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#Study Description
Brief Summary
The purpose of this study is to determine whether cabergoline is effective in reducing the incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe cases; and to derive biomarkers for the risk of developing OHSS.
Detailed Description
Severe ovarian hyperstimulation syndrome (OHSS) occurs in up to 2% of in-vitro fertilisation (IVF) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced perfusion of vital organs, renal failure, acute respiratory failure, and even death.
The long term aim is to develop a comprehensive strategy in reducing the incidence and severity of OHSS in in-vitro fertilisation (IVF) cycles. Our short term aim (2-3 years) is to test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and severity of OHSS in high risk women undergoing controlled ovarian hyperstimulation (COH) in fresh IVF cycles through a reduction in vasoactive cytokine levels, specifically in serum vascular-endothelial growth factor (VEGF).
Specifically we will:
1. Conduct a randomised double-blind placebo-controlled trial in women at high risk of developing OHSS during a fresh COH-IVF cycle
2. Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.
#Intervention
- DRUG : Cabergoline
- Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
- Other Names :
- Dostinex
- DRUG : Placebo
- 1 tablet daily for 8 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with more than 20 oocytes collected after COH in both gonadotropin-releasing hormone (GnRH) agonist and antagonist cycles
Exclusion Criteria:
* Patients with allergy to dopamine agonists
* Patients who undergo in-vitro maturation cycles
* Patients where GnRH analogues have been used to trigger oocyte maturation in antagonist cycles
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01535859
|
{
"brief_title": "Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers",
"conditions": [
"Ovarian Hyperstimulation Syndrome"
],
"interventions": [
"Drug: Cabergoline",
"Drug: Placebo"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT01535859",
"official_title": "A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2012-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-07",
"last_updated_that_met_qc_criteria": "2012-02-17",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-20",
"first_submitted": "2012-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded and the non-blinded group. The blinded subjects will be informed that we were testing the reliability of a new device for body posture assessment and these youngsters will did not receive any information with regards to physical activity. Conversely, the non-blinded subjects were informed that the device was an accelerometer that assessed physical activity levels and patterns. Participants will be instructed to wear the accelerometer for 4 consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall duration and the duration relative to the quality of the physical activity patterns (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group during the 4-day monitoring, then compared between the two groups using the Student's t test.
#Intervention
- DEVICE : GT3X Actigraph accelerometer.
|
#Eligibility Criteria:
Inclusion Criteria:
* 10 <= age <= 18 years adolescent
* normal clinical examination,
* normal nutritional status at baseline defined by a weight / height ratio between - 2 and + 2 DS DS
Exclusion Criteria:
* abnormal ECG
* known chronic disease
* acute infection dating back at least a week.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02844101
|
{
"brief_title": "Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity",
"conditions": [
"Physical Activity"
],
"interventions": [
"Device: GT3X Actigraph accelerometer."
],
"location_countries": [
"France"
],
"nct_id": "NCT02844101",
"official_title": "Assess Whether Knowledge by the Children and Adolescents of the Function of the Accelerometer Determines Its Amount of Physical Activity",
"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)": "2013-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-27",
"last_updated_that_met_qc_criteria": "2016-07-25",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-26",
"first_submitted": "2016-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This an open label study using a FDA-cleared TMS stimulation protocols which will be used to treat patients who have responded or remitted from depression using acute clinical TMS therapy at the University of Missouri-Columbia Neuromodulation Clinic. TMS therapy will be given to subjects at monthly intervals. Depression severity questionnaires will be given monthly to determine if the subjects original response to TMS can be maintained. Subjects will be tapered down from antidepressant medication prior to TMS maintenance treatment. Results will be analyzed to determine the effectiveness and feasibility of maintenance TMS therapies in a clinical setting.
Detailed Description
This an open label study using Transcranial Magnetic Stimulation (TMS) as a maintenance treatment for subjects that have seen a clinically significant response or remission from their depressive symptoms after having had an acute clinical course of TMS. All potential subjects must have been treated at the University of Missouri Columbia Neuromodulation Clinic to qualify.
There are 2 arms in this study. The first is a group of patients who will not receive any TMS treatments and will be followed for a year, and have their depression severity assessed monthly using the Personal Health Questionnaire (PHQ9), and the Quick Inventory of Depressive Symptoms.
The second arm will receive TMS treatments 5 times/month for 12 months, be assessed for changes in depressive symptom severity monthly using the PHQ9 and QIDS. TMS treatment protocols will consist of wither the standard 20min 10Hz protocol, or a 3min theta-burst protocol. The protocol used will be determined by what worked for the subject when they were treated clinically at the University of Missouri Columbia Neuromodulation clinic. Subjects in this arm will be tapered of antidepressant medication prior to monthly TMS treatment and will remain antidepressant free for the duration of the study.
The study will be a year long in duration.
#Intervention
- DEVICE : TMS treatment
- TMS using either a standard 10hz 20min or 3 min theta burst protocol
- Other Names :
- Transcranial Magnetic Stimulation
|
#Eligibility Criteria:
Inclusion Criteria:
* Must have recently (within 4 weeks) completed an acute TMS course (full 36 treatments) at the University of Missouri Columbia Neuromodulation clinic
* Must have clinically responded to the acute TMS treatment course (>=50% improvement according to the clinical depressive scale used - usually the PHQ-9)
* Must be able sign consent
* Must have a current address and phone number
* Must have current mental health care provider, either psychiatrist or general practioner who they see for mental health symptom management
* Must be able to taper off antidepressant medication before 1st monthly treatment block (treatment group only)
Exclusion Criteria:
* - Subject that has not completed a full acute treatment course, including taper
* Subjects that have changed anything that may not make them safe for TMS, which are (all changes will be reviewed by study MD, and will not necessarily be excluded possibly depending on severity):
* Any new metal near head
* Any new medical devices that cannot be removed
* Any new pregnancies (verbally confirmed)
* Seizures that occurred post-acute TMS treatment
* Any uncontrolled cardiovascular disease
* Any new head trauma
* Any new illness causing injury to brain
* Any new medications which cannot be altered or lowered that may be contraindicated for TMS treatment
* Any drug or alcohol use deemed by the study doctor as unsafe for TMS treatment
* Subjects unwilling to sign consent or follow study procedures
* Subjects with known extended travel plans which may affect study procedures and scheduled TMS treatment
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
|
NCT04076644
|
{
"brief_title": "Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder",
"conditions": [
"MDD"
],
"interventions": [
"Device: TMS treatment"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04076644",
"official_title": "Maintenance of Response To Transcranial Magnetic Stimulation (TMS) in Major Depressive Disorder (MDD) Using Monthly TMS Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-01",
"study_completion_date(actual)": "2021-09-01",
"study_start_date(actual)": "2019-09-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-04",
"last_updated_that_met_qc_criteria": "2019-08-29",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-03",
"first_submitted": "2019-08-23",
"first_submitted_that_met_qc_criteria": "2022-12-08"
}
}
}
|
#Study Description
Brief Summary
Cognitive function, behavioral and psychological symptoms, and quality of life will improve after administration of cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy in patients with dementia.
Detailed Description
This study will base on the pattern of behavioral and psychological symptoms of dementia, to verify and compare the effectiveness of the three non-pharmacological complementary interventions, cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy on patients' cognitive function, behavior and psychological symptoms, and quality of life.
#Intervention
- BEHAVIORAL : Reminiscence
- The 10 session topics include 'Happy to seeing you', 'Childhood stories', 'Food flavor', 'Our old songs', 'Festival', 'My family', 'My Carrier', 'Unforgettable events', 'My home', and 'My award'.
small group intervention (8-12 per group), expected total number of group is 5.
- Other Names :
- Reminiscence complementary therapy
- BEHAVIORAL : Cognitive stimulation
- The 10 session topics include 'psycial activities', 'sound', 'face', 'food', 'word association', 'number and games', 'being creative', 'categorizing objects', 'orientation', and 'team qiuz'.
small group intervention (8-12 per group), total number of group is 5.
- BEHAVIORAL : Aroma-massage
- Researcher will conduct hand and arm massage to a patient, once a week, each time session for 30 mins with natural tested and safe aroma-essential oil.
|
#Eligibility Criteria:
Inclusion Criteria:
* been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education
* able to communicate verbally or nonverbally
* able to understand short sentences
* can sit for at least 50 mins.
Exclusion Criteria:
* no hospitalization within the past two weeks
* not under severe acute illness
* no psychiatric disorders.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02126059
|
{
"brief_title": "Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research",
"conditions": [
"Dementia"
],
"interventions": [
"Behavioral: Cognitive stimulation",
"Behavioral: Reminiscence",
"Behavioral: Aroma-massage"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT02126059",
"official_title": "The Health Effects of Cognitive Stimulation, Reminiscence, and Aroma-massage Complementary Interventions on Different Behavior Patterns of Patients With Dementia: Comparative and Longitudinal Research",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2015-07",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-17",
"last_updated_that_met_qc_criteria": "2014-04-27",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-29",
"first_submitted": "2014-04-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Introduction: The COVID-19 vaccine is an effective measure for preventing and controlling COVID-19 epidemics, and the World Health Organization lists older adults as a high-priority group for COVID-19 vaccination. However, the willingness of older people to be vaccinated against COVID-19 remains an important issue in achieving herd immunity. We investigated the effectiveness of a COVID-19 vaccine intervention for older adults, based on self-determination theory.
Methods and analysis: Questionnaires were administered to assess vaccine willingness at baseline and at 6 weeks following educational intervention programs concerning vaccination against COVID-19. Four nursing homes with a population size of over 100 will be selected and randomized into intervention and control groups. The control group will undergo conventional intervention methods, and the intervention group will undergo a comprehensive intervention program based on self-determination theory.
Ethics and dissemination: The study has been approved by the Ethics Committee of Taizhou Hospital, Zhejiang Province, China (approval number: K20230832).
Detailed Description
1. Study design and data collection This class pilot study will be conducted in September 2023 at a nursing home in Taizhou, China. This study has been approved by the Ethics Committee of Taizhou Hospital, Zhejiang Province, China (approval number: K20230832). All procedures will be performed in accordance with the guidelines of our institutional ethics committee and in compliance with the Declaration of Helsinki. The respondents' information will remain anonymous.
2. Patients and public involvement The study participants will be not involved in the design, implementation, or reporting of the study.
2.1 Recruitment 2.2.1 Inclusion criteria
1. 60 years old or above
2. Have not been vaccinated for COVID-19 or have not completed the fourth booster shot of the COVID-19 vaccine
3. Able to communication and willing to participate in the survey voluntarily 2.2.2 Exclusion criteria
(1) People with contraindications to vaccination (2) People with communication disorders (3) Those who do not want to participate in the survey 2.3.3 Grouping of study participants We will select four senior care institutions in Taizhou City with a population of 100 or more residents. We will divide them into intervention and control groups.
2.4 Sample size The sample size was determined using G\*Power software v3.1.9.2 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). It will be estimated for repeated measures between the two groups at a significance level of 0.05, effect size of 0.19, and power of 95%. The final calculated sample size is 182 participants. Assuming a 10% attrition rate over the course of the intervention, we set a target of recruiting 200 participants. Based on the number of repeated measurements, this represented 100 participants in each group.
2.5 Composition of investigators
1. One master's degree in public health
2. Four master's degrees in infection
3. Two physicians in infectious diseases
4. Two trained locals 2.6 Intervention 2.6.1 Control group: traditional health education In the control group, a conventional intervention will be used, and health education brochures on the COVID-19 vaccine will be distributed for the study participants to read on their own time. The contents of the brochure included basic knowledge concerning the SARS-CoV-2 coronavirus, COVID-19 vaccine, herd immunity, and precautions for vaccination.
2.6.2 Self-determination theory-based health education measures The intervention group received self-determination theory-based interventions, with targeted interventions proposed based on the self-determination theory-including health-related talks and sharing sessions. To ensure that older individuals with varying levels of literacy understood the intervention, the process was conducted in the local native dialect. Health lectures will be conducted to elicit and acknowledge the perspectives and emotions of our cohort of older adults toward vaccination, support their choices and initiatives, and provide a rationale for vaccination-related recommendations while communicating with them to better understand their major barriers toward vaccination. This will be done with the idea of meeting the autonomy and competence needs of our cohort, based on one of the basic premises of self-determination theory. Health-related lectures empower older adults to make autonomous decisions through cognitive reframing . It has been found that successful vaccination planning relies on people acquiring appropriate and adequate health-related knowledge. The three basic psychological needs of older adults will be met through communication and interaction, both with them and with significant members of their lives (e.g., caregivers, family members, doctors, and nurses) during sharing communication sessions. We also will seek to motivate the participants by asking them questions and awarding them gifts during each health lecture and sharing session. Competence needs will be met by developing challenges for our participant cohort . The entire intervention will last 6 weeks, and will be followed by a face-to-face questionnaire.
#Intervention
- OTHER : Self-determination theory-based health education measures
- In the control group, a conventional intervention will be used, and health education brochures on the COVID-19 vaccine will be distributed for the study participants to read on their own time. The intervention group will receive self-determination theory-based interventions, with targete interventions proposed based on the self-determination theory-including health-related talks and sharing sessions. To ensure that older individuals with varying levels of literacy understood the intervention, the process will be conducted in the local native dialect.
- Other Names :
- traditional health education
|
#Eligibility Criteria:
Inclusion Criteria:
(1) >= 60 years; (2) had not previously been vaccinated with a COVID-19 vaccine, or had not yet received their fourth booster dose of the vaccine; and (3) had the ability to communicate verbally and volunteered to participate in the survey.
Exclusion Criteria:
(1) contraindications to vaccination; (2) communication disorders; and (3) unwillingness to participate.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06575114
|
{
"brief_title": "COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory",
"conditions": [
"Old Age; Debility",
"Vaccine Hesitancy",
"Vaccine Refusal"
],
"interventions": [
"Other: Self-determination theory-based health education measures"
],
"location_countries": [
"China"
],
"nct_id": "NCT06575114",
"official_title": "COVID-19 Vaccination Willingness in Older Adults Based on Self-determination Theory",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-17",
"study_completion_date(actual)": "2023-11-17",
"study_start_date(actual)": "2023-09-01"
},
"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)": "2024-08-28",
"last_updated_that_met_qc_criteria": "2024-08-26",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-08-28",
"first_submitted": "2024-08-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project aims to evaluate the effect of thank you cards on patient experience survey response rate.
#Intervention
- OTHER : Thank you card
- A card thanking the patient for choosing NYU and entrusting us with their care. The card notifies the patient that they may receive a patient satisfaction survey after discharge.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients who have been discharged from the designated hospital units during the study period
Exclusion Criteria:
* N/A
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04994366
|
{
"brief_title": "Increasing Patient Experience Survey Responses",
"conditions": [
"Patient Satisfaction"
],
"interventions": [
"Other: Thank you card"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04994366",
"official_title": "Increasing Patient Experience Survey Responses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-14",
"study_completion_date(actual)": "2021-11-14",
"study_start_date(actual)": "2021-07-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-10",
"last_updated_that_met_qc_criteria": "2021-07-30",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-06",
"first_submitted": "2021-07-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. In addition, the study will examine if the rate of smoker calls to the helpline is greater if the support person receives 3 intervention calls, 1 intervention call, or no calls (written materials only, control condition).
Detailed Description
We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a 'real-world' setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.
#Intervention
- BEHAVIORAL : telephone counseling 3 sessions
- 3 sessions of telephone counseling
- BEHAVIORAL : telephone counseling 1 session
- 1 session of telephone counseling
- BEHAVIORAL : written materials only
- written materials only
|
#Eligibility Criteria:
Inclusion Criteria:
* The support person must
1. reside in Minnesota
2. be 18 years or older
3. provide written informed consent
4. be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
5. want to support a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months
6. be able and willing to participate in all aspects of the study
7. have access to a working telephone
8. have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration.
Exclusion Criteria:
* Support persons will be excluded if another support person from the same household has enrolled.
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
|
NCT01331226
|
{
"brief_title": "Support Person Intervention to Promote a Smoking Helpline",
"conditions": [
"Tobacco Cessation"
],
"interventions": [
"Behavioral: telephone counseling 3 sessions",
"Behavioral: written materials only",
"Behavioral: telephone counseling 1 session"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01331226",
"official_title": "Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2011-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-10",
"last_updated_that_met_qc_criteria": "2011-04-06",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-07",
"first_submitted": "2011-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with McCune-Albright syndrome (MAS)
#Intervention
- DRUG : Fulvestrant
- Participants will receive intramuscular injection of fulvestrant as stated in arm description.
- Other Names :
- Faslodex, ZD9238
|
#Eligibility Criteria:
Inclusion Criteria:
* Females less than or equal to 10 years (prior to 11th birthday)
* Diagnosis of MAS
* PPP associated with MAS
Exclusion Criteria:
* Received any prior treatment for PPP associated with MAS with fulvestrant
* Abnormal platelet count or liver function tests
* Bleeding disorders
* Long term anticoagulation therapy
* Known hypersensitivity to any component of the study drug
Sex :
FEMALE
Ages :
- Minimum Age : 1 Year
- Maximum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00278915
|
{
"brief_title": "Faslodex in McCune-Albright Syndrome",
"conditions": [
"Puberty, Precocious",
"McCune-Albright Syndrome"
],
"interventions": [
"Drug: Fulvestrant"
],
"location_countries": [
"France",
"United States",
"Germany",
"Russian Federation",
"Italy",
"United Kingdom"
],
"nct_id": "NCT00278915",
"official_title": "An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12-08",
"study_completion_date(actual)": "2023-07-20",
"study_start_date(actual)": "2006-01-31"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-05",
"last_updated_that_met_qc_criteria": "2006-01-17",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-01-19",
"first_submitted": "2006-01-17",
"first_submitted_that_met_qc_criteria": "2011-06-21"
}
}
}
|
#Study Description
Brief Summary
Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC) have poor prognosis and further decreases the survival in these patients. It has been believed that cirrhosis is irreversible and that treatment should focus on preventing the progression of liver fibrosis/dysfunction and its complications.
Currently the only effective treatment is liver transplantation, an increasingly limited and expensive resource especially in developing countries. Furthermore, transplantation comes with a requirement for lifelong immunosuppression, and considerable long-term side effects that include chronic renal failure, post-transplant lymphoproliferative disease, and cardiovascular complications.
Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for patients with end stage liver diseases. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells. Animal and human studies suggested that such cells might contribute to the regeneration after different kinds of liver injuries . In animal models, after liver injury, bone marrow-derived circulating pluripotent cells have been reported to participate in liver repopulation with both non-parenchymal cells and hepatocytes. This repopulation process, however, seems to be highly dependent on the type of liver injury and experimental conditions. Fusion with hematopoietic cells has been substantiated as a mechanism by which hepatocytes can regenerate, and studies have demonstrated improved liver histology and survival in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF) . Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and acute on chronic liver failure (ACLF) . However there is insufficient data on whether G-CSF improves survival and prognosis in patients with cirrhosis.
Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis . However there is scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis.
#Intervention
- DRUG : standard medical therapy
- diuretics, albumin infusion, antibiotics, nutrition, and variceal banding wherever needed
- DRUG : G-CSF
- G-CSF at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days then every 3 monthly for 3 days till 1 year
- DRUG : Growth Hormone
- Growth Hormone in low dose of 1unit sc daily for 1 year
|
#Eligibility Criteria:
Inclusion Criteria:
Decompensated Cirrhosis of liver.
Exclusion Criteria:
* Acute on chronic liver failure
* Spleen diameter of larger than 180 mm
* Diagnosis of concomitant hepatocellular carcinoma or other active malignancy
* Upper gastrointestinal bleed due to portal hypertension in the previous 7 days
* Recent episode of portal vein thrombosis
* Severe renal dysfunction creatinine (>1.5mg/dl)
* Severe cardiac dysfunction
* Uncontrolled diabetes or diabetic retinopathy
* Acute infection or disseminate intravascular coagulation
* Active alcohol abuse in last 3months
* Known hypersensitivity to G-CSF and GH
* Human immunodeficiency virus seropositivity
* Pregnancy
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
|
NCT02451033
|
{
"brief_title": "Granulocyte Colony Stimulating Factor And Growth Hormone In Cirrhosis Of Liver: An Open Label Study",
"conditions": [
"Cirrhosis"
],
"interventions": [
"Drug: standard medical therapy",
"Drug: Growth Hormone",
"Drug: G-CSF"
],
"location_countries": [
"India"
],
"nct_id": "NCT02451033",
"official_title": "Granulocyte Colony Stimulating Factor And Growth Hormone In Cirrhosis Of Liver: An Open Label Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2015-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-29",
"last_updated_that_met_qc_criteria": "2015-05-20",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-21",
"first_submitted": "2015-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. This is a phase IIa dose-response and safety study of inhaled fentanyl aerosol (25µg/dose) in Chinese patients with breakthrough cancer pain.
Detailed Description
Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The medication for background pain during screening were maintained until the end of the study. Each patient would be treated and observed for 6 episodes of targeted BTcP. Patients were randomly assigned to 1 of the 6 prespecified dose sequences which were established by a computer-generated schedule of active drug and placebo in a 4:2 ratio. All patients and personnel involved with the study (including investigators and investigation site personnel) were blinded to the medication codes.
#Intervention
- DRUG : Inhaled fentanyl aerosol
- Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.
- DRUG : Placebo
- Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age of 18 years or above
* Subjects must be diagnosed with cancer.
* Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be <4 within 1week before screening.
* In the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day,The breakthrough cancer pain score should be >=4 assessed by NRS
* ECOG status of 0 to 2.
* Subjects must consent to take adequate contraception during the study and 1 months after the study. Women of childbearing potential must show negative in the pregnancy test before dosing.
* The subject must be able to understand the requirements of the study and provide a written informed consent.
Exclusion Criteria:
* History or suspected allergies to fentanyl.
* HGB < 80 g/L, NEUT <=1.0 × l09/L, PLT <=50 × l09/L；ALT and AST higher than 3 times of ULN;total bilirubin and Cr higher than 1.5 times of ULN;PaO2 <95%;FEV1/FVC<70% and FEV1 accounted for less than 80% of the predicted value.
* Any uncontrolled disease (e.g., severe mental, neurological, infectious, cardiovascular, respiratory and other systemic diseases).
* Tumor infiltration to central nervous system.
* Subjects are not able to slef evaluate pain intensity using NRS
* Receive surgery in past 3 weeks
* Treatment with any form of radiotherapy winth 1week prior to study entry that could alter pain or response to pain medication.
* Taking monoamine oxidase inhibitors(MAOIs), CYP3A4 inhibitors or inducers within 14 days of the screening
* Participated in other clinical trials in past 1months.
* Pregnancy and breast-feeding women, women of childbearing age ready to conceive, and pregnancy test positive.
* Other conditions that may affect the informed consent, compliance with the protocol, study results and safety of the subject.
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
|
NCT05531422
|
{
"brief_title": "Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP",
"conditions": [
"Breakthrough Cancer Pain"
],
"interventions": [
"Drug: Inhaled fentanyl aerosol",
"Drug: Placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT05531422",
"official_title": "Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-15",
"study_completion_date(actual)": "2023-04-27",
"study_start_date(actual)": "2021-10-20"
},
"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)": "2024-06-12",
"last_updated_that_met_qc_criteria": "2022-09-06",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-08",
"first_submitted": "2022-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial studies whether Everolimus is efficacious in treating neurofibromatosis 2.
Detailed Description
Everolimus (RAD001) has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation and has obtained marketing authorization (Certican®) for prophylaxis of rejection in renal and cardiac transplantation in a number of countries, including the majority of the European Union. Everolimus has been in development for patients with various malignancies since 2002. Everolimus 2.5mg, 5mg and 10mg tablets were approved under the trade name Afinitor® for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent® (sunitinib) or Nexavar® (sorafenib) in the US, EU and several other countries and is undergoing registration in other regions worldwide. Afinitor® was also recently approved for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapeutic intervention but are not candidates for curative surgical resection. Everolimus is being investigated as an anticancer agent based on its potential to act: 1. Directly on the tumor cells by inhibiting tumor cell growth and proliferation; and 2. Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity.
For pediatric cancer patients, safety of RAD001 has been established in a phase 1 trial and the recommended phase II dose is 5 mg/m2 once daily. This existing pediatric data allows for inclusion of children in this phase 2 trial, which is an important consideration since some NF2 patients with the most aggressive clinical course present at school age.
