <6 and >12 years
* no valid height and weight data at two visits
* BMI <85th percentile at all 6 <= age <= 12 year-old well child visits
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02278705
|
{
"brief_title": "Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status",
"conditions": [
"Overweight",
"Childhood Obesity"
],
"interventions": [
"Other: Attention to BMI",
"Other: Attention to high-BMI-related Medical Risk",
"Other: No attention to high BMI or high-BMI-related medical risk"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02278705",
"official_title": "Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-09",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-19",
"last_updated_that_met_qc_criteria": "2014-10-29",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-30",
"first_submitted": "2014-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage.
Primary Outcome Measures:
- Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to diagnosis and anticoagulation treatment of AF during the study period; comparison of complications between those with and without anticoagulation treatment according to CHADSVASc score.
Secondary Outcome Measures:
* The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes within 30 days after anticoagulation pause and the prevalence of stroke and intracranila bleeding in relation to INR level \< 2, 2-3 and \>3.
* Trauma as a risk factor for intracranial bleeding: percentage and risk factors for intracranial bleeding with or without trauma. Type of preceding trauma and type of intracranial bleeding.
* The time relation between diagnosis of AF and type of intracranial complications: Kaplan Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after 1st diagnosis of AF in patients with and without anticoagulation
* The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED score and anticoagulation/antithrombotic treatment
* Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and intracerebral bleeding in patients with and without anticoagulation
* Factors related to underuse of anticoagulation treatment. Data on reasons for not starting or stopping aticoagulation in those with indication of oral anticoagulation
* Operations and procedure as risk factor for stroke: Frequency and type of operations performed \< 30 days before stroke. Data on length of perioperative pause in anticoagulation and use of bridging therapy and timiing of stroke are collected.
* Cardioversions as a risk factor for stroke: Frequency of stroke and TIA \< 30 days after cardioversion in relation to use of anticoagulation and CHADSVASc score
* The risk of stroke and intracranial bleeding in relation to type of AF (permanent, persistent, paroxysmal) and concomitant carotid disease
Estimated Enrollment: 6000 patients.
Detailed Description
Approximately 20% of stroke is caused by atrial fibrillation (AF) and 1% of patients with AF suffer from intracranial hemorrhage. Thus, the net benefit of AF management is the key factor in choosing the successful treatment (pharmacological and interventional).
In this retrospective Finnish multicenter study the investigators collect data on patients with intracranial thromboembolic events or intracranial hemorrhage and AF during the study period. All such patients ≥18 years of age are identified and relevant clinical details are retrospectively gathered from the hospital records of the participating hospitals into an internet-based CRF. The total study period is from 2003 to 2012.
All case records are reviewed using standardized data collection protocol to get information on baseline characteristics and medication of the patients, management of the patients before and during the index complication and during a 30-day follow-up after each complication.
Diagnosis of atrial fibrillation is based 12-lead electrocardiography according to the standard criteria.
Stroke is documented clinically and confirmed by computerized tomography or magnetic resonance imaging to be caused by cerebral infarction. Diagnosis of transient ischemic attacks are based on clinical diagnosis by neurologist when stroke is not confirmed by imaging. After completion of manual registration of data, a computer-based cross-checking of strokes is performed from discharge register data of the included patients to ensure the complete coverage of all events. Diagnosis of inctracranial bleedings are based on patient record and classified as subdural, subarachnoidal and intracerebral and possible preceding trauma is registered. Outcome measures are classified by study neurologist when necessary.
Antigoagulation treatment, INR levels during the index complication, possible pauses in treatment and their casues are registered togethr with information on antiplatelet treatments.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation.
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02146040
|
{
"brief_title": "Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study)",
"conditions": [
"Stroke",
"Transient Ischemic Attacks",
"Intracranial Hemorrhage",
"Atrial Fibrillation"
],
"interventions": null,
"location_countries": [
"Finland"
],
"nct_id": "NCT02146040",
"official_title": "Incidence and Clinical Predictors of Stroke and Intracranial Hemorrhage in Patients With Atrial Fibrillation. A Retrospective Multicenter Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05",
"study_completion_date(actual)": "2022-05-30",
"study_start_date(actual)": "2013-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-23",
"last_updated_that_met_qc_criteria": "2014-05-20",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-23",
"first_submitted": "2014-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.
Detailed Description
The study will be split into 3 parts: Part A, Part B \& Part C.
The overall study will enrol up to 136 healthy males; maximum of 68 in Part A, maximum of 44 in Part B and maximum of 24 in Part C.
The purpose of Part A is to evaluate the safety, tolerability and concentration of RXC007 in the blood when it is given as a single dose on one occasion at different dose strengths. In addition, one group in Part A will investigate the effect of food on the safety, tolerability and concentration of RXC007 in the blood by taking a single dose of RXC007 following an overnight fast and then following a high fat breakfast. Part A will consist of 6 planned groups of 6 participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group. If required and determined as necessary following dose escalation data review, Part A may enrol up to a maximum of 4 additional cohorts with a maximum of 8 participants within each cohort.
Part A of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of a maximum of 5 days with 4 overnight stays) and a post-study follow-up visit on Day 15. For the food effect cohort, an additional treatment period (consisting of a maximum of 5 days with 4 overnight stays) will be undertaken following an approximately 4-week washout period with a second follow-up visit to be conducted on Day 15 following the second treatment period.
The purpose of Part B is to evaluate the safety, tolerability and concentration of RXC007 in the blood when it is given as a single dose once a day for a period of 14 days at different dose strengths. Part B will consist of up to 2 planned groups of 6 participants; each group investigating a different dose strength based on the data generated during Part A of the study. If required and determined as necessary following dose escalation data review, Part B may enrol up to a maximum of 4 additional cohorts with a maximum of 8 participants within each cohort.
Part B of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of a maximum of 18 days with 17 overnight stays) and a post-study follow-up visit on Day 28.
Within each cohort in Part A and Part B, 4 participants will receive RXC007 with the remaining 2 participants receiving a matching placebo. Each cohort will follow a dose leader schedule, whereby 2 participants (1 active, 1 placebo) will be dosed a minimum of 24 hours prior to the remaining 4 participants in the cohort. Between each cohort, safety and PK data up to the 72-hour post-last dose time point for Part A and up to Day 17 in Part B will be evaluated by a Dose Escalation Review Committee (DERC) to determine whether it is appropriate to dose escalate into the next cohort. If required, i.e., the safety or pharmacokinetics (PK) data indicates, dose modifications may be made in order to select an intermediate/lower dose. In addition, modifications may be made following both treatment periods for the food effect cohort in Part A to dose all remaining cohorts in Part A and Part B in a fed state (with a standardised breakfast) and in Part B, the dose regime may be modified in terms of frequency to increase dosing from once per day to multiple times per day. In addition, decisions may be made that the proposed length of the in-house treatment period in both Part A \& Part B should be reduced by one day (from Day 4 to Day 3 in Part A and from Day 17 to Day 16 in Part B).
The purpose of Part C is to evaluate the safety, tolerability and effect of RXC007 on the concentration of rosuvastatin and metformin in the blood to determine as to whether RXC007 affects the activity of the processes by which certain types of drugs are broken down (metabolised) in the body and therefore, whether RXC007 has the potential to interact with other drugs, affecting their desired effect in the body i.e., evaluating the drug-drug interaction potential of RXC007.
Part C will consist of 2 groups of 12 participants; Group 1 evaluating the drug-drug interactions of RXC007 and rosuvastatin (at a dose strength of 10 mg in an oral tablet formulation) and Group 2 evaluating the drug-drug interactions of RXC007 and metformin (at a dose strength of 500 mg in an oral tablet formulation). The dose strength of RXC007 to be evaluated will be selected based on review of the data generated in Part B of the study.
Part C of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of either a maximum of 14 days with 13 overnight stays for Group 1 or a maximum of 11 days with 10 overnight stays for Group 2) and a post-study follow-up visit approximately 14 days following the last dose of RXC007 with rosuvastatin or metformin (either Day 23 or Day 21 respectively for Group 1 and Group 2).
#Intervention
- DRUG : RXC007
- RXC007 will be administered in the form of oral capsules at selected doses starting at 2 mg to 4 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one single dose on one occasion and for Part B, dosing frequency is single doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.
All participants in Part C (24) will receive active RXC007 in the form of oral capsules as single doses.
- DRUG : RXC007 Matching Placebo
- The matching placebo for RXC007 will be administered in the form of oral capsules matched to the number of active RXC007 capsules at each dose level to 2 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one placebo dose on one occasion and for Part B, dosing frequency is single placebo doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.
There is no placebo intervention for Part C of the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male participants, between 18 and 55 years, inclusive.
* Male participant (and female partner of childbearing potential) willing to use a highly effective method of contraception or 2 effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 3 months after last dose of IMP/NIMP.
* Participant with a body mass index (BMI) of 18.0 <= age <= 32.0 kg/m2.
* Participant with a body weight of 60 kg or greater.
* No clinically significant history of previous allergy / sensitivity to RXC007, rosuvastatin or metformin, or any of the excipients contained within the IMP/NIMP.
* No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP/NIMP.
* Haemoglobin and haematocrit above the lower limit of the normal range for the reference laboratory.
* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 1.5 times the upper limit of the normal (ULN) range for the reference laboratory.
* Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP/NIMP (N.B.: A positive test result may be repeated at the Investigator's discretion).
* Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
* No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP/NIMP including a PR interval > 220ms, QRS width > 120ms and QTcF interval > 450 ms.
* No clinically significant abnormalities in vital signs (e.g., blood pressure (systolic blood pressure > 140 mmHg) / heart rate, respiration rate, oral temperature) determined within 28 days before first dose of IMP/NIMP.
* Participant must be available to complete the study (including all follow-up visits).
* Participant must satisfy an Investigator about his fitness to participate in the study.
* Participant must provide written informed consent to participate in the study.
* Participants with a negative COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test on admission (if required).
Exclusion Criteria:
* A clinically significant history of gastrointestinal disorder likely to influence IMP/NIMP absorption.
* A clinically significant history of infection in the last 3 months.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, antacids (Part C Cohort 1 only), any product known to be a substrate mainly metabolised by CYP enzymes within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP/NIMP.
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
* Participants who are unable to demonstrate the ability to swallow multiple 'dummy' capsules (i.e., an empty gelatin capsules) of the size proposed for administration in a particular cohort/dose level (up to and including size 00).
* Participant with a glomerular filtration rate less than 80 mL/min/1.73m2 (calculated by Cockcroft-Gault equation.
* A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units of alcohol a week) within the past two years.
* Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
* Participation in a NCE clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP/NIMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
* Donation of 450 mL or more blood within the 3 months before the first dose of IMP/NIMP.
* Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc.), which would prevent participants from consuming a high-fat breakfast or standardised meal.
* Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).
* Participants who have received a COVID-19 vaccine injection within 28 days prior to the first dose of IMP/NIMP.
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
|
NCT04931147
|
{
"brief_title": "A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers",
"conditions": [
"Fibrosis",
"Inflammation",
"Idiopathic Pulmonary Fibrosis",
"Non-alcoholic Steatohepatitis",
"Liver Diseases",
"Kidney Diseases"
],
"interventions": [
"Drug: RXC007",
"Drug: RXC007 Matching Placebo"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04931147",
"official_title": "A Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-08",
"study_completion_date(actual)": "2023-03-08",
"study_start_date(actual)": "2021-05-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2021-06-11",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-18",
"first_submitted": "2021-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.
Detailed Description
The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart Failure related events associated with signs and symptoms of pulmonary congestion and in the subject HF therapy management.
The OptiVol feature is based on the measurement of daily intrathoracic impedance values, measurements that can be used to track changes in the subject's thoracic fluid status over time. An Alert warns the patient whenever a programmable threshold has been reached.
The study is divided into three phases.
The first phase is double-blinded and designed to determine the sensitivity and positive predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related hospitalizations with signs and/or symptoms of pulmonary congestion.
In the second phase of the study, the Alert is turned ON and the positive predictive value of the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary congestion will be evaluated.
The third phase of the study allows for remote subject therapy management using the OptiVol Patient Alert. The patient management strategy is then based on the experience gained in the second study phase Physician actions taken in the occurrence of a Patient Alert will be summarized.
#Intervention
- DEVICE : Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.
- SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.
|
#Eligibility Criteria:
Inclusion Criteria:
* Successfully implanted InSync Sentry device (< 34 days post implant or pocket revision)in the pectoral region;
* At least one HF-related hospitalization that required administration of IV medication (inotropes, nitrates, diuretics) within the last 12 months
* The Subject has a market released, transvenous, high voltage Right Ventricular lead
* The Subject is able to detect a Patient Alert signal
Exclusion Criteria:
* <18 years (or under a minimum age required by local law)
* Moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
* Post heart transplant or awaiting heart transplantation
* Primary pulmonary hypertension
* Renal insufficiency requiring dialysis
Amendment to the inclusion criteria (Jul 06):
* Inclusion of patients with Concerto/Virtuoso devices.
* At least one HF-related hospitalization that required administration of IV (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 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
|
NCT00400985
|
{
"brief_title": "Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure",
"conditions": [
"Heart Failure, Congestive"
],
"interventions": [
"Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool."
],
"location_countries": [
"Belgium",
"United Kingdom"
],
"nct_id": "NCT00400985",
"official_title": "Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-08",
"study_completion_date(actual)": "2009-08",
"study_start_date(actual)": "2005-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-22",
"last_updated_that_met_qc_criteria": "2006-11-16",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-11-17",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": "2018-01-09"
}
}
}
|
#Study Description
Brief Summary
This is a single-center randomized phase III clinical trial, the VWD-Woman Trial, in which 20 pregnant subjects with von Willebrand disease (VWD), defined as VWF ristocetin co-factor activity (VWF:RCo) \<0.50 IU/ml (historic) and previous history of bleeding are enrolled. Subjects will include women with VWD age 18 years and older, excluding those who have a bleeding disorder other than VWD. Once enrolled, subjects who meet all of the inclusion and none of the exclusion criteria will be randomized to recombinant Von Willebrand factor (rVWF, Vonvendi ®) with Tranexamic Acid (TA, Cyclokapron®); or recombinant Von Willebrand factor (rVWF, Vonvendi®) alone to prevent postpartum hemorrhage after vaginal or caesarean delivery. The primary endpoint is quantitative blood loss (QBL) by a labor suite nurse at delivery. Secondary endpoints include safety assessment for postpartum lochial blood loss by Pictorial Blood Assessment Chart (PBAC), transfusion, blood products, thromboembolic events, and hysterectomy within 21 days; and mechanism of PPH reduction by VWF assays (VWF:RCo, VWF:Ag, VIII:C), fibrinogen, and d-dimer. Blood draws are at 5 time points, including at 36 weeks' gestation (screening), on admission for childbirth, and at 1 day, 2 days, and 21 days after delivery. The VWD-Woman Trial is considered greater than minimal risk as study drugs are given at delivery and special coagulation studies are obtained.
Detailed Description
The purpose of this 8-week single center, randomized, open-label phase III trial to compare recombinant von Willebrand factor (rVWF, Vonvendi®)) plus tranexamic acid (TA, Cyclokapron®) vs. rVWF alone to prevent postpartum hemorrhage (PPH) in women with Von Willebrand disease (VWD). VWD is an inherited bleeding disorder that occurs in 1% of the population. It is caused by deficient or defective von Willebrand factor (VWF). Treatment at delivery is with VWF concentrate, based on U.S. and European guidelines, and as DDAVP, a non-VWF protein, is contraindicated as it may cause hyponatremia (low salt) and seizures due to fluid replacement at delivery. Yet, blood loss is 1.5-fold greater in VWD than non-VWD controls. The investigators believe this is due to physiologic (protective) fibrinolysis (clot breakdown) in the first 3 hours after delivery, which may protect controls from excess clotting after delivery, but which may increase bleeding in subjects with VWD. PPH a significant cause of maternal morbidity and mortality in women. PPH is defined as \>1000 ml within the first 24 hours of vaginal or cesarean delivery. PPH peaks in the first 2-3 hours postpartum, a time during which there is early activation of the fibrinolytic system, with a 2-fold increase TPA (tissue plasminogen activator). So while uterine atony is the major cause of PPH, accounting for 63% of PPH cases, but in 37% of cases, uterotonic agents fail.
TA is an anti-fibrinolytic therapy (prevents clot breakdown) which reduces bleeding and prevents clot breakdown in surgery, trauma, and in controls at delivery, if it is given within 3 hours of delivery. In the WOMAN trial, a large trial of over 10,000 women without bleeding disorders, TA was safe and effective in reducing PPH when given intravenously (in a vein) within 3 hours of vaginal or cesarean delivery. As TA is approved by the US. Food and Drug Administration (FDA) to treat and prevent bleeding in VWD, the investigators propose to study rVWF plus TA vs. VWF alone to reduce PPH in subjects with VWD. This is a pilot study to determine if recruitment, randomization, and study drug administration can be performed successfully, and shows preliminary safety and efficacy in subjects with VWD. rVWF (Vonvendi®) will be administered by intravenous infusion before delivery and on day 1 and day 2 postpartum. Tranexamic acid (Cyclokapron®) will be administered by intravenous infusion within 3 hours postpartum. Randomization will be at delivery to either rVWF at delivery and on day 1 and day 2 postpartum, plus TA within three hours postpartum; or rVWF alone at delivery and on day 1 and day 2 postpartum.
#Intervention
- DRUG : Recombinant Von Willebrand factor
- Recombinant Von Willebrand factor(Vonvendi) is an intravenous therapy that replaces missing VWF to restore hemostasis and reduce bleeding with surgery or delivery.
- Other Names :
- rVWF, Vonvendi
- DRUG : Tranexamic Acid Injection [Cyklokapron]
- Tranexamic acid (Cyclokapron) is an intravenous anti-fibrinolytic therapy that prevents clot breakdown and reduces bleeding with surgery or delivery.
- Other Names :
- TA, Cyclokapron
|
#Eligibility Criteria:
Inclusion Criteria:
* Pregnant females >= 18 years
* Confirmed VWD, as defined by VWF:RCo < 0.50 IU/dL and previous history of bleeding
* Willingness to have blood drawn
* Willing to be randomized to one of two treatments at delivery and for 2 days postpartum.
* Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken.
* Willing to return at 21 days for final blood draw and review of diary.
Exclusion Criteria:
* Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders.
* Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke.
* Platelet count < 100,000/ ul.
* Past allergic reaction to VWF or tranexamic acid.
* Surgery within the past 8 weeks.
* Inability to comply with study protocol requirements.
* Concomitant use of antiplatelet drugs, anticoagulants, or NSAIDs. Aspirin will be allowed for preeclampsia prevention.
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives containing substantial quantities of VWF within 5 days of study.
* History of renal disease.
* Inability to comply with study requirements.
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
|
NCT04344860
|
{
"brief_title": "Prevent Postpartum Hemorrhage in Women with Von Willebrand Disease: the VWD-WOMAN Trial",
"conditions": [
"Von Willebrand Diseases",
"Postpartum Hemorrhage"
],
"interventions": [
"Drug: Recombinant Von Willebrand factor",
"Drug: Tranexamic Acid Injection [Cyklokapron]"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04344860",
"official_title": "Prospective, Randomized Trial Comparing Recombinant Von Willebrand Factor (rVWF) Plus Tranexamic Acid Vs. RVWF Alone to Reduce Postpartum Hemorrhage in Women with Von Willebrand Disease: the VWD-WOMAN Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-28",
"study_completion_date(actual)": "2024-09-01",
"study_start_date(actual)": "2021-06-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-13",
"last_updated_that_met_qc_criteria": "2020-04-09",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-14",
"first_submitted": "2020-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension
#Intervention
- DRUG : brimonidine/timolol fixed combination
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of glaucoma or ocular hypertension in both eyes
* Patient requires IOP-lowering in both eyes
Exclusion Criteria:
* Uncontrolled medical conditions
* Contraindication to beta-andrenoceptor antagonist or brimonidine therapy
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00332345
|
{
"brief_title": "Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension",
"conditions": [
"Ocular Hypertension"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00332345",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1999-08",
"study_completion_date(actual)": "1999-08",
"study_start_date(actual)": "1999-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-05-30",
"last_updated_that_met_qc_criteria": "2006-05-30",
"last_verified": "2011-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-01",
"first_submitted": "2006-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.
#Intervention
- DRUG : Bevacizumab
- Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.
- Other Names :
- Avastin®
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab
* Participant who received only 1 cycle of bevacizumab maintenance treatment
* Meet summary of product characteristics guidelines
Exclusion Criteria:
* Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
* 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
|
NCT02093000
|
{
"brief_title": "A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma",
"conditions": [
"Lung Adenocarcinoma"
],
"interventions": [
"Drug: Bevacizumab"
],
"location_countries": [
"Hungary"
],
"nct_id": "NCT02093000",
"official_title": "A Multicenter, Prospective, Non-interventional Study of Maintenance Avastin® (Bevacizumab) Following Induction Treatment With Platinum Doublet Plus Avastin® in Patients With Advanced Lung Adenocarcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-31",
"study_completion_date(actual)": "2018-01-31",
"study_start_date(actual)": "2014-11-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-23",
"last_updated_that_met_qc_criteria": "2014-03-19",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-20",
"first_submitted": "2014-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.
#Intervention
- DRUG : Placebo
- one capsule BID
- DRUG : n-aceylcysteine
- 450 mgm BID
|
#Eligibility Criteria:
Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -
Exclusion Criteria: None, except known intolerance to n-acetylcysteine
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00609102
|
{
"brief_title": "Antioxidant Treatment of Type 2 Diabetes",
"conditions": [
"Type 2 Diabetes"
],
"interventions": [
"Drug: n-aceylcysteine",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00609102",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2008-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-24",
"last_updated_that_met_qc_criteria": "2008-01-23",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-06",
"first_submitted": "2008-01-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of EHCV containing Sofosbuvir, Ribavirin, and Natural anti-hemolytic (B) evaluating the safety and efficacy for both arms.
Sponsor: Wadi El Nil Hospital
Study Centers Planned: Approximately 2 sites in Egypt
Detailed Description
Study Design:
Part A
Randomized, open-label study in treatment naïve and treatment experienced adults with chronic genotype 4 HCV infection.
Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), RBV, or other approved or experimental HCV specific direct acting antivirals.
Treatment-experienced is defined as:
1. IFN Intolerant
2. Non-response
3. Relapse/Breakthrough
It is planned that 40 + 40 subjects will be enrolled in the study such that an approximate even number of treatment naïve and treatment experienced subjects will be enrolled across the 2 treatment arms:
Arm 1 Sofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks
Arm 2 Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg, and Natural anti-hemolytic (AH) at 200 mg for 12-24 weeks Treatment assignments will be stratified according to prior treatment experience and the presence or absence of cirrhosis.
Cohorts:
Cohort is a single-arm, open-label, non-randomized design in subjects who completed treatment in Part A of the study with SOF+RBV for 12-24 weeks or in Part B of the study with single dose EHCV (2 Tablet) containing SOF/RBV/AH FDC for 12-24 weeks.
Diagnosis and Main Eligibility Criteria: HCV RNA \> 104 IU/mL or HCV RNA \> LLOQ and did not achieve SVR 12 after completing prior treatment in this study with chronic genotype 4 HCV infection. Treatment-naïve or treatment experienced adults, male and non-pregnant/non-lactating female subjects, ages 18 years or older. See Section 1 and 1.2 of the protocol for detailed Inclusion and Exclusion criteria.
Study Procedures/
Frequency: Study visits for all subjects will occur at screening, Baseline/Day 1. On-treatment visits will occur as follows:
• Part A, Arm 1 and 2 - at the end of Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 All subjects will complete a 4-Week Post-treatment visit regardless of treatment duration. Subjects with HCV RNA \< LLOQ will continue to 12 Week and 24 Week Post treatment visits unless confirmed viral relapse occurs at which time subjects will be early terminated from the study.
Screening assessments include safety laboratory tests (chemistry, hematology, coagulation, and urinalysis), 12 lead ECG, HCV RNA, serology (HBV, and HIV), hemoglobin A1c, urine drug screen, liver imaging, serum B-hCG (for all female subjects of child-bearing potential), physical examination (with height and bodyweight), vital signs, medical history, concomitant medications, and adverse events. In addition, subjects being screened for Part A and Part B (Cohort 1) will have HCV genotyping and IL28B genotyping performed.
On-treatment assessments include safety laboratory tests (chemistry, hematology, and coagulation), HCV RNA, urine pregnancy tests (for all female subjects of child-bearing potential), physical examination, vital signs, concomitant medications, and adverse events.
Post-treatment assessments include HCV RNA, urine pregnancy tests (for all female subjects of child-bearing potential), vital signs, concomitant medications, and adverse events.
Samples will be collected at Baseline/Day 1 and every visit Plasma samples will be collected during treatment visits for pharmacokinetic (PK) analysis of study drug (Part A only). Untested samples will be archived for up to 10 years.
Test Product, Dose, and Mode of Administration: SOF is manufactured as a 400 mg tablet for oral administration. Subjects will take 1 tablet for a total dose of 400 mg orally once daily in the morning with RBV (1000 mg) splitted on 2 doses daily 600 mg on morning and 400 mg on evening and with food for 12-24 weeks.
The fixed dose EHCV combinations in Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg, and Natural anti-hemolytic (AH) at 200 mg. Subjects will take 2 tablet with food for 12-24 weeks.
Reference Therapy, Dose, and Mode of Administration: None
Criteria for Evaluation:
Safety: Adverse events will be collected from baseline through the 4 Week Post-Treatment Visit and AEs related to study procedures, will be collected from when subjects sign the consent form. Clinical laboratory tests will be performed during treatment through the 12 Week Post-Treatment Visit.
Efficacy: Efficacy will be evaluated using scheduled assessments of HCV RNA performed using COBAS® TaqMan® HCV Test, v2.0 for Use with the High Pure System.
PK Part A only. A single PK blood sample will be collected at all study visits while on Treatment.
Statistical Methods: The primary efficacy endpoint is SVR12 (ie, HCV RNA \< LLOQ 12 weeks post-treatment) in all subjects who are randomized and treated. No statistical hypothesis testing will be performed. For each of the two treatment groups, a 2-sided 95% confidence interval using the exact binomial distribution will be constructed.
Part A: With a sample size of 40 subjects in each arm, a two sided 95% exact confidence interval will extend at most 29% in length.
Part B: With a sample size of 40 subjects in each treatment group in Cohort 1, a 2-sided 95% exact confidence interval will extend at most 32% in length.
Secondary efficacy endpoints include the proportion of subjects with SVR4 and SVR24.
All continuous endpoints will be summarized using an 8 number summary (n, mean, standard deviation, and median, Q1, Q3, minimum, maximum) by treatment duration. All categorical endpoints will be summarized by number and percentage of subjects who meet the endpoint definition.
Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or using an 8 number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group.
Data from Part B will be analyzed separately from Part A and may be reported separately.
This study will be conducted in accordance with the guidelines of Good Clinical Practices (GCPs) including archiving of essential documents.
#Intervention
- DRUG : Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg
- The fixed dose EHCV combinations in Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg, and Natural anti-hemolytic (AH) at 200 mg. Subjects will take 2 tablet with food for 12-24 weeks.
- DRUG : Sofosbuvir tablet (SOF) 400 mg - once daily
- SOF is manufactured as a 400 mg tablet for oral administration. Subjects will take 1 tablet for a total dose of 400 mg orally once daily in the morning with RBV and with food for 12-24 weeks.
- DRUG : Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening
- RBV (1000 mg.) splitted on 2 doses daily - 600 mg on morning and 400 mg on evening with SOF and with food for 12-24 weeks.
|
#Eligibility Criteria:
Inclusion Criteria
Inclusion Criteria for Part A
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
* Willing and able to provide written informed consent.
* Male or female, age >= 18 years.
* HCV RNA >= 104 IU/mL at screening.
* Confirmed chronic HCV infection as documented by either:
a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
* HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation.
* The subject's medical records must be sufficient to categorize prior treatment history as one of the following:
i) IFN-intolerant: subject had documented intolerance to IFN during prior IFN therapy of up to 12 weeks duration ii) Non-response: subject did not achieve undetectable HCV RNA levels on treatment iii) Relapse/Breakthrough: subject achieved undetectable HCV RNA levels during treatment or within 4 weeks after treatment and later showed detectable HCV RNA
An Absence of cirrhosis is defined as any one of the following:
* Liver biopsy within 2 years of Screening showing absence of cirrhosis
* Fibroscan with a result of <= 12.5 kPa within 6 months of Baseline/Day1
* FibroTest score of <= 0.48 AND APRI of <= 1 performed during Screening In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test.
* Body mass index (BMI) >= 18 kg/m2.
* Screening ECG without clinically significant abnormalities.
* Subjects must have the following laboratory parameters at screening:
* ALT <= 10 x the upper limit of normal (ULN)
* AST <= 10 x ULN
* Hemoglobin >= 12 g/dL for male, >= 11 g/dL for female subjects
* Platelets > 50,000 cells/mm3
* INR <= 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
* Albumin >= 3 g/dL
* Direct bilirubin <= 1.5 x ULN
* HbA1c <= 10%
* Creatinine clearance (CLcr) >= 60 mL/min, as calculated by the Cockcroft-Gault equation
* Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
* A female subject is eligible to enter the study if it is confirmed that she is:
1. Not pregnant or nursing
2. Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years with cessation [for 12 months] of previously occurring menses), or
3. Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women <= 50 years with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 6 months after last dose of RBV:
* Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
Or
* Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 6 months after the last dose of RBV. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone-containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.
