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#Study Description
Brief Summary
This study is a pilot study (feasibility and acceptability study), which will compare feasibility and efficacy outcomes between a 12-week Exercise Program and control group in RAC residents.
Detailed Description
Study Design and Recruitment This study compared the delivery feasibility and outcomes of a 12-week combined resistance and weight bearing exercise programme which the investigators named the GrACE programme. Participant recruitment and assessment occurred over a five-month period.
The RAC was approached about participation via email and telephone follow-up. Potential participants were identified at a meeting with the facility Service Manager. Participants were screened via the inclusion criteria at the meeting with the Service Manager and a Registered Nurse, and written consent was attained prior to participation. Following an explanation of the procedures, purposes, benefits and associated risks of the study, participants had the opportunity to ask questions. A total of 37 older RAC adults provided written informed consent for the study. The exercise group contained 20 participants and the control group 17 participants. Ethical approval to conduct this study was attained from Bond University's Human Ethics Research Committee (RO 1823).
Intervention: the GrACE programme Previous work by our group trialled a successful exercise programme in respite day care that could promise benefits to those in RAC (HenwoodWooding \& de Souza 2013). In brief, the GrACE programme included a number of targeted weight-bearing exercises (using body weight and dumbbells) and a range of seated, non-resisted upper- and lower-body dynamic and reaching movements. While developed for respite care older adults, the programme was slightly modified for the RAC setting; initially using reduced range of motion and resistance, and an extended conditioning/familiarisation phase. The conditioning phase lasted for three weeks in which technique was emphasised without using any weights or additional resistance. The focus of this technique of the conditioning phase was to develop the correct technique and minimise the potential for any delayed onset muscle soreness or adverse effects. After concluding the conditioning phase, participants were able to use light dumbbells (often starting with 0.5kg) increasing to heavier dumbbells (up to 4kg) with their increasing capacity over the course of the programme. Participants performed the exercises twice per week for 12 weeks. Training sessions lasted approximately 45 minutes, were separated by at least 48 hours and were delivered by an allied health professional experienced working with RAC adults.
Control Group All subjects assigned to the control group were given the option to engage in other activities that were offered by the facility during the 12-week intervention period. Activities were facility specific, and included Zumba Gold aerobic exercise and walking, however no specific resistance exercises were offered.
Data Collection Reasons for refusal (non-consent) to participate were recorded (Henwood 2014). All muscle function outcome measures in this study have been previously validated for use with older adults, and their protocols reported elsewhere (Henwood, Wooding \& de Souza 2013; Sterke et al. 2012). Assessments were completed one-on-one with each participant. During muscle function measures assessments, participants were encouraged to rest as needed and given verbal support and encouragement to reduce any potential burden to the participant.
#Intervention
- OTHER : Exercise
- to determine the feasibility of the GrACE (Group Aged Care Exercise) programme in RAC, with the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength.
- OTHER : Control
- to compare with the GrACE (Group Aged Care Exercise) programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention group
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 65 years and over,
* Residing in a RAC,
* Able to walk with a walker and/or walking stick or could self-ambulate and,
* Could provide informed consent.
Exclusion Criteria:
* End-stage terminal and/or life expectancy <6-months (ethical reasons),
* Two person transfer or unable to self-ambulate (due to increased falls risk),
* Unable to communicate or follow instructions (personal needs beyond the scope of this project),
* Insufficient cognitive function to provide informed consent and,
* Dangerous behaviours that would endanger the client or research staff.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02640963
|
{
"brief_title": "Feasibility and Benefits of Group Based Exercise in Residential Aged Care Adults",
"conditions": [
"Geriatric Disorder",
"Sarcopenia"
],
"interventions": [
"Other: Exercise",
"Other: Control"
],
"location_countries": null,
"nct_id": "NCT02640963",
"official_title": "Feasibility and Benefits of Group Based Exercise in Residential Aged Care Adults: a Pilot Study for the GrACE Programme",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2015-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-21",
"last_updated_that_met_qc_criteria": "2015-12-28",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-29",
"first_submitted": "2015-12-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This Phase 1 study will assess the pharmacokinetic effect of multiple doses PF 06700841 (administered once a day) on a single dose of a combination oral contraceptive, in 18 healthy female participants who are not of childbearing potential.
Detailed Description
This is a Phase 1, randomized, 2 way crossover, multiple-dose, open label study of the effect of multiple doses PF-06700841 on single dose combination oral contraceptive (OC) pharmacokinetics (PK) in healthy female participants aged 18-60.
The study consists of a screening phase (up to 28 days prior to Day 1); two treatment periods during which participants are resident in the Clinical Research Unit (CRU) and a final follow-up telephone contact, which will be conducted after 28-35 following administration of the last dose.
Participants will be randomized to 1 of 2 treatment sequences. A total of 18 healthy female participants (9 in each treatment sequence) will be enrolled in the study. Each treatment sequence will consist of 2 periods in a single fixed sequence. Participants will be screened within 28 days of the first dose of investigational product. Participants will report to the Clinical Research Unit (CRU) the day prior to Day 1 dosing in Period 1 for both treatment sequences, and will report to the CRU the day prior to Day 1 dosing in Period 2 for Treatment Sequence 2. In Treatment Sequence 1, participants will remain in the CRU for up to 21 days and 20 nights. There will be no washout period in Treatment Sequence 1. In Treatment Sequence 2, participants will remain in the CRU for up to 22 days and 20 nights. Participants in treatment sequence 2 will have an outpatient washout period of at least 10 days between Period 1 and Period 2. A single administration of OC in the form of 1 PORTIA or equivalent tablet will be administered in one of the two periods (reference treatment) and in the alternative treatment period, daily doses of 60 mg PF-06700841 will be administered for 13 days with a single dose of OC being administered on Day 10. PK (AUCinf, Cmax, AUClast, Tmax and t½) of OC will then be assessed at pre OC dose and over 96 hours, post OC dosing.
Safety assessments will be conducted at the CRU.
#Intervention
- DRUG : PF-06700841
- 60 mg by mouth (PO) once daily (QD).
- DRUG : Ethinyl estradiol (EE) and levonorgestrel (LN)
- Oral tablet containing 30 mcg EE and 150 mcg LN.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy females aged 18 <= age <= 60
* Not of childbearing potential
* Body mass index of 17.5 <= age <= 30.5 kg/m2
* Body weight > 50 kg
* Capable of giving signed informed consent
Exclusion Criteria:
* Evidence or history of clinically significant disease including irritable bowel disease; HIV; Hep B and Hep C; acute or chronic infection history; lymphoproliferative disorder; tuberculosis; hearing loss; sensitivity to heparin or heparin-induced thrombocytopenia
* Any condition affecting drug absorption
* Participants who have experienced major trauma or surgery in the 3 months prior to baseline
* Participants in imminent need for surgery
* Use of prescription or non-prescription drugs within 7 days or 5 half-lives prior to dosing
* Previous administration with an investigational drug within 30 days or 5 half-lives prior to dosing
* A positive urine drug test
* Hypertension
* ECG anomalies
* Significant laboratory anomalies
* History of drug abuse with less than 6 months of abstinence prior to the baseline visit
* History of alcohol abuse within 6 months of screening
* History of nicotine use within 30 days of baseline visit
* Any contraindications to OC
* History of discontinued use of OC for medical reasons
* Febrile illness within 5 days prior to dosing
* Vaccination with live or attenuated virus or live viral components within 6 weeks prior to dosing
* History of major organ transplant
* History of severe allergic or anaphylactic reaction to kinase inhibitors
* have donated blood of 500mL or more within 60 days prior to dosing
Sex :
FEMALE
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
|
NCT04267250
|
{
"brief_title": "Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids",
"conditions": [
"Healthy Female Volunteers"
],
"interventions": [
"Drug: PF-06700841",
"Drug: Ethinyl estradiol (EE) and levonorgestrel (LN)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04267250",
"official_title": "A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06700841 ON THE PHARMACOKINETICS OF SINGLE DOSE ORAL CONTRACEPTIVE STEROIDS IN HEALTHY FEMALE PARTICIPANTS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-06",
"study_completion_date(actual)": "2020-11-06",
"study_start_date(actual)": "2020-08-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-13",
"last_updated_that_met_qc_criteria": "2020-02-10",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-12",
"first_submitted": "2020-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.
Detailed Description
This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.
#Intervention
- PROCEDURE : TAP block
- TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
- Other Names :
- Transversus abdominis plane block
- DRUG : Morphine
- Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
- Other Names :
- Opioids
- DRUG : Ropivacaine
- Ropivacaine 0.25% 20 ml each side
- Other Names :
- Anaropin
|
#Eligibility Criteria:
Inclusion Criteria:
* Cesarean section with general anesthesia.
* The ASA classification was from II to III
Exclusion Criteria:
* The acute fetal impairment.
* The severe live or renal failure.
* Tolerance opioids
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03634111
|
{
"brief_title": "The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section",
"conditions": [
"Obstetric Pain"
],
"interventions": [
"Procedure: TAP block",
"Drug: Morphine",
"Drug: Ropivacaine"
],
"location_countries": [
"Vietnam"
],
"nct_id": "NCT03634111",
"official_title": "The Transversus Abdominis Plane Block",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-15",
"study_completion_date(actual)": "2018-03-31",
"study_start_date(actual)": "2017-07-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-16",
"last_updated_that_met_qc_criteria": "2018-08-14",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-16",
"first_submitted": "2018-08-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).
Detailed Description
Medical oncology is aimed to increase patient's survival, even at metastatic stages, in addition to disease-related and treatment-related symptoms. However, providing palliative care (PC) which includes symptoms management, nutritional support, psychosocial support, as well as assistance on end-of-life preferences, may be as important as survival issues to improve quality of life in such setting. In France, PC has been traditionally offered late, at end-life stage, although the World Health Organization recommends providing PC as earlier as possible in the course of the disease, in order to increase quality of life.
Decades ago, PC services were initiated in France in order to provide a medical alternative to the use of questionable medical practices regarding the end of life period: abandonment, euthanasia, and inappropriate aggressive therapy. According to the French society of palliative care, PC is an approach aimed to provide active care, in a holistic approach, to the person with a serious, progressive or terminal illness. The objective of PC is to relieve pain and other distressing symptoms, but also to take into account the psychological, social and spiritual suffering. PC offers an interdisciplinary support system to help patients and their relatives. As mentioned previously, PC has been in France (but also in the US) usually offered late, at end-life stage. Actually, PC access became a Right guaranteed by the Law, for patients and their families in 1999. This context should explain why even nowadays, PC often means ' end of life ' not only for the lay-man for the general public but also for caregivers, and some doctors.
The last World Health Organization (WHO) recommendations are far less restrictive than the 1996 French recommendations, as it is stated that PC should be offered as earlier as possible in the course of the disease, in order to increase quality of life, and to positively influence the course of illness. The World Health Organization recommendations add that PC is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to better understand and manage distressing clinical complications.
In a recent randomized study, 151 patients with newly diagnosed metastatic non-small-cell lung cancer were randomized to receive either early PC (EPC) combined with standard oncologic care or standard oncologic care alone. It was hypothesized that patients, who received EPC, compared with patients who received standard oncologic care only, would have a better quality of life (primary endpoint). The first visit with the PC service set up within the first 12 weeks, and the median number of visits in the EPC group was 4. In this study, the authors referred to the recommendations of the National Consensus Project for Quality Palliative Care. Among patients with metastatic non-small-cell lung cancer, EPC led to significant improvements in quality of life. In addition, EPC led to significant improvements in mood, as well as in overall survival (median survival, 11.6 vs. 8.9 months; HR=0.60, p = 0.02)), despite less aggressive end-of-life care.
Following the publication of this American study, the American Society of Clinical Oncology recommends nowadays that 'combined standard oncology care and PC should be considered earlier in the course of the illness for any patient with metastatic cancer....'. However, it is clear that a gap exists (not only in France) between this recommendation and the current practice. In addition, there is no consensus on how early PC should be integrated in oncologic services, even though an underpowered small randomized trial reported recently an insignificant better survival favoring early versus delayed (3 months later) initiation of PC.
The results of the study described above, although formally restricted to the field of metastatic non-small-cell lung cancers, have modified the perception of many oncologists about the objectives of PC. However, additional clinical studies should be done before considering EPC as an additional survival input in other advanced malignancies.
The median survival of metastatic upper gastrointestinal (GI) cancers such as pancreatic cancers, gastric cancers, and biliary tract cancers did not exceed 10-11 months, which is as poor as reported with metastatic lung cancers. Standard of care in the metastatic setting in upper GI cancers are described in ad hoc French guidelines, i.e.: 'Thésaurus National de Cancérologie Digestive'. Briefly, standard of care in metastatic pancreatic cancer in the first-line setting lies on the combination of fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX regimen) for patients without any cholestasis and in good performance status, and on gemcitabine monotherapy. In metastatic biliary tract cancers, standard of care lies on gemcitabine-based regimen (gemcitabine monotherapy, gemcitabine plus cisplatin, or gemcitabine plus fluorouracil). Besides HER2 positive metastatic gastric/gastrooesophageal patients who present with much better prognosis, and should be treated with trastuzumab-based regimen, most of patients with metastatic gastric/gastrooesophageal HER2 negative patients (IHC + or IHC ++ with negative fish/sish) have poor prognosis, with similar survival rates than patients with other upper GI malignancies. In that setting, several regimens may be offered to patients, such as the following: Folfox, EOX/ECX, Folfiri, LV5FU2-cisplatin, Capecitabine-platinum salt or docetaxel-based regimen ...). Several experimental treatments (antiangiogenics, met inhibitors, modulators of immune check points, etc...) are currently tested in metastatic gastric/gastrooesophageal cancers, but these treatments are restricted to patients in good health condition who accept to participate to clinical trials, and none of these trials have yet produced meaningful survival benefit in the first-line setting.
To summarize, therapeutic advances in the setting of metastatic upper GI cancers are infrequent, and often modest. Providing an extra survival benefit for these patients with EPC, may contribute to deeply modify the practice of care of oncology in France.
#Intervention
- BEHAVIORAL : Early Palliative Care visit
- A PC visit is a visit done by a PC physician. Any kind of visits done by other professionals IS NOT a PC visit.
Five PC visits are scheduled in this arm.
- OTHER : EORTC-QLQ-C30 questionnaire
- The Quality of Life is assessed with the QLQ-C30 questionnaire at baseline, 12 and 24 weeks after inclusion, as well as every 8 weeks thereafter.
- OTHER : HADS score
- The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at baseline, and then 12 and 24 weeks after inclusion.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with an upper gastrointestinal metastatic cancer: pancreatic, biliary tract, esophageal or gastric (including junctional Siewert 2 and 3 cancers) cancers.
NB: gastrooesophageal junctional cancers with dysphagia and/or gastric/gastrooesophageal cancers with unknown or positive HER2 status are not eligible.
* Patients planed to be treated with first-line chemotherapy for metastatic disease.
* Age >= 18 years
* Life expectancy >= 1 month
* Performance status (OMS) <= 2
* Good understanding of French language
* Signed and dated informed consent
* Patients covered by government health insurance
Exclusion Criteria:
* Locally advanced cancer
* Junctional Siewert 1 gastrooesophageal cancer
* Gastric or junctional gastrooesophageal cancer with dysphagia (Atkinson>2)
* Gastric or junctional gastrooesophageal cancer with unknown or positive HER2 status (IHC: +++ or IHC ++ and FISH/SISH +)
* Compression of the biliary tract requiring a bypass
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
|
NCT02853474
|
{
"brief_title": "Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy",
"conditions": [
"Gastric Cancer",
"Pancreas Cancer",
"Bile Duct Cancer",
"Gastroesophageal Cancer",
"Esophageal Cancer"
],
"interventions": [
"Other: EORTC-QLQ-C30 questionnaire",
"Other: HADS score",
"Behavioral: Early Palliative Care visit"
],
"location_countries": [
"France"
],
"nct_id": "NCT02853474",
"official_title": "Impact of Early Palliative Care on Overall Survival of Patients With Metastatic Upper Gastrointestinal Cancers, Treated With First-line Chemotherapy: a Randomized Phase III Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12",
"study_completion_date(actual)": "2022-12",
"study_start_date(actual)": "2016-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-26",
"last_updated_that_met_qc_criteria": "2016-07-29",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-03",
"first_submitted": "2016-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Syracuse University Fit Families is designed to increase the activity level and frequency of the children through modified activities using adapted equipment and, importantly, to increase the families' comfort level in having their children participate in a variety of physical activities, including team and individual sports.
Detailed Description
Syracuse University Fit Families is designed to increase the activity level and frequency of the children through modified activities using adapted equipment and, importantly, to increase the families' comfort level in having the children participate in a variety of physical activities, including team and individual sports. By increasing physical activity levels, investigators can reduce sedentary behaviors that lead to conditions such as obesity and cardiovascular diseases. The investigators will provide a series of workshops that will also teach children and families how to access nearby facilities and modify familiar activities, resulting in health benefits for all. Children, and parents will be involved in developmentally designed, land-based and aquatic physical activities. Parents will be engage in vibrant discussions with professionals and other parents who share similar experiences.
Services provided through the Syracuse University Fit families program are designed to improve the emotional, social and physical well-being of the participants. This program will include 1) educational seminars for parents on topics that improve awareness, advocacy, and access to community services; 2) inclusive games and modified sports for children, and parents to improve self-awareness, social interactions, and physical fitness; 3) individual consultation with physical activity professionals to address children's and families' social and recreational needs; and 4) opportunities for social networking for families participating in the program, including mentoring of youth by adapted sports athletes.
The project is proposed to run from November 2015 through June 2017. Five one-day workshops will be offered annually to participants covering topics of: 1) sensory integration, 2) communication, 3) motor development and physical activity; 4) aquatic; and 5) sport opportunities (individual and team sport). As part of program evaluation, the investigators will be conducting measurements on parents (e.g., quality of life, physical activity levels) and children (e.g., social communication, sensory behaviors, quality of life, physical activity levels, blood pressure). The investigators will assess these in a pre-post fashion in order to determine whether the program has led to generalized improvements in these areas. The testing procedure requires minimal invasion and it is not overwhelming for the participants. The investigators have implemented similar procedures in previous programs.
#Intervention
- OTHER : Intervention: Syracuse University Fir Families Program (SUFFP)
- The SUFFP (Syracuse University Fit Families Program) is a randomized clinical trial, were 40 children with autism spectrum disorders ages 5-11 and at least one parent were randomly assigned to one of two group-based conditions; interventions or a control wait list group.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of autism spectrum disorders
* Children with autism spectrum disorders 5 <= age <= 11 years
* Must be ambulatory
* Must be able to follow verbal or picture directions with support.
* Must not exhibit aggressive behavior.
Exclusion Criteria:
* Children with autism spectrum disorders younger than 4 <= age <= 11 years
* Children with autism spectrum disorders older than 11 years
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02940899
|
{
"brief_title": "Syracuse University Fit Families Program: Autism",
"conditions": [
"Autism Spectrum Disorders"
],
"interventions": [
"Other: Intervention: Syracuse University Fir Families Program (SUFFP)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02940899",
"official_title": "Fit Families Program for Children With Autism",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-30",
"study_completion_date(actual)": "2018-12-30",
"study_start_date(actual)": "2015-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-04",
"last_updated_that_met_qc_criteria": "2016-10-19",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-21",
"first_submitted": "2016-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Hypertension affects 37% of the Veteran population, making it the most common medical condition treated by the VA Health Care System. Physical activity is the first line of defense in the treatment and management of hypertension. However, individuals with hypertension have impaired muscle blood flow and exhibit exaggerated increases in blood pressure during exercise (exercise pressor reflex or EPR) leading to exercise intolerance and increased risk of stroke and heart attack. The cause of these impairments is not known, but it is highly likely that free radical production and the subsequent increase in oxidative stress plays a significant role. Two aims are proposed; Aim 1 will identify the physiological consequences of elevated oxidative stress in hypertension, and Aim 2 will utilize an antioxidant treatment to ameliorate the effects of an exaggerated EPR allowing the safe performance of a clinical exercise rehabilitation program which will then, itself, attenuate the EPR and reduce hypertension.
Detailed Description
Nearly 37% of all Veterans are clinically hypertensive, making hypertension the most common medical condition in the VA Health Care System. Importantly, of the 67 million Americans diagnosed with hypertension less than half are being effectively treated for their condition. Hypertension constitutes a major risk factor for cardiovascular disease and when left untreated leads to the development of heart failure, coronary heart disease, peripheral artery disease, stroke, and renal disease. Exercise and regular physical activity are considered the cornerstones of prevention and management of hypertension. However, individuals with hypertension exhibit exercise intolerance characterized by impaired skeletal muscle blood flow and heightened afferent fiber sensitivity leading to an exaggerated or greater than normal physiologic increase in blood pressure during exercise (i.e. exercise pressor reflex or EPR). This imbalance between the beneficial effects of exercise and exercise intolerance creates an interesting paradox, the causes and consequences of which are poorly understood. The etiology of hypertension is undoubtedly complex, however a common denominator in this condition, elevated oxidative stress, may contribute to impaired muscle blood flow and heightened skeletal muscle afferent feedback leading to the exaggerated EPR. Previous work from the investigators' laboratory and others suggests that elevated oxidative stress associated with aging impairs muscle blood flow. Additionally, free radicals, the initiators of oxidative stress, can directly stimulate skeletal muscle afferent fibers leading to the exaggerated EPR. Importantly, the role of oxidative stress in regulating muscle blood flow and afferent fiber function in human hypertension has not been determined. Preliminary studies support a significant role of oxidative stress in impairing muscle blood flow and contributing to the exaggerated EPR in hypertension. With this information as context two aims are proposed that will systematically identify the consequences of elevated oxidative stress in hypertension. Specific Aim 1 will determine the consequences of oxidative stress by examining how elevated free radicals contribute to heightened skeletal muscle afferent feedback and impaired muscle blood flow during exercise in hypertension leading to the exaggerated EPR. Additionally, vascular endothelial cells collected from an antecubital vein will provide novel insight regarding the endothelium as potential source of elevated oxidative stress in hypertension. Specific Aim 2 will determine the effectiveness of combined antioxidant therapy and exercise rehabilitation in the treatment of hypertension. The overall goal of this proposal is to provide novel information regarding the role of oxidative stress as a critical regulator of cardiovascular and hemodynamic responses to exercise in hypertension. By identifying potential causes and consequences of oxidative stress, important insight will be gained facilitating the development of novel approaches and therapeutic strategies for the treatment of hypertension. Importantly, the practical applications tested in these studies (i.e. antioxidant treatment and combined exercise rehabilitation) are designed to identify and document effective countermeasures to aid in the treatment and management of hypertension allowing for the safe performance of exercise in a large number of Veterans.
#Intervention
- DIETARY_SUPPLEMENT : Oral Antioxidant
- Consisting of vitamins C, E and alpha lipoic acid.
- OTHER : Exercise rehabilitation
- 8 weeks of exercise rehabilitation
|
#Eligibility Criteria:
Inclusion Criteria:
* A total of 72 middle-aged (40 - 60 years) healthy and hypertensive men and women will participate in these protocols after providing written informed consent.
* The investigators aim to include a 1 to 1 ratio of females and males in each group.
* Individuals diagnosed or presenting with stage 1 and stage 2 hypertension (range 140/90 to 179/109 mmHg, according to the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP) may be eligible for this study.
* Blood pressure status will be assessed in triplicate in the laboratory during the medical exam and during a 24 hour period using ambulatory blood pressure monitoring.
* Both methods must confer hypertension for study enrollment.
* Other than hypertension, all hypertensive patients will be otherwise healthy and free of overt disease as assessed by:
* medical history;
* standard blood chemistries (chem. 7 panel),
* ECG at rest;
* limb vascular examination (ankle-brachial BP index > 0.9);
* resting BP > 140/90 mmHg; and
* skinfold % body fat assessment.
* Subjects will have a body mass index (BMI) between 19 and 30 and have plasma glucose concentrations < 7.0 mmol/L under fasting conditions and < 11.1 mmol/L at 120 minutes of an oral glucose tolerance test (OGTT), as defined by the American Diabetes Association.
* To reduce heterogeneity of the hypertensive subjects while maintaining a 'real world' approach the following classes of drugs will be allowed;
* diuretics,
* angiotensin converting enzyme (ACE) inhibitors,
* and angiotensin II receptor blockers (ARB).
* Healthy normotensive subjects will be matched to their hypertensive counterparts and will be free from overt cardiovascular disease according to the criteria described above.
Inclusion/Exclusion criteria with specific reference to the exaggerated exercise pressor reflex:
* Hypertensive subjects must exhibit a 10 mmHg or greater increase in MAP at 25% of their workrate maximum during knee extension exercise to be included in this study.
* Established criteria defining a cut off for an 'exaggerated' exercise pressor reflex does not exist.
* Therefore, the investigators have set the operational definition at a 10 mmHg or greater increase in MAP during 25% of workrate maximum knee extensor exercise.
* This 10 mmHg increase in MAP was chosen as this value closely matches the investigators' preliminary data (Figure 1) and previous reports while concomitantly corresponding to an increase in BP that is at least 2 standard deviations greater than the normotensive response (i.e. 6 2 (SD) mmHg increase in MAP at 25% of their workrate maximum).
* The magnitude of the exercise-induced increase in MAP will be determined during preliminary testing.
* It should be noted that the magnitude of the pressor response is graded in relation to exercise intensity, therefore, by establishing an inclusion criterion of 10 mmHg at 25% of workrate maximum, the lowest intensity to be used in the proposed studies, the investigators have set a conservative standard for study enrollment.
Exclusion Criteria:
* Candidates demonstrating dyslipidemia based on the National Cholesterol Education Program Guidelines of plasma total cholesterol > 240 mg/dl with LDL-cholesterol > 160 mg/dl will be excluded from participation.
* Hypertensive patients receiving dual or monotherapy treatment for hypertension may be included.
* Less frequently prescribed classes of drugs for hypertension (beta blockers, aldosterone receptor blocker, centrally acting sympatholytics, calcium channel blocker, direct vasodilators, renin inhibitors, and alpha blockers) will be excluded.
* Additionally, subjects reporting a history of myocardial infarction, unstable cardiac ischemia, recent cardiac catheterization, carotid artery disease, transient ischemic attack will be excluded.
* Participants must have no orthopedic limitations that would prohibit them from knee-extensor exercise or aerobic activity including cycle ergometry or treadmill exercise.
* Due to the age requirement of the subjects women may be either pre or post-menopausal.
* All pre-menopausal women will be studied during days 1 - 7 of their menstrual cycle to standardize the influence of female hormones.
* Women taking hormone replacement therapy (HRT) currently or in the preceding year will be excluded from the proposed studies due to the direct vascular effects of HRT and the variety of regimes employed.
* Participants will be made up of primarily Veterans.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02034422
|
{
"brief_title": "Understanding the Exercise-Hypertension Paradox",
"conditions": [
"Hypertension"
],
"interventions": [
"Other: Exercise rehabilitation",
"Dietary Supplement: Oral Antioxidant"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02034422",
"official_title": "Understanding the Exercise-Hypertension Paradox: Implication for Rehabilitation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2014-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-12",
"last_updated_that_met_qc_criteria": "2014-01-09",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-13",
"first_submitted": "2014-01-09",
"first_submitted_that_met_qc_criteria": "2023-10-27"
}
}
}
|
#Study Description
Brief Summary
The main goal of our project is the study of subcutaneous and visceral (SAT and VAT) adipose tissue taken during bariatric surgery (Single port sleeve gastrectomy) of subjects with HIV infection, anf morbid obesity with undetectable viral load (VL) and having HIV lipohypertrophy particularly truncal. The study covers both the morphology of adipocytes,fibrosis, immune activation and inflammation, gene expression, pharmacology of antiretroviral drugs (ARV) and the measurement of viral replication in the adipose tissue and the plasma before and after bariatric surgery.
Detailed Description
The choice of the sleeve gastrectomy is based on choosing an effective technique with few complications, no rupture of digestive continuity and therefore little malabsorptive effect with a better quality of life.
The intervention of sleeve gastrectomy offers a unique opportunity to study the SAT and VAT of HIV obese patients before and after bariatric surgery, to analyze the specific modifications of this tissue and to better understand the pathophysiology of this disease. The term associated with changes in cardiometabolic comorbidities and their improvement after weight loss will be important elements in the management of these patients. It is therefore important to evaluate whether the fibrosis term changes observed in HIV patients will change the effectiveness of the intervention.
In the general population, obesity is a major public health problem. It is considered an inflammatory disease, multifactorial with chronic evolution, which requires long-term medical care and / or surgery . Indeed, the body mass index (BMI) correlates with increased mortality mainly due to cardiovascular diseases (hypertension, coronary artery disease), cancer and diabetes. Finally, overweight and obesity are the leading causes of liver disease in Western countries resulting in nonalcoholic fatty liver disease, a term that includes all the hepatic lesions observed in overweight and obesity: steatosis, steatohepatitis, fibrosis, cirrhosis or hepatocellular carcinoma. Nonalcoholic fatty liver disease reflects not only the presence of insulin resistance but also participates in its installation. Reducing overweight is therefore a key part of treatment to reduce chronic inflammation, insulin resistance and liver damage.
There is little data in the literature on the prevalence of obesity in the population of HIV patients. In France, the prevalence of obesity in the French Hospital Database on HIV is 15.1% among women and 5.3% among men, similar to prevalence in the general population. Patients born in sub-Saharan Africa have a higher risk with 20.7% versus 12.2% in women and 10.9% versus 4.7% for men.
No data is available on the obesity complications described in the general population in our population of obese HIV patients. Nevertheless, apart from obesity, patients infected with HIV develop cardiovascular and metabolic complications well documented in recent years.
French and international recommendations agree that the management of obesity should be multidisciplinary. In the treatment, surgical treatment is the treatment of choice in French and international recommendations in the following indications:
* morbid obesity (BMI ≥ 40 kg / M²) resistant to medical treatment and exposing patients to serious complications that can not be controlled by the specific treatment
* obesity with BMI between 35 and 40 kg / M² with comorbidities associated with life-threatening or functional outcomes: cardiovascular disease, musculoskeletal disease, severe metabolic disorders not controlled by maximal medical therapy. In each case, the indication can be considered in patients who have had access to specialized medical care for at least 6 months, also including complementary approaches (diet, physical activity, management of psychological problems, treatment complications).
At present, the sleeve gastrectomy is the technique of choice in the general population with, compared to other bariatric surgery techniques such as bypass, reducing complications, length of hospital stay, operative time, a gain in term quality of life without disruption of digestive continuity and therefore little or no malabsorption. This lack of malabsorption it an argument of choice in our HIV patients on cART with a reduced risk of malabsorption of ARV and vitamin deficiencies such as vitamin D deficiency already well described in HIV. The minimally invasive approach (1 trocar), routinely performed by Dr. G. Pourcher for obese patients whether they are infected with HIV, reduces surgical risk. This Single port also allows easy access to SAT, VAT and liver.
The management of obesity in the HIV population, now having a similar life expectancy should be the same as that of the general population but remains to this day very marginal. The literature on the subject is almost 'poor' Additionally, comorbid conditions existing in the population of HIV patients are a target population requiring support at least equivalent to that of the general population.
|
#Eligibility Criteria:
Inclusion Criteria:
* Documented HIV-1 infection,
* Aged to 18 at 65 ans,
* Obesity defined as a Body Mass Index (BMI)> 35 kg / M² with comorbidities Or BMI > 40 kg/M²
* Forget bariatric surgery after a positive opinion of the specialized multidisciplinary meeting
* on stable antiretroviral therapy for 12 months
* with controlled HIV infection (<50 copies / ml)
* Signed informed consent
* Karnofsky Index > 80 %
* Patient affiliated or beneficiary of a national insurance scheme (article L1121 <= age <= 11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
Exclusion Criteria:
* Uncontrolled severe infection
* Current pregnancy (positive HCG)
* Saving justice, guardianship
* Participation to another study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02820337
|
{
"brief_title": "Pathophysiological Study of Adipose Tissue of Patients Infected With HIV",
"conditions": [
"HIV"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT02820337",
"official_title": "ObéVIH : Pathophysiology of Adipose Tissue of Obese HIV-infected Patients Undergoing a Sleeve Gastrectomy Using Single Port",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12",
"study_completion_date(actual)": "2023-12-15",
"study_start_date(actual)": "2016-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-02",
"last_updated_that_met_qc_criteria": "2016-06-28",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-30",
"first_submitted": "2016-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.