RAD001 was recently approved by the Food and Drug Administration (FDA) for the treatment of children and adults with subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS). Although surgical resection is effective at tumor reduction, serious complications may follow a radical resection, such as permanent deafness and facial nerve damage. Most importantly, the tumors often recur after surgery. Radiation therapy (RT) has been proposed as an alternative. However, its safety and efficacy in the NF2 population has not been established. A medical therapy option is desperately needed. This study is a single-center, 2-stage, phase II open-label study. All subjects will get RAD001 taken continuously until disease progression or unacceptable toxicity. The primary objective of this study is to look at the objective response rate to RAD001 in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. Participation will consist of screening/baseline visit(s), Day 1, Weeks 1, 2, and 4; and up to 12 cycles and will include standard of care procedures such as medical history, vital signs, physical examinations, ECGs, MRIs, audiograms, and laboratory tests. Novartis will provide the RAD001 free of charge to eligible study subjects. The primary efficacy response for study purposes will be a greater than or equal to 15% reduction in tumor volume in any of the target tumors (partial response). Complete disappearance of any of the target tumors will constitute a complete response (CR).
#Intervention
- DRUG : Everolimus (RAD001) , Afinitor®
- Everolimus will be provided by Novartis. Everolimus is formulated as tablets for oral administration of 2.5 mg, 5 mg, 10 mg strength. Everolimus will be self-administered (by the patients themselves) or administered by the patient's parent or guardian (for minors). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. Depending the age-based dosing schedule, everolimus should be administered orally once (or twice) daily, preferably in the morning (and evening), at the same time every day with our without food. Everolimus tablets should be swallowed whole with a glass of water. The tablets must not be chewed or crushed. In cases where tablets can not be swallowed, the tablets should be disintegrated in water just prior to being taken. Everolimus will be administered orally as per the age-based dosing schedule continuously from study day 1 until progression of disease or unacceptable toxicity.
- Other Names :
- Afinitor®
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 3 years and body surface area >= 0.5 m2
* Meets diagnostic criteria for NF2
* At least one volumetrically measurable and >= 0.5 cc NF2-related brain or spinal tumor (schwannoma, ependymoma, meningioma - histological confirmation not required) with radiographic evidence of progression (either as unequivocal progression on conventional MRI, or a >10% volume increase by 3D volumetrics) over the past <=12 months, designated as the primary target tumor OR Volumetrically measurable and >= 0.5 cc VS with ipsilateral progressive hearing loss over the past <=12 months, designated as the primary target tumor
* Progressive Hearing Loss Criteria for Enrollment: Audiogram showing drop in pure tone average (PTA) of 10dB HL at >= 2 nonconsecutive or consecutive frequencies or drop in speech discrimination score (SDS) below the 95% critical difference threshold, compared to previous audiogram <= 1 year prior.
* Karnofsky/Lansky performance status (PS) 50 <= age <= 100%. Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Adequate bone marrow function as shown by: ANC >= 1.5 x 109/L, Platelets >= 100 x 109/L, Hb > 9 g/dL
* Adequate liver function as shown by:
1. serum bilirubin <= 1.5 x ULN
2. ALT and AST <= 2.5x ULN
* INR <= 1.5. (Anticoagulation is allowed if target INR <= 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of enrollment.)
* Adequate renal function: serum creatinine <= 1.5 x ULN
* Fasting serum cholesterol <=300 mg/dL OR <= 7.75 mmol/L AND fasting triglycerides <= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
* Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy
* Any neurologic deficits must be stable for >= 1 week
* Able to provide signed informed consent (or consent by parent/legal guardian for minors)
Exclusion Criteria:
* Patients currently receiving medical anticancer therapies or who have received medical anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, antibody based therapy, etc.)
* Radiation therapy to a study target tumor within 1 year prior to enrollment, or any radiation therapy within 4 weeks prior to enrollment.
* Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
* Prior treatment with any investigational drug within the preceding 4 weeks
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
* Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
* Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
1. Symptomatic congestive heart failure of New York heart Association Class III or IV
2. unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
3. severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
4. uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy.)
5. active (acute or chronic) or uncontrolled severe infections
6. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
* A known history of HIV seropositivity
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
* Patients with an active, bleeding diathesis
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. (Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
* Male patient whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
* Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01419639
|
{
"brief_title": "Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2",
"conditions": [
"Neurofibromatosis Type II"
],
"interventions": [
"Drug: Everolimus (RAD001) , Afinitor®"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01419639",
"official_title": "Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2011-10"
},
"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)": "2017-07-18",
"last_updated_that_met_qc_criteria": "2011-08-17",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-18",
"first_submitted": "2011-08-17",
"first_submitted_that_met_qc_criteria": "2015-07-08"
}
}
}
|
#Study Description
Brief Summary
SHR-A1403 is a humanized IgG2, anti-C-Met monoclonal antibody conjugated to microtubule inhibitor (c-Met ADC).The aim of this study is to assess the safety and tolerability of SHR-A1403，to define the dose limited toxicity（DLT）and the maximum tolerated dose (MTD)，to evaluate the pharmacokinetics of SHR-A1403，to assess the antitumor activity of SHR-A1403 in patients with advanced solid tumors preliminarily and to recommend the reasonable dosage regimen of SHR-A1403 for the follow-up clinical trial.
Detailed Description
This study is a phase I clinical trial of single arm，open-label，dose escalation with single and multiple doses.The safety,PK and preliminary efficacy of SHR-A1403 were evaluated respectively in the patients with advanced solid tumors that have invalid standard treatment or no standard and effective treatment.SHR-A1403 is administered with intravenous infusion every three weeks (q3w) for a treatment cycle.Dose limiting toxicities (DLT) observation will end after 3 weeks from the start of study treatment(21 days). The dose escalation is designed by Modified Toxicity Probability Interval-2 Designs（mTPI-2) and will continue until an MTD or preliminary RP2D is identified. 3 patients are enrolled and observed in the initial dose. After completing the DLT assessment, the next decision of dose escalation will be performed according to the mTPI-2 detailed dose climbing/descending plan. After each decision, 3 other patients will be enrolled in the next phase of dose escalation until the maximum number of subjects specified in the study protocol or the dose escalation terminated by the Safety Monitoring Committee(SMC).
The study consists of 3 periods: Screening Period (up to 14 days before the first dose), Treatment Period, and Follow-up Period (up to 3 months after the last dose of study treatment).
The safety and tolerability of SHR-A1403 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examinations, vital signs, ECG, and adverse events (AEs) as defined by the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 4.03). Safety will be monitored throughout the study.
Response assessment will be performed by the end of Cycle 2 (6 weeks after the first infusion). Subsequently, post-dose tumor response evaluations will be performed every 6 weeks for the first 6 months, then by every 12 weeks thereafter, and at short-term follow up. For subjects who discontinue study treatment, tumor imaging should also be performed at end of therapy. Tumor imaging will be performed for all subjects as feasible (e.g., may not be able to be performed in subjects who withdraw consent or would not be performed in subjects who are lost to follow-up) until documented progression of disease, intolerable toxicity, initiation of a new antitumor therapy, withdrawal of consent, or the occurrence of death or end of study, whichever occurs first.
Blood samples collected pre-dose and post-dose will be analyzed for PK variables. In general, PK data analysis will include, but will not be limited to, time to maximal serum concentration (tmax), maximal serum concentration (Cmax), area under the curve from time 0 to Day 21 of Cycle 1 (AUC0-21d), and observed terminal half life (t1/2) in Cycle 1; as well as concentration (average) (Cavg), area under the curve from time 0 to the end of the dosing interval (Day 21) after repeated dosing (AUC0-τ), t1/2, clearance at steady state (CLss), volume of distribution during terminal phase (Vz), and accumulation ratio (Rac) (AUC0-τ/AUC0-21d) for longer-term analyses.
Tumor tissue samples will be collected in pre- and post-treatment for additional exploratory biomarkers. Tumor samples of Pre-treatment (i.e., Screening) could be obtained for c-Met status analysis by IHC through either subject's archived paraffin tissues or fresh (preferred) biopsies, and tumor tissue biopsies of post-treatment at C2D8 , pre- and post-treatments are optional. In addition, blood samples will also be collected in pre- and post-treatment and serum will be prepared for circulatory biomarker (soluble c-Met) analysis by ELISA at screening and C2D8; these blood samples are required in the study.
#Intervention
- DRUG : SHR-A1403
- SHR-A1403 is a humanized anti C-Met immunoglobulin G2 (IgG2) monoclonal antibody conjugated with microtubule inhibitor. SHR-A1403 is provided as the lyophilized powder,40 mg/vial.SHR-A1403 was given intravenously per 3 weeks at the day 1.Intravenous infusion over 30 min
- Other Names :
- HTI-1066
|
#Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at both the Screening and baseline visits;
* Life expectancy >=12 weeks
* Diagnosed (histologically or cytologically) with solid tumors and documented as advanced or metastatic disease for which there is no known effective anti-tumor treatment (refractory to or relapsed from standard therapies);
* Subjects must have measurable lesion(s) per RECIST v1.1 guideline at the Screening visit.
* Adequate laboratory parameters during the Screening Period as evidenced by:
* Absolute neutrophil count (ANC)>=1.5×109/L (1,500/mm3)；
* Platelets >=100×109/L (100,000/mm3)；
* Hemoglobin (Hgb) >=9.0 g/dL (90 g/L)；
* Albumin levels >=2.8 g/dL；
* Total bilirubin <=1.5×ULN (<=3×ULN for subjects with liver metastases)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
* 2.5×ULN; for subjects with liver metastases, ALT and AST <=5×ULN；
* Serum creatinine <=1.5×ULN or creatinine clearance >=50 mL/min based on Cockcroft-Gault equation；
* Subjects must have a washout period >=4 weeks since the last dose of cytotoxic chemotherapy，non-cytotoxic chemotherapy(including any previous TKI treatment), any investigational therapy, any prior immuno-oncology or monoclonal antibody products administered and >=6 weeks since the last dose of chemotherapy of mitomycin C or nitrosoureas prior to the first dose of SHR-A1403;
* Pregnancy and Contraception:
* Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment;
* Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of study drug;
* A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year, when used consistently and correctly);
* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment and not be breast feeding. Female subjects of non-childbearing potential must be surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing) OR naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing, with a follicle stimulating hormone (FSH) level at Screening of >=40 mIU/mL;
* Willing and able to comply with clinic visits and study-related procedures;
* voluntarily participating in this clinical trial, understanding the study procedures and providing signed informed consent.
Exclusion Criteria:
* Known history of Grade 3 or Grade 4 hypersensitivity to any components (antibody-drug conjugate [ADC], total antibody, unconjugated toxin) of the SHR-A1403 product, or sensitivity to humanized monoclonal antibody products);
* Any radiation or surgery within 4 weeks prior to the first dose of SHR-A1403, except for minor palliative intent(this is to be discussed with sponsor);
* Unresolved toxicities from previous anticancer therapy,defined as toxicities not yet resolved to NCI CTCAE (current version) grade <=1 at baseline (other than alopecia and other tolerable AEs upon discussion with sponsor) . Subjects with chronic grade 2 toxicities may be eligible at the discretion of the investigator and discussion with sponsor;
* Central nervous system tumors or active central nervous system (CNS) metastasis by imaging diagnosis;
* Cardiac disease (New York Heart Association [NYHA] classes II-IV) including myocardial infarction,unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment within a minimum 6 months before enrollment;
* Active HBV and HCV infection (HBV virus copy number>50 IU/mL, HCV virus RNA positive);
* History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV) or other acquired or congenital immune- deficient disease, or history of any organ transplantation;
* Any other medical(such as severe hypertension, diabetes, thyroid disease, etc.) or psychiatric or social condition deemed by the investigator to be likely serious hazards to a subject's rights, safety, welfare, or interfere with ability to sign informed consent, cooperate and participate in the study, interpret the results.
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
|
NCT03856541
|
{
"brief_title": "A Study of SHR-A1403 in Patients With Advanced Solid Tumor",
"conditions": [
"Advanced Solid Tumor"
],
"interventions": [
"Drug: SHR-A1403"
],
"location_countries": [
"China"
],
"nct_id": "NCT03856541",
"official_title": "A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR-A1403 With Intravenous Infusion in Patients With Advanced Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-30",
"study_completion_date(actual)": "2020-05-07",
"study_start_date(actual)": "2019-02-13"
},
"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)": "2022-10-28",
"last_updated_that_met_qc_criteria": "2019-02-25",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-27",
"first_submitted": "2019-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.
Detailed Description
Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Alzheimer's disease is the most common form of dementia, the most common neurodegenerative disease in older adults, and the 6th leading cause of death in the US. Neuropsychiatric symptoms (apathy, depression, anxiety) and altered gait and balance are prominent secondary symptoms of Alzheimer's disease that increase medical costs and decrease quality of life for both the person with dementia and their caregiver.
In a report from the Secretariat (Executive Board, 134th Session, December 20th, 2013), the World Health Organization identified a need to integrate evidence-based palliative care services into the continuum of care for serious chronic diseases, including Alzheimer's disease. However, two recent NIH workshops identified major gaps in the evidence supporting the wider use of non-pharmacologic activities to ameliorate secondary symptoms of chronic disease. Arts-based activities were identified as particularly understudied for symptom management, given growing evidence that various arts-based activities can improve quality of life, relieve symptoms, and reduce reliance on medications. It is important that these benefits can be achieved without adding medications. Dance is an arts-based activity that can improve quality of life, decrease symptoms of depression, and improve balance in healthy older adults, those with Parkinson disease, and Alzheimer's disease. Thus, dance is a non-pharmacological intervention that simultaneously addresses two sets of prominent secondary symptoms in Alzheimer's disease: 1) gait and balance and 2) neuropsychiatric symptoms. However, the mechanisms through which dance exerts these effects are unknown.
Pilot data from the investigators' laboratory suggest that participating in a group improvisational movement class twice weekly improved balance and connectivity in motor-related brain regions, as well as improving mood and connectivity in brain regions associated with social engagement. Improvisation is the ability to create new gestures and movements spontaneously. Improvisation can be a part of many different art forms. However, improvisational movement can also be practiced as a specific dance form. The objective in improvisational movement is that choreographed movement is replaced by a cue or prompt that allows the possibility for multiple responses. This unique form of dance is especially well-suited for people with dementia because it: 1) does not rely heavily on memory of repeated movements; 2) can be seamlessly adapted to include sitting, standing, or moving around the room; 3) is cognitively challenging; and 4) fosters a social, playful atmosphere. Participants seemed to benefit from both the social nature of the class and the movement. Therefore, the overall aim of this proposal is to experimentally determine the independent and combined effects of dance movement and social engagement on quality of life in people with early stage dementia, and test the neural mechanisms of these effects.
To accomplish this goal, the investigators will use a 2x2 factorial design and randomize 120 community-dwelling older adults adjudicated as having early-stage dementia of the presumed Alzheimer's type to one of four 3-month interventions: 1) Dance Group, 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.
It is not hypothesized that dance affects the underlying disease course, and therefore no improvement is expected in cognition.
#Intervention
- BEHAVIORAL : Dance Group
- Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
- BEHAVIORAL : Non-Group Dance
- The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
- BEHAVIORAL : Social Group
- The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
- BEHAVIORAL : No Contact
- The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
|
#Eligibility Criteria:
Inclusion Criteria:
Age 60 <= age <= 85 years
Adjudicated as having mild cognitive impairment or early-stage dementia of Alzheimer's, vascular, or mixed Alzheimer's/vascular type
MRI compatible
English speaking
Have study partner who is around the person with dementia approximately 10 hours/week and is willing to be an active study partner.
Able to attend bi-weekly intervention classes or come to study visits for no-contact control.
Not enrolled in another interventional study for at least 3 months prior to beginning this study.
Exclusion Criteria:
Untreated depression
Other causes of dementia (for example, frontotemporal, early onset, Lewy body or Parkinsonian dementia)
Current cancer treatment or other major medical problems that might independently affect cognition or movement
Other neurological disorders (e.g., Parkinson disease, multiple sclerosis)
Taking medication that could negatively influence safety during intervention
Planned extensive travel during the study period
Any reason for which the study doctor or personal physician feels the intervention is contraindicated for the participant
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03333837
|
{
"brief_title": "Improvisational Movement for People With Memory Loss and Their Caregivers",
"conditions": [
"Alzheimer's Disease (Incl Subtypes)",
"Dementia",
"Mild Cognitive Impairment"
],
"interventions": [
"Behavioral: Non-Group Dance",
"Behavioral: Dance Group",
"Behavioral: Social Group",
"Behavioral: No Contact"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03333837",
"official_title": "IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-26",
"study_completion_date(actual)": "2021-05-26",
"study_start_date(actual)": "2018-02-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-27",
"last_updated_that_met_qc_criteria": "2017-11-03",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-07",
"first_submitted": "2017-11-01",
"first_submitted_that_met_qc_criteria": "2022-07-26"
}
}
}
|
#Study Description
Brief Summary
Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).
Detailed Description
Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).
Donors and recipient were followed up after hospital discharge with laboratory investigation, abdominal ultrasound, MRCP in selected cases every month for the first month, then every 6 months and then every year postoperatively. Follow up visits included clinical examination, laboratory investigation, doses of immunosuppressive, radiological examination, and doppler US.
The primary outcome was the amount of blood loss during transection. Secondary outcomes were operative time, time of transection, speed of transection/minutes , number of ligation used, degree of postoperative injury which assessed by daily liver function, WBC, C reactive protein, pathological changes at the cut surface, postoperative morbidity (including biliary leakage, collection), cost and hospital stay.
#Intervention
- DEVICE : harmonic scalpel
- parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.
- Other Names :
- Group A
- DEVICE : spray mode diathermy
- parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.
- Other Names :
- Group B
|
#Eligibility Criteria:
Inclusion Criteria:
Consecutive patients, who were treated for end stage liver cirrhosis by LDLT
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02617498
|
{
"brief_title": "Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection",
"conditions": [
"End Stage Liver Disease"
],
"interventions": [
"Device: spray mode diathermy",
"Device: harmonic scalpel"
],
"location_countries": null,
"nct_id": "NCT02617498",
"official_title": "Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2013-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-22",
"last_updated_that_met_qc_criteria": "2015-11-25",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-01",
"first_submitted": "2015-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to assess Internet and social media use in dermatology patients
Detailed Description
The Internet and social media bear potential in terms of heath care consumer education, prevention of diseases and dissemination of evidence-based information. The use of the internet and social media platforms both by dermatologists and patients is rapidly evolving. In order to improve the presence and visibility of dermatology-related evidence-based informations on the Internet and in social media, the use and behavior of dermatology patients in this context is studied in more detail.
#Intervention
- OTHER : patient questionnaire
- self-administered patient questionnaire regarding the different aspects of internet and social media use in dermatology patients
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients treated at the Department of Dermatology of University Hospital Basel
Exclusion Criteria:
* Insufficient knowledge of German language
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
|
NCT03913598
|
{
"brief_title": "Internet and Social Media Use in Dermatology Patients",
"conditions": [
"Dermatologic Diseases"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03913598",
"official_title": "Internet and Social Media Use in Dermatology Patients - a Survey",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-20",
"study_completion_date(actual)": "2019-04-20",
"study_start_date(actual)": "2019-03-21"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-18",
"last_updated_that_met_qc_criteria": "2019-04-10",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-12",
"first_submitted": "2019-04-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a research study to test the effectiveness of nab-paclitaxel + carboplatin + MPDL3280A for treatment of non-small-cell lung carcinoma (NSCLC), which is a type of lung cancer. The study aims to determine if chemotherapy combined with immune-based therapy can lead to improvement in tumor response rates over historical response rates with chemotherapy alone.
Detailed Description
Lung cancer is the most common cancer in both men and women worldwide, accounting for 13% of incident cancers. In 2015, it was estimated there would be 221,200 new lung cancers diagnosed in the United States, with 158,040 lung cancer deaths. Approximately 85% of all lung cancers are characterized as non-small cell lung cancer (NSCLC).
Repeated studies have shown neoadjuvant cytotoxic chemotherapy to be safe prior to surgical resection of NSCLC with no difference in extent of surgical procedures performed, operative morbidity and mortality. The debate remains as to whether neoadjuvant or adjuvant chemotherapy is the best approach, with advantages and disadvantages to each.
The investigators propose that new therapies such as immune checkpoint inhibitors that demonstrate promising clinical activity in the advanced disease setting must be incorporated into the neoadjuvant setting, in order to maximize benefit early in a patient's treatment course, and with a suitable surrogate endpoint that can be used to establish a preliminary efficacy signal, prior to initiation of a large confirmatory study.
#Intervention
- DRUG : MPDL3280A
- MPDL3280A is a human, Fc optimized, monoclonal antibody directed against the protein ligand programmed cell death-1 ligand 1 (PD-L1), with potential immune checkpoint inhibitory and antineoplastic activities. Atezolizumab binds to PD-L1, blocking its binding to and activation of its receptor programmed death 1 (PD-1) expressed on activated T-cells, which may enhance the T-cell-mediated immune response to neoplasms and reverse T-cell inactivation. MPDL3280A 1200 mg will be administered as a 60 minute IV infusion on first administration, then over 30 minutes subsequently if tolerated.
- Other Names :
- Atezolizumab, RG7446
- DRUG : Carboplatin
- Carboplatin is a second-generation platinum compound with a broad spectrum of antineoplastic properties. Carboplatin contains a platinum atom complexed with two ammonia groups and a cyclobutane-dicarboxyl residue. This agent is activated intracellularly to form reactive platinum complexes that bind to nucleophilic groups, thereby inducing intrastrand and interstrand DNA cross-links, as well as DNA-protein cross-links. These carboplatin-induced DNA and protein effects result in apoptosis and cell growth inhibition. Carboplatin area under the curve (AUC)=6 will be administered as a 30 minute IV infusion immediately after nab-paclitaxel.
- Other Names :
- Paraplatin, Paraplatin-Aqueous (AQ)
- DRUG : Nab-paclitaxel
- Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity. Nab-paclitaxel binds to and stabilizes microtubules, preventing their depolymerization and so inhibiting cellular motility, mitosis, and replication. Nab-paclitaxel 100 mg/m2 will be administered as a 30 minute IV infusion.
- Other Names :
- Abraxane
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have pathologically confirmed non-small cell lung cancer, of either squamous or non-squamous histology.
* Stage 1B-3A
* Deemed surgically resectable by a thoracic surgeon
* Age >= 18 years
* Radiologically measurable disease, as defined by response evaluation criteria in solid tumours (RECIST) v1.1
* Ability to understand and the willingness to sign a written informed consent document
* Females of child-bearing potential must:
* Either commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception (<=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 90 days following treatment completion.
* Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.
* Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression
* Tumor tissue should be of good quality based on total and viable tumor content.
* Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period.
* Adequate organ and marrow function as defined below:
* Lymphocyte count >=300/microliter (mcL)
* Neutrophil count >=1,500/mcL
* Hemoglobin >=9.0g/dl
* Platelets >=100,000/mcL
* Total bilirubin <=1.5 x institutional upper limit of normal (ULN) (*Patients with Gilbert's disease: <=3 x ULN)
* Aspartate aminotransferase (AST)(SGOT)/alanine aminotransferase (ALT)(SGPT) <=2.5 × ULN
* Alkaline phosphatase <=2.5 x ULN
* International normalized ratio (INR) and activated partial thromboplastin time (aPTT) <= 1.5 x ULN (*Unless the patient is on therapeutic anticoagulation)
* Serum creatinine <=1.5 x ULN or
* Creatinine clearance >=50 mL/min/1.73 m2 by Cockcroft-Gault estimation
Exclusion Criteria:
* Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 5 years prior to initiation of study treatment; however, the following are allowed:
* Hormone-replacement therapy or oral contraceptives
* Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
* Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score <= 6, and prostate-specific antigen (PSA) <= 10 mg/mL, etc.)
* Patients who are receiving any other investigational agents concurrently.
* Patients with no smoking history
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MPDL3280A, carboplatin, or paclitaxel.
* Patients with active hepatitis B or C infections or a history of HIV infection.
* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive for the antibody test to detect antibodies to hepatitis B core antigen (anti-HBc) are eligible.
* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including tuberculosis (TB), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
* Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are permitted provided that they meet the following conditions:
* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
* Rash must cover less than 10% of body surface area (BSA)
* Disease is well controlled at baseline and only requiring low potency topical steroids
* No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
* Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
* Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
* Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
* Patients must not have >= Grade 2 pre-existing peripheral neuropathy (per CTCAE)
* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study
* Pregnant women
* History of interstitial lung disease or pneumonitis of any cause
Immunotherapy-Related Exclusion Criteria:
* Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4)), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
* Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1
* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02716038
|
{
"brief_title": "Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC",
"conditions": [
"Carcinoma, Non-Small-Cell Lung"
],
"interventions": [
"Drug: Carboplatin",
"Drug: Nab-paclitaxel",
"Drug: MPDL3280A"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02716038",
"official_title": "A Single-arm, Phase II Study of Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in Resectable Non-small Cell Lung Cancer (NSCLC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-01",
"study_completion_date(actual)": "2022-10-01",
"study_start_date(actual)": "2016-06-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-12",
"last_updated_that_met_qc_criteria": "2016-03-17",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-22",
"first_submitted": "2016-03-17",
"first_submitted_that_met_qc_criteria": "2023-11-21"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise. Participants will perform two constant tests (cycling and running) at an intensity corresponding to Borg's scale of Rating of Perceived Exhaustion (RPE) (6-20) = 15 (i.e., hard). Using a body map template, participants will report every 15s the perceived locations with discomfort and pain independently of the magnitude of the discomfort and pain.