* Intrauterine device (IUD) with a failure rate of < 1% per year
* Female barrier method: cervical cap or diaphragm with spermicidal agent
* Tubal sterilization
* Vasectomy in male partner
* All male study participants must agree to consistently and correctly use a condom, while their female partner agrees to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive listed below, from the date of screening until 7 months after their last dose of RBV:
* Implants of levonorgestrel
* Injectable progesterone
* Oral contraceptives (either combined or progesterone only)
* Contraceptive vaginal ring
* Transdermal contraceptive patch
* Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
* Subject must be of generally good health as determined by the Investigator.
* Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Inclusion Criteria for Part B
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
* Willing and able to provide written informed consent.
* Male or female, age >= 18 years.
* HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation. Historical result from prior participation in this study is acceptable, if applicable.
* Cohort 1 only: HCV RNA >= 104 IU/mL at screening.
* Chronic HCV infection (>= 6 months) documented by medical history.
* Cohort 1 only: HCV treatment naïve, defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV specific direct acting antiviral agent
* BMI >= 18 kg/m2
Absence of cirrhosis is defined as any one of the following:
1. Liver biopsy within 2 years of Screening showing absence of cirrhosis
2. Fibroscan with a result of <= 12.5 kPa within 6 months of Baseline/Day1 C- Fibro Test score of <= 0.48 AND APRI of <= 1 performed during Screening
In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test.
* Screening ECG without clinically significant abnormalities.
* Subjects must have the following laboratory parameters at screening:
* ALT <= 10 x the upper limit of normal (ULN)
* AST <= 10 x ULN
* Hemoglobin >= 12 g/dL for male, >= 11 g/dL for female subjects
* Platelets > 50,000 cells/mm3
* INR <= 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
* Albumin >= 3 g/dL
* Direct bilirubin <= 1.5 x ULN
* HbA1c <= 10%
* Creatinine clearance (CLcr) >= 60 mL/min, as calculated by the Cockcroft-Gault equation
Subjects who received prior treatment in this study and who currently do not fulfill all of the above requirements may be enrolled in Part B Cohort 2 at the request of the Investigator and with the approval of the Medical Monitor or Study Director.
* Subject has not been treated with any investigational drug or device within 28 days of the Baseline/Day 1 visit.
* A female subject is eligible to enter the study if it is confirmed that she is:
D Not pregnant or nursing e Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years with cessation [for 12 months] of previously occurring menses), or
F Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women <= 50 years with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 30 days after the last dose of LDV/SOF or 6 months after last dose of RBV:
* Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
Or
* Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 30 days after the last dose of LDV/SOF or 6 months after the last dose of RBV.
* Intrauterine device (IUD) with a failure rate of < 1% per year
* Female barrier method: cervical cap or diaphragm with spermicidal agent
* Tubal sterilization
* Vasectomy in male partner
* Implants of levonorgestrel
* Injectable progesterone
* Oral contraceptives (either combined or progesterone only)
* Contraceptive vaginal ring
* Transdermal contraceptive patch
* All male study participants must agree to consistently and correctly use a condom from Baseline until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV. If their female partner is of childbearing potential (as defined above), she must use 1 of the methods of birth control listed above from the date of screening until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV.
* Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV or 90 days after their last dose of LDV/SOF, as applicable.
* Subject must be of generally good health as determined by the Investigator.
* Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Exclusion Criteria
Exclusion Criteria for Part A
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
* for treatment naïve subjects only: Prior exposure to IFN, RBV, or other approved or experimental direct-acting antiviral targeting the HCV.
* for treatment-experienced subjects: prior exposure to a NS5a inhibitor, NS5b nucleotide inhibitor, or NS5b non-nucleotide inhibitor targeting the HCV
* Pregnant or nursing female or male with pregnant female partner.
* Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
* Contraindication to RBV therapy e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
* History of malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.
* Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day).
* Clinically-relevant drug or alcohol abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription should be approved by the investigator.
* History of solid organ transplantation.
* Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
* History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
* History of significant pulmonary disease, significant cardiac disease or porphyria.
* Excessive alcohol ingestion, defined as 3 glasses/day (1 glass is equivalent to 284 mL beer, 125 mL wine, or 25 mL distilled spirits) for females and 4 glasses/day for males.
* History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
* Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.
* Known hypersensitivity to RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
Exclusion Criteria for Part B
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
* For treatment naïve subjects only (Cohort 1): Prior exposure to IFN, RBV, or other approved or experimental direct-acting antiviral targeting the HCV.
* Current or prior history of any of the following:
A Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) B Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol, or, current evaluation for a potentially clinically significant illness (other than HCV) C Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug D Solid organ transplantation E Significant pulmonary disease, significant cardiac disease or porphyria F Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 6 months prior to Baseline/Day 1 or that has not required medication in the last 12 months may be enrolled.
G Any malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.), or current evaluation for possible malignancy H Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy I Significant drug allergy (such as anaphylaxis or hepatotoxicity)
* Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Use of any prohibited concomitant medications
* Contraindication to RBV therapy, including significant history of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
* In the judgment of the investigatory, any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with subject treatment, assessment of compliance with the protocol
* Pregnant or nursing females or male with pregnant female partner
* Known hypersensitivity to RBV, SOF, or formulation excipients
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02483156
|
{
"brief_title": "Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection",
"conditions": [
"Hepatitis c"
],
"interventions": [
"Drug: Sofosbuvir tablet (SOF) 400 mg - once daily",
"Drug: Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg",
"Drug: Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT02483156",
"official_title": "Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2015-07"
},
"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)": "2016-10-17",
"last_updated_that_met_qc_criteria": "2015-06-24",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-26",
"first_submitted": "2015-06-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.
Detailed Description
Screening took place up to 90 days before quarantine. Volunteers completed an informed consent and underwent screening assessments to determine their eligibility.
There were 2 study groups:
Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to attend Quarantine on Day -2 or -1.
Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.
Volunteers remained in quarantine unit for 8 days after inoculation.
At day 28, end of study visit, volunteers seen and assessed by a study physician for well-being, on-going symptoms and adverse events.
#Intervention
- DRUG : PrEP-001
- Other Names :
- JNJ-43260295-AAM
- OTHER : Placebo Comparator
- Other Names :
- G-004
|
#Eligibility Criteria:
Inclusion Criteria:
* Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
* Female subjects were required to provide of a history of reliable contraceptive practice.
Exclusion criteria:
* Subjects who have a significant history of any tobacco use at any time.
* Any history or evidence of any clinically significant cardiovascular, dermatological gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal disease.
* Abnormal ECG
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
|
NCT03220048
|
{
"brief_title": "Study Examining PrEP-001 in Healthy Subjects",
"conditions": [
"Influenza A H3N2"
],
"interventions": [
"Drug: PrEP-001",
"Other: Placebo Comparator"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03220048",
"official_title": "A Phase II, Repeated Dose, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Healthy Subjects Subsequently Challenged With Influenza A/Perth/16/2009 (H3N2) Virus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2015-09-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-12",
"last_updated_that_met_qc_criteria": "2017-07-14",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-18",
"first_submitted": "2017-06-13",
"first_submitted_that_met_qc_criteria": "2019-10-23"
}
}
}
|
#Study Description
Brief Summary
The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.
#Intervention
- BIOLOGICAL : Monovalent A/H1N1 influenza vaccine
- This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups.
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females 6 months of age to 17 years on the day of enrollment;
* Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable;
* Individuals in good health;
* Subjects, subject's parents or legal guardians that are able to comply with all study procedures;
* Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion Criteria:
* Subject's parents or legal guardians who are not able to comprehend and to follow all required study procedures;
* Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
* Individuals with any serious chronic or progressive disease according to judgment of the investigator;
* History of any anaphylaxis, serious vaccine reactions to any excipients and to eggs (including ovalbumin) and chicken protein;
* Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1.
* Receipt of another investigational agent within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study;
* Individuals who receive any other vaccine 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within four weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until one week prior to and after one week study vaccinations;
* Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
* Individuals with axillary temperature >= 38.0 degrees Celsius within 3 days of intended study vaccination;
* Known or suspected alteration of immune function;
* History of progressive or severe neurologic disorder;
* Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
* If female, of childbearing potential, and has not used any of the 'acceptable contraceptive methods' for at least 2 months prior to study entry;
* Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
* Members of research staff or their relatives.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00971542
|
{
"brief_title": "Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age",
"conditions": [
"Pandemic Influenza"
],
"interventions": [
"Biological: Monovalent A/H1N1 influenza vaccine"
],
"location_countries": [
"Netherlands",
"Chile",
"Germany",
"Dominican Republic",
"Belgium"
],
"nct_id": "NCT00971542",
"official_title": "A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02",
"study_completion_date(actual)": "2011-07",
"study_start_date(actual)": "2009-09"
},
"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)": "2011-10-12",
"last_updated_that_met_qc_criteria": "2009-09-02",
"last_verified": "2011-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-03",
"first_submitted": "2009-09-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.
#Intervention
- BEHAVIORAL : COMB
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM)
Exclusion Criteria:
* Current suicidality or severe depression
* Current psychosis
* Current alcohol or substance abuse
* Concurrent psychotherapy for TTM
* Psychotropic meds (for any disorder) that have not been stable for >4 weeks
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
|
NCT01878110
|
{
"brief_title": "Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania",
"conditions": [
"Trichotillomania",
"Hair-Pulling Disorder"
],
"interventions": [
"Behavioral: COMB"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01878110",
"official_title": "Treatment Development Study of the COMB Model of Trichotillomania",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2013-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-15",
"last_updated_that_met_qc_criteria": "2013-06-12",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-14",
"first_submitted": "2013-06-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.
Detailed Description
Proof of Mechanism
#Intervention
- DRUG : PF-03715455
- 20mg, Inhaled, single dose
- DRUG : PH-797804
- 30mg, Oral, single dose
- DRUG : Placebo for PF-03715455
- Single dose, inhaled, Placebo for PF-03715455
- DRUG : Placebo for PH-797804
- Single Dose, Oral, Placebo for PH-797804
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female (of non-child bearing potential) subjects, aged 18 <= age <= 50 years.
* Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
* Subjects who have normoresponsive airways.
* Subjects who are able to successfully complete screening sputum inductions.
Exclusion Criteria:
* Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
* Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
* Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing
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
|
NCT01314885
|
{
"brief_title": "Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers",
"conditions": [
"Chronic Obstructive Pulmonary Disease (COPD)"
],
"interventions": [
"Drug: Placebo for PF-03715455",
"Drug: PH-797804",
"Drug: Placebo for PH-797804",
"Drug: PF-03715455"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01314885",
"official_title": "Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2011-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-02",
"last_updated_that_met_qc_criteria": "2011-03-14",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-15",
"first_submitted": "2010-11-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present study will refine and conduct a preliminary efficacy evaluation of Care to Plan. Care to Plan is an online care planning tool that provides a succinct and clear overview of various types of dementia caregiver interventions, administers a brief validated assessment of risk, and generates individualized recommendations for dementia caregivers as well as resources that link users to a selected recommendation.
There remains a lack of individualized information that can directly meet the diverse needs of caregivers or their relatives with Alzheimer's disease or a related dementia (ADRD). This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support.
Detailed Description
Given the well-documented health implications of dementia family caregiving, existing interventions are designed to modify the more challenging aspects of care for a relative with Alzheimer's disease or a related dementia (ADRD) in order to improve key outcomes. However, current research has yet to discern which caregivers are most likely to benefit from different types of interventions or services. There also remains a lack of individualized information that can directly meet the heterogeneous needs of caregivers or their relatives with ADRD. This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support. The research team has developed and tested the feasibility and utility of an online care planning tool prototype (called Care to Plan, or CtP) that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for ADRD caregivers as well as resources that link users to a selected recommendation. The goal of CtP is to offer a more efficient, user-directed process to link ADRD caregivers to the services that may be most appropriate for them given their needs, the needs of their relatives, and other contextual characteristics. We will deploy and more fully evaluate CtP for family caregivers of persons with ADRD who seek services in Riverside Health System (RHS) in the state of Virginia. The Specific Aims are to: 1) Implement CtP for 20 family members of persons with ADRD in four RHS clinical sites (Phase I) over a 1-month period; and 2) Evaluate the preliminary efficacy and implementation of CtP (Phase II) via an embedded randomized controlled evaluation for 100 newly enrolled ADRD caregivers over a 6-month period. We anticipate that the CtP will serve as an innovative, low-cost tool that both families and long-term service and support providers can utilize to better meet the diverse needs of family caregivers of persons with ADRD in their communities.
#Intervention
- BEHAVIORAL : Care to Plan
- Care to Plan (CtP) is an online care planning tool that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for Alzheimer's disease and related dementia (ADRD) caregivers as well as resources that link users to a selected recommendation. Caregivers will complete the tool with the guidance of a CtP interventionist (Senior Care Navigator/Riverside Health System staff). The interventionist will discuss CtP recommendations with caregivers and help caregivers enroll in a recommended support service if so desired.
- BEHAVIORAL : Usual Care
- Receive care as usual.
Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study.
|
#Eligibility Criteria:
Inclusion Criteria: The care recipient has received a provider diagnosis of Alzheimer's disease or a related dementia (ADRD); and 2) the caregiver is 21 years or older; 3) English-speaking; 4) self-identifies as someone who provides help to the person with ADRD because of their cognitive impairments; 5) the caregiver indicates a willingness to use Care to Plan (CtP); and 6) caregiver resides in one of 4 Riverside Health regions (based on zip code).
Exclusion Criteria: Those who do not meet the inclusion criteria above are not eligible. Additionally, those who endorse a history of a serious mental health disorder whose: a) symptoms have exacerbated in the last six months, and b) are not receiving steady, ongoing pharmacological or other treatment for these symptoms, will be excluded from the project.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03901456
|
{
"brief_title": "Care to Plan: a Tailored Resource for Family Members of Persons With Dementia",
"conditions": [
"Dementia",
"Alzheimer Disease",
"Memory Loss"
],
"interventions": [
"Behavioral: Usual Care",
"Behavioral: Care to Plan"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03901456",
"official_title": "Care to Plan: Preliminary Efficacy of a Tailored Resource for Family Members of Persons With Dementia",
"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)": "2019-09-01"
},
"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)": "2023-06-02",
"last_updated_that_met_qc_criteria": "2019-04-01",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-03",
"first_submitted": "2019-03-28",
"first_submitted_that_met_qc_criteria": "2023-06-01"
}
}
}
|
#Study Description
Brief Summary
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process.
Detailed Description
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.
The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:
Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:
1. Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.
2. The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.
1. Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit.
2. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.
3. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments
#Intervention
- BEHAVIORAL : Patient Preference in Treatment Decision Making
- The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Exclusion Criteria:
* Men with breast cancer.
* Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.
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
|
NCT03350854
|
{
"brief_title": "Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Behavioral: Patient Preference in Treatment Decision Making"
],
"location_countries": null,
"nct_id": "NCT03350854",
"official_title": "An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01-31",
"study_completion_date(actual)": "2017-08-09",
"study_start_date(actual)": "2016-03-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-22",
"last_updated_that_met_qc_criteria": "2017-11-20",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-22",
"first_submitted": "2017-10-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle prescription (Rx) program, supported by in-person coaching and innovative health technologies. The program improves the health of Canadians and reduces their risk for chronic disease by tackling three major risk factors that are shared across a number of chronic diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS participant receives an individualized healthy living Rx for exercise, physical activity (step counts) and healthy eating, supported by coaching and technology tools to promote long-term health behaviour change. For this study, the investigators will undertake a 6-month pilot pragmatic randomized controlled trial (RCT), conducted within 5 clinic settings in Southwestern Ontario. The primary aim is to conduct an outcome evaluation to determine the effectiveness of the HeS program in helping at-risk individuals increase physical activity levels, improve eating habits, and improve other health behaviours and health indicators.
Detailed Description
The HealtheSteps™ (HeS) program was developed to improve the health of Canadians and reduce their risk for chronic disease (CD) and brings together emerging evidence from the areas of physical activity, nutrition, behaviour change, health technologies, and knowledge transfer, and moves knowledge into practice. HeS is an evidence-based, viable, and scalable healthy lifestyle solution to tackle the epidemic of CD in Canada. HeS goes beyond traditional health promotion messaging to give individuals a specific plan of action to improve their health and provides community settings with hands-on training, and resources from study knowledge brokers (KBs) to facilitate program uptake and sustainability. The investigators suggest that a widely available HeS program has the potential to impact the lives of Canadians at-risk for and living with CD; shift practice patterns within Family Health Teams (FHTs), Community Health Centres (CHCs) and clinics; reduce health care costs associated with CD; and inform policy decisions about health resource allocation and human resource planning. A scaled-up HeS program will offer at-risk Canadians an opportunity to actively participate in an evidence-based, community-focused, affordable (no cost to participant), healthy lifestyle program supported by point-of-care coaching and innovative electronic Health (eHealth) technologies.
This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. It will take place within 5 clinic settings in Southwestern Ontario. Following assessment of eligibility and baseline measurements, participants will be individually randomized (1:1; stratified by clinical setting) to either the intervention group (receiving the HeS program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the HeS program after a 6 month delay. All participants (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 6 months in both groups; additional follow-up measurements will be taken in the intervention group only at 12 months and again at 18 months (from baseline). Groups will be compared at 6-months in order to examine effectiveness of the HeS program; further, follow-up to 12 and 18 months will be used to look at maintenance of any changes in the intervention group only.
#Intervention
- BEHAVIORAL : HealtheSteps Program
- 6-month evidence-based lifestyle Rx program: At set time points over the 6-month period, participants have in-person visits with a HeS coach at the clinic setting. At each in-person session, the participant receives an individualized Rx for exercise, physical activity (step count) and healthy eating. The HeS Coach and participant then engage in a coaching/goal setting conversation to set detailed plans and goals to achieve their prescriptions. Participants independently choose which activities they will take part in to achieve their lifestyle Rx's and goals. In between in-person sessions, the participants have access to a suite of free-of-charge health technology support tools to: a) track their exercise, physical activity, and healthy eating; and b) receive virtual coaching and support.
|
#Eligibility Criteria:
Inclusion Criteria:
* One or more self-reported or measured risk factors for chronic disease including: a) objectively-measured body-mass index of greater than or equal to 25 kg/m2; b) less than 150 minutes of exercise per week; c) greater than 3 hours of sitting per day; d) less than 8 fruit and vegetable servings per day; e) diagnosis of metabolic syndrome or type 2 diabetes
* Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering 'No' to all questions or receiving clearance from a healthcare provider)
Exclusion Criteria:
* Unable to comprehend letter of information and consent documentation
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
|
NCT02413385
|
{
"brief_title": "Evidence-Based Lifestyle Prescription Program: Pilot Study",
"conditions": [
"Chronic Disease",
"Sedentary Lifestyle",
"Overweight"
],
"interventions": [
"Behavioral: HealtheSteps Program"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02413385",
"official_title": "Canadian Diabetes Strategy Research Project - HealtheSteps™: Exercise and Healthy Eating Prescriptions to Reduce the Risk of Diabetes in Rural and Remote Communities: A Pilot Pragmatic Randomized Controlled Trial (Project 3).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2017-03",
"study_start_date(actual)": "2015-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-09-28",
"last_updated_that_met_qc_criteria": "2015-04-06",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-09",
"first_submitted": "2015-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 \& 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.
#Intervention
- DRUG : Indomethacin
- Indomethacin was given via suppository at time of induction for anesthesia (2 x 50 mg) followed by one 50 mg suppository at 6, 12, 18 and 24 hours following cardiac bypass surgery.
- Other Names :
- Indocin
- DRUG : Acetaminophen & Indomethacin
- Subjects were given a loading dose of acetaminophen (1300 mg) and indomethacin (50 mg)by suppository at the time of induction for anesthesia and then given 650mg acetaminophen + 25 mg indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.
- Other Names :
- Tylenol, Indocin
- DRUG : Acetaminophen
- Subjects were given a loading dose of 2600 mg of acetaminophen (via suppository) at time of induction for anesthesia then given 1300mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
- Other Names :
- Tylenol
|
#Eligibility Criteria:
Inclusion Criteria:
* scheduled to undergo either elective coronary artery bypass or single valve replacement
* normal platelet count
* normal prothrombin time
* normal partial thromboplastin time
* normal serum creatinine
Exclusion Criteria:
* sensitivity to study drugs
* history of bleeding diathesis
* renal dysfunction
* active peptic ulcer
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01073670
|
{
"brief_title": "Indomethacin and Cardiac Bypass Surgery",
"conditions": [
"Hemorrhage"
],
"interventions": [
"Drug: Acetaminophen",
"Drug: Indomethacin",
"Drug: Acetaminophen & Indomethacin"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01073670",
"official_title": "Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-04",
"study_completion_date(actual)": "2002-04",
"study_start_date(actual)": "2000-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-02-23",
"last_updated_that_met_qc_criteria": "2010-02-22",
"last_verified": "2010-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-23",
"first_submitted": "2010-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of Caucasian men and women, respectively, over the age of 50. The percentage of men and women affected over the age of 70 increases to 80% and 60% of Caucasian men and women, respectively. Although alopecia is considered a minor dermatologic condition, it is seen as a serious condition with major life consequences by those with alopecia and has been associated with increased incidence of myocardial infarction, hypertension and hypercholesterolaemia. Androgenetic alopecia is associated with feelings of anxiety, depression and various personality disorders among men and women due to physical appearance. Depression, anxiety, aggressiveness, impaired quality of life and social inadequacy have been documented. The presence of alopecia in women is particularly stressful.
ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells, include regenerative cell populations derived from adipose tissue and thus are potentially important to multiple disease processes and therapeutic applications for the repair and regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells may promote hair regeneration by increasing the hair-inducing ability of dermal papillae (DP) cells.
The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF cells for the treatment of alopecia.
Detailed Description
This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study to determine initial safety and feasibility of a single injection of autologous adipose-derived SVF cells for the treatment of alopecia.
Up to 8 subjects who have been diagnosed with androgenetic alopecia will be asked to participate. Before the procedure the density (number of hairs per square centimeter) and thickness (mm) of the hair will be measured and compared to the same measurements after the procedure. All adverse events will be recorded and evaluated for severity.
Subjects will be asked to come into the office on the following days: pre-procedure visit, 24 hours post procedure visit, 6 weeks post procedure visit, 3 months post procedure visit and 6 months post procedure visit.
#Intervention
- PROCEDURE : Stromal Vascular Fraction Cells (SVF Cells) Injection
- The procedure involves the injection of stromal vascular fraction cells (SVF Cells) into the scalp. The injection will be performed once in the middle of two perpendicular sides of a 2 x 2 cm area.
- Other Names :
- SVF Cells
- PROCEDURE : Liposuction
- Tissue collection involving the micro-harvest of subcutaneous adipose tissue to harvest the stromal vascular fraction cells (SVF Cells).
- Other Names :
- Collection of adipose tissue
- OTHER : Hair Measurements
- Hair measurements will be performed using a computerized handheld USB camera at baseline, 6 weeks, and months 3 and 6 after treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects will be in good health (ASA Class I-II) with a BMI < 35.
* Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
* Able and willing to make the required study visits.
* Able and willing to give consent and follow study instructions.
* Must speak, read and understand English
Exclusion Criteria:
* History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
* Allergic to lidocaine, epinephrine, Vancomycin, cephalexins, cephalosporins, penicillins, chlorhexidine gluconate, or tattoo ink
* Individuals with a propensity for keloids
* Individuals with diminished decision-making capacity will not be included in this research study.
* Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin).
* Use of concomitant treatments to improve hair growth, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
* Smoking and other tobacco use.
* Pregnancy or lactating period for females
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02729415
|
{
"brief_title": "Point-of-Care Adipose-derived Cells for Hair Growth",
"conditions": [
"Androgenetic Alopecia"
],
"interventions": [
"Other: Hair Measurements",
"Procedure: Stromal Vascular Fraction Cells (SVF Cells) Injection",
"Procedure: Liposuction"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02729415",
"official_title": "Point-of-Care Adipose-derived Cells for Hair Growth",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-31",
"study_completion_date(actual)": "2019-01-31",
"study_start_date(actual)": "2016-10"
},
"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)": "2019-03-25",
"last_updated_that_met_qc_criteria": "2016-03-31",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-06",
"first_submitted": "2016-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In Spain, an estimated 690,000 persons have epilepsy, of whom 270,000 have active epilepsy (defined as those who have had a seizure in the last 5 years). It is estimated that 30% of patients diagnosed with epilepsy are drug-resistant. Patients with loss of consciousness or impaired awareness during seizures are at higher risk of injury due to accidents. To prevent such injuries, it is important that patients are sufficiently knowledgeable about their disease to allow them to avoid risk behavior.
In this project, we want to know if visualization of self seizures has an impact on the perception of the severity of the disease, as well as on the risky behavior habits.
Detailed Description
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care.
Main aims:
To determine whether self-visualization of seizures in patients with epilepsy modifies risk perception compared with patients not viewing their own seizures.
To determine whether viewing their seizures leads patients with epilepsy to plan changes in their risk behavior compared with patients not viewing their own seizures.
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care.
Sample size: Accepting an alpha risk of 0.05 and a beta risk lower than 0.2 on bilateral comparison, 50 participants will be needed in the intervention group and 25 in the control group to detect statistically significant differences between the proportion of patients showing behavioral change. It is expected that behavioral change will occur in 40% of the intervention group and 10% of the control group and that losses to follow-up will be 10%.
Variables: Sociodemographic, risk perception, intention to change behavior, perception of disease severity, quality of life, mood/depression, personality traits, anxiety.
Data collection: pre and post visualization of self seizures, and three months after discharge.
A descriptive analysis will be performed, with percentages and frequencies for qualitative variables and mean ± standard deviation (or median \[range\] depending on the normality of the distribution) for quantitative variables. Inferential analysis will be conducted with the chi-square test or nonparametric tests depending on the behavior of the variables obtained.
This project has been approved by the Clinical Research Ethics Committee of the hospital performing the study.
#Intervention
- PROCEDURE : own seizures visualization
- At the hospital discharge, patients
|
#Eligibility Criteria:
Inclusion Criteria:
* for the control group: patients aged >= 18 years admitted to the Epilepsy Unit of Hospital del Mar who voluntarily accept to participate in the study after prior psychological assessment.
* for the control group: patients admitted to the Epilepsy Unit of Hospital Germans Tries who voluntarily accept to participate in the study.
Exclusion Criteria:
* Patients with no risk behavior according to the ad hoc questionnaire administered on admission.
* Cognitive impairment preventing adequate comprehension of the study.
* Vision-impaired patients and those with language barriers.
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
|
NCT04311151
|
{
"brief_title": "Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior",
"conditions": [
"Epilepsy",
"Epilepsy; Seizure",
"Risk Behavior",
"Risk-Taking"
],
"interventions": [
"Procedure: own seizures visualization"
],
"location_countries": null,
"nct_id": "NCT04311151",
"official_title": "Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-31",
"study_completion_date(actual)": "2020-02",
"study_start_date(actual)": "2017-01-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-17",
"last_updated_that_met_qc_criteria": "2020-03-14",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-17",
"first_submitted": "2020-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly adult male subjects.
#Intervention
- DRUG : ASP8825
- Oral
- Other Names :
- gabapentin enacarbil
|
#Eligibility Criteria:
Inclusion Criteria:
* Body weight: >=50.0 kg and <80.0 kg
* Body mass index BMI: >=17.6 and <26.4 [BMI= Body weight (kg)/(Height (m))2]
Exclusion Criteria:
* Subjects who received any study drugs in other clinical trials or post-marketing studies within 120 days before screening
* Subjects who received or are scheduled to receive medications (including over-the-counter [OTC] drugs) within seven days before the hospital admission day of period 1.
* Subjects who deviate from the normal range of blood pressure, pulse rate, body temperature and standard 12-lead ECG at screening or the hospital admission day of period 1
* Subjects who meet any of the criteria for laboratory tests at screening or the hospital admission day of period 1. Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
* Subjects with a complication of drug allergies
* Subjects who developed upper gastrointestinal symptoms (e.g., nausea, vomiting, and stomachache) within seven days before the hospital admission day of period 1
* Subjects with a complication or history of hepatic disease (hepatitis viral and drug-induced liver injury, etc.)
* Subjects with a complication or history of heart disease (cardiac failure congestive, angina pectoris and arrhythmia requiring treatments, etc.)
* Subjects with a complication or history of respiratory disease (severe asthma bronchial and bronchitis chronic, etc.) (except for a history of non-severe infantile asthma)
* Subjects with a complication or history of alimentary disease (severe peptic ulcer, reflux esophagitis, etc.) (except for a history of appendicitis)
* Subjects with a complication or history of renal disease (acute kidney injury, glomerulonephritis, nephritis interstitial, etc.) (except for a history of calculus)
* Subjects with a complication or history of cerebrovascular disorder (cerebral infarction, etc.)
* Subjects with a complication or history of malignant tumor
* Subjects who have a habit of excessive alcohol drinking or smoking
* Subjects who previously received administration of ASP8825
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 44 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02632331
|
{
"brief_title": "ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: ASP8825"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT02632331",
"official_title": "Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-02",
"study_completion_date(actual)": "2009-02",
"study_start_date(actual)": "2009-01"
},
"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)": "2015-12-16",
"last_updated_that_met_qc_criteria": "2015-12-14",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-16",
"first_submitted": "2015-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
the study will measure the decrease in redness on the face of rosacea subjects
#Intervention
- DRUG : Oxymetazoline
- RLD
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-lactating female, 18 years or older.
* Signed informed consent form that meets all criteria of current Food and Drug Administration regulations.
* Females of childbearing potential must not be pregnant or lactating.
* Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
* Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
* Have < 3 inflammatory lesions on the face.
* Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that is reflective of the overall targeted areas.
* Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional stress and alcoholic beverages) during the study.
Exclusion Criteria:
* Forms of rosacea that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of study endpoints
* Patient has a skin condition that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of rosacea
* Patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc.
* Patients with moderate to severe telangiectasial masses
* History of blood dyscrasia.
* Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the Investigator, would put the subject at undue risk or compromise the study assessments.
* History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would place the subject at undue risk.
* Female patients taking hormonal contraceptives or oral estrogen for less than one month or those that plan to change the dosage regimen during the course of the study.
* Previous participation in this study.
* Employees of the Investigator or research center or their immediate family members.
* Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
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
|
NCT03352323
|
{
"brief_title": "An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea",
"conditions": [
"Rosacea",
"Erythema"
],
"interventions": [
"Drug: Oxymetazoline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03352323",
"official_title": "Evaluation of the Reduction in Erythema by Oxymetazoline Hydrochloride Topical Cream, 1% in Adults With Moderate to Severe Facial Erythema Associated With Rosacea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-06",
"study_completion_date(actual)": "2018-03-30",
"study_start_date(actual)": "2017-10-18"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-08",
"last_updated_that_met_qc_criteria": "2017-11-21",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-24",
"first_submitted": "2017-11-07",
"first_submitted_that_met_qc_criteria": "2020-12-09"
}
}
}
|
#Study Description
Brief Summary
The investigators want to test in this non-randomized clinical trial a new method of administrating Pilocarpine medicine into the skin during the Sweat testing process that does not use any electrical current.
Detailed Description
Sweat collection tests are done when a patient is suspected of having cystic fibrosis. This procedure for collection of sweat samples is called the Sweat Test and the measurement of sweat chloride concentration from the collected sweat sample is the gold standard for the diagnosis of Cystic Fibrosis.
When the sweat test is performed for patients in a hospital lab, the standard method uses a small electrical current to push pilocarpine medicine into the skin of the forearm, after which sweat is collected for testing. However, many people do not make enough sweat during this standard method of testing and have to come back for repeated testing. The investigators want to test a new method of putting Pilocarpine medicine into the skin during the Sweat testing process that does not use any electrical current.
The testing will be done once for every participant and no further follow up or additional testing is needed. The study team plans to invite healthy adults who are not taking any medicines to participate through a flyer posted in Emory Children's Center bulletin board. For those interested in participating, the study will be explained to them in detail and an informed consent will be obtained. The subjects will be asked to sit for 45 minutes on a chair as the study related procedures are completed on their arms. The right forearm will be used for pilocarpine iontophoresis method and the left forearm will be used for microneedle-based stimulation method for a period of 5 minutes. An additional microneedle control patch (without any Pilocarpine) will be placed on the left forearm to make sure that there are no skin changes from the microneedles. After the first 5 minutes, the sweat collection devices (Macroduct) will be placed on both forearms to collect sweat samples from each site. After the completion of this 30-minute collection phase, the Macroduct collectors will be removed by the study team and the subject testing will be complete. The study team will store the sweat samples to measure their chloride concentration at the end of the enrollment phase of the study.
This study will be conducted in a research room at Emory Children's Center and no compensation will be provided to the participants. At the end of the study, the research team will compare the two methods based on how much sweat was produced in each individual's arms with either of these methods. The results of this study will help to improve the current technique of sweat testing and help reduce the need for repeated testing in patients being evaluated for Cystic Fibrosis.
#Intervention
- DEVICE : Pilocarpine microneedle patch
- Each microneedle (MN) patch contains an array of solid, water-soluble, micron-scale needles that encapsulate the medication (Pilocarpine). The patch form can be placed directly on the skin.
- Other Names :
- Microneedle patch
- DEVICE : Pilocarpine Iontophoresis
- Pilocarpine Iontophoresis is a process of transdermal pilocarpine delivery by use of a voltage gradient on the skin. An agar gel disc containing pilocarpine is placed under the electrodes which are connected to the Macroduct 3700 Sweat Inducer device.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >18 years
* Signed a written informed consent
* Not taking any medications
* No known medical diagnoses or chronic conditions
Exclusion Criteria:
* Age <18 years
* Family history of Cystic Fibrosis
* History of skin disorders (eczema, psoriasis etc.) that could prevent sweat testing on forearms
* Current medication use
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
|
NCT04732195
|
{
"brief_title": "Pilocarpine Microneedles for Sweat Induction (PMN-SI)",
"conditions": [
"Cystic Fibrosis"
],
"interventions": [
"Device: Pilocarpine microneedle patch",
"Device: Pilocarpine Iontophoresis"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04732195",
"official_title": "A Pilot Study to Compare the Efficacy of Pilocarpine Microneedles With Iontophoresis Method for Sweat Induction in Healthy Human Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-17",
"study_completion_date(actual)": "2022-03-17",
"study_start_date(actual)": "2022-01-20"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-22",
"last_updated_that_met_qc_criteria": "2021-01-28",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-01",
"first_submitted": "2021-01-25",
"first_submitted_that_met_qc_criteria": "2023-04-26"
}
}
}
|
#Study Description
Brief Summary
The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.
#Intervention
- PROCEDURE : robot-assisted surgery
- da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
- PROCEDURE : laparoscopic right-hemicolectomy
- Conventional laparoscopic procedures
|
#Eligibility Criteria:
Inclusion Criteria:
* primary cancer
* right-side located tumor (from cecum to proximal transverse colon)
Exclusion Criteria:
* tumor with obstruction
* tumor with perforation
* clinically advanced tumor (T4 stage)
* tumor with distant metastases
* synchronous tumor
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
|
NCT01042743
|
{
"brief_title": "Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial",
"conditions": [
"Colon Cancer"
],
"interventions": [
"Procedure: laparoscopic right-hemicolectomy",
"Procedure: robot-assisted surgery"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01042743",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2010-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-12-20",
"last_updated_that_met_qc_criteria": "2010-01-05",
"last_verified": "2011-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-06",
"first_submitted": "2010-01-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.
Patients were divided into three equal groups:
Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.
Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.
Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).
Detailed Description
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.
For each patient:
1. Complete history was taking to exclude allergy to hyoscine butylbromide, medical disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease ...etc.) and any contraindication for vaginal delivery.
2. General examination of the patients including (pulse, blood pressure, temperature).
3. Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
4. Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
5. Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of liquor, site of placental attachment and fetal heart rate.
Patients were divided into three equal groups:
Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.
Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.
Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).
#Intervention
- DRUG : hyoscine butylbromide
- Intravenous administration of hyoscine butylbromide during first stage of labor
- Other Names :
- Dospa
- DRUG : placebo
- 2ml of saline intravenous
- Other Names :
- saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 35 years
* Primigravdae or multigravida
* Gestational age between completed 37- 41 weeks + 6 days.
* Uncomplicated cephalic singleton pregnancy occipto-anterior position.
* Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
* Intact amniotic membranes.
* High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus
Exclusion Criteria:
* Multigravidae.
* Multiple fetus.
* Malpresentation.
* Patients with indications of elective caesarean section.
* Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
* Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
* Patients presented to causality with spontaneous rupture of membranes.
* Spontaneous rupture of membranes during the active phase of first stage of labour.
* Oxytocin induction or augmentation.
* Patients who underwent epidural anesthesia or other types of analgesia
Sex :
FEMALE
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
|
NCT03055390
|
{
"brief_title": "Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women",
"conditions": [
"Vaginal Delivery"
],
"interventions": [
"Drug: hyoscine butylbromide",
"Drug: placebo"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03055390",
"official_title": "Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-10",
"study_completion_date(actual)": "2022-02-03",
"study_start_date(actual)": "2017-02-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-10",
"last_updated_that_met_qc_criteria": "2017-02-14",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-16",
"first_submitted": "2017-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the 'open lung approach' providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery.
Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.
Detailed Description
Research questions
1. Does mechanical ventilation with the use of higher levels of PEEP(Positive End Expiratory Pressure) and intra-operative RMs (Recruitment maneuvers) protect against pulmonary complications in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
2. Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs protect against extra-pulmonary complications in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
3. Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs shorten length of hospital stay of patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
4. Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs ameliorate post-operative wound healing in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
5. Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs attenuate post-operative unexpected need for ICU admission (i.e., before surgery the patient is not scheduled for admission to the ICU, but eventually is admitted) or ICU readmission in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
6. Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs influence intra-operative complications related to the ventilator strategy (i.e., de-saturation, hypotension during recruitment, need for vasopressors) or ICU readmission in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
Methods In this international randomized controlled trial all patients with high or intermediate risk for post-operative pulmonary complications following non-laparoscopic abdominal surgery with general anesthesia are eligible for participation. To identify such patients the ARISCAT risk score is used.
Patients are randomly assigned to mechanical ventilation with levels of PEEP at 12 cmH2O with the use of recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with levels of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy).
Patients are ventilated with a volume-controlled mechanical ventilation strategy. Although it is left to the discretion of the attending anesthesiologist to use different fractions of inspired oxygen, it is advised to use at least 0.4, with the lowest oxygen fraction to maintain oxygen saturation ≥ 92%. The I:E ratio is set at 1:2, and the respiratory rate is adjusted to reach normocapnia (etCO2 between 35 and 45 mmHg). Tidal volumes of \< 8 mL/kg predicted body weight (PBW) are advised to be used.
Recruitment maneuvers, as part of the lung-protective strategy, are performed directly after intubation, after any disconnection from the mechanical ventilator, and directly before tracheal extubation. Recruitment maneuvers should not be performed when patients are hemodynamic unstable, as judged by the attending physician. To obtain standardization among centers, recruitment maneuvers are performed as follows:
1. peak inspiratory pressure limit is set at 45 cmH2O
2. tidal volume is set at 8 ml/kg PBW and respiratory rate at 6-8 breaths/min (or lowest respiratory rate that anesthesia ventilator allows), while PEEP is set at 12 cmH2O
3. inspiratory to expiratory ratio (I:E) is set at 1:2
4. tidal volumes are increased in steps of 4 ml/kg PBW until a plateau pressure of 30-35 cmH2O
5. 3 breaths are administered with a plateau pressure of 30-35 cmH2O
6. peak inspiratory pressure limit, respiratory rate, I:E, and tidal volume are set back to settings preceding each recruitment maneuver, while maintaining PEEP at 12 cmH2O
The study protocol stresses that routine general anesthesia, post-operative pain management, physiotherapeutic procedures and fluid management must be used in the peri-operative as well as the post-operative period according to each centers specific expertise and routine clinical use, to minimize interference with the trial intervention.
Centres The investigators aim to recruit as many centres as possible worldwide, but expect a minimum of 40 centres.
Ethics approval National co-ordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centres will not be permitted to record data unless ethics approval or an equivalent waiver is in place. The investigators expect that in most, if not every participating country, a patient informed consent will be required.
Monitoring Monitoring of patient safety and reviewing of safety issues is performed by a designated independent Data Safety and Monitoring Board. The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki. All (serious) adverse events will be collected by the National Coordinators and sent in a blinded fashion to a designated SAE manager, who presents the events to the DSMB for evaluation.
Interim analysis One main concern is not to withhold positive effects of the open lung mechanical ventilation strategy to the control group. Therefore, interim analyses are performed after 300 and 600 patients. The first interim analysis is performed when 300 patients have successfully been included and followed-up. If the intervention has a strong trend for improving post-operative pulmonary complications (as defined above) with a p-value \< 0.0005 is found at 300 patients or \< 0.014 at 600 patients, termination of the study is considered. The third and final analysis is performed at 900 patients with a p-value of 0.045 for significance. When post-operative pulmonary complications occur significantly more frequent in the intervention group, terminating the study due to harm will be considered when p ≤ 0.022 for each interim analysis.
Blinding The patient is blinded for the allocated treatment during the trial. In the participating centers at least 2 investigators are involved with the study. One researcher is involved with mechanical ventilation practice in the operation room, he/she will be blinded for the randomized intervention most closely to the time of tracheal intubation (depending on local situation) - the second investigator, blinded for randomization arm, will score the primary and secondary post-operative endpoints.
Data collection Data will be collected at inclusion pre-operatively, intra-operatively and post-operatively on day 1, day 2, day 3, day 4, day 5, day of discharge and on day 90. Data collection will be performed by an investigator blinded for the randomization group at the bedside, except on day 90 if the patient is discharged. In that case follow-up will be performed by telephone. Data will be coded by a patient identification number (PIN) of which the code will be kept safe at the local sites. The data will be transcribed by local investigators onto an internet based electronic CRF.
Sample size calculation The required sample size is calculated from an estimated effect size derived from data collected in the ARISCAT study and previous studies on the incidence of postoperative pulmonary complications. A two group χ2 test with a 0.05 two-sided significance level will have 80% power to detect the difference (in post-operative pulmonary complications) between conventional mechanical ventilation (24%) and open lung mechanical ventilation (16.5%) (Odds ratio of 0.626) when the sample size in each group is 450.
Statistical analysis Normally distributed variables will be expressed by their mean and standard deviation; not normally distributed variables will be expressed by their medians and interquartile ranges; categorical variables will be expressed as n (%). In test groups of continuous normally distributed variables, Student's t-test will be used. Likewise if continuous data are not normally distributed the Mann-Whitney U test will be used. Categorical variables will be compared with the Chi-square test or Fisher's exact tests or when appropriate as relative risks. Where appropriate statistical uncertainty will be expressed by 95% confidence levels.
Primary outcome is the total occurrence of pulmonary complications within the first 5 post-operative days, presented as a percentage. The percentage will be analyzed as continuous data. If the data is normally distributed, Student's t-test will be used or when not normally distributed the Mann-Whitney U test will be used.
As this is a randomized controlled trial, we expect that randomization in this large study population will sufficiently balance the baseline characteristics. Baseline balance is tested and imbalance compensated in all pre-operative variables and on ARISCAT scores. However if imbalance occurs, the confounding factor will be corrected using a multiple logistic regression model. For this we will treat the proportion as a binary response (complications occur during day one to day five post-operative).
Time to event variables (primary and secondary outcomes) are analyzed using a proportional hazard model adjusted for possible imbalances of patients' baseline characteristics. Time course variables (e.g. repeated measures of vital parameters, blood values, VAS-scores, actual mobility) are analyzed by a linear mixed model. The linear mixed models procedure expands the GLM so that the data are permitted to exhibit correlated and non-constant variability. The model includes two factors: 1) study group (fixed factor, intervention or control group), each level of the study group factor can have a different linear effect on the value of the dependent variable; 2) time as a covariate, time is considered to be a random sample from a larger population of values, the effect is not limited to the chosen times.
Organization The study is conducted by the PROVHILO collaboration. National co-ordinators will lead the project within individual nations and identify participating hospitals, translate study paperwork, distribute study paperwork and ensure necessary regulatory approvals are in place. They provide assistance to the participating clinical sites in trial management, record keeping and data management. Local coordinators in each site will perform randomization and mechanical ventilation, supervise data collection and ensure adherence to Good Clinical Practice during the trial.
Study Population Adult patients with high or intermediate risk for postoperative pulmonary complications undergoing open abdominal surgery with general anesthesia
#Intervention
- PROCEDURE : Lung protective strategy ventilation
- Patients are randomized and intra-operatively ventilated with a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers)
|
#Eligibility Criteria:
Inclusion Criteria:
* Open abdominal surgery
* General anesthesia
* High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]
Exclusion Criteria:
* Age > 18 years
* Body mass index > 40 kg/m2
* Laparoscopic surgery
* Previous lung surgery (any)
* Persistent hemodynamic instability, intractable shock (considered hemodynamic unsuitable for the study by the patient's managing physician)
* History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
* Recent immunosuppressive medication (receiving chemotherapy or radiation therapy within last 2 months)
* Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's)
* Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days
* Pregnancy (excluded by laboratory analysis)
* Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
* Neuromuscular disease (any)
* Consented for another interventional study or refusal to participate in the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01441791
|
{
"brief_title": "PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery",
"conditions": [
"Postoperative Respiratory Complications"
],
"interventions": [
"Procedure: Lung protective strategy ventilation"
],
"location_countries": [
"Netherlands",
"United States",
"Chile",
"Belgium",
"Germany",
"Austria",
"Spain",
"Italy",
"Croatia",
"United Kingdom"
],
"nct_id": "NCT01441791",
"official_title": "Protective Ventilation During General Anesthesia for Open Abdominal Surgery - a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2011-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-09",
"last_updated_that_met_qc_criteria": "2011-09-26",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-28",
"first_submitted": "2011-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
#Intervention
- DEVICE : Respimat inhaler
- Respimat inhaler
- DRUG : tiotropium+olodaterol (low dose)
- 2.5 µg tiotropium + 5 µg olodaterol
- DRUG : tiotropium + olodaterol (high dose)
- 5 µg tiotropium + 5 µg olodaterol
- DEVICE : Respimat inhaler
- Respimat inhaler
- DEVICE : Respimat inhaler
- Respimat inhaler
- DRUG : placebo to tiotropium+olodaterol
- comparator
|
#Eligibility Criteria:
Inclusion criteria:
* All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
* All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with, at visit 1:
a post-bronchodilator 30% <= FEV1 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1
* Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years Patients who have never smoked cigarettes must be excluded.
* Patients must be able to perform technically acceptable pulmonary function tests (spirometry), must be able to complete multiple symptom-limited cycle ergometry tests (and for a subset also shuttle walk tests), as required in the protocol.
* Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
Exclusion criteria:
* Patients with a significant disease other than COPD
* Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN will be excluded regardless of clinical condition
* Patients with a history of asthma
* A diagnosis of thyrotoxicosis
* A diagnosis of paroxysmal tachycardia (>100 beats per minute)
* A history of myocardial infarction within 1 year of screening visit (Visit 1)
* Unstable or life-threatening cardiac arrhythmia
* Hospitalized for heart failure within the past year
* Known active tuberculosis
* A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
* A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure
* A history of cystic fibrosis
* Clinically evident bronchiectasis
* A history of significant alcohol or drug abuse
* Any contraindications for exercise testing
* Patients who have undergone thoracotomy with pulmonary resection
* Patients being treated with any oral ß-adrenergics
* Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
* Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
* Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
* Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea or morbid obesity
* Patients with an endurance time >=25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry
* Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1)
* Patients with known hypersensitivity to ß-adrenergic drugs, anticholinergic drugs, BAC, EDTA or any other component of the RESPIMAT inhalation solution delivery system
* Pregnant or nursing women
* Women of childbearing potential not using a highly effective method of birth control.
Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
* Patients who have previously been randomized in this study or are currently participating in another study
* Patients who are unable to comply with pulmonary medication restrictions prior to randomization
At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests:
* Patients who complete level 12 at the incremental shuttle walk test at visit 1a.
* Patients with an endurance time >=15 minutes during the training (Visit 2a) or baseline (visit 3a) endurance shuttle walk test.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01525615
|
{
"brief_title": "A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Drug: tiotropium+olodaterol (low dose)",
"Drug: placebo to tiotropium+olodaterol",
"Drug: tiotropium + olodaterol (high dose)",
"Device: Respimat inhaler"
],
"location_countries": [
"France",
"Italy",
"United States",
"Germany",
"Canada",
"Hungary",
"Spain",
"Argentina",
"Finland",
"United Kingdom"
],
"nct_id": "NCT01525615",
"official_title": "A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2012-02"
},
"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)": "2016-08-29",
"last_updated_that_met_qc_criteria": "2012-02-01",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-03",
"first_submitted": "2012-02-01",
"first_submitted_that_met_qc_criteria": "2015-08-12"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics (PK) of NNZ-2566 in healthy volunteers, when administered orally.
Detailed Description
Double-blind, placebo-controlled, randomized (with a 6:2 randomization for active versus placebo) safety, dose-escalation, and pharmacokinetic study of NNZ-2566.
Three cohorts will be sequentially dosed, starting with two cohorts receiving a single dose (6mg/kg followed by 30mg/kg). The third cohort will receive two 100mg/kg doses over the course of one day and following a formal safety review the same subjects will then receive two 100mg/kg doses each day for five days.
#Intervention
- DRUG : NNZ-2566
- Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.
- Other Names :
- NNZ-2566 Lot NNZP25
- DRUG : Placebo
- Lemon flavoured cordial and Water for Injection
- Other Names :
- Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Males: 60.0 <= age <= 100.0 kg, Females: 50.0 <= age <= 100.0 kg (inclusive).
* Males: Body mass index (BMI) of 20 <= age <= 30.0, Females: BMI of 18.5 <= age <= 30.0 kg/m2 (inclusive).
* Healthy, determined by a medical history with particular attention to:
* drug history identifying any known drug allergies and the presence of drug abuse;
* any chronic use of medication
* thorough review of body systems: no clinically significant abnormal findings on physical examination and electrocardiogram (ECG),
* Adequate venous access in arms to allow collection of blood samples.
* Fluent in the English language.
* Have voluntarily given written informed consent.
Exclusion Criteria:
* Pregnant and lactating females.
* History of allergy/hypersensitivity to any of the ingredients of the formulations
* History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, gynecological, ENT or musculoskeletal disorders, psychiatric disease or hematological disorders.
* Any history of asthma during the last 10 years.
* Creatinine clearance <65 mL/min.
* Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product.
* History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture.
* History of hepatitis B, a positive test for hepatitis B surface antigen, a history of hepatitis C, a positive test for hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies.
* Any evidence of organ dysfunction, or any clinically significant clinical laboratory value which, in the opinion of the Investigator would jeopardize the safety of the subject or impact on the validity of the study results, including a liver function test (LFT) >1.5 x upper limit of normal (ULN).
* Those who may have difficulty abstaining from alcohol during the 48 hr prior to dose administration and until completion of the Study Exit visit.
* History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse.
* Difficulty in abstaining from any prescription medications for 14 days prior to dose administration and for the duration of the study.
* Difficulty in abstaining from over-the-counter (OTC) medications or herbal supplements for 14 days prior to dose administration and for the duration of the study, (with the exception of occasional analgesia, vitamin and other nutrient supplement use, at the discretion of the Investigator).
* Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g. coffee, tea, cola and chocolate) during the 48 hrs prior to dose administration and for the duration of the study.
* History of any psychiatric illness which may impair the ability to provide written informed consent.
* Poor compliers or those unlikely to attend.
* Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
* Standard blood donation (usually 550 mL) within the 12-week period before dose administration.
* Unusual dietary habits and excessive or unusual vitamin intakes.
* Vaccination or immunizations within 30 days of initial dose administration.
* Whilst there were no QT/QTc effects seen in the human volunteers at a dose of 20 mg/kg administered intravenously as a 10 min infusion, until the effects of the drug on QT/QTc interval have been formally characterized, the study will use the exclusion criteria defined in International Conference on Harmonisation (ICH) Guideline E14 to exclude subjects with a risk of QT/QTc prolongation, namely:
* A marked baseline prolongation of corrected QT interval >450 ms in two ECGs, or
* A history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
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
|
NCT01420042
|
{
"brief_title": "Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration",
"conditions": [
"Brain Injuries, Traumatic"
],
"interventions": [
"Drug: Placebo",
"Drug: NNZ-2566"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT01420042",
"official_title": "A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NNZ-2566 in Healthy Subjects, Following Oral Administration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-09",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-11-22",
"last_updated_that_met_qc_criteria": "2011-08-17",
"last_verified": "2012-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-19",
"first_submitted": "2011-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study, we intend to divide the subjects who have been confirmed recurrent HCC into two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio frequency. We will compare the non-tumor survival time, long-term survival rate between the two groups, summarize the merits and demerits of both groups, and try to establish a standardized therapy and treatment for the this kind of patients through prospective studies on the molecular biological difference of pathological samples between the first and second surgeries.
Detailed Description
The recurrence and metastasis of primary liver cancer (PLC) have always been a tough problem for surgeons. Gu Hong-guang reported the five years recurrence rate in PLC subjects reached 75\~100%, among which 60% were discovered within three years after surgeries, with the peak appearing at 18\~24 months. According to a report delivered by Zhong-Shan Hospital, the recurrence rate of small HCC was 40%, and that of large HCC was 1.9 times of small HCC. Chen Han agreed that the recurrence rate in 1\~2 years reached 71.6%, while in 2\~11 years was 28.4%. With the rapid development of iconography and surgical techniques, it is possible for surgeon to resect the recurrent HCC now. In 1986, Nagasue et al. reported the excision of recurrent HCC and proved that comparing with non-surgical treatment, subjects with recurrent HCC excision got a higher survival rate. However, the excision rate of recurrent HCC has always been an arguable point. Nakajima et al. suggested the excision rate in 133 subjects was 24%, while Matsuda et al. agreed that in 91 subjects reached 44%, and Zhoo reported that in 384 subjects was 35%; Kakazu et al. insisted that in 286 subjects was 17%; Nagasue et al. said that in 290 subjects was 30%; Shoto et al. reported that in 341 subjects was 19% and Poon et al. advocated that in 244 subjects was 10%. He Sheng summarized the 1295 subjects in recent five years, and only 106 of them had the opportunities to have excision again (8.18%). Sugimachi, Minagawa et al. reported separately the 5 year survival rate in recurrent HCC subjects were 47.5% and 56.0%, which showed no significant difference with the first surgeries, but better therapeutic effects, meanwhile, third and forth surgeries could also get similar survival rate, which indicated that surgical excision is a vital treatment in recurrent HCCs. Chen Han in our hospital reported the first, third, fifth, and tenth year survival rate in 162 recurrent HCC subjects who underwent first surgical treatment were separately 96.8%, 66.7%, 43.6% and 21.8%; while that in subjects who received second surgical treatment were separately 94.7%, 44.9% and 25.0% at the first, third, and fifth year (mean survival time was 45 months, and average survival time was 54 months).
In this study, we intend to divide the subjects who have been confirmed recurrent HCC into two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio frequency. We will compare the non-tumor survival time, long-term survival rate between the two groups, summarize the merits and demerits of both groups, and try to establish a standardized therapy and treatment for the this kind of patients through prospective studies on the molecular biological difference of pathological samples between the first and second surgeries.
#Intervention
- OTHER : PRFA or PMCT
- PRFA or PMCT 30-35W for 10-15minutes one cycle,three cycles
- PROCEDURE : surgery
- only surgery
|
#Eligibility Criteria:
Inclusion Criteria:
* 20~60 years;
* diagnosed HCC pathologically, and confirmed recurrent HCC through ultrasonic B, CT, MRI or DSA test;
* has a good condition in vital organs such as heart, lung, and kidney;
* has a good liver function: Child A level, or nearly A level after hepatoprotection treatment;
* solitary small cancer focus (diameter <5cm), or the number of recurrent HCC focus is no more than three and all of them grow in the same lobe of liver;
* without jaundice (not including jaundice in the bile ducts), without ascites or extensive metastasis outside the liver;
* without invasion to portal vein.
Exclusion Criteria:
* subjects refuse to participate in this study;
* subjects cannot be followed up regularly;
* subjects with severe heart, lung, kidney diseases;
* subjects with liver CP level B or C, and serum creatinine >=2×ULN;
* subjects with severe bone marrow depression, such as neutrophil counting is lower than 1.5 × 109.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00822562
|
{
"brief_title": "Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer",
"conditions": [
"Hepatocellular Carcinoma"
],
"interventions": [
"Procedure: surgery",
"Other: PRFA or PMCT"
],
"location_countries": [
"China"
],
"nct_id": "NCT00822562",
"official_title": "Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-01",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-01",
"last_updated_that_met_qc_criteria": "2009-01-13",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-14",
"first_submitted": "2009-01-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, multi-center, open-label, parallel group study with three arms:
* Rasburicase alone
* Rasburicase followed by Allopurinol
* Allopurinol alone
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
Detailed Description
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.
#Intervention
- DRUG : Rasburicase (SR29142)
- 30-min IV infusion
- DRUG : Allopurinol
- Oral administration
|
#Eligibility Criteria:
Inclusion Criteria:
* Meets high risk or at potential risk for tumor lysis syndrome (TLS):
A patient is at high risk for TLS if he/she presents with:
* Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
* A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
* Acute myeloid leukemia (AML);
* Chronic myeloid leukemia (CML) in blast crisis; or
* High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.
A patient is at potential risk for TLS if he/she presents with:
* A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
* Lactate dehydrogenase (LDH) >= 2 x upper limit of normal (ULN) (IU/L)
* Stage III-IV disease
* Stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter
In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 3
* Age >= 18 years
* Life expectancy > 3 months
* Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
* Signed written 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
|
NCT00230178
|
{
"brief_title": "Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome",
"conditions": [
"Tumor Lysis Syndrome",
"Cancer",
"Hyperuricemia"
],
"interventions": [
"Drug: Rasburicase (SR29142)",
"Drug: Allopurinol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00230178",
"official_title": "Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-12",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2004-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-01-12",
"last_updated_that_met_qc_criteria": "2005-09-28",
"last_verified": "2010-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-30",
"first_submitted": "2005-09-28",
"first_submitted_that_met_qc_criteria": "2009-11-30"
}
}
}
|
#Study Description
Brief Summary
Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.
#Intervention
- DRUG : mifepristone 200 mg
- mifepristone would be given the day before the procedure
- DEVICE : osmotic dilator insertion
- osmotic dilators (3-6) would be inserted as usual the day before the procedure
|
#Eligibility Criteria:
Inclusion Criteria:
* women aged 18 <= age <= 45 having pregnancy termination at 14 <= age <= 16 weeks
Exclusion Criteria:
* multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00986921
|
{
"brief_title": "Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks",
"conditions": [
"Abortion"
],
"interventions": [
"Drug: mifepristone 200 mg",
"Device: osmotic dilator insertion"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00986921",
"official_title": "Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks",
"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": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-31",
"last_updated_that_met_qc_criteria": "2009-09-28",
"last_verified": "2013-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-30",
"first_submitted": "2009-09-23",
"first_submitted_that_met_qc_criteria": "2013-09-29"
}
}
}
|
#Study Description
Brief Summary
Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation of lipoproteins. This observational study will evaluate the association between frequency of blood donation - expected to be associated with relatively reduced body iron stores in frequent donors - and carotid atherosclerosis. The primary outcome variable will be whether the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is greater in infrequent (less than or equal to 1 donations/year greater than or equal to 5 years) vs. frequent (greater than or equal to 4 donations/year greater than or equal to 5 years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) and 60 infrequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) blood donors will be recruited for this study from the Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be assessed for study eligibility and cardiovascular risks during the screening visit. The presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters will be assessed during a second visit.