#Intervention
- DRUG : Albiglutide 30 mg weekly
- Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
- DRUG : Albiglutide 50 mg weekly
- Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
- DRUG : Placebo
- Albiglutide matching placebo will be available as a pen injector
- DRUG : Liraglutide 0.9 mg daily
- Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
* Body mass index (BMI) 17 to 40 kg/ m^2 inclusive
* Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
* Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)
Exclusion Criteria:
* History of type 1 diabetes mellitus
*Female subject is pregnant, lactating, or <6 weeks postpartum
*
* Clinically significant cardiovascular and/or cerebrovascular disease
* Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
* Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
* Prior use of a TZD or GLP-1R agonist within 4 months before Screening
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01733758
|
{
"brief_title": "A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Albiglutide 50 mg weekly",
"Drug: Placebo",
"Drug: Liraglutide 0.9 mg daily",
"Drug: Albiglutide 30 mg weekly"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01733758",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2013-02"
},
"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)": "2016-09-22",
"last_updated_that_met_qc_criteria": "2012-11-21",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-27",
"first_submitted": "2012-11-21",
"first_submitted_that_met_qc_criteria": "2015-04-30"
}
}
}
|
#Study Description
Brief Summary
The need for moral injury interventions is increasingly being recognized as a domain in Veteran care that must be addressed. Consequences of exposure to morally injurious events include risk for suicide, substance abuse, and refractory symptoms of PTSD and depression. Exposure to morally injurious events is also highly prevalent among Veterans. Thus, interventions addressing moral injury are crucial to helping Veterans build meaningful lives. Psychotherapies explicitly targeting moral injury and functional recovery associated with this construct are limited in VHA. The proposed study serves as a first step in addressing this gap in the literature through the development of a recovery-oriented, evidence-based treatment approach for moral injury among warzone Veterans who report functional impairments related to moral emotions. The proposed pilot study will evaluate the acceptability of this intervention and the feasibility of the design for a future study to test the treatment's capacity to improve patients' functioning.
Detailed Description
Warzone Veterans exposed to morally injurious events frequently experience numerous difficulties in functioning. These Veterans often report suicidal ideation and behavior, substance abuse, symptoms of depression and PTSD, and problems in resuming valued living (e.g., spiritual practice, close relationships). Despite the transdiagnostic nature of moral injury, there are no moral injury-specific transdiagnostic interventions. Existing interventions tend to be focused on treating moral injury in the context of PTSD. In addition to an emphasis on PTSD, these interventions target beliefs associated with moral injury as causal factors in the development and maintenance of suffering. An emphasis on altering beliefs associated with moral injury may not optimally facilitate functional recovery as moral pain from moral violations may be justified. As one third of warzone Veterans endorse exposure to morally injurious events, it is vital to develop interventions that can be efficiently disseminated in VHA to facilitate functional recovery. The ideal intervention must simultaneously address moral emotions and promote values consistent behavior in the face of these emotions.
Acceptance and Commitment Therapy for moral injury (ACT-MI) is a recovery-based, psychosocial treatment ideally suited for Veterans endorsing difficulties in functioning related to moral injury. ACT teaches skills to help Veterans relate differently to painful thoughts, emotions, urges, and sensations. Rather than focusing on symptom reduction, ACT is an evidence-based intervention that directly targets functional recovery by assisting Veterans in identifying and engaging in values-consistent behavior even in the presence of distress. In Veteran populations specifically, ACT has been demonstrated effective in treating suicidal ideation and depression and as a result, has been 'rolled-out' as an evidence based psychotherapy for depression within VHA. ACT-MI operates on the principles of ACT, with an explicit focus on the social functions of moral emotions. ACT-MI is the only intervention for moral injury that is based on social functionalism which purports that moral emotions (e.g., shame, pride) serve evolutionary purposes essential to group survival. Thus learning to interact with moral emotions differently is crucial to recovery. In ACT-MI, a group-based intervention is used to facilitate in-vivo exposure to moral emotions in the context of values. The proposed two arm randomized controlled pilot study will evaluate the acceptability of ACT-MI and an active control treatment, and determine the feasibility of the randomized controlled trial design for a future full-scale efficacy study. To accomplish this goal the investigators will continue to refine ACT-MI. Veterans enrolled will be randomized to: (a) Present Centered Therapy (PCT) or (b) ACT-MI, both of which will consist of 12, 90-minute group sessions. The specific aims of this study are to: (1) Evaluate the acceptability of the ACT-MI intervention for Veterans experiencing impairment in functioning associated with moral injury, (2) Determine the feasibility of the efficacy study design, and to (3) Select measures and calculate the necessary sample size for a future efficacy study. The performance of validated scales will be measured, in addition to selected NIH Patient Reported Outcomes Measurement Information System modules. All participants will complete a baseline assessment, post treatment, and follow-up assessment one and three months after completion of ACT-MI or PCT. Participants in both groups will also complete a post-treatment assessment on the acceptability of the intervention. The proposed study represents a crucial first step in a line of research likely to yield a recovery oriented, empirically-supported intervention for moral injury among Veterans. The objectives of ACT-MI directly align with Rehabilitation Research and Development's goal to improve Veteran functioning, increase community reintegration, and to facilitate Veteran centered care.
Note, as of March 7, 2024: Completed recruitment for baselines, still collecting data for post treatment, 1-month, and 3-month follow-ups
#Intervention
- BEHAVIORAL : Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
- Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.
- Other Names :
- ACT-MI
- BEHAVIORAL : Present Centered Therapy (PCT)
- Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right.
- Other Names :
- PCT
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible for VHA care
* Has been deployed to a warzone
* Has experienced a morally injurious event which continues to interfere with functioning
* Willing to be randomized and participate in either of the two conditions
Exclusion Criteria:
* Inability to provide informed consent
* Inability to complete study measures, e.g.:
* due to significant acute intoxication/withdrawal symptoms
* mania
* psychosis
* aggression
* catatonia
* cognitive impairment
* Imminent suicide risk
* Membership in a vulnerable population, e.g.:
* pregnant women
* History of significant violence towards VA staff
* Participation in another psychotherapy research study
* Current participation in an EBP for a condition related to moral injury
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 89 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03760731
|
{
"brief_title": "Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans",
"conditions": [
"Moral Injury"
],
"interventions": [
"Behavioral: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)",
"Behavioral: Present Centered Therapy (PCT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03760731",
"official_title": "Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-10-31",
"study_completion_date(actual)": "2024-10-31",
"study_start_date(actual)": "2019-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-11",
"last_updated_that_met_qc_criteria": "2018-11-29",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-30",
"first_submitted": "2018-11-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The project uses big data analysis techniques such as wavelet transform and deep learning to analyze physiological signals from neurocritical patients and build a model to evaluate intracranial condition and to predict neurological outcome. By identification of correlations among these parameters and their trends, we may achieve early detection of anomalies and enhance the ability in judgement of current neurological condition and prediction of prognosis. By continuous input of the past and contemporary data in the ICU, the model will be modified repeatedly and its accuracy improves as the model grows. The model can be used to recognize abnormalities earlier and provide a warning system. Clinicians taking care of neurocritical patients can adjust their treatment policy and evaluate the outcome according to such system.
#Intervention
- DEVICE : intracranial pressure monitoring
- The patients may have either intracranial pressure (ICP) monitor insertion or external ventricular drainage that can be used as ICP monitor.
- Other Names :
- physiological monitoring
|
#Eligibility Criteria:
Inclusion Criteria:
* Age equal to or older than 20 years
* Neurocritical patients admitted to intensive care unit (ICU), including but not limited to traumatic brain injury, hemorrhagic stroke, ischemic stroke, brain infection, brain tumor and acute hydrocephalus.
* Patients who have undergone cranial surgery and had intracranial pressure monitor inserted or external ventricular drainage. The central monitor of ICU is able to collect the data continuously
Exclusion Criteria:
* Age younger than 20 years.
* Continuous monitoring of intracranial pressure is not feasible.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03362346
|
{
"brief_title": "Signal Analysis for Neurocritical Patients",
"conditions": [
"Brain Injuries, Acute"
],
"interventions": [
"Device: intracranial pressure monitoring"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03362346",
"official_title": "Analysis of Physiological Signals From Neurocritical Patients in Intensive Care Units Using Wavelet Transform and Deep Learning",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-24",
"study_completion_date(actual)": "2018-05-31",
"study_start_date(actual)": "2017-12-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-06",
"last_updated_that_met_qc_criteria": "2017-12-04",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-05",
"first_submitted": "2017-11-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.
Detailed Description
Wound infections are common and serious complications of anesthesia and surgery. Even in patients who are kept normothermic and given supplemental oxygen, the incidence of wound infection after colon resection exceeds 5%. About 80% of these resections are done for colon cancer, the third leading cause of cancer death. The average surgical wound infection prolongs hospitalization by a week and substantially increases cost. Major factors influencing the incidence of surgical wound infection include the site and complexity of surgery, underlying illness (including treatment with immunosuppressive drugs), timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia, and tissue oxygen tension.
The primary defense against surgical pathogens is oxidative killing by neutrophils. Oxygen is a substrate for this process, and the reaction critically depends on tissue oxygen tension throughout the observed physiological range. It is therefore unsurprising that subcutaneous tissue oxygen tension (PsqO2) is inversely correlated with the risk of surgical wound infection. Primary determinants of tissue oxygen availability include arterial oxygen tension, hemoglobin concentration, and local perfusion.
An additional determinant of peripheral oxygen delivery is cardiac output. Mild hypercapnia increases cardiac output: for example, augmenting arterial carbon dioxide tension (PaCO2) just 10-12 mmHg increases the cardiac index 15%. Our preliminary studies confirm that mild hypercapnia increases cardiac output and additionally indicate the hypercapnia markedly improves tissue oxygenation. For example, tissue oxygen tension increased 16 mmHg, from 58 to 74 mmHg over a 20 mmHg range of PaCO2 in anesthetized volunteers. We have also shown that increasing PaCO2 by just 15 mmHg increased tissue oxygen tension 16 mmHg in surgical patients. Similar results were observed in morbidly obese patients. Previous work indicates that similar increases in PsqO2 reduces the risk of surgical wound infection by about 30%. We thus propose to test the hypothesis that mild hypercapnia significantly reduces the incidence of surgical wound infection in normothermic patients undergoing colon resection. Secondary outcomes will include the duration of hospitalization, cost of care, the incidence of nosocomial pneumonia, the incidence of postoperative nausea and vomiting (PONV) and return to function.
High intra- and postoperative oxygen concentration (80%, as opposed to 30% oxygen) has been shown to reduce the rate of wound infection by more than 50%. Therefore, the protocol implemented high intraoperative oxygen concentrations for all patients this trial. However, within the first 500 enrolled patients a recent trial reported a better outcome for patients with low perioperative oxygen concentrations. Although that trial was less well controlled and underpowered, the conflicting evidence indicates that additional study is needed. We will therefore simultaneously test the hypothesis that supplemental oxygen reduces infection risk.
Patients undergoing colon surgery are generally at high risk for postoperative nausea and vomiting (PONV). According to results from meta-analyses, a single intraoperative dose of dexamethasone is effective and safe for the prophylaxis for PONV. Dexamethasone has thus been recommended as a first-line prophylaxis for PONV. However, none of the previous PONV trials have focused on wound infections nor had a sufficiently long observational period to rule out potential concerns of an increased incidence of wound infection. We will therefore also test the hypothesis that dexamethasone does not increase the risk of surgical wound infection. The second and third hypotheses will be added to the protocol, using a factorial design, after the first 500 patients are enrolled.
#Intervention
- OTHER : Mild intraoperative hypercapnia (50 mmHg vs. 30 mmHg)
- OTHER : Supplemental oxygen (80% vs. 30%)
- DRUG : Dexamethasone
- 4 mg
- DRUG : Placebo
- placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Colon resection expected to last >2 and <6 hours
Exclusion Criteria:
* Bowel obstruction
* Fever
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
|
NCT00273377
|
{
"brief_title": "The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection",
"conditions": [
"Surgical Wound Infection",
"Surgery, Colon"
],
"interventions": null,
"location_countries": [
"Austria",
"Ireland",
"United States"
],
"nct_id": "NCT00273377",
"official_title": "The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection",
"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)": "2002-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-29",
"last_updated_that_met_qc_criteria": "2006-01-05",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-01-09",
"first_submitted": "2006-01-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.
#Intervention
- DRUG : [11C]-Lu AF90103
- PET ligand administrated as a single intravenous bolus injection
|
#Eligibility Criteria:
Inclusion Criteria:
* The participant has a body mass index (BMI) >=18.5 and <=30.0 kilograms (kg)/square meter (m^2) at the Screening Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.
Exclusion Criteria:
* The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has had surgery or trauma with significant blood loss <3 months prior to the first dose of study drug.
* The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and exclusion criteria may apply.
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05306366
|
{
"brief_title": "A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants",
"conditions": [
"Healthy Young Men"
],
"interventions": [
"Drug: [11C]-Lu AF90103"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT05306366",
"official_title": "Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-07",
"study_completion_date(actual)": "2022-06-07",
"study_start_date(actual)": "2022-03-23"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-14",
"last_updated_that_met_qc_criteria": "2022-03-23",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-01",
"first_submitted": "2022-03-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will determine the effectiveness of a specialized psychotherapy for treating elderly stroke survivors who are depressed.
Detailed Description
A stroke occurs when blood cannot reach part of the brain, either because of a blocked blood vessel (ischemic stroke) or because of a burst blood vessel (hemorrhagic stroke). When a part of the brain is deprived of blood, brain cells in that part often die or are at risk of dying. In addition to physical difficulties, older adults who survive strokes can also suffer from depression and cognitive dysfunction. Effective psychotherapy treatments that provide rehabilitation for problems in emotions and thinking are still needed. Ecosystem focused therapy (EFT) is a specialized psychotherapy that helps patients learn problem-solving skills and make adjustments in their environment. This study will determine the effectiveness of EFT in reducing depression and improving functioning and quality of life in older adults who experienced an ischemic stroke and are now depressed.
Participation in this study will last 1 year. Participants will be randomly assigned to receive one of two treatments: EFT or education in stroke and depression (ESD). Both treatments will be led by therapists and will involve 12 sessions over 25 weeks, with sessions occurring weekly for the first month, every other week for the second 2 months, and monthly for the last 3 months. EFT will involve the following: teaching the participant skills for solving problems related to adjusting to a stroke, altering the participant's physical environment to accommodate new needs, and helping the family or caregiver to assist in the participant's adaptation. ESD will involve providing the participant with education on living with a stroke and depression. Study assessments will include interviews and will occur at nine time points: at baseline and after 2, 3, 6, 10, 14, 20, 26, and 52 weeks. These assessments will measure participants' mood, thinking, and functioning. A family member or caregiver of the older adult participant must also be able to participate in the study, in order both to complete assessments and effectively implement EFT.
#Intervention
- BEHAVIORAL : Ecosystem Focused Therapy (EFT)
- 12 therapist-led sessions over 25 weeks, in which a participant will learn problem-solving skills, the participant's physical environment will be modified, and the family or caregiver will facilitate the participant's adaptation. Active participation in treatment and rehabilitation for stroke will also be targeted by EFT's problem-solving approach, creating synergy among treatments.
- BEHAVIORAL : Education in stroke and depression
- Information and resources on living with stroke and depression will be provided in 12 sessions over 25 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of unipolar major or minor depression, as assessed by the Structured Clinical Interview for Depression (SCID) for the Diagnostic and Statistical Manual-IV
* Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 15
* Admitted to Burke Rehabilitation Hospital soon after ischemic stroke
* Mini Mental State Examination (MMSE) score greater than 17
* Command of English sufficient to comprehend study questionnaires and interventions
* Has family member or professional caregiver willing and able to participate in patient's treatment
Exclusion Criteria:
* Moderately severe to severe dementia, as defined by an MMSE score less than 17
* Moderate to severe aphasia
* Placed in a nursing home after discharge
* Diagnosis of psychotic depression
* High suicide risk (i.e., intent or plan to attempt suicide in near future)
* Presence of illnesses other than stroke (e.g., untreated thyroid or adrenal disease, pancreatic cancer, and lymphoma)
* Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
* Currently being treated for depression with psychotherapy
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00944762
|
{
"brief_title": "Ecosystem Focused Therapy for Treating Older Depressed Stroke Survivors",
"conditions": [
"Ischemic Stroke",
"Depression"
],
"interventions": [
"Behavioral: Education in stroke and depression",
"Behavioral: Ecosystem Focused Therapy (EFT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00944762",
"official_title": "Ecosystem Focused Therapy for Depressed Stroke Survivors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": "2012-04",
"study_start_date(actual)": "2009-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-23",
"last_updated_that_met_qc_criteria": "2009-07-22",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-23",
"first_submitted": "2009-07-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A computer program was developed with the same task, but with two possibilities of user interaction: a) interface with contact: in which the individual touches the computer screen to finish the task and b) interface without contact: in which the individual perform a hand movement in front of the Kinect. Were evaluated 29 individuals with CP who constituted the experimental group and 28 individuals without deficiency who composed the control group with matching age and sex.
Detailed Description
A total of 57 individuals were included in this study, 29 individuals with CP who constituted the experimental group and 28 individuals without deficiency, aged between 6 and 15 years, with understanding of the task to be performed. Of these, 14 formed the experimental group 1 that performed the task on Kinect (CP-Group1) and 15 individuals formed the control group 1 (TD-Group1), 15 formed the experimental group 2 (CP-Group2) and 13 individuals formed the control group 2 (TD-Group2), all control groups matched for age and sex with the experimental group 1 and 2, all without any disability.
All individuals with CP who were evaluated manage to stay well seated to function in the upper limbs and have independent walking even necessary aid walker or crutches.
Material and Apparatus Software specialists developed a package of games, named Team Bridge Games, and for this study, was used the Check Limit Game. This game allows the use of a Kinect sensor for motion capture (without contact interface), as well as a touch screen (with contact interface). The virtual reality tool used was developed by the Information Systems Laboratory of EACH / USP which features on the computer a task in which several balls are on the screen and must be touched to change color. The goal is to change the maximum of balls color in 15 seconds. The touch is performed through the touch screen corresponding to the physical environment with tap or by means of touchless environment using a virtual interface offered by Kinect system. Data regarding performance will be analyzed considering the number of hit balls.
Procedure and Design To perform the task virtual research participants will be positioned at the computer so that they are adjusted in height (this will depend on the physical composition of each participant) and away from the computer screen, approximately 1.5m., and also the interface used thus enabling the beginning of the task.
It were previously explained to the participant as it should do it with the Kinect, which through actual movement the individual has the ability to perform a task, using an avatar, each with their specific implementation, with one of the upper limbs and fingers of one hand respectively; should be aware of the start of the task as the verbal command of the researcher, for each phase of the task to be performed has duration of 7 minutes and 30 seconds, 1 minute and 15 seconds respectively, with five-minute interval, consisting of the acquisition phase ( the activity will be repeated 30 times / attempts), retention (will repeat the activity 5 times / attempts) and transfer (activity will be repeated 5 times / attempts) respectively.
Considering an estimated running time of approximately 30 minutes in just one meeting. Both the experimental group and the control group performed two tasks: real and virtual environment, where the control and experimental group-1 performed the following sequence: Acquisition = Kinect, Retention = Kinect and Transfer = Touchscreen; the experimental control group-2 and performed the following sequence: Acquisition = Touchscreen, Retention = Touchscreen and Transfer = Kinect.
#Intervention
- DEVICE : Cerebral Palsy - Kinect
- Group with Cerebral Palsy that will perform the task on Kinect
- DEVICE : Cerebral Palsy - Touchscreen
- Group with Cerebral Palsy that will perform the task on Touchscreen
- DEVICE : Control Group - Kinect
- Group with typical development that will perform the task on Kinect
- DEVICE : Control Group - Touchscreen
- Group with typical development that will perform the task on Touchscreen
|
#Eligibility Criteria:
Inclusion Criteria:
* individuals with a diagnosis PC (for the experimental group);
* diparesis and spastic hemiparesis;
* with gross motor function classification as levels I, II and III according to the Gross Motor Function Classification System (GMFCS).
Exclusion Criteria:
* individuals who have undergone surgery or performing chemical neuromuscular blockade for less than 6 months in the upper limbs;
* associated diseases;
* changes in cognitive functions that preclude cooperation and understanding in the proposed activities.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03352440
|
{
"brief_title": "Different Virtual Reality Devices in People With Cerebral Palsy",
"conditions": [
"Cerebral Palsy"
],
"interventions": [
"Device: Control Group - Kinect",
"Device: Cerebral Palsy - Kinect",
"Device: Control Group - Touchscreen",
"Device: Cerebral Palsy - Touchscreen"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT03352440",
"official_title": "The Use of Different Devices Through Virtual Reality in People With Cerebral Palsy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-01",
"study_completion_date(actual)": "2017-12-01",
"study_start_date(actual)": "2017-01-20"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-02",
"last_updated_that_met_qc_criteria": "2017-11-21",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-24",
"first_submitted": "2017-11-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.
Detailed Description
Surgery is the primary and most effective treatment of breast cancer, but residual disease in the form of scattered micrometastases and tumor cells are usually unavoidable. Whether minimal residual disease results in clinical metastases is a function of host defense and tumor survival and growth. At least three perioperative factors shift the balance toward progression of minimal residual disease:
1. Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), increases concentrations of pro-angiogenic factors such as VEGF, and releases growth factors that promote local and distant growth of malignant tissue.
2. Anesthesia impairs numerous immune functions, including those of neutrophils, macrophages, dendritic cells, T-cell, and natural killer cells.
3. Opioid analgesics inhibit both cellular and humoral immune function in humans, increase angiogenesis, and promote breast tumor growth in rodents.
However, regional analgesia attenuates or prevents each of these adverse effects by largely preventing the neuroendocrine surgical stress response, eliminating or reducing the need for general anesthesia, and minimizing opioid requirement. Animal studies indicate that regional anesthesia and optimum postoperative analgesia independently reduce the metastatic burden in animals inoculated with breast adenocarcinoma cells following surgery. Preliminary data in cancer patients are also consistent: paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis approximately four-fold (95% CI of estimated hazard ratio is 0.71 - 0.06) during a 2.5 to 4-year follow-up period compared to opioid analgesia. The investigators will thus test the hypothesis that recurrence after breast cancer surgery is lower with regional anesthesia/analgesia than with general anesthesia and opioid analgesia.
In this multi-center trial, Stage 1-3 patients having mastectomies will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and opioid analgesia. As with all time-to-event trials, interim and final analyses are based on the number of outcome events (recurrences in this case) rather than enrollment. The number of patients required is just an estimate and varies based on actual recurrence rates which in turn depend on patients' stage and grade, and ancillary treatments. There will be three evenly spaced interim analyses and a final analysis at 351 recurrences. Confirming our hypothesis will indicate that a minor modification to anesthetic management, one that can be implemented with little risk or cost, will reduce the risk of cancer recurrence - a complication that is often ultimately lethal.
#Intervention
- DRUG : General anesthesia and opioids
- General anesthesia, usually with sevoflurane, and opioid analgesia
- Other Names :
- General anesthesia
- DRUG : Regional analgesia and propofol
- Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
- Other Names :
- Regional analgesia
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1 <= age <= 3, Nodes 0 <= age <= 2)
* Scheduled for unilateral or bilateral mastectomy with or without implant (isolated 'lumpectomy' will not qualify)
* Isolated 'lumpectomy' with axillary node dissection (anticipated removal of at least five nodes)
* Written informed consent, including willingness to be randomized to morphine or regional analgesia
Exclusion Criteria:
* Previous surgery for breast cancer (except diagnostic biopsies)
* Inflammatory breast cancer
* Age < 18 or > 85 years
* Scheduled free flap reconstruction
* ASA Physical Status >= 4
* Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
* Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
* Other cancer not believed by the attending surgeon to be in long-term remission
* Systemic disease believed by the attending surgeon to present >= 25% two-year mortality
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00418457
|
{
"brief_title": "Regional Anesthesia and Breast Cancer Recurrence",
"conditions": [
"Breast Neoplasms"
],
"interventions": [
"Drug: General anesthesia and opioids",
"Drug: Regional analgesia and propofol"
],
"location_countries": [
"China",
"United States",
"Germany",
"Singapore",
"Austria",
"Ireland"
],
"nct_id": "NCT00418457",
"official_title": "Regional Anesthesia and Breast Cancer Recurrence",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02",
"study_completion_date(actual)": "2019-12",
"study_start_date(actual)": "2007-01"
},
"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)": "2020-06-16",
"last_updated_that_met_qc_criteria": "2007-01-03",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-04",
"first_submitted": "2007-01-03",
"first_submitted_that_met_qc_criteria": "2020-06-03"
}
}
}
|
#Study Description
Brief Summary
The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls in three refugee camps in Ethiopia. The study design will employ a two group wait-list cluster randomized controlled trial where girls will be invited to participate in the COMPASS program, assigned to groups of approximately 20 for the purposes of the program, complete a pre-test baseline assessment, and will then be randomized by group to the intervention or control condition. In addition, qualitative research will address additional questions of acceptability, processes of change and best practice.
Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to determine whether the participants receive the intervention or are placed on the wait-list immediately following the baseline. Those that do not get the curriculum during the study will receive it following the endline phase of the study so as to not create tensions or jealousies.
The intervention, the COMPASS program, will involve a structured intervention for girls between the ages of 13-19 that is intended to engage adolescent girls, those who are influential in their lives, service providers and other stakeholders, with the ultimate goal of co-creating environments in which girls are valued and safe. The program is centered on establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.
Detailed Description
The study assessment will employ a mixed methods approach with most data collection occurring at pre-test/baseline and post-intervention. Quantitative survey methods will be used to evaluate attitudes towards a host of topics related to physical and financial assets and health-related behaviors. Survey questions will be administered using Audio Computer Assisted Self-Interviewing (ACASI). Quantitative methods will be used to yield statistical measures of the scale of changes in attitudes, skills, and behaviors due to the intervention.
Qualitative methods at baseline will include focus group discussions with caregivers and participatory methods with girls to assess topics such as self-esteem, empowerment, safety, and resilience. Endline qualitative methods include in-depth interviews with caregivers, and small-group warm-up activities with adolescent girls, followed by in-depth interviews.
#Intervention
- BEHAVIORAL : COMPASS
- COMPASS (Creating Opportunities through Mentoring, Parental involvement and Safe Spaces) is a program for 13-19 year old girls in three refugee camps in Ethiopia. The program is a structured intervention that is intended to engage adolescent girls, through life skills training and establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.
- BEHAVIORAL : No intervention
- Wait list control group will not receive an intervention. After the follow-up study, the wait-list control group will receive the regular COMPASS program
|
#Eligibility Criteria:
Inclusion Criteria:
* female
* aged 13 <= age <= 19
* speak one of the languages included in the study (Sudanese Arabic, Funj/Berta, Maban, Regarig and Engesena Quickly dialects)
* give informed consent
Exclusion Criteria:
* cognitive impairment
Sex :
FEMALE
Ages :
- Minimum Age : 13 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02506543
|
{
"brief_title": "Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia",
"conditions": [
"Sexual Assault",
"Interpersonal Relations",
"Marital Status",
"Domestic Violence"
],
"interventions": [
"Behavioral: COMPASS",
"Behavioral: No intervention"
],
"location_countries": [
"Ethiopia",
"United States"
],
"nct_id": "NCT02506543",
"official_title": "Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2015-08"
},
"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)": "2018-02-08",
"last_updated_that_met_qc_criteria": "2015-07-21",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-23",
"first_submitted": "2015-07-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.
Detailed Description
In the current randomized waiting-list-controlled pilot study, we investigate a new manualized therapeutic approach, which is based on mindfulness- and body-psychotherapy and which has been specifically developed for the treatment of tinnitus patients (Tinnitus Atemtherapie; http://www.maria-holl.de/). Essential components of the treatment program include mindfulness, meditation, selfmassage, and breathing exercises. These components are intended to help patients use their inner resources to accept responsibility for themselves, become more self-sufficient and develop symptom acceptance.
#Intervention
- BEHAVIORAL : Mindfulness-based therapy
- Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).
- BEHAVIORAL : Treatment after waiting time
- Treatment was performed after completion of the active arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* Chronic tinnitus (duration >= 6 months)
* German speaking
* Subjective tinnitus
Exclusion Criteria:
* Instable medical conditions
* Objective tinnitus
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
|
NCT01540357
|
{
"brief_title": "Mindfulness-based Therapy in Chronic Tinnitus",
"conditions": [
"Chronic Tinnitus"
],
"interventions": [
"Behavioral: Treatment after waiting time",
"Behavioral: Mindfulness-based therapy"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01540357",
"official_title": "Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2010-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-27",
"last_updated_that_met_qc_criteria": "2012-02-27",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-28",
"first_submitted": "2012-02-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to describe the oral health status of patients suffering from schizophrenia and schizoaffective disorders in a psychiatric institute in France.
Detailed Description
Schizophrenia concerns 21 million people in the world and 600 000 in France according to the World Health Organization. This pathology decreases the patient's quality of life and one patient out of two will try to commit suicide and 10% will die. Oral health is an important factor for general well being. The litterature shows that schizophrenic patients tend to visit less dental surgeries than the general population. Patients will often visit the surgery in emergency and dentist often choses to extract instead of a restorative solution. Thus, schizophrenic subjects are 3,4 more likely to become edentulous compared to the general population.
This is a cross-sectional epidemiological study on patients suffering from schizophrenia and and schizoaffective disorders in a psychiatric institution. A dental assessment will be conducted to provide clinical data on oral health. (DMFT, hygiene, mouth dryness, prosthesis) and a survey of their diet, medication, oral quality of life, social security coverage and patients view regarding dental care (Anxiety and Healthcare renunciation).
This is an observational study (oral examination and survey), so no treatment will be compared. The oral health status will be evaluated during one single oral examination and survey during the patient's stay at hospital.
|
#Eligibility Criteria:
Inclusion Criteria:
* Schizophrenic patients and patients with schizoaffective disorders at the Charles Perrens Hospital
* Willing to participate in the study
* 18 years and above
Exclusion Criteria:
* Patients mentally unable to participate or refusing to participate in this study.
* Patient hospitalized under duress
* Minor
* Patients unable to read, speak or write French
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
|
NCT04191200
|
{
"brief_title": "Oral Status of Patients Suffering From SCHIZophrenia Followed at Charles Perrens Hospital",
"conditions": [
"Dental Diseases",
"Schizophrenia"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04191200",
"official_title": "Etat BUCCO-dentaire de Patients Atteints de SCHIZophrénie et de Troubles Schizo-affectif Suivis au Centre Hospitalier de Charles Perrens",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2019-09-24"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-30",
"last_updated_that_met_qc_criteria": "2019-12-06",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-09",
"first_submitted": "2019-11-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Severe trauma induces massive metabolic changes that are characterized by hypermetabolism with increased energy expenditure and catabolism. Early enteral and, if necessary, parenteral feeding is a major focus of modern intensive care medicine.
After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads to a decrease in energy expenditure. Whereas other survivors of severe trauma typically regain muscle mass during rehabilitation, spinal cord injury patients typically continue to lose muscle mass over time, which also leads to changes in body composition. The time course of these changes is not known. Continuing nutrition without adaption to the reduced energy expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury patients to the known unfavorable metabolic consequences. Knowledge of the time course of these changes would help to provide adequate caloric intake to the patients and improve our ability for nutrition counseling.
The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients to determine the changes in energy expenditure and body composition. Major inclusion criteria are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS (American Spinal Injury Association Impairment Scale) A, B or C.
Measurements of energy expenditure, body composition and nutritional markers in venous blood are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation (at the latest after 26 weeks).
|
#Eligibility Criteria:
Inclusion Criteria:
* patients admitted for acute treatment and rehabilitation after traumatic spinal cord injury
* no longer then two weeks after onset of spinal cord injury
* age 18 - 70 years
* body mass index 18 <= age <= 30
* neurological level C4 to Th12
* American Spinal Injury Association Impairment Scale (AIS) A, B or C
Exclusion Criteria:
* complications during acute treatment, which make study participation impossible or would endanger the recovery of the patient
* pre-existing diabetes mellitus type 1 and 2
* pre-existing hypercholesterolemia
* untreated hypothyroidism or hyperthyroidism
* invasive mechanical ventilation
* cardiac pacemaker
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
|
NCT01980784
|
{
"brief_title": "Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury",
"conditions": [
"Spinal Cord Injuries"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01980784",
"official_title": "Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-02",
"study_start_date(actual)": "2012-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-28",
"last_updated_that_met_qc_criteria": "2013-11-04",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-11",
"first_submitted": "2013-10-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.
Detailed Description
This is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric patients. The treatment period is three days, and during the study the subjects will rate the taste and palatability of the suspension or (for younger children) their parents will rate the child´s acceptance of the suspension.
The study consists of a screening period, a 3 day treatment period and a 1 week follow-up period.
#Intervention
- DRUG : Nitisinone
- Oral suspension
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with HT-1 currently managed on Orfadin (nitisinone) capsules.
* Age from 1 month to less than 18 years.
* Signed informed consent.
Exclusion Criteria:
* Any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
* Enrollment in another concurrent clinical study, or intake of an investigational medicinal product (IMP), within one month prior to inclusion in this study.
* Foreseeable inability to cooperate with given instructions or study procedures.