Detailed Description
1. Intro Pain recently was defined as distressing experience associated with actual or potential tissue damage with sensory, cognitive, emotional, and social components. Pain can be seen as perceptual marker within physical exercise. Individuals can report on a number of perceptual markers such as the changes in exertive pain which was shown to be a distinct source of information than reports of PE during cycling for instance. The perceptual markers of pain are still little investigated within exercise settings.
From another side, to best understand exertive pain, one needs to consider several dimensions of pain including the sensory-discriminative, affective-motivational, and the cognitive-evaluative dimensions. Several number of studies within the exercise science have focused on the sensory-discriminative dimension of pain. Results from these have suggested a linear relationship between pain perception and the power output in diverse effort settings including cycling, static and dynamic handgrip squeezing, and incremental treadmill running. Indeed, the comparison of ratio of leg pain to arm pain during cycling and running has also demonstrated that the ratio of leg to arm pain increases across higher intensities.
Most of the extant work however centred on pain and PE from a group-based standpoint to lead to group-based conclusions. Traditionally, within exercise science, variables are measured at distinct, low-frequency time points, and then are either averaged over the course of the trial or reported at the measured time. In turn, such practices make it difficult to measure dynamic feed-forward and feedback control mechanisms inherent in these variables. Taken these together, studying pain and discomfort from an individual, case-by-case standpoint, in a high-frequency time points setting, may present unique benefits. Considering that the physiological and psychological variables (e.g., PE) present fluctuations during heavy constant-power cycling when reporting at a measurement frequency of 15s it seems plausible to assume that pain locations can also fluctuate. Consequently, it may be useful to distinguish amongst differential types of spatiotemporal pain fluctuations patterns during exercise. Mapping these dynamics can help predict individual-specific fatigue in the course of exercise. The functional role of fluctuating dynamics has already been studied in psychological (e.g., volitional states, thought processes) and kinematic variables during constant-power exercise performed until volitional exhaustion. These approaches are important in that the suppression of the intra- individual variability performed by a statistical averaging may hide the properties of individual systems.
In this vein, we tend to study and delineate individualized pain and discomfort patterns in exercise. The purpose of this study will be to study the individual spatiotemporal structure and dynamics of topologically defined areas of perceived body discomfort and pain during exercise.
2. Methods 2.1 Participants To determine the sample size for this study a power analysis was conducted using G\*Power 3.1. In studies of thought processes larger effect sizes have been reported. Thus, using an effect size of d = 1.0, α \< 0.05, power (1 - β) = 0.80, a sample size of n = 11 emerged. Caucasian physical education students (age range: 18 - 30 years) undergoing regular aerobic exercise will be recruited to participate voluntarily in the study. Students will receive oral and written information regarding the study. They will be additionally encouraged to ask questions if there would still any ambiguities.
2.2 Materials and procedure Completion of this study will took a total of three sessions, separated by one-week intervals, and each of approximately 30 minutes. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). At this time, participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks, respectively, in a counter-balanced assigned order.
2.2.1. Monitoring for Discomfort and Pain Every 15s during exercise, upon the researcher's prompts, participants will report bodily locations with discomfort and pain on a body map scale.
2.2.2. Constant-power Cycling Task The task will include an incremental warm-up session and a constant-power cycling which will be performed up to volitional exhaustion. The constant-power cycling will begin when participants will report RPE = 15 during the incremental warm-up and the cycling task will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence for five consecutive seconds at the sitting position.
2.2.3. Constant-velocity Running Task The task will include an incremental warm-up (identical to the running baseline test) and a constant velocity run which will be performed up to volitional exhaustion. The constant velocity run will start when participants will achieve and report RPE = 15 during the incremental warm-up and will last up to volitional exhaustion when they could no longer be able to maintain the imposed velocity.
2.2.4. Commitment check Upon the completion of all testing procedures participants will answer questions about complete commitment to measure their commitment levels to the reporting tasks (a) and commitment to task (b), on an 11-point Likert-type scale with anchors ranging from 0 (not at all) to 10 (greatly).
2.3 Data collection and analysis All the locations for each participant will be transformed to binary vectors. Investigators will analyse the effects of the time steps using repeated measures ANOVAs. Principal component analysis (PCA) will be used to reduce the dimensionality of the local discomfort and/or pain data (that will be obtained from the 50-item pain map). The data and time of each testing session will be reported in a list. All data can be reconstructed for each participants.
#Intervention
- OTHER : Exercise
- Completion of this study will took a total of three sessions, separated by one-week intervals. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). Participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks. The constant-power cycling and running will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence.
|
#Eligibility Criteria:
Inclusion Criteria:
Participants had no sport specialization but were engaged in a wide range of aerobic activities at least three times a week. Inclusion criterion for the study was the absence of chronic pain and injuries, and normal weight: BMI from 18.5 to 25.
Exclusion Criteria:
Participants professionally specialized in sports and poorly active (<3 times a week) were excluded from the study. Exclusion was made also for the participants who suffered neuropathic and/or chronic pain. Underweighted and overweighed participants were excluded.
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
|
NCT02876705
|
{
"brief_title": "Spatiotemporal Patterns of Pain During Exercise",
"conditions": [
"Pain"
],
"interventions": [
"Other: Exercise"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02876705",
"official_title": "Spatiotemporal Patterns of Pain and Discomfort During Exhausting Exercise",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2016-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-11",
"last_updated_that_met_qc_criteria": "2016-08-18",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-24",
"first_submitted": "2016-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. The researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.
Detailed Description
Optical technologies under development at the Beckman Laser Institute.
Diffuse Optical Spectroscopy Imaging is a method for studying absorption and scattering (optical properties) of tissue in humans. It is related to near-infrared spectroscopy , but allows for more quantitative and thorough measurements. The researcher use Diffuse Optical Spectroscopy to measure fatty tissue, water, blood concentration level during weight loss program to determine the effect of sustained changes in weight or relapses.
#Intervention
- OTHER : Weight Control
- Weight Control
|
#Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index greater than 25, overweight
* Participation in Weight Loss program
Exclusion Criteria:
* A medical history of myocardial infarction or cerebrovascular stroke
* Pregnancy or planned pregnancy during the course of the study period
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02146885
|
{
"brief_title": "The Use of Diffuse Optical Spectroscopy to Characterize in Response to Weight-Loss Intervention",
"conditions": [
"Overweight"
],
"interventions": [
"Other: Weight Control"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02146885",
"official_title": "The Use of Diffuse Optical Spectroscopy to Characterize Adipose Tissue Oxygenation and Vascular Reactivity in Response to Weight-Loss Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01-13",
"study_completion_date(actual)": "2017-01-13",
"study_start_date(actual)": "2013-01-08"
},
"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)": "2022-11-01",
"last_updated_that_met_qc_criteria": "2014-05-20",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-05-26",
"first_submitted": "2014-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fed conditions
#Intervention
- DRUG : Levetiracetam
- 1000 mg tablet
- Other Names :
- KEPPRA
|
#Eligibility Criteria:
Inclusion Criteria:
* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria:
* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.
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
|
NCT00827320
|
{
"brief_title": "Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions",
"conditions": [
"Seizures"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00827320",
"official_title": "A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-06",
"study_completion_date(actual)": "2007-06",
"study_start_date(actual)": "2007-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-23",
"last_updated_that_met_qc_criteria": "2009-01-21",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-22",
"first_submitted": "2009-01-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to develop initial efficacy, feasibility, and safety data regarding the use of Tamoxifen in combination with amphotericin B and fluconazole in the treatment of cryptococcal meningitis. The results of the study will inform the design and feasibility of a larger study powered to a survival endpoint. The study hypothesis is that adding tamoxifen to standard antifungal therapy increases the rate of clearance of yeast from cerebrospinal fluid. Increased rates of clearance of yeast from cerebrospinal fluid have previously been associated with improved clinical outcomes, including survival and disability.
Detailed Description
A randomized, open-label trial with 2 parallel arms: standard antifungal therapy versus tamoxifen augmented antifungal therapy during the first 2 weeks (induction phase) of treatment. The study will recruit in two sites in Ho Chi Minh City: the Hospital for Tropical Diseases (HTD), and Cho Ray Hospital (CRH). 25 patients will be enrolled into the two study arms (intervention versus control). All anti-fungal administration will be directly observed by ward staff.
Intervention arm: Induction phase treatment (days 1-14): Tamoxifen will be given orally in a dose of 300mg/day for the first 14 days following randomization. It will be administered by nasogastric tube where patients are unconscious. In addition patients will receive amphotericin 1mg/kg once daily iv and fluconazole 800mg once daily orally. The tamoxifen will be administered in the morning combined with amphotericin and fluconazole dose.
Control arm: Induction phase treatment (days 1-14): Patients will receive amphotericin 1mg/kg/day combined with fluconazole 800mg once daily for the first 2 weeks. Amphotericin and fluconazole will be administered simultaneously.
The primary efficacy endpoint will be the rate of clearance of yeast cells from cerebrospinal fluid (CSF) over the first 2 weeks following randomisation. Patients will be followed for 10 weeks, which is conventional in clinical trials in cryptococcal meningitis. After the first 2 weeks of study treatment, all patients will receive fluconazole 800mg/day for 8 further weeks, until the study end. At this point, HIV infected patients will be switched to long term secondary prophylaxis with fluconazole 200mg/day as per standard practice. For HIV uninfected patients, the decision to continue antifungal treatment, and at which dose, will be made on a case by case basis by the attending physician in consultation with the patient.
#Intervention
- DRUG : Tamoxifen
- Tamoxifen will be given orally in a dose of 300mg/day for the first 14 days following randomization. It will be administered by nasogastric tube where patients are unconscious. The Tamoxifen will be administered in the morning combined with amphotericin and fluconazole dose.
- Other Names :
- Nolvadex - D
- DRUG : Amphotericin B
- Patients will receive amphotericin 1mg/kg/day i.v. once daily orally for the first 2 weeks.
- Other Names :
- Amphotret
- DRUG : Fluconazole
- Patients will receive fluconazole 800mg once daily orally for the first 2 weeks. Amphotericin and fluconazole will be administered simultaneously. After the first 2 weeks of study treatment, all patients will receive fluconazole 800mg/day for 8 further weeks, until the study end.
- Other Names :
- Zolmed 200
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Cryptococcal meningitis (CM) defined as a syndrome consistent with CM and one or more of:
* positive CSF India ink (budding encapsulated yeasts),
* C. neoformans cultured from CSF or blood,
* positive cryptococcal antigen Lateral Flow Antigen Test (LFA) in CSF
* Informed consent to participate given by patient or acceptable representative
* Known HIV infection status, or patient agrees to HIV testing on this admission
Exclusion Criteria:
* Pregnancy or breast-feeding
* History of thromboembolic disease such as pulmonary embolism or deep venous thrombosis
* On anti-coagulant medication
* On medication known to prolong the QT interval other than fluconazole, such as fluoroquinolones or antidepressants.
* Known cardiac conduction defect including long QT syndromes
* QTc at baseline > 500ms
* Currently receiving treatment for cryptococcal meningitis and having received > 4 days of anti-cryptococcal meningitis therapy
* Known allergy to Tamoxifen
* Currently or history of receiving treatment with Tamoxifen for breast cancer or other indication
* Current or history of uterine cancer including endometrial cancer and uterine sarcoma
* Renal failure (defined as creatinine >3*ULN (upper limit of normal), despite adequate hydration)
* Failure to consent - the patient, or if they are incapacitated, their responsible relative, declines to enter the study
* Allergy to amphotericin B or fluconazole
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
|
NCT03112031
|
{
"brief_title": "Treatment With Tamoxifen in Cryptococcal Meningitis",
"conditions": [
"Meningitis Streptococcal",
"Hiv",
"Meningitis",
"Meningoencephalitis"
],
"interventions": [
"Drug: Amphotericin B",
"Drug: Fluconazole",
"Drug: Tamoxifen"
],
"location_countries": [
"Vietnam"
],
"nct_id": "NCT03112031",
"official_title": "A Randomized Trial of Tamoxifen Combined With Amphotericin B and Fluconazole for Cryptococcal Meningitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-17",
"study_completion_date(actual)": "2018-07-17",
"study_start_date(actual)": "2017-10-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-02",
"last_updated_that_met_qc_criteria": "2017-04-07",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-13",
"first_submitted": "2017-03-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to understand the biochemistry of different types of Limb-Girdle Muscular Dystrophy (LGMD) and to determine appropriate outcome measures for future clinical treatment trials for LGMD. It is being conducted at two sites in the Cooperative International Neuromuscular Research Group (CINRG). It involves a one day clinical evaluation at a participating institution that will take approximately four to six hours, and will involve strength testing and muscle functional testing by a physical therapist, an evaluation by a physician, pulmonary function testing, a complete cardiac evaluation with electrocardiogram (ECG or EKG) and echocardiogram (Echo), and involve two blood draws, one before the evaluation and one after the evaluation is complete. During the visit, the participant will be asked to fill out a couple of questionnaires asking questions about quality of life and activity limitations, as well as his/her understanding of their diagnosis with regards to etiology (or cause of their muscle disorder), genetics, and inheritance of their muscle disorder.
Detailed Description
Specific Aims:
Aim 1: Evaluate integrity of the extracellular matrix in patients with LGMD by measuring serum growth factors and cytokines and compare these to a disease control (BMD) and normal volunteers.
Aim 2: Measure growth factors and cytokines following medical evaluation and compare them to the baseline levels.
Aim 3: Discovery Aim for future multicenter clinical trials in LGMD. Aim 3A: Abstract medical records with particular emphasis on age of disease onset, initial clinical symptoms, progression and location of the muscular weakness, treatments attempted, and other medical complications. A review of the diagnostic testing performed will also be conducted.
Aim 3B: Perform complete clinical evaluation including anthropometric measures, evaluation of joint limitations, timed functional testing, muscle strength, pulmonary function, and a cardiac assessment.
Aim 3C: Determine patient understanding of diagnosis of LGMD and genetic testing results. A questionnaire will be generated that addresses the patient's understanding of his/her diagnosis as well as their understanding of genetic concepts of autosomal recessive inheritance, genes, molecular testing and implications for themselves as well as their family.
Aim 3D: Quality of Life (QOL) questionnaires will be administered. These will be used to identify functional limitations by the patients and compare those limitations with the clinical evaluation.
Study Description
Only one visit will be necessary for this study. The study visit includes:
1. Review of the informed consent form
2. Blood collection Blood will be collected for the following: DNA extraction to confirm genotype if not already performed; Muscle Enzymes before and after physical evaluation; and Growth factors and cytokines: before and after physical evaluation.
3. Medical history review
4. Physical Examination
5. Questionnaires: Participants will complete 3 questionnaires: Diagnosis and genetic testing, ACTIVLIM, and INQoL
6. Clinical Evaluator assessment which includes: Manual Muscle Testing, Quantitative Muscle Testing, Pulmonary Function Testing, Anthropometric measurements, and Timed and Functional testing
7. Cardiac evaluation will include: Electrocardiogram and Echocardiogram
Control subjects will be required to come to the test site to complete the informed consent process, clinical evaluator assessment, and have blood drawn before and after the clinical evaluator assessment. No other examinations or procedures will be performed on the control participants.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older.
* Diagnosis of LGMD2I, LGMD2A, LGMD2B, or BMD as determined by muscle biopsy immunohistochemistry, immunoblotting, or molecular analysis.
* Able to travel to study site
* Normal controls will be recruited as either friends of the study participants or through separate recruitment.
Exclusion Criteria:
* Unable to travel to study site.
* Do not have the diagnosis of LGMD2I, LGMD2A, LGMD2B, or BMD after review of clinical testing.
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
|
NCT00893334
|
{
"brief_title": "Evaluation of Limb-Girdle Muscular Dystrophy",
"conditions": [
"Becker Muscular Dystrophy",
"Limb-Girdle Muscular Dystrophy, Type 2A (Calpain-3 Deficiency)",
"Limb-Girdle Muscular Dystrophy, Type 2B (Miyoshi Myopathy, Dysferlin Deficiency)",
"Limb-Girdle Muscular Dystrophy, Type 2I (FKRP-deficiency)"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00893334",
"official_title": "Evaluation of Limb-Girdle Muscular Dystrophy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "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)": "2014-03-07",
"last_updated_that_met_qc_criteria": "2009-05-05",
"last_verified": "2014-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-06",
"first_submitted": "2009-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system.
Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.
#Intervention
- DEVICE : Virtual reality gaming
- This study aims to combine the motivational delivery of therapy which is an immersive virtual reality with the foundational concepts of mirror therapy. By utilizing a recalibration software, the participant will be able to achieve magnified movements on their screen as compared to the limited movement that is occurring in reality. The recalibration software takes each plane of movement of the gaming controller and magnifies the participant's range of motion in order to promote greater participation and success in the game that they are playing (Walkin VR). By using the fundamental concepts of mirror therapy in an immersive virtual reality setting, the investigators aim to mimic the results of mirror therapy while increasing motivation and adherence to the therapeutic program to increase overall upper extremity function.
|
#Eligibility Criteria:
Inclusion Criteria:
* Self-reported diagnosis of stroke
* Greater than 2 years post-stroke
* Access to reliable transportation
* History of weakness/hemiparesis of one upper limb
Exclusion Criteria:
* Significant vision impairment or blindness
* Non-English speaking
* History of seizure or seizure disorder
* Health conditions which would be exacerbated by low-intensity exercise
* Inability to use arms independently for exercise
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
|
NCT05856669
|
{
"brief_title": "The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke",
"conditions": [
"Stroke",
"Hemiparesis"
],
"interventions": [
"Device: Virtual reality gaming"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05856669",
"official_title": "The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-16",
"study_completion_date(actual)": "2023-10-16",
"study_start_date(actual)": "2023-09-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-11",
"last_updated_that_met_qc_criteria": "2023-05-03",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-12",
"first_submitted": "2023-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of relapsed small cell lung cancer.
Detailed Description
This is a Phase II, open label, single arm, multicenter study of NK012 in patients with sensitive relapsed SCLC (at least 90 days since first line therapy) or refractory relapsed SCLC (\< 90 days since first line therapy). NK012 will be administered by intravenous infusion over 30 minutes once every 28 days (on Day 1 of each cycle). Patients will be screened for UGT1A1 polymorphism prior to enrollment.
#Intervention
- DRUG : NK012
- 30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m\^2 (or 18 mg/m\^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m\^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of SCLC, which has relapsed after first line chemotherapy for extensive-stage SCLC or first-line chemoradiotherapy for limited-stage SCLC.
* Have received one, and only one, prior chemotherapy or chemoradiotherapy regimen for either newly diagnosed extensive-stage disease or limited-stage disease.
* Prior therapies must be completed at least 4 weeks prior to enrollment and patients must have recovered from all acute toxicities.
* Measurable disease by RECIST.
* ECOG performance status of 0 <= age <= 2.
* At least 18 years.
* Adequate bone marrow function as defined by absolute neutrophil count of greater than or equal to 1,500/mm^3 and platelets of greater than or equal to 100,000/mm^3.
* AST (SGOT) and ALT (SGPT) levels no greater than 3 x the institutional ULN, and total bilirubin less than or equal to 1.5 x ULN.
* Serum creatinine less than or equal to 1.5 x ULN, or creatinine clearance greater than or equal to 60 mL/min (Cockcroft-Gault formula) for patients with serum creatinine levels > 1.5 x ULN.
* Able to understand and show willingness to sign a written informed consent document.
Exclusion criteria:
* Patient has Gilbert's Syndrome.
* Prior chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
* Lack of recovery from adverse effects due to agents administered more than 4 weeks prior to study entry.
* Concurrent use of other investigational agent.
* History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for > 1 week.
* Prior exposure to topoisomerase 1 inhibitors (i.e., irinotecan, topotecan, camptothecin).
* Concurrent serious infections requiring parenteral therapy.
* Pregnant or of childbearing potential and not using methods to avoid pregnancy. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed infants while on this study.
* Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias or poorly controlled angina.
* History of serious ventricular arrhythmia (VT or VF, greater than or equal to 3 beats in a row), QTc greater than or equal to 450 msec for men and 470 msec for women, or LVEF less than or equal to 40% by MUGA or ECHO.
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
|
NCT00951613
|
{
"brief_title": "A Study of NK012 in Patients With Relapsed Small Cell Lung Cancer",
"conditions": [
"Small Cell Lung Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00951613",
"official_title": "A Phase II Study of NK012 in Sensitive Relapsed and Refractory Relapsed Small-Cell Lung Cancer (SCLC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-20",
"last_updated_that_met_qc_criteria": "2009-08-02",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-08-04",
"first_submitted": "2009-05-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.
#Intervention
- COMBINATION_PRODUCT : Radiopaque Etonogestrel (ENG) Implant
- 68 mg subdermal implant
- Other Names :
- Org 32222, Nexplanon, Implanon-NXT, SCH900415, MK-8415
|
#Eligibility Criteria:
Inclusion Criteria:
* Not diagnosed with perimenopause or menopause.
* Heterosexually active with a partner who is not known to be subfertile, sterilized, or infertile, and is seeking contraception for pregnancy.
* Palpable intact ENG implant in the upper inner-arm for 36 months from the date of insertion at the time of enrollment, and has documentation of the insertion date (for example, Nexplanon user card or medical record completed on the date of insertion).
* Does not desire a pregnancy within the 24 months after enrollment, is willing to continue use of the implant for an additional 24 months, and is not intending to use any other form of contraception (eg, condoms) from enrollment until after implant removal at 24 months post enrollment.
* Good physical and mental health in the medical judgment of the investigator.
* History of regular menstrual cycles of 21 to 35 days before the insertion of the ENG implant or before hormonal contraceptive use (which may have preceded the current implant use).
* Able and willing to adhere to all required study procedures, including study visits and eDiary entries, and not planning to relocate during the study.
Exclusion Criteria:
* Conceived a pregnancy during use of the current implant or a past contraceptive implant.
* Known or suspected pregnancy at the time of screening or enrollment visit.
* History of subfertility or infertility.
* Breastfeeding.
* Untreated gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis.
* Significantly abnormal cervical cytology (Pap) or pathology results either at screening or documented in the 36-month period prior to enrollment.
* Current use of an intrauterine device/intrauterine system (IUD/IUS).
* Presence of more than one ENG implant.
* Use of daily/monthly hormonal contraceptives, sex steroids, or GnRH agonist/antagonist within 3 months prior to enrollment.
* Use of injectable hormonal contraceptive with 3-month duration within 9 months prior to enrollment.
* Use of injectable GnRH agonist with 3-month duration within 10 months prior to enrollment .
* Use of medications that induce liver enzymes within 2 months prior to enrollment.
* Untreated or unresolved vaginal bleeding or spotting attributable to underlying pathology in the 12 months before screening.
* Frequent, prolonged, or excessive vaginal bleeding/spotting in the 12 months prior to screening which has not been evaluated to detect underlying pathology.
* History of venous thromboembolism or arterial thromboembolism, transient ischemic attack, angina pectoris, or claudication.
* Any condition associated with an increased risk of venous thromboembolism.
* Uncontrolled or severe hypertension at screening visit.
* Clinically significant liver disease, including active viral hepatitis or cirrhosis.
* History of malignancy within 5 years before screening, except treated skin cancer.
* History of sex steroid-influenced malignancies (eg, genital organs, breasts).
* History or presence of liver tumors (benign or malignant).
* Known allergy/sensitivity or contraindication to the ENG implant or lidocaine with epinephrine.
* History of drug or alcohol abuse or dependence within 24 months prior to enrollment. Routine use of alcohol or marijuana that is not considered abuse or dependence is not exclusionary.
* Use of an investigational drug within 2 months prior to enrollment. Long-term follow up of an investigational compound for COVID-19 is allowed 2 months after the last administered dose.
* Staff or immediate family members of the investigational site or Sponsor directly involved with this study.
Sex :
FEMALE
Ages :
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04626596
|
{
"brief_title": "A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)",
"conditions": [
"Contraception"
],
"interventions": [
"Combination Product: Radiopaque Etonogestrel (ENG) Implant"
],
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT04626596",
"official_title": "A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger",
"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)": "2020-11-19"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-13",
"last_updated_that_met_qc_criteria": "2020-11-06",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-12",
"first_submitted": "2020-11-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This multicenter, prospective study of children with hydrocephalus will examine whether or not ventricle size is associated with poor cognitive outcomes. It is expected that results will indicate larger ventricular size at 6 months after surgery for the initial treatment of hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.