Detailed Description
Iron has been proposed to contribute to atherogenesis in humans by facilitating the oxidation of lipoproteins. This observational study will evaluate the association between frequency of blood donation - expected to be associated with relatively reduced body iron stores in frequent donors - and carotid atherosclerosis. The primary outcome variable will be whether the presence and extent of asymptomatic carotid atherosclerosis as measured by ultrasound is greater in infrequent (less than or equal to 1 donations/year greater than or equal to 5 years) vs. frequent (greater than or equal to 4 donations/year greater than or equal to 5 years) blood donors. Body iron stores, lipid and hemostatic parameters, nitric oxide formation, inflammatory parameters, and markers of vascular oxidative stress will be analyzed as secondary outcome measures. Laboratory analysis and ultrasound testing will be performed blinded to the patient's phlebotomy and iron status. Sixty frequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) and 60 infrequent (n=40 males greater than 40 y/o, n=20 females greater than 50 y/o) blood donors will be recruited for this study from the Department of Transfusion Medicine, W. G. Magnuson Clinical Center. All donors will be assessed for study eligibility and cardiovascular risks during the screening visit. The presence of atherosclerotic lesions by carotid ultrasound and secondary outcome parameters will be assessed during a second visit.
|
#Eligibility Criteria:
INCLUSION CRITERIA:
Age greater than or equal to 40 years for males and greater than or equal to 50 years for females.
Standard eligibility criteria for blood donation, per guidelines established by the Food and Drug Administration and the American Association of Blood Banks.
Ability to provide consent after full information is provided.
EXCLUSION CRITERIA:
Pregnancy or lactation.
Patients with clinically significant dementia or psychiatric disturbances, including alcohol and substance abuse.
Presence of the following American Heart Association cardiovascular risks: diabetes mellitus, hypertension (systolic greater than 140 mmHg, diastolic greater than 90 mmHg), smoking (greater than 10 cigarettes/day), high density lipoprotein cholesterol less than 35 mg/dL, hyperlipidemia (total cholesterol greater than 240 mg/dL), family history of premature coronary heart disease.
Anticoagulant, thrombolytic, hemorrheologic and/or antiplatelet agents (within the last 10 days).
Any other condition or therapy which in the opinion of the investigators may pose a risk to the patient or confound the results of the study.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00001589
|
{
"brief_title": "Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors",
"conditions": [
"Carotid Atherosclerosis",
"Myocardial Infarction"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00001589",
"official_title": "Comparison of Asymptomatic Carotid Atherosclerosis Between Frequent and Infrequent Blood Donors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2002-05",
"study_start_date(actual)": "1997-04"
},
"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)": "2008-03-04",
"last_updated_that_met_qc_criteria": "1999-11-03",
"last_verified": "2002-05"
},
"study_registration_dates": {
"first_posted(estimated)": "1999-11-04",
"first_submitted": "1999-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS) have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been shown to effectively reduce the incidence of PLMs in patients with RLS. The current study aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal BP elevations associated with PLMs in patients with RLS.
#Intervention
- DRUG : Rotigotine
- Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
- DRUG : Placebo
- Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is informed and given ample time and opportunity to think about her/his participation and give her/his written informed consent
* Subject understands the investigational nature of the study and is willing and able to comply with the study requirements. Subject is willing to accept that he/she might be treated with placebo during the Treatment Period
* Subject is able to apply/remove the study patch correctly
* Subject is male or female, and is >=18 and <=75 years
* Subject meets the diagnosis of idiopathic Restless Legs Syndrome (RLS) based on the 4 essential clinical features according to the International Restless Legs Syndrome Study Group (Allen et al,2003): 1. An urge to move legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs (The urge to move can be present without uncomfortable sensations. Arms or other body parts can also be affected) 2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity, such as lying or sitting 3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues 4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present)
* Subject has a score of >=11 on the RLS-Diagnostic Index (RLS-DI) (Benes and Kohnen, 2009)
* Subject has an initial response to previous dopaminergic treatment for RLS or has no previous dopaminergic treatment (ie, de novo)
* The subject's Body Mass Index (BMI) is >=18 kg/m^2 and <=35 kg/m^2
* At Baseline subject has a score of >=15 on the IRLS (indicating moderate to severe RLS)
* At Baseline subject has a score of >=4 points on the CGI Item 1 assessment (indicating moderately ill)
* At Baseline subject has a score of >=15 PLM/h on the Periodic Limb Movements Index (PLMI) based on polysomnography (PSG) (recorded during the second night) as assessed by the investigator
* Subjects are on a concomitant dose of antihypertensives that is at a stable dose for at least 4 weeks prior to Baseline and hypertension is reasonably controlled while the subject agrees to continue at this dose for the duration of the study, or subject has not received concomitant treatment with antihypertensives for at least 4 weeks prior to Baseline and does not intend to start such use during the study
Exclusion Criteria:
* Subject has RLS due to renal insufficiency (uremia), iron deficiency anemia, or rheumatoid arthritis
* Subject has RLS associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), tri- and tetra-cyclic antidepressants, mianserine, or lithium or H2-blockers (eg, cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbiturates, and other hypnotics
* Subject has a history of sleep disturbances, such as sleep apnea syndrome (including obstructive sleep apnea), narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy either observed during PSG (local PSG evaluations) or evidenced by subject history
* Subject has uncontrolled hypertension according to the judgment of the investigator
* Subject has additional clinically relevant concomitant diseases, such as attention deficit hyperactivity disorder, polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy
* Subject has other central nervous system diseases, such as Parkinson's disease, dementia, progressive supranuclear paresis, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, or Alzheimer's disease.
* Subject has a prior history of psychotic episodes
* Subject has a history of chronic alcohol or drug abuse within the previous 12 months
* Subject has any medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this study
* Subject has clinically relevant cardiac dysfunction and/or arrhythmias (eg, suspected conduction system dysregulations, second or third degree atrioventricular block, complete left or right bundle branch block, sick sinus syndrome, New York Heart Association Class III or IV congestive heart failure, or had a myocardial infarction within 12 months prior to Screening [Visit 1])
* Subject has clinically relevant venous or arterial peripheral vascular disease
* Subject has a malignant neoplastic disease requiring therapy within 12 months prior to Screening (Visit 1)
* Subject is currently receiving treatment with any of the following drug classes: neuroleptics, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, budipine, dopamine antagonist antiemetics (except domperidone), opioids, benzodiazepines, monoamine oxidase (MAO) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, sedative antihistamines, psychostimulates, or amphetamines. If subject has received such therapy, a Washout Period of at least 7 days prior to Baseline (Visit 2) is required before starting treatment in this study
* Subject is pregnant, nursing, or is a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent
* Subject is a shift worker or performs other continuous non-disease-related life conditions which do not allow regular sleep at night
* At Screening Visit or Baseline Visit subject has symptomatic orthostatic hypotension
* Subject is treated with dopamine agonists within a period of 14 days prior to Baseline or L-dopa within 7 days prior to Baseline
* Subject has a medical history indicating intolerability to prior dopaminergic therapy (if pretreated)
* Subject has received previous treatment with Rotigotine
* Subject has participated in another study of an investigational drug or device within the 28 days prior to Visit 2 (Baseline) or is currently participating in another study of an investigational drug
* Subject has a known hypersensitivity to any of the components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis
* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
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
|
NCT01455012
|
{
"brief_title": "Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome",
"conditions": [
"Restless Legs Syndrome"
],
"interventions": [
"Drug: Rotigotine",
"Drug: Placebo"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01455012",
"official_title": "Multicenter, Double-Blind, Placebo-Controlled, Two-Arm, Randomized, Parallel, Treatment Intervention, Sleep Lab Phase 4 Study to Assess the Effect of Rotigotine on Nocturnal Blood Pressure in Patients With Idiopathic Restless Legs Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2011-09"
},
"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)": "2013-07-26",
"last_updated_that_met_qc_criteria": "2011-10-17",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-19",
"first_submitted": "2011-10-10",
"first_submitted_that_met_qc_criteria": "2013-05-14"
}
}
}
|
#Study Description
Brief Summary
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
#Intervention
- DRUG : CMV Immune globulin
- CMV IvIg 150mg/kg x 6 doses
|
#Eligibility Criteria:
Inclusion Criteria:
* Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection
* receiving no more than 48 hrs of therapy prior to study enrollment
Exclusion Criteria:
* serum creatinine <2.2 at the time of enrollment
* no prior use of CMV IgG
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
|
NCT00214240
|
{
"brief_title": "The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease",
"conditions": [
"Cytomegalovirus"
],
"interventions": [
"Drug: CMV Immune globulin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00214240",
"official_title": "The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-04",
"study_completion_date(actual)": "2007-04",
"study_start_date(actual)": "2000-01"
},
"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)": "2012-07-26",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-21",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to learn more about the potential effects of visible light on the skin. More specifically, this study will examine whether an incandescent lamp (light bulb) or LED light bulb can cause skin to become darker. Investigators will determine the minimum threshold dose required to achieve immediate pigmentation darkening (IPD), persistent pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types IV - VI utilizing two visible light sources.
#Intervention
- OTHER : Part A: Baseline-Week 2
- The study doctor will shine 2 different light bulbs (one a regular or incandescent bulb and the other an LED light bulb) on 12 different areas of patients skin approximately 6 square centimeters in size (less than 1 square inch or the size of your thumb nail). Each light bulb will be exposed to your skin for approximately 20 - 35 minutes. After exposure, the study doctor will perform skin assessments at 3 time points:
1. Immediately after the light exposure;
2. 30 minutes after light exposure; and
3. 1 hour after light exposure.
- OTHER : Part B: Week 4-Week 12
- The study doctor will perform the same 4 skin assessments used in Part A at each visit to assess potential changes in your skin: Digital Photography
1. Visual Clinical Assessment
2. Spectroscopy
3. Colorimetry
|
#Eligibility Criteria:
Inclusion Criteria:
* Be a healthy volunteer with Fitzpatrick skin types I-VI;
* Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
* Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
* Agree to follow and undergo all study-related procedures.
Exclusion Criteria:
* Women who are lactating, pregnant, or planning to become pregnant;
* Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation;
* Patients with a known history of photosensitivity disorders;
* Photosensitizing medications may be continued throughout of the study at the discretion of the investigator ;
* Patients with a known history of melanoma or non-melanoma skin cancers;
* Concomitant use of tanning beds;
* Sun exposure of the irradiated or control areas;
* Patients with serious systemic disease.
* Patients with a known history of hypersensitivity to adhesives including adhesive tape.
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
|
NCT02663921
|
{
"brief_title": "Visible Light Study",
"conditions": [
"Skin Disease",
"Pigment Disorders"
],
"interventions": [
"Other: Part A: Baseline-Week 2",
"Other: Part B: Week 4-Week 12"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02663921",
"official_title": "Determination of the Minimal Dose of Visible Light Required to Achieve Immediate Pigment Darkening, Persistent Pigment Darkening, and Delayed Tanning for Fitzpatrick Skin Types IV-VI Utilizing Two Visible Light Sources.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-17",
"study_completion_date(actual)": "2019-04-17",
"study_start_date(actual)": "2015-09"
},
"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)": "2019-06-17",
"last_updated_that_met_qc_criteria": "2016-01-21",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-26",
"first_submitted": "2016-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To characterize the relationship of renal biomarkers (Creatinine, albumin, Cystatin C, NGAL, beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the variation over age, measured in serum and urine of healthy children. Unused residual blood and urine samples will be used for testing the renal Parameters.
Detailed Description
Despite relevant research in renal biomarkers, there is currently no optimal marker available that reliably quantifies kidney function and indicates kidney injury in its early stages. The combination of two or more biomarkers might be a more promising approach than investigating a single parameter. The relationship of renal biomarkers (creatinine, albumin, Cystatin C, NGAL, beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the variation over age in infants and children (without chronic kidney disease) is investigated.
The biomarkers in urine samples are explored to find less invasive means of quantifying renal health.
Patients between the age of 0 and 12 years undergoing blood with or without urine sampling as part of their diagnostic workup are eligible for the study. Unused residual blood and urine samples will be used for testing the renal parameters.
#Intervention
- OTHER : blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)
- relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.
- OTHER : urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)
- relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy patients for elective surgery, requiring venous access via peripheral venous canula
Exclusion Criteria:
* chronic kidney disease
* acute kidney failure (stage 2 or above as defined by Kidney Disease Improving Global Outcomes (KDIGO) consensus 2012))
* sepsis
* shock
* major haemorrhage
* second or third degree burns
* liver failure
* chronic diseases with effecting the kidney (systemic lupus erythematosus, amyloidosis)
Sex :
ALL
Ages :
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03751397
|
{
"brief_title": "Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.",
"conditions": [
"Renal Biomarkers in Children"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03751397",
"official_title": "Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-05",
"study_completion_date(actual)": "2020-06-05",
"study_start_date(actual)": "2018-12-17"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-14",
"last_updated_that_met_qc_criteria": "2018-11-20",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-23",
"first_submitted": "2018-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Women of color (WOC) in South Florida, the region with the highest HIV rates in the U.S., experience significant barriers to accessibility, uptake, and utilization of Pre-exposure prophylaxis (PrEP) for HIV prevention, despite FDA approval since 2012. The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida, primarily African American, Latina, and Haitian women in 3 designated Ending the HIV Epidemic (EHE) counties: Miami-Dade, Broward, and Palm Beach counties.
Detailed Description
The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida. We will conduct an exploratory pilot of the PrEP intervention, using a quasi-experimental design, among 80 multi-ethnic WOC in Miami-Dade, Broward, and Palm Beach counties to evaluate feasibility, acceptability, and fidelity. PrEP uptake, adherence, and retention in care will be measured over a 4-month period, including biomarkers of adherence. Adult women initiating or returning to PrEP services at our collaborating sites will be recruited, consented, enrolled and complete baseline assessments. They will participate in an adapted Integrating ENGagement and Adherence Upon Entry (iENGAGE) intervention to address social determinants of health barriers to maintaining PrEP care.
#Intervention
- BEHAVIORAL : iENGAGE for PrEP
- This intervention originally developed for people living with HIV (PLWH), is designed to promote engagement, retention, and adherence to treatment by addressing the social determinants of health that often act as barrier to remaining in care and achieving viral suppression. Based on our experience with this intervention we believe that it is well suited to similarly promote engagement, retention, and utilization of PrEP care among our proposed target population of WOC by a) removing barriers to care and b) addressing unmet needs by providing c) point-to-point linkage to care services delivered by multi-disciplinary teams of individuals within or outside of the health facility, and d) the use of telehealth visits to facilitate engagement in care and improve health visit attendance. The original iENGAGE is a 4-session, in-clinic behavioral intervention.
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years;
* female and identifying as female gender;
* able to provide informed consent;
* willing to document a negative HIV antibody test before starting PrEP;
* reporting recent sexual risk (e.g., sex without condoms in last 3 months, sexually transmitted infection (STI) diagnosis in the last 6 months, post-exposure prophylaxis (PEP) use in the last 12 months, transactional sex, partners who are HIV+);
* report history of alcohol and other drug (AOD) use in last 3 months;
* willing to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
* currently not cognitively impaired;
* reporting no history of bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.
Exclusion Criteria:
* < 18 years;
* not female at birth
* unable to provide informed consent;
* unwilling to document a negative HIV antibody test before starting PrEP;
* unwilling to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
* currently cognitively impaired;
* reporting recent history of bipolar disorder, psychosis, or inpatient psychiatric hospitalization
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
|
NCT05338996
|
{
"brief_title": "Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color",
"conditions": [
"HIV Prevention",
"PrEP Adherence"
],
"interventions": [
"Behavioral: iENGAGE for PrEP"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05338996",
"official_title": "Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-31",
"study_completion_date(actual)": "2023-05-31",
"study_start_date(actual)": "2021-10-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-27",
"last_updated_that_met_qc_criteria": "2022-04-20",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-21",
"first_submitted": "2022-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objective: Diabetes and periodontitis are two chronic inflammatory diseases sharing specific etiopathogenetic mechanisms, and both cause severe inflammation and destruction. The aim of the present study was to determine the receptor expressions of Peroxisome proliferative-activated receptor (PPAR)-γ, Retinoid X receptor (RXR)-α, Vitamin D receptor (VDR), and nuclear factor kappa B (NF-κB) expressions in healthy gingiva and diseased gingival samples with diabetes.
Methods: 45 participants as 1; healthy controls (C), 2; periodontitis group (P), and 3; diabetes and periodontitis group (DP) were enrolled. Plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were recorded in all participants. Two gingival biopsies from each participant were obtained, and one underwent histological tissue processing while the other underwent RT-PCR analysis of nuclear receptors. Inflammatory and fibroblast cell counts, PPAR-γ, RXR-α, and VDR were evaluated.
Results: Fibroblast cells were lowest in the DP group and highest in the healthy group. PPAR-γ, VDR, RXR, and NF-κB expressions were higher in the healthy controls in the RT-PCR analysis and similar in the other groups. Immunohistochemistry analysis also showed similar results.
Conclusion: Results concluded that healthy gingival samples had higher PPAR-γ, RXR, VDR, and NF-κB expressions, and the immunohistochemistry results also supported this finding. The healthy gingiva contained higher fibroblast cells and lower inflammatory cells.
Detailed Description
The present study protocol was approved by the ethical committee of the Medical Ethics Committee of Tokat Gaziosmanpasa University. The study was designed as a cross-sectional clinical study and conducted at Tokat Gaziosmanpaşa University Faculty of Dentistry Department of Periodontology. Informed consent was obtained from all participants, and detailed oral and radiological examination was performed by an experienced clinician (H.B.Y.).
Forty-two participants, 14 participants in each group, were enrolled in the study. The study groups were as follows.
Healthy controls (C, mean age 41.05±1.80, seven men, seven women) Periodontitis patients with stage 3 grade B, (P, mean age 42.35±1.92, seven men, seven women) Patients with diabetes and periodontitis with stage 3 grade C, (DP, mean age 41.09±1.28, seven men, seven women)
All patients and healthy individuals went through a detailed oral examination, and periodontal health and periodontitis diagnosis were based on the criteria defined by the recent classification of periodontal health and diseases in the 2017 International World Workshop for a Classification of Periodontal Diseases and Conditions \[21\].
All participants were never smokers. Exclusion criteria were conditions which might affect the inflammatory state, the existence of less than ten or over missing teeth, tobacco or any drug use, presence of pregnancy or lactation, and existence of antibiotic or periodontal therapy within previous six months. Diabetes patients in the present study had HbA1c values greater than 7.0 even though they were under diabetic treatment. And the diabetic patients who had HbA1c values below 7.0 were not included.
Clinical measurements Clinical parameters were plaque index (PI), gingival index (GI) and clinical attachment levels (CAL), and all analyses were performed before the biopsy procedure. Full mouth measurements and the measurements of the relevant teeth were recorded separately. CAL was measured from the cement-enamel junction to the bottom of the periodontal pocket and Williams's type periodontal probe was used for measurements (Hu-Friedy Co., Chicago, IL, USA). PI and GI measurements were performed via an explorer (Hu-Friedy Co., Chicago, IL, USA). All analyses were performed from six points, three from buccal aspect and three from the palatal aspect as mesial, middle, and distal sites for both teeth. A mean value of six measurements was recorded.
Collection of Gingival Samples Gingival biopsies were obtained according to a protocol by a previous study \[22\]. Two gingival biopsies were obtained from each participant. Gingival sampling in periodontally healthy individuals was performed by crown lengthening procedure in the routine treatment protocol or before orthodontically indicated tooth extraction. In the periodontitis groups, biopsies were obtained from the inflamed gingival tissue with minor surgical periodontal procedures. All biopsies were obtained from posterior maxillary teeth (tooth #4, #5, #6 or #7).
Firstly, local anesthesia was performed, and a gingival sample was dissected with a tissue scissor from an area with requiring either gingivectomy/crown lengthening procedures from patients with impaired gingival topography or before tooth extraction indicated for orthodontic treatment in healthy individuals. As for the periodontitis patients, a gingival sample was dissected using a tissue scissor during the scaling and root planning procedure from the gingival areas with severe gingival inflammation. One gingival sample from each participant was immediately placed in 10% neutral buffered formalin for 48 hours and underwent histological tissue processing. The other samples of each participant were immediately frozen at -80⁰C until the day of analysis.
Histopathological Evaluation All histological procedures were performed by an experienced blinded researcher (F.G.). Gingival samples which underwent histological tissue processing were first washed and cleansed from formalin and were dehydrated with alcohol series. Then all tissues were cleared with xylene and embedded in paraffin blocks. Each block sectioned throughout as serial sections and three sections from each block were selected for Hematoxylin-eosin (H\&E) staining. Fibroblast and inflammatory cell infiltration were evaluated from H\&E stained slides under 1000x magnification via a light microscope .
For fibroblast and inflammatory cell evaluation, the gingival area at the connective tissue border neighboring gingival epithelium was evaluated. A cell counting frame of 10.000 µm2 area was selected under 1000x magnification. The total inflammatory cells (neutrophil, lymphocyte, eosinophil, and macrophage cells) within the frame were counted as inflammatory cell counting. The fibroblasts were also counted likewise. The measurements were performed from three different points, and the mean of these three measurements was recorded \[23\].
PPAR-γ, RXR-α, and VDR Immunohistochemistry Immunohistochemistry was performed as reported in previous studies \[23-26\]. Three sections were chosen for each immunohistochemistry staining from each participant. Firstly, all slides were deparaffinized and dehydrated with alcohol series. After washing with distilled water, antigen retrieval was performed via sodium citrate buffer (pH 6.0) for two h at 70°C, and then endogenous peroxidase activity was suppressed with 3% hydrogen peroxide treatment. After hydrogen peroxide treatment, all slides were incubated with normal rabbit serum for 30 min. After normal serum incubation, primary antibody diluents were prepared and applied to the samples overnight at a humidified chamber at 4⁰C. The primary antibodies were goat polyclonal anti-PPAR-γ antibody (1:250), anti-RXR-α antibody (1:250), and anti-VDR antibody (1:250). After primary antibody incubation, all slides were washed with phosphate buffer solution (PBS) three times for five minutes (3x5) and biotinylated immunoglobulin G was applied for 30 min. Again a wash of 3x5 PBS, all samples were exposed to a streptavidin-horseradish peroxidase-conjugated reagent for another 30 min. After washed with 3x5 PBS, all sections were treated with AEC chromogen to visualize staining. Counterstaining was performed with Meyer's hematoxylin, and sections were mounted. After allowing dry for two days, samples were examined under 400x magnification using light microscopy \[23, 24\].
Immunohistochemical semi-quantitative H SCORE Analysis Immunohistochemistry evaluation was performed on three different areas in each section, and three sections were evaluated for each patient. Nine measurements were performed for each participant. All cells were marked according to their staining as no staining '0', low staining '1', mild staining '2', and dense staining '3'. Staining scores were converted to a numeric value as 'H score' through a formula (∑Pi(i+l)) which is a frequently used value for immunohistochemistry \[23, 24\]. In this formula, i shows the staining intensity score and Pi: indicates the percentage of the stained cells.
RT-PCR Analysis The primers to be used for the genes were shown in table 1. The RNA isolation and RT-PCR analysis performed according to a previous study \[27\]. Briefly, for RT-PCR analysis, first gingival tissues were homogenized and subjected to sonication to reveal RNA in the tissues and tissue supernatants were obtained. Then the supernatants were submitted to the total mRNA isolation step. The tissues treated with Qiazole, then allowed to incubate in the shaker for 5 minutes. At the end of 5 minutes, chloroform was added to the medium containing the cells and incubation continued for 3 minutes at room temperature and then the samples were centrifuged. At the end of the centrifuge, the supernatant at the top of the tube transferred to another tube. Afterward, isopropanol was added to the supernatant and incubated for 10 minutes at room temperature, and the centrifugation step was repeated. At the end of the centrifugation, the pellet deposited at the bottom was washed with 75% ethanol, remaining supernatant was centrifuged again and suspended in pure, sterile water without RNase. mRNAs were determined by spectrophotometric method. Then using the qRT-PCR kit, one µg mRNA were transformed into single-step cDNA using specific primers targeting the gene of interest, later the genes were identified with the help of qRT-PCR (Verso, Thermo Fisher Scientific, Massachusetts, USA). The results were normalized to the β-actin control gene.
Statistical Analysis The power of the study was over 85% based on a previous study with a similar study design \[25\]. IBM SPSS software was used for statistical analysis. One Sample K-S test was used to test the normality. For the fibroblast cell counts, inflammatory cell counts, and CAL, One Way ANOVA followed by Tukey test used. For other parameters, Mann Whitney U and Kruskal Wallis tests were used. Data were presented as mean ± SD or percentage as appropriate. p \< 0.05 were considered statistically significant.
#Intervention
- PROCEDURE : Gingival biopsy
- Two gingival biopsies from each participant were collected.
|
#Eligibility Criteria:
Inclusion Criteria:
* Periodontally healthy
Exclusion Criteria:
* Smokers
* Inflammatory state
* The existence of less than ten or over missing teeth
* drug use
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04245982
|
{
"brief_title": "PPAR, RXR, and VDR Expressions in Diabetes",
"conditions": [
"Diabete Mellitus",
"Periodontitis"
],
"interventions": [
"Procedure: Gingival biopsy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04245982",
"official_title": "PPAR-γ, RXR, VDR, and NF-κB Expressions in Gingival Tissue Samples of Healthy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-01",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2019-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-31",
"last_updated_that_met_qc_criteria": "2020-01-27",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-29",
"first_submitted": "2020-01-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial evaluated how effective and safe Cipro XR was in treating female patients with signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated.
#Intervention
- DRUG : Ciprofloxacin
- Cipro XR 500 mg tablets taken once daily
|
#Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years (inclusive)
* Patients with at least two of the following clinical signs and symptoms of an uUTI:
* Dysuria
* Frequency
* Urgency
* Suprapubic pain
* Patients with onset of symptoms < 72 hours prior to study entry
* Patients with one positive pre-treatment clean-catch midstream urine culture at enrollment in the study, defined as > 10000 CFU/mL (study drug treatment is permitted prior to the availability of urine culture results)
* Positive leukocyte esterase (LE) (1+ or greater) utilizing a urine dipstick method of analysis
* Patients willing to give written informed consent
* Cultures must be performed on pre-treatment clean-catch midstream urine (MSU) specimens
Exclusion Criteria:
* Males
* Women who are pregnant, nursing, or not using two medically accepted, effective methods of birth control
* Patients with known or suspected hypersensitivity to quinolones
* Patients unable to take oral medication for any reason
* Patients with an asymptomatic bacteriuria
* Patients with complicated UTI, defined as: a clinical syndrome characterized by the development of systemic and local signs and symptoms of fever (> 38.3°C/101°F orally), chills, malaise, flank pain, back pain, or costovertebral angle (CVA) pain or tenderness
* Symptoms as outlined in the inclusion criteria occurring in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of urinary catheterization
* Patients with symptoms of a UTI within the 4 weeks prior to the present episode
* Patients with the onset of symptoms >72 hours prior to study entry
* Patients with three or more episodes of any UTI in the past 12 months
* Patients with evidence of factors predisposing to the development of UTIs, including calculi, stricture, primary renal disease (e.g. polycystic renal disease), or neurogenic bladder
* Patients who received systemic antimicrobial therapy within 48 hours prior to entry
* Patients with a neutrophil count < 1000/mm3, CD4 < 200/mm3 or other conditions associated with significant depression in host defense; HIV testing is not mandatory
* Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol
* Patients with a previous history of tendinopathy associated with fluoroquinolones
* Patients diagnosed with a rapidly fatal underlying disease (death expected within six months)
* Patients requiring concomitant use of theophylline
* Patients previously enrolled in this clinical study
* Patients taking an investigational drug in the last 30 days
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 44 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00669994
|
{
"brief_title": "Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections",
"conditions": [
"Urinary Tract Infection"
],
"interventions": [
"Drug: Ciprofloxacin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00669994",
"official_title": "Prospective, Open Label Non-comparative, Multi-center Trial to Evaluate the Efficacy and Safety of Cipro® XR 500 mg Once Daily for 3 Days in Treating Female Patients With Acute, Uncomplicated, Symptomatic Lower Urinary Tract Infections",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2003-10",
"study_start_date(actual)": "2003-07"
},
"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)": "2014-12-19",
"last_updated_that_met_qc_criteria": "2008-04-29",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-01",
"first_submitted": "2008-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the single-center, open, randomized, single-dose, two-cycle, two-sequence, cross-over bioequivalence of test preparation apixaban tablet 2.5mg and reference preparation 2.5mg in healthy adult subjects in fasting and fed state
Detailed Description
Fasting test: 24 subjects were planned to be enrolled. Each subject was randomly assigned to one of the two groups according to a randomization table. In the first cycle, after fasting for at least 10 h, all subjects received the corresponding study drug orally in sequence starting with the first subject in the fasted state, with one group of subjects receiving the test preparation apixaban tablets 2.5 mg orally and the other group receiving the reference preparation apixaban tablets 2.5 mg orally, and then 7 days later crossed over to the second cycle of the study, which was the same as the first cycle.
Postprandial trial: 30 subjects are planned to be enrolled. According to the randomization table, each subject will be randomly assigned to one of the two groups. In cycle 1, after fasting for at least 10 h, all subjects will consume one high-fat, high-heat meal starting 30 ± 0.5 min prior to study drug administration, starting with the first subject in sequence and finishing before drug administration. One group of subjects received 2.5 mg of apixaban tablets and the other group received 2.5 mg of apixaban tablets , 7 days after crossover dosing, for the second cycle of the study.