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01734889
|
{
"brief_title": "Taste and Palatability of Orfadin Suspension",
"conditions": [
"Hereditary Tyrosinemia, Type I"
],
"interventions": [
"Drug: Nitisinone"
],
"location_countries": [
"France",
"Germany",
"United Kingdom"
],
"nct_id": "NCT01734889",
"official_title": "Taste and Palatability of Orfadin Suspension. An Open, Non-controlled 3 Day Study in Pediatric Patients With Hereditary Tyrosinemia Type 1 Treated With Orfadin.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-03",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2012-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-11-06",
"last_updated_that_met_qc_criteria": "2012-11-27",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-28",
"first_submitted": "2012-11-22",
"first_submitted_that_met_qc_criteria": "2014-01-21"
}
}
}
|
#Study Description
Brief Summary
The investigators aimed to explore effects of dexmedetomidine on modulation of perioperative blood glucose and relevant hormone during the general anesthesia with surgery time ≥ 4 hours, and the effects on postoperative complications. 75 participants (American Society of Anesthesiologists grades I or II, of both sexes,aged 40-80 yr,with BMI of 18.5-27 kg/m2) scheduled for elective surgery under general anesthesia with surgery time ≥ 4 hours were enrolled in this study. The participants were divided into four groups: group C (control saline group, no dexmedetomidine use), group D1 (dexmedetomidine loading dose 1 mcg/kg, maintenance dose 0.25 mcg/kg/h), group D2 (dexmedetomidine loading dose 1 mcg/kg, maintenance dose 0.5 mcg/kg/h).10 minutes before anesthesia induction, all participants were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group. Blood samples were taken at the beginning of dexmedetomidine (T0), the beginning of skin incision (T1), 1 h after skin incision (T2), the end of the surgery (T3) and 1 h after patient transfer to PACU (T4) for the value of blood glucose,lactate and relevant hormones. Also, investigators also record the total amount of propofol and sufentanil at the end of surgery,and the complications within 24 h after the surgery.
#Intervention
- DRUG : dexmedetomidine
- 10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergoing operations over 4 h under general anesthesia,ASA physical status I or II, irrespective of showing gender bias, aged between 50 <= age <= 75 years, and having a body mass index (BMI) between 18.5 <= age <= 28 kg/m2.
Exclusion Criteria:
* the patients with bradycardia, hypoglycemia, heart disease, adrenal tumor,diabetes or showed >=7.0 mmol/L, or HbA1c level >=6.5%.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03788538
|
{
"brief_title": "Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones",
"conditions": [
"Dexmedetomidine",
"Blood Glucose"
],
"interventions": [
"Drug: dexmedetomidine"
],
"location_countries": [
"China"
],
"nct_id": "NCT03788538",
"official_title": "Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-01",
"study_completion_date(actual)": "2020-06-01",
"study_start_date(actual)": "2017-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-03",
"last_updated_that_met_qc_criteria": "2018-12-26",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-27",
"first_submitted": "2018-12-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Fluid challenge is frequently used in fluid management of critically ill patients. Assessing whether there is a preload reserve that can be used to increase the stroke volume by delivering a small amount of fluid in a short period of time. Optimization of fluid therapy is very important in intensive care patients. Inappropriate fluid therapy can cause significant morbidity and even mortality. Increased intracranial pressure is one of these important complications. In the present study, we planned to evaluate the effect of a fluid challenge on intracranial pressure by measuring the optic nerve sheath diameter (ONSD).
Detailed Description
The fluid challenge is a simple volume resuscitation evaluation method that provides an indication of the patient's likelihood of benefiting from an increase in the intravenous fluid volume. Both the fluid challenge and fluid responsiveness are evaluated by interpreting the change in hemodynamic parameters after 500 mL of crystalloid (or 250 mL of colloid) solution is infused over 10-15 min. This is done in an attempt to regulate the fluid therapy of hemodynamically unstable patients in order to prevent fluid overload. In the present study, we aim to investigate the effect of the fluid challenge maneuver on intracranial pressure in ICU patients with hemodynamic instability through measuring the optic nerve sheath diameter by ultrasonography.
Patients in the intensive care unit undergoing a fluid challenge were included in this prospective observational study. A fluid challenge is defined as a 500 mL crystalloid infusion administered over 10 min, and fluid responsiveness is defined as a subsequent increase in stroke volume of at least 15%. The ONSD and hemodynamic variables will be measured by ultrasonography before (T0), at the end (T1), and 30 min after the fluid challenge (T2). The primary outcome of the study is the change in intracranial pressure associated with the fluid challenge, and the secondary outcome is the relationship between fluid responsiveness and the change in ONSD.
#Intervention
- DIAGNOSTIC_TEST : Measurement of optic nerve sheath diameter
- The fluid challenge effects of optic nerve sheath diameter
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with no known intracranial pathology.
* Patients with systolic blood pressure < 90 mmHg
* Patients with mean blood pressure < 65 mmHg
* Patients with tachycardia (heart rate 100 beats/min)
* Patients with mottled skin, oliguria (diuresis of less than 20 ml/hr or 0.5 ml/kg/hr for two hours), and acute renal failure.
* Patients with arterial lactate concentration > 2 mmol/L
Exclusion Criteria:
* Patients with known intracranial hypertension
* Patients in the early postpartum period
* Patients with severe mitral or aortic regurgitation
* Patients with cardiac arrhythmia
* Patients unable to be evaluated due to poor echogenicity
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
|
NCT04928040
|
{
"brief_title": "Effect of Fluid Challenge on Intracranial Pressure",
"conditions": [
"Fluid Challenge",
"Increased Intracranial Pressure"
],
"interventions": [
"Diagnostic Test: Measurement of optic nerve sheath diameter"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04928040",
"official_title": "Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-01",
"study_completion_date(actual)": "2022-01-16",
"study_start_date(actual)": "2021-06-22"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-31",
"last_updated_that_met_qc_criteria": "2021-06-09",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-16",
"first_submitted": "2021-06-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.
|
#Eligibility Criteria:
Inclusion Criteria:
* attending routine outpatient visits,
* aged 24 <= age <= 50,
* having a BMI >= 18.50 kg/m2
Sex :
ALL
Ages :
- Minimum Age : 24 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04205318
|
{
"brief_title": "FTO Gene Variants and Diet in Obesity",
"conditions": [
"Obesity",
"Diet Habit",
"Genetic Predisposition"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT04205318",
"official_title": "Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-01",
"study_completion_date(actual)": "2018-12-31",
"study_start_date(actual)": "2017-03-01"
},
"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)": "2019-12-19",
"last_updated_that_met_qc_criteria": "2019-12-17",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-19",
"first_submitted": "2019-07-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Asthma and COPD are common chronic diseases of respiratory system. The correct use of inhalers is crucial in terms of efficacy of the treatment, however both asthma and COPD patients quite frequently misuse the inhalers. The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
In included patients the inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be collected:
* general demographic information and education level
* information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
* Asthma Control Test or COPD Assessment Test (respectively for asthma and COPD)
* assessment of quality of life (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
* cognitive functions assessment using Mini-Mental State Examination
* the simplified assessment of vision impairments
* the results of spirometry
Detailed Description
Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases of respiratory system. Asthma affects about 5% of adults in Poland. The inhaling therapy is the cornerstone of asthma treatment, especially inhaled glucocorticosteroids (ICS). The correct use of inhalers is crucial for efficiency of the therapy and reduction of undesirable side effects of medications. COPD is also a common chronic respiratory disease that affects about 10% of adults above 40 years old. The most important action to prevent and to treat COPD is to stop smoking. The main medications used by COPD patients are inhaled bronchodilators. Both asthma and COPD patients misuse the inhalers.
The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
Patients:
Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study. Power analysis and sample size calculations indicated that a sample size of 215 subjects (with either asthma or COPD) would provide statistical power to detect even weak correlation (r=0.2) assuming error alpha = 0.05, beta = 0.20 and 10% drop out.
Study design
In included patients inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be gathered:
* general demographic information and education level
* information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
* Asthma Control Test and COPD Assessment Test respectively for asthma and COPD
* assessment of quality of life with the disease (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
* cognitive functions assessment using Mini-Mental State Examination
* the simplified assessment of vision impairments
* the results of spirometry The main outcome will be correlation between inhalation technique and other above mentioned factors.
Identification of factors influencing the inhaling errors in patients with asthma or COPD will enable to plan the actions to improve the efficiency of inhaler medications use. At the end of the study all patients will be taught how to use their inhalers properly.
#Intervention
- OTHER : Assessment of correctness of inhaling technique
- Assessment of correctness of inhaling technique in patients with asthma or COPD
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent for participating in the study
* Age 18 -85 years
* COPD or asthma diagnosed at least 3 months prior to enrolment
* using of at least one inhaler regularly every day
* using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)
Exclusion Criteria:
* Lack of informed consent
* Age <18 years or > 85 years
* Diagnosis of asthma or COPD shorter than 3 months before enrollment
* Using inhalers unregularly.
* Symptoms of infection 5 days prior to beginning of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04203446
|
{
"brief_title": "Factors Influencing on Correctness of Inhalation Technique.",
"conditions": [
"Asthma",
"COPD"
],
"interventions": [
"Other: Assessment of correctness of inhaling technique"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT04203446",
"official_title": "Assessment of Clinical Factors Influencing on Correctness of Inhalation Technique in Adults With Asthma or COPD.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-15",
"study_completion_date(actual)": "2023-01-30",
"study_start_date(actual)": "2019-10-30"
},
"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)": "2023-02-21",
"last_updated_that_met_qc_criteria": "2019-12-17",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-18",
"first_submitted": "2019-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and possibly with an increased cardiovascular morbidity and mortality. Statins lower serum cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on indicators of cardiovascular risk such as dyslipidemia and vascular function as well as safety in patients with PBC.
Detailed Description
Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids. Hypercholesterolemia is an established risk factor for cardiovascular morbidity and mortality. Since many PBC patients have a very slow progression of their underlying liver disease cardiovascular risk factors may become more relevant as prognostic facors. Whether statins lower serum cholesterol levels and reduce the cardiovascular risk in PBC patients remains to be determined. Statins are generally well tolerated and are not associated with an increased risk of hepatotoxicity in patients with nonalcoholic fatty liver disease (NAFLD). However only limited data on safety on statins in chronic cholestatic liver diseases are available. In a recent pilot study at the Medical University of Graz atorvastatin did not statistically increase liver enzymes in PBC patients. However, data on long-term treatment with atorvastatin in these patients are not yet available. Moreover, long-term treatment with statins may have potential beneficial immunomodulatory effects on the disease course of PBC in analogy to other immune-mediated disorders such as rheumatoid arthritis and multiple sclerosis.
#Intervention
- DRUG : Atorvastatin
- oral, 10 mg, daily, 48 weeks
- Other Names :
- Sortis10 mg, 1-21927, C10AA05
|
#Eligibility Criteria:
Inclusion Criteria:
* LDL-cholesterol > 130 mg/dl
* Primary biliary cirrhosis (AMA positive or biopsy proven)
* Male or female gender
* Age 18 <= age <= 70 years
* Normal kidney function
Exclusion Criteria:
* Primary biliary cirrhosis Stage III-IV (Ludwig Score)
* Liver cirrhosis
* Decompensated liver disease ( > Child-Pugh class B, ascites, esophageal varices)
* ALT or AST > 2x ULN
* Pregnancy or breastfeeding
* Premenopausal women without certain contraception
* Known hypersensitivity to HMG-CoA reductase inhibitors
* Current treatment with lipid-lowering agents other than atorvastatin; immunosuppressants, macrolides
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
|
NCT00844402
|
{
"brief_title": "Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis",
"conditions": [
"Primary Biliary Cirrhosis",
"Hypercholesterolemia"
],
"interventions": [
"Drug: Atorvastatin"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT00844402",
"official_title": "Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-11",
"study_completion_date(actual)": "2007-11",
"study_start_date(actual)": "2006-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-02-16",
"last_updated_that_met_qc_criteria": "2009-02-13",
"last_verified": "2009-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-16",
"first_submitted": "2009-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants.
Detailed Description
Participants will be randomized to 1 of 4 treatment sequences (1-4). Each participant will participate in 4 treatment periods. One formulation of rivoceranib will be administered per treatment period. Blood samples will be collected predose and up to 120 hours postdose to evaluate the pharmacokinetics (PK) of rivoceranib and its major metabolites.
#Intervention
- DRUG : Rivoceranib
- Rivoceranib will be supplied as film-coated tablets for oral administration as 4 different formulations: Formulation 1, 3, and 4 = 250 milligrams; Formulation 2 = 200 milligrams.
- Other Names :
- Rivoceranib Mesylate, Apatinib Mesylate
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants must have a body mass index from 18.5 to 32.0 kilograms (kg)/meter squared (inclusive) and a weight of >= 50 kg at Screening.
* Participants must be able to provide informed consent after risks and benefits have been explained. Participants must be capable of understanding, able to sign a written informed consent, and willing to comply with the protocol requirements.
* Participants must agree to discontinue intake of beverages and foods known to interfere with cytochrome P450 (CYP) metabolic enzymes such as: grapefruit- and quinine-containing food and beverages (for example, tonic water, bitter lemon), orange juice, pomelos, cranberry, pomegranate, starfruit, Seville oranges (or marmalade made from them), garlic supplements or licorice, within 14 days prior to first dosing.
* Participants must be in general good health as determined by the principal investigator (PI), based on pre-study medical and surgical history, physical examination, and clinical laboratory tests.
* Participants must have normal blood pressure at Screening: systolic blood pressure < 130 millimeters of mercury (mmHg) and diastolic blood pressure < 85 mmHg.
* Participants must have no clinically significant laboratory test results (<= 1.5 x upper limit of normal for serum aspartate aminotransferase and alanine aminotransferase) at Screening.
* Participants must have no clinically significant laboratory test results for prothrombin time, activated partial thromboplastin time, and international normalized ratio (> 20% outside the normal ranges) at Screening and Check-in.
Exclusion Criteria:
* Participants who have participated in any investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, prior to the first dosing.
* Participants with any medical or surgical condition that may interfere with the absorption, distribution, or metabolism of the study drugs.
* Participants who have a history of hypersensitivity to rivoceranib or any of its excipients.
* Participants who are unwilling or unable to avoid xanthine- and caffeine-containing drinks (including many soft drinks, energy drinks, coffee, and tea) and foods (such as chocolate or coffee flavored) from 72 hours prior to first dosing.
* Participants unable to refrain from or anticipate the use of:
* any non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing
* any investigational drugs and prescription medications within 28 days prior to the first dosing. Use of any drugs or herbal remedies known to be significant inhibitors or inducers of CYP 3A4 and 2D6 enzymes for 28 days prior to the first dosing
* appropriate sources (for example, Flockhart Table) will be consulted to confirm lack of PK/pharmacodynamic interaction with study drugs
* Participants with corrected QT interval by Fridericia's formula > 460 microseconds or have clinically significant electrocardiogram findings, in the opinion of the PI, at Screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05287360
|
{
"brief_title": "A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Rivoceranib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05287360",
"official_title": "A Phase 1, Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Bioequivalence of Four Formulations of Oral Rivoceranib Tablets in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-16",
"study_completion_date(actual)": "2022-03-24",
"study_start_date(actual)": "2021-12-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-18",
"last_updated_that_met_qc_criteria": "2022-03-10",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-18",
"first_submitted": "2022-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.
Detailed Description
The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.
#Intervention
- DEVICE : ThermoSuit(R) System
- The ThermoSuit device is used to cool patients using direct contact of the skin with cold water.
|
#Eligibility Criteria:
Inclusion Criteria:
* Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
* Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
* Estimated or known > 18 yearsyears.
* Intubation, ventilation and placement of esophageal probe.
* Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS <= 8].
Exclusion Criteria:
* Height greater than 188 cm.
* Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
* Core temperature less than 35°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space,nasopharynx, or central blood vessel).
* Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
* Known pregnancy.
* Response to verbal commands after ROSC (but before enrollment).
* Known terminal illness that preceded the arrest.
* Known enrollment in another study of a device, drug, or biologic.
* Major trauma or other co-morbidity requiring urgent surgery.
* Improving neurologic status.
* > 4 hours since return of spontaneous circulation.
* Unknown time of arrest.
* Severe or known coagulopathy (with active bleeding).
* Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00384319
|
{
"brief_title": "Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients",
"conditions": [
"Cardiac Arrest",
"Comatose"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT00384319",
"official_title": "Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-06",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2006-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-01-04",
"last_updated_that_met_qc_criteria": "2006-10-04",
"last_verified": "2007-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-06",
"first_submitted": "2006-10-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Several studies show an association between chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with physical inactivity, advanced age and systemic inflammation The use of coronary computed tomography (CCT) with multiple detectors is a diagnostic method for coronary disease, describing the anatomy and severity of arterial obstruction. One way of estimating the cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.
The aim of this observational study is to establish the correlation between the CCS and lung function. It will also correlate the presence of irreversible airway obstruction with significant coronary lesions.
Patients over 40 years referred to CCT who agree to participate in the study will perform a spirometry with bronchodilator and collect a blood sample to measure serum markers of inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP), tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the general population and in subgroups: smokers, former smokers and nonsmokers.
One year after the CCT patients will be contacted by the investigators and accessed for emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory events.
The investigators hypothesis is that reduced lung function is independently associated with elevated CCS and is, also a risk factor for increased hospital admission and coronary events.
The concomitant assessment of lung function and CCS can contribute knowledge about the epidemiological association between pulmonary disease and CAD. This can also add to evidence for the use of spirometry as a marker of cardiovascular risk.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients referred for coronary CT.
* Age greater than 40 years
Exclusion Criteria:
* History of myocardial revascularization (surgical or percutaneous)
* Cognitive-functional incapacity to perform spirometry
* Contraindication for administration of 400 mcg of albuterol
* Acute myocardial infarction or unstable angina within 2 weeks
* Angina pectoris class III or IV according to the Canadian Cardiovascular Society
* Heart failure New York Heart Association class III or IV
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
|
NCT01734629
|
{
"brief_title": "Pulmonary Disease in Patients Referred for Coronary CT",
"conditions": [
"Coronary Artery Disease",
"Atheroscleroses",
"COPD",
"Respiratory Diseases"
],
"interventions": null,
"location_countries": [
"Brazil"
],
"nct_id": "NCT01734629",
"official_title": "Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2011-04"
},
"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)": "2014-12-03",
"last_updated_that_met_qc_criteria": "2012-11-26",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-27",
"first_submitted": "2012-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the long term safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant
#Intervention
- DRUG : FTY720
|
#Eligibility Criteria:
Inclusion Criteria
* Patients who completed the 12 month core study
* Patients who gave written informed consent to participate in the study Exclusion Criteria
* Not applicable Other protocol-defined exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00239811
|
{
"brief_title": "Long Term Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients",
"conditions": [
"Renal Transplantation"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00239811",
"official_title": "A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double Dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-05",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2004-04"
},
"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)": "2011-11-02",
"last_updated_that_met_qc_criteria": "2005-10-13",
"last_verified": "2011-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-17",
"first_submitted": "2005-10-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).
Detailed Description
The investigators propose a pilot, single center, double blind, randomized, parallel, placebo controlled trial comparing 2 (BoNT) injection patterns for treatment of moderate to severe essential tremor. The investigators will recruit 20 patients with (ET).
#Intervention
- DRUG : Botulinum toxin
- Botulinum injections into dominant upper extremity using protocol outlined above.
- Other Names :
- BoNT
- OTHER : Placebo
- Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
* Having bothersome hand tremor in dominant hand with a hand TRS >=2
* On stable medications during last 30 days prior to enrollment.
Exclusion Criteria:
* Presence of secondary causes of tremor, such as dystonia and parkinsonism
* Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
* History of surgical treatment for (ET).
* Dementia as defined by DSM-V criteria
* Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of >=15 (PHQ-9 scores 1 <= age <= 4 Minimal depression; 5 <= age <= 9 Mild depression; 10 <= age <= 14 Moderate depression; 15 <= age <= 19 Moderately severe depression; 20 <= age <= 27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
* Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of >=15 (GAD-7 scores 0 <= age <= 4: minimal anxiety; 5 <= age <= 9: mild anxiety; 10 <= age <= 14: moderate anxiety; 15 <= age <= 21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
* Significant renal, hepatic, cardiac and thyroid 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
|
NCT02909907
|
{
"brief_title": "Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)",
"conditions": [
"Essential Tremor"
],
"interventions": [
"Other: Placebo",
"Drug: Botulinum toxin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02909907",
"official_title": "Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles Versus Flexor Muscles Alone for the Treatment of Essential Hand Tremor (FLEX-D ET)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02",
"study_completion_date(actual)": "2018-02-28",
"study_start_date(actual)": "2016-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-08",
"last_updated_that_met_qc_criteria": "2016-09-19",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-21",
"first_submitted": "2016-08-11",
"first_submitted_that_met_qc_criteria": "2019-04-01"
}
}
}
|
#Study Description
Brief Summary
Background: Epidemic Keratoconjunctivitis (EKC) is a form of adenoviral conjunctivitis. It is highly infectious disease mainly affect the outer eye surface and has a frequency to happen in epidemics especially in closed communities such as hospitals, schools and factories.
purpose: The purpose of this study to compare between the modified and the ordinary method of treatment for EKC.
Patients and methods: Three hundred fifty patients of EKC were enrolled in the study. The diagnosis was made by clinical picture and laboratory investigations. Group 1 had two hundred patients 120 males, 80 females (age from 18 to 60 years) were treated by the modified method and group 2 had one hundred fifty patients 100 males,50 females (age from 18 to 58 years) were treated with the ordinary method. The study was hold between November 2014 to October 2018 in Security forces Hospital, Riyadh, Saudi Arabia. Patients were followed up for 3 months up to 2 years. The main outcome were improvement in clinical picture and recovery.
Detailed Description
Patients and Methods Three hundred fifty patients suffered from EKC were enrolled in the study. Their diagnosis was made by clinical picture and laboratory investigations. Group 1 had two hundred patients 120 males, 80 females (age from 18 to 60 years) were treated by the modified method and group 2 had one hundred fifty patients 100 males,50 females (age from 18 to 58 years) were treated with the ordinary method. The study was done between November 2014 to October 2018 in Security forces Hospital, Riyadh, Saudi Arabia. Patients were followed up for 3 months up to 2 years. The main outcomes were improvement in patients clinical picture and recovery. All patients signed a consent for inclusion in the study and the study was approved by the ethical committee and it was in agreement with declaration of Helsinki tents.
All cases were diagnosed by clinical symptoms and signs as shown in table (2\& 3) and conjunctival smear for some suspected patients which revealed lymphocytes predominance. Slit lamp examination and visual acuity measurement were done and grading of ocular symptoms and signs were estimated according to severerity into normal, mild, moderate or severe. The patients were divided into group 1 in which patients were treated by the modified method (Povidone Iodine 5% eye wash irrigation) and group 2 in which patients were treated by the ordinary method.
Modified method The eye was topically anesthetized, then eye wash with Povidone Iodine 5% (povidone-iodine, Alcon) eye irrigation every day until the patients recovered. Manual removal of pseudo membranes with non toothed forceps and cotton tipped applicator on slit lamp. Antibiotic eye drops (moxifloxacin 0.5%) QID. Lubricant eye drops (tears natural free minims eye drops) QID. Cold compresses. Topical corticosteroid eye drops (fluorometholone 0.1%) QID in cases of subepithelial infiltrates or pseudomemrane formation.
Usual method The same way of management except the eye wash with Povidone Iodine 5% . Steroids was used for symptomatic relief but it do not lower the disease pathway. It suppress the corneal inflammation, improve overall comfort but they also prolong clearance of the virus and the lesions may recur if steroid is prematurely discontinued.
#Intervention
- DRUG : Povidone-Iodine
- Povidone-Iodine 5% eye wash
- Other Names :
- Group1
- DRUG : Normal Saline Flush
- Normal Saline eye wash
- Other Names :
- Group 2
|
#Eligibility Criteria:
Inclusion Criteria:
* Including adult patients with 18 <= age <= 60 old
* Patients with BCDVA of >= 20/80 in the study eye
* If the patent have bilateral EKC only one eye included in the study
* Patients attending all the required follow up visits as advised.
Exclusion Criteria:
* Children
* Patients with ocular infection rather than EKC
* Patients with corneal ulceration or bacterial keratitis
* Immunocompromised patients
* Glaucoma
* Patients not attending the required follow up visits.
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
|
NCT04169919
|
{
"brief_title": "Modified Treatment for Epidemic Keratoconjunctivitis (EKC)",
"conditions": [
"Symptoms and Signs"
],
"interventions": [
"Drug: Povidone-Iodine",
"Drug: Normal Saline Flush"
],
"location_countries": null,
"nct_id": "NCT04169919",
"official_title": "Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10",
"study_completion_date(actual)": "2018-10",
"study_start_date(actual)": "2014-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-20",
"last_updated_that_met_qc_criteria": "2019-11-18",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-20",
"first_submitted": "2019-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify the maximum tolerated dose (MTD) when MORAb-066 is administered IV once weekly on a 28-day cycle.
#Intervention
- DRUG : MORAb-066
- MORAb-066 infusion.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients must meet the following criteria in order to be included in this clinical trial:
* Histologically or cytologically confirmed diagnosis of breast, colorectal, pancreas, or NSCLC (adenocarcinoma) that is metastatic or unresectable for which there is no effective therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 (see Appendix A).
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Subject has recovered (to Grade less than or equal to 1) from all clinically significant toxicities related to prior antineoplastic therapies with the exception of alopecia and bone marrow and organ functions (described separately below).
* Adequate organ system function less than or equal to 2 weeks prior to Day1, defined as follows:
* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
* Platelets greater than or equal to 100 x 10^9/L
* Hemoglobin greater than or equal to 9 g/dL
* Prothrombin time/partial thromboplastin time (PT/PTT) within institutional limits of normal
* Serum total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 x ULN if no liver involvement or less than or equal to 5 x ULN with liver involvement.
* Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 mL/min as calculated by the Cockcroft-Gault method, OR 24-hour measured urine creatinine clearance greater than or equal to 50 mL/min.
* Life expectancy of greater than or equal to 12 weeks.
* Female patients of child-bearing potential (see Appendix C), and all male patients must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after their last MORAb-066 administration. A barrier method of contraception must be included.
* Patients must be greater than or equal to 18 years.
* Patients entering this study will be asked to provide archival tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, the subject will still be eligible for enrollment into the study.
* Ability to understand the nature of this study and give written informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from trial entry:
* Patients currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
* Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of MORAb-066. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of MORAb-066 is required.
* Any major surgery, chemotherapy, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed greater than or equal to 2 weeks).
* Subject has received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) less than or equal to 28 days or limited field radiation for palliation less than or equal to 14 days prior to starting study drug or has not recovered from side effects of such therapy.
* Known intracranial involvement, leptomeningeal metastases or spinal cord compression due to disease.
* Known allergy or hypersensitivity to monoclonal antibodies.
* Known bleeding diathesis, such as factor deficiency, factor inhibitor, platelet disorder, or who are on active anticoagulation, or any dose of aspirin within 5 days prior to first dose of MORAb-066.
* Known prior significant bleeding history.
* Patients with ureteral stents or 3+ blood in the urine at baseline.
* Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
* Patients who received a previous mAb therapy and have evidence of an immune or allergic reaction or previously documented HAHA reaction.
* A serious non-healing wound, active ulcer, or untreated bone fracture. An abdominal fistula or gastrointestinal perforation less than 6 months prior to treatment.
* History of hematemesis or hemoptysis (defined as having bright red blood of 1/2 teaspoon or more per episode) less than or equal to 1 month prior to study enrollment.
* Subject has cardiac dysfunction including any of the following:
* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction function
* QTcF greater than 470 msec
* History of documented congestive heart failure (New York Heart Association functional classification III-IV [see Appendix B])
* Angina not well-controlled by medication
* A serious active infection (bacterial or fungal) at the time of treatment, or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment.
* Chronic inflammatory disorder(e.g., inflammatory bowel disease, active vasculitis).
* Herbal preparations/medications must be discontinued 7 days prior to first dose of study drug (see Section 5.3.1).
* Known diagnosis of human immunodeficiency virus, Hepatitis B or Hepatitis C.
* History or current diagnosis of glomerulonephritis
* History of clinically significant or current diagnosis of hematuria.
* Women who are pregnant or lactating.
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
* Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01761240
|
{
"brief_title": "Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC",
"conditions": [
"Breast Cancer",
"Pancreatic Cancer",
"Colorectal Cancer",
"Carcinoma, Non-Small-Cell Lung",
"Adenocarcinoma"
],
"interventions": [
"Drug: MORAb-066"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01761240",
"official_title": "A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-066, a Humanized Monoclonal Antibody to Human Tissue Factor, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or Non-Small Cell Lung Cancer (Adenocarcinoma) Malignancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02-09",
"study_completion_date(actual)": "2016-02-09",
"study_start_date(actual)": "2013-06-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-29",
"last_updated_that_met_qc_criteria": "2013-01-03",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-04",
"first_submitted": "2013-01-03",
"first_submitted_that_met_qc_criteria": "2023-09-26"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the efficacy and tolerability in 'real-world' clinical practice, of adjunctive zonisamide treatment in adult patients with developmental disabilities and epilepsy.
Detailed Description
While a number of randomized double-blind controlled trials have demonstrated the value of zonisamide in the treatment of seizures, such studies lend limited insight into the efficacy and tolerance of zonisamide in real-world clinical practice. Furthermore, randomized trials tend to inquire about negative effects, such as adverse reactions, while positive effects such as improvement in mood, or sense of well-being are not similarly categorized. In addition, there is little information about experience with zonisamide specifically in adult patients with mental retardation (MR) / developmental disabilities (DD). Anecdotal experience suggests that zonisamide is exceptionally well-tolerated, and is associated with an improved general sense of well-being and quality of life in non-DD patients. In patients with MR/DD, observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing antiepileptic drugs.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or Female, at least 18 years
* Diagnosis of mental retardation
* Uncontrolled seizures or intolerable side effects from current AEDs
* Legal guardian is able to consent
Exclusion Criteria:
* Sulfa allergy
* Prior exposure to zonisamide
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
|
NCT00298818
|
{
"brief_title": "Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation",
"conditions": [
"Epilepsy",
"Mental Retardation",
"Developmental Disabilities"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00298818",
"official_title": "Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation / Developmental Disabilities",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-12",
"study_completion_date(actual)": "2008-03",
"study_start_date(actual)": "2002-08"
},
"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)": "2008-05-20",
"last_updated_that_met_qc_criteria": "2006-03-02",
"last_verified": "2008-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-03-03",
"first_submitted": "2006-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help to support parents in their efforts to quit smoking.
Detailed Description
The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying in a randomized controlled trial whether it can help to support parents in their efforts to quit smoking.
#Intervention
- OTHER : CHICA Smoking Cessation Module
- The CHICA module helped to screen parents for smoking and assist them in quitting.
- OTHER : CHICA Placebo
- This was CHICA without the study module.
|
#Eligibility Criteria:
Inclusion Criteria:
Parent of child in our clinics who reported cigarette smoking
Exclusion Criteria:
Not smoking
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
|
NCT01334216
|
{
"brief_title": "Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting",
"conditions": [
"Cigarette Smoking"
],
"interventions": [
"Other: CHICA Smoking Cessation Module",
"Other: CHICA Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01334216",
"official_title": "Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2008-07"
},
"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)": "2017-09-13",
"last_updated_that_met_qc_criteria": "2011-04-12",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-13",
"first_submitted": "2011-04-11",
"first_submitted_that_met_qc_criteria": "2017-01-24"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the drug, called AEG35156, can be safely given to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with refractory or relapsed AML.
Detailed Description
This is a phase I/II, single-arm, open-label, study to establish the recommended dose and activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions. Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse after an initial CR that lasted less than 6 months or primary refractory AML. Fixed dose of idarubicin and ara-C will be given, plus one of eight doses of AEG35156: 12, 24, 48, 75, 110, 165, 250 and 350mg/m2. A maximum of 54 patients will be treated in cohorts of size 3, starting at 12mg/m2, and not skipping any untried dose level when escalating. Following dose escalation, approximately 20 patients will be treated at the best acceptable dose as determined by the method of Thall and Cook (2004).
#Intervention
- DRUG : XIAP antisense
- 2 days loading dose followed by weekly 2hr infusion
|
#Eligibility Criteria:
Inclusion Criteria
* Subjects with relapsed or refractory AML, except those with APL (acute promyelocytic leukemia), that are about to receive their initial treatment for first relapse after an initial CR that lasted less than 6 months or for primary refractory AML that have an expected complete response rate <=20%. The initial diagnosis of AML has to be based on the presence of > 10% blasts in marrow or blood, and the diagnosis of relapsed/refractory AML based on the presence of either > 10% blasts in marrow or blood or 5 <= age <= 10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100,000 /uL, or neutrophil count < 1000 /uL).
* Peripheral AML blast count < 50,000 /uL that is not projected to rise above 50,000 /uL within 5 days of beginning treatment.
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
* Subjects must be >18 years.
* Male, or female subjects who are post-menopausal (amenorrhagic for at least 12 months), or surgically or biologically sterile. Females of childbearing potential with a negative serum pregnancy test 72 <= age <= 96 hours prior to the 1st infusion in the study and using adequate forms of contraception for the duration of the study, including 30 days after the last treatment. Adequate methods of contraception should be used by both male and female subjects.
* Subjects must have adequate organ and immune function as indicated by the following laboratory values:
* Parameter Laboratory Values
* Serum creatinine; <2.0mg/dL
* Total Bilirubin <2.0mg/dL
* AST (SGOT) and ALT (SGPT) <3 X ULN * *ULN: Institution's upper limit of normal.
* The subject must understand and be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
* The subject, or the subject's legal guardian, must have given written personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.
Exclusion Criteria
* Clinical evidence of active CNS leukemic involvement.