Detailed Description
The current literature is inconclusive regarding the direct association between large ventricle size and poorer cognitive outcomes. This uncertainty stems from relatively few studies, problems with study design (possible confounding factors), varying study populations of hydrocephalus, and conflicting evidence. If the association is proven then aggressive strategies must be developed to maximally decrease ventricular size in these children to preserve long-term cognitive functioning. However, if the association is disproven then previous reservations for procedures such as Endoscopic Third Ventriculostomy (ETV) or higher-resistance shunting to prevent overdrainage complications will be further minimized. Either finding has a major potential to further improve the quality of life in our pediatric hydrocephalus patients. This study is unique as it will include pediatric patients presenting with hydrocephalus from a wide range of etiologies. This study is also unique in that we propose to conduct a brief pre-operative neuropsychological examination to act as internal controls along with the outcomes obtained at a more extensive neuropsychological examination at six months after initial hydrocephalus treatment surgery.
|
#Eligibility Criteria:
Inclusion Criteria: Patients will be eligible for enrollment if they:
* are 5 years or older; and
* have been newly diagnosed with hydrocephalus to be managed surgically with either a cerebrospinal fluid (CSF) shunt or an ETV; and
* have one of the following etiologies for hydrocephalus: aqueductal stenosis, supratentorial and posterior fossa tumors both benign and malignant, post-traumatic, myelomeningocele, tectal gliomas, post-infectious, and following spontaneous intraventricular hemorrhage (IVH). Malignant tumors have been included as the neuropsychological deficits secondary to adjuvant chemotherapy and radiation have not been demonstrated within the proposed study's 6 month window.
Exclusion Criteria: Patients will be ineligible for enrollment if ANY of the following is true or anticipated:
* present with a Glasgow Coma Scale (GCS) score of less than 14/15, cerebellar mutism, or cognitive deficits so severe as to make neuropsychological testing impossible; OR
* have etiologies of diffuse intrinsic pontine glioma, atypical teratoid rhabdoid tumor, or any tumor with cerebral or spinal metastases (these patients' clinical course and survival are highly unpredictable); OR
* are not expected to survive for 6 months; OR
* are unable or unwilling to participate in the study and with the neuropsychological exam; OR
* due to limitations of neuropsychological testing, blind and deaf children will be excluded. Children for whom English is not their primary language will be included if they have attended 1 or more years of English language based schooling.
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01797627
|
{
"brief_title": "Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus",
"conditions": [
"Hydrocephalus"
],
"interventions": null,
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT01797627",
"official_title": "Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-29",
"last_updated_that_met_qc_criteria": "2013-02-20",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-22",
"first_submitted": "2012-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.
#Intervention
- DRUG : Tiotropium
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with suspected chronic obstructive pulmonary disease (COPD)
* 3 or more positive answers in COPD questionnaire
* Age > 40 years
Exclusion Criteria:
* Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
* Patient treated with Spiriva in the past year
* Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics
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
|
NCT00615992
|
{
"brief_title": "Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": null,
"location_countries": [
"Austria"
],
"nct_id": "NCT00615992",
"official_title": "Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-08",
"last_updated_that_met_qc_criteria": "2008-02-13",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-14",
"first_submitted": "2008-01-24",
"first_submitted_that_met_qc_criteria": "2009-11-17"
}
}
}
|
#Study Description
Brief Summary
purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center
Detailed Description
was a retrospective study of all patients who underwent planned deliveries for placenta accreta at King Hussein Medical Centre (KHMC) from August 2011 to October 2014.Demographic characteristics were recorded. Ultrasound (U/S) and magnetic resonance imaging (MRI) were used for the diagnosis. Surgery for all patients were performed by multidisciplinary teams. All information were obtained from patient's files.
#Intervention
- PROCEDURE : Bakrey balloon insertion within the uterus and caesarean hysterectomy
- Creating an intrauterine tamponade to stop the uterine bleeding by inflating an intrauterine balloon with 600 cc of saline versus undergoing hysterectomy if conservative management failed
- Other Names :
- Interventional radiological insertion of balloon to obstuct the internal iliac artery
|
#Eligibility Criteria:
Inclusion Criteria:
* all placenta previa accreta cases encountered in our institution over three year period
Exclusion Criteria:
*
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03668795
|
{
"brief_title": "Surgical Management of Placenta Accreta",
"conditions": [
"To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03668795",
"official_title": "Surgical Management of Placenta Accreta a Three Year Experience at King Hussein Medical Center",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10-30",
"study_completion_date(actual)": "2017-11-30",
"study_start_date(actual)": "2011-08-01"
},
"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)": "2018-09-17",
"last_updated_that_met_qc_criteria": "2018-09-11",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-13",
"first_submitted": "2018-09-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.
Detailed Description
This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days of treatment.
#Intervention
- DRUG : Bilastine
- Other Names :
- Alektos
- DRUG : Loratadine
- Other Names :
- Claritin, Histadin, Loranil, Loritil, Loralerg
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
* patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)
Exclusion Criteria:
* pregnancy or breast-feeding;
* non-allergic rhinitis (vasomotor, infectious or drug-induced);
* known hypersensitivity to antihistamines;
* clinical disorders that might affect the assessment;
* nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
* therapy with immunotherapy;
* use of antihistamines or disodium cromoglycate within the past four weeks;
* use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks;
* use of topical antihistamines or nasal decongestants within the last 48 hours;
* use of deposit steroid within the last month.
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
|
NCT02513290
|
{
"brief_title": "Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine",
"conditions": [
"Allergic Rhinitis"
],
"interventions": [
"Drug: Bilastine",
"Drug: Loratadine"
],
"location_countries": null,
"nct_id": "NCT02513290",
"official_title": "Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-05-07",
"last_updated_that_met_qc_criteria": "2015-07-30",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-31",
"first_submitted": "2015-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.
Detailed Description
PRIMARY OBJECTIVES:
I. To investigate and define anticipated and unanticipated adverse events (AEs) related to a daily virtual mindfulness intervention delivered via short message service (SMS) text messaging and to test its safety in the postoperative period amongst patients with cancer.
II. To determine the feasibility and acceptability of a novel, brief mindfulness intervention delivered via SMS text messaging in the postoperative period amongst patients undergoing surgery for cancer.
III. To determine the feasibility and acceptability of an artificial intelligence platform to deliver and receive SMS text messages for the purpose of delivering pain assessment tools and collecting and storing pain-specific and patient reported outcomes.
OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
ARM II: Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
#Intervention
- OTHER : Survey Administration
- Complete Survey
- OTHER : Interview
- Complete Interview
- OTHER : Text Message-Based Navigation Intervention
- Complete mindfulness intervention
- Other Names :
- Automated Text Message-Based Navigation, Text Message-Based Navigation
- OTHER : Interview
- Complete interview
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 18 years
* Open abdominal surgery for cancer
* Ownership of smartphone (iOS or Android operating systems) with SMS texting capabilities
* Ability to read
* Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by each participating institution.
Exclusion Criteria:
* Patients with contraindications to abdominal surgery and/or general anesthesia
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
|
NCT05346692
|
{
"brief_title": "Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer",
"conditions": [
"Hematopoietic and Lymphoid System Neoplasm",
"Malignant Solid Neoplasm"
],
"interventions": [
"Other: Interview",
"Other: Text Message-Based Navigation Intervention",
"Other: Survey Administration"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05346692",
"official_title": "A Prospective, Double-Arm Pilot Study to Investigate the Safety, Feasibility and Acceptability of a Digital Mindfulness Intervention Following Open Abdominal Surgery for Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-12",
"study_completion_date(actual)": "2023-07-12",
"study_start_date(actual)": "2022-03-28"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-14",
"last_updated_that_met_qc_criteria": "2022-04-21",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-26",
"first_submitted": "2022-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this double blind, crossover study participants will consume a cranberry beverage and a cranberry-flavored beverage for 2 weeks each. Gut permeability will be assessed weekly using aspirin and food-grade sugar molecules. Participants will be asked to provide urine, blood, saliva and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the cranberry beverage
Detailed Description
Obesity, stress, liver disease, alcoholism, diabetes, and autoimmune diseases in humans or animal models are associated with altered intestinal permeability; consequently, maintenance of the gastrointestinal barrier is an emerging area of interest. The purpose of this randomized, double-blind, controlled crossover study is to compare the difference between the change from baseline in gastroduodenal permeability after drinking a cranberry or control beverage for two weeks. Gastroduodenal permeability will be assessed following aspirin challenge by measuring urinary sucrose in the 0 to 5-hour urine collection after differential sugar probes are consumed. Urine will be collected for an additional 19 hours (24 hours total) to assess whole gut permeability. A 4-week washout period will separate the interventions. Stool and fasting blood and saliva samples will be obtained before and during the intervention periods to assess fecal microbial communities and markers of intestinal barrier, immune function and oxidative stress. It is anticipated that cranberry juice will selectively increase intestinal Akkermansia bacteria, reduce markers of inflammation and oxidative stress, increase mucosal immunity, and protect the gastroduodenal barrier from an aspirin challenge.
#Intervention
- OTHER : Cranberry Beverage
- The cranberry beverage will provide 50 kcals and 4.0 grams of fiber per day from whole milled cranberries, water, cranberry natural flavor and sucralose.
- OTHER : Control Beverage
- The control beverage will provide 50 kcals per day and is a color, taste matched sugar sweetened beverage formulated with water, sucrose, citric acid, cranberry natural flavor, malic acid, xanthum gum, sucralose and artificial color (red 40, blue 1).
|
#Eligibility Criteria:
Inclusion Criteria
* Have a BMI >= 30 kg/m2 and a waist circumference >= 35 inches for women and >= 40 inches for men.
* Have had a stable weight for 3 months (<5 kg or ~11 lbs body weight change)
* Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, naproxen, or indomethacin, for the full length of the study.
* Willing to discontinue consumption of wine and berries throughout the 12-week study.
* Willing and able to avoid consumption of any cranberry juice, whole cranberries, and dried cranberries during the two weeks leading up to the study and during the study, not including the study beverage.
* Willing to avoid beer and cocktails on the day before and the day of the sugar probe tests.
* Willing to avoid the use of antidiarrheal or laxative medication on a regular or an 'as-needed basis' during the full length of the study.
* Willing to provide urine, saliva, blood, and stool samples during the study collection periods.
* Have used aspirin in the past and did not experience adverse effects.
* Willing to consume three tablets (325 mg each or 975 mg total) twice within a 9 to 12-hour period. This challenge will be repeated four times during the 12-week study.
* Willing and able to complete daily and weekly questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits.
* Willing to discontinue consumption of fermented foods or probiotics.
* Willing to discontinue consumption of fiber supplements.
* Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact immune function or inflammation during the pre-baseline period and throughout the study protocol.
* Willing and able to consume 4.23 oz of a cranberry beverage four times daily (~16 oz total/d) for the 2-week study interventions.
* Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on four occasions.
* Willing and able to complete the informed consent form in English.
* Willing to provide a social security number to receive study payment.
Exclusion Criteria
* Currently being treated for a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, or colostomy) other than GERD or diverticular disease
* Currently being treated for or type 1 diabetes or type 2 diabetes by medication
* Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
* Allergy to aspirin or cranberries.
* Participate in moderate or high exercise activities during a typical week.
* Currently smoking (including vaping) tobacco products
* Women who are lactating, pregnant, or are attempting to get pregnant.
* Use of another investigational product within 3 months of the screening visit.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03957239
|
{
"brief_title": "The Effect of a Cranberry Beverage on Intestinal Permeability and Gastrointestinal Function in Generally Healthy Adults",
"conditions": [
"Intestinal Permeability",
"Gastrointestinal Function"
],
"interventions": [
"Other: Control Beverage",
"Other: Cranberry Beverage"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03957239",
"official_title": "The Effect of a Cranberry Beverage on Intestinal Permeability and Gastrointestinal Function in Generally Healthy Adults With a BMI ≥ 30: a Randomized, Double-blind, Controlled, Crossover Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-02",
"study_completion_date(actual)": "2020-01-02",
"study_start_date(actual)": "2019-09-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-07",
"last_updated_that_met_qc_criteria": "2019-05-17",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-21",
"first_submitted": "2019-05-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Previously our retrospective study showed that almost half of the patients with acute alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young age being risk factors for recurrence. The aim of this prospective follow-up study was aimed to find out the risk factors in detail.
Detailed Description
Patients admitted to Tampere University Hospital for first acute alcoholic pancreatitis were included. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase \> 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded. Alcohol consumption and dependency were detected. Serum and fecal markers of the endocrine and exocrine function and secretin stimulated MRCP were studied. The patients were followed median 38 (25 - 61) months for the recurrences and had a follow up visit at two years to investigate trends in the alcohol consumption.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who survived their first acute alcoholic pancreatitis. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded.
* High alcohol consumption was detected
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
|
NCT00523874
|
{
"brief_title": "Recurrence of Acute Alcoholic Pancreatitis",
"conditions": [
"Recurrent Acute Pancreatitis"
],
"interventions": null,
"location_countries": [
"Finland"
],
"nct_id": "NCT00523874",
"official_title": "Recurrence of Acute Alcoholic Pancreatitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-05",
"study_start_date(actual)": "2001-01"
},
"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)": "2007-09-03",
"last_updated_that_met_qc_criteria": "2007-08-31",
"last_verified": "2001-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-03",
"first_submitted": "2007-08-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this randomized controlled pilot study is to examine the preliminary effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms and spousal relationship status) of a newly developed intervention for individuals with dementia and their family caregivers that combines elements of the established care consultation (CC) approach with additional counseling modules (CC+C). Outcomes for Veterans with dementia and their family caregivers (e.g., depressive symptoms, care-related burden, quality of life, pleasant events, etc.) will be assessed after 6 months of treatment and again at 12 months.
Detailed Description
Background: Dementia affects over 7% of Veterans age 65 and above seeking care through the Veteran's Health Administration (VHA), amounting to one out of every eleven Veterans in some VISNs. The unique functional and behavioral impairments associated with Alzheimer's or a related dementia (ADRD) contribute substantially to psychological and physical morbidity of family caregivers and high rates of nursing home placement, with 60% of ADRD caregivers rating the emotional stress of caregiving as 'high or very high,' and over one third reporting depressive symptoms. Although numerous evidence-based interventions have been developed to reduce caregiver burden and improve mental health and functional outcomes of the person with dementia, a recent systematic review noted almost none of these interventions 'make it off of the shelf' to be readily available in clinical settings. Care Consultation (CC) has emerged as a rare exception. CC is an evidence-based telephone intervention delivering psychoeducation, care coordination, and resource referrals in diverse areas such as safety and mental and behavioral health support. Yet CC's focus on coaching and support is inadequate for dyads experiencing high levels of distress. A stepped-intervention approach would address the VA's efficiency needs while allowing the flexibility for more resource-intensive additional counseling beyond the established CC framework when warranted by high dyad distress. This CDA-2 proposal would move such a dyadic intervention forward.
Objectives: 1) Manualize the integration of care consultation and counseling components (i.e., the CC+C intervention). CC+C is guided by a rehabilitation recovery-based conceptual model to address the most common high distress targets (e.g., relationship distress, Veteran or caregiver depression, anxiety, or pain) using patient-centered approaches. 2) Evaluate preliminary effectiveness and feasibility of the CC+C Intervention in a randomized controlled pilot study of distressed dyads to compare: a) the established CC intervention, to b) the CC+C intervention on Veteran and caregiver outcomes. 3) Conduct exploratory analyses of the CC+C intervention on Veteran long-term care placement at six and 12 months and examine two key treatment moderators (behavioral symptoms and spousal relationship status) that may impact intervention engagement and response to treatment.
The investigators hypothesize that: 1) Caregivers assigned to CC+C will have greater reductions in caregiver burden at 6 months than those assigned to CC alone. 2) Indicators of relationship strain (i.e., marital distress and/or mutuality) will show greater improvement in CC+C than CC at 6 months. 3) Gains in shared pleasant events, social engagement, and quality of life will be greater in CC+C than in CC alone at 6 months. 4) Participants with dementia in both groups will have reduced depressive symptoms at 6 months. The investigators will also explore the impact of the two interventions on rates of placement in long-term care facilities (such as nursing homes, VA Community Living Centers or other supportive living environments) at 6 and 12 months.
Methods: Ten modules combining successful elements from existing manualized therapies and exercises developed by the investigative team during the CDA1 period will be integrated with CC into a draft CC+C intervention manual. The manual will be finalized with input from the mentoring team and an Expert Advisory Panel for completeness, feasibility, and safety and risk considerations. Next 68 distressed Veterans with dementia and their family caregivers will be recruited and randomized to either the CC+C intervention group or the CC comparison group. Patient, caregiver, and relationship outcomes (e.g., burden, depressive symptoms, anxiety, quality of life, relationship distress) will be measured at baseline, 6 months, and 12 months. Treatment implementation and feasibility data will be collected.
Anticipated Impacts: The goal of this career development study is to acquire the knowledge, skills and experience necessary to successfully compete for an RR\&D Merit Review Award evaluating a randomized controlled trial powered to establish efficacy and test effectiveness of the CC+C intervention. Rehabilitation-focused interventions that maximize functioning are essential for successful non-institutional VA dementia care in the future. Work completed during the CDA2 period will serve as a foundation for a career committed to this goal. The impact of this work will be realized when an efficacious and highly-accessible intervention, such as the telephone-based dyadic intervention being piloted, becomes available for aging Veterans and their families.
#Intervention
- BEHAVIORAL : Counseling (C)
- The counseling component incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
- BEHAVIORAL : Care Consultation (CC)
- Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the 'initial assessment,' which then immediately shapes development of concrete action plans.
|
#Eligibility Criteria:
Inclusion Criteria:
Veterans:
* Must be age >= 19 years
* Must have a diagnosis of dementia or a related disorder
* Must live in the community (i.e. not in a VA Community Living Center, nursing home, or other facility)
* Must cohabitate with a caregiver
* Must have reliable access to a telephone
* Must be willing to consent to participate or provide assent in conjunction with proxy consent if their decision-making capacity is compromised
Caregivers:
* Must be age >= 19 years
* Must self-identify as assisting with care for at least 8 hours/week
* Must be willing to consent to participate
Exclusion Criteria:
Veterans:
* Currently incarcerated
* Currently pregnant
* Dyads experiencing low levels of distress
Caregivers:
* Currently incarcerated
* Currently pregnant
* Experiencing severe cognitive impairment that would impair their ability to communicate during an interview
* Dyads experiencing low levels of distress
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02585232
|
{
"brief_title": "Optimizing Dementia Care",
"conditions": [
"Alzheimer's Disease",
"Dementia",
"Dementia, Vascular",
"Caregivers",
"Veterans"
],
"interventions": [
"Behavioral: Care Consultation (CC)",
"Behavioral: Counseling (C)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02585232",
"official_title": "Optimizing Dementia Care Through Collaborative Recovery Interventions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-05",
"study_completion_date(actual)": "2020-10-22",
"study_start_date(actual)": "2016-10-01"
},
"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)": "2022-01-11",
"last_updated_that_met_qc_criteria": "2015-10-21",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-23",
"first_submitted": "2015-10-14",
"first_submitted_that_met_qc_criteria": "2021-08-13"
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that propofol, when compared to sevoflurane, causes the upper airway to collapse more easily and causes less activity in the tongue muscle. Additionally, the investigators hypothesize that, under increased carbon dioxide concentrations of the air inhaled, the upper airway will be less likely to collapse under anesthesia and there will be increased activity in the tongue muscle under both propofol and sevoflurane, when compared to breathing normal concentrations of carbon dioxide, as in room air. Furthermore the investigators hypothesize that anesthesia disrupt the breathing swallow coordination, an effect additionally altered by increased carbon dioxide through increased respiratory drive.
Detailed Description
Upper airway patency depends on an appropriate balance between the dilating force of pharyngeal muscles and the collapsing force of negative intraluminal pressure, which is generated by respiratory 'pump' muscles. The genioglossus (GG) protects pharyngeal patency in humans. This muscle receives various types of neural drive, distributed differentially across the hypoglossal motoneuron pool, including phasic (inspiratory) and tonic (non-respiratory) drives. In addition, reflex GG activation in response to negative pharyngeal pressure stabilizes upper airway patency both in humans and in rats. General anesthetic agents, including propofol and sevoflurane, predispose the upper airway to collapse, at least in part by decreasing upper airway muscle activity.
Theoretically anesthetics could affect upper airway dilator activity by several mechanisms, including an anesthetic-induced, dose-dependent decrease in hypercapnic and hypoxic ventilatory drive, hypoglossal motoneuron depression, decreased skeletal muscle contractility, an increase in phasic GG activity as a result of decreased arterial blood pressure, and an increase in phasic hypoglossal nerve discharge.
Previous studies have shown that certain anesthetics, including pentobarbital and isoflurane, can increase genioglossus phasic activity in rats and in humans. The effects of propofol on airway collapsibility have been studied in humans however, to our knowledge, they have not been measured under conditions of hypercapnia. Studies of airway collapsibility under sevoflurane anesthesia have been performed in children, but no data exists for airway collapsibility in sevoflurane-anesthetized adults. Similarly no data exists on the effects of sevoflurane on GG activity
In a previous trial of pentobarbital-anesthetized volunteers, the investigators observed that mild hypercapnia (5 - 10 mmHg above baseline) produced a significant increase in flow rate and GG phasic activity, as well as a smaller increase in GG tonic activity. If our proposed study shows a beneficial effect, then the investigators plan a follow-up study addressing the possibility that hypercapnia may be used therapeutically for airway protection. A similar concept has already been considered for critically ill ICU patients.
However, previous studies have shown that a hypercapnia-induced increase in ventilatory drive can inhibit airway protective reflexes by disrupting the breathing swallowing coordination. In order to assess the safety of induced mild hypercapnia as an intervention for airway protection, we evaluated whether variable levels of hypercapnia occurring during anesthesia with sevoflurane and propofol impair the coordination of breathing and swallowing compared with the effects of anesthesia alone.
With this pharmaco-physiological interaction study on healthy adults we aim to:
1. Compare the effects of sevoflurane and propofol on upper airway closing pressure, upper airway muscle control and breathing.
2. Assess the effects of evoked hypercapnia (carbon dioxide reversal) on propofol-induced upper airway collapsibility
3. Evaluate the effects of sevoflurane, propofol, and induced hypercapnia on coordination of breathing and swallowing.
Comparative drug studies on airway effects of anesthetics in humans are important for defining an optimal anesthetic regimen for patients at risk of airway collapse, such as patients with obstructive sleep apnea. Our studies are also particularly relevant for patients undergoing procedural sedation, which is typically being conducted under spontaneous ventilation with the upper airway being unprotected. In addition, our results may increase our understanding of postoperative airway obstruction, a common complication in the post-anesthesia recovery room.
#Intervention
- DRUG : Propofol
- Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.
- DRUG : Sevoflurane
- Sevoflurane will be administered via mask inhalation to achieve anesthesia.
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) class I
* Age between 18 and 45
* BMI 18 <= age <= 28 kg/m^2
Exclusion Criteria:
* Concurrent significant medical illness (heart disease including untreated hypertension, Clinically significant kidney disease, liver disease, or lung disease, History of myasthenia gravis or other muscle and nerve disease)
* Anxiety disorder requiring treatment
* Concurrent medications known to affect anesthesia, upper airway muscles or respiratory function (e.g., gabaergic anxiolytics, antipsychotics)
* Individuals with a history of allergy or adverse reaction to lidocaine, propofol, or sevoflurane
* For women: pregnancy
* Suggestion of obstructive sleep apnea (OSA) or any other sleep disorder (e.g. witnessed apneas, gasping or choking during sleep, unexplained excessive daytime sleepiness)
* History of drug or alcohol abuse
* Acute intermittent porphyria
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
|
NCT01557920
|
{
"brief_title": "The Effects of General Anesthetics on Upper Airway Collapsibility in Healthy Subjects",
"conditions": [
"Airway Complication of Anaesthesia",
"Healthy"
],
"interventions": [
"Drug: Sevoflurane",
"Drug: Propofol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01557920",
"official_title": "The Effects of Sevoflurane, Propofol, and Carbon Dioxide 'Reversal' on Upper Airway Collapsibility in Healthy, Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2013-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-13",
"last_updated_that_met_qc_criteria": "2012-03-16",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-20",
"first_submitted": "2012-03-15",
"first_submitted_that_met_qc_criteria": "2016-03-21"
}
}
}
|
#Study Description
Brief Summary
With the progressive aging of the population in industrialized countries, acute calculous cholecystitis (ACC) has been constantly increasing among elderly. Because ACC is the most common complication of biliary gallstone disease and the population will become older, ACC in elderly is expected to increase. In 2017, the incidence of gallstone disease in Italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. Since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. In order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. The present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.