#Intervention
- DRUG : test apixaban tablets
- specification: 2.5 mg, manufacturer: Disha Pharmaceutical Group Co., Ltd., Shandong, China
- DRUG : reference apixaban tablets
- specification: 2.5 mg, manufacturer: Bristol-Myers Squibb Manufacturing Company, USA
|
#Eligibility Criteria:
Inclusion Criteria:
* Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions;
* Be able to complete the study according to the requirements of the test plan;
* Subjects (including male subjects) agreed to have no pregnancy plan and to voluntarily take effective contraceptive measures within 3 months from the end of the study after signing the informed consent;
* Male and female subjects aged 18 years and above;
* Male subjects weigh at least 50kg. Female subjects weighed at least 45 kilograms. Body Mass index = weight (kg)/height 2 (m2), within the range of 18.0 to 26.0kg/m2 (including the critical value)
Exclusion Criteria:
* Prior disease of the neuropsychiatric, respiratory, cardiovascular, digestive, hematolymphatic, hepatic or renal insufficiency, endocrine, skeletal-muscular system, or other disease, and the investigator determines that this prior medical history may have an impact on drug metabolism or safety;
* Persons who have smoked more than 5 cigarettes per day on average during the 3 months prior to screening;
* Persons with a history of specific allergies (asthma, urticaria, eczema, etc.), allergic persons (e.g., allergy to two or more drugs, food), known hypersensitivity to this drug component or (including but not limited to) rivaroxaban;
* Lactose intolerant individuals (e.g., those who have experienced diarrhea from drinking milk)
* History of alcohol abuse (>= 14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits over 40 degrees, or 100 ml of wine) within the last year;
* Have donated blood or lost >= 400 ml of blood within 3 months prior to the trial, or intend to donate blood or blood components during or within 3 months after the trial;
* A history of dysphagia or any gastrointestinal disorder that interferes with drug absorption
* Use of any recombinant cytochrome P450 3A4 (CYP3A4) or permeability glycoprotein (P-gp) inhibitors (e.g., ketoconazole, itraconazole, voriconazole and posaconazole, ritonavir, diltiazem, naproxen, amiodarone, verapamil, quinidine, famotidine, macrolides, nitroimidazoles, sedative-hypnotics, fluoroquinolones, antihistamines), CYP3A4 and P-gp inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital or St. John's wort, omeprazole, glucocorticoids);
* Any anticoagulant, platelet aggregation inhibitor, selective 5-hydroxytryptamine reuptake inhibitor or 5-hydroxytryptamine norepinephrine reuptake inhibitor or non-steroidal anti-inflammatory drug used within 30 days prior to the trial and drugs that may cause severe bleeding, such as common heparin and heparin derivatives (including low molecular weight heparin), oligosaccharides that inhibit coagulation factor Xa (e.g. sulforaphane sodium), prothrombin II direct inhibitors thrombolytic agents, thienopyridines (e.g., clopidogrel), dipyridamole, dextran, sulpiride, vitamin K antagonists, and other oral anticoagulants;
* Taking any prescription, over-the-counter, herbal or nutraceutical medication within 14 days prior to the administration of the study drug;
* have taken a special diet (caffeine, alcohol, or xanthine-rich foods and beverages, including dragon fruit, mango, grapefruit, chocolate, or tea), or smoked, or had a significant change in exercise habits, or other factors affecting drug absorption, distribution, metabolism, or excretion within 48 h prior to the administration of the study drug
* Those with a positive alcohol screening test;
* Those who have participated in another clinical trial of a drug and taken the test drug within 3 months prior to taking the study drug
* Abnormalities of clinical significance as judged by the clinician, including physical examination, vital signs examination, electrocardiogram examination or clinical laboratory examination (including routine blood, urine, blood biochemistry, coagulation function examination)
* Those with creatinine clearance <= 50 mL/min;
* Those with coagulation disorders, or those with bleeding tendencies (e.g., frequent recurrent gum bleeding), or those with increased bleeding risk events within the past 6 months, previous intracranial bleeding, gastrointestinal bleeding, purpura, or those who have undergone major surgery within the past 30 days, or those with active pathologic bleeding
* positive for hepatitis B surface antigen, positive for hepatitis C antibodies, positive for HIV antibodies, or positive for primary syphilis screening
* Those with positive substance abuse screening or a history of substance abuse within the past five years
* Subjects with a history of blood or needle sickness, difficulty in blood collection or inability to tolerate venipuncture blood collection
* Subjects who are unable or incapable of complying with ward management regulations
* Subjects who have had a major illness or major surgical procedure within 4 weeks prior to administration of study drug
* Subjects who are unable to complete the trial for personal reasons;
* Subjects who are judged by the investigator to be unfit to participate in the study of this trial
* Female subjects who are breastfeeding or have a positive pregnancy test result during the screening period or during the course of the trial
* Female subjects who are using oral contraceptives 30 days prior to taking the study drug and during the trial
* Female subjects using long-acting estrogen or progestin injections or implant tablets within 6 months prior to study drug administration and during the trial
* Female subjects who had unprotected sex two weeks prior to screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05841446
|
{
"brief_title": "Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: reference apixaban tablets",
"Drug: test apixaban tablets"
],
"location_countries": [
"China"
],
"nct_id": "NCT05841446",
"official_title": "Single-center, Open, Randomized, Single-dose, Two-cycle, Two-sequence, Crossover Bioequivalence Study to Evaluate the Effects of the Test and the Fed States",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-17",
"study_completion_date(actual)": "2021-04-07",
"study_start_date(actual)": "2021-03-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-03",
"last_updated_that_met_qc_criteria": "2023-05-01",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-03",
"first_submitted": "2023-04-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.
Detailed Description
Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded 'in vitro' and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by our research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol. Our research group has also experience in preparing clinical-grade MSC from bone marrow for other clinical trials and has all the necessary facilities and permissions to comply with GMPs imposed by recent EU legislation. Finally, our clinical team has a wide experience in regenerative therapies in several previous clinical trials for bone and cartilage.
We present here an alternative proposal, aiming to anti-inflammation and regeneration by injection of single dose of mesenchymal stem cells expanded from autologous bone marrow by the GMP-complying IBGM-Valladolid procedure (MSV). Treatment involves two non-invasive surgical procedures with low morbidity: obtaining bone marrow under local anesthesia and sedation, and 4 weeks later, articular injection of the cell product (20 millions MSVs). The injection of cells does not even require anesthesia and obtaining bone marrow requires an outpatient admission two hours following safety criteria.
Patients will be evaluated clinically, including pain score (VSA), pain and disability indexes (WOMAC and Lequesne) and life quality (SF-36), and by radiologic and MRI procedures no contrast and allowing quantification of morphological and structural changes of the cartilage region studied (MRI T2-mapping).
The design of the study is an open-label prospective, multicenter study. It will recruit 12 patients with osteoarthritis of II-IV Kellgren and Lawrence grades, Patients will be evaluated clinically by previous studies imaging (X-rays and MRI). If they are eligible for the study we shall provide them information about the clinical trial with the 'Patient Information Sheet, quoting them for the Inclusion Visit. In the 'Inclusion Visit' if the patient decides to participate in the test should sign the Informed Consent Document and a schedule for MRI and X-rays will be scheduled. The results of this exploration will be considered the standard to which compare any given change in the controls at 6 and 12 months. On this visit, routine preoperative examinations are performed (EKG, chest X-ray AP, basic analytic coagulation tests and identification of HIV, Lues and hepatitis B and C and the valuation by the Internal Medicine Service).
During the visit V0 we shall verify that all inclusion criteria persist and not exclusion criteria have appeared, and we shall program V1 (to obtain bone marrow) and provide a preliminary date for MSV injection 4 week later (V2). After application, the patients will have follow-up schedule at 8 days (V3), 3 (V4), 6 (V5), 12 (V6) and eventually 24 months (V7) as detailed below.
V0: Eligibility. Clinical History. Analysis, Imaging test. Programming of the following visits V1 (day 0): Bone marrow aspiration under local anesthesia and sedation V2 (day 23). MSV Implantation. V3 (+8 days from Implantation): Security evaluation. V4 (+3 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires.
V5 (+6 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
V6 (+12 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
V7 (+24 months from Implantation): Security evaluation. VAS, WOMAC, Lequesne Index, SF-36 questionnaires, RX, RNM.
#Intervention
- OTHER : Autologous bone marrow mesenchymal stem cells (MSV)
- Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection.
- Other Names :
- MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
* Chronic knee pain with mechanical characteristics.
* No local or systemic septic process.
* Haematological and biochemical analysis without significant alterations that contraindicate treatment.
* Informed written consent of the patient.
* The patient is able to understand the nature of the study
Exclusion Criteria:
* Age over 75 or under 18 years or legally dependent
* Any sign of infection
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
* Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
* Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
* Women who are pregnant or intend to become pregnant or breast-feeding
* Neoplasia
* Immunosuppressive states
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 76 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01183728
|
{
"brief_title": "Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells",
"conditions": [
"Osteoarthritis, Knee",
"Knee Degenerative Disease",
"Knee Osteoarthritis"
],
"interventions": [
"Other: Autologous bone marrow mesenchymal stem cells (MSV)"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01183728",
"official_title": "Regeneration of Articular Cartilage in Grade II, III and IV Knee Osteoarthritis by Intraarticular Injection of Autologous Bone Marrow Stem Cells Expanded ex Vivo With a GMP Procedure Developed by IBGM-Valladolid (MSV)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-09",
"study_start_date(actual)": "2010-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-15",
"last_updated_that_met_qc_criteria": "2010-08-13",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-18",
"first_submitted": "2010-08-13",
"first_submitted_that_met_qc_criteria": "2015-01-07"
}
}
}
|
#Study Description
Brief Summary
Acute exposure of the unacclimatized human body to high altitude leads to health complications, such as loss of exercise performance capacity and fatigue. The investigators have found that the combination of the xanthine drug theophylline and the endothelin receptor antagonist ambrisentan improves the exercise performance capacity of rats under simulated high altitude. In young, healthy human volunteers, this combination of drugs has not increase toxicity over the single compounds under sea-level conditions. The aim of this study is to test whether the combination of theophylline, supplied as its more soluble formulation aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267 meters, under both resting and exercising conditions. The study also aims to test whether this drug combination improves exercise capacity in humans. In this study, human subjects will be randomized to one of four treatment sequences and receive the same study drug(s) throughout all procedures. The study consists of an initial exercise test, followed by two cycles of drug testing at simulated high altitude: Cycle 1 - resting subjects receiving study drug at simulated altitude and continually monitored for safety with pharmacodynamic and pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only safe under simulated high altitude, but also improves exercise performance capacity, in comparison with placebo.
#Intervention
- DRUG : Aminophylline 400 mg
- Xanthine derivative
- Other Names :
- Mixture of theophylline and ethylene diamine
- DRUG : Ambrisentan 5 mg
- Endothelin receptor antagonist
- Other Names :
- Letairis, Volibris
- OTHER : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must give written Informed Consent to participate in the study prior to undergoing any screening procedures. The subject will be given a signed and dated copy of the Informed Consent.
* Subjects must be healthy non-smoking (for 6 months or greater at commencement of Cycle 1) adult male and female volunteers; at least 18 through 50 years at screening, with a BMI of 18 <= age <= 33 kg/m2 and weighing at least 143 lbs. (65 kg). Subjects' health status will be determined by the medical history, physical examination, vital signs, ECG, blood chemistry, hematology, and urinalysis performed at screening.
* Subjects must be willing to fast a minimum of 2 hours prior to screening.
* Subjects must be willing to abstain from alcohol and xanthine-containing food and beverages from 48 hours before check-in for each study day,
* Women who are of non-childbearing potential, must be:
* Surgically sterile (removal of both ovaries and/ or uterus at least 12 months prior to dosing) and with an FSH level at screening of >= 40 mIU/mL.
* Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing on Day -1, and with an FSH level at screening of >= 40 mIU/mL.
* Women of child-bearing potential must have a negative serum or urine pregnancy test at screening, during the study, and must agree to avoid pregnancy during study and for three months after the last dose of study drug. Pregnancy is tested at screening, during check-in of each testing cycle, during the follow-up visit, and at any given point if deemed necessary to the PI or designate. During treatment, women of child-bearing potential must use two acceptable methods of contraception at the same time unless the subject has had a documented tubal sterilization or chooses to use a Copper T 380A IUD or LNG 20 IUS, in which case no additional contraception is required. Abstinence is not considered a form of contraception. Medically acceptable contraceptives include: (1) documented surgical sterilization (such as a hysterectomy), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD) or intrauterine system (IUS).
* Male subjects must agree to take all necessary measures to avoid causing pregnancy in their sexual partners during the study and for three months after the last dose of study drug. Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicidal. Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
* Subjects must agree not to donate blood, platelets, or any other blood components 30 days, or plasma 90 days, prior to consenting and for 1 month after the last dose.
* Male subjects must agree not to donate sperm during the study and for 12 weeks after the last dose.
Exclusion Criteria:
* Subjects with laboratory results outside the normal range, if considered clinically significant (CS) by the PI or delegate. In addition, subjects must have a hemoglobin concentration of >= 12.0 g/dL.
* A mental capacity that is limited to the extent that the subject cannot provide legal consent or understand information regarding the side effects of the study drug.
* Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years.
* Unwillingness or lack of ability to comply with the protocol, or to cooperate fully with the PI and site personnel.
* Use of any of the following:
* Any concomitant medication including oral contraceptive hormones. Subjects who have received any prescribed or non-prescribed (over-the-counter [OTC]) systemic medication, topical medications, or herbal supplements within 14 days from Day 1. St. John's Wort (hypericin) must not have been taken for at least 30 days prior to Cycle 1, Day 1.
* Any drugs, foods or substances known to be strong inhibitors or strong inducers of CYP enzymes (also known as cytochrome P450 enzymes); especially CYP 1A2, or Pgp within 7 days prior to Cycle 1, Day 1.
* Clinically significant ECG abnormality in the opinion of the PI or delegate.
* Vital signs or clinically significant laboratory values at the screening visit that in the opinion of the PI or delegate would make the subject an inappropriate candidate for the study.
* A VO2 max value of less than 42 mL/kg/min, as determined during exercise testing at screening. This value represents an educated estimate, and may be changed, to include new information, at the discretion of the PI.
* A history of, or otherwise indicated predisposition for, claustrophobia, i.e. the fear of closed, narrow spaces (because of the limited size of the high altitude chamber).
* A history of 'undeserved' altitude sickness, i.e. altitude sickness at only moderate altitude. This would consist of altitude-related headaches, dizziness, or nausea during plane rides, or when traveling to moderately elevated locations of less than 2,743.2 meters/ 9,000 ft
* Has taken any other investigational drug during the 30 days prior to the screening visit or is currently participating in another investigational drug clinical trial.
* Made any significant donation or have had a significant loss of blood within 30, or donated plasma within 90 days of consenting.
* Receipt of a transfusion or any blood products within 90 days prior to commencement of Cycle 1
* History or manifestation of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematologic or other medical disorders. For the purpose of the study, individual fitness and health are more important than family history of disease burden as a criterion for participation. For example, an individual may have significant family history of cardiovascular disease; however, the individual subject's active lifestyle makes a manifestation of such disease at young ages unlikely. To account for such expected variation, the ultimate decision whether to exclude or include an individual based on family history or manifestation of disease will be made by the PI. The PI may choose to use physiological assessments, such as e.g. ECG, blood pressure, and VO2 max fitness level as an aid for decision making.
* Any condition that might interfere with the absorption of the study medications or influence the interpretation of the results of the study.
* Subjects who are carriers of the Hepatitis B surface antigen (HbsAg), Hepatitis C antibody, or HIV antibody.
* Serious mental or physical illness within the past year.
* Male subjects who consume more than 28 units of alcohol per week and female subjects who consume more than 21 units of alcohol per week (one unit of alcohol equals 250 mL of beer, 100 mL of a medium glass of wine, or 25 mL of spirits) or those subjects who have a significant history of alcoholism or drug/ chemical abuse within the last 2 years.
* Failure to agree to abstain from alcohol, cola, tea, coffee, chocolate and other caffeinated drink/ food from 48 h before check-in for Cycles 1 & 2.
* Subjects who have used tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within 6 months prior to commencement of Cycle 1
* Women of childbearing potential who are pregnant (as based on test results) or are breast feeding
* Subjects who have a history of hypersensitivity or idiosyncratic reaction to any of the products administered during the study.
* Subjects who, in the opinion of the PI (or delegate), should not participate in the study.
* Subjects who are employed by the Duke Clinical Research Unit and/or the Duke Hypobaric/ Hyperbaric Center
* Subjects who have a history of unexplained syncope or fainting from the collection of blood; i.e., autonomic dysfunction.
* Subjects who have a history of hypotension, including orthostatic hypotension. The ultimate decision about exclusion or inclusion of a potential subject is made by the PI.
* Lack of ability to understand verbal and/ or written English.
* History of clinically significant illness within 4 weeks prior to commencement of Cycle 1. In case a subject develops an illness between any of the study activities (Screening, Cycle 1, and Cycle 2), the subject may be removed from the study, if it deems appropriate and/ or necessary to the PI.
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
|
NCT01794078
|
{
"brief_title": "A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude",
"conditions": [
"Acute Mountain Sickness and Fatigue"
],
"interventions": [
"Drug: Aminophylline 400 mg",
"Other: Placebo",
"Drug: Ambrisentan 5 mg"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01794078",
"official_title": "A Randomized, 4-Sequence, Double-Blind Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2013-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-13",
"last_updated_that_met_qc_criteria": "2013-02-14",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-18",
"first_submitted": "2013-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.
Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.
Detailed Description
The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.
Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and \<65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.
We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake
#Intervention
- BEHAVIORAL : Mentoring/educational session
- 12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.
|
#Eligibility Criteria:
Inclusion Criteria:
* self-identification as Hispanic or Somali
* member of an HPs social network
* age>=18 and <65
* willingness to participate in all aspects of the study
* provision of informed consent.
Exclusion Criteria:
* pregnancy at the time of enrollment
* serious medical conditions or disabilities that would make physical activity difficult.
* To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.
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
|
NCT04273503
|
{
"brief_title": "Pilot Social Network Weight Loss Intervention",
"conditions": [
"Diet, Healthy",
"Weight Loss"
],
"interventions": [
"Behavioral: Mentoring/educational session"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04273503",
"official_title": "Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-26",
"study_completion_date(actual)": "2020-06-30",
"study_start_date(actual)": "2020-01-28"
},
"study_design": {
"allocation": "NA",
"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)": "2021-07-30",
"last_updated_that_met_qc_criteria": "2020-02-14",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-18",
"first_submitted": "2020-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.
#Intervention
- BEHAVIORAL : Weight Gain Prevention for Women Project
|
#Eligibility Criteria:
Inclusion Criteria:
* Body mass index of 21 through 30
Exclusion Criteria:
* Presence of chronic disease that precludes regular physical activity or changes in dietary intake
* Currently receiving treatment for psychological disorder
* Currently pregnant or having given birth within last 12 months
* Use in last 3 months of weight loss medications or other drugs that affect body weight
* Participation in a weight loss program in last 12 months
* Planning to relocate outside the study area in the next 3 years
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 44 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00011102
|
{
"brief_title": "Prevention of Weight Gain",
"conditions": [
"Obesity",
"Body Weight Changes"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00011102",
"official_title": "Prevention of Weight Gain in Women Aged 25 Through 44",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2001-12",
"study_start_date(actual)": "2001-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": null,
"masking": null,
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-01-14",
"last_updated_that_met_qc_criteria": "2001-02-08",
"last_verified": "2010-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-02-09",
"first_submitted": "2001-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Obesity is a complex and multifactorial disease. Excess weight is related to endothelial dysfunction, inflammation and oxidative stress which increases the risk for cardiovascular diseases. High-intensity interval exercise can release vasodilatory substances and promote increased muscle blood flow.
Detailed Description
This study evaluated the effects of the recovery interval duration (1 vs. 3 min) in high intensity interval exercise (HIIE) on the hemodinamics responses in obese individuals. Twelve obese subjects (27 ± 3.8 yrs) were evaluated, who underwent three experimental sessions with a randomized crossover design: one control session (no exercise) and two HIIE sessions with the same workload (10 x 1min @92%VO2max / 1\[HIIE 1\] or 3\[HIIE 3\] min @0%). Forearm blood flow (FBF) and blood pressure (BP) were measured before and after the experimental sessions. Heart rate and relative perceived exertion were assessed during HIIE.
#Intervention
- PROCEDURE : HIIE 1
- In the HIIE 1 session, all the subjects performed 10 stimuli of 1 min at high intensity (92% of VO2Max) with passive recovery (without exercise) of 1 min.
- PROCEDURE : HIIE 3
- In the HIIE 3 session, the subjects performed the same stimulus of the HIIE1, but with passive recovery of 3 min. Both protocols started with a warm-up of 5 min at 50% of the VO2Peak performed on a T2-100 GE Healthcare® treadmill (Lynn Medical, Wixon, Michigan, USA).
- PROCEDURE : Control
- In the control session, participants remained seated for 30 min. During HIIE 1 and 2, HR and RPE were assessed immediately after stimulus intervals (ten measurements at each HIIE). In all sessions, the subjects remained in supine position to obtain hemodynamic measurements which were obtained before and at 10 min, 30 min and 60 min after the HIIE and control sessions.
|
#Eligibility Criteria:
Inclusion criteria for the study were obesity and the conditions of being insufficiently active, non-smokers and without previous history of: heart disease, obstructive or restrictive pulmonary diseases, and orthopedic morbidities. Fifty-one (51) subjects were evaluated for eligibility, and 39 subjects were excluded after an initial interview since they did not meet the aforementioned inclusion criteria.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03376906
|
{
"brief_title": "The Effects of High Intensity Interval Exercise in Obese",
"conditions": [
"Obesity",
"Endothelial Dysfunction"
],
"interventions": [
"Procedure: HIIE 1",
"Procedure: HIIE 3",
"Procedure: Control"
],
"location_countries": null,
"nct_id": "NCT03376906",
"official_title": "The Effects of High Intensity Interval Exercise With 1- and 3- Min Recovery Times in Obese",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-20",
"study_completion_date(actual)": "2017-01-30",
"study_start_date(actual)": "2016-06-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-19",
"last_updated_that_met_qc_criteria": "2017-12-13",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-19",
"first_submitted": "2017-02-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i) Performance scores in normal and severely visually impaired subjects with a clinical diagnosis of retinitis pigmentosa (RP) on MLYMT and MLSDT at multiple luminance levels and (ii) reliability and content validity of MLYMT and MLSDT.
Detailed Description
Two assessment visits will be conducted in order to evaluate functional visual performance in severely vision impaired subjects with RP and normally sighted subjects. Two visits will occur at week 0 and week 4 with functional vision assessments occurring at both visits in order to assess visit-to-visit variability. For the MLYMT, navigational vision will be assessed using each eye and binocularly at up to 6 different light levels (range 0.3 to 100 lux). Subjects will also perform the Multi-Luminance Shape Discrimination Test (MLSDT) which assesses near object recognition under different lighting levels. MLYMT and MLSDT performance will be evaluated together with Best Corrected Visual Acuity (BCVA), Visual Field (VF) and responses to visual function questionnaires. Subjects will be assigned to one of two cohorts based on presence or absence of RP in addition to BCVA performance.
#Intervention
- OTHER : Observational
- The goal of this observational study is to assess the reliability and validity of the multi-luminance Y-Mobility Test (MLYMT) and multi-luminance shape description test (MLSDT) for evaluation of subjects with severe vision impairment due to RP.
Normally sighted subjects will provide a control group. The MLYMT consists of two LED panels, one of which is illuminated at multiple luminance levels, positioned at the end of Y-configuration. Seven obstacles are placed ahead of the panels, which the test subject should detect and avoid before reaching and touching the lit panel.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Able to comprehend and give informed consent.
* Able to comply with testing and all protocol tests.
* Eligible for 1 of 2 cohorts listed below:
Cohort 1: Normally Sighted Participants with clinically normal ocular findings and BCVA better than logMAR 0.3 (as confirmed by ETDRS letter score > 73) in each eye Cohort 2: Severely Sight Impaired Participants with BCVA no better than logMAR 1.6 in better seeing eye, and worse than LogMAR 1.9 in the worse seeing eye, and a clinical diagnosis of advanced RP
Exclusion Criteria:
* Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
* Presence of any condition other than RP Disease that impairs visual acuity or visual fields e.g., visually significant cataract or visual field loss in glaucoma
* Presence of neurological condition that impairs visual acuity or visual field, e.g., hemianopia secondary to stroke
* Individuals who refuse or are incapable of performing mobility testing
* Individuals with retinal prosthesis (such as ARGUS-II)
* Participation in Nanoscope studies NTXMCO-002 (RESTORE) or NTXMCO-004 (STARLIGHT)
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
|
NCT05820100
|
{
"brief_title": "Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT",
"conditions": [
"Retinitis Pigmentosa",
"Retinal Dystrophy"
],
"interventions": [
"Other: Observational"
],
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT05820100",
"official_title": "A Prospective Multi-Center Observational Study to Assess the Reliability and Validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Test (MLSDT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-17",
"study_completion_date(actual)": "2023-10-17",
"study_start_date(actual)": "2023-04-25"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-05",
"last_updated_that_met_qc_criteria": "2023-04-06",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-19",
"first_submitted": "2023-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).
#Intervention
- DRUG : Aprocitentan
- A single oral dose of 25 mg.
- Other Names :
- ACT-132577
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Women of childbearing potential (WoCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective methods of contraception from screening up to 30 days after study treatment.
* A Women of non-childbearing potential (WoNCBP) must meet one of the following criteria:
* Previous bilateral salpingectomy, salpingo-oophorectomy or hysterectomy.
* Premature ovarian failure confirmed by a specialist gynecologist.
* Post-menopausal, defined as 12 consecutive months with amenorrhea prior to screening without alternative medical cause and confirmed with a follicle stimulating hormone test.
* Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
* Normal renal function confirmed by a creatinine clearance at screening according to Cockcroft and Gault adjusted to age.
* Additional principal inclusion criteria for subjects with moderate hepatic impairment (Group 1)
* Moderate hepatic function impairment due to liver cirrhosis defined as a score of 7 <= age <= 9 (inclusive) according to the Child-Pugh classification.
* Systolic blood pressure 95 to 160 mmHg, diastolic blood pressure 60 to 95 mmHg, and pulse rate 50 to 100 bpm (inclusive), measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 pre-dose.
* International normalized ratio equal or less than 2.5 at screening.
* Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1 and expected to be stable during the conduct of the study.
* Additional principal inclusion criteria for healthy subjects (Group 2)
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
Exclusion Criteria:
* Pregnant or lactating women.
* Previous exposure to aprocitentan and/or macitentan.
* Known hypersensitivity to any excipients of the drug formulation.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Any signs or symptoms of active, ongoing infection judged to be clinically relevant by the investigator (special attention should be given to COVID-19, e.g., fever, dry cough, dyspnea, sore throat, or fatigue).
* Subjects must adhere to the clinical site's house rules, which include, amongst others, polymerase chain reaction testing for SARS-CoV-2 at screening and admission.
* Legal incapacity or limited legal capacity at screening.
* Additional exclusion criteria for subjects with moderate hepatic impairment (Group 1)
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion (ADME) of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Hepatic cancer, primary biliary cirrhosis, or any form of cholestatic disease.
* Clinical evidence or suspected acute liver failure as judged by the investigator.
* Encephalopathy grade greater than 2.
* Severe ascites and/or pleural effusion.
* Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening & on Day -1, except for those related to liver cirrhosis.
* Additional exclusion criteria for healthy subjects (Group 2)
* Clinically relevant findings on the physical examination at screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion (ADME) of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening & on Day -1.
* Clinically relevant abnormalities on a 12-lead ECG, recorded after 5 min in the supine position at screening & on Day 1 pre-dose.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04252495
|
{
"brief_title": "The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics",
"conditions": [
"Hepatic Impairment",
"Healthy Subjects"
],
"interventions": [
"Drug: Aprocitentan"
],
"location_countries": [
"Germany",
"Poland"
],
"nct_id": "NCT04252495",
"official_title": "An Open-label Phase 1 Study to Investigate the Effect of Moderate Hepatic Impairment Due to Liver Cirrhosis on the Pharmacokinetics of a Single Dose of 25 mg Aprocitentan",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-05",
"study_completion_date(actual)": "2021-05-06",
"study_start_date(actual)": "2020-06-26"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-23",
"last_updated_that_met_qc_criteria": "2020-01-31",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-05",
"first_submitted": "2020-01-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome
#Intervention
- DEVICE : Platelet-rich plasma
- Blood will be drawn from a vein in the patient's arm into an 11 ml Eclipse platelet-rich plasma Tube. The blood is processed using a centrifuge machine from eclipse medical. After centrifugation, the platelet poor portion will be separated from the platelet-rich portion. The proximal nail folds are cleansed with alcohol. Using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-rich plasma is injected into 8 proximal nail folds.
- DEVICE : Platelet-poor plasma
- Blood will be drawn from a vein in the patient's arm into an 11 ml Eclipse platelet-rich plasma Tube. The blood is processed using a centrifuge machine from eclipse medical. After centrifugation, the platelet poor portion will be separated from the platelet-rich portion. The proximal nail folds are cleansed with alcohol. Using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-poor plasma is injected into 2 proximal nail folds.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who have been diagnosed with brittle nails
* Must understand and voluntarily sign an informed consent form
* Must be male or female and aged 18 <= age <= 95 years at time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements
* A nail clipping with histopathology that is negative for the presence of dermatophyte infection
* Patient must present with at least a score of 2 on the PGA scale.