* Patients with left-ventricular ejection fractions <50%.
* Active and uncontrolled infection. Patients with an infection that are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
* Current evidence of invasive fungal infection (blood or tissue culture).
* Current evidence of an active second malignancy except for non-melanoma skin cancer.
* Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a subject's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
* Neurological or psychiatric disorders that would interfere with consent or study follow-up.
* Known or suspected intolerance or hypersensitivity to the study materials [or closely related compounds] or any of their stated ingredients.
* History of alcohol or other substance abuse within the last year.
* Use of another investigational agent or participation in a clinical trial within the last 14 days prior to enrolment. Subjects who have used a previous AS agent for at least 90 days will be excluded.
* Female subjects who are pregnant or lactating, or females with a positive pregnancy test at screening must be excluded.
* Subjects that have previously been enrolled into this study and subsequently withdrawn must also be excluded.
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
|
NCT00363974
|
{
"brief_title": "Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML",
"conditions": [
"Leukemia, Myelomonocytic, Acute"
],
"interventions": null,
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00363974",
"official_title": "An Open-Label Phase I/II Study of XIAP Antisense AEG35156 Administered to Patients With Refractory/Relapsed AML in Combination With Chemotherapy",
"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)": "2005-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"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)": "2009-12-01",
"last_updated_that_met_qc_criteria": "2006-08-10",
"last_verified": "2009-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-15",
"first_submitted": "2006-08-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The authors retrieved in-patient medical data, including the expense, from the 2010 Thailand Nationwide Hospital Admission Database, which is part of the National Health Security Office (NHSO). The diagnosis of digestive diseases with any form of colitis listed in the causes, either as principal diagnosis or co-morbidity, coding by the ICD-10 was recorded. The inclusion criteria were: 1) diagnosis of enterocolitis due to Clostridium difficile (ICD10-A07); and 2) age of more than 18 years. If the data was incomplete, the case was excluded. The baseline characteristics, including age, sex, co-morbidity disease and history of endoscopy or surgery, were recorded. The burden of CDI was evaluated by length of hospital stay (LOS), mortality rate, and hospital charge.
#Intervention
- OTHER : Colitis with CDI treatment
- All patients will be treated with standard treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* The patients with the diagnosis of Clostridium difficile (ICD10-A07)
* Age of more than 18 years.
Exclusion Criteria:
* Data incompleted
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
|
NCT02327520
|
{
"brief_title": "Clostridium Difficile Infection: the First Report in Southeast Asia by 2010 Nationwide Study",
"conditions": [
"Clostridium Difficile Infection"
],
"interventions": [
"Other: Colitis with CDI treatment"
],
"location_countries": null,
"nct_id": "NCT02327520",
"official_title": "The Burden of Clostridium Difficile Infection in Thai Population: the First Report in Southeast Asia by 2010 Nationwide Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2010-01"
},
"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)": "2014-12-30",
"last_updated_that_met_qc_criteria": "2014-12-24",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-30",
"first_submitted": "2014-12-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The prevalence of overweight and obesity among older adults has reached an all-time high, which puts this age group at high risk for associated comorbidities such as type 2 diabetes, cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and economic uncertainty, many middle-aged and older Americans tried to save on their food purchases during the 2007-2009 recession. Grocery coupons, available through newspapers, mail, and increasingly online, are one of several promotional tools that supermarkets and warehouse clubs use to promote sales. It is estimated that nationally 27% of households are frequent grocery coupon users who shop at a variety of retailers. Despite the increasing popularity of grocery coupons, little is known about the extent to which they may promote obesogenic home food environments and eating behaviors. Many coupons advertise the purchase of large quantities of prepackaged and processed foods and often reward shoppers by adding 'free' products if they purchase certain quantities. Availability and easy accessibility of large portions of energy dense foods in the home has been shown to promote increased intake. The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary intake, weight status, and home food availability among middle-aged and older adults. A second aim of this study is to test, in a randomized-controlled trial, the effects of incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in dietary intake, body mass index/waist circumference, home food availability, and grocery coupon use among frequent coupon users and non-coupon users.
#Intervention
- OTHER : Financial incentives
|
#Eligibility Criteria:
Inclusion Criteria:
* 40 - 70 years
* frequent grocery coupon users
* non-coupon users
Exclusion Criteria:
* dieting
* medication use or medical conditions known to affect food intake and weight
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01710124
|
{
"brief_title": "Buy 1 Get 1: Role of Grocery Coupons in Promoting Obesogenic Home Food Environments and Eating Behaviors",
"conditions": [
"Obesity"
],
"interventions": [
"Other: Financial incentives"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01710124",
"official_title": "Buy 1 Get 1: Role of Grocery Coupons in Promoting Obesogenic Home Food",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07",
"study_completion_date(actual)": "2013-07",
"study_start_date(actual)": "2013-01"
},
"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)": "2015-06-11",
"last_updated_that_met_qc_criteria": "2012-10-16",
"last_verified": "2012-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-18",
"first_submitted": "2012-10-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.
Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
#Intervention
- DRUG : Spesolimab
- Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.
- DRUG : Placebo
- Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.
- DRUG : Spesolimab
- Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.
- DRUG : Spesolimab
- Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.
- DRUG : Spesolimab
- Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.
- DRUG : Spesolimab
- Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 75 of legal age (according to local legislation) at screening.
* Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.
* PPP PGA of at least moderate severity (>=3) at screening and baseline.
* A minimum PPP ASI score of 12 at screening and baseline.
* Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
* Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
* Further criteria apply.
Exclusion Criteria:
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
* Presence or known history of anti-TNF-induced PPP-like disease.
* Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).
* Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
* Further criteria apply.
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
|
NCT04015518
|
{
"brief_title": "A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis",
"conditions": [
"Palmoplantar Pustulosis (PPP)"
],
"interventions": [
"Drug: Spesolimab",
"Drug: Placebo"
],
"location_countries": [
"France",
"Japan",
"Netherlands",
"United States",
"Poland",
"Germany",
"Taiwan",
"United Kingdom",
"Canada",
"Russian Federation",
"Australia",
"Hungary",
"Belgium",
"Czechia",
"Korea, Republic of"
],
"nct_id": "NCT04015518",
"official_title": "Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-06",
"study_completion_date(actual)": "2021-07-28",
"study_start_date(actual)": "2019-07-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-28",
"last_updated_that_met_qc_criteria": "2019-07-09",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-11",
"first_submitted": "2019-07-09",
"first_submitted_that_met_qc_criteria": "2022-07-01"
}
}
}
|
#Study Description
Brief Summary
This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing are termed 'ototoxic'. One such drug is the chemotherapy called cisplatin. Currently, if a patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy protocols and may be retested only when it is requested by their oncologist and when the Veteran can arrange an appointment. Researchers think that hearing testing prior to every treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from treatment. The purpose of this study is to compare the current method of monitoring hearing (audiology clinic protocols termed 'usual care') with a new portable hearing monitoring program (a comprehensive program of ototoxicity monitoring termed 'COMP-VA') that tests hearing using a portable hearing testing audiometer and a variety of efficient tools and techniques so that testing can occur prior to each cisplatin treatment at any quiet location in the hospital.
Detailed Description
Research objectives are to compare the effectiveness of ototoxicity monitoring implemented using Comp-VA or usual care with regard to (1) improving Veterans' hearing and quality of life outcomes, (2) assisting oncologists in pre-treatment counseling and therapeutic planning and (3) increasing use of post-treatment rehabilitative services.
The investigators plan to recruit a total of 320 Veterans undergoing cisplatin chemotherapeutic treatment over 4 years and 120 control subjects.
Program Evaluation: Hearing testing prior to treatment will be done in order to establish eligibility, enroll and randomize each subject into one of two study arms. At 5 weeks and at one year post-randomization hearing will be re-tested in order to obtain an estimate of longitudinal trends in hearing and quality of life assessment. Use of audiological services following treatment from the randomized subjects will be tracked. Finally, data will also be collected at each treatment interval to track use of counseling tools and oncology personnel treatment decisions.
Serial measurements from subjects receiving cisplatin prior to treatment who are randomized to:
Comp-VA group will get a screening hearing test prior to treatment, at each treatment interval and at one-month post-treatment. Auditory testing will be done on or near the Chemo Unit and will include otoscopy, immittance testing, and a hearing testing done by the Veteran using a self-testing procedure, and may be tested using distortion product otoacoustic emissions (DPOAEs), if they cannot take a reliable hearing test.
Usual care group will receive a full audiometric evaluation (otoscopy, immittance testing, air conduction and bone conduction hearing testing, speech audiometry, and distortion product otoacoustic emissions, DPOAEs) scheduled in the audiology clinic sound booth according to Audiology Service ototoxicity monitoring protocols. Testing will be arranged according to availability of appointments and patient convenience.
Additionally data will also be collected from control subjects who are similar in age and are tested at intervals similar to the chemotherapy subjects.
#Intervention
- OTHER : COMP-VA
- Hearing testing at each treatment interval by the comp-va audiologist
- OTHER : Standard of care
- Hearing testing done in the audiology clinic after oncology referral or patient self referral
|
#Eligibility Criteria:
Inclusion Criteria:
All Veterans entering cisplatin chemotherapy will be informed of the project and invited to participate unless the Veteran was excluded by CPRS review or medical advice.
Exclusion Criteria:
* Experimental subjects must be prescribed cisplatin for treatment of cancer to be enrolled in the treatment arms of this study.
Criteria for excluding subjects (chemotherapy and controls subjects) from this study will be:
* cognitively or physically unable to participate (patient or nurse report patient is incapable of participating), CPRS indication that subject exhibits aggressive behavior, subject has documented dementia, Alzheimer's disease, or severe psychosocial disorder, CPRS notes indicate individual is not legally capable of providing informed consent (subject has a legal guardian)
* unable to provide reliable behavioral hearing test responses (for either program evaluation hearing test or baseline, pre -treatment hearing test) as indicated by intra-session behavioral threshold reliability criterion of > +5 dB)
* exhibits Meniere's disease or retrocochlear disorder based on hearing test results, patient report or notes in CPRS
* exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, patient report, or notes in CPRS
* unwilling to participate
* hearing thresholds > 70 dB SPL at 4 kHz and below (based on DPOAE 'no response' data from a similar protocol described in Bibliography Reference 32, Table 3). The last exclusion was adopted in an effort to increase the potential that DPOAEs will be measurable in a large number of subjects.
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
|
NCT02099786
|
{
"brief_title": "Randomized Trial Comparison of Ototoxicity Monitoring Programs",
"conditions": [
"Cisplatin Ototoxicity",
"Hearing Loss"
],
"interventions": [
"Other: COMP-VA",
"Other: Standard of care"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02099786",
"official_title": "Comprehensive Ototoxicity Monitoring Program for VA: A Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-05",
"study_completion_date(actual)": "2018-05-05",
"study_start_date(actual)": "2015-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-09",
"last_updated_that_met_qc_criteria": "2014-03-26",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-31",
"first_submitted": "2014-02-26",
"first_submitted_that_met_qc_criteria": "2019-09-17"
}
}
}
|
#Study Description
Brief Summary
Schizophrenia is a devastating and costly illness. One-third to one-half of people with schizophrenia do not respond to the most current drugs leaving clozapine as the best alternative for treatment. However, over 60% of people treated with clozapine continue to have persistent symptoms and cognitive impairments. Little data is available to support evidence-based recommendations to guide clinicians in treating these patients. Preliminary data has suggested that adjunct treatment with minocycline may offer robust symptom improvement in patients with schizophrenia, including those taking clozapine. Minocycline has had interesting effects; including suggesting it may have a significant role in treatment of neurologic and psychiatric disorders. Minocycline is currently available generically; its side effects are well-described and minimal. The proposed double-blind treatment study seeks to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology. This knowledge could lead to the more effective treatment of patients with schizophrenia. The research itself may lead to a better understanding of the pathophysiology of positive symptoms and cognitive impairments, which could contribute to improved treatments in the future.
#Intervention
- DRUG : Minocycline
- Minocycline Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition.
- DRUG : Placebo
- Placebo Dosing:
Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition.
|
#Eligibility Criteria:
Inclusion Criteria:
* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Male or Female
* Age: 18 <= age <= 65
* Caucasian or Non-Caucasian
* At least six months of clozapine treatment
* Clozapine treatment for incomplete symptoms response (evidence of two failed previous trials of antipsychotics)
* Current dose of 200 mg/day for at least 3 months AND a documented clozapine blood level 350 ng/ml prior to study start (maximum clozapine dose of 900 mg/day)
* BPRS total score of 45 or more on the 18 item version (scale: 1 <= age <= 7)
* BPRS positive symptom item total score of 8 or more
* BPRS positive symptom score of 4 or greater on at least one item
Exclusion Criteria:
* History of organic brain disease
* DSM-IV diagnosis of Mental Retardation
* DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
* DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine)
* Pregnancy or lactation
* Significant renal or liver impairment
* Previous known hypersensitivity to tetracyclines
* Current treatment with tetracycline or derivative
* Current treatment with lamotrigine
* Treatment with oral contraceptives
* Current known infection
* Treatment with cholestyramine or colestipol
* Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
* Treatment with warfarin
* Abnormal (considered positive) Lyme titer
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
|
NCT01433055
|
{
"brief_title": "Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Drug: Placebo",
"Drug: Minocycline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01433055",
"official_title": "Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2011-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-28",
"last_updated_that_met_qc_criteria": "2011-09-12",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-13",
"first_submitted": "2011-07-21",
"first_submitted_that_met_qc_criteria": "2017-06-07"
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).
Detailed Description
Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.
#Intervention
- DRUG : Onabotulinumtoxin A
- Intravaginal pelvic floor injection one series
- Other Names :
- Botox
- DRUG : Kenalog
- Intravaginal pelvic floor injection one series
- Other Names :
- triamcinolone
|
#Eligibility Criteria:
Inclusion Criteria:
* Provide informed consent
* Healthy women > age 18 regardless of menopausal status
* Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
* High-tone pelvic floor dysfunction on vaginal exam
* A pelvic pain score of > 4 on screening Visual Analog Scale (VAS)
* Pain perceived to be in the pelvis that has been present for at least 3 months.
Exclusion Criteria:
* Patients that have had Botox to the bladder within the last 8 months
* Patients that have had Botox outside the bladder of > 160 u within the last 12 weeks.
* Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
* Pregnancy
* Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
* Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
* Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
* Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
* Systolic blood pressure > 160 mm Hg on screening blood pressure
* Heart rate > 110 beats/minute on screening heart rate
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
|
NCT02369068
|
{
"brief_title": "Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain",
"conditions": [
"Pelvic Pain"
],
"interventions": [
"Drug: Kenalog",
"Drug: Onabotulinumtoxin A"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02369068",
"official_title": "A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-26",
"study_completion_date(actual)": "2018-09-24",
"study_start_date(actual)": "2015-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-24",
"last_updated_that_met_qc_criteria": "2015-02-16",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-23",
"first_submitted": "2015-02-05",
"first_submitted_that_met_qc_criteria": "2019-01-16"
}
}
}
|
#Study Description
Brief Summary
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.
Detailed Description
The 'MiCo - Mirena or conventional medical treatment for menorrhagia' study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).
Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697 (NCT00864136), 14536.
#Intervention
- DRUG : Levonorgestrel (Mirena, BAY86-5028)
- Women using Mirena for treatment of menorrhagia
- DRUG : Hormonal treatment
- Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens)
- DRUG : Antifibrinolytic treatment
- Antifibrinolytic treatment (such as tranexamic acid)
|
#Eligibility Criteria:
Inclusion Criteria:
* Women between the ages of 18 <= age <= 45 (inclusive) not intending to become pregnant during the next year
* Women complaining of heavy menstrual bleeding over several consecutive cycles
* Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
* Informed consent (where required by laws or regulations)
Exclusion Criteria:
* The contraindications and warnings of the respective Summary of Product Characteristics (Mirena®, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
* Women taking hormone replacement therapy
* Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
* Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
* Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia
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
|
NCT01085487
|
{
"brief_title": "MiCo - Mirena or Conventional Medical Treatment for Menorrhagia",
"conditions": [
"Idiopathic Menorrhagia"
],
"interventions": [
"Drug: Hormonal treatment",
"Drug: Antifibrinolytic treatment",
"Drug: Levonorgestrel (Mirena, BAY86-5028)"
],
"location_countries": [
"Jordan",
"Ukraine",
"Colombia",
"Albania",
"Romania",
"South Africa",
"Venezuela",
"Bosnia and Herzegovina",
"Macedonia, The Former Yugoslav Republic of",
"Syrian Arab Republic",
"Moldova, Republic of",
"Lebanon",
"Czech Republic",
"Croatia"
],
"nct_id": "NCT01085487",
"official_title": "MiCo - Mirena or Conventional Medical Treatment for Menorrhagia (MA0901)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2009-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-10",
"last_updated_that_met_qc_criteria": "2010-03-11",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-12",
"first_submitted": "2010-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one of the major determinants of long term graft survival. There are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . This includes infection and bleeding. The non invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very good yield of detecting and scoring fibrosis.
In this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biops
Detailed Description
Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one of the major determinants of long term graft survival. There are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . This includes infection and bleeding. The non invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very good yield of detecting and scoring fibrosis.
In this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biopsy
#Intervention
- DIAGNOSTIC_TEST : Elastography arm
- Renal ultrasound elastography to detect and classify the degree of fibrosis
|
#Eligibility Criteria:
Inclusion Criteria:
Renal transplant patients of more than 2 years duration, Chronic allograft nephropathy proved by renal biopsy done within 1 month from the date of the strain elastography, Body mass index less than 30 kg/m2, Skin allograft distance of less than 3.5 cm, Parenchyma thickness of more than 1 cm and no fluid accumulation around the allograft.
Exclusion Criteria:
Body mass index more than 30 kg/m2, Skin allograft distance more than 3.5 cm, Parenchymal thickness less than 1 cm, Presence of any fluid collection around the allograft, GFR less than 15 ml/min, Graft stones or backpressure and less than 14 years or more than 55 years.
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05682313
|
{
"brief_title": "Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy",
"conditions": [
"Chronic Allograft Nephropathy"
],
"interventions": [
"Diagnostic Test: Elastography arm"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05682313",
"official_title": "Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-13",
"study_completion_date(actual)": "2022-10-24",
"study_start_date(actual)": "2021-01-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-12",
"last_updated_that_met_qc_criteria": "2022-12-27",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-12",
"first_submitted": "2022-12-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Explorative study on a medical device with two steps. The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.
The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.
Detailed Description
This diagnostic study will be performed in two steps, in the goal of evaluating a new device, called elastograph.
The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.
The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.
#Intervention
- DEVICE : Cutometer
- 3 measures by cutometer on each area: the mean value will be the final value
- Other Names :
- Cutometer MPA 580 (Monaderm)
- DEVICE : High resolution ultrasonography (echography)
- Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
- Other Names :
- Dermcup (Atys medical)
- DEVICE : Elastography
- 10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
- Other Names :
- high resolution elastography pulse
- PROCEDURE : Skin biopsy
- Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients group
* More than 18 years
* Inform consent form signed
* Affiliated to medical insurance
* No allergy to local anaesthetic drugs known
* For patients with lymphedema of upper limb: unilateral lymphedema occurred after a surgery and/or radiotherapy clinically confirmed by a dermatologist or a physician trained to lymphology, or primitive lymphoedema clinically confirmed by a dermatologist or a physician trained to lymphology, whom the unilateral characteristic will be proved by a recent lymphoscintigraphy (less than 2 years)
* For patients with lymphedema of lower limb: unilateral lymphedema occurred after a surgery and/or radiotherapy clinically confirmed by a dermatologist or a physician trained to lymphology, or primitive lymphoedema clinically confirmed by a dermatologist, whom the unilateral characteristic will be proved by a recent lymphoscintigraphy (less than 2 years)
* For patients with venous insufficiency without leg ulcer: venous insufficiency without ulcer, clinically diagnosed by a dermatologist or a physician trained to angiology
* For patients with venous insufficiency with ulcer: venous insufficiency with ulcer, clinically diagnosed by a dermatologist or a physician trained to angiology
* Healthy group
* Healthy volunteer
* More than 18 years-old
* Without any cutaneous pathology on the studied areas
* No venous insufficiency ; this will be confirmed by a physician trained to stages of venous insufficiency and will be defined by absence of: edema, varicosities, dilated veins, telangiectasia, venous dermatitis, sclerosis, leg ulcer
* Inform consent form signed
* Affiliated to medical insurance
* No allergy to local anaesthetic drugs known
* Matched according to age (± 10 years), gender and weight (± 20 kg) to patients with venous insufficiency
Exclusion Criteria:
* Patients group
* History of aesthetic surgery on studied areas
* Cutaneous abnormalities (including scars) on studied areas, except for signs of lymphedema or venous insufficiency
* Acute or offset chronic pathology which doesn't allow long-timed explorations (according to investigator's assessment)
* Inability to understand information and to sign the consent form (linguistics reasons or neuro-psychological)
* Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy
* Person under guardianship
* Healthy group
* Haemophilia or equivalent pathology
* Cutaneous abnormalities on studied areas (including scars)
* History of aesthetic surgery on studied areas
* Acute or offset chronic pathology which doesn't allow long-timed explorations (according to investigator's assessment)
* Inability to understand information and to sign the consent form (linguistics reasons or neuro-psychological)
* Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without antecedent of hysterectomy
* Person under guardianship
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
|
NCT02061254
|
{
"brief_title": "Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)",
"conditions": [
"Venous Insufficiency",
"Lymphedema"
],
"interventions": [
"Device: Elastography",
"Procedure: Skin biopsy",
"Device: Cutometer",
"Device: High resolution ultrasonography (echography)"
],
"location_countries": [
"France"
],
"nct_id": "NCT02061254",
"official_title": "Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2014-04"
},
"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)": "2015-09-01",
"last_updated_that_met_qc_criteria": "2014-02-10",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-12",
"first_submitted": "2014-02-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is aimed at assessing how Roux-en-Y gastric bypass (RYGP) impacts on energy and nutrients' intake, energy expenditure, and nutritional status in obese patients. It will try quantitate energy and protein balance after RYGP, and to identify how RYGP effects the intake of various common dietary protein sources 16 female patients with BMI \> 40 kg/m2 and on a waiting list for bariatric surgery will be included. The following measurements will be performed before, and 1, 3, 6, 12, and 36 months after RYGP
* body weight
* body composition (bio impedancemetry)
* basal metabolic rate (open circuit indirect calorimetry)
* 24-hour urinary urea excretion
* fasting blood chemistry
* energy and macronutrient's intake (3-day dietary recall)
#Intervention
- PROCEDURE : Roux-en-Y gastric bypass (RYGP)
|
#Eligibility Criteria:
Inclusion Criteria:
* age 18 <= age <= 65 years
* gender: females
* body mass index >35 kg/m2
Exclusion Criteria:
* GI tract diseases
* endocrine diseases
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01891591
|
{
"brief_title": "Assessment of Nutritional Status After Gastric Bypass Surgery",
"conditions": [
"Obesity",
"Nutritional Deficiencies"
],
"interventions": [
"Procedure: Roux-en-Y gastric bypass (RYGP)"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01891591",
"official_title": "Assessment of Nutritional Status and Vitamin Deficiencies in Obese Subjects After Gastric Bypass Surgery",
"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)": "2008-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-07-03",
"last_updated_that_met_qc_criteria": "2013-07-02",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-03",
"first_submitted": "2013-06-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal.
B. The secondary purpose of the study is to determine whether there are any changes in biometry measurements before and after the inlay removal and how the changes affect the calculated IOL power.
Detailed Description
This will be a prospective study in which no more than 20 subjects will be implanted with IC-8 IOL following the removal of the KAMRA inlay. The refractive target of the IC-8 eye will be -0.75 D MRSE.
Subjects will be screened for eligibility and consented before enrolled. Following enrollment, the inlay will be removed, and the eye will be monitored for corneal and refractive stability before the implantation of the IC-8 IOL. Corneal stability is defined as keratometry readings in each meridian within ± 0.50 D, and/or the stability of the corneal topography as determined by the principal investigator, over two consecutive visits at least two weeks apart. Refractive stability is defined as manifest refractive sphere and cylinder measurements that are each within ± 0.50 D over two consecutive visits at least two weeks apart, or based on investigator judgment. When corneal and refractive stability are achieved, the IC-8 IOL will be implanted following cataract extraction by phacoemulsification.
#Intervention
- DEVICE : IC-8 IOL
- The AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics.
|
#Eligibility Criteria:
Inclusion Criteria:
i. Subjects must sign and be given a copy of the informed consent form. ii. Subjects with BCDVA of 20/40 or worse, or significant visual symptoms/complaints as a result of cataract in the study eye.
iii. Subjects must be > 45 years at the time of screening. iv. Subjects must be willing and able to return for scheduled follow up examinations for 12 months after surgery.
v. Subjects who underwent uneventful KAMRA inlay implantation and who currently still have the inlay in the eye.
vi. Potential visual acuity following cataract removal and IOL implantation projected to be 0.8 or better (Snellen 20/25) as determined by diagnostic testing or investigator's medical judgment.
Exclusion Criteria:
i. Patients who had any type of intraocular surgery or refractive surgery (with the exception of KAMRA inlay implantation).
ii. Requiring an intraocular lens outside the available power range of +15.5 to +27.5 diopters.
iii. Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos.
iv. Preoperative corneal astigmatism > 1.5 diopters (as determined by corneal topography or keratometry in either eye) or irregular corneal astigmatism.
v. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.8 or worse during the study.
vi. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, etc.).
vii. Glaucoma suspect, uncontrolled ocular hypertension, or history of glaucomatous changes in the retina or visual field.
viii. Subjects with uncontrolled systemic disease. ix. Subjects with previous retinal pathology in either eye.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03320473
|
{
"brief_title": "IOL Implantation After KAMRA Inlay Removal",
"conditions": [
"Cataract",
"Presbyopia"
],
"interventions": [
"Device: IC-8 IOL"
],
"location_countries": [
"Philippines"
],
"nct_id": "NCT03320473",
"official_title": "A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-20",
"study_completion_date(actual)": "2022-06-20",
"study_start_date(actual)": "2017-12-05"
},
"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)": "2023-05-10",
"last_updated_that_met_qc_criteria": "2017-10-22",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-25",
"first_submitted": "2017-10-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.
The main question(s) it aims to answer are:
\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.
Detailed Description
This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).
#Intervention
- PROCEDURE : Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block
- To prevent postoperative pain, the researchers applied a subcostal transversus abdominis plane block in addition to the posterior transversus abdominis plane block to a group of patients who underwent surgery with a midline incision due to major gynecological cancer.
- PROCEDURE : Patients undergoing rectus sheat block and posterior transversus abdominis plane block
- To prevent postoperative pain, the researchers applied a rectus sheath block in addition to the posterior transversus abdominis plane block to a group of patients who were operated on through a midline incision due to major gynecological cancer.
|
#Eligibility Criteria:
Inclusion Criteria:
* >18 years
* ASA II-III
Exclusion Criteria:
* Those who are allergic to local anesthetics
* BMI> 40 kg/m2
* Those with chronic pain
* Those with a history of previous abdominal surgery
* Patients who refuse the use of postoperative patient-controlled analgesia
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
|
NCT06342076
|
{
"brief_title": "Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery",
"conditions": [
"Postoperative Pain",
"Postoperative Complications",
"Analgesia",
"Regional Anesthesia Morbidity"
],
"interventions": [
"Procedure: Patients undergoing rectus sheat block and posterior transversus abdominis plane block",
"Procedure: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06342076",
"official_title": "Comparison of the Efficacy of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block for Postoperative Analgesia in Major Open Gynaecological Cancer Surgery: a Prospective Randomised Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-01",
"study_completion_date(actual)": "2024-03-01",
"study_start_date(actual)": "2024-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-11",
"last_updated_that_met_qc_criteria": "2024-03-28",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-02",
"first_submitted": "2024-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.
#Intervention
- DRUG : neratinib
- HKI-272
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy
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
|
NCT00366600
|
{
"brief_title": "Study Evaluating HKI-272 Administered to Healthy Subjects",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00366600",
"official_title": "Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Healthy Subjects.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-09-11",
"last_updated_that_met_qc_criteria": "2006-08-18",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-21",
"first_submitted": "2006-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The rate of venous thromboembolic events in trauma patients at high risk for deep vein thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours will be equivalent or less than a similar group of patients given a standard every 12 hour dose of low molecular weight heparin.
Detailed Description
Venous thromboembolism (VTE) is a common and potentially life threatening complication of major trauma. The risk of developing deep vein thrombosis (DVT) following major trauma exceeds 50% unless adequate chemoprophylaxis is used. Recent national quality improvement initiatives, such as the Surgical Care Improvement Project (SCIP), mandate the risk stratification of hospitalized patients and the use of VTE prophylaxis based on the risk assessment. Low Molecular Weight Heparin (LMWH, enoxaparin) and Low Dose Unfractionated Heparin (LDUH) are commonly used alternatives for VTE chemoprophylaxis following major trauma. LMWH became favored in most trauma centers following a prospective randomized controlled trial comparing the two agents that demonstrated superior efficacy and equivalent safety of LMWH over a twice per day dosing of LDUH. The results of this study were largely responsible for practice guideline recommendation changes favoring the use of LMWH in trauma patients by both the American College of Chest Physicians (ACCP) and the Eastern Association for the Surgery of Trauma (EAST). , This landmark paper did not, however, utilize a three times a day (every 8 hours) dosing of LDUH for prophylaxis, which is the dosing schedule recommended by earlier trials. LDUH administered every 8 hours was demonstrated to have similar efficacy to LMWH in trauma patients in a recent retrospective study. These results call into question the validity of the conclusions of the 1996 study. Because LDUH is less expensive ($0.50/dose) than LMWH (Enoxaparin, $28/dose), similar effectiveness would imply a significant reduction in the cost of prophylaxis and increased value to patients, providers and accountable care organizations and tax-payers.
To validate this hypothesis the investigators propose to achieve the following study objectives:
1. Assess the degree of risk for VTE in each patient admitted to the trauma service
2. Determine the rate of VTE events in high risk trauma patients receiving either:
* LMWH (30mg enoxaparin) given every twelve hours
* LDUH (5000 Units unfractionated Heparin) given every eight hours.
3. Identify and quantify any adverse events associated with either treatment arm.
4. Compare the value of LMWH versus LDUH in the prophylactic treatment of VTE disease in trauma patients.
#Intervention
- DRUG : 5000 Units unfractionated Heparin Q 8 hr
- Venous thromboembolic prophylaxis medication
- Other Names :
- LDUH
- DRUG : 30mg enoxaparin Q12 hr
- Venous thromboembolic prophylaxis
- Other Names :
- Lovenox, LMWH, enoxaparin
|
#Eligibility Criteria:
Inclusion Criteria:
* Admitted to Scripps Mercy Trauma Service
* >=18 Years old
* Stratified to either Significant or Highest risk of VTE by ACCP guidelines
Exclusion Criteria:
* Estimated Injury Severity Score (ISS) <=9
* Likely to be discharged before hospital day 7
* Systemic coagulopathy defined with an International Normalized Ratio (INR) of >=1.2
* Body Mass Index (BMI) >40
* Likely to Survive for <7 Days
* Pregnancy
* Evidence of renal insufficiency (Cr >=1.3)
* Delayed transfer to this facility (>24 hrs)
* Prisoners
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
|
NCT01729559
|
{
"brief_title": "Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin",
"conditions": [
"Venous Thromboembolic Disease",
"Deep Vein Thrombosis",
"Pulmonary Embolism"
],
"interventions": [
"Drug: 30mg enoxaparin Q12 hr",
"Drug: 5000 Units unfractionated Heparin Q 8 hr"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01729559",
"official_title": "Venous Thromboembolic Prophylaxis After Major Trauma: A Randomized Controlled Trial of Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2012-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-07-18",
"last_updated_that_met_qc_criteria": "2012-11-19",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-20",
"first_submitted": "2012-11-14",
"first_submitted_that_met_qc_criteria": "2016-06-07"
}
}
}
|
#Study Description
Brief Summary
This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information and condom use and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.
Detailed Description
This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information, condom use, and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.
The intervention involves targeted and tailored bio-psycho-educational interventions directed at organizational behavior change and social influence modeling through training peers and managers. The intervention site will receive peer and manager trainings consisting of specific information on STIs along with standard care, held on a day convenient to the participants and at the establishment or neutral location.
In addition to quick pre-post tests before and immediately after the intervention, participants will be interviewed 6-12 months after the intervention to evaluate the effects of the intervention on their STI/HIV knowledge, attitudes, beliefs, safer sex practices, and social support.
#Intervention
- BEHAVIORAL : HIV/STI intervention
- The intervention covers HIV101 information, reproductive health and human rights national policies, goal setting activities as individuals and as a group, results of prior research on ethics of doing research with sex workers.
|
#Eligibility Criteria:
Inclusion Criteria:
* self-identification as conducting sex work or working in a venue where sex work occurs.