#Intervention
- PROCEDURE : Laparoscopic Cholecystectomy
- Laparoscopic Cholecystectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* acute calculous cholecystitis
Exclusion Criteria:
* tumors of the biliary tract
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
|
NCT04596306
|
{
"brief_title": "Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study.",
"conditions": [
"Acute Cholecystitis"
],
"interventions": [
"Procedure: Laparoscopic Cholecystectomy"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04596306",
"official_title": "Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: More Complex But Equally Safe and Effective. A Retrospective Study on 879 Patients.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-31",
"study_completion_date(actual)": "2020-11-30",
"study_start_date(actual)": "2020-01-01"
},
"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)": "2021-01-19",
"last_updated_that_met_qc_criteria": "2020-10-15",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-22",
"first_submitted": "2020-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent to RYGBP, LAGB and their relation with obesity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of morbid obesity
* Being underwent LAGB or RYGBP
Exclusion Criteria:
* Having prior abdominal surgery history
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01613391
|
{
"brief_title": "Effect of Roux-en-Y Gastric Bypass Versus Laparoscopic Adjustable Gastric Band Operations on Resistin, Apelin and Visfatin Peptides",
"conditions": [
"Morbid Obesity"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT01613391",
"official_title": "Effect of Roux-en-Y Gastric Bypass Versus Laparoscopic Adjustable Gastric Band Operations on Resistin, Apelin and Visfatin Peptides",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-02",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2011-07"
},
"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)": "2012-06-11",
"last_updated_that_met_qc_criteria": "2012-06-06",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-06-07",
"first_submitted": "2012-06-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism.
Detailed Description
The study looked into how meal frequency influences bone remodeling, focusing on the Procollagen Type 1 N-terminal propeptide (P1NP) marker, which indicates bone production. Bone remodeling is a continual process in which osteoclasts break down bone tissue and osteoblasts form new bone tissue. Dietary patterns are increasingly recognized as influencing bone remodeling and general bone health, with meal frequency playing an important role in bone metabolism.
To perform the study, 30 healthy adult males aged 19 to 30 were recruited from Jordan using informational flyers. They participated in a randomized controlled intervention experiment. The participants were randomly allocated to one of two groups: one group ate three meals per day and the other ate eight meals per day. This dietary pattern was followed for three consecutive days in what was referred to as Phase 1 of the study.
Following Phase 1, there was a one-week washout phase to remove any residual effects from the previous food pattern. Following the washout period, the participants were moved to an alternate meal frequency (i.e., those who had three meals per day were now eating eight, and vice versa) for another three days, known as Phase 2.
Blood samples were collected from participants at baseline (before beginning the food intervention) and after each phase of the trial. The levels of P1NP in the blood samples were determined using an enzyme-linked immunosorbent assay (ELISA), a widely used laboratory technique for detecting and quantifying chemicals.
#Intervention
- OTHER : Meal Frequency Manipulation
- The intervention involves altering meal frequency among participants. One group consumes three standardized meals per day, while the other consumes eight smaller, more frequent meals. Meals are designed to meet nutritional needs and adhere to dietary guidelines. The aim is to assess the impact of meal frequency on bone remodeling by measuring the blood biomarker P1NP at various points during the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy individuals aged between 19 and 30 years
* Absence of medical conditions affecting bone remodeling, including:
* Hyper/hypothyroidism
* Diabetes
* Cancer
* Renal problems
* Paget's disease
* Cushing's disease
* Multiple myeloma
* Rickets
* Osteomalacia
* Hypogonadism
* Osteoporosis
* Metastatic carcinoma
* Gaucher's disease
* Hairy cell leukemia
Exclusion Criteria:
* Abnormal food habits, including:
* Night eating or frequent diet changes
* Shift work
* Daytime sleepers
* Irregular sleeping patterns
* Use of medications or supplements impacting bone remodeling, calcium homeostasis, or sleep patterns
* History of a broken or fractured bone within the last 6 months before the study
* Exclusively enlisting male volunteers to eliminate the potential influence of maternal hormones, such as estrogen, on bone remodeling dynamics
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06359483
|
{
"brief_title": "The Impact of Meal Frequency on Bone Remodeling in Healthy Adults",
"conditions": [
"Healthy Adults"
],
"interventions": [
"Other: Meal Frequency Manipulation"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT06359483",
"official_title": "A Randomized Controlled Pilot Study on the Short-Term Impact of Meal Frequency on Bone Remodeling in Healthy Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-04",
"study_completion_date(actual)": "2021-07-04",
"study_start_date(actual)": "2021-06-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-11",
"last_updated_that_met_qc_criteria": "2024-04-05",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-11",
"first_submitted": "2024-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Serum samples of asthmatic patients will be screened for serum biomarkers
#Intervention
- DIAGNOSTIC_TEST : Serum biomarker testing
- Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 - 65 years
* physician-diagnosed asthma
Exclusion Criteria:
* No clear asthma phenotype
* Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
* > 15 pack years
* No sputum available
* Respiratory infection
* Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04377958
|
{
"brief_title": "Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma",
"conditions": [
"Asthma",
"Biomarkers"
],
"interventions": [
"Diagnostic Test: Serum biomarker testing"
],
"location_countries": null,
"nct_id": "NCT04377958",
"official_title": "Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10",
"study_completion_date(actual)": "2020-05",
"study_start_date(actual)": "2016-12"
},
"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)": "2020-05-08",
"last_updated_that_met_qc_criteria": "2020-05-04",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-07",
"first_submitted": "2020-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Compare the objective remission rate of A140 and Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer for 12 weeks
Detailed Description
In this study, a multicenter, randomized, double-blind, controlled trial design was used to compare the efficacy and safety of A140 or Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer patients
Objective to compare the 12 week objective response rate (ORR) of A140 and ebitur combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer.
#Intervention
- DRUG : Double blind control period A140
- experiment arm： Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv), Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h) control arm: Drug Erbitux:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv) Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h)
- Other Names :
- KL-140
- DRUG : Open single period A140
- Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv), Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h)
- Other Names :
- KL-140
|
#Eligibility Criteria:
Inclusion Criteria:
* Be able to understand the procedures and methods of this study, be willing to strictly abide by the clinical trial protocol to complete this trial, and sign the informed consent voluntarily
* Male or female subjects aged 18 <= age <= 75 years (including 18 and 75 years)
* Histologically proven diagnosis of metastatic colorectal cancer. No previous systemic chemotherapy for metastatic colorectal cancer. Patients who have completed adjuvant chemotherapy before the start of the study can be enrolled, Platinum containing chemotherapy needs to end for more than 12 months, and non platinum containing chemotherapy needs to end for more than 6 months;
* KRAS and NRAS genotypes in tumor tissues were wild type, and BRAF-V600E mutation was not found；
* At least one measurable lesion by computer tomography(CT) or magnetic resonance imaging (MRI)according to RECIST1.1 criteria (not in an irradiated area)
* Eastern Cooperative Oncology Group(ECOG)performance status of 0 or 1 at trial entry；
* Life expectancy of at least 16 weeks；
* The level of organ function before the first medication met the following requirements:
1. Peripheral blood cell count: leukocyte count >= 3×10ˆ9 / L, neutrophil count >= 1.5× 10ˆ9 / L, platelet count >= 75 × 10ˆ9 / L, hemoglobin >= 90 g / L;
2. Liver function: total bilirubin <= 1.5 ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 ULN; AST and ALT<= 5 ULN in subjects with liver metastasis;
3. Renal function: serum creatinine <= 1.5 ULN.
* Fertile subjects (male and female) were required to receive effective medical contraceptive measures until 3 months after the last study (see Annex 4 for specific contraceptive measures).
Exclusion Criteria:
* Those who are known to have an allergic reaction to any component of the study drug；
* Local treatments such as radiotherapy, radiofrequency ablation, intervention, etc or surgical procedures (excluding prior diagnostic biopsy) in the 28 days before first administration；
* Known brain metastasis and/or leptomeningeal disease；
* People with complete intestinal obstruction and incomplete intestinal obstruction requiring treatment. However, patients whose obstruction is relieved by fistula or stent placement can be included in the group;
* Active severe clinical infection (> Grade 2, NCI-CTCAE version 5.0), including active tuberculosis；
* Uncontrolled diabetes (fasting blood glucose >=10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease. Except for radiation pneumonia that has recovered), liver failure；
* Clinically significant cardiovascular diseases, such as heart failure (NYHAⅢ-Ⅳ), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>100mmHg), echocardiography The figure shows the ejection fraction <50%, the history of myocardial infarction within the past two years；
* Renal replacement therapy；
* > Grade 1 Peripheral Nerve Disorder (NCI-CTCAE Version 5.0)；
* History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation；
* Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix；
* HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA >= 1×10ˆ4 copy number/ml or >= 2000 IU/ml), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleotide HCV RNA>= 1×10ˆ3 copies/ml or >= 200 IU/ml)；
* Patients with coagulation dysfunction, meet any of the following conditions: prothrombin time (PT) >= 1.5 ULN， thrombin time (TT) >= 1.5 ULN,activated partial thromboplastin time (APTT) >= 1.5 ULN;
* Previously treatment with VEGF pathway targeted therapy and EGFR monoclonal antibody；
* Past treatment history:
1. Receiving other anti-tumor treatments (including anti-tumor treatments with traditional Chinese medicines, such as Aidi injection, Kanglaite injection, Kangai injection, cininobufosin, brucea javanica oil, etc.) within 4 weeks before the first administration of the study ；
2. Long-term systemic immunotherapy, or hormone therapy for anti-tumor purposes (physiological replacement therapy, except for those with hypothyroidism who take thyroxine);
3. Have received G-CSF, GM-CSF, whole blood or blood component transfusions within 4 weeks before the first medication of the study;
4. Have received other experimental drugs or interventional clinical studies within 4 weeks before the first medication of the study；
* Pregnancy (confirmed by blood pregnancy test) or lactation；
* There is currently alcohol or drug dependence；
* There is a clear neurological disease or mental illness that has not been cured, including epilepsy, dementia, schizophrenia, etc；
* Adverse events of previous treatment (except for hair loss) did not return to grade 1 or below (NCI-CTCAE version 5.0)；
* The researcher believes that the patient has other factors that affect the efficacy or safety evaluation of this study
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
|
NCT04835142
|
{
"brief_title": "Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC",
"conditions": [
"Metastatic Colorectal Cancer"
],
"interventions": [
"Drug: Open single period A140",
"Drug: Double blind control period A140"
],
"location_countries": [
"China"
],
"nct_id": "NCT04835142",
"official_title": "Phase III Clinical Study Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-22",
"study_completion_date(actual)": "2024-01-26",
"study_start_date(actual)": "2020-12-31"
},
"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)": "2024-08-05",
"last_updated_that_met_qc_criteria": "2021-04-05",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-08",
"first_submitted": "2021-03-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of our research titled 'The effect of the exercise program developed for the upper extremity in diabetic individuals on dexterity, grip strength and proprioception' is to examine the effect of the exercise program created for upper extremity problems in diabetic individuals on dexterity, wrist proprioception and upper extremity functionality. Secondary aims of our study; the exercise program created for upper extremity problems; to investigate the effects of grip strength, neuropathic pain, light touch, proprioception, muscle viscoelastic properties, anxiety and depression levels and quality of life of individuals.
The strength of different grip types will be measured, and an evaluation will be made in a short time from the muscle surface with a device called MyotonPro to determine the characteristics of the muscles in hands and arms. In addition to these, 6 separate questionnaires will evaluate the functionality of hands, wrists and upper extremities, pain level, satisfaction level, difficulty level in daily living activities, neuropathic pain problems, depression and anxiety levels and quality of life. In addition, different senses in the upper extremity and hand-wrist will be tested. These measurements will take 1 hour in total and will be repeated 3 times at 6-week intervals. Participant will divide on 2 groups and treatment group will perform exercises with physiotherapist and control group will take conventional physiotherapy program for diabetes. Comparison will be between groups.
Detailed Description
* 12 weeks/ 3 days a week/ 40 minutes of physiotherapy program will be planned. Patients will complete the exercises with a physiotherapist once a week, and home programs given as homework according to weekly targets will be checked by phone calls twice a week. In the first session, information about diabetes will be given and training will be given.
* Content of the exercises; There will be warm-up exercises, pinch grip, full grip, nerve and tendon gliding exercises, exercises that improve proprioception, functional exercises, strengthening exercises and stretching exercises. Control group will be in conventional physiotherapy program once a week as treatment group. The program is going to include aerobic exercise recommendation and basic stretching and strengthening exercises focusing upper extremity muscles.
This research will shed light on the rehabilitation programs to be planned for problems involving the hand in individuals with diabetes.
#Intervention
- OTHER : Exercise
- * Joints targeted by exercise; bilateral wrist, metacarpophalangeal, proximal and distal interphalangeal joints, elbow and shoulder joints.
* The muscles targeted by the exercises; lumbricals, iinterosseals, thenar and hypothenar muscles, forearm flexors, forearm extensors, forearm supinators and pronators, elbow flexors and extensors, and shoulder girdle muscles.
* Content of the exercises; There will be warm-up exercises, pinch grip, full grip, nerve and tendon gliding exercises, exercises that improve proprioception, functional exercises, strengthening exercises and stretching exercises.
- OTHER : Conventional Physiotherapy
- For control group there will be aerobic exercise recommendation and resistive exercises focused on upper extremity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteering to participate in the research
* Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)
Exclusion Criteria:
* Insufficient cognitive level
* Traumatic nerve injury
* Presence of congenital anomaly in the upper extremity
* Presence of systematic disease (eg rheumatologic)
* Having a problem involving the neurological system
* Having undergone surgery involving the upper extremity in the last 6 months
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
|
NCT05974878
|
{
"brief_title": "The Effect of the Physiotherapy Program for Diabetic Individuals on Dexterity, Proprioception, and Functionality",
"conditions": [
"Diabetes Mellitus Type 2"
],
"interventions": [
"Other: Exercise",
"Other: Conventional Physiotherapy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05974878",
"official_title": "The Effect of the Physiotherapy Program Developed for the Upper Extremity in Diabetic Individuals on Dexterity, Proprioception, and Functionality",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-01",
"study_completion_date(actual)": "2023-12-19",
"study_start_date(actual)": "2023-05-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-04",
"last_updated_that_met_qc_criteria": "2023-07-26",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-03",
"first_submitted": "2023-05-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared to administration of placebo.
#Intervention
- DIETARY_SUPPLEMENT : Omega-3 (Triglyceride form)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18 and <= 90 at the time of informed consent
* Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms
* Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye
* Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye
Exclusion Criteria:
* Allergy to fish oil or safflower oil
* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy
* LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study
* Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand
* Contact lens wear within 12 hours of any study visits
* Pregnancy or lactation during the study
* Abnormal nasolacrimal drainage (by history)
* Punctal cauterization or punctal plug placement within 60 days of screening
* Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc...) within 3 weeks (21 days) of Screening and at any time during the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02260960
|
{
"brief_title": "The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease",
"conditions": [
"Dry Eye Disease"
],
"interventions": [
"Dietary Supplement: Omega-3 (Triglyceride form)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02260960",
"official_title": "The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03",
"study_completion_date(actual)": "2015-03",
"study_start_date(actual)": "2014-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-08-04",
"last_updated_that_met_qc_criteria": "2014-10-08",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-09",
"first_submitted": "2014-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Mental disorders are common in youth and adults. Symptoms of mental are aggravated by unemployment. Compared to the working population, the unemployed have higher rates of poor health, a tendency toward negative emotionality and depression, show symptoms of exhaustion more frequently, and experience disturbed sleep or have a sleep disorder. It can be reasonably expected that unemployment in adolescents and young adults causes the same symptoms and behaviors as in adults. In those youth with a mental disorder, particularly an untreated one, the transfer from school to the employment market can be hindered. At the same time, the investigators notice an increase in early disability pensions due to mental health issues among adolescents. Thus, the early recognition and treatment of mental disorders and psychological strain is crucial in promoting the employment of young people and supporting their connection to the employment market.With this project the investigators want to implement an early intervention and reach out to unemployed youth. The investigators identified the period between graduation and first employment as the ideal moment of intervention, because this time period is a critical period in which young people are exposed to increasing personal challenges. Conducting an intervention before a psychological stress transforms into a mental disorder, can prevent harm and suffering to the afflicted person. In addition, early intervention could help prevent the need to enroll in the early disability pension program.
Detailed Description
Mental disorders are common. A WHO study shows (Gore, Bloem, Ferguson, Coffey and Mathers, 2011) that during adolescence; most of the years lost because of illness are due to neuropsychiatric disorders such as depression, substance abuse and schizophrenia. Steinhausen, Metzke and Kannenberg (1998) found that 22% of the children and adolescents living in the canton of Zurich, suffer from mental disorders. The figures are comparable with Wittchen, Nelson and Lachner (1998) who fund 27% of the adolescents fitting the DSM IV (Diagnostic and Statistical Manual) criteria for mental disorders.
Mental disorders are particularly stressful in combination with unemployment. Unemployed are often in a worse physical condition compared to employed people; they tend to negative emotional states and depression, fatigue and sleep disorders. It is to be expected that unemployment will have the same effect on adolescents. Fergusson, Horwood and Lynskey (1997) showed that in 16 to 25 years old, the increase of the unemployment was correlated with the increase of mental distress having consequences like depression, anxiety, substance abuse and attempts to suicide.
The aim of this project is to validate a screening tool for the early recognition of mental disorders among young unemployed. The screening tool will be composed by no more than 50 items.
The participants will be requested to fill out the screening tool and in a second phase, they will be asked to participate in a face to face, standardized clinical Interview, the Munich-Composite International Diagnostic Interview (M-CIDI) (Wittchen, Lachner, Wunderlich and Pfister, 1998).
To ensure that the screening tool differentiates between 'at risk' and 'non at risk' patients, the sample will be composed by 40 unemployed young adults, Age 16-25 and 40 working young adults, age 16-25.
Statistical Analysis: After the data collection the data from the screening and the clinical interview will be tested for sensitivity and specificity. To evaluate both the Receiver Operating Characteristic (ROC) and other methods will be used. The prognostic validity of the screening tool will be additionally calculated with a logistic regression. The data analysis will be executed with SPSS 21.
Missing data will be excluded from the sample.
#Intervention
- OTHER : Screening
- Participants will fill out a short screening questionnaire where different aspects of mental health and behavioral problems will be assessed.
|
#Eligibility Criteria:
Inclusion Criteria:
* 40 unemployed Young adults, Age 16 <= age <= 25,
* 40 working Young adults, Age 16 <= age <= 25,
* informed consent to participate in the study.
Exclusion Criteria:
* insufficient understanding of the German language.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02401984
|
{
"brief_title": "Zurcher Adolescent Screening for Mental Disorder",
"conditions": [
"Mental Disorders"
],
"interventions": [
"Other: Screening"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT02401984",
"official_title": "Zürcher Adoleszenz-Screening-Instrument Psychischer Störungen",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2015-08",
"study_start_date(actual)": "2015-03"
},
"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)": "2017-02-07",
"last_updated_that_met_qc_criteria": "2015-03-27",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-30",
"first_submitted": "2015-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications.
#Intervention
- OTHER : Parenteral Nutrition
- Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who completed head and neck cancer surgery and got a feeding tube perioperatively
* Patients of legal age
* Patients who can understand and read Scandinavian languages
Exclusion Criteria:
* Patients with allergy to components in parenteral nutrition
* Patients where it is impossible to give parenteral nutrition
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
|
NCT03042195
|
{
"brief_title": "Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients",
"conditions": [
"Head and Neck Neoplasm"
],
"interventions": [
"Other: Parenteral Nutrition"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03042195",
"official_title": "Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09",
"study_completion_date(actual)": "2017-09",
"study_start_date(actual)": "2016-12-18"
},
"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)": "2018-04-10",
"last_updated_that_met_qc_criteria": "2017-02-01",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-03",
"first_submitted": "2016-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.
Detailed Description
Some people with a history of Lyme disease continue to have problems despite having received 'textbook duration' antibiotic therapy. When memory, attention, or thinking problems persist, the syndrome is called persistent Lyme disease (PLD). This study seeks to answer critical scientific questions about the treatment and cause of PLD symptoms.
This 24-week treatment study will evaluate each patient's response to treatment using neuropsychological testing and state-of-the-art brain imaging. The brain tests include neuropsychological testing of memory and attention, brain imaging (MRI and PET scans) to look at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and studies of the fluid that surrounds the brain (cerebrospinal fluid). The treatment involves 10 weeks of either intravenous antibiotic called ceftriaxone (also known as Rocephin) or intravenous placebo (inactive substance). After the first visit to Columbia Presbyterian Medical Center, the remaining treatments will be done in the patient's home. Patients will be screened over the phone and in person to confirm study eligibility.
#Intervention
- DRUG : ceftriaxone
|
#Eligibility Criteria:
Inclusion Criteria:
Eligible participants must:
* Be 18 <= age <= 65 years
* Have persistent problems with memory, verbal fluency, or attention after having contracted Lyme disease.
* Be able to travel to New York for 4 <= age <= 5 evaluations over the course of one year. Travel costs for participants in need may be partially or fully reimbursable.
* Have had a history of well-documented Lyme disease using the CDC's clinical criteria and a current positive IgG Western blot or PCR.
* Have received, at some point in the past at least 3 weeks of IV antibiotic therapy for Lyme disease.
Exclusion Criteria:
Ineligible from participation are people with the following:
* Other major medical or neurologic problems
* Smoke more than 10 cigarettes a day
* Uncontrolled high blood pressure
* Allergy to ceftriaxone (Rocephin)
* History of marked cocaine abuse
Twenty healthy subjects are also being sought for the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00037479
|
{
"brief_title": "Brain Imaging and Retreatment Study of Persistent Lyme Disease",
"conditions": [
"Lyme Disease",
"Lyme Neuroborreliosis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00037479",
"official_title": "PET and MRI Imaging of Persistent Lyme Encephalopathy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "1999-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": null,
"masking": null,
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-12-07",
"last_updated_that_met_qc_criteria": "2002-05-17",
"last_verified": "2005-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-05-20",
"first_submitted": "2002-05-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT regimen.
#Intervention
- DRUG : tibolone
- uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time).
- Other Names :
- Livial
- DRUG : low-dose estradiol/noresterone
- Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets.
Subjects were to take 1 Activelleâ tablet and 1 Livialâ-matched placebo tablet, orally, once a day (preferably at the same time).
- Other Names :
- Activelle®
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must be healthy and postmenopausal women, >= 45 and < 65 years, with an intact uterus.
* Subjects must have been postmenopausal for less than 15 years.
* Body Mass Index >18 and =< 32 kg/m2.
* Voluntary written informed consent is required.
Exclusion Criteria:
* Any unexplained abnormal uterine bleeding after the menopause.
* Double layer endometrial thickness = 6 mm as assessed by transvaginal ultrasonography.
* Treatment with oral estrogen and/or progestogen therapy within 4 weeks prior to screening, or treatment with transdermal therapy and local estrogen applications within 4 weeks prior to screening.
* Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (occasional use of estrogen-containing vaginal cream is allowed after the appropriate wash-out period is completed). Estrogen combined with sequential administration of progestogen should have been at least 10 days per 28 day cycle.
* The following wash-out periods apply:
* 4 weeks for transdermal hormonal treatment, local estrogen applications or other non-hormonal medication known to act on the relief of vasomotor symptoms (e.g. clonidine)
* 4 weeks for phytoestrogens, tibolone, intra-uterine or oral progestogen and oral estrogen/progestogen therapy
* 6 months for progestogen implants or injections and estrogen/progestogen injectable therapy.
* Any subjects who are either using phytoestrogens, tibolone, intra-uterine or oral progestogen, progestogen implants or injections, estrogen/progestogen combination therapy or any other non-hormonal medication known to act on the relief of vasomotor symptoms and who have not observed the appropriate wash-out periods (see previous exclusion criteria).
* Any serious disease or disorder; or any endocrine disorder; (controlled hypo/hyperthyroidism and diabetes mellitus Type II is allowed).
* Diseases for which exogenous hormonal steroids are contraindicated.
* History or presence of any malignancy, except successfully treated nonmelanoma skin cancers.
* History or presence of cardiovascular or cerebrovascular conditions:
* thrombophlebitis, thrombosis or thromboembolic disorders.
* History or presence of liver, gallbladder (subjects who have had a cholecystectomy will not be excluded) or renal disease, epilepsy or classical migraine headaches.
* History or presence of clinically significant depression or other psychiatric disorders which, in the investigator's judgment, might compromise or confound the subject's participation in the trial.
* Uncontrolled high blood pressure: systolic pressure > 170 mmHg and/or diastolic pressure > 105 mmHg, measured after 5 minutes in a sitting position.
* Abnormal cervical Pap smear (corresponding to PAP = III, or LSIL, HSIL, ASCUS, AGCUS in the Bethesda classification)
* Abnormal, clinically significant results of the mammography.
* Presence of fibrocystic disease of the breast.