Exclusion Criteria:
* Inability of the patient to provide written informed consent for any reason.
* Subject has psoriasis, lichen planus, dermatophyte infection or other confounding abnormalities that are severe enough to result in a clinically abnormal fingernail
* Use of any medication within 90 days prior to start of study
* Inability to abstain for nail polishes, nail gels during the study period
* Subject is pregnant or planning pregnancy.
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
|
NCT04941807
|
{
"brief_title": "Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome",
"conditions": [
"Nail Diseases"
],
"interventions": [
"Device: Platelet-rich plasma",
"Device: Platelet-poor plasma"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04941807",
"official_title": "Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-12",
"study_completion_date(actual)": "2023-04-12",
"study_start_date(actual)": "2021-03-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-23",
"last_updated_that_met_qc_criteria": "2021-06-21",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-28",
"first_submitted": "2021-06-21",
"first_submitted_that_met_qc_criteria": "2024-03-28"
}
}
}
|
#Study Description
Brief Summary
The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients
Detailed Description
The primary objective of the present study was to assess the safety of increasing dose levels of Thrombosomes in bleeding patients with thrombocytopenia. The secondary objective was to explore early signals of clinical efficacy of Thrombosomes in this population. The secondary objectives included: 1) Evaluation of the impact on WHO (World Health Organization) bleeding scores at various timepoints; 2) number and type of blood products infused through day 6 follow-up period; and 3) post hoc analysis of hematology, coagulation, and chemistry.
#Intervention
- BIOLOGICAL : Thrombosomes
- Freeze-dried platelets
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults up to 74 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count >= 5,000 and <= 70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.
* Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
* No platelet inhibitor drugs within 5 days prior to infusion and through Day 6 follow-up period.
Exclusion Criteria:
* History or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: transient ischemic attack, stroke, myocardial infarction, stent placement, valve replacement and/or repair
* Currently with an active acute infection, or suspected infection, a single oral temperature of >= 101° F or a temperature of >= 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
* Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT (activated partial thromboplastin time) values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
* History of any inherited coagulation or platelet function, disorder or ITP (idiopathic thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS (hemolytic-uremic syndrome)
* Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
* Treatment with an investigational drug within 1 month of infusion, other than for treatment of their underlying disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03394755
|
{
"brief_title": "Thrombosomes® in Bleeding Thrombocytopenic Patients",
"conditions": [
"Thrombocytopenia",
"Hematologic Diseases",
"Bone Marrow Aplasia"
],
"interventions": [
"Biological: Thrombosomes"
],
"location_countries": [
"Norway",
"United States"
],
"nct_id": "NCT03394755",
"official_title": "A Phase I, Multi-Center, Open-Label, Dose Escalation Study of Thrombosomes® in Bleeding Thrombocytopenic Patients in Three Cohorts",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-01",
"study_completion_date(actual)": "2019-09-25",
"study_start_date(actual)": "2018-03-19"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-14",
"last_updated_that_met_qc_criteria": "2018-01-08",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-09",
"first_submitted": "2018-01-03",
"first_submitted_that_met_qc_criteria": "2023-04-13"
}
}
}
|
#Study Description
Brief Summary
This study will evaluate whether or not engaging family members of patients admitted to the ICU in 'Family Care Rituals' will reduce stress related symptoms of PTSD, depression and anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are defined as several domains in which family participation may be of benefit, focusing on the 5 physical senses as well as the personal care of the patient and spirituality of the patient
Detailed Description
Over the previous century, the location of where people die has shifted from home to either hospitals or nursing homes, with 20% of patients dying in the ICU. Several deficiencies for End-of-Life (EOL) care provided in the ICU have been identified in literature; most of them are related to communication, decision making, sense of control, spirituality, preparation for death, pain and symptom management. Symptoms of stress, anxiety or depression as well as discordance between the perceptions of care by the health care providers (physicians and nurses) and the family members may all be related to these shortcomings. These symptoms are likely from multiple factors in the ICU that strip the family of the ability to provide any direct care or nurturing for their loved one, as families did when people died at home. Moreover, qualitative studies suggest that families want and value a role as a care provider for their loved ones in the ICU. In a pilot study, the investigators identified several domains in which family participation may be of benefit, focusing on the 5 physical senses, personal care of the patient, and spirituality of the patient and family. These areas were incorporated as Family Care Rituals (FCR) in which family members can participate while their loved one is in the ICU
The investigators are conducting a multi-center, multinational prospective evaluation of FCR with the hypothesis that FCR will primarily reduce symptoms of PTSD, as well as anxiety and depression in the surviving family members at 90 days after death or discharge from the ICU. Additionally, the intervention's effect on concordance of care as measured on day of enrollment and ICU day 5 via a questionnaire administered to the family members, the day-time nurse and the attending physician will be evaluated. ICU utilization, family satisfaction, and validation of the END of live scorING System (ENDING-S) are also being evaluated. To understand what care rituals are being performed at the bedside as well as the impact on bedside nursing care, nursing is also completing daily surveys.
The investigators are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the incidence of PTSD in family members is 33%. To reduce the rate of PTSD for family members in the interventional arm to 17%, 114 experimental subjects and 114 control subjects will need to be enrolled to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. An uncorrected chi-squared statistic will be used to evaluate this null hypothesis.
#Intervention
- BEHAVIORAL : Family Care Rituals
- Family members being enrolled are given a pamphlet outlining the Family Care Rituals. They are informed of the opportunity to perform these rituals, but that they are in no way obligated to do so.
Family members are then surveyed at enrollment, and 90 days post ICU discharge for symptoms of PTSD, as well as depression, and anxiety.
Family members, day-time nursing, and attending physicians are surveyed for concordance of care at enrollment and ICU day 5.
Demographic information is also collected on the patient and the family members at enrollment Nursing completes surveys while the patient is in the ICU noting what care rituals, if any, are being performed. Additionally, they are asked to complete a survey indicating their opinion of the impact on the care they deliver
|
#Eligibility Criteria:
Inclusion Criteria:
* Families of patients admitted to the intensive care unit (ICU) with attending physician predicted ICU mortality of greater than 30%.
* Patients with ICU length of stay greater than 4 days, regardless of mortality, are considered for ENDING-S score
Exclusion Criteria:
* Families of patients with an anticipated ICU length of stay less than 24 hours
* Families of patients admitted to the ICU for palliative/comfort care only
* Families of patients with age less than 18
* Families of patients who are pregnant
* Families of patients who are incarcerated
* Family members who are less than 18
* Family members who are pregnant
* Family members who are incarcerated
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
|
NCT02875912
|
{
"brief_title": "Prospective Evaluation of Family Care Rituals in the ICU",
"conditions": [
"Stress Disorders, Post-Traumatic",
"Depression",
"Anxiety"
],
"interventions": [
"Behavioral: Family Care Rituals"
],
"location_countries": [
"Italy",
"United States"
],
"nct_id": "NCT02875912",
"official_title": "PROSPECTIVE EVALUATION OF FAMILY CARE RITUALS IN THE ICU AND VALIDATION OF THE END-of-Life ScorING-System (ENDING-S), a Multicenter, Multinational Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-12",
"study_completion_date(actual)": "2017-06-12",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "NON_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)": "2017-07-13",
"last_updated_that_met_qc_criteria": "2016-08-18",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-23",
"first_submitted": "2016-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The IMPACT-SIRIO 5 is a randomized, double-blind, phase III clinical trial aimed to evaluate safety and efficacy of PCSK9 inhibition on clinical outcome in patients during the inflammatory stage of the COVID-19. During the hospitalization participants will be randomized in a 1:1 ratio to either receive PCSK9 inhibitor (evolocumab) or to receive placebo (saline solution). Furthermore, all people included in the study will be treated in accordance to the latest recommendations on the treatment of patients infected with SARS-CoV-2.
#Intervention
- DRUG : Evolocumab
- A single subcutaneous administration of 140 mg evolocumab
- DRUG : Saline solution
- A single subcutaneous injection of 1ml of 0,9% saline solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent for participation in the study
* Male and female age 18 or more at the time of signing the informed consent
* SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
* COVID-19 pneumonia with a typical radiological changes
* PaO2/FIO2 ratio less than or equal to 300
* COVID-19 Pneumonia in cytokine storm with elevated serum level of interleukin-6
Exclusion Criteria:
* Use of fibrates other than fenofibrate or fenofibric acid
* Known active infections or other clinical condition that contraindicate PCSK9 inhibitors
* Known systemic hypersensitivity to PCSK9 inhibitors
* Estimated glomerular filtration rate <30 ml/min/1.73 m2
* Absolute neutrophil count (ANC) less than 2000/mm3
* A platelet count less than 50000/mm3
* Creatine kinase (CK) greater than 3x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3x upper limit of normal (ULN)
* Not expected to survive for more than 48 hours from screening
* Unrelated co-morbidity with life expectancy <3 months.
* Pregnancy
* Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
* Patient being treated with other immunomodulators (except for glucocorticoids).
* Patient included in any other interventional trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04941105
|
{
"brief_title": "Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19",
"conditions": [
"Sars-CoV-2 Infection"
],
"interventions": [
"Drug: Saline solution",
"Drug: Evolocumab"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT04941105",
"official_title": "Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19: the Randomized, Double-blind, Phase III IMPACT-SIRIO 5 Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-17",
"study_completion_date(actual)": "2022-05-17",
"study_start_date(actual)": "2021-06-01"
},
"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)": "2023-04-21",
"last_updated_that_met_qc_criteria": "2021-06-24",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-28",
"first_submitted": "2021-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label, single-sequence, 2-period crossover study in healthy subjects.
In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.
Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).
Detailed Description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
#Intervention
- DRUG : Omaveloxolone
- Omaveloxolone Capsules, 150 mg, administered orally
- Other Names :
- RTA 408
- DRUG : Efavirenz
- Efavirenz Tablet, 600 mg, administered orally once daily
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males and/or females, 18 <= age <= 55 of age (inclusive) at the time of screening.
* BMI at screening between 18.0 and 32.0 kg/m2 (inclusive)
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion Criteria:
* Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
* Use of any prescription medication before the first study drug administration (within 14 days before initial study drug administration or within 5 half-lives of the prescription medication, whichever is longer), and until after the last protocol-specified blood sample is prohibited, other than use of hormonal contraception.
* Clinically significant abnormal 12 lead ECGs
* Personal history of unexplained syncopal events, or family history of long QT syndrome or sudden unexplained death in a young person.
* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
* History of drug or alcohol abuse in the last 6 months
* Positive hepatitis panel and/or positive human immunodeficiency virus test.
* Presence of hypotension (diastolic blood pressure <=50 mmHg, systolic blood pressure <=90 mmHg) or hypertension (diastolic blood pressure >= 140 mmHg, systolic blood pressure >= 90 mmHg)
* Blood donation (excluding plasma donation) within 56 days prior to screening and plasma donation within 7 days before screening.
* Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.
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
|
NCT05909644
|
{
"brief_title": "An Open-label DDI Study of Omaveloxolone in Healthy Subjects",
"conditions": [
"Healthy Adult Subjects"
],
"interventions": [
"Drug: Efavirenz",
"Drug: Omaveloxolone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05909644",
"official_title": "A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-30",
"study_completion_date(actual)": "2023-08-30",
"study_start_date(actual)": "2023-07-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-02",
"last_updated_that_met_qc_criteria": "2023-06-08",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-18",
"first_submitted": "2023-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise.
This study aimed to assess the ability of PLB to change the breathing pattern, degree of dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise. Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by forced oscillation technique.
#Intervention
- BEHAVIORAL : Pursed-lip breathing
- Pursed-lip breathing involves a nasal inspiration followed by expiratory blowing against partially closed lips, avoiding forceful exhalation.
- BEHAVIORAL : Normal Breathing
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
* Regular treatment at Clementino Fraga Filho University Hospital (UFRJ)
Exclusion Criteria:
* Exacerbation in the preceding 4 weeks
* SpO2<85% at peak exercise
* Other diseases that may contribute to dyspnea and exercise intolerance
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01173328
|
{
"brief_title": "Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in COPD",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Behavioral: Pursed-lip breathing",
"Behavioral: Normal Breathing"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT01173328",
"official_title": "Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in Chronic Obstructive Pulmonary Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2009-10",
"study_start_date(actual)": "2007-03"
},
"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)": "2010-08-02",
"last_updated_that_met_qc_criteria": "2010-07-30",
"last_verified": "2008-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-08-02",
"first_submitted": "2010-07-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.
#Intervention
- PROCEDURE : Pudendal block
- Administration of a pudendal block at the conclusion of vaginal surgery.
|
#Eligibility Criteria:
Inclusion Criteria:
* Consenting, English speaking women between ages 18 and 80 who will undergo vaginal surgery
* Ability to read VAS Scores
* Specific vaginal procedures include, but are not limited to:
Perineoplasty Complete vaginectomy Le Forte colpocleisis Anterior repair, posterior repair, and/or enterocele repair Transvaginal mesh use Transvaginal mesh excision Sacrospinous ligament fixation Uterosacral ligament suspension Vaginal paravaginal defect repair Midurethral sling placement Sphincteroplasty Vaginal hysterectomy, with or without removal of tube(s) and/or ovary(s), with or without repair of enterocele
Exclusion Criteria:
* History of chronic pelvic pain
* Currently taking sedatives
* Liver disease
* Renal disease
* Women who did not consent for the study.
* Intraoperative concern for increased blood loss
* Unable to speak English
* Unable to understand VAS Scores
* Undergoing concomitant abdominal or laparoscopic procedures
* Allergy to bupivacaine or triamcinolone
* Planned abdominal or laparoscopic procedures.
* Patients who are ineligible for non-narcotic pain medications, such as an allergy to acetaminophen or NSAIDs
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04198714
|
{
"brief_title": "Pudendal Nerve Block in Vaginal Surgery",
"conditions": [
"Nerve Block",
"Pain, Postoperative",
"Pelvic Floor Disorders",
"Pelvic Organ Prolapse",
"Pudendal Neuralgia",
"Surgery"
],
"interventions": [
"Procedure: Pudendal block"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04198714",
"official_title": "The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-13",
"study_completion_date(actual)": "2021-09-13",
"study_start_date(actual)": "2019-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-12",
"last_updated_that_met_qc_criteria": "2019-12-11",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-13",
"first_submitted": "2019-12-10",
"first_submitted_that_met_qc_criteria": "2024-03-12"
}
}
}
|
#Study Description
Brief Summary
The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early development of diaphragmatic atrophy in as early as 18 hours of complete diaphragm inactivity. These changes in muscle properties result in a decrease in the force generating capability of the muscle, ultimately resulting in difficulty to restore spontaneous breathing and a subsequent prolonged weaning process or failure. A prolonged weaning period is associated with longer duration of MV, which may result in a cascade of further diaphragm dysfunction, weakness, and injury.
Stimulation of the phrenic nerves to produce diaphragm contraction and activity is a possible mechanism to reduce MV related diaphragm dysfunction. Two promising studies have shown the potential of repetitive phrenic nerve stimulation on inducing diaphragm activity in human subjects with trains of pulses via both cervical and bilateral phrenic nerve stimulation. However, neither study provided optimal stimulation settings. As such, the primary purpose of this study is to investigate the optimal settings for noninvasive phrenic nerve stimulation to induce diaphragm contraction.
#Intervention
- OTHER : Uni- and bilateral magnetic phrenic nerve stimulation
- Uni- and bilateral magnetic phrenic nerve stimulation using different coils, stimulation patterns (frequency, intensity, number of pulses) and locations (neck, chest).
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Age: 18 - 35 years
* Non-smoking
* Healthy
* Able to communicate in English
* Normal lung function
* Normal Body mass index between 18.5 and 24.9 kg/m2
* Willingness to adhere to the study rules
Exclusion Criteria:
* Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular, neuromuscular, gastrointestinal or muscle system
* Women who are pregnant or breast feeding or have the intention to become pregnant during the course of the study
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Known or suspected non-compliance, drug or alcohol abuse
* Intake of medication affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system or gastrointestinal or muscle system
* Presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators
* Any metal or electronics inside of the body
* History of seizures or epilepsy
* Tattoos on the stimulation sites
* Previous enrolment into the current study
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
|
NCT04176744
|
{
"brief_title": "Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation",
"conditions": [
"Healthy"
],
"interventions": [
"Other: Uni- and bilateral magnetic phrenic nerve stimulation"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT04176744",
"official_title": "Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-15",
"study_completion_date(actual)": "2020-07-15",
"study_start_date(actual)": "2019-12-09"
},
"study_design": {
"allocation": "NA",
"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)": "2020-08-12",
"last_updated_that_met_qc_criteria": "2019-11-21",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-25",
"first_submitted": "2019-11-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The current study experimentally investigates whether reducing highly processed (HP) foods (defined in this study as foods high in added sugars) leads to, psychological and / or behavioral indicators of withdrawal. The following hypotheses are tested:
1. To test the hypothesis that reducing highly processed food intake will result in higher daily reports of physical (e.g. headaches), cognitive (e.g. difficulty concentrating), and affective (e.g., irritability) withdrawal symptoms).
2. To test the hypothesis that reducing highly processed food intake will result in increased negative affect (e.g., irritability, depression) as indicated by and psychological (self - reported distress ratings; daily emotion / mood reports) measures.
3. To test the hypothesis that reducing highly processed food intake will result in increased food craving as indicated by psychological (self - report craving ratings; daily craving report) measures.
All activities are completed remotely. Participants complete 4 phone appointments with a trained member of the research team. Daily questionnaires and ecological momentary assessments are completed at home between phone appointments. The initial call signs electronic consent and gets baseline measurements (questionnaires). After the initial call, participants start an active assessment period (pre / post dietary change assessments). Pre-dietary change includes at home questionnaires and ecological momentary assessments while eating a typical diet. It also includes the second phone appointment. Post-dietary change includes at home questionnaires and ecological momentary assessments while consuming 3 days of food portions lower in highly processed foods. Participants will complete a food journal on the remaining 2 days of post - dietary change assessment to report what food they ate. Post - dietary change also includes the third phone appointment. The second and third phone appointments each include computer tasks and questionnaires. The final phone appointment is a debriefing interview. Participants planning to continue eating a healthier diet may also be invited to complete a follow-up period, which involves answering a short questionnaire at home every other day for two weeks. 7 individuals had in-person data collected prior to the pandemic requiring a shift to virtual data collection.
#Intervention
- BEHAVIORAL : Dietary Change (low in highly processed foods)
- For post-dietary change, food is provided for 3 days (participants provide own food and do food journals the other 2 days to confirm adherence). University of Michigan's Nutrition Obesity Research Center (NORC)'s Metabolic Kitchen prepares the food. Low HP food diet is based on prior methods where participants are placed on an isocaloric diet composed of 5% or less of calories from added sugar and 10% or less of overall calories from total sugar. No foods that meet the criteria for a HP food (defined by Kant and colleagues) that corresponds to: sweeteners (sugar, candy, etc); carbonated and non-carbonated beverages (fruit drinks, sweetened / diet beverages, etc.); baked / dairy desserts (cookies, ice cream, etc.); salted snacks (potato chips, etc.) and fast foods (pizza, cheeseburgers, etc.) are included in diet portions. The overall macro nutrient composition of the diet will be approximately 20-25% of kcal from protein, 30-35% of kcal from fat, and 40-50% of kcal from carbohydrates.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 25 to 40
* Access to internet, private computer and smart phone
* Overweight (self-report BMI above 25.0)
* Moderately or Highly motivated to eat a healthier diet
* Mild, moderate or severe levels of addictive like eating (2 or higher on the Yale Food Addiction Scale)
* Fluent in english
* Willing to follow dietary guidelines provided by study team and eat only provide food for 3 days. Willing to delay dietary change until instructed to do so
Exclusion Criteria:
* Use of nicotine in the past month, cannabis in the past month, or illicit drugs in the past 6 months
* Weight fluctuation of 20+ pounds in the last 3 months
* Attempted weight loss using a formal weight loss program (e.g. weight watchers) in the last month
* Prior weight loss surgery (e.g. bariatric surgery)
* Medications or medical conditions that may impact study results such as medications that impact appetite, heart rate, or reward functioning (e.g. taking synthroid or has diabetes)
* Current major psychiatric diagnoses (e.g., bipolar, schizophrenia, substance use disorder, eating disorder)
* A diagnosis of a restrictive eating disorder in the past 5 years (anorexia nervosa, bulimia nervosa, purging disorder)
* Significant dietary restrictions (e.g. allergies, veganism)
* currently pregnant, breastfeeding, trying to get pregnant, or within 6 months of giving birth
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04105712
|
{
"brief_title": "The Biobehavioral Impact of Diet Quality on Affect and Craving",
"conditions": [
"Food Addiction",
"Withdrawal"
],
"interventions": [
"Behavioral: Dietary Change (low in highly processed foods)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04105712",
"official_title": "The Biobehavioral Impact of Diet Quality on Affect and Craving",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-21",
"study_completion_date(actual)": "2021-10-21",
"study_start_date(actual)": "2019-06-18"
},
"study_design": {
"allocation": "NA",
"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)": "2021-11-01",
"last_updated_that_met_qc_criteria": "2019-09-24",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-26",
"first_submitted": "2019-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to see which one of two medicines (topical gentian violet \[GV\] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC were assessed.
Detailed Description
A5265 was a phase III, open-label (both the researchers and participants know which treatment was being administered) clinical trial to compare the safety and efficacy of topical GV to that of oral nystatin suspension. Male and female HIV-1 positive participants ≥ 18 years of age were randomized (as if by the toss of a coin) with equal probability and stratified by CD4+ T-cell counts and the use of antiretroviral therapy at the time of study entry to receive either topical GV solution (5 mL swish and gargle for 1 minute and spit two times daily) or nystatin oral suspension (5 mL swish for 1 minute and swallow four times daily) for 14 days. Therapy was considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of oral candidiasis was done by an evaluator who was blinded to the treatment assignment. A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled; and participants are expected to be on the study for about 13 weeks.
#Intervention
- DRUG : Gentian Violet
- Participants were administered topical Gentian violet solution, orally, twice daily for 14 days.
- DRUG : Nystatin oral suspension
- Participants were administered Nystatin oral suspension 4 times a day for 14 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
* Pseudomembranous candidiasis documented by a complete oral exam (i.e., white or yellow spots or plaques with an underlying erythematous base, located in any part of the oral cavity) at the screening visit. Participants with documented angular chelitis and/or erythematous candidiasis without pseudomembranous candidiasis were not eligible to enroll in the study.
* If on an antiretroviral therapy (ART), initiation of regimen at least 12 weeks prior to study entry, and willingness of participant to remain on current ART regimen until the study-defined 14-day treatment period was complete. NOTE: Participants who were not ART-naïve and not on ART were eligible to participate in the study if they did not intend to initiate ART during the study- defined 14-day treatment period.
* CD4+ cell count obtained within 30 days prior to study entry at a DAIDS-approved laboratory.
Exclusion Criteria:
* Documented or presumptive signs or symptoms of esophageal candidiasis (e.g., dysphagia) during the screening period unless endoscopic examination of the esophagus was performed, and fungal esophagitis were excluded.
* Use of any investigational drug currently or within 30 days prior to study entry. NOTE: For purposes of this study, drugs available under an FDA-authorized expanded access program was NOT considered investigational.
* Concurrent vaginal candidiasis within 21 days prior to study entry.
* Use of inhaled or systemic corticosteroids within 14 days prior to study entry.
* Use of any antifungal agents within 30 days prior to study entry.
* Anticipated need for systemic or oral/topical antifungal agents for other diagnoses within the study-defined 14-day treatment period.
* Intend to initiate ART during the screening period, at study entry, or within the study-defined 14-day treatment period.
* Intend to use any additional oral topical treatments within the study- defined 14-day treatment period.
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serious illness, in the opinion of the site investigator, requiring systemic treatment.
* Hospitalization within 30 days prior to study entry for HIV or HIV-related conditions.
* Previous or current history of porphyria.
* Presence of oral warts during the screening period or at the study entry visit before randomization.
* Current wearing of full dentures or a maxillary partial denture at study entry
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
|
NCT01427738
|
{
"brief_title": "Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis",
"conditions": [
"HIV-1 Infection"
],
"interventions": [
"Drug: Nystatin oral suspension",
"Drug: Gentian Violet"
],
"location_countries": [
"Botswana",
"India",
"Kenya",
"Zimbabwe",
"South Africa",
"Uganda",
"Malawi"
],
"nct_id": "NCT01427738",
"official_title": "A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Gentian Violet Oral Solution to That of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-09",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2011-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-02-16",
"last_updated_that_met_qc_criteria": "2011-09-01",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-02",
"first_submitted": "2010-11-03",
"first_submitted_that_met_qc_criteria": "2015-02-12"
}
}
}
|
#Study Description
Brief Summary
As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.
Detailed Description
This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.
#Intervention
- DIAGNOSTIC_TEST : Tri-modality biopsy
- When the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
* Age >= 18
* Written informed consent after participant's information
Exclusion Criteria:
* Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
* Pure GGO lesion
* Patients at increased risk of bleeding
1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy
2. Coagulopathy: Thrombocytopenia (< 100,000/mm3) or prolonged PT (INR > 1.5)
* Patient with existing or risk of pulmonary and cardiovascular decompensation
* Intolerance to sedation
* Vulnerable groups such as pregnant woman, breast feeding, etc.
* Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility
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
|
NCT06123312
|
{
"brief_title": "Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions",
"conditions": [
"Lung Nodule"
],
"interventions": [
"Diagnostic Test: Tri-modality biopsy"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT06123312",
"official_title": "Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions- A Prospective Observational Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-01",
"study_completion_date(actual)": "2024-10-04",
"study_start_date(actual)": "2023-11-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-27",
"last_updated_that_met_qc_criteria": "2023-11-03",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-08",
"first_submitted": "2023-11-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
#Intervention
- DRUG : DPP-IV Inhibitor
- Escalating doses po bid
- DRUG : Metformin
- As prescribed
- DRUG : Placebo
- po bid
|
#Eligibility Criteria:
Inclusion Criteria:
* adult patients 18 <= age <= 75 years;
* type 2 diabetes;
* stable metformin therapy for >=3 months before screening.
Exclusion Criteria:
* women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
* type 1 diabetes;
* any anti-hyperglycemic medication other than metformin in the last 3 months.
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
|
NCT00111631
|
{
"brief_title": "A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes",
"conditions": [
"Diabetes Mellitus Type 2"
],
"interventions": [
"Drug: Placebo",
"Drug: DPP-IV Inhibitor",
"Drug: Metformin"
],
"location_countries": [
"United States",
"Germany",
"Canada",
"Australia",
"Puerto Rico",
"Italy"
],
"nct_id": "NCT00111631",
"official_title": "A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-10",
"study_completion_date(actual)": "2006-10",
"study_start_date(actual)": "2005-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-02",
"last_updated_that_met_qc_criteria": "2005-05-24",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-05-25",
"first_submitted": "2005-05-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries.
Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.
Detailed Description
Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries.
Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.
The aimed is to shed light to the obscure areas of diagnosis in neurobrucellosis and have detailed general and neurologic features
#Intervention
- DIAGNOSTIC_TEST : MoCA
- Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were \<26. Maximum score is 30.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >18 years with laboratory-confirmed brucellosis
Exclusion Criteria:
* Previous neuropsychiatric disease
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
|
NCT04301752
|
{
"brief_title": "Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis",
"conditions": [
"Brucellosis"
],
"interventions": [
"Diagnostic Test: MoCA"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04301752",
"official_title": "Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-01",
"study_completion_date(actual)": "2020-03-01",
"study_start_date(actual)": "2019-02-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-18",
"last_updated_that_met_qc_criteria": "2020-03-06",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-10",
"first_submitted": "2020-03-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a single-center observational study on adolescents to determine predictors of the early steps of the formation of atherosclerosis and to quantify their influence on Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity.
A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.
Detailed Description
EVA4YOU is a cross-sectional study enrolling 3000 students and apprentices aged between 14 and 19 years. Examinations are conducted at schools and companies throughout Tyrol, Austria and include laboratory measurements; standardized medical interviews; anthropometry; liver elastography; ultrasonography of the carotid artery and the aorta, and blood pressure, bioelectrical impedance; visceral abdominal fat-tissue-thickness measurement, pulse-wave velocity measurements.
The study hypothesis is that the cardiovascular risk factors measured already influence the formation of atherosclerosis (measured as carotid and aortic Intima-Media Thickness and Pulse-Wave-Velocity) in adolescents.
A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adolescents at the age of 14 <= age <= 19
* Signed informed consent of subjects (and legal guardian if subject < 18 years)
Exclusion Criteria:
* Persons, who are suspended upon a court order or upon other legal processes or are accommodated according to the Hospitalization Act, or for whom a custodian is appointed (or appointment is initiated).
* Persons with impaired power of judgment
* Persons who are currently engaged in military or community service
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04598685
|
{
"brief_title": "Early Vascular Ageing in the YOUth",
"conditions": [
"Atherosclerosis",
"Cardiovascular Risk Factor",
"Cardiovascular Diseases",
"Cardiovascular Pathology",
"Life Style",
"Vascular Diseases",
"Vascular Stiffness",
"Non-Alcoholic Fatty Liver Disease",
"Hypertension",
"Obesity",
"Overweight",
"Headache",
"Sleep",
"Sleep Disorder"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT04598685",
"official_title": "Early Vascular Ageing in the YOUth - An Observational Study Into the Predictors of Atherosclerotic Changes in Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-28",
"study_completion_date(actual)": "2023-03-31",
"study_start_date(actual)": "2021-02-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-12",
"last_updated_that_met_qc_criteria": "2020-10-15",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-22",
"first_submitted": "2020-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is a single-dose acute clinical trial aiming at identifying aggregate metabolic phenotypes for the main dietary (poly)phenols and assessing the factors associated with their formation.