Exclusion Criteria:
* those not actively engaging in sex work activities or working in a venue or area where sex work occurs.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02071264
|
{
"brief_title": "Effects of an HIV Intervention Among Sex Workers in the Philippines",
"conditions": [
"HIV/AIDS Prevention"
],
"interventions": [
"Behavioral: HIV/STI intervention"
],
"location_countries": [
"Philippines"
],
"nct_id": "NCT02071264",
"official_title": "Effects of an HIV Intervention Among Female and Male Entertainers and Spa/Sauna Workers in the Philippines",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2013-08"
},
"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)": "2021-04-27",
"last_updated_that_met_qc_criteria": "2014-02-24",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-25",
"first_submitted": "2014-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Inflammatory bowel disease (IBD) is a term that defines a chronic disease characterized by inflammation of the intestine. It includes ulcerative colitis (UC) and Crohn's disease (CD). The objective of the study was to administer a treatment based on a group adaptation of the BMGIM in patients with inflammatory bowel disease (IBD) and assess its impact on state of mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and levels of acute and chronic stress.
To achieve the objectives a quasi-experimental, quantitative, qualitative, analytical, and prospective study was performed. 41 patients with IBD divided into a test group (24 patients), who received 8 sessions over 8 weeks, and a control group (17 patients). A saliva sample was taken from each patient before and after each session to determine cortisol levels (acute stress) and IgA (immunocompetence) using ELISA. A series of questionnaires were completed as follows: HADS (perceived anxiety), MOOD (state of mind), and CCVEII (quality of life). Similarly, a hair sample was taken before the first and after the last session to determine the cumulative cortisol level (chronic stress) using ELISA.
#Intervention
- OTHER : BMGIM Music Therapy Method
- The BMGIM method is today one of the models recognized by the international music therapy community, deserving this distinction those approaches that develop a solid theoretical and practical body, with specific training programs as training for new therapists, and that also promote the scientific research as a way to develop the method and Music Therapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Over 18 years,
* Diagnosed IBD (EC or UC) in the remission phase,
* They did not receive treatment with corticosteroids at least in the two months prior to the start of the study,
* They did not receive any extra pharmacological treatment,
* Attend the collaborating hospital center with the study, in this case, the University General Hospital of Valencia,
* Attend the schedule and schedule established for the study,
* Accept the conditions of participation in the study indicated in the signed informed consent prior to the start of the study
* * Do not take corticosteroids during the 8 weeks between the pre-test and the post-test,
* * Perform the pre-test before starting session 1 (in case of experimental group) or appointment 1 (in case of control group); and then the retest at the end of session 8 (in the case of an experimental group) or appointment with nursing after 8 weeks (in the case of a control group).
* * In the case of the patients belonging to the experimental group, who at the end of the 8 weeks of treatment would have attended at least 6 of the 8 sessions established (and that, obligatorily, 2 of them were 1 and 8, where the shots were taken) sample and completed the questionnaires).
Exclusion Criteria:
The patients who were excluded from this study were those who did not meet the requirements indicated in the inclusion criteria, or who showed aversion or rejection to this type of therapy.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03999294
|
{
"brief_title": "Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease",
"conditions": [
"Bowel Diseases, Inflammatory",
"Crohn Disease",
"Colitis, Ulcerative"
],
"interventions": [
"Other: BMGIM Music Therapy Method"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03999294",
"official_title": "The Influence of the Bmgim Music Therapy Method in the Reduction of Stress in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis): Quantitative and Qualitative Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-30",
"study_completion_date(actual)": "2017-01-31",
"study_start_date(actual)": "2015-04-01"
},
"study_design": {
"allocation": "NON_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)": "2019-06-26",
"last_updated_that_met_qc_criteria": "2019-06-25",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-26",
"first_submitted": "2019-06-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.
Detailed Description
This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.
The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
#Intervention
- DRUG : Sodium risedronate
- Sodium risedronate tablets
- Other Names :
- Benet 17.5mg Tablets, Actonel 17.5mg Tablets
|
#Eligibility Criteria:
Inclusion Criteria:
* Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02106455
|
{
"brief_title": "Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -",
"conditions": [
"Osseous Paget's Disease"
],
"interventions": [
"Drug: Sodium risedronate"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT02106455",
"official_title": "Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-24",
"study_completion_date(actual)": "2017-10-24",
"study_start_date(actual)": "2008-08-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-03",
"last_updated_that_met_qc_criteria": "2014-04-07",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-08",
"first_submitted": "2014-04-03",
"first_submitted_that_met_qc_criteria": "2019-02-15"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
Detailed Description
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
#Intervention
- DEVICE : Active Breathing Coordinator (ABC)
- The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
- Other Names :
- ABC
- RADIATION : Radiation Therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
* Adequate pulmonary function
* Presence of 5 cc of the heart or liver with the simulation fields
* Karnofsky Performance Status (KPS) equal to or greater than 70
Exclusion Criteria:
* Pregnant women
* Patients who have had previous ipsilateral breast or thoracic radiation therapy
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
|
NCT00328783
|
{
"brief_title": "Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Device: Active Breathing Coordinator (ABC)",
"Radiation: Radiation Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00328783",
"official_title": "A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07",
"study_completion_date(actual)": "2011-07",
"study_start_date(actual)": "2002-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-11",
"last_updated_that_met_qc_criteria": "2006-05-19",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-22",
"first_submitted": "2006-05-19",
"first_submitted_that_met_qc_criteria": "2014-03-28"
}
}
}
|
#Study Description
Brief Summary
In the present study, the role of chronic (10 weeks) intake of low dose (2g/day) of EPA+DHA in whole body protein metabolism, and functional performance and systemic inflammation will be examined, and whether adding either HMB at 3.0 g/d to the low dose of EPA+DHA (2.0 g/d) will enhance these effects even more.
Detailed Description
Weight loss commonly occurs in patients with Chronic Obstructive Pulmonary Disease (COPD), negatively influencing their quality of life, treatment response and survival. Furthermore, limb muscle dysfunction (weakness and/or enhanced fatigue) is a major systemic comorbidity in patients with Chronic Obstructive Pulmonary Disease (COPD), negatively affecting their exercise performance, physical activity, quality of life, and mortality. As nutritional abnormalities are main contributors to muscle loss and dysfunction in COPD, nutritional support is viewed as an essential component of integrated care in these patients.
Although nutritional support is effective in the treatment of weight loss in COPD, attempts to increase muscle mass and function in COPD by supplying large amounts of protein or calories to these patients have been small. This suggests that gains in muscle mass and function are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators and other researchers found that low muscle mass in COPD was strongly associated with elevated whole body protein turnover and increased myofibrillar protein breakdown rates indicative of muscle contractile protein loss. The investigators have extended this finding recently to normal weight COPD patients characterized by muscle weakness using a more precise and accurate pulse method of tau-methylhistidine tracer.
A substantial number of COPD patients, underweight as well as normal weight to obese, are characterized by an increased inflammatory response as evidenced by elevated levels of the pro-inflammatory cytokines (Tumor Necrosis Factor (TNF)-α, Interleukin (IL) 6 and 8, and the soluble TNF-α receptors (55 and 75). Furthermore, CRP levels are elevated in COPD and associated with reduced quadriceps strength, lower maximal and submaximal exercise capacity and increased morbidity.
One of the few agents capable to suppress the generation of pro-inflammatory cytokines are eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), primary ω-3 fatty acids found in fish oils.
Previous experimental research and clinical studies in cachectic conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA), in combination with docosahexaenoic acid (DHA), has been shown to effectively inhibit weight loss in several disease states, however weight weight and muscle mass and function increase was not present or minimal. Also in healthy older adults, fish oil can slow the decline in muscle mass and function. A randomized clinical trial in COPD patients showed that extra nutritional supplementation with PUFAs daily of 1000 mg EPA+DHA as adjunct to exercise training during 8 weeks enhanced exercise capacity but did not lead to muscle mass gain. The patients who did not respond adequately (\< 2% gain in weight), had a higher TNF-α level than those who did gain sufficient weight, which is in line with previous data in COPD showing an association between an increased systemic inflammation with non-response to nutritional therapy.
Although previous studies support the concept of EPA+DHA supplementation to ameliorate the systemic inflammatory response and decrease protein breakdown, there is no information present on the effects of EPA+DHA supplementation on whole body and muscle protein metabolism in COPD. The investigators have recently examined the dose-response effects of 0, 2 and 3.5 g of EPA+DHA intervention ( EPA / DHA) for 4 weeks in stable moderate to severe COPD patients (8pts /group) (unpublished data) but were not able to find a positive effect of muscle mass and strength, even with the highest dose, likely related to the relatively short (4 week) supplementation period. The effect of EPA+DHA intervention on whole body and muscle protein synthesis and breakdown rates is currently being analysed.
Although numerous animal studies have shown the benefit of HMB in downregulating muscle protein breakdown under catabolic conditions, there is very little data in COPD patients. Others have tested HMB (3g/d) in COPD patients in the ICU and reported anti-inflammatory benefits and improvement in pulmonary function. In patients with bronchiectasis, 24 week supplementation with an ONS containing HMB (1.5g/d) versus standard of care during pulmonary rehabilitation program, resulted in benefits on body composition, muscle strength and QoL. A combination of HMB and EPA/DHA in a mouse model of cancer cachexia showed a synergy between the two ingredients on preventing muscle loss and downregulation of muscle protein degradation.
#Intervention
- DIETARY_SUPPLEMENT : Capsule + Powder supplementation
- For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm).
- OTHER : stable tracer infusion
- labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day
|
#Eligibility Criteria:
Inclusion criteria
* Ability to walk, sit down and stand up independently
* Ability to lie in supine or slightly elevated position for 8.5 hours
* Age 45 - 100
* Clinical diagnosis of COPD, including moderate to very severe chronic airflow limitation, and an FEV1 < 70% of reference FEV1 (GOLD II-III). If subjects are on β2 agonists, only those subjects with <10% improvement in FEV1 will be included.
* Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
* Shortness of breath on exertion
* Willingness and ability to comply with the protocol, including:
* Refraining from intense physical activities (72h) prior to each study visit
* Adhering to fasting state and no smoking from 10 pm ± 2h onwards the day prior to each study visit
Exclusion Criteria
* Participants 86 and older that fail to get physician approval
* Established diagnosis of malignancy
* Established diagnosis of Insulin Dependent Diabetes Mellitus
* History of untreated metabolic diseases including hepatic or renal disorder
* Presence of acute illness or metabolically unstable chronic illness
* Recent myocardial infarction (less than 1 year)
* Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
* BMI >= 45 kg/m2
* Dietary or lifestyle characteristics:
* Daily use of supplements containing EPA+DHA or HMB prior to the first test day
* Use of protein or amino acid containing nutritional supplements within 5 days of first test day
* Indications related to interaction with study products. Known hypersensitivity to fish and/or shellfish and/or soy
* Use of long-term oral corticosteroids or short course of oral corticosteroids 4 weeks preceding first test day
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03796455
|
{
"brief_title": "Fish Oil and HMB Supplementation in COPD",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Dietary Supplement: Capsule + Powder supplementation",
"Other: stable tracer infusion"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03796455",
"official_title": "Effects of Low Dose of Fish Oil (EPA+DHA) vs. Combined EPA+DHA and HMB Supplementation on Protein Metabolism, Muscle Mass and Functional Capacity in Moderate to Severe COPD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-01",
"study_completion_date(actual)": "2020-04-01",
"study_start_date(actual)": "2018-04-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-07",
"last_updated_that_met_qc_criteria": "2019-01-07",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-08",
"first_submitted": "2018-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the FLUID Trial is to conduct a pragmatic, multi-centre, open label randomized cluster cross-over trial (RCT) to determine whether fluid administration with 0.9% saline as compared to Ringer's lactate decreases death or re-admission to hospital with 90 days of the index admission.
Detailed Description
Crystalloid fluids are used extensively for acutely ill patients who are admitted to hospital. Two fluids most commonly used are 0.9% saline and Ringer's Lactate. Both are used to rehydrate patients, restore fluid volume and help stabilize blood pressure and failing organ and both have been used for several decades. Until recently, it was thought the fluids are essentially equivalent other than some minor differences related to the concentration of salt components (sodium and chloride) and buffers (Ringer's Lactate has lactate as a buffer). The safety of 0.9% saline is now being questioned due to its high chloride content and its association with the development of hyperchloremic metabolic acidosis. Until recently, the evidence base supporting the superiority of Ringer's Lactate has been derived from observational studies. Two recent pilot studies in critically ill patients comparing 0.9% saline to balanced crystalloid fluids (Ringer's lactate and/or Plasma-Lyte, another balanced crystalloid) did not detect clinical outcome differences between the fluid groups, but the trials were not powered to do so. Furthermore, two multiple period cluster cross-over studies conducted at one institution comparing 0.9% saline to balanced crystalloids (Ringer's lactate and Plasma-Lyte) in the emergency department (ED) and intensive care unit (ICU) found small differences in a composite outcome which included death, requirement for dialysis or persistent renal dysfunction, in favor of balanced crystalloids. In contrast, two large multi-centre randomized trials (BaSICS, n=11 052 and PLUS, n=5037) examined the efficacy of NS as compared with a balanced crystalloid (RL and Plasma-Lyte 148, respectively) on the primary outcome 90-day mortality. Neither of these trials detected a difference in 90-day mortality; in BaSICS, the mortality rate was 22.0% versus 21.8%; in PLUS, mortality was 27.2% versus 26.4%. Renal function did not differ between the fluid groups in either trial, although the PLUS trial was stopped early due to recruitment challenges and insufficient funding during the pandemic. In a systematic review of 13 critical care trials to January 2022 and 35 884 participants, there were no detectable differences in renal function. In low risk of bias trials, there was no significant difference in mortality for the 0.9% saline as compared with balanced crystalloid group (28.2% and 27.9%, respectively; relative risk (RR) 0.96 (95% CI 0.91 to 1.01)), nor renal function. However, authors concluded that there is a high probability balanced crystalloids reduce death since the CIs ranged from a 9% relative reduction to a 1% relative increase in death. Authors and editorialists urge the conduct of large multi-centre randomized trials, with longer-term patient centred outcomes supported by health economic evaluations to provide confirmatory evidence to guide future clinical practice and resource allocation related to these usual care crystalloid fluids.
Small differences in clinical outcomes between crystalloid resuscitation fluids are highly relevant. Furthermore, small absolute differences in important clinical outcomes may translate into substantial savings to hospitals and the health care system. The FLUID trial will determine if there are differences in the clinically important outcomes of death and hospital re-admissions. FLUID is novel in its design because it is a hospital wide pragmatic cluster cross-over comparative effectiveness trial that will be conducted in both academic and community sites which will use provincial health administrative data available through the Institute of Clinical Evaluative Sciences (ICES) for all clinical data collection. Our trial will answer this fundamental fluid resuscitation question and determine if Ringer's Lactate is superior to 0.9% saline at much lower cost in comparison to an individual patient randomized controlled trial (RCT), or even a conventional cluster RCT.
#Intervention
- DRUG : Ringer's lactate
- Half of the hospitals will be randomized to Ringer's Lactate for a 12 week study period; after a 2 week run-out, the study fluid will be switched to 0.9% saline for another 12 week study period, followed by a 2 week run-out.
- Other Names :
- Lactated Ringer's
- DRUG : 0.9% saline
- Half of the hospitals will be randomized to 0.9% saline for a 12 week study period; after a 2 week run-out, the study fluid will be switched to Ringer's Lactate for another 12 week study period, followed by a 2 week run-out.
- Other Names :
- sodium chloride 0.9%
|
#Eligibility Criteria:
Inclusion Criteria:
● All adult and pediatric patients with an index admission to the participating hospitals during study periods
Exclusion Criteria:
* neonates
* physicians may opt out of the use of the allocated study fluid for a specific patient
Sex :
ALL
Ages :
- Minimum Age : 29 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04512950
|
{
"brief_title": "Crystalloid FLUID Choices for Resuscitation of Hospitalized Patients",
"conditions": [
"Fluid Therapy"
],
"interventions": [
"Drug: 0.9% saline",
"Drug: Ringer's lactate"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04512950",
"official_title": "Crystalloid FLUID Choices for Resuscitation of Hospital Patients: A Pragmatic Cluster Cross Over Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-13",
"study_completion_date(actual)": "2020-06-13",
"study_start_date(actual)": "2016-08-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-23",
"last_updated_that_met_qc_criteria": "2020-08-11",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-14",
"first_submitted": "2019-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.
This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.
#Intervention
- BIOLOGICAL : Influenza vaccine GSK2186877A formulation 1
- Intramuscular administration, 2 doses
- BIOLOGICAL : Influenza vaccine GSK2186877A formulation 2
- Intramuscular administration, 1 dose
- BIOLOGICAL : Fluarix
- Intramuscular administration, 1 dose
|
#Eligibility Criteria:
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
* Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
* Child in care
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Prior receipt of any influenza vaccination (seasonal or pandemic) or planned administration during the study period.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone >0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to consumption of egg proteins.
* History of any neurological disorders or seizures (including febrile convulsion).
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
* Acute disease and/or fever at the time of enrolment:
* Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >=38.0°C on rectal setting.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever might be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
* Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 35 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01096056
|
{
"brief_title": "Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Fluarix",
"Biological: Influenza vaccine GSK2186877A formulation 2",
"Biological: Influenza vaccine GSK2186877A formulation 1"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01096056",
"official_title": "Safety and Immunogenicity of GSK2186877A Candidate Seasonal Influenza Vaccine in Healthy Children 6 to 35 Months of Age.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12-13",
"study_completion_date(actual)": "2010-12-13",
"study_start_date(actual)": "2010-04-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-24",
"last_updated_that_met_qc_criteria": "2010-03-29",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-30",
"first_submitted": "2010-03-29",
"first_submitted_that_met_qc_criteria": "2012-04-12"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate different types of exercise programs (virtual group-based exercise program; personal exercise program; wait-list control) across 12-weeks on the physical and mental health of older adults during the current Covid-19 pandemic.
#Intervention
- BEHAVIORAL : Virtual Group Intervention
- Participants will receive weekly exercise courses delivered virtually to a group of older adults. This intervention will last for 12 weeks. Participants in addition to participating in exercise will have designated time after each exercise class to socially connect. Participants in this condition will also receive a t-shirt.
- BEHAVIORAL : Personal Exercise Intervention
- Participants will receive weekly exercise courses delivered virtually. These classes will be pre-recorded so the individual can complete sessions at any time that is convenient for them.
|
#Eligibility Criteria:
Inclusion Criteria:
* 65+ years old
* be able to speak and read English
* one participant in the study per household (Spouses, significant others, or family members can take part in the exercise programs with the study participant; however, they will not be able to provide data and won't be remunerated for participating)
* not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
* participants must be able to access the internet at home via a personal smartphone, tablet (e.g., ipad), or computer (device used must have camera capabilities)
* low active individuals (i.e., less than 150 minutes of moderate-to-vigorous physical activity per week)
* currently living in Canada
Exclusion Criteria:
* age of less than 65 years
* unable to read and speak in English
* inability to participate in moderate-to-vigorous physical activity (including a lack of ability to receive doctor's clearance for participating in physical activity)
* lack of internet access which does not allow them to access online materials
* device used to access the internet does not have a camera/video capabilities
* active individuals (e.g., participate in greater than 150 minutes of moderate-to-vigorous physical activity each week)
* living outside Canada
* not the first person from a household to enroll in the study
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04412343
|
{
"brief_title": "The Seniors COvid-19 Pandemic and Exercise Study",
"conditions": [
"Well-Being (Psychological Flourishing)",
"Depression",
"Quality of Life",
"Loneliness",
"Physical Activity",
"Social Identification",
"Physical Health"
],
"interventions": [
"Behavioral: Virtual Group Intervention",
"Behavioral: Personal Exercise Intervention"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04412343",
"official_title": "The Seniors COvid-19 Pandemic and Exercise Study: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-05",
"study_completion_date(actual)": "2020-10-05",
"study_start_date(actual)": "2020-05-23"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-03",
"last_updated_that_met_qc_criteria": "2020-05-29",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-02",
"first_submitted": "2020-05-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This will be a randomized single sequence open label study. This study is designed to determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and the total duration of study participation for each subject will be approximately 8 weeks. During the treatment period, subjects will be admitted to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min), followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days 3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus a 600 mg dose of EFZ.
#Intervention
- DRUG : Retosiban
- Retosiban will be supplied as clear colorless solution for infusion (300 mg in 20 mL via). Subject will receive loading dose of 6 mg over 5 min infusion followed by 6 mg/hour infusion for 12 hrs on Day 1 and Day 18.
- DRUG : EFZ 600 mg
- EZF 600 mg will be supplied as a yellow, capsular-shaped, film-coated tablet. Subjects will receive EFZ 600mg OD in the evening from Day 3 till Day 18.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male/females aged between 18 and 45 years inclusive, at the time of signing the informed consent.
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GlaxoSmithKline (GSK) Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Body weight >=50 kilogram (kg) and body mass index within the range 19 <= age <= 29.9 kg/m^2.
* A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotrophin (hCG) test at screening or prior to dosing; AND Agrees to use the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit; OR has only same-sex partners, when this is her preferred and usual lifestyle.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
* Based on averaged corrected QT interval (QTc) values of triplicate electrocardiograms obtained over a brief recording period: QTc < 450 milliseconds (msec); or QTc < 480 msec in subjects with Bundle Branch Block.
Exclusion Criteria:
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* History of regular alcohol consumption within 6 months of the study defined as: For United States (US) sites: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
* Subjects with a history of seizures will be excluded from this trial.
* Subjects with a history of severe or serious psychiatric disease requiring hospitalization, history of social ideation or attempt, or on ongoing psychiatric treatment will be excluded from this study.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* A positive pre-study drug/alcohol screen.
* A positive test for Human Immunodeficiency Virus (HIV) antibody.
* Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Lactating females.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01867996
|
{
"brief_title": "A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)",
"conditions": [
"Obstetric Labour, Premature"
],
"interventions": [
"Drug: EFZ 600 mg",
"Drug: Retosiban"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01867996",
"official_title": "To Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) Co-administered With EFAVIRENZ",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09-26",
"study_completion_date(actual)": "2013-09-26",
"study_start_date(actual)": "2013-06-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-11",
"last_updated_that_met_qc_criteria": "2013-05-30",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-04",
"first_submitted": "2013-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in routine use in intensive care unit. However, jet nebulizers remain the most frequently used nebulizers.
On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased using a vibrating-mesh nebulizer as compared to a jet nebulizer.
Lung distribution of nebulized particles delivered through a HFNC has never been investigated in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers through a HFNC by SPECT-CT.
#Intervention
- DRUG : Technetium-99m - Diethylenetriaminepentaacetic acid
- 99mTc-DTPA solution placed on the nebulizer reservoir
- DEVICE : Aeroneb Solo
- DEVICE : Jet Nebulizer
- OTHER : Single photon emission computed tomography
- Imaging technique to investigate lung aerosol distribution
- OTHER : Spirometry
- FEV1, FVC assessment
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy respiratory function
Exclusion Criteria:
* Pulmonary disease
Sex :
MALE
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
|
NCT02429817
|
{
"brief_title": "Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula",
"conditions": [
"Healthy"
],
"interventions": [
"Other: Single photon emission computed tomography",
"Drug: Technetium-99m - Diethylenetriaminepentaacetic acid",
"Other: Spirometry",
"Device: Aeroneb Solo",
"Device: Jet Nebulizer"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02429817",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2015-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-05",
"last_updated_that_met_qc_criteria": "2015-04-24",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-29",
"first_submitted": "2015-04-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa
#Intervention
- DRUG : Levodopa/carbidopa/entacapone
- Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
- DRUG : Levodopa/carbidopa
- Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female patients ages >= 30 and <= 80 years.
* A clinical diagnosis of idiopathic Parkinson's disease.
* Taking a stable dose of levodopa/carbidopa (>= 300 and <= 600mg) for a period of at least 1 month prior to study entry.
* Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.
* 1 full tablet, and/or
* 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
* Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
* Must have a minimum UPDRS part II (ADL) score of 9.
* Patients without dyskinesia or with mild dyskinesia.
* Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
* Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.
Exclusion Criteria:
* Previous or current use of entacapone.
* History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
* Unstable Parkinson's disease patients.
* Patients who experience severe dyskinesia.
* The following levodopa/carbidopa doses and strengths are not permitted:
* Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
* Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
* Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
* Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
* Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
* Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
* Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
* Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
* Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00391898
|
{
"brief_title": "Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off",
"conditions": [
"Parkinson's Disease"
],
"interventions": [
"Drug: Levodopa/carbidopa",
"Drug: Levodopa/carbidopa/entacapone"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT00391898",
"official_title": "A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06",
"study_completion_date(actual)": "2008-06",
"study_start_date(actual)": "2006-10"
},
"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)": "2011-03-15",
"last_updated_that_met_qc_criteria": "2006-10-24",
"last_verified": "2011-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-25",
"first_submitted": "2006-10-24",
"first_submitted_that_met_qc_criteria": "2011-02-16"
}
}
}
|
#Study Description
Brief Summary
This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
Detailed Description
There is a need for a non-scheduled stimulant medication that can provide symptom control for children with ADHD as the conventional stimulant products do.
Currently, the top line amphetamine product Adderall XR (R) for the treatment of children with ADHD involves a once-a-day morning dosing of up to 30 mg per day per Adderall XR (R) Package Insert. New River Pharmaceuticals has developed three NRP104 dose strengths of 30 mg, 50 mg, and 70 mg to provide amphetamine base equivalent to Adderall XR (R) 10 mg, 20 mg, and 30 mg, respectively. Adderall XR (R) and other amphetamine and methylphenidate containing preparations are liable to intravenous abuse.
As part of the development of NRP104 for treatment of children with ADHD, it is important to evaluate the abuse potential of NRP104 given intravenously in comparison to immediate release d-amphetamine. This study will conduct relevant information to address appropriately the objectives of determining abuse potential of intravenously administered NRP104.
#Intervention
- DRUG : NRP104
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subject is 18 <= age <= 55 of age, inclusive.
* Except for women who are post menopausal or surgically sterile, all female subjects must have a negative urine pregnancy test at screening and at admission to the research unit. They must abstain from sexual activity, or use acceptable contraceptives throughout the study, and for 30 days after the last dose of study drug. Acceptable contraceptives include double barrier method (such as condom with spermicidal gel or diaphragm with spermicidal gel), IUDs and hormonal contraceptives which must be pharmacologically effective prior to study drug exposure.
* Meet DSM-IV criteria for the diagnosis of substance abuse.
* Have a history of IV drug use.
* Subject must be in good health and have venous access sufficient for (1) IV drug administration and (2) blood collection, as determined by medical history, physical exam, and clinical labs.
* Agree to be admitted to the inpatient research unit for a minimum of 8 days, and be able to complete all protocol-specified assessments.
* Able to understand that they can withdraw from the study at any time.
* Minimum reading level of Grade Six as determined by the REALM test, at the investigator's discretion.
* Subject must voluntarily consent to participate in this study.
Exclusion Criteria:
* History of clinically significant gastrointestinal, renal, hepatic, endocrine, oncologic, hematologic, neurologic, psychologic, immunologic or pulmonary disorders; or cardiovascular disease, tuberculosis, epilepsy, diabetes, psychosis, glaucoma, or any condition which in the opinion of the Investigator would jeopardize the safety of the subject or impact study results or prevent the subject from completing the study.
* Presence or history of any medically diagnosed, clinically significant Axis I psychiatric disorders other than substance abuse (including bipolar disorder, any psychotic disorder, and Tourette's disorder or family history of Tourette's).
* Serious suicidal risk determined by the investigator.
* Presence of a severe learning difficulty or mental retardation, or any condition that would interfere with participation or completion of the study.
* History of allergic or adverse response or hypersensitivity to d-amphetamine or NRP104.
* Participation in a previous clinical trial within 30 days prior to study initiation.
* Blood loss, donation of one pint or more, or plasma donation within 60 days prior to study initiation.
* Clinically significant abnormalities at screening or admission on results of ECG or lab tests, including lab deviations requiring acute medical intervention or further medical attention.
* Treated with a monoamine oxidase inhibitor, currently or within 13 days of initiation of the study medication.
* Require any of the following medications: clonidine or other alpha-2 adrenergic receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) theophylline, coumarin anticoagulants, or anticonvulsants; or have taken an SSRI in the 35 days before initiation of the study medication.
* Currently physically dependent on benzodiazepines as determined by clinical evaluation and/or urine drug screen at screening.
* Currently physically dependent on opiates as determined by naloxone challenge.
* Currently physically dependent on alcohol as determined by clinical evaluation or has a positive Breathalyzer test at screening or admission and confirmed by a second reading.
* Preexisting severe gastrointestinal narrowing.
* Use of any prescription medications (except birth control methods) within 14 days of admission, or will require any prescription medications, or any over-the-counter (OTC) medications (other than acetaminophen), or herbal supplements or vitamins during the study.
* Positive urine pregnancy test at screening or admission.
* Female subject is pregnant or lactating.
* Another member of the subject's household currently participating in the study.
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
|
NCT00247572
|
{
"brief_title": "Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories",
"conditions": [
"Attention Deficit Disorder With Hyperactivity",
"Amphetamine-Related Disorders",
"Substance-Related Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00247572",
"official_title": "A Double-Blind Placebo- and Active-Controlled, Single-Dose Crossover PD and PK Study to Evaluate the Safety, Tolerability and Abuse Liability of IV Administered NRP104 25 mg and 50 mg in Adult Volunteers With Histories of Stimulant Abuse",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-11",
"study_start_date(actual)": "2005-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-11-04",
"last_updated_that_met_qc_criteria": "2005-10-31",
"last_verified": "2007-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-11-02",
"first_submitted": "2005-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Effect of training of patients with dysphagia
Detailed Description
A randomised controlled study in the effect of training in patients with dysphagia.
The patients are randomised for training or for usual care.
#Intervention
- OTHER : Chin Tuck Against Resistance
- Training in 6 weeks 3 times a day.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with dysphaigia
* Patients living in the participating locations
Exclusion Criteria:
* Patients who are linguistically or cognitively unable to participate
* Patients who are unable to collaborate about the training
* Palliative patients
* Patients with a probe
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
|
NCT04402307
|
{
"brief_title": "Effect of Training of Patients With Dysphagia",
"conditions": [
"Dysphagia"
],
"interventions": [
"Other: Chin Tuck Against Resistance"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT04402307",
"official_title": "Effect of Training of Patients With Dysphagia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-31",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2019-03-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-13",
"last_updated_that_met_qc_criteria": "2020-05-22",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-26",
"first_submitted": "2019-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This subject is mainly to study difference of Congenital cataract preoperative related parameters in children with or without Microcornea within Less than one year old. A total of 186 eyes of 117 people were collected with relevant ocular biological parameters, including age, horizontal diameter of the cornea, Eye axis, intraocular pressure, steep axis of corneal curvature, flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth. At present, because the definition of patients with small cornea is not clear enough, the study subjects are divided into 4 groups according to the horizontal corneal diameter of 9.0mm, 9.5mm, and 10.0mm, namely ≤9.0mm group, 9\~9.5mm group, 9.5\~10.0mm group and The \>10.0mm group compares the differences between each other, and tries to provide a reference for the diagnosis of children with small cornea at a young age.
#Intervention
- DEVICE : Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth
- observation
|
#Eligibility Criteria:
Inclusion Criteria:
* Congenital cataract children with or without Microcornea within Less than one year old
* Complete collection of eye biological parameters before the first-stage Congenital cataract surgery
* The nutritional status and development of the included subjects have no obvious defects
Exclusion Criteria:
* congenital persistent pupilary membrane
* lens sublaxation or lens dislocotion
* Marfan syndrome
* Down's Syndrome
* Peters abnormality
* Fevr
* history of obvious eye trauma
* obvious macula
* long-term (local or systemic) use of glucocorticoids.
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 12 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04852341
|
{
"brief_title": "Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old",
"conditions": [
"Microcornea Within One Year of Age"
],
"interventions": [
"Device: Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth"
],
"location_countries": [
"China"
],
"nct_id": "NCT04852341",
"official_title": "Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-01",
"study_completion_date(actual)": "2021-01-01",
"study_start_date(actual)": "2015-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-21",
"last_updated_that_met_qc_criteria": "2021-04-15",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-21",
"first_submitted": "2021-04-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors
Detailed Description
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.
This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.
#Intervention
- BIOLOGICAL : CAB-ROR2-ADC
- Conditionally active biologic anti-ROR2 antibody drug conjugate
- Other Names :
- BA3021
- BIOLOGICAL : PD-1 inhibitor
- PD-1 inhibitor
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
* Patients must have measurable disease.
* For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
* Age >= 18 years.
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least three months.
Exclusion Criteria:
* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of >= Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3021 administration.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03504488
|
{
"brief_title": "CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)",
"conditions": [
"Non Small Cell Lung Cancer",
"Triple Negative Breast Cancer",
"Melanoma",
"Head and Neck Cancer"
],
"interventions": [
"Biological: CAB-ROR2-ADC",
"Biological: PD-1 inhibitor"
],
"location_countries": [
"Poland",
"United States",
"Taiwan",
"Spain",
"Hong Kong",
"Greece"
],
"nct_id": "NCT03504488",
"official_title": "A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-30",
"study_completion_date(actual)": "2024-12-30",
"study_start_date(actual)": "2018-06-27"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-15",
"last_updated_that_met_qc_criteria": "2018-04-12",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-20",
"first_submitted": "2018-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate whether a 4-week physical fitness training (target intervention) in stroke patients (subacute stage) increase the walking speed and activities of daily living compared with a control intervention (relaxation exercises). The target or control intervention is performed in addition to standard rehabilitation treatment.