* Presence of otosclerosis.
* Known hypersensitivity to any of the ingredients of the trial medication.
* Any subjects using either steroids, drugs known to affect sexual functioning and mood (antidepressants, psychoactive drugs, sedatives, neuroleptics, narcotics, benzodiazepines), drugs know to interfere with the pharmacokinetics of the steroids (hydantoins, primidone, rifampicin, barbiturates, carbamazepine, griseofulvin, warfarin, ketoconazole, or products containing St. John's wort), or raloxifene hydrochloride. A wash-out period of 4 weeks will apply to subjects using these drugs. Sporadical use of benzodiazepines (twice or less a week) is allowed
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00431093
|
{
"brief_title": "Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)",
"conditions": [
"Menopause"
],
"interventions": [
"Drug: tibolone",
"Drug: low-dose estradiol/noresterone"
],
"location_countries": null,
"nct_id": "NCT00431093",
"official_title": "A Multicenter, Randomized, Double-Blind, Double Dummy, Group-Comparative Trial to Compare the Effects of Livial® and Activelle ® on the Vaginal Bleeding Pattern, Vasomotor Complaints, Vaginal Atrophy, QoL and Sexual Function",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-03",
"study_completion_date(actual)": "2005-03",
"study_start_date(actual)": "2002-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-03",
"last_updated_that_met_qc_criteria": "2007-02-02",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-02-05",
"first_submitted": "2007-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to assess the mass balance recovery from excreta of carbon 14 labelled BI409306 (\[14C\] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.
#Intervention
- DRUG : 14C-BI 409306
- Other Names :
- 14C-BI 409306 oral solution
|
#Eligibility Criteria:
Inclusion criteria:
* Healthy male genotyped as CY2C19 poor metabolizer (PM) or extensive metabolizer (EM) according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrogardiogramm), and clinical laboratory tests. PM is defined as carrier of two non-functional alleles *2 and *3 of the CYP2C19 gene (diplotypes *2/*2; *2/*3; *3/*3). EM is defined as carrier of two functional alleles of the CYP2C19 gene (absence of *2, *3, *17; diplotype *1/*1).
* Age of 30 <= age <= 65 (incl.).
* BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.).
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
* A history of regular bowel movements (averaging 1 or more bowel movements per day; subjects with regular bowel movements of >3 per day will be excluded).
* Subjects who are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 90 days after the last dose of IMP.
Exclusion criteria:
* Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogramm) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. Any significant history of ocular or eye disease.
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Sex :
MALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02597998
|
{
"brief_title": "Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: 14C-BI 409306"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02597998",
"official_title": "Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration of 25 mg [14C]-BI 409306 as Oral Solution in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12-11",
"study_completion_date(actual)": "2015-12-11",
"study_start_date(actual)": "2015-09-15"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-07",
"last_updated_that_met_qc_criteria": "2015-11-04",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-05",
"first_submitted": "2015-09-30",
"first_submitted_that_met_qc_criteria": "2023-08-10"
}
}
}
|
#Study Description
Brief Summary
The purpose of this clinical trial is to evaluate the safety and clinical effectiveness of intravitreal bevacizumab (Lumiere®) in the single-dose form, for the treatment of patients with wet AMD.
Detailed Description
Age-related macular degeneration is the main cause of severe vision loss in patients over 65 years of age. There is solid evidence of the efficacy and safety of bevacizumab in the treatment of wet AMD. However, it has not been registered for such indication yet.
In response to the need for a proper adaptation, Lumiere® has been developed in a single-dose, sterile dosage containing bevacizumab 5 mg/vial in 0.2 mL injectable solution.
This adaptation is intended to assure intravitreal administration avoiding the risk of contamination and potential adverse consequences, such as endophthalmitis and blindness, associated to reutilization or repackaging of bevacizumab vials for oncological use.
#Intervention
- DRUG : Bevacizumab (Lumiere®)
- The first three doses of bevacizumab (Lumiere®) were administered via intravitreal injection on a monthly basis. A safety evaluation was conducted in the first month. Following the first three doses, continuation of the treatment (up to 6 doses) was decided according to response.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients > 50 years diagnosed with wet age-related macular degeneration having indication of antiangiogenic therapy.
* Both genders.
* Subjects able to give informed consent.
Exclusion Criteria:
* Patients with contraindication to receive bevacizumab:
* Hypersensitivity to the active ingredient or to some of the formula excipients.
* Hypersensitivity to products derived from CHO cells or to other human recombinant antibodies or humanized antibodies.
* Patients having received intravitreal antiangiogenic therapy prior to wet AMD treatment.
* Patients receiving previous systemic antiangiogenic therapy.
* Wet AMD in the healing period or disciform scar.
* Pregnant, breastfeeding or childbearing-aged women.
* Any person with choroidal neovascularization not associated to wet AMD.
* History of retinal or intraocular surgery in the affected eye in the last three months.
* Vitrectomy in the affected eye.
* Any significant ocular infection, active or suspected, having compromised or able to compromise the eye to be studied.
* Ocular inflammatory disease.
* Myopia exceeding -8 diopters.
* Extensive subfoveal subretinal hemorrh> 2 yearspapillary diameter (PD).
* Coexistence of other severe ocular diseases: uncontrolled ocular hypertension, terminal glaucoma, diabetic retinopathy, retinal vein thrombosis, optic atrophy.
* History of stroke or myocardial infarction in the last 6 months.
* Patients with coagulopathies.
* Patients physically or mentally disabled to participate in such visual tests.
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
|
NCT03668054
|
{
"brief_title": "Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration (Wet AMD)",
"conditions": [
"Age-Related Macular Degeneration"
],
"interventions": [
"Drug: Bevacizumab (Lumiere®)"
],
"location_countries": [
"Argentina"
],
"nct_id": "NCT03668054",
"official_title": "Clinical Study for Evaluating the Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-30",
"study_completion_date(actual)": "2018-05-30",
"study_start_date(actual)": "2017-02-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-28",
"last_updated_that_met_qc_criteria": "2018-09-10",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-12",
"first_submitted": "2018-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
For patients recovering from acute illness, the ability to stand, walk, climb stairs, and participate in therapy are critical to their recovery and eventual discharge to the least restrictive environment. Orthostatic hypotension is a common finding in medically ill adult and elderly patients and is a potentially reversible contributor to functional impairment. This 4-year project will be a randomized controlled trial of a multidisciplinary-multicomponent intervention to determine whether routine identification and treatment of OH improves functional outcomes such as: balance, fall rates, therapy participation, length of stay, transfer to acute care hospital, and discharge location. Routine screening and management of OH may improve outcomes for rehabilitation and long term care patients, as well other high-risk patient populations.
Detailed Description
Objectives Orthostatic hypotension (OH) is a condition that contributes to falls, dizziness, syncope, transient ischemic attack, and impaired functional status. OH is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic BP within 3 min of standing. The objectives of this study are to: (1) Examine the effect of OH treatment on functional outcomes, and OH prevalence during a subject's inpatient stay, and (2) Evaluate whether OH treatment during a subject's inpatient stay affects fall prevalence, and functional outcomes by 12 months after discharge.
Plan This 4-year project will be a randomized controlled trial of a multidisciplinary-multicomponent intervention to improve OH in patients admitted to Nursing Home (NH) and rehabilitation settings. During the 37-month enrollment period, the investigators expect to consent 350 subjects who will be randomized into intervention and control groups (175 subjects each). During their stay, subjects in the intervention group will receive a standardized treatment for their OH, or to prevent OH, while those in the control group will receive usual care. The investigators expect that 85% will remain in the study until they are discharged from the NH/rehabilitation unit. Following discharge, the investigators will conduct weekly phone calls to monitor incidence of falls for one month. Subsequently, at 12-months post-discharge, the investigators will conduct a chart review, and the study will terminate. The investigators expect 85% of the subjects discharged from the NH/rehabilitation unit that were enrolled in the study will remain in the study at 12-months post discharge. The investigators performed a 'pilot' study on up to 10 subjects while waiting for adequate staffing to conduct the study with blinded data collectors.
Methods The investigators will evaluate OH blood pressure responses, symptoms during standing, and whether there are any specific adverse outcomes related to treatment. In addition, the investigators will evaluate whether treatment of OH improves: motor functional independence measure (mFIM) scores, therapy participation, length of stay, transfer to the acute care hospital, discharge location, and mortality.
Clinical Relevance OH is a very common finding in many medically ill adult and elderly patients, and is associated with falls, syncope, and hip fractures. More aggressive screening (possibly the 6th vital sign) and management of this condition may improve outcomes for rehabilitation and long term care patients at the investigators' site as well other high-risk patient populations.
#Intervention
- OTHER : Medication review
- Current scheduled and as needed medications will be reviewed. Those medications with potentially hypotensive actions will be identified. There will be a joint review by Provider, Pharmacist, and Research staff of those medications and the patient's current clinical status. Plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).
- Other Names :
- Chart review
- OTHER : Nutrition/Salt intake
- Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to tray, or addition of salty foods/beverages (V8) will be considered as appropriate. Subjects receiving tube feedings will have water flushes replaced with saline flushes. Subjects with a history of congestive heart failure will be liberalized slowly and monitored closely by both the research and treatment team.
- Other Names :
- Review orders, Change nutrition/Salt intake orders
- OTHER : Education
- The research intervention staff will review symptoms of OH with patient/family and explain pathophysiology using a standardized pt information handout (NINDS 2007), subjects will be encouraged to spend maximal time out of bed, and to ambulate on ward as much as possible.
- OTHER : Exercise
- The patient's PT and/or Provider will review patient function for the ability to perform appropriate exercises and train patients (Ten Harkel, van Lieshout et al. 1994); (Bouvette, McPhee et al. 1996). Research staff will reinforce using these exercises while standing.
- Other Names :
- Physical therapy
- OTHER : Drug Recommendations
- The protocol permits the study physician to recommend medications for orthostatic hypotension. The patient's clinical team can implement, ignore, or modify these recommendations and only the clinical team can write orders for them. Fludrocortisone may be given 0.05mg at bedtime up to 0.2mg twice a day (Ten Harkel, Van Lieshout et al. 1992). Subjects with a history of congestive heart failure or peripheral edema will be carefully monitored. Sodium chloride tablets may be given starting at 1gm daily and increased to 2 gms twice daily \[Mukai 2002; Grubb 2003\]. Subjects with a history of congestive heart failure or peripheral edema will be carefully reviewed and monitored closely by the research staff and the treatment team. Midodrine may be given 2.5-5mg daily to three times daily \[Low, 1997\]. The dose will be started at 2.5mg every morning and then increased to 5mg every morning, then 5mg every morning and afternoon, then 5mg three times a day.
- Other Names :
- Consultant recommendation
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients admitted to the nursing home, and rehabilitation unit
Exclusion Criteria:
* hospice admission
* respite admission
* long-stay admission
* transplant admission
* inability to stand
* expected length of stay less than 14 days
* patients specifically admitted for treatment of OH
* cognitive dysfunction of such a severity that the admitting provider does not feel the patient could understand the study and safely participate in the data collection
* administrative exclusion, such as safety concerns of staff due to violent tendencies of patient
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
|
NCT01030874
|
{
"brief_title": "Orthostatic Hypotension Treatment on Rehab Unit",
"conditions": [
"Orthostatic Hypotension",
"Falls"
],
"interventions": [
"Other: Exercise",
"Other: Drug Recommendations",
"Other: Education",
"Other: Medication review",
"Other: Nutrition/Salt intake"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01030874",
"official_title": "Effect of Treatment of Orthostatic Hypotension on a Rehabilitation Unit",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2011-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-01",
"last_updated_that_met_qc_criteria": "2009-12-11",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-12-14",
"first_submitted": "2009-12-10",
"first_submitted_that_met_qc_criteria": "2021-06-10"
}
}
}
|
#Study Description
Brief Summary
A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury. Patients undergoing craniotomy to treat traumatic brain injury will be enrolled. All patients will undergo standard perioperative coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count), whereas ROTEM-guided group will additionally be tested with ROTEM. 'Cases' will be managed according to a ROTEM-based algorithm, and 'Controls' will be treated as usual (based on clinical judging). Comparative analysis of acquired demographic, clinical and laboratory data will be performed. The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
Detailed Description
Aim of the study:
To assess the utility of thromboelastometry for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury.
Objectives:
To evaluate perioperative prevalence and characteristics of thromboelastometry identified coagulopathy in neurosurgical patients with isolated traumatic brain injury; To assess the correlation between routine laboratory test results and thromboelastometric findings; To evaluate the influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury; To evaluate the utility of thromboelastometry for goal-directed coagulation management, and its possible influence on clinical outcome.
Study background:
Traumatic brain injury still accounts for a considerable proportion of preventable deaths worldwide. The prevalence of coagulation derangements among patients with traumatic brain injury (TBI) is high and approximates 30 % (1,2). The main hypothesis explaining the development of coagulopathy in the absence of massive bleeding is extensive release of tissue factor from the damaged brain tissue and subsequent over-activation of coagulation leading to consumption of coagulation substrates. The presence of coagulopathy in the setting of TBI is associated with high risk of intracranial hemorrhagic insult progression and death (3,4). Many authors investigating coagulopathy associated with traumatic brain injury have used routine coagulation tests, such as APTT, PT, INR, fibrinogen levels. However, those tests do not reflect the overall clot quality and reflect only separate parts of the coagulation process.
Craniotomy for traumatic brain injury is an urgent high-risk procedure presenting a serious challenge for the anesthesiology team. Significant, diffuse bleeding is not infrequent, and the spectrum of neurosurgical hemostatic options is limited. Moreover, even small amounts of intracranial blood may be life-threatening. Therefore the maintenance of optimal physiologic clotting capacity is crucial. Literature data investigating the use of ROTEM in TBI patients is still limited (5,6).
The investigators believe that thromboelastometry could provide novel insights into the dynamic coagulation changes of TBI patients. Moreover, it could serve as a clinical tool for targeted coagulation management in the perioperative period of patients undergoing craniotomies for intracranial traumatic hematomas, and prove beneficial for patient outcome.
Materials and methods:
A prospective open-label case-control study will be performed. Adult isolated traumatic brain injury patients undergoing craniotomy and will be enrolled. Required sample size was calculated based on the average number of craniotomies performed to treat traumatic brain injury during the past five years in a tertiary neurosurgical centre. The investigators plan to enroll 70 patients into the ROTEM-guided group (Cases), and 70 patients into the conventional therapy group (Controls). All patients will undergo standard coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count) preoperatively, and 3 days postoperatively, whereas ROTEM-guided group patients will additionally be tested with ROTEM (EXTEM, INTEM, FIBTEM, APTEM). Coagulation management decisions in the ROTEM-guided group will be made according to a ROTEM-based algorithm for goal-directed hemostatic therapy. Conventional therapy group will be treated as usual. Perioperative demographic, clinical and laboratory data of study patients will be registered. Early neurological state (on postoperative days 1,2,3,7, and until discharge) will be assessed according to the Glasgow coma scale. Late neurological outcome (6 and 12 months postoperatively) will be assessed according to Glasgow outcome scale. Comparative analysis of Case and Control groups will be performed. Perioperative prevalence and characteristics of coagulopathy in neurosurgical patients with isolated traumatic brain injury will be estimated. Correlation between routine laboratory test results and thromboelastometric findings will be assessed. The influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury will be assessed. The influence of goal-directed coagulation management on clinical outcome will be evaluated.
Anticipated scientific and clinical benefits:
The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
#Intervention
- OTHER : Thromboelastometry-guided haemostatic treatment
- Administration of blood products and/or procoagulants is based on thromboelastometric assays.
|
#Eligibility Criteria:
Inclusion Criteria:
* Isolated traumatic brain injury (within 48 hours) (AIS head >= 3)
* Urgent craniotomy is necessary
* A written informed consent is acquired from the patient or his/her representative
Exclusion Criteria:
* Refusal / inability to acquire an informed consent
* Significant trauma to other body regions (AIS other regions >= 3)
* Data on significant chronic hepatic or hematologic illness
* Use of oral anticoagulants or antiplatelet agents
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03616808
|
{
"brief_title": "Thromboelastometry-identified Haemostatic Changes in Isolated Traumatic Brain Injury",
"conditions": [
"Coagulation Disorder",
"Brain Injuries, Traumatic",
"Bleeding"
],
"interventions": [
"Other: Thromboelastometry-guided haemostatic treatment"
],
"location_countries": [
"Lithuania"
],
"nct_id": "NCT03616808",
"official_title": "The Influence of Thromboelastometry-identified Haemostatic Changes on Haemorrhagic Progression of Intracranial Injury and Clinical Outcome in Patients With Isolated Traumatic Brain Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-30",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2018-08-21"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-06",
"last_updated_that_met_qc_criteria": "2018-07-31",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-06",
"first_submitted": "2018-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
#Intervention
- DRUG : Uridine
|
#Eligibility Criteria:
Inclusion Criteria:
* DSM-IV-TR diagnosis of Bipolar I Depression
* 18 <= age <= 65 of age, inclusive
* Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
* Duration of current depressive episode of at least four weeks by Day 1
* Competent to give informed consent
Exclusion Criteria:
* Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of > 12 at Screening and/or Day 1
* Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
* A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
* Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
* An Axis II diagnosis that is likely to interfere with protocol compliance
* Initiation of or increase in psychotherapy within 4 weeks of Screening
* Psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on Day 1; fluoxetine within 2 weeks of initiation of study drug on Day 1
* Serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the MADRS at Screening and/or Day 1
* History of sensitivity to any of the ingredients in the study drug
* Clinically significant abnormality in any screening laboratory results
* Clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
* Women who are pregnant, breastfeeding, or refuse to use adequate birth control
* Current seizure disorder
* Participation in an investigational drug study within twenty-eight days of Day 1
* Current psychotic episode
* Clozaril use and/or electroconvulsive therapy within six months of Day 1
* Failure of three or more adequate trials of standard therapies for depression during the current episode
* Current episode of depression is longer than one year
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
|
NCT00322764
|
{
"brief_title": "Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression",
"conditions": [
"Bipolar Depression"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00322764",
"official_title": "Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-11-09",
"last_updated_that_met_qc_criteria": "2006-05-04",
"last_verified": "2007-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-08",
"first_submitted": "2006-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest Refractive Spherical Equivalent) ≤ -8.25 D.
Detailed Description
This is a prospective multi-center clinical trial in which a total of 360 eyes of consecutive subjects will be enrolled, treated with the VisuMax™ Femtosecond Laser, and followed for a 12-month period. The study will be conducted at up to 8 clinical sites.
Enrollment will be phased such that 100 eyes will be initially enrolled and followed. When 50 of the initial eyes have reached the 3-month follow-up exam, an interim clinical study report will be submitted to FDA along with a request to continue enrollment up to 360 eyes.
Subjects will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Baseline and postoperative measurements will include manifest refraction, cycloplegic refraction, distance visual acuity (best corrected and uncorrected), slit-lamp examination, fundus examination, corneal topography, central corneal pachymetry, mesopic pupil measurement, wavefront analysis, mesopic contrast sensitivity, and intraocular pressure (IOP).
#Intervention
- DEVICE : Treatment with the VisuMax™ Femtosecond Laser
- The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
- Other Names :
- VisuMaxTM Femtosecond Laser
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects age 22 years and older;
* Spherical myopia from >= -1.00 D to <= -8.00 D, with <= -0.50 D cylinder and MRSE <= -8.25 D in the eye to be treated;
* A stable refraction for the past year, as demonstrated by a change in MRSE of <= 0.50 D in the eye to be treated;
* A difference between cycloplegic and manifest refractions of < 0.75 D spherical equivalent in the eye to be treated;
* UCVA worse than 20/40 in the eye to be treated;
* BSCVA at least 20/20 in the eye to be treated;
* Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery;
* All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated;
* Central corneal thickness of at least 500 microns in the eye to be treated;
* Willing and able to return for scheduled follow-up examinations;
* Able to provide written informed consent and follow study instructions in English.
Exclusion Criteria:
* Mesopic pupil diameter > 8.0 mm;
* Cylinder > -0.50 D;
* Treatment depth is less than 250 microns from the corneal endothelium;
* Eye to be treated is targeted for monovision;
* Fellow eye has BSCVA worse than 20/40;
* Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
* History of or current anterior segment pathology, including cataracts in the eye to be treated;
* Clinically significant dry eye syndrome unresolved by treatment in either eye;
* Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated;
* Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
* Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
* History of ocular herpes zoster or herpes simplex keratitis;
* Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
* Difficulty following directions or unable to fixate;
* Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
* History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
* History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
* Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
* History of known sensitivity to planned study medications;
* Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
* Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01638390
|
{
"brief_title": "Use of the VisuMax™ Femtosecond Laser",
"conditions": [
"Myopia"
],
"interventions": [
"Device: Treatment with the VisuMax™ Femtosecond Laser"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01638390",
"official_title": "Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2012-07"
},
"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)": "2019-03-21",
"last_updated_that_met_qc_criteria": "2012-07-09",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-11",
"first_submitted": "2012-07-02",
"first_submitted_that_met_qc_criteria": "2018-12-12"
}
}
}
|
#Study Description
Brief Summary
Low and very low carbohydrate diets, such as the Atkins' Diet, have recently gained attention for their potential health benefits from weight loss and have gained some scientific support from a growing number of studies. Benefits have been noted in relation to raised 'good' cholesterol, lower 'bad' cholesterol and triglycerides. Other studies have shown an advantage in substituting vegetable fat for carbohydrate in insulin resistant individuals and in some instances in type 2 diabetes where improvements were seen in 'good' cholesterol and blood sugars. At the same time, our research have been exploring diets containing less processed carbohydrates and other components which in combination (portfolio diet) have a similar cholesterol lowering effect to drug therapy.
Therefore we wish to determine whether our cholesterol-lowering components (portfolio diet) should be incorporated into lower carbohydrate diets especially to preserve 'good' cholesterol and lower 'bad' cholesterol for decreasing the risk of heart disease.
Detailed Description
All subjects will undergo two parallel 2-phase treatments. On one treatment, subjects will be placed on a low fat diet for one month (control run-in diet) and then for the second month will continue on the low- fat diet (i.e. low-MUFA) with the addition of the portfolio components. The order of these two phases will not be randomized. The other treatment will be similar to the above except that the background diet of the portfolio phase will be high in monounsaturated fat (high-MUFA). Subjects will be allocated randomly to either treatment. Diets will be metabolically controlled and all food will be provided at weekly intervals.
Subjects will come after a 12h overnight fast to the Risk Factor Modification Center at St. Michael's Hospital or the Department of Nutritional Sciences, University of Toronto immediately prior to commencement of each treatment phase and at weekly intervals during the course of each study period. Prior to the start of the study, subjects will be instructed on details of the study diet protocol. They will also be asked to maintain a constant level of physical activity throughout the course of the study. At all visits, body weight (in kg) will be obtained in indoor clothing, without shoes, and blood pressure will be taken twice in the dominant arm after subjects have been seated for at least 20 minutes. Height (in cm) will be recorded at the first visit. Throughout the study period, subjects will maintain the diet prescribed on their initial visit. At every other visit of each treatment phase, subjects will provide a fasting blood sample. The kinetic tests of lipoprotein metabolism will be performed during the 4th and 8th week of the study. At baseline and during the last week of each study phase, 24h urine collection and 12h breath hydrogen collections will be completed.
The measurement of apolipoprotein in vivo kinetics will be carried out using a primed-constant infusion of \[D3\]L-leucine. This protocol allows for the determination of the kinetics of all apolipoproteins simultaneously. Kinetics studies will be conducted in the constantly fed state where participants receive 1/30th of their daily energy requirements every half-hour for the whole duration of the test (15 hours). These methods are described in detail in previous publications from our group. Briefly, at 7am on the morning of the study, after a 12-hour overnight fast, participants will be admitted to the Toronto General Hospital Clinical Investigation Unit and two intravenous catheters (IV's) will be inserted, one into each forearm vein. One IV will be for infusion of the stable isotope described below and one for withdrawal of blood samples. After achieving a steady state (3hrs after the small half-hourly meals), subjects will first receive a bolus injection of 10 µmol/kg of body weight of \[D3\]L-leucine (\[D3\]L-leucine 98%, C/D/N Isotopes) dissolved in physiological saline (0.9% NaCl) and then a constant infusion of 10 µmol/kg/h of \[D3\]L-leucine for 12 hours via an intravenous line inserted into a left forearm vein. Blood samples will be collected at regular intervals (0, 1/2, 1, 2, 4, 6, 8, 10, 11, 12hrs). All lipoprotein subfractions will be separated by sequential ultracentrifugation and frozen thereafter at -80oC until they are processed for analysis.