The treatment consists of a nutritional challenge representative of the consumption of (poly)phenols in Europeans (so-called oral (poly)phenol challenge test, OPCT) and foresees the supplementation of three standardized tablets rich in (poly)phenols, prepared from various commercially available plant extracts constituting sources of specific (poly)phenols. Urinary excretion of (poly)phenol metabolites will be evaluated at 24 hours after tablet consumption or, for two subgroups of volunteers, at different time points for 24 hours upon tablet consumption. Blood pressure and heart rate will also be measured and anthropometric data collected. Information will be collected on genetic polymorphisms related to the metabolism of (poly)phenols, gene expression, standard cardiometabolic health biomarkers, cardiometabolic risk scores and gut microbiota profile, through the collection of urine, blood and stool samples. Volunteers will follow a (poly)phenol-free diet before and after the OPCT. To check compliance with food restrictions, a 24-hour recall will be carried out on each visit. For a sub-group of 50 subjects, 3 months after the first challenge, the OPCT will be repeated with further urinary and fecal collection.
#Intervention
- DIETARY_SUPPLEMENT : Oral (poly)phenol challenge test (OPCT)
- Nutritional challenge with standardized (poly)phenol-rich tablets
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult (18 <= age <= 74 y)
* BMI 18.5 <= age <= 35 kg/m^2
Exclusion Criteria:
* Past cardiovascular events and metabolic diseases including diabetes
* Inflammatory bowel diseases or gastro-intestinal surgery
* Renal (GFR<60 ml/min) or hepatic diseases (liver enzymes >2.5 fold higher)
* Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism)
* Mental disorders
* Antibiotic therapy within the last month
* Food allergies
* Pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05414084
|
{
"brief_title": "Aggregate Metabolic Phenotypes for (Poly)Phenols: Development of an Oral (Poly)Phenol Challenge Test (OPCT)",
"conditions": [
"Individual Variability in (Poly)Phenol Metabolism",
"Cardiometabolic Health"
],
"interventions": [
"Dietary Supplement: Oral (poly)phenol challenge test (OPCT)"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT05414084",
"official_title": "Identification of Aggregate Metabolic Phenotypes for the Main Dietary (Poly)Phenols and Assessment of the Factors Associated With Their Formation: Development of an Oral (Poly)Phenol Challenge Test (OPCT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-26",
"study_completion_date(actual)": "2023-05-26",
"study_start_date(actual)": "2022-05-31"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-23",
"last_updated_that_met_qc_criteria": "2022-06-07",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-10",
"first_submitted": "2022-05-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.
Detailed Description
Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be a female between 13 <= age <= 45 years
* Must have a history of seizures
* Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill
Exclusion Criteria:
* Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
Sex :
FEMALE
Ages :
- Minimum Age : 13 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00296413
|
{
"brief_title": "A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive",
"conditions": [
"Epilepsy"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00296413",
"official_title": "Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-02",
"study_completion_date(actual)": "2009-02",
"study_start_date(actual)": "2006-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-14",
"last_updated_that_met_qc_criteria": "2006-02-23",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-02-27",
"first_submitted": "2006-02-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery.
Design: Multicenter retrospective cohort study.
Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest follow-up. Evolution of body mass index (BMI) will be also analyzed.
Hospital eligibility: High volume centers (\> 200 bariatric operations per year) from at least three continents, maintaining a prospective database, as well as having published previously critically on their outcome.
Study population: Adult patients who underwent primary minimally invasive (laparoscopic / robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May 2017.
Patient Exclusion criteria: detailed later.
Data collection Deadline: 1st September 2017 - 30 April 2018
Detailed Description
Background With the growing complexity and cost of modern surgical practice, quality assessment becomes mandatory. The notion of quality and quality assessment is widely recognized and used in the world of business and manufacturing. A possible tool of quality assessment is benchmarking. Benchmarking is a process of measuring performance by comparison to the outcomes achieved by the best 'service provider' in a specific domain. Usually, a benchmark describes the ''best possible'' outcome of a benchmarking subject to whom comparison can be performed. In the surgical community, however, such benchmarks - best possible outcomes - for specific procedures, not just the pooled overall performance, are lacking.
In 2016, a first landmark study defining benchmark outcomes for liver resection was published in Annals of Surgery by a group of international authors invited and guided by our department. More recently, further surgical outcomes (liver transplantation, minimally invasive esophagectomy) have been benchmarked and have been accepted for publication.
Since laparoscopic bariatric surgery has become a standardized and widely performed procedure worldwide, quality assessment is of major importance. To identify the best possible outcomes (i.e. the benchmarks), data from high-volume centers (based on official IFSO criteria) in low risk patients will be analyzed. These benchmarks will serve as 'optimal outcomes' for comparison with single center outcomes, high-risk patients and future developments.
Aim The primary aim is to define benchmark outcomes based on assessment of post procedural complications according to the Clavien-Dindo classification for surgical complications and the comprehensive complication index CCI™ at discharge and at 90-days. The CCI® expresses morbidity on a continuous numeric scale from 0 (no complications) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity. Secondary outcome measure are patient survival and excess BMI loss (EBMIL).
Data Security This multicenter international study is designed to harvest prospectively collected retrospective data via an encrypted (i.e. Secure Sockets Layer (SSL) protocol) online platform (https://bbenchmarks.org/) that meets Food and Drug Administration (FDA) standards and is accessible only by secured login membership.
Confidential center specific data: Centers' outcomes will be individually analyzed in a first step to screen for center-specific differences. Benchmarks will be computed from each center's results in a second step. No center-specific data will be published. Instead, all complications or adverse outcomes will be anonymously reported, as fractions of the total study population. Each center, of course, will be free to publish their own data, as they wish.
Further use of cohort data: Future studies based on the collected data may emerge from this multicenter study, such as comparing outcomes in patients with or without specific comorbidities with benchmark outcomes. For further data usage, additional ethics approval may be required.
#Intervention
- PROCEDURE : bariatric surgery (RYGB or SG)
- laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy for severe obesity
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients of 18 <= age <= 65 years
* Low risk profile (please read 'exclusion criteria'),
* Maximum preoperative BMI of 50 kg/m2
* Primary laparoscopic/robotic proximal Roux-en-Y gastric bypass or sleeve gastrectomy
* Documented follow-up of at least 90 days
Exclusion Criteria:
* Open surgery
* Previous intra-abdominal surgery (including previous bariatric surgery)
* Pre-operative BMI over 50 kg/m2
* Age > 65 years
* Cardiovascular disease (e.g. cardiac arrhythmia, stroke, coronary artery disease) (Hypertension is allowed)
* History of thromboembolic events and/or therapeutic anticoagulation
* Diabetes mellitus (Type I and Type II, as defined by the American Diabetes Association)
* Obstructive sleep apnea (recurrent episodes of upper airway collapse during sleep)
* Chronic obstructive pulmonary disease (FEV1/FVC<0.7)
* Chronic kidney disease (eGFR < 30ml/min/1.72 m2)
* Inflammatory bowel disease (ulcerative colitis, Crohn's)
* Immunosuppression therapy (e.g. steroids, calcineurin inhibitors, etc)
* Patients who underwent associated procedures (for example: cholecystectomy, hiatoplasty, liver biopsy)
* ASA score > 2
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03440138
|
{
"brief_title": "Defining Benchmarks in Bariatric Surgery",
"conditions": [
"Benchmark",
"Bariatric Surgery",
"Roux-en-y Gastric Bypass",
"Sleeve Gastrectomy",
"Complications"
],
"interventions": [
"Procedure: bariatric surgery (RYGB or SG)"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03440138",
"official_title": "Defining Benchmarks in Bariatric Surgery - A Global Analysis of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-10",
"study_completion_date(actual)": "2019-09-17",
"study_start_date(actual)": "2017-10-17"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-19",
"last_updated_that_met_qc_criteria": "2018-02-13",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-20",
"first_submitted": "2018-02-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.
Detailed Description
Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.
#Intervention
- OTHER : Ventilation strategy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients coming in for cardiac surgical procedures will be recruited into the study.
* Both men and women will be recruited into the study.
* All patients over the age of 18 will be recruited into the study.
* Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.
Exclusion Criteria:
* Patients with preexisting respiratory failure and active infection will be excluded from the study.
* Patients undergoing one lung ventilation during surgery will be excluded from the study.
* Patients undergoing emergency cardiac surgery will be excluded from 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
|
NCT00538161
|
{
"brief_title": "Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient",
"conditions": [
"Acute Respiratory Distress Syndrome"
],
"interventions": [
"Other: Ventilation strategy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00538161",
"official_title": "Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2011-01",
"study_start_date(actual)": "2007-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-17",
"last_updated_that_met_qc_criteria": "2007-10-01",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-02",
"first_submitted": "2007-09-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.
Detailed Description
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Questionnaire items including demographic characteristics, understanding of COVID-19, attitude toward COVID-19 vaccine. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.
#Intervention
- OTHER : Perceptions and attitudes towards COVID-19 and COVID-19 vaccine
- Attitude towards COVID-19; Knowledge about COVID-19 vaccine
|
#Eligibility Criteria:
Inclusion Criteria:
* age >= 18
* recipients after liver transplantation surgery
Exclusion Criteria:
* Incomplete data (missing questionnaire information), such as lack of age, gender, indication for transplantation, time after transplantation and other indicators
* loss to follow-up
* COVID-19 vaccination before liver transplantation
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
|
NCT05532592
|
{
"brief_title": "Investigation on the Hesitancy of COVID-19 Vaccination Among Liver Transplant Recipients in China",
"conditions": [
"Vaccine Hesitancy"
],
"interventions": [
"Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine"
],
"location_countries": [
"China"
],
"nct_id": "NCT05532592",
"official_title": "Investigation on the Hesitancy of COVID-19 Vaccination Among Liver Transplant Recipients in China",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-10",
"study_completion_date(actual)": "2022-05-30",
"study_start_date(actual)": "2022-04-27"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-08",
"last_updated_that_met_qc_criteria": "2022-09-07",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-08",
"first_submitted": "2022-09-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Before having an operation doctors use expressions such as high risk, or low risk to describe the chance of complications occurring. Complications include things such as strokes and heart attacks and even death. It is thought that using words like this, instead of percentages makes it easier for patients to understand their level of risk. It is also often hard for a doctor to give a patient an exact percentage.
It is important that patients have a good understanding about their level of risk associated with an operation so they can make informed decisions about whether to go ahead with it. This is an important part of taking consent before an operation.
The aim of this study is to assess whether using expressions such as high risk and low risk to communicate the chance of a complication occurring during an operation is useful.
Different patients may assign different meanings to these expressions. If it is found that patients interpret these expressions differently from how the doctor intended it would suggest that the way doctors communicate risk to patients should be reviewed.
Patients will be asked if they are willing to participate in the study and after giving consent they will complete a questionnaire. The questionnaire will list various expressions used by doctors to describe the chance of a complication occurring during an operation, such as high risk and low risk. Each participant will be asked to give a percentage for each of the expressions. The questionnaire will be completed by patients who are waiting to have an operation at the Royal Hallamshire Hospital.
Detailed Description
Shared decision-making is central to the consent process prior to surgery and anaesthesia. Verbal probability expressions are commonly used by clinicians to help describe the level of risk. Common examples of verbal probability expressions are shown below with the estimated numerical risk shown in parentheses:
* High risk (1:100)
* Moderate risk (1:100-1:1000)
* Low risk (1:1000-1:10 000)
* Standard risk (varies depending on patient/procedure etc.)
* Very low risk (1:10 000)
* Minimal risk (1:100 000)
* Negligible risk (1:1 000 000)
Verbal probability expressions are commonly used because they are perceived as being easier to understand than, for example, percentage risk, as this is affected by how numerate a patient is. Clinicians often prefer verbal probability expressions as they avoid assigning an exact percentage of risk; this is because risk prediction is an inexact science and from an individual patient perspective, risk of complications is often a dichotomous outcome - their individual experience will be either a 0% or 100% incidence of complications, depending on whether it happens to them or not. Percentage risk only really applies to large populations, not individual patients.
Shared decision-making is central to the consent process prior to surgery and anaesthesia. With pre-operative clinics, risk indices are often described according to Calman's verbal scale illustrated above (high, moderate, low, very low etc.). However, the actual level of harm that is perceived by the patient and clinician may differ, due a variety of factors, not least a lack of understanding of the underlying numerical concepts. In addition, the level of risk assigned to these by clinicians and the level perceived by patients may differ. For example, a clinician may view a 20% probability of a complication after cancer surgery is high-risk, when compared to their own experience of the procedure; the patient who is living with the disease may see this as a low-risk, given their individual perception of the disease.
This study aims to investigate this and to see if verbal probability expressions are still useful for communication of pre-operative risk. If the study finds large inter-individual variability between patients, then this would suggest that the use of verbal probability expressions in discussions should be reviewed. This may include the need for verbal probability expressions to be used in conjunction with a numerical estimate of risk, or for the terms used (high-risk, low-risk) to be revised. The results of this study may have significant implications at national level in terms of the consent process for surgical procedures.
After gaining consent, a questionnaire with various verbal probability expressions will be completed by clinicians and patients. Each participant will be asked to assign a percentage of likelihood (i.e. a numerical translation) of an adverse outcome according to each verbal probability expression. For example, one patient may perceive the phrase 'high-risk' as an incidence risk in excess of 50%, whilst another may perceive the risk to be 20%.
A researcher will be available to answer any questions will occur during the completion of the questionnaire.
The study is observational.
The numerical translation of different verbal probability expressions will be displayed graphically to illustrate variation (if any). For example, if the phrase 'high-risk' is perceived by patients as a percentage risk ranging from 20-70%, whilst anaesthetists and surgeons perceive 'high-risk' as 10-20%, then this particular verbal probability expression would be of limited value.
We will use ANOVA to analyse if there is any difference in the level risk assigned to different verbal probability expressions by patients and anaesthetists (after testing for normality of data distribution). For example, do patients recognise a meaningful difference between low and minimal risk?
Regression analyses will also be undertaken to determine if any patient factors alter the perception of risk. This will include: sex; calculated Surgical Outcome Risk Tool score; cancer vs. non-cancer surgery; ethnicity; and surgical speciality.
|
#Eligibility Criteria:
Inclusion Criteria:
* Any patient due to undergo surgery who attends pre-operative assessment clinic
Exclusion Criteria:
* Inability to speak/read English; inability to provide own 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
|
NCT03720834
|
{
"brief_title": "Verbal Probability Expressions in Peri-operative Risk",
"conditions": [
"Surgery--Complications",
"Risk Reduction"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03720834",
"official_title": "What is the Numerical Translation of Verbal Probability Expressions Used by Patients and Doctors in the Context of Communication of Peri-operative Risk?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-21",
"study_completion_date(actual)": "2019-07-21",
"study_start_date(actual)": "2018-11-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-18",
"last_updated_that_met_qc_criteria": "2018-10-24",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-25",
"first_submitted": "2018-10-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.
Detailed Description
In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.
#Intervention
- DRUG : Org 36286 (corifollitropin alfa)
- A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing \>= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing \<= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).
- Other Names :
- corifollitropin alfa
|
#Eligibility Criteria:
Inclusion Criteria:
* Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
* >=18 and <= 39 years at the time of signing informed consent;
* a. First group: Body weight >= 50 kg and BMI >= 18 and <= 29 kg/m^2; b. Second group: Body weight <= 60 kg and BMI <= 29 kg/m^2;
* Normal menstrual cycle length: 24 <= age <= 35 days;
* Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
* Normal routine diagnostic hysteroscopy and endometrial biopsy;
* Willing and able to sign informed consent.
Exclusion Criteria:
* History of or any current (treated) endocrine abnormality;
* History of ovarian hyper-response1 or history of ovarian hyperstimulation
syndrome (OHSS);
* History of or current polycystic ovary syndrome (PCOS);
* A basal antral follicle count > 20 (size < 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2 <= age <= 5);
* Less than 2 ovaries or any other ovarian abnormality;
* Presence of unilateral or bilateral hydrosalpinx (visible on USS);
* Presence of unilateral or bilateral endometriomas (>10 mm; visible on USS);
* More than three unsuccessful COS cycles since the last established ongoing
pregnancy (if applicable);
* History of non- or low ovarian response to FSH/hMG treatment;
* FSH or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2 <= age <= 5);
* Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
* Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
* History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Previous use of Org 36286;
* Use of hormonal preparations within 1 month prior to screening;
* Administration of investigational drugs within three months prior to signing
informed consent.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 39 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00702351
|
{
"brief_title": "A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788)",
"conditions": [
"In Vitro Fertilization"
],
"interventions": [
"Drug: Org 36286 (corifollitropin alfa)"
],
"location_countries": null,
"nct_id": "NCT00702351",
"official_title": "A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 μg or 150 μg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-03-26",
"study_completion_date(actual)": "2007-07-11",
"study_start_date(actual)": "2005-12-09"
},
"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)": "2022-02-02",
"last_updated_that_met_qc_criteria": "2008-06-19",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-20",
"first_submitted": "2008-06-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS).
Detailed Description
Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).
#Intervention
- BEHAVIORAL : Mind-Body Bridging Program
- Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
- Other Names :
- MBBP
- BEHAVIORAL : Sleep Hygiene
- Treatment as usual
- Other Names :
- SH
|
#Eligibility Criteria:
Inclusion Criteria:
* Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.
* On the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see Study Procedure). In addition, they must also be able to attend the second session the following week.
Exclusion Criteria:
* The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00933959
|
{
"brief_title": "Pilot Study on Sleep Management for US Veterans",
"conditions": [
"Insomnia"
],
"interventions": [
"Behavioral: Sleep Hygiene",
"Behavioral: Mind-Body Bridging Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00933959",
"official_title": "A Pilot Study of Two Contrasting Intervention Programs for Sleep Management",
"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)": "2008-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-07-08",
"last_updated_that_met_qc_criteria": "2009-07-06",
"last_verified": "2009-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-08",
"first_submitted": "2009-06-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective treatment for GVHD caused by a bone marrow transplant.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the safety and the feasibility of the addition of vorinostat to tacrolimus and methotrexate GVHD prophylaxis.
SECONDARY OBJECTIVES:
I. To determine day 100 grades 2-4 acute GVHD. II. To determine 1-year overall survival and relapse-free survival. III. To correlate plasma concentrations of inflammatory markers of acute GVHD. IV. To correlate protein acetylation in peripheral blood mononuclear cells before and after administration of vorinostat.
OUTLINE:
Patients receive vorinostat orally (PO) twice daily (BID) on days -10 to 100. Beginning on day -3, patients receive tacrolimus intravenously (IV) continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180.Patients also receive methotrexate IV once daily (QD) on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up periodically for 1 year.
#Intervention
- DRUG : vorinostat
- Given PO
- Other Names :
- L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
- DRUG : tacrolimus
- Given IV or PO
- Other Names :
- FK 506, Prograf
- DRUG : cyclosporine
- Given IV or PO
- Other Names :
- ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune
- DRUG : methotrexate
- Given IV
- Other Names :
- amethopterin, Folex, methylaminopterin, Mexate, MTX
- OTHER : laboratory biomarker analysis
- Correlative studies
- OTHER : pharmacological study
- Correlative studies
- Other Names :
- pharmacological studies
|
#Eligibility Criteria:
Inclusion Criteria:
* A prospective patient for allogeneic HSCT for hematologic conditions, both malignant and non-malignant; donor can be unrelated marrow or peripheral blood cells; a patient with history of central nervous system (CNS) involvement is eligible if CNS disease is in remission at time of study consideration
* The donor and recipient must have a human leukocyte antigen (HLA)-8/8 allelic match at the HLA-A, -B, -C, and -DRB1; high-resolution typing is required for all alleles
* Diagnoses to be included:
* Acute myelogenous leukemia at the following stages:
* First remission
* Second or subsequent remission
* Complete remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment and < 5% blasts in the bone marrow
* Chronic myelogenous leukemia at the following stages:
* First or subsequent chronic phase:
* Patient refused tyrosine kinase therapy or is otherwise not suited for it
* Stable, not hematologic remission: blasts present in marrow and/or peripheral blood, but disease does not qualify as accelerated or blast phase
* Hematologic remission: no blast cells or precursor cells in the blood or marrow
* Partial cytogenetic remission: Philadelphia chromosome positive (Ph+) metaphases > 0% but < 35%
* Complete cytogenetic remission: absence of Ph+ metaphases
* Accelerated phase - any one of the following symptoms:
* White blood cells (WBC) difficult to control (> 50 x 10^9/L despite therapy)
* Rapid doubling of WBC (< 5 days)
* 10% blasts in blood or marrow
* 20% blasts and/or promyelocytes in blood or marrow
* 20% basophils and/or eosinophils in blood
* Anemia or thrombocytopenia unresponsive to standard treatment
* Persistent thrombocytosis (> 1000 x 10^9/L)
* Cytogenetic abnormalities in addition to Ph+
* Increasing splenomegaly
* Marrow fibrosis
* Myelodysplastic syndromes at any of the following stages:
* Refractory anemia
* Refractory anemia with ringed sideroblasts
* Refractory cytopenia with multilineage dysplasia
* Refractory cytopenia with multilineage dysplasia and ringed sideroblasts
* Refractory anemia with excess blasts-1 (5 <= age <= 10% blasts)
* Refractory anemia with excess blasts-2 (10 <= age <= 20% blasts)
* Myelodysplastic syndrome, unclassified
* Myelodysplastic syndrome (MDS) associated with isolated del (5q)
* Chronic myelomonocytic leukemia
* Primary Myelofibrosis
* Intermediate-2 risk or high risk disease
* Patients should have extinguished standard of care options prior to being considered for this trial
* Chronic lymphocytic leukemia
* Complete remission: the disease is completely absent and no relapse occurred prior to the preparative regimen; requires all of the following:
* Nodular partial remission: complete response with persistent lymphoid nodules in bone marrow
* Partial remission: reduction of more than 50% in the disease burden regardless of the number of lines of therapy received
* Mature B cell malignancies
* Patients should have extinguished standard of care options prior to being considered eligible for this trial
* First complete remission (CR1) confirmed: complete disappearance of all known disease; the term 'confirmed' is defined as a laboratory and/or pathological or radiographic determination.
* CR1 unconfirmed (CRU1): complete disappearance of all known disease with the exception of persistent scan abnormalities of unknown significance; the term 'unconfirmed' is defined as scan abnormalities of unknown significance that are not biopsied or otherwise evaluated
* Second or subsequent complete remission (CR2+) confirmed: the recipient relapsed, then achieved complete absence of disease without radiographic evidence of disease
* CR2+ unconfirmed: the recipient has achieved a second or subsequent complete response but has persistent radiographic abnormalities of unknown significance.
* Partial remission: reductions of >= 50% in greatest diameter of all sites of known disease and no new sites
* Karnofsky >= 70%
* Life expectancy of greater than 6 months
* Total bilirubin =< 2.5 mg% (unless from Gilbert's disease or disease-related)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3.0 X institutional upper limit of normal
* Estimated or actual glomerular filtration rate (GFR) > 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal; GFR should be corrected for body surface area (BSA)
* Diffusing capacity of the lung for carbon monoxide (DLCO) > 50%; DLCO should be corrected for hemoglobin
* Forced expiratory volume in 1 second (FEV1) > 50%
* Forced vital capacity (FVC) > 50%
* Ejection fraction >= 50%
* The effects of vorinostat on the developing human fetus are unknown; for this reason and because histone deacetylase inhibitor agents as well as other therapeutic agents used in this trial (e.g., tacrolimus and methotrexate) are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of vorinostat administration
* Ability to understand and the willingness to sign a written informed consent document
* Patients must be able to swallow capsules/tablets
Exclusion Criteria:
* Patients who are not a candidate for an unrelated donor allogeneic HSCT based on the current institutional bone marrow transplant (BMT) program clinical practice guidelines; organ function criteria will be utilized per the current institutional BMT program clinical practice guidelines; there will be no restriction to study entry based on hematological parameters
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
* Patients undergoing a total body irradiation (TBI)-based conditioning regimen (TBI 1200 centigray [cGy])
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiographic findings and/or culture results) that the infection is well-controlled; patients under treatment for infection will be enrolled only after clearance from the Principal Investigator (PI)
* Pregnant women are excluded from this study because vorinostat is a histone deacetylase inhibitor agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vorinostat, breastfeeding should be discontinued if the mother is treated with vorinostat
* Patients with evidence of human immunodeficiency virus (HIV) seropositivity and/or positive polymerase chain reaction (PCR) assay, human T-lymphotropic virus (HTLV)1/HTLV2 seropositivity; the safety of allogeneic HSCT is not yet well-established for this population
* Patients with evidence of hepatitis B or hepatitis C PCR positivity; hepatitis reactivation following myelosuppressive therapy can lead to fatal complications
* Patients with a history of prolonged corrected QT interval (QTc) syndrome
* Patients asking or who have had prior treatment with a drug like vorinostat (i.e., valproic acid) within the last 30 days
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
|
NCT01789255
|
{
"brief_title": "Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies",
"conditions": [
"Accelerated Phase Chronic Myelogenous Leukemia",
"Adult Acute Myeloid Leukemia in Remission",
"Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities",
"Adult Acute Myeloid Leukemia With Del(5q)",
"Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)",
"Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)",
"Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)",
"Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)",
"Adult Grade III Lymphomatoid Granulomatosis",
"B-cell Chronic Lymphocytic Leukemia",
"Chronic Myelogenous Leukemia, BCR-ABL1 Positive",
"Chronic Myelomonocytic Leukemia",
"Chronic Phase Chronic Myelogenous Leukemia",
"Contiguous Stage II Adult Burkitt Lymphoma",
"Contiguous Stage II Adult Diffuse Large Cell Lymphoma",
"Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma",
"Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma",
"Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma",
"Contiguous Stage II Adult Lymphoblastic Lymphoma",
"Contiguous Stage II Grade 1 Follicular Lymphoma",
"Contiguous Stage II Grade 2 Follicular Lymphoma",
"Contiguous Stage II Grade 3 Follicular Lymphoma",
"Contiguous Stage II Mantle Cell Lymphoma",
"Contiguous Stage II Marginal Zone Lymphoma",
"Contiguous Stage II Small Lymphocytic Lymphoma",
"Cutaneous B-cell Non-Hodgkin Lymphoma",
"Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue",
"Graft Versus Host Disease",
"Intraocular Lymphoma",
"Myelodysplastic Syndrome With Isolated Del(5q)",
"Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable",
"Nodal Marginal Zone B-cell Lymphoma",
"Noncontiguous Stage II Adult Burkitt Lymphoma",
"Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma",
"Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma",
"Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma",
"Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma",
"Noncontiguous Stage II Adult Lymphoblastic Lymphoma",
"Noncontiguous Stage II Grade 1 Follicular Lymphoma",
"Noncontiguous Stage II Grade 2 Follicular Lymphoma",
"Noncontiguous Stage II Grade 3 Follicular Lymphoma",
"Noncontiguous Stage II Mantle Cell Lymphoma",
"Noncontiguous Stage II Marginal Zone Lymphoma",
"Noncontiguous Stage II Small Lymphocytic Lymphoma",
"Post-transplant Lymphoproliferative Disorder",
"Primary Central Nervous System Hodgkin Lymphoma",
"Primary Central Nervous System Non-Hodgkin Lymphoma",
"Recurrent Adult Acute Myeloid Leukemia",
"Recurrent Adult Burkitt Lymphoma",
"Recurrent Adult Diffuse Large Cell Lymphoma",
"Recurrent Adult Diffuse Mixed Cell Lymphoma",
"Recurrent Adult Diffuse Small Cleaved Cell Lymphoma",
"Recurrent Adult Grade III Lymphomatoid Granulomatosis",
"Recurrent Adult Hodgkin Lymphoma",
"Recurrent Adult Immunoblastic Large Cell Lymphoma",
"Recurrent Adult Lymphoblastic Lymphoma",
"Recurrent Grade 1 Follicular Lymphoma",
"Recurrent Grade 2 Follicular Lymphoma",
"Recurrent Grade 3 Follicular Lymphoma",
"Recurrent Mantle Cell Lymphoma",
"Recurrent Marginal Zone Lymphoma",
"Recurrent Small Lymphocytic Lymphoma",
"Refractory Anemia",
"Refractory Anemia With Excess Blasts",
"Refractory Anemia With Ringed Sideroblasts",
"Refractory Chronic Lymphocytic Leukemia",
"Refractory Cytopenia With Multilineage Dysplasia",
"Refractory Hairy Cell Leukemia",
"Relapsing Chronic Myelogenous Leukemia",
"Secondary Central Nervous System Hodgkin Lymphoma",
"Secondary Central Nervous System Non-Hodgkin Lymphoma",
"Small Intestine Lymphoma",
"Splenic Marginal Zone Lymphoma",
"Stage I Adult Burkitt Lymphoma",
"Stage I Adult Diffuse Large Cell Lymphoma",
"Stage I Adult Diffuse Mixed Cell Lymphoma",
"Stage I Adult Diffuse Small Cleaved Cell Lymphoma",
"Stage I Adult Hodgkin Lymphoma",
"Stage I Adult Immunoblastic Large Cell Lymphoma",
"Stage I Adult Lymphoblastic Lymphoma",
"Stage I Chronic Lymphocytic Leukemia",
"Stage I Grade 1 Follicular Lymphoma",
"Stage I Grade 2 Follicular Lymphoma",
"Stage I Grade 3 Follicular Lymphoma",
"Stage I Mantle Cell Lymphoma",
"Stage I Marginal Zone Lymphoma",
"Stage I Small Lymphocytic Lymphoma",
"Stage II Adult Hodgkin Lymphoma",
"Stage II Chronic Lymphocytic Leukemia",
"Stage III Adult Burkitt Lymphoma",
"Stage III Adult Diffuse Large Cell Lymphoma",
"Stage III Adult Diffuse Mixed Cell Lymphoma",
"Stage III Adult Diffuse Small Cleaved Cell Lymphoma",
"Stage III Adult Hodgkin Lymphoma",
"Stage III Adult Immunoblastic Large Cell Lymphoma",
"Stage III Adult Lymphoblastic Lymphoma",
"Stage III Chronic Lymphocytic Leukemia",
"Stage III Grade 1 Follicular Lymphoma",
"Stage III Grade 2 Follicular Lymphoma",
"Stage III Grade 3 Follicular Lymphoma",
"Stage III Mantle Cell Lymphoma",
"Stage III Marginal Zone Lymphoma",
"Stage IV Adult Burkitt Lymphoma",
"Stage IV Adult Diffuse Large Cell Lymphoma",
"Stage IV Adult Diffuse Mixed Cell Lymphoma",
"Stage IV Adult Diffuse Small Cleaved Cell Lymphoma",
"Stage IV Adult Hodgkin Lymphoma",
"Stage IV Adult Immunoblastic Large Cell Lymphoma",
"Stage IV Adult Lymphoblastic Lymphoma",
"Stage IV Chronic Lymphocytic Leukemia",
"Stage IV Grade 1 Follicular Lymphoma",
"Stage IV Grade 2 Follicular Lymphoma",
"Stage IV Grade 3 Follicular Lymphoma",
"Stage IV Mantle Cell Lymphoma",
"Stage IV Marginal Zone Lymphoma",
"Stage IV Small Lymphocytic Lymphoma",
"Testicular Lymphoma",
"Waldenström Macroglobulinemia"
],
"interventions": [
"Drug: cyclosporine",
"Drug: methotrexate",
"Drug: vorinostat",
"Other: laboratory biomarker analysis",
"Drug: tacrolimus",
"Other: pharmacological study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01789255",
"official_title": "A Pilot Trial of Vorinostat Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease Following Unrelated Donor Hematopoietic Stem Cell Transplantation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2013-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-24",
"last_updated_that_met_qc_criteria": "2013-02-07",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-12",
"first_submitted": "2013-02-07",
"first_submitted_that_met_qc_criteria": "2015-10-13"
}
}
}
|
#Study Description
Brief Summary
This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients
Detailed Description
For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, some criticize ERP arguing that patients are asked to return home too early, while they have not recovered a satisfactory autonomy. Few studies have investigated the comfort and quality of home life of patients who have had ERP. We recently conducted a retrospective study to evaluate this quality of life. It turns out that patients report little postoperative pain, a sufficient degree of autonomy at home, and a high general satisfaction score (\> 8.5 on a numerical scale of 0 to 10). However dietary and digestive difficulties were described by about one third of the patients questioned. \[6\] Others have also reported a caloric-protein deficit during the immediate postoperative period after colorectal surgery, up to the 7th day in some of their patients \[7\].