#Intervention
- PROCEDURE : physical fitness training
- PROCEDURE : relaxation
|
#Eligibility Criteria:
Inclusion Criteria for patients:
* diagnosis of stroke within 5 <= age <= 45 days after stroke
* age >= 18 years
* able to sit for at least 30 seconds
* Barthel index < =65 at inclusion
* considered able to perform aerobic exercise as determined by responsible physician
* Written informed consent of the patient
Exclusion Criteria:
* Patient considered unable to comply with study requirements
* stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm or arteriovenous malformation
* patients with progressive stroke
* unable to perfom the required exercises due to
1. medical problems
2. musculo-skeletal problems
3. neurological problems
* required help to at least 1 persons to walk before stroke due to neurological or non-neurological co-morbidities
* life expectancy of less than 1 year as determined by responsible physician
* alcohol or drug addiction within the last 6 months
* significant current psychiatric illness as defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality
* current participation in another intervention study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01953549
|
{
"brief_title": "Physical Fitness Training in Subacute Stroke (PHYS-Stroke)",
"conditions": [
"Stroke"
],
"interventions": [
"Procedure: relaxation",
"Procedure: physical fitness training"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01953549",
"official_title": "Physical Fitness Training in Subacute Stroke (PHYS-Stroke)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-06",
"study_completion_date(actual)": "2017-11-01",
"study_start_date(actual)": "2013-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-06",
"last_updated_that_met_qc_criteria": "2013-09-26",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-01",
"first_submitted": "2013-06-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a single-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System in patients with Type 2 Diabetes Mellitus.
Detailed Description
The study enrolls 44 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group receive insulin regimen set by the AI assisted system and patients in Control group receive insulin regimen set by physicians. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University and consist of a 7-day intervention period. Patient allocation will be stratified by HbA1c, BMI and previous total insulin doses.The primary endpoint is the percentage of time of sensor glucose measurements in targeted range (3.9-10 mmol/L) during the 7-days trial period.
#Intervention
- DRUG : AI assisted insulin system
- The patients receive the insulin regime set by AI assisted insulin titration system
- DRUG : Physician based insulin regime
- Patients receive the insulin regime recommended by physicians
|
#Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 18 <= age <= 75 years;
* Subjects who had been diagnosed with type 2 diabetes;
* Subjects who are on treatment with insulin for at least 3 months;
* HbA1c: 7.0%-11.0%.
Exclusion Criteria:
* Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
* Subjects who change the insulin regimens during hospitalization;
* BMI >= 45kg/m2;
* Women who are pregnant or nursing;
* Subjects with severe cardiac, hepatic, renal or general diseases;
* Subjects with psychiatric disorders or impaired cognitive function;
* Subjects with severe edema, infections or peripheral circulation disorders;
* Patients treated with surgery during hospitalization;
* Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
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
|
NCT04053959
|
{
"brief_title": "Artificial Intelligence Assisted Insulin Titration System",
"conditions": [
"Type 2 Diabetes"
],
"interventions": [
"Drug: AI assisted insulin system",
"Drug: Physician based insulin regime"
],
"location_countries": [
"China"
],
"nct_id": "NCT04053959",
"official_title": "A Study to Assess the Effect and Safety of Artificial Intelligence Assisted Insulin Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients: A Single-center, Open-labeled, Parallel, Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-22",
"study_completion_date(actual)": "2020-04-15",
"study_start_date(actual)": "2019-09-27"
},
"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)": "2020-07-27",
"last_updated_that_met_qc_criteria": "2019-08-10",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-13",
"first_submitted": "2019-08-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to evaluate the feasibility and acceptability of the flash glucose monitoring system together with a structured education programme in individuals with Type 2 Diabetes.
Detailed Description
Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.
For Adults, this phase consists of screening and intervention periods.
Screening Period (Week -2 to -1):
Participants will be asked to wear a blinded flash glucose monitoring system and will be asked to continue testing their capillary glucose readings at least once daily for 2 weeks (week -2 to week -1). Sensor glucose measurements are not available to both participants and investigators during this screening period. Participants who are able to wear the sensor for the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for the 2 weeks (\>10 readings/2weeks), will proceed on with the intervention period.
Intervention Period (Week 0 - 26):
Participants will wear a personal version of the flash glucose monitoring system continuously for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will receive an education package that consists of Diabetes nurse educator and/or dietitian appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.
Paediatric participants will not undergo blinded sensor wear but will undergo the intervention period, with the schedule of wear identical to the adults'. The education curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24. Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.
#Intervention
- COMBINATION_PRODUCT : Flash Glucose Monitoring and structured education
- A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children
|
#Eligibility Criteria:
Inclusion Criteria:
Adults
* Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
* Singapore Citizen or Permanent Resident
* Treatment with diet and exercise alone or other glucose-lowering therapies except prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus, Insulin Toujeo, Insulin Detemir) are permitted.
* Self-reported regular blood glucose testing via CBG (more than 3/week)
Children
* Children and adolescents (Age between 12 and 21 years) with Type 2 diabetes and HbA1c >8% at the time of enrolment
* Singapore Citizen or Permanent Resident
* Insulin replacement as part of diabetes management
Exclusion Criteria:
* Age above 75 years
* Type 1 diabetes, monogenic diabetes
* Prandial insulin (quick-acting insulin or premixed insulin)
* Cancer requiring treatment in the past 5 years
* Chronic renal failure (eGFR<45ml/min) or dialysis
* Amputation of lower limbs (excluding toe amputations)
* Bariatric surgery for weight loss
* Current systemic treatment with steroids
* Pregnancy, attempting pregnancy or lactation.
* Haemolytic anaemia or haemoglobinopathy
* Prior use of the flash glucose monitoring system
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03837262
|
{
"brief_title": "GLucose Monitoring Programme SingaporeE (GLiMPSE)",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Combination Product: Flash Glucose Monitoring and structured education"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT03837262",
"official_title": "GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-23",
"study_completion_date(actual)": "2020-04-30",
"study_start_date(actual)": "2019-03-25"
},
"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)": "2020-09-09",
"last_updated_that_met_qc_criteria": "2019-02-08",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-12",
"first_submitted": "2019-02-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study tests the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects. Blood levels of THC and CBD, inflammatory biomarkers, and insulin resistance will be measured in both studies.
Detailed Description
According to the National Institute of Diabetes and Digestive and Kidney Diseases, over 30 million people in the US have diabetes, and just over 84 million people have pre-diabetes. Concurrently, 30 states and the District of Columbia have legalized cannabis for medical and/or recreational use and over the past decade, cannabis use among adults has more than doubled.
Public perception and some scientific data suggest that cannabis causes acute over-eating, creating concern that public and legal acceptance of cannabis use will worsen the obesity epidemic in the United States, where more than two-thirds of US adults (68.8%) are currently overweight or obese. Paradoxically, cross sectional data demonstrate associations between chronic cannabis use and lower body mass index (BMI), prevalence of obesity, insulin resistance, waist circumference, and actual rates of type 2 diabetes despite data supporting higher caloric intake acutely.
This study examines the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects.
#Intervention
- OTHER : Study A: Single use of cannabis flower product
- Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
- OTHER : Study B: Ad libitum cannabis use for four weeks or no cannabis use
- Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* Cannabis users in Study A must have smoked or vaped cannabis at least once since January 1st 2014 with no negative effects but NOT used in the past three months
* Cannabis users in Study B must have been a regular (at least weekly) user for at least a year
* Non-users in Study B cannot have used any cannabis in the previous year
* Weight stable (<5 pound fluctuation in the past six months)
* Planning to remain in the Boulder-Denver area for the next month
* Fasting blood glucose greater than or equal to 55 mg/dl and less than or equal to 126 mg/dl
* Cannabis users in Study A must endorse knowledge of the procedure(s) for smoking or vaping cannabis
Exclusion Criteria:
* Known auto-immune disease
* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
* Daily tobacco (cigarette, E-cigs, smokeless) user, given the impact of tobacco smoking on insulin function
* Blood alcohol level greater than 0 at screening
* Current use of medications for glucose lowering, immunosuppression, or anti-inflammation
* Acute illness
* Current use of psychotropic medications
* Current diagnosis of diabetes
* Heavy drinking as defined by an Alcohol Use Disorders Test (AUDIT)
* Females can not be pregnant or trying to become pregnant
* Females can not be nursing mothers
* Have donated blood in the 8 weeks before the study or intend to donate blood in the 8 weeks after the study.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04114903
|
{
"brief_title": "Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity",
"conditions": [
"Type 2 Diabetes",
"Obesity",
"Cannabis Use",
"Insulin Sensitivity"
],
"interventions": [
"Other: Study B: Ad libitum cannabis use for four weeks or no cannabis use",
"Other: Study A: Single use of cannabis flower product"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04114903",
"official_title": "Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-01",
"study_completion_date(actual)": "2024-12-01",
"study_start_date(actual)": "2019-11-08"
},
"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)": "2024-12-06",
"last_updated_that_met_qc_criteria": "2019-10-01",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-03",
"first_submitted": "2019-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion, and mass balance of orally administered radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808 administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.
#Intervention
- DRUG : [14C]-CRN00808
- Investigational drug
- DRUG : CRN00808
- Investigational drug
|
#Eligibility Criteria:
Inclusion Criteria:
* Male subjects 19 <= age <= 55 of age
* BMI 18 to 30 kg/m2
Exclusion Criteria:
* Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
* History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
* Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
* Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
* Use of any prior medication without approval of the investigator within 14 days prior to admission
* Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
* History of alcohol or substance abuse in the past 6 months
* Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04246749
|
{
"brief_title": "Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: [14C]-CRN00808",
"Drug: CRN00808"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT04246749",
"official_title": "A Phase 1, Open-label, Two-cohort, Single Dose Study to Assess the Mass Balance, Route of Elimination, and Metabolic Profile of [14C] Labeled CRN00808 and Absolute Bioavailability of CRN00808 in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-25",
"study_completion_date(actual)": "2019-10-25",
"study_start_date(actual)": "2019-09-17"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-29",
"last_updated_that_met_qc_criteria": "2020-01-27",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-29",
"first_submitted": "2020-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
the objective of this study to asses the effect of touch screen tablet on fine motor functions
#Intervention
- OTHER : touch screen tablet
- traditional occupational therapy in addition to games on tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* hemiplegia
* mid spasticity of upper limb
* able to follow instructions
Exclusion Criteria:
* fixed deformities visual or respiratory problem
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04785417
|
{
"brief_title": "Effect of Touch Screen Tablet on Fine Motor Functions",
"conditions": [
"Hemiplegic Cerebral Palsy"
],
"interventions": [
"Other: touch screen tablet"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04785417",
"official_title": "Effect of Touch Screen Tablet on Fine Motor Function un Children With Hemiparetic Cerebral",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-10",
"study_completion_date(actual)": "2023-05-10",
"study_start_date(actual)": "2021-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-10",
"last_updated_that_met_qc_criteria": "2021-03-04",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-05",
"first_submitted": "2021-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of the study is to demonstrate that the efficacy of peginterferon alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic hepatitis C virus infection genotype 2 or 3 given for 12 weeks is non-inferior to 24 weeks.
Detailed Description
Primary Objective of the Study: To demonstrate that the efficacy of peginterferon alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 given for 12 weeks is non-inferior to 24 weeks.
#Intervention
- DRUG : Peginterferon alfa-2a 40KD and Ribavirin
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female patients >=18 years
* Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
* Serum HCV-RNA quantifiable at >600 IU/mL by the Roche AMPLICOR HCV MONITOR® Test, v2.0.
* HCV genotype 2 or 3 infection confirmed within the past 2 years preceding the initiation of test drug dosing.
* Elevated serum ALT activity documented on at least one occasion within the past 12 months preceding the initiation of test drug dosing.
* Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 2 years) as judged by a local pathologist.
* Compensated liver disease (Child-Pugh Grade A clinical classification)
* Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomization
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
* All fertile males and females receiving ribavirin must be using effective contraception during treatment and during the 6 months after treatment end
Exclusion Criteria:
* Women with ongoing pregnancy or breast feeding
* IFN or ribavirin therapy at any previous time
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
* Any investigational drug <=6 weeks prior to the first dose of study drug.
* HCV genotype 1, 4, 5 or 6 infection.
* Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
* Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* History or other evidence of decompensated liver disease
* Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
* Serum creatinine level >2 mg/dl (>124 µmol/L) or creatinine clearance <50 ml/minute at screening
* Severe psychiatric disease, especially depression, as judged by the treating physician.
* History of a severe seizure disorder or current anticonvulsant use
* History of immunologically mediated disease, severe chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
* Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
* Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions.
* Inability or unwillingness to provide informed consent or abide by the requirements of the study
* Male partners of women who are pregnant
* Ηemoglobin <11.3 g/dL (<7.0 mmol/L) in women or <12.9 g/dL (<8.0 mmol/L) in men at screening.
* Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
* Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
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
|
NCT00143000
|
{
"brief_title": "Multicenter Study Evaluating 12 Versus 24 Weeks Therapy With Peginterferon and Ribavirin for Hepatitis C Virus (HCV) Genotype 2 or 3",
"conditions": [
"Hepatitis C Virus"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT00143000",
"official_title": "A Multicenter Study Evaluating the Efficacy and Safety of 12 Weeks Versus 24 Weeks Peginterferon Alfa-2a 40KD Combination Therapy With Ribavirin in Interferon Naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-10",
"study_start_date(actual)": "2004-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-04-07",
"last_updated_that_met_qc_criteria": "2005-09-01",
"last_verified": "2008-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-02",
"first_submitted": "2005-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.
#Intervention
- DRUG : Etrozulimab
- Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
- Other Names :
- PRO145223, RO5490261, RG7413
- DRUG : Placebo
- Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of UC established at least 3 months prior to Day 1
* Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
* Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
* Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
* Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
* Use of highly effective contraception as defined by the protocol
* Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
Exclusion Criteria:
* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
* Prior or planned surgery for UC
* Past or present ileostomy or colostomy
* Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
* Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
* Any prior treatment with rituximab
* Any treatment with tofacitinib during screening
* Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
* Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
* Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
* History of recurrent opportunistic infections and/or severe disseminated viral infections
* History of organ transplant
* Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
* Received a live attenuated vaccine within 4 weeks prior to Day 1
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
|
NCT02100696
|
{
"brief_title": "A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors",
"conditions": [
"Ulcerative Colitis"
],
"interventions": [
"Drug: Etrozulimab",
"Drug: Placebo"
],
"location_countries": [
"Netherlands",
"United States",
"Poland",
"Germany",
"Romania",
"Austria",
"Switzerland",
"Czechia",
"United Kingdom",
"France",
"Israel",
"Australia",
"Hungary",
"Argentina",
"Italy",
"Denmark",
"Mexico",
"Brazil",
"Korea, Republic of",
"Lithuania",
"Canada",
"Spain",
"Belgium",
"Greece"
],
"nct_id": "NCT02100696",
"official_title": "Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-16",
"study_completion_date(actual)": "2020-04-16",
"study_start_date(actual)": "2014-05-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-13",
"last_updated_that_met_qc_criteria": "2014-03-27",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-01",
"first_submitted": "2014-03-27",
"first_submitted_that_met_qc_criteria": "2021-05-20"
}
}
}
|
#Study Description
Brief Summary
This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments
#Intervention
- DRUG : imatinib
|
#Eligibility Criteria:
Inclusion criteria
* Healthy male or female subjects (postmenopausal women)
* Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion criteria
* Smokers
* Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 2 weeks prior to dosing.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* A past medical history or presence of clinically significant ECG abnormalities including:
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
* Women taking any biphosphonates (Fosomax like drugs)
* History of being immunocompromised, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00422825
|
{
"brief_title": "Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: imatinib"
],
"location_countries": null,
"nct_id": "NCT00422825",
"official_title": "A Phase I, Open-label, Randomized, Crossover Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in a Modified Release Formulation (MR2) and Compare the Bioavailability Between MR2 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-09",
"study_completion_date(actual)": "2006-09",
"study_start_date(actual)": "2006-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-04-05",
"last_updated_that_met_qc_criteria": "2007-01-16",
"last_verified": "2016-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-17",
"first_submitted": "2007-01-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.
Detailed Description
This is a prospective observational study assessing the interest of preoperative thoracic block (injection of local anesthetic around the serratus muscle under ultrasound guidance) in the prevalence of chronic pain 3 months after a conservative breast cancer surgery.
Information on the present survey was given during pre-operative consultation and signed informed consent was obtained to enter the study.
The management of patients undergoing minor surgery for breast cancer is standardized within our department and reported in our previous study. After starting the induction of anesthesia and insertion of a laryngeal mask, a regional analgesia technique was performed under ultrasonography. Twenty ml of ropivacaine 3.75mg/ml were injected under the serratus muscle, at the lateral edge of the minor pectoralis muscle. In the absence of contraindications, multimodal analgesia consisted of paracetamol, non-steroidal anti-inflammatory drugs and nefopam. Postoperative intravenous morphine titration was possible in patients presenting a pain score \>3/10 (numeric pain intensity scale from 0 = no pain to 10 = maximum imaginable pain) in the recovery room. If 0.1mg/kg of morphine did not permit to alleviate pain, ketamine titration was initiated by the anesthesiologist.
The incidence of patients that required opioids titration in the recovery room (and the dose injected) was recorded.
The questionnaire sent to the patients 3 months after their surgery was mainly composed of closed questions. This questionnaire included pain score, location of pain, analgesic drugs consumption, neuropathic component (self-administered questionnaire derived from the Neuropathic Pain 4 Questions - DN4 questionnaire), impact of quality of life using the Brief Pain Inventory.
|
#Eligibility Criteria:
Inclusion Criteria:
* women
* > 18 years
* with 'American Society of Anesthesiologists-ASA' physical status 1 to 3
* with unilateral breast cancer adenocarcinoma treated surgically by conservative tumorectomy associated or not to sentinel lymph node dissection on an ambulatory basis
Exclusion Criteria:
* None
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
|
NCT03912948
|
{
"brief_title": "Chronic Pain and Minor Breast Cancer Surgery",
"conditions": [
"Surgery",
"Breast Cancer",
"Pain, Postoperative",
"Pain, Chronic"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT03912948",
"official_title": "Prospective Cohort Study Assessing Chronic Pain in Patients With Thoracic Blocks Following Minor Surgery for Breast Cancer.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-30",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2019-04-01"
},
"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)": "2020-03-04",
"last_updated_that_met_qc_criteria": "2019-04-10",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-11",
"first_submitted": "2019-04-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This Canadian, multi-centre, prospective, observational real-world study is designed to collect patient-reported outcome data on the use of Akynzeo® (netupitant/palonosetron) for the prevention of nausea and vomiting in oncology patients receiving highly emetogenic chemotherapy (HEC).
Detailed Description
The study will assess quality of life using the Functional Living Index of Emesis (FLIE) questionnaire and generate Real World Evidence in support of existing clinical trial data, including effectiveness and safety of Akynzeo® in the real world setting for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
#Intervention
- DRUG : 300mg netupitant/0.5mg palonosetron hydrochloride
- Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)
- Other Names :
- Akynzeo®
|
#Eligibility Criteria:
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
* Patient scheduled to receive a highly emetogenic chemotherapy (HEC).
* Patient scheduled to receive antiemetic prevention with Akynzeo® according to the approved Canadian Product Monograph as deemed medically necessary by the participating physician independently from this study.
* Age >= 18 years.
* Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®.
* Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent prior to or at the screening visit.
* Patient is able and willing to comply with the study protocol for the entire length of the study and will follow all study requirements, procedures and complete all visits as required.
* Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol.
Exclusion Criteria:
* Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding.
* Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®.
* Concomitant use of pimozide, terfenadine, astemizole, or cisapride.
* Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by 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
|
NCT03649230
|
{
"brief_title": "Observational Study on the Use of Akynzeo® in Patients Receiving HEC",
"conditions": [
"Chemotherapy-Induced Nausea and Vomiting"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT03649230",
"official_title": "A Phase IV, Real World Observational Study On The Use Of Akynzeo® (Netupitant/Palonosetron) For The Prevention Of Nausea and Vomiting in Oncology Patients Receiving Highly Emetogenic Chemotherapy (HEC) Over Multiple Cycles.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-30",
"study_completion_date(actual)": "2020-01-30",
"study_start_date(actual)": "2018-10-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-18",
"last_updated_that_met_qc_criteria": "2018-08-24",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-28",
"first_submitted": "2018-08-23",
"first_submitted_that_met_qc_criteria": "2022-10-13"
}
}
}
|
#Study Description
Brief Summary
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Detailed Description
CAIN457F2302 (Core Study): Completed Sep 9 2015
CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
#Intervention
- BIOLOGICAL : Secukinumab (AIN457)
- AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
- Other Names :
- AIN457
- BIOLOGICAL : Placebo
- Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
|
#Eligibility Criteria:
Inclusion criteria:
* Male or non-pregnant, non-lactating female patients
* Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening
* At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >=6 swollen joints out of 66 with at least 1 of the following at screening:
* Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR
Rheumatoid Factor positive and with at least 1 of the following at screening:
* High sensitivity C-reactive protein (hsCRP) >= 10 mg/L OR Erythrocyte sedimentation rate (ESR) >= 28 mm/1st hr
* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
* Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week)
Exclusion criteria:
* Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria
* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
* Other protocol-defined inclusion/exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01377012
|
{
"brief_title": "Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": [
"Biological: Placebo",
"Biological: Secukinumab (AIN457)"
],
"location_countries": [
"Japan",
"India",
"Colombia",
"United States",
"Guatemala",
"Mexico",
"Thailand",
"Canada",
"Hungary",
"Panama",
"Puerto Rico",
"Argentina",
"Italy",
"Turkey",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT01377012",
"official_title": "A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-09-09",
"study_completion_date(actual)": "2015-09-09",
"study_start_date(actual)": "2011-08-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-29",
"last_updated_that_met_qc_criteria": "2011-06-17",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-20",
"first_submitted": "2011-06-17",
"first_submitted_that_met_qc_criteria": "2017-02-09"
}
}
}
|
#Study Description
Brief Summary
A randomised controlled trial will be performed to evaluate the effects of lung volume reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood pressure and to improved endothelial function.
For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving immediate LVRS and group 2 receiving LVRS after a delay of 3 months.
Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure will be measured at baseline and 3 months after surgery and no surgery, respectively (group 2 receiving surgery only after a delay of 3 months will serve as control group) to investigate the effects of LVRS on the described outcomes.
Detailed Description
Not desired
#Intervention
- PROCEDURE : Lung volume reduction surgery
- Lung volume reduction surgery
|
#Eligibility Criteria:
Inclusion criteria:
* Dyspnea at rest or at minimal physical activity, severe limitation of exercise capacity (6-min walk distance < 350 m).
* Acceptance of an increased perioperative mortality (approximately 2 %) and/or morbidity (long lasting hospitalization due to prolonged air leaks)
* COPD (GOLD guidelines) with severe obstructive ventilatory defect (FEV1 <35% predicted)
* Functional aspects of lung emphysema, i.e. irreversible hyperinflation with a residual volume to total lung capacity ratio (RV/TLC) of >0.65 and an impaired total lung diffusion capacity (DLCO), usually < 40% predicted.
* Pulmonary emphysema confirmed by high resolution computer tomography
Exclusion criteria: - Current smokers
* Age > 75years
* 'Vanishing' lung or diffuse lung emphysema on CT, FEV1 <20% predicted and DLCO <20% predicted, and hypercapnia (PaCO2 >7.3kPa)
* Overt active coronary artery disease, severe left ventricular function impairment
* Pulmonary hypertension with a mean pulmonary artery pressure >35 mmHg at rest
* Acute bronchopulmonary infection, bronchiectasis on high resolution tomography
* Pulmonary cachexia (body mass index <18kg/m2)
* Neoplastic disease with a life expectancy of less than 2 years
* Addiction to alcohol/drugs
* Relevant renal (creatinine >150ug/ml), active gastroenterological (GI-bleeding in the previous year, abnormal liver function, active inflammatory bowel disease) or active neurological disease.
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
|
NCT01020344
|
{
"brief_title": "Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Procedure: Lung volume reduction surgery"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01020344",
"official_title": "Randomized Controlled Trial on the Cardiovascular Effects of Lung Volume Reduction Surgery in Patients With Chronic Obstructive Pulmonary Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2009-11"
},
"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)": "2014-10-16",
"last_updated_that_met_qc_criteria": "2009-11-24",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-25",
"first_submitted": "2009-11-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema, and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized Split-Mouth Clinical Trial
Detailed Description
Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and trismus frequently jeopardize patients' well-being after the extraction of third molars. Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction. Refrigerated serums were used to work with cold serum, and since the refrigerator temperature was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to assess the influence of saline irrigation at various temperatures (4°C, 25°C) on postoperative edema, pain, and trismus after the extraction of impacted third molars.
Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to compare pairs, and a Wilcoxon signed-rank test was used to compare groups.
#Intervention
- PROCEDURE : saline irrigation at various temperatures (4°C, 25°C)
- cold serum application
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 30 who were classified as ASA (American Society of Anesthesiologists)1 and who required the removal of impacted third molars on either the right or left side of the mandible;
* Presence of impacted mandibular third molars on panoramic radiographs, bilaterally symmetrical, with bone retention and bone removal for extraction, position B class 2 of impacted teeth according to the Pell and Gregory Classification System, and mesioangular position according to the Winter Classification;
* Absence of systemic disease and habitual smoking behavior and absence of an allergy to the drugs to be used postoperatively.
Exclusion Criteria:
* Patients with a history of taking antibiotics and analgesics for at least one month;
* Having an infection in the operation area and acute pericoronitis or severe periodontal disease before the operation;
* The existence of cysts and tumors within proximity of the impacted third molar.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06020053
|
{
"brief_title": "Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars",
"conditions": [
"Impacted Third Molar Tooth"
],
"interventions": [
"Procedure: saline irrigation at various temperatures (4°C, 25°C)"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06020053",
"official_title": "Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-30",
"study_completion_date(actual)": "2022-06-09",
"study_start_date(actual)": "2021-03-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-31",
"last_updated_that_met_qc_criteria": "2023-08-27",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-31",
"first_submitted": "2023-07-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. During the screening evaluation, subjects will have a physical exam and medical history taken by either the PI or a Co investigator. In addition, routine blood tests and radiological exams will be performed, to determine eligibility. Following enrollment, patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each cycle of treatment patients will have a physical examination, as well as routine blood work. The first scan will be done prior to initiation of treatment, and the next will be done at completion of chemotherapy. A short quality of life questionnaire will also be administered prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.
Detailed Description
The adjuvant treatment of resected pancreatic cancer is currently in flux. Many in the United States continue to use 5FU-based chemotherapy with radiation to the pancreatic bed. Some in the States, and most investigators in Europe, use a 5FU based chemotherapy-alone approach, based on the ESPAC-1 data. Many investigators believe that since gemcitabine is a more active drug in the metastatic setting, it should be moved 'up front' in the adjuvant treatment of pancreatic cancer patients. At Columbia, we offer gemcitabine-based treatments with discussions with patients regarding risks, benefits, and limitations in current knowledge. We have usually offered radiation to those with positive margins, and chemotherapy alone to those without. Based on the early studies using gemcitabine, we believe that this will ultimately prove to be a more effective adjuvant drug than 5FU. Some patients have asked for GTX in the adjuvant setting as well, prompting the creation of this trial. Because of concerns about increased toxicity of this regimen, determination of patient safety will be the primary objective of this study, through careful monitoring of adverse events. This trial will be a chemotherapy-only study, offered to those with clean margins of resection.
Taxotere administered 'weekly' has activity in a variety of tumor types including breast, lung, ovarian and prostate cancer. Patients with advanced breast cancer, including some who had previously been treated with paclitaxel or anthracyclines, have responded to the weekly administration of Taxotere. The recommended dose of weekly Taxotere is 30-40 mg/m2/week for 6 out of 8 weeks. The same dose intensity can be achieved on a 3 out of 4 week basis. However, this protocol will give drugs 2 out of every 3 weeks, thus dose intensity is less.
Weekly administration of Taxotere is well tolerated and produces substantially less myelosuppression than is observed with standard Taxotere administration every 3 weeks. Acute toxicities are uncommon, as is peripheral neuropathy. Prolonged treatment with weekly Taxotere, may result in chronic toxicities (including, asthenia (fatigue), anemia, edema, excessive lacrimation (epiphora), and onycholysis). Chronic toxicities are most prominent when Taxotere is administered on a continuous weekly basis, i.e., without a break, and are delayed in onset by providing breaks in treatment (for example, treating 6 out of 8 weeks or 3 out of 4 weeks); these chronic toxicities occur at a lower cumulative dose when a continuous weekly schedule of Taxotere is utilized.
Premedication with dexamethasone is recommended for all patients receiving weekly Taxotere therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. A variety of dexamethasone schedules have been used in studies with weekly Taxotere. Dexamethasone 4 to 8 mg x 3 doses taken orally the night before, the morning of, and the evening after Taxotere administration appears to be an effective schedule. We have found that a single low dose of 10 mg IV before the Taxotere usually prevents anaphylaxis and the pedal edema associated with this drug.
#Intervention
- DRUG : Gemcitabine
- Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV
- Other Names :
- Gemzar
- DRUG : Docetaxel
- Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV
- Other Names :
- Taxotere
- DRUG : Capecitabine
- Day 1-14: capecitabine at 1000 mg/m2/day divided into 2 doses given two times a day (BID) by mouth (PO) Maximum dose 2000mg/day divided into BID dosing
- Other Names :
- Xeloda
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection.
* Ineligible for other high priority national or institutional studies.
* Time from surgical recovery greater than three weeks, but less than six weeks.
* All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy.
* Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
* Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months after completion of treatment. They must understand the risks of infertility possibly associated with adjuvant treatment.
* Clinical Parameters:
* Age >= 18 to <= 75 years
* Performance status 0 <= age <= 2 (ECOG)
* Peripheral Neuropathy must be < grade 1
* Able to tolerate oral medications
* Absolute Neutrophil Count > 1,500 ul
* White Blood Count > 3,000/ul
* Platelet count > 100,000/ul
* BUN < 1.5 x ULN
* Creatinine < 1.5 x ULN
* Hemoglobin > 8.0 g/dl
* Serum Albumin > 2.5 mg/dl
* Total Bilirubin < 3.0 mg/dl
* AST <=4.0 x ULN
* ALT <=4.0 x ULN
* Alkaline Phosphatase <=4.0 x ULN]
* CA 19 <= age <= 9 should be normal post surgery. Can still be put on protocol with elevation if clinically significant for inflammation or infection, not cancer
Exclusion Criteria:
* Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
* Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body.
* Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
* Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
* Any prior investigational agent/therapy or any investigational agent/therapy while on protocol.
* Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drug formulated with polysorbate 80 will be excluded.
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
|
NCT00882310
|
{
"brief_title": "A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer",
"conditions": [
"Pancreatic Cancer"
],
"interventions": [
"Drug: Docetaxel",
"Drug: Gemcitabine",
"Drug: Capecitabine"
],
"location_countries": null,
"nct_id": "NCT00882310",
"official_title": "A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2006-09"
},
"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)": "2016-07-25",
"last_updated_that_met_qc_criteria": "2009-04-15",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-16",
"first_submitted": "2009-03-23",
"first_submitted_that_met_qc_criteria": "2016-05-16"
}
}
}
|
#Study Description
Brief Summary
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.
#Intervention
- DRUG : trastuzumab [Herceptin]
- 600 mg subcutaneously using a single-use injection device on Day 1
- DRUG : trastuzumab [Herceptin]
- 600 mg subcutaneously using a handheld syringe on Day 1
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male patients, 18 <= age <= 45 of age, inclusive
* No history of hypersensitivity or allergic reactions following drug administration
* No history of clinically significant or clinically relevant cardiac condition
* No history of previous anticancer treatment
* Body mass index (BMI) between 18 <= age <= 32 kg/m2, inclusive
Exclusion Criteria:
* Positive test result for drugs of abuse
* Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
* Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
* Clinically significant abnormal laboratory values
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01344863
|
{
"brief_title": "A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: trastuzumab [Herceptin]"
],
"location_countries": [
"New Zealand"
],
"nct_id": "NCT01344863",
"official_title": "A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2011-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-02",
"last_updated_that_met_qc_criteria": "2011-04-28",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-29",
"first_submitted": "2011-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP) delivered through a partnership of domestic relations courts, community service providers and the NBP research team. This is the first attempt to offer the population of families seeking divorce an evidence-based prevention program shown to have long-term effects on youth problem outcomes. It is estimated that over a third of U.S. children experience parental divorce, which confers elevated risk for multiple problems in childhood and adulthood including substance use and abuse, smoking, mental health problems, high risk sexual behavior, and physical health problems. Efficacy trials of the NBP found positive effects at post-test, 6-year and 15-year follow-ups. For example, at 6-year follow-up the participation in NBP led to reductions in marijuana, drug and alcohol use and a 37% reduction in prevalence of diagnosed mental disorder; and reductions in externalizing problems, internalizing problems and high risk sexual behavior. Positive effects also occurred for grade point average (GPA) and self esteem. For many of the effects of the NBP, the effects were stronger for youth who were at higher risk at program entry. Many of the program effects were mediated through the program effects to strengthen parenting. Funded by an Advanced Center for Intervention and Services Research grant (NIMH P30 MH068685) the investigators modified the NBP to translate it from a prototype tested in efficacy trials into a program that can be effectively delivered by community service providers and one that is appropriate across diverse cultural groups, and fathers as well as mothers. Pilot testing of the modified NBP and training and monitoring systems has demonstrated that they are highly acceptable to parents and providers. The investigators also developed and experimentally tested a system of parent recruitment that was found to be effective in getting parents to enroll (sign up to participate) in the NBP but, similar to other prevention parenting programs, initiation (attendance at one or more sessions) in the NBP in the pilot was low.