#Intervention
- PROCEDURE : High MUFA dietary portfolio
- high monounsaturated fat background diet to dietary portfolio
- PROCEDURE : Low MUFA dietary portfolio
- low monounsaturated fat background diet to dietary portfolio
|
#Eligibility Criteria:
Inclusion Criteria:
* men and postmenopausal women
* Body mass index > 18.5 kg/m2 and < 40 kg/m2
* Fasting plasma triglyceride (TG) concentration > 2.5 mmol/l and < 6.0 mmol/l at recruitment.
* Fasting plasma LDL cholesterol concentration > 3.4 mmol/l at recruitment.
* Fasting plasma HDL cholesterol concentration < 1.0 mmol/l at recruitment.
* living within a 40 km radius of St. Michael's Hospital.
Exclusion Criteria:
* Premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle and the difficulty of synchronising the timing of three one month studies with the same point in the menstrual cycle.
* Taking cholesterol medications at the start of the study. However, with their physician's approval those who wish to join but are already taking cholesterol-lowering medications (or cholesterol lowering natural health products) may join the study providing the medications (or natural health products) are stopped for at least 2 weeks before starting the study and throughout the study.
* Patients with uncontrolled high blood pressure will be excluded. The cut off for raised blood pressure has been taken as greater than 140/90mmHg. Patients with systolic blood pressure between 140 <= age <= 150mmHg and diastolic blood pressure between 90 <= age <= 95mmHg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. For patients in the above normal range (as above), a letter will be required from the physician responsible for their care.
* Changing the type or dose of their drug treatment during the study.
* Those judged as having a likelihood of being non-compliant with instructions for whatever reason. Those with low compliance to lipid-lowering therapy will not be selected.
* Food allergies
* Evidence or history of diabetes, renal liver disease or gastrointestinal disease. Patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyperabsorbers of plant sterols.
* Patients with major cardiovascular event (stroke or myocardial infarction), with secondary causes of hypercholesterolemia (or untreated hypothyroidism), with uncontrolled blood pressure, major disability or disorder such as liver disease, renal failure or with major surgery < 6 months prior to randomization. Individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will also be excluded.
* Antibiotic use within the last three months.
* Hormone replacement therapy.
* Smokers or have significant alcohol intake (>1 drink/d).
* Disallowed medications will be cholesterol lowering drugs which if prescribed by patients' physicians while on the study will be a reason for discontinuation from the study. Introduction of cholesterol lowering natural health products during the study will also be a reason for withdrawing a participant from the study.
* individuals with acute (<6 weeks) or chronic (>6 weeks) infections, either bacterial or viral, or individuals suffering from chronic inflammatory diseases
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00430430
|
{
"brief_title": "Lipoprotein Turnover on Low- and High-MUFA Portfolio Diets",
"conditions": [
"Hyperlipidemia",
"Cardiovascular Diseases",
"Diet Therapy"
],
"interventions": [
"Procedure: Low MUFA dietary portfolio",
"Procedure: High MUFA dietary portfolio"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00430430",
"official_title": "Lipoprotein Turnover on Low- and High-MUFA Portfolio Diets",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-04",
"study_completion_date(actual)": "2009-04",
"study_start_date(actual)": "2007-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-27",
"last_updated_that_met_qc_criteria": "2007-01-30",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-02-01",
"first_submitted": "2007-01-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
Detailed Description
This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.
#Intervention
- OTHER : Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator
- One pack of each product (1 to 10) will be consumed on a separate occasion
- Other Names :
- No sugar chewable candies
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 <= age <= 55 years, inclusive at Visit 1 (Day -11).
* BMI of 18.5 to 32.0 kg/m2, inclusive, at Visit 1 (Day -11).
* Have normal bowel movement habit (<3 bowel movements/d to >2 bowel movements/week) based on the BHD-BSS collected at Visit 2 (Day -4).
* Consumes fiber at an amount no more than the average American diet [based on consumption of high-fiber containing plant-based foods (e.g., fruits, vegetables, legumes, pulses, nuts, and products labeled as good or excellent sources of fiber)].
* Smokes 10 cigarettes or less in a day and has no plan to change nicotine habits during the study period.
* Non-user or former users (cessation >=12 mo) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period.
* Willing to maintain habitual dietary, lifestyle, and physical activity (with exceptions per study instructions) throughout the trial and willing to adhere to dietary, lifestyle, and physical activity requirements of the study.
* Willing to limit alcohol consumption to <=3 standard drinks/d and <=7 standard drinks/week throughout the trial.
* Willing to refrain from exclusionary medications, supplements, and products throughout the study.
* No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion Criteria:
* Moderate or severe GI symptoms or 3-d total score of >2 for any individual GI symptom based on the baseline GITQ collected at Visit 2 (Day -4). Mild burping and/or flatulence totaling a 3-d score of >2 is acceptable.
* Has a clinically significant GI-related reaction towards GI symptom-causing foods (e.g., beans and legumes, vegetables high in inulin, sodas or fruit drinks, sugar alcohols, inulin, fructooligosaccharides, gluten, and dairy products [see Appendix 3]) as judged by the Clinical Investigator.
* Female subjects who typically experience change in GI symptoms or bowel habits (e.g., increased or decreased laxation, bloating, abdominal cramping) at the time of menstruation. Subjects with these issues may be included if they are able to reliably predict the onset and duration of their menstruation-related symptoms (e.g., always occur only during the first two days of menses), in the judgment of the Clinical Investigator. Test visits will be scheduled around menses.
* Female subjects who is unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation.
* Abnormal laboratory test results of clinical significance at Visit 1 (Day -11), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -4), for subjects with abnormal laboratory test results.
* Clinically important GI condition that would potentially interfere with the evaluation of the study products (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
* Recent (within 2 weeks of Visit 1; Day -11) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as >=3 loose or liquid stools/d).
* Self-reported history (within 6 weeks of Visit 1; Day -11) of constipation or diarrhea at the discretion of the Clinical Investigator.
* Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
* Uncontrolled hypertension (systolic blood pressure >=140 mm Hg or diastolic blood pressure >=90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -11). One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -11), in the judgment of the Clinical Investigator. If taken, the repeat blood pressure measurement will be used to determine eligibility. Stable use of hypertension medication is allowed [defined as no change in medication regimen within the 3 mo prior to Visit 1 (Day -11)].
* Any known food allergy as well as intolerance or sensitivity to study product ingredients (Appendix 13).
* Extreme dietary habits or physical activity patterns at the discretion of the Clinical Investigator.
* History or presence of cancer in the prior 2 y, except for non-melanoma skin cancer.
* Major trauma or any other surgical event within 3 mo of Visit 1 (Day -11).
* Signs or symptoms of an active infection of clinical relevance within 5 d of Visit 1 (Day -11). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to Visit 1 (Day -11)*
* Weight loss or gain > 4.5 kg in the 3 mo prior to Visit 1 (Day -11).
* Currently or planning to be on a weight loss regimen during the study.
* Antibiotic, antifungal, or antiparasitic use within 3 mo of Visit 1 (Day -11) and throughout the study period.
* Use of steroids within 1 mo of Visit 1 (Day -11) and throughout the study period. Use of nasal and non-prescription topical treatments is allowed.
* Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDS) within 1 mo of Visit 1 (Day -11).
* Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements and/or suppositories, antacids, anti-diarrheal agents, and/or anti-spasmodic within 3 weeks of Visit 1 (Day -11). Standard multivitamin and mineral supplements are allowed.
* Participated in endoscopy or endoscopy preparation within 3 mo prior to Visit 1 (Day -11).
* Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -11).
* Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Subjects who are pregnant during the study will be discontinued.
* Recent history (within 12 mo of screening; Visit 1; Day -11) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks/week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
* Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
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
|
NCT05794100
|
{
"brief_title": "Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance",
"conditions": [
"Tolerance",
"Healthy Population"
],
"interventions": [
"Other: Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05794100",
"official_title": "Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-30",
"study_completion_date(actual)": "2022-07-30",
"study_start_date(actual)": "2021-10-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-03",
"last_updated_that_met_qc_criteria": "2023-03-28",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-03",
"first_submitted": "2021-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.
#Intervention
- DRUG : Duloxetine
- Single dose of 60 mg of duloxetine
- Other Names :
- Cymbalta
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects between the ages of 18 and 60 years.
* Subjects must be of good general health by history and physical exam.
* Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure), no BMI requirement.
* Ten normal control subjects who have met the inclusion criteria and have not received bariatric surgery and who are matched to the surgery subjects according to body mass index, age and sex.
* Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
* No contraindications to receiving a single capsule of 60 mg of duloxetine
Exclusion Criteria:
* Allergy to duloxetine or any of its constituents.
* Candidates who are pregnant or nursing
* Candidates currently receiving any antidepressant.
* Candidates that are determined to be poor metabolizers for CYP2D6
* Subjects who smoke or use any nicotine products
* Candidates currently receiving a medication that interacts with duloxetine.
* Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
* Candidates experiencing or with a history of vomiting or diarrhea associated with bariatric surgery
* Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.
* Candidates who have participated in an investigational drug study in past 30 days.
* Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00989157
|
{
"brief_title": "Effects of Gastric Bypass on Blood Levels of Duloxetine",
"conditions": [
"Bariatric Surgery"
],
"interventions": [
"Drug: Duloxetine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00989157",
"official_title": "A Preliminary Comparison of the Effect of Roux-en-Y Bariatric Surgery on Blood Levels of Duloxetine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-11",
"last_updated_that_met_qc_criteria": "2009-10-01",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-02",
"first_submitted": "2009-10-01",
"first_submitted_that_met_qc_criteria": "2014-07-17"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study will test whether using prazosin, which is an FDA-approved blood pressure medication, in combination with varenicline reduces sleep problems that can be associated with using varenicline for smoking cessation. In addition, the study will examine the combined effects of these medications on smoking and drinking.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.
Detailed Description
The study comprises an 8-week double-blind, within-subjects, crossover design of varenicline (up to 2mg per day) plus either prazosin (up to 8mg per day) (V+P) or placebo (V) with 20 heavy drinking smokers. Each medication phase is 3 weeks with a 2-week medication washout in between. Participants are asked to make a practice quit attempt for 3 days the last week of each medication phase.
This is an exploratory study to look at two primary aims:
1. Evaluate the effect of prazosin on sleep disturbance caused by varenicline in heavy drinking smokers prior to quitting smoking.
Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone.
2. Evaluate the effect of prazosin on sleep disturbance caused by varenicline during smoking cessation in heavy drinking smokers.
Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than V alone We will also investigate the combined effects of prazosin and varenicline on smoking behavior (i.e., smoking urge) and alcohol consumption (i.e., drinks per drinking day) as exploratory aims.
#Intervention
- DRUG : Varenicline
- Titrated over 1 week to a maximum dose of 2mg/day
- Other Names :
- Chantix
- DRUG : Prazosin
- Titrated over 3 weeks to a maximum dose of 8mg/day
- Other Names :
- Minipress
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* at least 18 years;
* current smoker [quantity of >= cigarettes per smoking day, frequency of >=3 times per week, and urinary cotinine >=2 on NicAlert dipstick;
* at least 4 occasions of heavy drinking in the past 30 days [5 or 4 standard drinks per occasion for males and females, respectively];
* no history of severe alcohol withdrawal syndrome;
* no new onset of psychiatric illness or psychotropic medications in last 90 days;
* no severe psychiatric illness [schizophrenia, bipolar disorder] or PTSD;
* no substance dependence other than nicotine, alcohol or marijuana;
* no medical contraindications for varenicline or prazosin;
* are willing to take medication and wear portable sleep monitoring devices;
* no risk for sleep apnea syndrome;
* able to read and write in English;
* not interested in quitting smoking immediately.
Exclusion Criteria:
* unable to complete the informed consent;
* do not meet criteria for heavy drinking;
* do not meet criteria for current smokers;
* unable to read/understand English;
* exhibit serious psychiatric illness (i.e. schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder), organic mood or mental disorders by history of psychological examination;
* meet criteria for alcohol dependence in past 12 months that is clinically severe;
* meet criteria for drug dependence in the last 12 months aside from marijuana, nicotine and alcohol;
* are seeking to quit smoking immediately;
* report current psychosis or suicidality;
* are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide);
* exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
1. any unexplained elevations in liver enzymes (i.e. transaminases, bilirubin);
2. clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
3. hepatic or renal impairment;
4. severe obstructive pulmonary disease;
5. diabetes mellitus requiring insulin or certain oral medications (i.e. sulfonylureas) and an A1C hemoglobin test score of >7 for participants not prescribed these medications;
6. baseline systolic blood pressure higher than 150 mm Hg of diastolic blood pressure higher than 95 mm Hg; (g) are scheduled for cataract surgery; (h) have a diagnosis of narcolepsy;
* have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
* have a history of clinically significant allergic reactions;
* have used any psychotropic drug in the past month, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months;
* intend to donate blood or blood products during the treatment phase of the study;
* have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 28 or weight less than 45 kg.
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
|
NCT02193256
|
{
"brief_title": "Varenicline + Prazosin for Heavy Drinking Smokers",
"conditions": [
"Cigarette Smoking",
"Alcohol Use Disorders"
],
"interventions": [
"Drug: Prazosin",
"Drug: Placebo",
"Drug: Varenicline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02193256",
"official_title": "Pilot Trial of Varenicline and Prazosin to Treat Heavy Drinking Smokers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-12",
"last_updated_that_met_qc_criteria": "2014-07-16",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-17",
"first_submitted": "2014-07-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study with low-dose LSD comprised 2 substudies in healthy subjects. Subjects who met all inclusion and no exclusion criteria provided written informed consent. Part 1 was an open-label dose-escalation study in hallucinogen non-naïve subjects with significant prior experience with hallucinogens, during which each subject received a single dose of LSD: 50, 75, or 100 µg. Part 2 was a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects with no prior experience with hallucinogens in the last 7 years, during which each subject was assigned to 1 of 8 cohorts and then randomly assigned to receive single doses of LSD 50 µg followed by 75 µg, or placebo followed by 75 µg, with dosing separated by at least 7 days. Subjects were followed up on the day after each dosing, and 1 week and 1 month after the last dose of study treatment. A total of 32 subjects were enrolled.
Detailed Description
This study with low-dose LSD comprised 2 substudies in different populations of healthy subjects:
Part 1: an open-label dose-escalation study in hallucinogen non-naïve subjects. Part 2: a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects.
Part 1: Open-label, dose escalation study This part was performed in a population of healthy subjects with significant prior experience with hallucinogens. There was a screening period of up to 28 days. Following provision of informed consent and completion of all screening assessments, eligible subjects were assigned to the open-label dose-escalation group.
Following completion of baseline assessments, each subject received a single dose of LSD: 50, 75, or 100 µg. This dose range was selected for assessment based on extensive historical and clinical LSD research. Subjects knew they would receive the experimental drug but were blinded to the dose level received. Subjects were followed up on the day after dosing and at 1 week and 1 month after dosing.
During screening, baseline, treatment, and follow-up, subjects underwent a series of assessments. Included amongst these assessments were cognitive tasks that were administered at baseline before administration of LSD and subsequently during the study. The open-label study subjects also provided samples for PK analysis.
Part 2: Double-blind, placebo controlled, randomised, crossover study This part commenced following evaluation of the results from Part 1. It was performed in a population of healthy subjects with no prior experience with hallucinogens during the last 7 years. There was a screening period of up to 28 days. Following provision of informed consent and completion of all screening assessments, eligible subjects were assigned to 1 of 8 cohorts and then randomly assigned to 1 of 2 treatment groups. Cognitive assessments were administered at baseline before administration of the first dose and subsequently during the study.
Following completion of baseline assessments, subjects entered a 2 week treatment period: the experimental non-crossover group received 2 sequential escalating single doses of LSD administered at levels determined in Part 1 (50 µg followed by 75 µg, or placebo followed by 75 µg), with dosing separated by at least 7 days; the placebo controlled crossover group received placebo followed at least 7 days later by a single dose of 75 µg LSD, as determined in Part 1. Subjects were followed up on the day after each dosing, 1 week after the second dose, and at 1 month after the last dose of study treatment.
During screening, baseline, treatment and follow-up days, subjects underwent a series of assessments.
#Intervention
- DRUG : Lysergic Acid Diethylamide (LSD) 50µg
- DRUG : Lysergic Acid Diethylamide (LSD) 75µg
- DRUG : Lysergic Acid Diethylamide (LSD) 100µg
- DRUG : Placebo/Lysergic Acid Diethylamide (LSD) 75µg
- DRUG : Lysergic Acid Diethylamide (LSD) 50µg/75µg
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subject aged 21 <= age <= 65 inclusive.
* For Part 1, subject has been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, on more than 3 occasions during their lifetime. For Part 2, Subject has not been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, during the past 7 years.
* Subject was able and willing to give written informed consent, adhere to the compliance terms during participation in the study, undergo the examinations and testing set forth in the clinical study protocol, and clearly and reliably communicate their subjective experiences to the investigator.
* Female participants of childbearing potential and male participants whose partner was of childbearing potential must have been willing to ensure that they or their partner used effective contraception during the study and for 3 months after the final study drug administration.
Exclusion Criteria:
A. General Health
* Subject had a presence or clinically relevant history of any psychiatric, respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as judged by the investigator.
* Subject had a resting blood pressure exceeding 140 mmHg (systolic) or 90 mmHg (diastolic), averaged across 4 assessments taken at least 1 minute apart on the same day.
* Subject had a presence or relevant history of organic brain disorders (e.g., intracranial hypertension, aneurisms, impaired consciousness, lethargy, or brain tumour).
* Subject had a relevant history of atopy, hypersensitivity, skin allergies, or allergic reactions to drugs.
* Subject had a clinical laboratory test result outside the reference ranges of the testing laboratory and considered clinically significant by the investigator.
* Subject was positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency (HIV) virus I or II at screening.
* Subject was a current smoker (i.e., had smoked within 1 month prior to the screening visit).
* Subject had a medical history that would affect the subject's safety or the study endpoints.
* Subject had used prescription drugs which might potentially interact with the pharmacokinetics of LSD or therapy within 14 days of first dosing, unless agreed as not clinically relevant by the PI and the Medical Monitor.
* Subject had used over the counter (OTC) medication or therapy, including megadose vitamin therapy (but excluding routine vitamins) within 7 days of first dosing, unless agreed as not clinically relevant by the PI and the Medical Monitor.
* Subject had donated or received any blood or blood products within the previous 3 months prior to first dosing.
* Subject could not use a computer to complete simple tasks such as responding to an email.
* Subject had used any investigational drug or participated in any clinical trial within 3 months of their first dosing.
* Subject had a current sleep disorder.
* Subject had a history of cataracts, active glaucoma or any other ophthalmic condition that could interfere with the eye blink assessment.
* Subject had veins unsuitable for venepuncture and/or cannulation.
* Subject had a corrected QT interval using Fridericia's correction >450 milliseconds.
* Subject was unlikely to cooperate with the requirements of the study, in the opinion of the PI or designee.
* Subject was pregnant or lactating
* Exclusion Part 2 only: Subject had a history of drug abuse or dependence in the last 12 months, had current drug abuse or dependence or had a positive result for drugs of abuse and alcohol tests at screening or admission.
B. Psychiatric Health
* Subject had a current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders fourth edition criteria for schizophrenia or other psychotic disorders (unless substance induced or due to a medical condition), bipolar I or II disorder, a major depressive episode, a manic or hypomanic episode, alcohol dependence or abuse (in the past 5 years), substance dependence and abuse (in the past 5 years), current panic disorder, obsessive compulsive disorder, social anxiety disorder, generalised anxiety disorder, anorexia, bulimia or post-traumatic stress disorder
* Subject had a first- or second-degree relative with schizophrenia, other psychotic disorders (unless substance-induced or due to a medical condition), or bipolar I or II disorder.
* Subject was receiving chronic administration of tricyclic antidepressants or lithium or acute administration of serotonin reuptake inhibitors, haloperidol, serotonin reuptake inhibitors or monoamine oxidase inhibitors.
* Subject was taking OTC doses of 5-hydroxytryptophan or St John's Wort or ayahuasca (which contains monoamine oxidase inhibitors in addition to dimethyltryptamine).
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05674669
|
{
"brief_title": "A Dose-Ranging Study of 50 µg to 100 µg LSD in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Lysergic Acid Diethylamide (LSD) 50µg",
"Drug: Lysergic Acid Diethylamide (LSD) 100µg",
"Drug: Lysergic Acid Diethylamide (LSD) 50µg/75µg",
"Drug: Placebo/Lysergic Acid Diethylamide (LSD) 75µg",
"Drug: Lysergic Acid Diethylamide (LSD) 75µg"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05674669",
"official_title": "A Phase 1, Single-centre, Dose-escalation Study Utilising Both Open-label and Double-blind Placebo-controlled Crossover Design Studies to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Low Doses of Lysergic Acid Diethylamide Ranging From 50 µg to 100 µg in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07-26",
"study_completion_date(actual)": "2017-07-17",
"study_start_date(actual)": "2015-10-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-06",
"last_updated_that_met_qc_criteria": "2023-01-05",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-06",
"first_submitted": "2022-07-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.
Detailed Description
In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.
#Intervention
- DIAGNOSTIC_TEST : Dobutamine stress test
- Test of myocardial reserve
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.
Exclusion Criteria:
* Aortic valve endocarditis
* aortic annulus >31mm
* preoperative pacemaker
* severe aortic insufficiency (>grad 3)
* rapid atrial fibrillation
* unprotected left main coronary stenosis not suitable for percutaneous intervention.
* unstable angina
* life expectancy less than 12 months
* mental disorder including dementia and condition which interferes with protocol compliance.
* renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
* Patients with metal not suitable for MRI.
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
|
NCT03107923
|
{
"brief_title": "Better Patient Selection to Transcatheter Aortic Valve Implantation",
"conditions": [
"Aortic Valve Stenosis",
"Left Ventricular Dysfunction",
"Myocardial Fibrosis"
],
"interventions": [
"Diagnostic Test: Dobutamine stress test"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT03107923",
"official_title": "Better Patient Selection to Transcatheter Aortic Valve Implantation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-31",
"study_completion_date(actual)": "2021-03-31",
"study_start_date(actual)": "2017-04-26"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-29",
"last_updated_that_met_qc_criteria": "2017-04-10",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-11",
"first_submitted": "2017-04-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and open surgery in right colon cancer.
Detailed Description
The incidence of colorectal cancer is increasing. Slight shift towards right colon cancer is noticed in the last 2 decades in Egypt. This can be attributed to advances in diagnostic tools and increased public health awareness as right sided colon cancer was almost presented late as most of tumors located in the capacious cecum. Hence, early diagnosis with good radical procedure offers better outcome, quality of life and survival. Many approaches for right colon resection were described. In this study we adopted the combined medial and caudal approach for right colon resection in cases of right colon cancer in both open and laparoscopic techniques.
Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery.
As combined medial and caudal approach is a radical procedure,the purpose of the present study was to compare between laparoscopic and open right hemicolectomy both done with combined medial and caudal approach in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 26 participants as number of cases with right hemicolon cancer is about 2 per month in our center. Those participants diagnosed as operable right sided colon cancer and the participants were divided into two groups:
Group I: Open combined medial and caudal right hemicolectomy included 13 participants Group II: Laparoscopic combined medial and caudal right hemicolectomy included 13 participants
All patients with inclusion criteria were subjected to preoperative assessment in the form of:
* Full history.
* Clinical evaluation.
* Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour marker CEA).
* Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
* Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
* Determined whether participants underwent open or laparoscopic operation is multifactorial e.g., patients desire, contraindications for laparoscopy and mass size if more than 5 cm preferred to have open surgery.
* Informed written consent taken from the patients or the legal guardian.
operative technique: both groups offered combined medial and caudal approach
* Fasting for 6 hours with no oral intake or only clear fluids intake the day before or better bowel preparation.
* After confirming the availability of blood of matching blood group, general anesthesia is inducted and prophylactic antibiotics are given.
* Patient positioning:
1. group I: (Open cases) The standard position for an open right hemicolectomy is supine with strapping of the ankle and wrists, such as the Trendelenburg position. The surgeon stands on the patient's left, and the first assistant stands across from the surgeon on the patient's right. The scrub nurse stands beside the surgeon. If a second assistant is needed, he or she usually stands across from the surgeon to the left of the first assistant.
2. group II: laparoscopic cases: The patient should be placed in the supine position with his two legs apart and arms tucked beside the body.
The surgeon should stand between the patient's legs with the assistant standing on the patient's left and the camera operator standing on the assistant's left side, and the scrub nurse on the patient's right side.
The video monitor is placed on the patient's upper right.
* Abdominal access and trocar placement by open or closed technique using veress needle for pneumoperitoneum with an intraperitoneal pressure of 14 mmHg.
* The procedure requires 5 trocars.
* A 10 mm trocar is placed 3 cm below umbilicus for the 30° angled telescope to get an adequate view. The incision would be enlarged to extract the specimen and performing anastomosis.