Aim of the study. The aim of this study is to assess caloric-protein intake up to one month after colorectal surgery within ERP.
General description. This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery according to an ERP at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients.
#Intervention
- OTHER : non applicable
- no intervention in this observational study
|
#Eligibility Criteria:
Inclusion Criteria:
* any patient scheduled for colorectal surgery within an ERP at CHU Liège
Exclusion Criteria:
* unable to answer the survey (cognitive disorders, bad knowledge of the French language)
* closure of loop ileostomy
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
|
NCT03749668
|
{
"brief_title": "Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP).",
"conditions": [
"Colorectal Surgery",
"Calorie Deficiency"
],
"interventions": null,
"location_countries": [
"Belgium"
],
"nct_id": "NCT03749668",
"official_title": "Dietary Survey During the First Month After Colorectal Surgery Within an Enhanced Recovery Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-08",
"study_completion_date(actual)": "2019-05-08",
"study_start_date(actual)": "2018-11-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-05",
"last_updated_that_met_qc_criteria": "2018-11-20",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-21",
"first_submitted": "2018-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced hepatobiliary cancer who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy.
Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study treatment.
#Intervention
- DRUG : BBI503
- Other Names :
- Amcasertib, BBI-503, BB503
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
* Histologically or cytologically confirmed hepatocellular carcinoma or cholangiocarcinoma, that is metastatic, unresectable, or recurrent; and for which no currently approved, standard anti-cancer treatment option is available. Patients must have received standard of care treatment prior to enrollment.
* >= 18 years
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
* Females of childbearing potential must have a negative serum pregnancy test
* Aspartate transaminase (AST) and Alanine transaminase (ALT) <= 5.0x the upper limit of normal (ULN)
* Hemoglobin > 8.0 g/dL
* Total bilirubin <= 2.5 x ULN
* Creatinine <= 1.5 x ULN or creatinine clearance > 50 mL/min according to the Cockcroft-Gault estimation.
* Absolute neutrophil count >= 1.5 x 10^9/L
* Platelets >= 60 x 10^9/L
* Life expectancy >= 3 months
* A patient with hepatocellular carcinoma (HCC) which has arisen out of any medical context must also meet the following criteria:
* Must not be a candidate for potentially curative resection
* Must be Child-Pugh class A or B7 (i.e., in order to be eligible, the total Child-Pugh score for a patient must be <= 7)
* Must have received prior treatment with sorafenib; and have had either disease progression during treatment or have had documented intolerance to sorafenib such that further treatment with sorafenib is not possible.
* Patients with uncontrolled massive ascites or presence of hepatic encephalopathy within four (4) weeks of first dose are excluded
* A patient with confirmed cholangiocarcinoma of any type must also meet the following criteria:
* Must have disease which is not amenable to surgical, radiation, or combined modality therapy with curative intent
* Must have received prior treatment with gemcitabine, either alone or in combination with a platinum agent. Patients who are not eligible for gemcitabine must have received an alternate first-line systemic chemotherapy regimen
Exclusion Criteria:
* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI503. Patients may begin BBI503 on a date determined by the investigator and medical monitor for the sponsor provided there is a minimum of 7 days since last receiving anti-cancer treatment, and that all prior treatment-related adverse events (AEs) have resolved or have been deemed irreversible.
* Major surgery within 4 weeks prior to first dose (requiring general anesthesia and/or inpatient hospitalization for recovery).
* Any known symptomatic or untreated brain metastases requiring increase of steroid dose within 2 weeks prior to starting on study. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
* Pregnant or breastfeeding
* Significant gastrointestinal disorder(s), in the opinion of the treating investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection); such that absorption of oral medications may be impaired.
* Unable or unwilling to swallow BBI503 capsules daily
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (e.g. no reliable transportation).
* Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current hepatobiliary malignancy.
* Abnormal ECGs which are clinically significant such as QT prolongation - QTc > 480 msec, clinically significant cardiac enlargement or hypertrophy, new bundle branch block, or signs of active ischemia. Patients with evidence of prior infarction who are New York Heart Association (NYHA) functional class II, III, or IV are excluded, as are patients with marked arrhythmia such as Wolff Parkinson White pattern or complete atrioventricular (AV) dissociation.
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
|
NCT02232633
|
{
"brief_title": "A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer",
"conditions": [
"Hepatocellular Carcinoma",
"Cholangiocarcinoma"
],
"interventions": [
"Drug: BBI503"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02232633",
"official_title": "A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-14",
"study_completion_date(actual)": "2017-12-14",
"study_start_date(actual)": "2015-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-14",
"last_updated_that_met_qc_criteria": "2014-09-03",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-05",
"first_submitted": "2014-09-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.
Participants will be asked to:
* Attend training sessions to learn proper Nordic Walking techniques.
* Engage in supervised Nordic Walking sessions for a specified duration and frequency.
* Keep a log of their walking activities and any falls or near falls experienced.
* Complete questionnaires to assess their fear of falling and overall physical activity levels.
If there is a comparison group:
Researchers will compare the intervention group, consisting of older adults participating in the Nordic Walking program, with a control group of older adults who do not receive the intervention. The comparison will be made to determine if Nordic Walking has a significant impact on reducing falls and fear of falling compared to the control group.
Detailed Description
Introduction:
this is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.
Background:
Falls and fear of falling are significant concerns among older adults, leading to physical impairments, psychological trauma, and a decline in abilities and quality of life. Exercise has been shown to be effective in improving muscle strength, balance, mobility, and postural control, all of which are risk factors for falls and FOF. However, traditional exercise programs have limitations in terms of cost, sustainability, and long-term adherence. Nordic Walking, a low-risk and low-tech intervention, has emerged as a promising alternative, offering numerous physical and mental health benefits.
Study Design:
The study will be conducted in two stages. Stage One will involve a two-arm, parallel, single-blind, randomized controlled pilot trial. Forty older adults at risk of falling will be recruited and randomly assigned to either a 10-week NW intervention group or a control group. The intervention group will receive supervised NW training sessions and will be coached to practice independently. The control group will receive regular phone calls to discuss healthy lifestyle habits.
Outcome Measures:
The study will collect feasibility and safety data, including recruitment, adherence, and follow-up rates, as well as adverse events. Effectiveness outcomes will be assessed using measures such as the Timed Up and Go (TUG) test, Stay Independent Falls Risk Assessment Tool, Falls Efficacy Scale-International (FES-I), Activities-Specific Balance Confidence Scale, and the Four-Square Step Test (FSST).
Data Analysis:
Descriptive statistics will be used to characterize participants and feasibility measures. Hedge's effect size and confidence intervals will be calculated. Independent samples t-tests and chi-square tests will be used to compare the intervention and control groups. The main focus of the analysis will be to estimate the effect size, test the intervention's feasibility and safety, and inform future studies.
Sample Size:
The study aims to recruit 40 participants (20 per group) to ensure study robustness and account for potential dropouts.
Stage Two:
In the second stage, qualitative interviews will be conducted with all participants in the intervention group to gather feedback on the acceptability, perceived value, barriers, and facilitators of participating. The data will be analyzed using interpretive description to identify themes and categories.
#Intervention
- OTHER : Exercise training
- The intervention will be a combination of both supervised and unsupervised sessions. Participants in the Nordic Walking (NW) treatment group will attend 5 one-hour group sessions, which will incorporate coaching principles.
- Other Names :
- Nordic walking
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be 60+ years old.
* Be at risk of falling, as determined by the Stay Independent Falls Risk Assessment Tool. This validated tool is recommended by the STEADI fall prevention program to evaluate risk of falling.
Exclusion Criteria:
* Inability to use walking poles due to medical conditions.
* Inability to walk 400m independently.
* Having a medical condition such as unstable cardiorespiratory status, impending angioplasty, or ataxia/dyskinesia (unsteady, staggering gait) that prevents them from participating in physical activities or using walking poles is prohibited.
* Taking part in any other structured exercise program.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05965011
|
{
"brief_title": "Nordic Walking to Manage Falls and Fear of Falling",
"conditions": [
"Risk of Falling"
],
"interventions": [
"Other: Exercise training"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05965011",
"official_title": "Walking on 'Four Legs' to Manage Falls and Fear of Falling",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-15",
"study_completion_date(actual)": "2023-11-30",
"study_start_date(actual)": "2022-08-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-13",
"last_updated_that_met_qc_criteria": "2023-07-19",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-28",
"first_submitted": "2023-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.
#Intervention
- DRUG : Nebivolol
- nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
- Other Names :
- Bystolic (TM)
- DRUG : Metoprolol ER (TM)
- Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
- Other Names :
- Toprol XL (TM)
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, ambulatory outpatients 18 <= age <= 79 years at screening
* Minimum 2-year history of Stage I/II hypertension
* Qualifying blood pressure criteria for study entry and for randomization
* Willing to adhere to the dietary compliance and undergo protocol procedures
* Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days
Exclusion Criteria:
* Have any form of secondary hypertension
* Have clinically significant respiratory or cardiovascular disease
* Presence/history of coronary artery disease or peripheral vascular disease
* Have diabetes mellitus, Type I or II
* Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
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
|
NCT00648895
|
{
"brief_title": "A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients",
"conditions": [
"Hypertension"
],
"interventions": [
"Drug: Nebivolol",
"Drug: Metoprolol ER (TM)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00648895",
"official_title": "Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-11"
},
"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)": "2010-09-20",
"last_updated_that_met_qc_criteria": "2008-03-28",
"last_verified": "2010-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-01",
"first_submitted": "2008-03-28",
"first_submitted_that_met_qc_criteria": "2010-08-30"
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation of the free dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903 XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed dose combination and the free dose combination, respectively; to compare the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed dose combination and as the free dose combination, respectively.
#Intervention
- DRUG : BI 1744 CL
- DRUG : BI 54903 XX
- DRUG : BI 1744 CL + BI 54903 XX FDC
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
* Age >= 21 and <= 50 years
* BMI >= 18.5 and <= 29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion Criteria:
* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
* Inability to refrain from smoking on trial days
* alcohol abuse (more than 40 g/day)
* Drug abuse
* Blood donation (> 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
For female Subjects:
* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilization, intrauterine pessary (IUP), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Exclusion criteria specific for this study due to the known class side effect profile of ß2-mimetics and inhaled corticosteroids:
* Asthma or history of pulmonary hyperreactivity
* Hyperthyreosis
* Allergic rhinitis in need of treatment
* Clinically relevant cardiac arrhythmia
* Bacterial and viral infections of the lung including tuberculosis
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02220660
|
{
"brief_title": "Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: BI 54903 XX",
"Drug: BI 1744 CL",
"Drug: BI 1744 CL + BI 54903 XX FDC",
"Drug: Placebo"
],
"location_countries": null,
"nct_id": "NCT02220660",
"official_title": "A Single-blind, Randomised, Two-way Crossover Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2009-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-20",
"last_updated_that_met_qc_criteria": "2014-08-19",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-20",
"first_submitted": "2014-08-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years
* Established diagnosis of cancer
* Signed informed consent
* Adequate CBC and chemistry to receive chemotherapy
Exclusion Criteria:
* Pregnancy
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
|
NCT00757094
|
{
"brief_title": "Safety and Feasibility of Fasting While Receiving Chemotherapy",
"conditions": [
"Fasting",
"Chemotherapy",
"Cancer"
],
"interventions": null,
"location_countries": [
"Saudi Arabia"
],
"nct_id": "NCT00757094",
"official_title": "Safety and Feasibility of Fasting While Receiving Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2008-09"
},
"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)": "2010-02-25",
"last_updated_that_met_qc_criteria": "2008-09-19",
"last_verified": "2010-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-22",
"first_submitted": "2008-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lung Protective Ventilation (LPV) is considered the gold standard of care nowadays. Even though, all over the world reported adherence to this concept, among anesthesiologists, is only 15%. The investigators hypothesized that the introduction of the Standard Operating Procedure (SOP) document will increase adherence to LPV among anesthesiologists. In this study, the investigators will record ventilating parameters during general anesthesia using Care Station Insights software. Then, the investigators will evaluate the recorded parameters and match them with LPV criteria. The adherence level to every parameter separately will be counted in percentage.
Detailed Description
In this study, the investigators will start by stating the current adherence level to the LPV concept during general anesthesia among anesthesiologists. Adherence will be calculated as percentage of cases that will met the criteria. The evaluation will be based on saved data in Care Station Insights software from General Electric. This software is running on anesthesia machines GE Aysis CS2.
The investigators will record and evaluate:
* Positive End Expiratory Pressure (PEEP) \[cmH2O\]
* Plateau Pressure (Pplat) \[cmH2O\]
* driving pressure \[cmH2O\]
* Tidal Volume/Ideal Body Weight (VT/IBW)
* number of recruitment maneuvers during a case
* phase of a case when recruitment maneuver is done (induction/maintenance/emergence)
Each parameter will be evaluated separately. The adherence level for each parameter will be interpreted as a percentage of cases that meet the LPV criteria in terms of the given parameter. The investigators will evaluate the 100 most recent cases, before the SOP introduction, to state the current adherence level.
After stating the current adherence level to the LPV during general anesthesia, the investigators will introduce the Standard Operating Procedure document (SOP). SOP introduction will be supplemented with an educational program regarding LPV.
The SOP will include:
* the definition of LPV
* the theoretical background of LPV
* LPV strategy recommendations/criteria
The educational program:
* set of 11 half-hour-long sessions with LPV experts
* induction recommendations
* preoxygenation recommendations
* PEEP intraoperative recommendations
* LPV strategy during general anaesthesia and perioperative complications
* LPV in specific situations
* laparoscopy
* robotics surgery
* pronation
* recruitment maneuvers during general anaesthesia
* extubation recommendations
* neuromuscular blockade and monitoring recommendations
* Adequacy of Anaesthesia (AoA) strategy
Then, the investigators will begin with recording the second set of ventilatory parameters. The investigators will collect the very same parameters to state the current adherence level to LPV during general anesthesia as in the first data set. Ventilatory parameters will be collected the same way as for the first data set, with the use of Care Station Insights software. Anesthesiologists giving the anesthesia care will not know neither the goal of the study nor which parameters are recorded.
After finishing collecting the second data set, based on sample size calculation, the investigators will evaluate these. The evaluation process will be identical to the evaluation process of stating the current adherence level. The investigators will evaluate each parameter separately. Adherence for each parameter will be interpreted as a percentage of cases that meet the LPV criteria in terms of the given parameter.
At the finish, the investigators will compare adherence levels before and after the SOP introduction.
#Intervention
- OTHER : Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.
- The Standard Operating Procedure document will be introduced. The SOP document will cover the theoretical background, definition, and recommendations/criteria of LPV. The SOP document will reflect the most recent LPV guidelines.
|
#Eligibility Criteria:
Inclusion Criteria:
* A general anaesthesia case with the airway secured with the endotracheal tube
Exclusion Criteria:
* General anaesthesia without time cycled ventilator regime
* General anaesthesia without airway secured with an endotracheal tube
* General anaesthesia in which the care is given by a member of the study team of this study
* General anaesthesia in which one lung ventilation is used
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
|
NCT05831683
|
{
"brief_title": "Standard Operating Procedure as a Valuable Tool to Increase Adherence to Lung Protective Ventilation Among Anesthesiologists.",
"conditions": [
"Adherence, Treatment"
],
"interventions": [
"Other: Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia."
],
"location_countries": [
"Czechia"
],
"nct_id": "NCT05831683",
"official_title": "Standard Operating Procedure as a Valuable Tool to Increase Adherence to Lung Protective Ventilation Among Anesthesiologists.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-11",
"study_completion_date(actual)": "2023-06-18",
"study_start_date(actual)": "2023-04-20"
},
"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)": "2024-08-06",
"last_updated_that_met_qc_criteria": "2023-04-14",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-26",
"first_submitted": "2023-04-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Haptoglobin (Hp) gene locus at chromosome 16q22 is polymorphic with two alleles denoted 1 and 2 .The gene product exists in three phenotypes: 1-1, 2-1, and 2-2.
The Haptoglobin 2 allele is found only in man and is believed to have arisen from the Haptoglobin 1 allele by a partial intragenic duplication. Haptoglobin 2 allele frequency is higher than the Haptoglobin 1 allele. It has been hypothesized that the Haptoglobin 2 allele was spread in man due to its selective advantage against life-threatening infections.
In vitro, only the Haptoglobin 2 allele protein, binds to the streptococcus T antigen, resulting in its aggregation and slowing its growth .
Individuals homozygous for the Haptoglobin 1 allele (1-1 genotype) are more prone to the streptococcal infection than individuals with the Haptoglobin 2 allele(2-1 or 2-2 genotype).
The investigators wish to explore the linkage between Hp phenotype and sepsis in pre-term neonates, considering that in this early stage in life, genetic properties which provide a defense against infectious agents will be of heightened importance.
Detailed Description
The Haptoglobin (Hp) gene locus at chromosome 16q22 is polymorphic with two alleles denoted 1 and 2 .The gene product exists in three phenotypes: 1-1, 2-1, and 2-2. Hp 2 allele DM individuals have larger myocardial infarctions than homozygous Hp 1 DM individuals. This may be due to differences in the antioxidant and anti-inflammatory properties of these proteins.The same phenomenon was demonstrated in a murine coronary ischemia-reperfusion model.
The Haptoglobin is an acute phase protein with anti-oxidant, bacteriostatic and anti-inflammatory functions.
The Haptoglobin 2 allele is found only in man and is believed to have arisen from the Haptoglobin 1 allele by a partial intragenic duplication. Haptoglobin 2 allele frequency is higher than the Haptoglobin 1 allele. It has been hypothesized that the Haptoglobin 2 allele was spread in man due to its selective advantage against life-threatening infections.
In vitro, only the Haptoglobin 2 allele protein, binds to the streptococcus T antigen, resulting in its aggregation and slowing its growth .
We proposed that in individuals homozygous for the Haptoglobin 1 allele (1-1 genotype), the streptococcal infection would be more severe than in individuals with the Haptoglobin 2 allele (2-1 or 2-2 genotype).
During a severe outbreak of impetigo in two infantry units in the Israeli Defense Forces, over 60% (57/91) of the soldiers developed impetigo caused by a single pathogen-group A streptococcus. 33% of them developed serious life-threatening complications requiring hospitalization. The risk of Haptoglobin 1-1 genotype individuals developing severe infection was significantly higher than individuals with Haptoglobin 2 genotype (45.5% (5/11) vs. 17.5% (14/80), risk ratio 2.6 (95% confidence interval 1.2-5.8), p=0.05). This supports the notion that the Haptoglobin genotype determines the susceptibility to streptococcus infection, an important pathogen early in human evolution, and explains the spread of Haptoglobin 2 allele in human.
Another study demonstrated that Diabetic dialysis patients at the age of 60 and above carrying the Hp1-1 phenotype had a lower mortality rate compared to the patients who are Hp2-2. However, younger population has shown the opposite. This can be explained by the survivorship pattern of Hp1-1 diabetic patients who have lower risk for diabetic complications. They will also survive dialysis in older age by suffering less from vascular complications compared to Hp2-2. However, in Hp2-2 younger patients, the infectious parameter is more significant and mortality will be lower.
We wish to explore the linkage between Hp phenotype and sepsis in pre-term neonates, considering that in this early stage in life, genetic properties which provide a defense against infectious agents will be of heightened importance.
During the study period of one year, all preterm neonates (a total of 150 preterm babies, 35 weeks or younger) admitted to the preterm unit at Carmel hospital will be typed for Hp phenotype by a blood test. Hp phenotyping needs only about 500 microliters of blood which will be taken during routine blood drawn. All blood samples will be identified with the patient's I.D. number and name in addition to the study consecutive serial number. The blood samples will be sent to the laboratory of vascular medicine in the faculty of medicine at the Technion. If the number of participating infants during one year will be insufficient (less than 150), we will ask for additional permission of the ethical committee to continue the study for the second year.
Septic neonates will be recognized by clinical deterioration (abnormal body temperature and/or disturbed skin perfusion and/or apathy and/or increase in apnea/bradycardia episodes and/or abnormal CBC, leukocytosis or leucopenia or left shift or thrombocytopenia) and concomitant positive blood cultures, without another explanation of non infectious etiology. Details of the bacteria including antibiotic resistance profile will be documented. Demographic data will be collected for all patients.
In addition data regarding known pre-maturity complications such as Retinopathy of Pre-maturity (ROP), Necrotizing Entero-Colitis (NEC), Broncho-Pulmonary Dysplasia (BPD) will be assessed and documented according to the admission summary.
Blood transport, Hp typing and data collection will be done by a MD student as part of her MD thesis.
As part of the informed consent, we will ask the permission for a possible follow up one year after discharge from the hospital which will be done by a phone questionnaire and acquiring the patients medical file data with the help of his family
|
#Eligibility Criteria:
Inclusion Criteria:
* Preterm babies born at 35 week gestational age and younger being admitted to the preterm unit in Carmel Medical Center over a period of one year.
Exclusion Criteria:
* Pre-term neonates with serious congenital defects.
Sex :
ALL
Ages :
- Minimum Age : 24 Weeks
- Maximum Age : 35 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00800449
|
{
"brief_title": "Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH)",
"conditions": [
"Neonatal Sepsis"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT00800449",
"official_title": "Prospective Assessment of the Distribution of Haptoglobin Phenotype in Septic and Non Septic Pre-term Neonates (PTSH)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-03",
"study_completion_date(actual)": "2011-09",
"study_start_date(actual)": "2007-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-14",
"last_updated_that_met_qc_criteria": "2008-12-01",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-02",
"first_submitted": "2008-11-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.
#Intervention
- DRUG : Atomoxetine
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with ADHD only or ADHD and Dyslexia
* At least 10 years and no more than 16 years
* IQ score of 80 or more
* Must be able to swallow capsules
Exclusion Criteria:
* Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Weigh less than 25 kg or greater than 70 kg
* Pregnant or breast feeding
* Documented history of bipolar I or II disorder, or psychosis
* Documented history of autism, Asperger's syndrome or pervasive developmental disorder
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00191048
|
{
"brief_title": "Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD",
"conditions": [
"Attention-Deficit/Hyperactivity Disorder",
"Comorbid Dyslexia"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00191048",
"official_title": "Open-Label Treatment With Atomoxetine Hydrochloride in Child and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-03",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-01-26",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2007-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-19",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The 'Class I compression' versus 'The two class III compressions' contrast will also be studied.
Efficacy will be measured by totalling the VAS scores for maximum pain experienced since the morning and evaluated by the patient at the end of the day.
Consumption of analgesics or the number of days of analgesic treatment necessary for the 3 compression types used will be compared.
One of the trial objectives is also to show that regular use of a class III compression product leads to a reduction in complications following sclerosis (by reducing the number of non-serious/serious complications specific to sclerosis: matting, pigmentation, inflammation, development of sclerosis requiring drainage, DVT, pulmonary embolism, etc.). The trial also aims to compare the rate of successful sclerosis between the three devices, success being defined by complete or partial occlusion of the great saphenous vein, leading to the disappearance of reflux at the crural level.
The other secondary objectives will be patient evaluation of comfort, ease of putting on and taking off the compression hose and a global appreciation of the procedure for echoguided endovenous injection of sclerotherapeutic foam into the great saphenous vein, followed by wearing compression hose.
Detailed Description
Not desired
#Intervention
- DEVICE : Compression Stockings
- The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The 'Class I compression' versus 'The two class III compressions' contrast will also be studied.
- Other Names :
- ACTYS 25 ®, Varisma Comfort Coton ®, Varisma Séduction ®
|
#Eligibility Criteria:
Inclusion Criteria:
General:
* Patient at least 18 years
* Patient agreeing to give her informed consent in writing
* Patient taking effective contraceptive on inclusion and not planning pregnancy during the trial period.
* Patient registered with the social security or equivalent regime;
Linked to the pathology:
* Patient suffering from truncal insufficiency of the SVG supplied either by reflux from the saphenofemoral junction, with or without competent terminal valve, or by collaterals or perineal varicosities in the subinguinal region and who is scheduled to have endovenous injection of sclerotherapeutic foam into the great saphenous vein presenting truncal reflux of at least one second, the diameter of which is at least 4 mm (no limit for maximum calibre) standing 15 cm from the inguinal fold (according to an echo-doppler taken less than three months prior to inclusion).
* Injection initially planned of 2% Aetoxisclerol, the injection volume of which is limited to 3 ml of liquid, i.e. less than 15 ml of foam, for complete filling of the great saphenous and a spasm. (to standardise the procedure before fitting the compression hose) Patient classified C2 to C5 (clinical stages in CEAP classification).
Exclusion Criteria:
* General:
* Patient regularly taking analgesics or anti-inflammatories.
* Patient suffering from a state or prior history of mental or psychiatric disorder or any other factor limiting aptitude to take an informed part and respect of the protocol; Patient suffering from chronic hepatopathology.
* Renal insufficiency (clearance < 60 ml/min. according to Cockcroft).
* Patient suffering from a known evolving malignant pathology.
* Patient suffering from decompensated cardiac or respiratory insufficiency.
* Patient who is pregnant or breast-feeding.
* Patient currently taking part in a clinical trial or who took part in a clinical trial during the month preceding inclusion.
* Person deprived of liberty by a legal or administrative decision, Adult patient protected by the law, under legal protection or guardianship.
Linked to the pathology/product:
* Patient suffering from LL pain other than vascular (sciatica, gonarthrosis, neuropathy, etc.)
* Patient presenting contraindications for class III venous compression (20 to 36 mmHg)
* Patient with a prior history of skin reactions following the use of venous compression products
* Scheduling a procedure for endovenous injection other than into the great saphenous vein during the period of study of the leg, planned during the 2 months following SVG sclerosis.
* Patient displaying post-thrombotic or primary anomalies of the deep vein network on the Echo-Doppler (less than 3 months before inclusion).
* Patient suffering from arteriopathy of the lower limbs with a systolic pressure index at the ankle of < 0.6
* Saphenous incompetence not meeting the anatomical and/or haemodynamic criteria defined in the inclusion criteria.
* Open ulcer in the LL (C6 of CEAP classification).
* Patient not tolerating compression or requiring chronic fitting of high pressure compression (in excess of 20 mmHg).
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
|
NCT01368159
|
{
"brief_title": "Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the Great Saphenous Vein",
"conditions": [
"Venous Disease"
],
"interventions": [
"Device: Compression Stockings"
],
"location_countries": null,
"nct_id": "NCT01368159",
"official_title": "Randomised, Comparative Trial in Parallel Groups and Blinded, to Compare Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the G.S V. Under Echography Control, Between Three Types of Medical Compression Hose",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2010-11"
},
"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)": "2011-09-14",
"last_updated_that_met_qc_criteria": "2011-06-06",
"last_verified": "2011-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-07",
"first_submitted": "2011-04-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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