Detailed Description
SPECIFIC AIMS This application requests funding to conduct a randomized effectiveness trial of The New Beginnings Program (NBP), a prevention program for divorced families, as delivered through a partnership of domestic relations courts, community service providers and the NBP research team. This partnership would be the first systematic attempt to offer the population of families seeking divorce an evidence-based prevention program shown to have long-term effects to reduce youth problem outcomes. It is estimated that over a third of U.S. children experience parental divorce which confers elevated risk for multiple problems in childhood, adolescence and adulthood including substance use and abuse, cigarette smoking, mental health problems, high risk sexual behavior, and physical health problems. When evaluated in efficacy trials, the NBP has been shown to have positive program effects at post-test, 6-year and 15-year follow-ups. For example, at 6-year follow-up the participation in NBP led to reductions in marijuana, drug and alcohol use; a 37% reduction in prevalence of diagnosed mental disorder; and reductions in externalizing problems, internalizing problems and high risk sexual behavior. Positive program effects also occurred for grade point average (GPA) and self esteem. For many of the short- and long-term effects of the NBP, the effects were stronger for youth who were at higher risk at program entry. Mediational analyses have shown that program effects on short-term and 6-year youth outcomes were mediated through the program effects to strengthen parenting. Funded by an Advanced Center for Intervention and Services Research grant (NIMH P30 MH068685) the investigators modified the NBP to translate it from a prototype tested in efficacy trials into a program that can be effectively delivered by community service providers and one that is appropriate for diverse cultural groups, a broad age range of youth, and fathers as well as mothers. The investigators also revised the methods for training, technical assistance and ongoing monitoring of implementation. Pilot testing of the modified NBP and training and monitoring systems has demonstrated that they are highly acceptable to parents and providers. The investigators also developed and experimentally tested a system of parent recruitment that builds on an infrastructure that exists in domestic relations courts in 46 states. This strategy was effective in getting parents to enroll (sign up to participate) in the NBP but, similar to other prevention parenting programs, initiation (attendance at one or more sessions) in the NBP in the pilot was low.
The Specific Aims are to:
1. Examine whether 1380 children in 920 divorcing families randomly assigned to the NBP or workshop controls, show greater improvement when assigned to the NBP on measures of positive parenting, youth substance use and mental health problems compared to controls. Assessments will occur at pre-test, post-test and 6-month follow-up. The study will also test whether program effects on youth outcomes at the 6-month follow-up are mediated by program-induced effects on positive parenting at post-test. This will be the first experimental evaluation of the effectiveness of an evidence-based parenting program to prevent substance use and mental health problems of youth from divorcing families when delivered through a partnership of the courts and community service providers.
2. Test whether the effects of the NBP are moderated by level of child risk at program entry, youth age, parent gender or parent's ethnicity \[i.e., Mexican American (MA) vs. non-Hispanic Caucasians (NHW)\]. Based on previous trials of the NBP, a significant program x baseline risk interaction is predicted with stronger program effects expected at higher levels of child risk. Because the program was modified and pilot tested to make it appropriate across ethnic groups, parent gender, and age of child, testing the interaction effect for these three variables is viewed as exploratory and no significant interactions are predicted.
3. Examine whether variability in implementation accounts for variability in parenting and youth outcomes. Multiple dimensions of implementation that have been found to relate to outcomes of prevention parenting programs will be measured (e.g., fidelity, group leader process quality, additive adaptation, participant responsiveness) and their unique contribution to program effects will be assessed. The investigators will also test whether gender or ethnicity moderate the relations between each dimension of implementation and outcomes.
4. Experimentally test whether a brief telephone engagement interview increases initiation (i.e. attending at least one session) relative to a standard informational contact. The effect of the engagement interview will be tested for the overall sample, and separately for males and females, and MA and NHW.
The results of this study have significant public health implications to reduce substance abuse and mental health problems of youth who experience parental divorce, a highly prevalent stressful event. Further, the proposed study addresses three issues that have substantial implications for the effectiveness of parent-focused preventive interventions: subgroup differences in program benefits, relations of dimensions of implementation to outcomes and engagement of parents in evidence-based parenting programs.
#Intervention
- BEHAVIORAL : New Beginnings Program
|
#Eligibility Criteria:
Inclusion Criteria:
* Filing for divorce or modification of a divorce decree within the past two years
* If never married, being in court to establish or change a parenting time agreement following separation in the past two years
* Having at least one child aged 3 to 18 with whom the parent spends three or more hours each week or one overnight every other week
* Being able to complete the program and assessments in English
* Not being mandated to a parenting class by the Juvenile Court or Child Protective Services.
Exclusion Criteria:
* Parents who received a divorce more than two years prior and did not have any court involvement in the past two years.
* Parents who could not complete the program or assessments in English
* Parents were mandated to a parenting program by Child Protective Services of Juvenile Court
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06132971
|
{
"brief_title": "Multi-court Trial of NBP to Prevent Substance Abuse and Mental Health Disorders (MTC)",
"conditions": [
"Divorce",
"Drug Abuse",
"Mental Health Disorder"
],
"interventions": [
"Behavioral: New Beginnings Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06132971",
"official_title": "Multi-court Trial of NBP to Prevent Substance Abuse and Mental Health Disorders",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-08-04",
"study_completion_date(actual)": "2017-01-31",
"study_start_date(actual)": "2012-07-30"
},
"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)": "2023-11-15",
"last_updated_that_met_qc_criteria": "2023-11-09",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-15",
"first_submitted": "2018-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.
Detailed Description
The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.
The population of the study consisted of individuals undergoing elective coronary angiography in the Cardiology Department of Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. The study was conducted in a randomized controlled manner with three groups: 34 individuals in music listening group (M1), 34 individuals in information training group (M2) and 34 subjects in control group. In order to collect data, CAG (Coronary angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale and Spielberg State and Trait Anxiety Scale were used. Data were collected by face to face interview technique. Descriptive statistics, Independet Simple test, Paired sample t test, Kruskall Wallis, Mann Whitney U test and Wilcoxon signed rank test were used in the analysis of the data and the significance level was accepted as p \<0.05.
#Intervention
- OTHER : music listening
- The music selected by the participants was played to the music listening group.
- OTHER : individual training
- Individual training group was trained on coronary angiography.
|
#Eligibility Criteria:
Inclusion Criteria:
Applying femoral CAG electively,
* The first time CAG will be held,
* Performing the CAG procedure for diagnostic purposes,
* Not trained on the CAG process,
* Volunteering to participate in the study,
* No problem in verbal communication,
* No hearing loss,
* Being able to read and write,
* Has not been diagnosed with psychiatric illness,
* Being conscious,
* Being >= 18 years.
Exclusion Criteria:
Radial application of CAG,
* Previously performing coronary angiography,
* Performing the CAG procedure for therapeutic purposes (stent, balloon, etc.),
* Having received training on the KAG process,
* Does not want to participate in the study
* Problems in verbal communication,
* Hearing loss,
* Psychiatric illness is found.
* Consciousness is closed.
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
|
NCT04651075
|
{
"brief_title": "Music Listenıng And Training Before Coronary Angıography",
"conditions": [
"Coronary Artery Disease",
"Anxiety",
"Music",
"Education"
],
"interventions": [
"Other: individual training",
"Other: music listening"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04651075",
"official_title": "Effects On Physıological Parameters And Anxiety Of Related Musıc And Informatıon Training Before Coronary Angiography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-01",
"study_completion_date(actual)": "2019-04-01",
"study_start_date(actual)": "2018-04-01"
},
"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)": "2022-04-21",
"last_updated_that_met_qc_criteria": "2020-11-25",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-03",
"first_submitted": "2020-06-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in previous clinical trials; however, the elimination routes and metabolic pathways of daprodustat have not been fully elucidated in humans. This is an open-label, single-center, non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male participants. The aim of the study is to assess the excretion balance of daprodustat using \[14C\]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion, administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose). Absolute bioavailability of an oral dose will also be assessed. Each participant will be involved in the study for up to 10 weeks which include a screening visit, two treatment periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The primary objective of the study is to gain a better understanding of the compound's excretory and metabolic profile. This study will include sampling of duodenal bile to conduct qualitative assessment of drug metabolites in this matrix in order to characterize biliary elimination pathways.
#Intervention
- DRUG : [14C]-GSK1278863 solution for IV infusion
- It is a clear, colorless solution free from visible particulate matter. Participants will receive 10 mL of 5 µg/mL of \[14C\]-GSK1278863 IV solution (total dose: 50 µg) by IV infusion over 1 hour.
- DRUG : [14C]-GSK1278863 oral solution
- It is a clear, colorless solution. Participants will receive 125 mL of 200 µg/mL of \[14C\]-GSK1278863 oral solution (total dose: 25 mg).
- DRUG : Daprodustat 6 mg oral tablet
- It is a 9.0 millimeter (mm) round, white film coated tablet.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 30 <= age <= 55, inclusive, at the time of signing the informed consent.
* Healthy, as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECG. A participant with a clinical abnormality or laboratory parameter (i.e., outside the reference range for the population being studied), which is not specifically listed in the eligibility criteria, may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Hemoglobin value at screening greater than the lower limit of the laboratory reference range and less than or equal to 16.0 gram (g) per deciliter (dL).
* History of regular bowel movements (averaging one or more bowel movements per day).
* Non-smoker, or ex-smoker who hasn't regularly smoked for the 6 months before screening.
* Body weight of 50 kilogram (kg) and above, and body mass index (BMI) within the range 19.0 <= age <= 31 kg per meter (m)^2 (inclusive).
* Participants must agree to use contraception as follows: participants with female partners of childbearing potential must agree to use a condom from the time of first dose of study treatment until 1 month after their last dose.
* Capable of giving signed informed consent.
* Willingness to give written consent to have data entered into The Over-volunteering Prevention System.
Exclusion Criteria:
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Participants with a history of cholecystectomy must be excluded.
* Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead ECG.
* Myocardial infarction or acute coronary syndrome <=12 weeks prior to screening through to enrollment (Day 1, treatment period 1).
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or which could constitute a risk when taking the study treatment, or interfere with the interpretation of data.
* Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant GI bleeding <=12 weeks prior to screening through to enrollment (Day 1, treatment period 1).
* History of malignancy within the two years before dosing, with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated prior to screening; currently receiving treatment for cancer; has a strong family history of cancer (e.g., familial cancer disorders).
* Mentally or legally incapacitated.
* Heart Failure: Class II, III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
* Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.
* Daprodustat is a substrate of cytochrome P4502C8 (CYP2C8). Co-administration of drugs that are inhibitors of this enzyme are prohibited.
* Past or intended use of over-the-counter or prescription medication including herbal medications prior to dosing except occasional use of paracetamol (acetaminophen), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study treatment until completion of the follow-up visit, unless in the opinion of the investigator and GSK medical monitor the medication will not interfere with the study.
* Current enrolment in a clinical trial; recent participation in a clinical trial and has received an investigational product within 3 months before their first dose in the current study.
* Exposure to more than 4 new chemical entities within 12 months before their first dose in the current study.
* Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months. A participant's previous effective dose will be reviewed by the medical investigator to ensure there is no risk of contamination/carryover into the current study.
* Received a total body radiation dose of greater than 10.0 millisievert (mSv) (upper limit of world health organization [WHO] category II) or exposure to significant radiation (e.g., serial x-ray or computed tomography [CT] scans, barium meal, etc.) in the 3 years before this study.
* Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
* Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
* QTc >500 millisecond (msec). The QTc must be the QTcB.
* Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening or within 3 months before the first dose of study treatment.
* Positive pre-study drug/alcohol screen.
* Positive human immunodeficiency virus (HIV) antibody test.
* Regular use of known drugs of abuse.
* Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >21 units. One unit is equivalent to 8 g of alcohol: a glass (approximately 240 milliliter [mL]) of beer, 1 small glass (approximately 100 mL) of wine or 1 (approximately 25 mL) measure of spirits.
* At screening, a supine blood pressure (BP) that is persistently higher than 140/90 millimeters of mercury (mmHg) taken in triplicate, unless deemed not clinically significant by the investigator.
* At screening, a supine mean heart rate (HR) outside the range of 40 <= age <= 100 beats per minute, unless deemed not clinically significant by the investigator.
* Has had an occupation which requires monitoring for radiation exposure, nuclear medicine procedures, or excessive x-rays within the past 12 months.
* Unable to refrain from consumption of prohibited food and drinks from 7 days before the first dose of study medication until the follow up visit.
* Participation in the study would result in donation of blood or blood products in excess of 550 mL within a 90 day period.
* Unwillingness or inability to follow the procedures, including the use of the Entero-Test capsule.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products in the 6 months prior to screening.
* History of drug abuse or dependence within 6 months of the study.
* History of sensitivity to daprodustat, or their components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK medical monitor, contraindicates their participation.
Sex :
MALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03239522
|
{
"brief_title": "Absorption and Elimination of Radiolabeled Daprodustat",
"conditions": [
"Anaemia"
],
"interventions": [
"Drug: Daprodustat 6 mg oral tablet",
"Drug: [14C]-GSK1278863 solution for IV infusion",
"Drug: [14C]-GSK1278863 oral solution"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03239522",
"official_title": "An Open-label Study in Healthy Male Participants to Determine the Mass Balance, Absolute Bioavailability and Pharmacokinetics of Daprodustat, Administered as a Single Intravenous Microtracer (Concomitant With an Oral Dose of Non-radiolabelled Daprodustat) and a Single, Oral Radiolabelled Dose",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-28",
"study_completion_date(actual)": "2017-11-28",
"study_start_date(actual)": "2017-10-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-03",
"last_updated_that_met_qc_criteria": "2017-08-01",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-04",
"first_submitted": "2017-07-17",
"first_submitted_that_met_qc_criteria": "2018-11-26"
}
}
}
|
#Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks
Detailed Description
Screening Phase: up to 42 days (consisting of a Screening Visit (V1), a washout period and Interim Screening Visit (V1a) when applicable, and a Baseline Visit (V2). The Screening Phase will serve multiple purposes: to allow for appropriate washout of prohibited medications; to allow for review of screening data; to establish a pre-treatment baseline of key outcome measures.
Treatment Phase: The duration of the treatment is 8 weeks. The purpose of the treatment phase is to evaluate the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of serious behavioral problems in children and adolescents with a diagnosis of Autistic Disorder..
Safety Follow-up Phase: All subjects will be followed up for safety (adverse events) at Day 16 after the last medication via telephone.
#Intervention
- DRUG : Aripiprazole Oral Solution
- Aripiprazole 2\~15 mg/day (2\~15 mL/day)
- Other Names :
- Abilify, Aripiprazole
- DRUG : Placebo Oral Solution
- Placebo 2\~15 mg/day (2\~15 mL/day)
- Other Names :
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained from a legally authorized guardianprior to the initiation of any protocol-required procedures.
* The subject and/or the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the Investigator.
* The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. In addition, the Childhood Autism Rating Scale (CARS) score is >=30.
* The subject has a Clinical Global Impressions-Severity (CGI-S) score >= 4 AND an ABC-I subscale score >=18 at screening (Visit 1 or Visit 1a) and baseline (V2).
* Environmental factors can be consistent throughout the trial period.
* The subject is a male or female child or adolescent 6 <= age <= 17 of age (6 <= age <= 17) at Baseline (V2).
Exclusion Criteria:
* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level >= 35 mIU/mL].
* Women with a positive pregnancy test or who are pregnant or breastfeeding.
* The subject has a current diagnosis of psychotic disorder such as bipolar disorder, schizophrenia, or depression.
* The subject is currently diagnosed with another disorder on the autism spectrum, including Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Disorder, Rett's Disorder, Childhood Disintegrative Disorder or Fragile-X Syndrome.
* The subject has a history of neuroleptic malignant syndrome.
* The subject represents a significant risk of committing suicide based on history or routine psychiatric status examination.
* The subject has had a seizure in the past year or the electroencephalograph examination is epileptiform discharge at screening.
* The subject has a history of severe head trauma or stroke；
* The subject has a history or current evidence of any unstable medical conditions (eg. history of congenital heart disease or arrhythmia, or cancer) that, in the judgment of the investigator would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
* Non-pharmacological therapy (e.g., psychotherapy, behavior modification, and education training, etc.) could not be stable prior to screening and consistent throughout the study, and the subject who needs to use acupuncture and moxibustion, auditory integration, biofeedback and transcranial magnetic stimulation therapy as supplemental replacement therapy in 7 days prior to taking investigational product or during the course of the trial.
* The subject is considered treatment resistant to antipsychotics medication, in the opinion of the Investigator, based on lack of therapeutic response to 2 different antipsychotics with reasonable doses after treatment of at least 3 weeks each.
* The subjects considered treatment resistant to aripiprazole in the opinion of the investigator based on lack of therapeutic response to an adequate dose and duration of aripiprazole treatment.
* The following laboratory test results, vital sign and Electrocardiograph (ECG) findings are exclusionary:
* QTc > 450 msec (male), QTc > 470 msec (female)
* Platelets (below the lower limit)
* Hemoglobin (below the lower limit)
* Neutrophils (below the lower limit)
* AST (SGOT) or ALT (SGPT) (above the upper limit)
* Creatinine (above the upper limit) In addition, subjects should be excluded if they have any other abnormal laboratory test result, vital sign result or ECG finding that in the investigator's judgment is clinically significant, in that it would impact the safety of the patient or the interpretation of the study results.
* The subject weighs < 15 kg.
* The subject has a known allergy or hypersensitivity to aripiprazole or other dihydrocarbostyrils (eg. carteolol, vesnarinone, and cilostazol).
* The subject has participated in any clinical trials with an investigational agent within the past month.
* Subjects who are likely to require prohibited concomitant therapy during the trial (refer to Section 7 Prohibited and Restricted Therapies).
* Subjects who participated in a previous clinical trial of aripiprazole (with the exception of Investigator Sponsored Trials).
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03487770
|
{
"brief_title": "Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder",
"conditions": [
"Autistic Disorder"
],
"interventions": [
"Drug: Placebo Oral Solution",
"Drug: Aripiprazole Oral Solution"
],
"location_countries": [
"China"
],
"nct_id": "NCT03487770",
"official_title": "A Multicenter, Randomized, Double-blind, Flexible-dosed, Placebo-controlled, Parallel-group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Autistic Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-21",
"study_completion_date(actual)": "2020-04-21",
"study_start_date(actual)": "2018-04-09"
},
"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)": "2020-12-29",
"last_updated_that_met_qc_criteria": "2018-04-02",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-04",
"first_submitted": "2018-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.
Two hypothesis will be tested:
1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.
#Intervention
- DRUG : Duloxetine Hydrochloride
- Flexible dose of 60 or 120 mg daily
- Other Names :
- Cymbalta, LY248686
- DRUG : Escitalopram
- 10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
- Other Names :
- Lexapro, Cipralex
|
#Eligibility Criteria:
Inclusion Criteria
* Male or female participants of at least 18 years who meet criteria for Major Depressive Disorder (MDD), single or recurrent episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV®-TR) disease diagnostic criteria.
* Participants (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current Alzheimer's Disease (AD) treatment to escitalopram for this current MDD episode, at the initial visit.
* Must have a baseline score of >= 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
* Must have a baseline score of >= 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
* Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
* Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
Exclusion Criteria:
* Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
* Have a diagnosis of dementia, Alzheimer's disease (AD), or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
* Concomitant participation in other studies with investigational or marketed products.
* Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference).
* Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
* Are investigator site personnel directly affiliated with this study and/or their immediate families. 'Immediate family' is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. 'Immediate family' is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera [medroxyprogesterone acetate injectable suspension, Pharmacia & Upjohn], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the participant's baseline (Visit 1) HAMD-17 scores on item 3 suicide are 3.
* Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
* Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
* Have any contraindication for the use of duloxetine based on Duloxetine Summary of Product Characteristics (SPC) or any contraindication for the use of escitalopram based on Escitalopram SPC.
* Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
* Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
* Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
* Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
* Have had Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation within the past year.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00810069
|
{
"brief_title": "Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder",
"conditions": [
"Major Depressive Disorder"
],
"interventions": [
"Drug: Duloxetine Hydrochloride",
"Drug: Escitalopram"
],
"location_countries": [
"France",
"Slovenia",
"Netherlands",
"Sweden",
"Denmark",
"Romania",
"Spain",
"Hungary",
"Italy",
"Turkey",
"Greece"
],
"nct_id": "NCT00810069",
"official_title": "Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02",
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2008-11"
},
"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)": "2011-06-21",
"last_updated_that_met_qc_criteria": "2008-12-16",
"last_verified": "2011-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-17",
"first_submitted": "2008-12-16",
"first_submitted_that_met_qc_criteria": "2011-05-20"
}
}
}
|
#Study Description
Brief Summary
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects
#Intervention
- DRUG : ARGX-113
- intravenous or subcutaneous administration
|
#Eligibility Criteria:
Inclusion Criteria:
* Male, between 18 <= age <= 55 years.
* Body mass index (BMI) between 18 <= age <= 30 kg/m2.
* Willingness and ability to understand the purpose and risks of the study and provide signed and dated informed consent.
* Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of an effective method of contraception until 90 days after the last administration of study drug.
* Subjects have to agree not to donate sperm until 90 days after the last administration of study drug.
* Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory findings.
* Agree to discontinue and refrain from intake of all medications, except occasional paracetamol use (maximum dose of 2 g/day and maximum of 10 g/2 weeks), at least 2 weeks prior to the first study drug administration. In addition, subjects must agree to the prohibitions and restrictions for this study.
* Subject is a non-smoker, and not using any nicotine containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to Screening.
Exclusion Criteria:
* Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
* Active infection; a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
* Subjects with known clinically relevant immunological disorders.
* History of severe allergic or anaphylactic reactions.
* Known history or any symptom of clinically significant illness in the 6 months before the first study drug administration.
* Presence or having sequelae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
* Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF > 450 ms [millisecond], or a known long QT syndrome). A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
* Clinically relevant abnormalities detected on vital signs prior to first dosing.
* Significant blood loss (including blood donation [> 500 mL]), or had a transfusion of any blood product within 12 weeks prior to the initial study drug administration or plan one within 4 weeks after the end of the study.
* Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
* The subject has a history of consuming more than 21 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 330 mL of beer, 110 mL of wine or 28 mL of spirits).
* Consumption of a large quantity of coffee, tea (> 6 cups per day) or equivalent.
* Concurrent participation or participation within 90 days prior to the initial study drug administration in a drug/device or biologic investigational research study.
* Administration of a vaccine within 60 days prior to initial study drug administration.
* Administration of any systemic immunosuppressant agent within 6 months prior to initial study drug administration.
* Administration of any systemic steroid within 2 months prior to initial study drug administration.
* Administration of an injectable drug within 30 days prior to the initial study drug administration.
* Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
* Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
* Unsuitable vein for infusion and/or blood sampling.
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
|
NCT03334084
|
{
"brief_title": "A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects",
"conditions": [
"Bioavailability Study"
],
"interventions": [
"Drug: ARGX-113"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT03334084",
"official_title": "A Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-19",
"study_completion_date(actual)": "2018-09-19",
"study_start_date(actual)": "2017-10-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-31",
"last_updated_that_met_qc_criteria": "2017-11-02",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-07",
"first_submitted": "2017-10-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to provide clinical information on a potential drug-drug interaction between daclatasvir and metformin.
Detailed Description
Daclatasvir is a recently approved anti-HCV agent that is a cytochrome P450 3a (CYP3A) substrate but does not affect CYP3A itself. It is also a moderate inhibitor of various membrane transporters such as organic anion-transporting polypeptide 1B1 (OATP1B1) , p-glycoprotein (P-gP), and organic cation transporter (OCT) 1 and 2.
Metformin is used to treat diabetes mellitus. It is an OCT-2 and OCT-1 substrate and when combined with daclatasvir increased levels of metformin may occur, with risk on hypoglycaemic episodes. The Summary of Product Characteristics (SmPC) of daclatasvir currently does not mention this potential drug-drug interaction.
HCV is associated with insulin resistance (IR) which may develop to diabetes mellitus (DM). The prevalence of IR in HCV infected patients is estimated varying from 30% to 70%. Several studies showed that IR has a negative impact on the achievement of an undetectable HCV viral load after completing 12 weeks of treatment (Sustained Virologic Response (SVR)).
This study aims to provide clinical information on a potential drug-drug interaction between daclatasvir and metformin.
#Intervention
- DRUG : Daclatasvir
- Other Names :
- Daklinza
- DRUG : Metformin
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 and not older than 55 years at screening.
* Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to Day 1.
* Subject has a Quetelet Index (Body Mass Index) of 18 to 35 kg/m2, extremes included.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition as established by medical history, physical examination, and electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to Day 1. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
* Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Exclusion Criteria:
* Creatinine clearance below 60mililiter/minute (ml/min).
* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Positive HIV test.
* Positive hepatitis B or C test.
* Pregnant female (as confirmed by an Human chorionic gonadotropin (hCG) test performed less than 4 weeks before day 1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the study.
* Therapy with any drug (for two weeks preceding Day 1), except for acetaminophen (max 2 gram/day).
* Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal and hepatic disorders (increased alanine aminotransferase (ALAT)/ASAT), hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the study and the procedures required.
* Participation in a drug study within 60 days prior to Day 1.
* Donation of blood within 60 days prior to Day 1.
* Febrile illness within 3 days before Day 1.
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
|
NCT02565862
|
{
"brief_title": "A Drug-drug Interaction Study Between Daclatasvir and Metformin",
"conditions": [
"Hepatitis C",
"Diabetes Mellitus",
"Insulin Resistance"
],
"interventions": [
"Drug: Daclatasvir",
"Drug: Metformin"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT02565862",
"official_title": "A Drug-drug Interaction Study Between the Novel Anti-hepatitis c Virus (HCV) Agent Daclatasvir and The Antidiabetic Agent Metformin in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-07",
"last_updated_that_met_qc_criteria": "2015-09-30",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-01",
"first_submitted": "2015-09-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the usability of the Colour Assessment and Diagnosis (CAD) test in children. To determine the prevalence of colour vision deficiency (CVD) among Turkish children, to identify the class of deficiency and to quanify severity of loss.
#Intervention
- DEVICE : the Colour Assessment and Diagnosis (CAD) test
- The CAD test (City Occupational Ltd, London, UK) measures the severity of red-green and yellow-blue colour vision loss according to red-green and yellow-blue thresholds which are expressed in CAD units and diagnoses accurately the subject's class of colour vision
|
#Eligibility Criteria:
Inclusion Criteria: children with aged 6 <= age <= 16 years, who attended the ophthalmology department at the Istanbul Medipol University -
Exclusion Criteria:Children with known or current evidence of ocular pathology (other than refractive errors), with history of long term use of medication, previous ocular surgery and those with chronic systemic diseases were excluded from the study
*
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:
Yes
|
NCT04048499
|
{
"brief_title": "Prevalence and Severity of Colour Vision Deficiency Among Turkish Children",
"conditions": [
"CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT04048499",
"official_title": "Prevalence and Severity of Colour Vision Deficiency Among Turkish Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-01",
"study_completion_date(actual)": "2019-03-01",
"study_start_date(actual)": "2018-01-01"
},
"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)": "2019-08-09",
"last_updated_that_met_qc_criteria": "2019-08-06",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-07",
"first_submitted": "2019-08-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients witk chronic kidney disease.
Detailed Description
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Chromium-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from NCC, NKCC and ENaC will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
#Intervention
- DRUG : Atorvastatin
- Zarator, 80 mg pr. day for 5 days
- Other Names :
- Zarator
- DRUG : Unikalk
- 1 tablet Unikalk pr day for 5. days
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women
* minimum 20 years
* Chronic Kidney disease
* Estimated GFR (eGFR) between 30 and 90 ml/min
Exclusion Criteria:
* Nephrotic Syndrome
* Diabetes mellitus
* Anamnestic or clinical signs of significant heart, lung, lever, kidney, thyroid and brain disease
* Neoplastic disease
* Alcohol abuse,
* Drug abuse
* Pregnancy or nursing
* Blood donation within a month before examination
* Hgb < 6,0
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01213498
|
{
"brief_title": "The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy",
"conditions": [
"Nephropathy",
"Cardiovascular Diseases"
],
"interventions": [
"Drug: Unikalk",
"Drug: Atorvastatin"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT01213498",
"official_title": "The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2010-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-21",
"last_updated_that_met_qc_criteria": "2010-10-01",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-04",
"first_submitted": "2010-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A quasi-experimental, prospective clinical trial with pre and post intervention measurements, whose porpuose is assess the efficacy of a therapeutic exercise protocol to treat neuropathic pain in Fabry Disease.
Detailed Description
There take part in this study women or men aged between 18 and 65 years, with a diagnosys by a physician specializing in Fabry disease with FabryScan. Patients must present a stable evolution, with a scoring system of disease severity (DS3) that must be less than 8 points per year in the last 2-3 years and they have to presence of neuropathic pain with a score greater than or equal to 4 in the questionnaire 'Douleur neuropathique (DN4)'.
#Intervention
- OTHER : Therapeutic Exercise
- Patients who meet the inclusion criteria and who want to carry out the workshops, fill out an informed consent explaining the procedure to be followed and accepting the cessation of data to carry out the study.
Patients will be divided into 2 working groups (approximately 10 patients in total, in a Gaucher disease group and in another Fabry disease). The workshops will be held at the foundation twice a month in sessions of 45 minutes of work for 3 months (May, June, July 2019). In these sessions the physiotherapists will show the new exercises to the patients. The exercises that are taught in that session should be done at home 3 times a week. In addition, a document will be delivered with the exercises to be carried out and the frequency and intensity of execution. The workshops will be guided at all times by a physiotherapist specialized in therapeutic exercise and EDL.
|
#Eligibility Criteria:
Inclusion criteria:
* Female or male patients between 18 years and 65 years.
* Patients diagnosed by a doctor specializing in Fabry disease with FabryScan.
* Fabry's disease must have a stable evolution, with a disease severity scoring system (DS3) that must be less than 8 points per year in the last 2 <= age <= 3 years.
* Presence of neuropathic pain with a score greater than or equal to 4 in the 'Douleur neuropathique (DN4)' questionnaire.
Exclusion criteria:
* Patients with an acute cardiovascular disease or with a heart or kidney transplant.
* Subjects with acute orthopedic problems that limit their participation in the study.
* Subjects with cognitive impairments that prevent them from filling in the questionnaires or understanding the exercises to be performed.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04050137
|
{
"brief_title": "Therapeutic Exercise to Treat Neuropathic Pain",
"conditions": [
"Gaucher Disease",
"Fabry Disease"
],
"interventions": [
"Other: Therapeutic Exercise"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT04050137",
"official_title": "Therapeutic Exercise to Treat Neuropathic Pain in Patients With Chronic Lisosomal Injuries: Learning and Service Project",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-01",
"study_completion_date(actual)": "2020-12-14",
"study_start_date(actual)": "2019-05-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-16",
"last_updated_that_met_qc_criteria": "2019-08-07",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-08",
"first_submitted": "2019-04-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to assess the effective of intraoperative use of tranexamic acid in reducing blood loss during telescoping nail application in cases of osteogenesis imperfecta.
Detailed Description
Osteogenesis imperfecta (OI) is a rare inherited pathology that consists of abnormal type one collagen synthesis that affects all structures in the body. The most important and early sign of this pathology is the appearance of fractures after low-energy trauma, progressive bowing of long bones, joint instability, and chronic bone pain. The most used classification is the one created by Sillence that initially had four types and now is expended to more than 15 types. A new nomenclature was published in 2014 in order to simplify the classification and help understand such an intricate pathology. Clinically, all systems in the body are affected, but changes to the musculoskeletal are the most severe; besides, a variable degree of bone brittleness is present. Patients are suffering from severe hyperlaxity, short stature, scoliosis, progressive bowing of the limbs, and chronic bone pain due to continuous microfractures.
The surgical treatment of osteogenesis imperfecta (OI) is negatively influenced by clinical features such as osteoporosis, limb deformities and bone changes caused by bisphosphonate therapy. Blood loss during telescoping nail application in patients with Osteogenesis Imperfecta is a serious problem especially patients with Osteogenesis Imperfecta type III are considered at high risk of blood loss during surgery because of capillary fragility and an altered platelet function.
Tranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries.
However, the effectiveness of tranexamic acid use in application of telescoping nail in osteogenesis imperfecta still remains unclear and no previously available study about this subject. The purpose of this study is to assess the effectiveness of intraoperative use of intravenous (IV) tranexamic acid in reducing total blood loss and transfusion rates for patients who will be operated with telescoping nail application for osteogenesis imperfecta.
Each patient with osteogenesis imperfecta, who consecutively will undergo telescoping femoral nail application with intraoperative use of tranexamic acid during 2022-2023, will be recruited in the study.
A total of 40 patients undergoing telescoping femoral nail application for osteogenesis imperfecta will be including in a prospective randomized study.
Taking detailed history and full clinical examination to exclude the presence of any medical disorder that prevents use of Tranexamic acid. Preoperative lab investigations are Complete Blood Count (CBC) to determine Hemoglobin HB level and Hematocrit value preoperatively.
Operations will be performing under general anesthesia, no tourniquet is using, and the intraoperative regime will be the same for all patients. Patients will be dividing into 2 groups; in group A (control); patients receiving no tranexamic acid, in group B (case); patients receiving 10-15mg/kg or 1g of tranexamic acid intravenously, given 30 minutes before skin incision in telescoping femoral nail application followed by another dose of intravenous tranexamic acid (10-15mg/kg; body weight average 1g) at time of wound closure.
Intraoperative blood loss shall be quantified by measuring irrigation fluid and the weight of surgical sponges used to dry the field intraoperatively by the researcher plus amount of blood in suction drain.
Comparison of blood loss between patients with first femoral osteotomy and patients with previous recurrent femoral osteotomies.
#Intervention
- DRUG : Tranexamic acid
- Tranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries.
- Other Names :
- Kapron
|
#Eligibility Criteria:
Inclusion Criteria:
All patients with osteogenesis imperfecta who will undergo telescoping femoral nail application in Assiut University Hospital - Department of Orthopaedic and Trauma Surgery between April 2022 and March 2023.
Exclusion Criteria:
* Known allergy to Tranexamic Acid
* History of any acquired disturbances of colour vision
* History of major comorbidities (e.g., severe ischemic heart disease)
* Refusal of blood products
* History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, or a prolonged partial thromboplastin time, active intravascular clotting & known congenital thrombophilia
* Preoperative use of anticoagulant therapy within five days before surgery
* Medical Unfit
* Participation in another clinical trial involving pharmaceutical drugs.
* Patients or their relatives who refuse to participate in the study
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05321199
|
{
"brief_title": "Tranexamic Acid During Telescoping Nail Application In Osteogenesis Imperfecta",
"conditions": [
"Osteogenesis Imperfecta"
],
"interventions": [
"Drug: Tranexamic acid"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05321199",
"official_title": "Efficacy of Intraoperative Use of Tranexamic Acid in Reducing Blood Loss During Telescoping Nail Application in Osteogenesis Imperfecta - Randomized Control Trials",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-30",
"study_completion_date(actual)": "2023-11-30",
"study_start_date(actual)": "2022-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-14",
"last_updated_that_met_qc_criteria": "2022-04-01",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-11",
"first_submitted": "2022-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes
Detailed Description
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm (3000 total), age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for more energy (less fatigue and/or better concentration/focus during screening); (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) indicate an interest in taking a plant derived cannabinoid product to help with their energy and/or focus.
Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded. People with a calculated BMI of 18.5 or less will be excluded.
Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
#Intervention
- DIETARY_SUPPLEMENT : Energy Study Product Usage
- Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* 21 years and older
* Resides in the United States
* Endorses: a desire for more energy (less fatigue) and/or a desire for better concentration (focus/attention)
* Selects more energy and/or better concentration as a primary reason for taking a cannabinoid product
* Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e.
CBD, THC) for the duration of participant engagement
* Expresses a willingness to take a study product and not knowing the product identity until the end of the study
Exclusion Criteria:
Pregnant, trying to become pregnant, or breastfeeding Reports a diagnosis of liver disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Calculated BMI 18.5 or less
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 105 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05502328
|
{
"brief_title": "Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes",
"conditions": [
"Energy"
],
"interventions": [
"Dietary Supplement: Energy Study Product Usage"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05502328",
"official_title": "Radicle™ Energy: A Randomized, Blinded, Placebo-controlled Study of Cannabinoid Formulations and Their Effects on Energy Levels, Focus, Appetite and Other Health Outcomes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-05-24",
"study_start_date(actual)": "2022-08-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-22",
"last_updated_that_met_qc_criteria": "2022-08-12",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-16",
"first_submitted": "2022-08-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Autism Spectrum Disorder (ASD) is a lifelong, neurodevelopmental disorder effecting one in fifty-nine children. Each individual with ASD is unique. Children with ASD may have trouble making friends, keeping friends, communicating their needs, engaging in leisure activities, learning to read and do math, and many other challenges. The children may engage in repetitive behaviors such as hitting themselves or flapping their hands, and may be over sensitive to particular sounds or lights which can make certain places, such as a store, very uncomfortable. Also, children with ASD may have challenging behaviors such as hitting others and excessive tantrums that can seem uncontrollable. 25 to 40 hours a week of intensive applied behavior analysis is the evidence-based treatment for children with ASD. Many children with ASD in rural areas and certain states are unable to access evidence-based treatment because of insurance barriers and lack of providers. The Competent Learner Model uses strategies from applied behavior analysis to target core skills that increase successful participation in life activities. Its program is applicable across all ages and developmental levels, and it has an online course of study which has been used to train professionals and lay people alike including parents. The purpose of this study was to assess the feasibility of training parents in applied behavior analysis using the Competent Learner Model with children with ASD who do not have access to treatment. The program consisted of a hybrid of group sessions for caregivers, coaching sessions for the caregiver-child dyads, and online units for caregivers. This project assessed participation in and satisfaction with the program as well as changes in parenting stress. Feedback from caregivers will be used to create a more satisfactory method of increasing accessing to families of children with Autism Spectrum Disorder in rural areas.
Detailed Description
Specific Aims: Many children with Autism in West Virginia are not able to access the evidence-based treatment, intensive applied behavior analysis, because of insurance barriers and lack of providers. Training parents in applied behavior analysis using the Competent Learner Model may allow children to access treatment. The purpose of this study was to determine if it is feasible to use online training units, group sessions for caregivers co-led by a parent, and family coaching sessions to improve the functioning of children with Autism. The current study is the first examination of Competent Learner Model as an independent intervention for parents using a hybrid of group and family sessions. Hypotheses: (1) Parent will complete therapy homework and attend 90% of sessions. (2) Parents will report a decrease in parenting stress.
Background: Autism is a lifelong, developmental disorder that affects 1 in 59 children, which represents about 720 children in the region of West Virginia where this study took place. Challenges for children with Autism include difficulty making and keeping friends, trouble talking to people, and insisting on rigid routines that interfere with daily life. The children may have challenging behavior such as hitting themselves, hitting others, and extreme meltdowns. Children may struggle to learn in typical classrooms, and may have trouble going to community events with their families. Families participate in fewer community activities leading to social isolation, and parents of children with Autism are more stressed than other parents. 25-40 hours per week of applied behavior analysis for 1-3 years is the evidence-based treatment for Autism. Many insurance companies in West Virginia specifically exclude services for children with Autism, and the Mountaineer Autism Project has estimated that only 1.6% of children with Autism in the state are receiving applied behavior analysis. Additionally, West Virginia has a limited number of providers for Autism. Children with Autism make greater progress across multiple settings (e.g., home, public) when their caregivers are involved in treatment, and coaching results in greater improvements in child behavior following behavioral parent training. Parent-implemented interventions for Autism are promising but more research is needed. When parents are trained to use the therapeutic strategies, the parent may be able to increase the child's skill development (e.g., self-care, functional academics, and social skills) across multiple settings and feel less stressed. The Competent Learner Model uses concepts and strategies from applied behavior analysis, Direct Instruction, and Precision Teaching to improve functioning of individuals with Autism. The program targets core skills that facilitate successful participation across all areas of an individuals' life, and it can be applied across all ages and developmental levels. A core component of the Competent Learner Model is the Course of Study, which has been used to train professionals and lay people. The Course of Study is a sequence of online training units using programmed instruction formats with embedded active student responding, video examples, and skill check outs. Coaching is a critical component of the program. While the Competent Learner Model uses well-researched strategies, the research of the program's effectiveness consists primarily of poster presentations and a handful of dissertations. One study found parents were better able to apply strategies and reported less stress when the parents were trained supplemental to their child's treatment. The effectiveness of the Competent Learner Model as implemented by parents independent of other treatment is unknown. Parent training using the Competent Learner Model may provide access to effective treatment for families. If this program is effective in training parents, it will increase access to effective services, decrease the amount of face-to-face time a parent must spend with a clinician and, thus, allow the clinician to serve a greater number of families simultaneously. More broadly, this treatment approach may present a treatment option for rural Americans with limited access to behavioral health outside of West Virginia as well. The study will contribute to the literature of training parents as therapists for their children with Autism.
|
#Eligibility Criteria:
Inclusion Criteria: Caregiver-child dyads were eligible to participate if:
* the child has a diagnosis of Autism
* the child was under 18-years-old
* the child's legal guardian consented to treatment
* the child's insurance was accepted at this clinic or the family will pay for the services
Exclusion Criteria: Children were excluded from the study if:
* they were currently receiving intensive applied behavior analysis in the home
* the caregiver would not consent to being videotaped.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04931043
|
{
"brief_title": "Feasibility of Competent Learner Model With Families of Children With ASD",
"conditions": [
"Autism Spectrum Disorder"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04931043",
"official_title": "Feasibility of Parent Training Using the Competent Learner Model With Families of Children With Autism Spectrum Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-12",
"study_completion_date(actual)": "2019-06-12",
"study_start_date(actual)": "2018-11-26"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-18",
"last_updated_that_met_qc_criteria": "2021-06-10",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-18",
"first_submitted": "2021-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The scientific objective of this program is to meet the rehabilitation needs of combat wounded Veterans with mild to moderate Traumatic Brain Injury (TBI) via telerehabilitation and determine the effect of this modality of care on patients' physical health and outcomes including function and community participation. The investigators will also evaluate the benefits and limitations of rehabilitation using telehealth from the Veteran and caregiver perspectives and evaluate the impact of rehabilitation via telehealth on Veterans Administration (VA) healthcare facility use.
Detailed Description
Rational: TBI can cause life-long impairments in physical, cognitive, behavioral and social function that are usually more disabling than the residual physical deficits. Recovery can continue many years after initial trauma. Little is known about optimal methodologies to treat the vast and complicated secondary manifestations of combat related TBI. Applicability: The goal of this rehabilitation program is eventually to optimally define telerehabilitation services for all Veterans with polytrauma, including accurate and efficient screening instruments, educational material for patients and families, family support, and family counseling to enhance care coordination and to maximize functional outcomes and quality of life.
Patient population: The program will help wounded Veterans with a diagnosis of TBI from combat operations in Iraq and Afghanistan. Many Veterans reside in rural and underserved areas. Although access to health care for rural patients remains a critical challenge, telerehabilitation may represent a viable means for the delivery of therapeutic services to such patients, particularly those served by the VA. The program has implications for civilian populations as well including those injured in automobile or industrial accidents and similar in illness to the cohort of Veterans the investigators intend to follow.
Clinical applications, benefits and risks: The goals of the rehabilitation project will be to enhance the wounded Veteran's capacity to process and interpret information and to improve his ability to function in all aspects of family and community life. It will involve a combination of restorative training which focuses on improving a specific cognitive function and compensatory training which educates Veterans on adapting to the presence of a cognitive deficit that may or may not be curable using singular one to one interventions as well as integrated interdisciplinary approaches to target multiple conditions. The investigators see no risks involved in this clinical intervention.
Projected time to achieve a consumer-related outcome: The results of the telerehabilitation project should immediately be available for dissemination throughout the VA. The VA has already committed itself to a nationwide rollout of similar telerehabilitation projects for wounded Veterans. Hence, the findings should have immediate application in VA care for returnees from combat.
The investigators recently added MyHealtheVet to the TeleRehab I care coordination for existing TeleRehab I subjects. MyHealtheVet is the VA's Personal Health Record and offers Veterans an additional way for Veterans to partner with the health care team in making informed decisions. MyHealtheVet is an existing, innovative program available to Veterans throughout the VA. (see https://www.myhealth.va.gov/index.html for additional information) Most of the remaining TeleRehabilitation Veterans are already enrolled in the MyHealtheVet program. Besides giving patients access to their health records and online prescription ordering, there is a secure messaging system with VA providers, who can save the secure message into the patient's electronic medical record (CPRS) with a single click.
A total of 75 of the 85 IRB-approved subjects were initially enrolled. The investigators wanted to enroll up to 10 new subjects, and the existing TeleRehab I subjects were all be asked to sign a revised ICF that adds MyHealtheVet to the study, and makes other changes to the ICF required by Tampa VA R\&D. If the subjects consent they will be required to register and be authenticated to use MyHealtheVet in order to participate or continue to participate in the study. An additional 6 subjects were enrolled for a total of 81 subjects on whom demographic data was collected. Sufficient data was collected on 75 subject for analyses of their responses to surveys.
MyHealtheVet enrollment and secure messaging authentication is required to continue in the study, and changes to the protocol will reflect this additional eligibility criterion. All other methods of communication with subjects and existing surveys will continue. Eventually MyHealtheVet will replace the LAMP for secure communications with the Care Coordinator.
#Intervention
- OTHER : Telerehabilitation
- Rehabilitation via computer assisted internet capabilities
|
#Eligibility Criteria:
Inclusion Criteria:
* Veterans or active duty military personnel discharged from the James A. Haley Veterans' Hospital in Tampa, FL or in rehabilitation there
* ages 18 and older
* have sustained a TBI as evidenced by primary or secondary diagnosis on initial admission, with or without comorbid Post-traumatic Stress Disorder (PTSD)
* enrolled and receiving medical services through the Tampa VA and medically stable as clinically determined by the patient's physician.
In order to add MyHealtheVet to the study as a method of care coordination, MyHealtheVet enrollment and secure messaging authentication is required to continue in the study. All other methods of communication with subjects and existing surveys will continue. Eventually MyHealtheVet will replace the LAMP for secure communications with the Care Coordinator.
Exclusion Criteria:
* Telerehab services will be offered only to those patients with low ADLs who require additional care and who stand to benefit from the care coordination program.
* The investigators will also exclude those who are severely injured or institutionalized. This includes patients with a severe psychopathology.
* Refusal to enroll in MyHealtheVet with Secure Messaging will eventually lead to subjects being dropped from the study.
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
|
NCT00676182
|
{
"brief_title": "Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury",
"conditions": [
"Traumatic Brain Injury",
"Post-traumatic Stress Disorder"
],
"interventions": [
"Other: Telerehabilitation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00676182",
"official_title": "Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2008-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-25",
"last_updated_that_met_qc_criteria": "2008-05-09",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-12",
"first_submitted": "2008-05-07",
"first_submitted_that_met_qc_criteria": "2016-03-24"
}
}
}
|
#Study Description
Brief Summary
This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.
Detailed Description
OBJECTIVES:
Primary:
To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery.
Secondary:
To determine the short term cosmetic and quality of life of the participants treated with this regimen.
To determine the local control of the participants treated with this regimen.
OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear.
PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.
#Intervention
- RADIATION : Radiation therapy
- Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks.
Intensity modulated radiation treatment is used.
|
#Eligibility Criteria:
Inclusion Criteria:
* female, aged between 18 <= age <= 70
* pathological confirmed breast invasive carcinoma
* patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy
* stage p T 1 <= age <= 2 N 0
* metastasis omitted by routine examinations in 1 months before enrollment
* complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count > 1.8 *10^9/L, hemoglobin > 8.0g/dl, platelet > 75 * 10^9/L
* hepatic and renal function in 2 weeks prior to study entry should be normal
* study entry within 60 days from whichever comes later: surgery or last chemotherapy
* women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry
* signs study specific informed consent prior to study entry
Exclusion Criteria:
* breast cancer with stage III/III (AJCC 7th)
* occult breast cancer
* in-situ breast carcinoma
* bilateral breast cancer
* male breast cancer
* breast lymphoma or breast sarcoma
* combined with Paget's disease
* received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy
* positive surgical margin
* axillary lymph nodes dissection or sentinel lymph node biopsy omitted
* regional lymph nodes radiation needed
* boost volume larger than 1/4 of the whole breast
* tumor bed unable to recognize on CT
* prior invasive malignant tumor history
* prior radiation to thoracic
* connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc.
* severe, active co-morbidity, defined as follows:
* unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* severe, acute bacterial or fungal infection within the last 2 weeks
* chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days
* pregnant women
Sex :
FEMALE
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
|
NCT03320421
|
{
"brief_title": "Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery",
"conditions": [
"Breast Cancer Female"
],
"interventions": [
"Radiation: Radiation therapy"
],
"location_countries": [
"China"
],
"nct_id": "NCT03320421",
"official_title": "Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-01",
"study_completion_date(actual)": "2019-01-01",
"study_start_date(actual)": "2017-01-01"
},
"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)": "2019-01-31",
"last_updated_that_met_qc_criteria": "2017-10-23",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-25",
"first_submitted": "2017-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing to participate in the study and meet the entry criteria assessed at the screening visit, will begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline migraine characteristics. During this baseline period, subjects will continue treating their migraines as usual, simply recording the information in a daily headache diary. Subjects who, after completing the baseline, continue to meet entrance criteria will be eligible to enter into the treatment phase and be randomized according to the Clinvest generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary assessments will collect study medication adherence, pain severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples will be collected and analyzed for ionized magnesium, electrolytes, and creatinine.
Detailed Description
This is a multi-center, double-blind, randomized, placebo-controlled, parallel study of MLD10 for the prevention of migraine headache. The study population will consist of approximately 142 male and female subjects between 18 and 65 years of age with frequent episodic migraine as defined by International Classification of Headache Disorders-3beta criteria. Two MLD10 (243 mg (milligrams) of elemental magnesium) or placebo caplets will be taken twice daily for a total daily dose of 486 mg.
VISIT 1 - SCREENING
The following will be completed at Visit 1:
1. Obtain written Informed Consent. The informed consent will be obtained in accordance with Good Clinical Practices (GCP) and all applicable regulatory requirements from each subject prior to participation in the study.
2. Verify Inclusion/Exclusion Criteria. Subjects will meet all the inclusion and none of the exclusion criteria.
3. Obtain demographics (race, ethnicity, sex, date of birth)
4. Obtain medical, medication, and headache history. Data collected will include medical history and diagnoses, age at onset of migraine and other pertinent migraine/headache history, history of acute and prophylactic headache medications within the past 30 days, and history of other recent/concomitant medications.
5. Obtain date of last menstrual cycle and perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
6. Perform physical and neurological examinations.
7. Measure vital signs (height, weight, resting heart rate, and blood pressure).
8. Review Baseline Headache Diary. Subjects will be instructed to complete a daily online headache diary. Assessments to be captured are start/stop time, severity, associated symptoms, use of rescue medications, and unusual symptoms.
9. Administer Columbia-Suicide Severity Rating Scale (C-SSRS).
10. Schedule Visit 2.
VISIT 2 - RANDOMIZATION
1. Verify Inclusion/Exclusion Criteria. Subjects must continue to meet all inclusion (including ≥ 3 days of migraine during baseline) and none of the exclusion criteria.
2. Perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
3. Measure vital signs (weight, resting heart rate, and blood pressure).
4. Record any changes to concomitant medications.
5. Record any Serious Adverse Events (SAE) since signing the Informed Consent.
6. Review Baseline Headache Diary for completeness and continuing eligibility.
7. Randomize subject
8. Review Month 1 Headache Diary instructions (same instructions as those discussed for Baseline Headache Diary).
9. Dispense Month 1 study medication. Subjects will be instructed how to take study medication, prohibited medications/foods, dosage limitations of study medication, and storage requirements. Subjects will be instructed to return all used/partially used/unused study medication at next office visit and medications reconciliation will be performed to ensure a compliance of at least 80%. Subjects not complying at an 80% level will be withdrawn, unless otherwise approved by the Sponsor and/or Clinvest. (Estimated to be \< 10%)
10. Administer C-SSRS.
11. Administer MIDAS.
12. Collect serum samples for electrolytes, creatinine, and ionized Mg.
13. Schedule Visit 3.
VISIT 3 - END OF TREATMENT PERIOD MONTH 1
1. Record any changes to concomitant medications.
2. Record any Non-Serious Adverse Events (NSAE) and/or SAEs.
3. Perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
4. Measure vital signs (weight, resting heart rate, and blood pressure).
5. Review Month 1 Headache Diary for completeness.
6. Review instructions for Month 2 Headache Diary (same instructions as those discussed for Month 1 Headache Diary).
7. Collect Month 1 unused study medication and used packaging. Confirm 85% compliance of medication usage per study protocol.
8. Dispense Month 2 study medication and review the dosage limitations of study medication, storage requirements, and to return all used/partially used/unused study medication at next office visit.
9. Perform drug accountability.
10. Administer C-SSRS.
11. Collect serum samples for electrolytes, creatinine, and ionized Mg.
12. Schedule Visit 4.
VISIT 4 - END OF TREATMENT PERIOD MONTH 2
1. Record any changes to concomitant medications.
2. Record any NSAEs/SAEs.
3. Perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
4. Measure vital signs (weight, resting heart rate, and blood pressure).
5. Review Month 2 Headache Diary for completeness.
6. Review instructions for Month 3 Headache Diary (same instructions as those discussed for Month 2 Headache Diary).
7. Collect Month 2 unused study medication and used packaging. Confirm 85% compliance for medication usage per study protocol.
8. Dispense Month 3 study medication and review the dosage limitations of study medication, storage requirements, and to return all used/partially used/unused study medication at next office visit.
9. Perform drug accountability.
10. Administer C-SSRS.
11. Collect serum samples for electrolytes, creatinine, and ionized Mg.
12. Schedule Visit 5.
VISIT 5 - END OF TREATMENT PERIOD MONTH 3
1. Record any changes to concomitant medications.
2. Record any NSAEs/SAEs.
3. Perform urine pregnancy test, if appropriate.
4. Measure vital signs (weight, resting heart rate, and blood pressure)
5. Perform physical/neurological examinations.
6. Collect Month 4 unused study medication and used packaging.
7. Perform drug accountability.
8. Administer SGIC \& complete PGIC.
9. Administer MIDAS.
10. Administer C-SSRS.
11. Collect serum samples for electrolytes, creatinine, and ionized Mg.
12. Exit subject.
#Intervention
- DRUG : MLD10
- Other Names :
- elemental magnesium
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* male or female, in otherwise good health, 18 <= age <= 65 of age.
* history of frequent episodic migraine (3 <= age <= 14 migraine days per month) (with or without aura) according to the International Classification of Headache Disorders-3beta for at least 3 months.
* onset of migraine before age 50.
* stable history of migraine at least 3 months prior to screening.
* not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
* if female of childbearing potential, has a negative urine pregnancy test at Visits 1 <= age <= 5 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as listed:
* complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for 7 days after completion or premature discontinuation from the study; surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); sterilization of male partner when in a monogamous relationship; intrauterine device with published data showing lowest expected failure rate is less than 1% per year; double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
* completion of online diary must be >= 80% compliance, unless otherwise approved by the Sponsor and/or Clinvest.
Exclusion Criteria:
* unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
* pregnant, actively trying to become pregnant, or breast-feeding.
* diagnosed with International Classification of Headache Disorders-3beta criteria for Chronic Migraine within 3 months prior to screening, at the time of screening, and/or during the baseline period.
* experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine within the last year.
* history of medication overuse headache (MOH) (Appendix II) in the 3 months prior to study enrollment or during the baseline phase.
* history of medication overuse (MO) of ergotamines, triptans, opioids, analgesics, NSAIDS and combination therapies, as defined by ICHD-3beta criteria and/or MO during baseline period.
* history of substance abuse and/or dependence, in the opinion of the Investigator.
* history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study.
* unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
* suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events.
* has significant risk of suicide, defined as a 'yes' answer to any of the following questions on the Columbia-Suicide Severity Rating Scale (C-SSRS), either at the screening visit (when assessing the prior 12 months) or at visit 2 (when assessing time since the screening visit):
1. Questions 4 or 5 on the suicidal ideation section
2. Any question on any item in the suicidal behavior section
* any psychiatric disorder with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in their ability to complete study activities.
* hypersensitivity, intolerance, or contraindication to the use of magnesium L-lactate dehydrate or any of its components.
* received any investigational agents within 30 days prior to Visit 1.
* plans to participate in another clinical study at any time during this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02322333
|
{
"brief_title": "MLD10 in the Prevention of Migraine in Adults",
"conditions": [
"Migraine"
],
"interventions": [
"Drug: MLD10",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02322333",
"official_title": "A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of MLD10 in the Prevention of Migraine Headache in Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-06",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-09",
"last_updated_that_met_qc_criteria": "2014-12-17",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-23",
"first_submitted": "2014-12-17",
"first_submitted_that_met_qc_criteria": "2020-09-16"
}
}
}
|
#Study Description
Brief Summary
This is an observational study aiming to study the use of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases, at Rheumatology clinics in western Sweden and also to investigate possible associations between CAM using habits and other characteristics of the patients.
Detailed Description
Complementary and alternative medicine (CAM) is treatment that primarily is given outside the institutions where conventional medicine is practised. CAM drugs are substances that often have a natural origin and are taken orally or used topically, for self-treatment. CAM methods are therapies where the patient often goes to a practitioner, for example acupuncture, massage, homeopathy or chiropractics.
Most cultures have their own history of traditional treatments, with herbal medicine or spiritual healers.
The use of complementary and alternative medicine (CAM) is widespread and increasing in many countries. The sales figures in Sweden for CAM drugs, functional foods and dietary supplements have increased from 450 million to 4250 million SEK between 1980 and 2007. Many people of today use CAM as a complement, rather than an alternative, to conventional healthcare. Some alternative methods, like acupuncture and massage, have also been integrated into conventional medicine.
The biological effects of drugs containing herbs or animal parts are often unknown and there is a hazard of interaction with prescribed medication.
The use of CAM drugs is often not communicated by the patient to the physician. A Swedish point observation study of patients admitted to Sahlgrenska hospital 2004 showed that 69 % of the patients had used CAM drugs at any time in their life, but only 27,5% had informed their doctor about it. The use of CAM drugs was seldom documented in the medical records of the patient.
The utilization of CAM among patients with rheumatic diseases in Sweden has never been studied before.
The aim of this trial was to study the use of CAM methods and CAM drugs among patients seen at rheumatology practises in the west of Sweden. To investigate which methods and drugs that are being used and to see if there are connections between using habits and factors like gender, age, rheumatic diagnoses, disease activity, medication and the patients experience of pain, fatigue and general health. We were also interested in finding out the reason for use of CAM, and if the patients had experienced beneficial effects or side effects of the use.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients were eligible for inclusion if they were attending the rheumatology clinic and had had an appointment there before.
Exclusion Criteria:
* Patients were excluded if they were on their first visit to the practice, had dementia or had difficulties understanding Swedish.
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
|
NCT00665275
|
{
"brief_title": "Complementary and Alternative Medicine Among Outpatients With Inflammatory Rheumatic Diseases in Western Sweden",
"conditions": [
"Rheumatic Diseases"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT00665275",
"official_title": "The Use of Complementary and Alternative Medicine Among Outpatients With Inflammatory Rheumatic Diseases in Western Sweden.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-07",
"study_completion_date(actual)": "2007-07",
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-04-23",
"last_updated_that_met_qc_criteria": "2008-04-18",
"last_verified": "2008-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-23",
"first_submitted": "2008-04-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
Detailed Description
Patients will be randomized to 1 of 3 doses of oral LXR015-1 for 28 days and patients will be monitored for adverse events for the duration of the study. Patients will continue to be monitored for least 4 weeks after completion of the dosing.
#Intervention
- DRUG : LXR015-1
|
#Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Documented HIV infection.
* CD4 cell count less than 200 cells/mm3.
Prior Medication:
Allowed:
Acute therapy for opportunistic infections or serious AIDS defining infections must be completed at least 28 days before study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Patients that are unable to take adequate oral intake (i.e. unable to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/oral/esophageal discomfort).
* Patients who have severe diarrhea as defined as >= 7 stools per day, or acute diarrhea due to a treatable cause.
NOTE:
* If the patient has Cryptosporidia, Mycobacterium avium, or Cytomegalovirus that is unresponsive to treatment and has less than 7 stools per day, the patient may participate in this study.
* Patients who have any severe or life-threatening laboratory or clinical abnormality, or are not expected to live for 8 weeks.
* Patients who have an active opportunistic infection, including tuberculosis, cryptococcosis, or other serious AIDS defining infections requiring immediate treatment. Acute therapy must be completed at least 28 days before study entry.
* Patients with unexplained elevated temperature >= 38.5 degrees C that persists for 7 days or more within 14 days before study entry.
* Patients with malignancy other than squamous or basal carcinomas of the skin. Patients with visceral Kaposi's sarcoma or lymphoma requiring systemic chemotherapy or radiation treatment will be excluded. Patients with Kaposi's of the skin or mucous membranes may enroll in this study.
* Patients, who in the judgment of the investigator are unable to comply with the protocol.
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior condition are excluded:
A known history of hypersensitivity reaction to soy protein or soy lecithin. NOTE:
* This hypersensitivity is identified through medical history, not skin testing.
Excluded:
* Systemic chemotherapy.
* Acute therapy for opportunistic infections or other serious AIDS defining infections.
* Intravenous rehydration as treatment for diarrhea.
Required:
Patient must be taking a stable regimen (about 8 weeks) of anti-viral, anti-opportunistic infection and/or anti-diarrheal (if patient has diarrhea) medications.
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
|
NCT00002365
|
{
"brief_title": "A Study of LXR015-1 in HIV-Infected Patients",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002365",
"official_title": "A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-06-24",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "1998-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compile acute procedural performance and clinical outcomes data for the Promus PREMIER everolimus-eluting coronary stent system in understudied/underserved patient populations including women and minorities.
#Intervention
- DEVICE : Percutaneous coronary intervention (Promus PREMIER)
- Interventional coronary artery stenting with Promus PREMIER study stent.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient must be at least 18 years
* Patient must sign informed consent form
* Patient has received at least one Promus PREMIER stent
* Patient self-identifies as one or more of the following:
* Female
* Black of African Heritage
* Hispanic/Latino
* American Indian or Alaska native
Exclusion Criteria:
* Not applicable
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
|
NCT02240810
|
{
"brief_title": "PLATINUM Diversity",
"conditions": [
"Atherosclerosis",
"Coronary Artery Disease"
],
"interventions": [
"Device: Percutaneous coronary intervention (Promus PREMIER)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02240810",
"official_title": "PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2014-10"
},
"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)": "2019-05-15",
"last_updated_that_met_qc_criteria": "2014-09-12",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-16",
"first_submitted": "2014-09-10",
"first_submitted_that_met_qc_criteria": "2019-05-09"
}
}
}
|
#Study Description
Brief Summary
Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
#Intervention
- DRUG : WAL801CL dry syrup
- DRUG : Ketotifen fumarate dry syrup
- DRUG : Ketotifen fumarate dry syrup placebo
- DRUG : WAL 801 CL dry syrup placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* 15 years or younger
* Body weight of 14 kg or more
* Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained with the past one year
* 'Moderate' or 'Severe' in the Allergic Rhinitis Severity Classification during the observation period
* The Patient Diary can be entered by the patient or parent
* Outpatients
Exclusion Criteria:
* Absolute necessity of treatment with a drug that may affect the evaluation of the effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid, vasopressors). Patients being treated with the following drugs, however, may be included
* Intal® Oral or Inhalation
* Any eye drops other than Zaditen® Eye Drop
* External preparations (liniment, poultice)
* Initiation of desensitisation therapy within the past 6 months
* Onset of acute upper respiratory inflammation during the observation period
* Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis, septal deviation*, sinusitis*, and hypertrophied adenoid*, of such a degree that the disease affects evaluation of the effect of the test drug (*: X-ray examination will be conducted if necessary)
* That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double antigen, and that the study will be conducted in the season of air-borne pollen, and symptoms may be exacerbated by pollen
* Present or past history of a convulsive disease, such as epilepsy (convulsion threshold values may be decreased by the comparator drug, ketotifen fumarate)
* Clinically significant abnormal changes in laboratory measurements, and thus judgement that the patient is ineligible for inclusion in this study; however, if the patient is judged as falling into Grade 2 or more according to the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study
* Clinically significant renal, hepatic or cardiac disease, or other complications, and thus judgement that the patient is ineligible for inclusion in the study; however, if the patient is judged as falling into Grade 2 or more according to the MHW Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study
* Past history of drug allergy
* 1 month, or 6 times as long as the half life of the investigational drug if it is over 1 month, will not have passed since participation in any other clinical trial study, at the time of the initiation of this study
* Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
Sex :
ALL
Ages :
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02182544
|
{
"brief_title": "WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis",
"conditions": [
"Rhinitis, Allergic, Perennial"
],
"interventions": [
"Drug: Ketotifen fumarate dry syrup placebo",
"Drug: WAL 801 CL dry syrup placebo",
"Drug: WAL801CL dry syrup",
"Drug: Ketotifen fumarate dry syrup"
],
"location_countries": null,
"nct_id": "NCT02182544",
"official_title": "Phase III Double-blind Comparative Study of WAL801CL Dry Syrup in Paediatric Perennial Allergic Rhinitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2001-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2001-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-14",
"last_updated_that_met_qc_criteria": "2014-07-02",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-08",
"first_submitted": "2014-07-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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