* A12 mm trocar is introduced 5 cm below the telescope port for the surgeon right hand instrument.
* A 5 mm port is inserted at the McBurney's point for the surgeon's left hand instrument.
* Additional two 5 mm trocars are placed at the opposite of McBurney's point and the right subcostal position respectively for the assistant to retract and display the colon and mesocolon.
Intraoperatively, all patients will be assessed for:
* Time of the procedure.
* Amount of blood loss.
post operatively: Postoperative medications given. Monitoring of vital signs and drains. post operative assesment of pain is subjective to the participant as he gave it a score from 1 to 10. minimal pain score(1 to 3), mild (4 to 6) and sever (7 to 10). Ambulation and clear oral fluids started when intestinal sounds are audible followed by soft diet. The intraperitoneal tube drain removed when there is less than 50cc of fluid per 24h or after performing ultrasonography.
Follow up:
Participants are reviewed as outpatients weekly for 1 month or more frequent if they develop any complications between their visits.
The postoperative pathological results, number of lymph node dissection, postoperative exhaust time, postoperative abdominal drain volume and duration, postoperative short term complications, hospital stay and postoperative pathological staging will be recorded.
#Intervention
- PROCEDURE : combined medial and caudal approach right hemicolectomy open and laparoscopic
- resection of right colon cancer by this radical approach
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed right colon cancer with colonoscopic biopsy.
* No invasion of the surrounding tissue.
* No distant metastasis except the liver.
Exclusion Criteria:
* Informed consent refusal
* Malignancy recurrence
* Distant metastasis except the liver.
* Locally advanced tumor.
* participants need emergent intervention e.g., intestinal obstruction or perforation.
* Contraindications specific for laparoscopy for laparoscopy cases
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05128708
|
{
"brief_title": "Combined Medial and Caudal Approach for Right Hemicolectomy",
"conditions": [
"Colon Cancer"
],
"interventions": [
"Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopic"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05128708",
"official_title": "Safety and Feasibility of the Combined Medial and Caudal Approach in Open and Laparoscopic Radical Right Hemicolectomy for Right Colon Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-28",
"study_completion_date(actual)": "2021-10-01",
"study_start_date(actual)": "2020-08-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-22",
"last_updated_that_met_qc_criteria": "2021-11-16",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-22",
"first_submitted": "2021-11-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS) insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains debatable. Despite the potential advantages of the UC insert over PS insert with its different design, there are concerns about inferior clinical outcome related to its use. Therefore, isokinetic performance was used in this study to objectively evaluate knee function after TKA and the clinical scores of the patients were also evaluated. To the best of our knowledge, no prospective randomized study has compared the isokinetic performance of the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study was that compared with the PS insert, the UC insert would be associated with a lower clinical outcome and isokinetic performance following TKA.
A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee Society Score (KSS) and isokinetic performance results of each patient were recorded preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic tests and patients were blinded to the study.
Detailed Description
Eligibility of all patients between 55 and 80 years, scheduled to undergo unilateral TKA on for primary knee osteoarthritis will be evaluated. The exclusion criteria are rheumatological joint diseases, previous knee surgery, neuromuscular diseases, bilateral TKA, or insufficiency of collateral ligaments. Patients will be randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the operation. Unblinded senior resident will implement the randomization. Patients and physiatrists performing isokinetic measurements will be blinded to group allocation.
During the UC and PS operations, Vanguard® Complete Knee System prosthesis (Zimmer Biomet Inc., Warsaw, IN, USA) will be implanted using the same surgical technique in all patients. The Vanguard anterior-stabilized (AS) insert is a UC deep-dish design with a 10 mm prominent anterior lip and 5mm posterior lip. This bone-conserving design prevents anterior femoral subluxation because of the prominent anterior lip. The insert design allows it to be used with the Vanguard cruciate-retaining femoral component and the highly congruent articulating surface increases rotational stability. There is more contact area between the femoral component and the weight-bearing surface to decrease the shear stress between the femur and polyethylene insert.
A tourniquet will be inflated to pressure of 300 mmHg after spinal anesthesia. All operations will be performed with the same surgical technique by a single senior surgeon. Patellar surface arthroplasty will be performed in all the cases. Both femoral and tibial prostheses will be implanted with pressured bone cement. A suction drain will be placed inside the knee capsule. On the morning of the first day after surgery patients will be mobilized under the supervision of the physical therapist. All patients will undergo the same rehabilitation procedure during the outpatient period and will be examined by the same physiatrist at the regular 3, 6, and 12-month follow-up visits.
The primary outcome is isokinetic performance, measured as peak knee extensor and flexor torque values in Newton-meters, on the operated knee. Measurements wilil be done preoperatively and at 3, 6, and 12-month follow-up examinations under the supervision of the same physiatrist. At same time points, the Knee Society Score (KSS) will be evaluated as well. Isokinetic measurements will be performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc., Shirley, NY, USA) by the same senior physiatrist. Patients will be positioned on the dynamometer with the hip in 90° in a sitting position for the knee flexion and extension measurements. Lateral movement of the knee will be prevented during full extension and flexion of the knee by a thigh strap on the operated leg. The physical therapist will help the patients to achieve proper positioning before each test. Concentric isokinetic knee flexion-extensions will be assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions will be completed by each patient. Instructions will be provided, and one trial repetition will then performed by all patients before the measurements were taken.
Sample size estimation will be performed using the extension peak torque as a primary effect variable. As there is no similar study with isokinetic measurements regarding this subject, a difference in mean values of 10 Nm and standard deviation of 12 Nm were assumed for each group. The group sample sizes of 31 and 31 achieved a power of 0.90 to detect a difference of 10 Nm between the two groups with estimated group standard deviations of 12 for each group and with a significance level (alpha) of 0.05 using a two-sided, two-sample test. Considering the loss to follow-up, two patients were added to each group. Thus, recruitment will end after 33 patients were assigned to either groups. All data will be calculated as mean and standard deviation. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed with SPSS 22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.). A value of p\< 0.05 will be considered statistically significant.
#Intervention
- DEVICE : Vanguard® Knee System
- Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 55 and 80 years
* Scheduled to undergo unilateral TKA on for primary knee osteoarthritis
Exclusion Criteria:
* Rheumatological joint diseases
* Previous knee surgery
* Neuromuscular diseases
* Bilateral TKA
* Insufficiency of collateral ligaments
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04419311
|
{
"brief_title": "Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties",
"conditions": [
"Osteoarthritis, Knee",
"Knee Arthritis"
],
"interventions": [
"Device: Vanguard® Knee System"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04419311",
"official_title": "Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-30",
"study_completion_date(actual)": "2018-03-30",
"study_start_date(actual)": "2017-01-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-16",
"last_updated_that_met_qc_criteria": "2020-06-03",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-05",
"first_submitted": "2020-06-01",
"first_submitted_that_met_qc_criteria": "2021-02-03"
}
}
}
|
#Study Description
Brief Summary
Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese patients with type 2 diabetes mellitus.
#Intervention
- DRUG : Low dose of BI 1356 BS
- DRUG : Medium dose of BI 1356 BS
- DRUG : High dose of BI 1356 BS
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Japanese patients with a diagnosis of type 2 diabetes mellitus treated with diet and/or exercise only or with one or two oral hypoglycaemic agents except glitazones
* Glycosylated haemoglobin A1 (HbA1c)
* <= 8.5% at screening for patients treated with diet and/or exercise and/or one oral hypoglycaemic agent or
* <= 8.0% at screening for patients treated with two oral hypoglycaemic agents
* Age >=21 and <= 70 years
* BMI >= 17.6 and <= 35 kg/m2
Exclusion Criteria:
* Any finding of the medical examination including blood pressure, pulse rate and electrocardiogram (ECG) deviating from normal and of not acceptable clinical relevance
* Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency (NYHA II-IV), known cardiovascular diseases including hypertension (>150/95 mmHg), stroke, and transient ischemic attack (TIA).
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, except for type 2 diabetes mellitus, hyperlipidaemia and medically treated hypertension
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders except polyneuropathy
* Chronic or relevant acute infections (e.g., human immunodeficiency virus (HIV), hepatitis)
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug before drug administration except anti-hypertensives, acetylsalicylic acid, and statins
* Use of drugs decreasing blood glucose within 10 days before drug administration
* Participation in another trial with an investigational drug within two months before drug administration
* Alcohol abuse
* Drug abuse
* Blood donation (100 mL or more within four weeks before drug administration)
* Excessive physical activities (within one week before drug administration or during the trial)
* Any laboratory value outside the reference range and the clinical relevance is not acceptable (or the value is more than three times higher than the upper limit of the normal range, e.g., liver enzymes such as aspartate aminotransferase (AST(serum glutamate oxaloacetate transaminase/ SGOT)), alanine transaminase (ALT(serum glutamate pyruvate transaminase/ SGPT)), alkaline phosphatase (γALP), and lactate dehydrogenase (LDH)
* Fasted blood glucose >240 mg/dL (=13.3 mmol/L) on two consecutive days during washout
* Serum creatinine above 1.3 mg/dL at screening
* Pregnancy or child-bearing potential patients and breast-feeding patients
* Not willing to use adequate contraception (condom use plus another form of contraception, e.g., spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02183324
|
{
"brief_title": "BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Placebo",
"Drug: Low dose of BI 1356 BS",
"Drug: High dose of BI 1356 BS",
"Drug: Medium dose of BI 1356 BS"
],
"location_countries": null,
"nct_id": "NCT02183324",
"official_title": "A Randomised, Double-blind, Placebo-controlled, Multiple Dose Phase II Study of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg in Tablet q.d. Administered Orally for 28 Days) to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Japanese Patients With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-06",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-28",
"last_updated_that_met_qc_criteria": "2014-07-04",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-07-08",
"first_submitted": "2014-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population.
Secondary Objectives:
To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment.
To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).
Detailed Description
The study duration included a screening period of up to 3 weeks, a treatment period of a minimum of 12 weeks and up to a maximum of 120 weeks (30 months), and at least 2 weeks after the last study treatment injection.
#Intervention
- DRUG : ALIROCUMAB SAR236553 (REGN727)
- Pharmaceutical form:solution Route of administration: subcutaneous
- Other Names :
- Praluent®
- DRUG : placebo (for injection training only)
- Pharmaceutical form:solution Route of administration: subcutaneous
- DRUG : ezetimibe
- Pharmaceutical form:capsule Route of administration: oral
- DRUG : atorvastatin
- Pharmaceutical form:tablet Route of administration: oral
- DRUG : rosuvastatin
- Pharmaceutical form:tablet Route of administration: oral
- DRUG : simvastatin
- Pharmaceutical form:tablet Route of administration: oral
|
#Eligibility Criteria:
Inclusion criteria:
Either A, B, C, D, or E below and not adequately controlled with a maximally tolerated dose of statin with or without other LMTs, all at stable doses for at least 4 weeks prior to the screening visit (Week-3):
A. Participants suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations greater than or equal to (>=)160 mg/dL (4.14 millimoles per liter [mmol/L]) despite treatment.
B. Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and two or more CV risk factors among this list:
* LDL-C greater than (>) 250 mg/dL (6.46 mmol/L) at the time of the familial hypercholesterolemia (FH) diagnosis (before treatment).
* Family history of premature-onset coronary heart disease (CHD; first-degree male relative with onset before age 55 years; first-degree female relative with onset before age 65 years).
* Metabolic syndrome.
* HDL-C less than (<) 40 mg/dL (1.03 mmol/L).
* Hypertension (blood pressure >140/90 mmHg or drug treatment).
* Lipoprotein a (Lp[a]) >=50 mg/dL (1.78 µmol/L).
* Tendon xanthoma.
C. Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and one of the following characteristics:
* Established CHD or other cardiovascular disease (CVD; history of acute myocardial infarction, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50 percent (%), or aortic abdominal aneurysm).
* Drug-treated type 2 diabetes mellitus or type 1 with target organ damage.
* Family history of first- or second-degree relative with very premature onset CHD (first- or second-degree male relative with onset before age 45; first- or second-degree female relative with onset before age 55).
D. Non-FH participants suffering from established CHD or other CVD (history of acute myocardial infarction (MI), ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50%, or aortic abdominal aneurysm) and with LDL-C concentrations >=130 mg/dL (3.36 mmol/L).
E. Participants suffering from progressive CVD (coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event [acute MI, ischemic stroke, ischemia-driven revascularization, unstable angina, transient ischemic attack] occurring despite stable doses of maximally tolerated LMT) with LDL-C concentrations >=100 mg/dL (2.59 mmol/L).
Exclusion criteria:
Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment.
Use of a fibrate other than fenofibrate within 4 weeks of the screening visit (Week-3) or between screening and enrollment.
Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for participants on simvastatin 80 mg for more than one year, who were eligible).
Use of statin other than simvastatin, atorvastatin, or rosuvastatin prior to the screening visit (Week-3) or between screening and enrollment, except when there was a documented reason for intolerance to the above mentioned potent statins (in which case the use of a different statin was allowed).
Fasting serum TG >400 mg/dL (>4.52 mmol/L) at the screening visit (Week -3). Uncontrolled hypertension (>180 mmHg systolic and/or >110 mmHg diastolic at randomization visit).
New York Heart Association Class III or IV congestive heart failure persisting despite treatment.
History of hemorrhagic stroke. Liver transaminases >3 times the upper limit of normal. Laboratory evidence of current hepatitis B or C infection. Creatine kinase >3 times the upper limit of normal. Estimated glomerular filtration rate <30 mL/min/1.73 m^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.
Male participant with a female partner of childbearing potential not protected by a highly-effective method(s) of birth control.
Participants eligible for enrollment into an ongoing clinical study of alirocumab conducted at the same investigational site.
Hypersensitivity to alirocumab or any of the excipients.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02476006
|
{
"brief_title": "Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Drug: ALIROCUMAB SAR236553 (REGN727)",
"Drug: rosuvastatin",
"Drug: atorvastatin",
"Drug: ezetimibe",
"Drug: simvastatin",
"Drug: placebo (for injection training only)"
],
"location_countries": [
"France",
"Slovakia",
"Slovenia",
"Poland",
"Germany",
"Romania",
"Canada",
"Austria",
"Greece",
"Spain",
"Switzerland",
"Hungary",
"Finland",
"Belgium",
"Czechia",
"Denmark"
],
"nct_id": "NCT02476006",
"official_title": "A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-12",
"study_completion_date(actual)": "2019-04-12",
"study_start_date(actual)": "2015-06-23"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-28",
"last_updated_that_met_qc_criteria": "2015-06-16",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-19",
"first_submitted": "2015-06-16",
"first_submitted_that_met_qc_criteria": "2020-03-13"
}
}
}
|
#Study Description
Brief Summary
The local data is insufficient to directly compare IV nalbuphine versus ibuprofen among people in this region. The findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general anesthesia.
#Intervention
- DRUG : Ibuprofen
- Patients were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward.
- DRUG : Nalbuphine
- Patients received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward.
|
#Eligibility Criteria:
Inclusion Criteria:
* Parturient females
* Aged between 18 <= age <= 45 years
* Gestational age above 32 weeks
* ASA class I to II
* Anticipated hospital stay for at least 24 hours
Exclusion Criteria:
* Known allergy to the drugs being evaluated in this study
* Renal and/or hepatic impairment (as per medical record)
* History of bronchial asthma or history or risk of intracranial hemorrhage (as per medical record)
* Low platelets count (<70000) or with bleeding diathesis
* BMI above 30 kg/m2
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
|
NCT06594224
|
{
"brief_title": "Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section",
"conditions": [
"Pain Management"
],
"interventions": [
"Drug: Nalbuphine",
"Drug: Ibuprofen"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06594224",
"official_title": "Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-31",
"study_completion_date(actual)": "2024-08-31",
"study_start_date(actual)": "2024-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2024-09-10",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-09-19",
"first_submitted": "2024-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.
#Intervention
- BIOLOGICAL : CM310
- CM310 injection
|
#Eligibility Criteria:
Inclusion Criteria:
* With atopic dermatis.
* Voluntarily sign the informed consent form.
Exclusion Criteria:
* Any major surgery planned during the research period.
* With intestinal parasitic infection within the first 6 months of screening.
* With any previous malignant tumors prior to screening.
* With any circumstance that is not suitable to participate in this study.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06162507
|
{
"brief_title": "Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis",
"conditions": [
"Atopic Dermatitis"
],
"interventions": [
"Biological: CM310"
],
"location_countries": [
"China"
],
"nct_id": "NCT06162507",
"official_title": "A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-04",
"study_completion_date(actual)": "2024-07-04",
"study_start_date(actual)": "2023-12-22"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-15",
"last_updated_that_met_qc_criteria": "2023-12-06",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-12-08",
"first_submitted": "2023-11-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
Detailed Description
This is a multicentre, open-label, randomized controlled trial in 152 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with Forxiga, metformin, insulin glargine and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C\<7.3% at the 12 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.
#Intervention
- DRUG : insulin glargine
- Dose is titrated to achieve fasting normoglycemia
- Other Names :
- Lantus
- DRUG : metformin
- Dose is titrated to 1 g bid or maximal tolerated dose
- DRUG : Forxiga
- Dose is titrated to 10 mg po daily or maximal tolerated dose
- Other Names :
- dapagliflozin
- BEHAVIORAL : Lifestyle therapy
- Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
- Other Names :
- diet and exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* men and women 30 <= age <= 80 years inclusive;
* type 2 diabetes mellitus diagnosed by a physician within 8 years prior to patient enrollment;
* anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization;
* HbA1C 6.5 <= age <= 9.5% inclusive on no hypoglycemic agents or HbA1C <= 8.0% on up to 2 glucose-lowering agents;
* body mass index >= 23 kg/m2;
* ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
* ability and willingness to self-inject insulin;
* provision of informed consent.
Exclusion Criteria:
* current use of insulin therapy;
* history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
* history of end-stage renal disease or renal dysfunction as evidenced by eGFR<60 mL/min/1.73 m2 by MDRD formula;
* history of lactic acidosis or diabetic ketoacidosis;
* active liver disease or elevated alanine transferase (ALT) levels >= 2.5 times upper limit of normal at the time of enrollment;
* history of bladder cancer or undiagnosed hematuria;
* history of breast cancer;
* history of polycythemia;
* evidence of volume depletion or hypotension (systolic blood pressure < 90 mmHg);
* systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg;
* diagnosed cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including:
1. any history of acute coronary syndrome, hospitalization for unstable angina, myocardial infarction, or revascularization with coronary artery bypass grafting or percutaneous coronary intervention;
2. other evidence of coronary artery disease;
3. peripheral vascular disease, valvular heart disease, cardiomyopathy, aortic dissection, tachyarrhythmias, bradyarrhythmias, prior stroke or TIA;
4. prior hospitalization for heart failure; or
5. ECG findings concerning for ischemic heart disease (i.e. pathological Q-waves, ST-segment-T-wave abnormalities in contiguous leads, left anterior hemiblock, left bundle branch block, second or third degree atrioventricular block).
* dependence on oxygen;
* history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
* history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
* history of any major illness with a life expectancy of < 3 years;
* history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
* any history of excessive alcohol intake, acute or chronic;
* currently pregnant, or breastfeeding, or not using a reliable method of birth control for the duration of the trial in all females with childbearing potential; reliable methods of birth control include oral contraceptive (birth control pill), hormonal injection, implant, patch, or vaginal ring, intrauterine device, barrier method (condom and spermicide), tubal ligation, partner vasectomy or abstinence;
* known hypersensitivity to metformin, Forxiga, or insulin glargine.
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
|
NCT02561130
|
{
"brief_title": "Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Behavioral: Lifestyle therapy",
"Drug: Forxiga",
"Drug: metformin",
"Drug: insulin glargine"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02561130",
"official_title": "Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2018-12-31",
"study_start_date(actual)": "2015-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-24",
"last_updated_that_met_qc_criteria": "2015-09-24",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-25",
"first_submitted": "2015-09-16",
"first_submitted_that_met_qc_criteria": "2020-11-02"
}
}
}
|
#Study Description
Brief Summary
This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS.
This study will consist of two treatment arms, MN-166 and matching placebo. Randomization will occur in a 2:1 ratio (MN- 166: placebo).
Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months; Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last dose.
During treatment phase, subjects return to the clinic at Months 3 and 6 and will be telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new or concomitant medications.
All subjects (subjects who complete the Double-blind Phase and subjects who complete the Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately 2 weeks after the last dose of study drug to assess adverse event status and to document concomitant medications.
Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional assessments will include regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs, ECGs, medical history, physical and neurological examinations.
#Intervention
- DRUG : Placebo (for MN-166)
- Other Names :
- Sugar pill manufactured to mimic MN-166 10 mg tablet
- DRUG : MN-166
- Other Names :
- ibudilast
- DRUG : riluzole
- Patient is given 50 mg riluzole twice daily.
- Other Names :
- Rilutek
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent is obtained and willing and able to comply with the protocol in the opinion of the Investigator.
* Male or female subjects ages >= 18 <= age <= 80, inclusive
* Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [Clinically Definite, Clinically Probable, Probable-Laboratory-Supported]
* Diagnosis of ALS with onset of less than or equal to 5 years from first clinical weakness
* Slow vital capacity >= 60% of predicted within 1 month prior to Treatment Day 1
* Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug. Subjects not currently taking riluzole will be started on 50 mg qd for the first 7 days followed by 50 mg bid for the following 21 days prior to screening. Patients may be screened during this time period but not started on study drug until they are on a stable dose of riluzole.
* All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Females of childbearing potential must use an effective method of contraception throughout the entire study period and for 30 days after study drug discontinuation.
* Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
* Males should practice contraception as follows: condom use and contraception by female partner.
* Able to swallow study medication capsules.
* Subject is willing and able to comply with the protocol assessments and visits, in the opinion of the study nurse/coordinator and the Investigator.
* Has no known allergies to the study drug or its excipients.
* Has received 23-valent pneumococcal vaccine within 4 years prior to starting clinical trial.
Exclusion Criteria:
* Use of tracheostomy, tracheostomy invasive mechanical ventilation [TIMV].
* Greater than 3% predicted loss in post-diagnosis vital capacity per month or a greater than 1 unit loss in post diagnosis ALSFRS-R total score per month [ exclusive of loss due to beginning use of assistive devices]
* Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT greater than 3 times the upper limit of the normal range)
* Renal insufficiency as defined by a serum creatinine greater than 1.5 times the upper limit of normal range
* Currently has a clinically significant psychiatric disorder or dementia which would preclude evaluation of symptoms.
* Has a clinically significant medical condition (other than ALS) including the following: neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological disorder, or central nervous system infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
* History of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* ECG finding of QTcB prolongation > 450 ms for males and > 470 ms for females at screening
* History of HIV (human immunodeficiency virus), clinically significant chronic hepatitis, or other active infection
* Subject has a history of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.
* Subject has a history of alcohol or substance abuse (DSM-IV-TR criteria) within 3 months prior to screening or alcohol or substance dependence (DSM-IV-TR criteria) within 12 months prior to screening.
* Subject has poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.
* Currently participating, or has participated in, a study with an investigational or marketed compound or device within 3 months prior to signing the informed consent.
* Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator.
Advanced ALS group will follow the same inclusion/exclusion as the early ALS subjects with the exception of the following:
Inclusion criteria:
* Diagnosis of ALS with onset of <=10 years from first clinical weakness
* On Non-invasive ventilator with Non-invasive pressure [P-NIV] or volume [V-NIV] cycled ventilation stable use for >= 4 hours daily for 1 month prior to Treatment Day.
* Slow vital capacity >= 20% of predicted (Knudsen 1983) within 1 month prior to Treatment Day 1
* Able to swallow study medication capsules or have gastrostomy tube access for delivery of contents of medication capsule.
Exclusion criteria:
* Use of tracheostomy, tracheostomy invasive mechanical ventilation [TIMV].
* No rate of progression exclusion.
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
|
NCT02238626
|
{
"brief_title": "Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)",
"conditions": [
"Amyotrophic Lateral Sclerosis"
],
"interventions": [
"Drug: riluzole",
"Drug: MN-166",
"Drug: Placebo (for MN-166)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02238626",
"official_title": "A Single-center, Randomized, Double-blind, Placebo-controlled, 6-month Trial Followed by an Open-label Extension to Evaluate the Safety, Tolerability and Clinical Endpoint Responsiveness of Ibudilast (MN-166) in Subjects With (ALS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2014-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-05",
"last_updated_that_met_qc_criteria": "2014-09-10",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-12",
"first_submitted": "2014-09-04",
"first_submitted_that_met_qc_criteria": "2021-10-07"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of imatinib in combination with dihydroartemisinin plus piperaquine in the treatment uncomplicated P. falciparum malaria in adult male patients.
Detailed Description
An exploratory study to examine the efficacy and safety of imatinib mesylate in combination with dihydroartemisinin plus piperaquine on suppression of parasitemia in patients with uncomplicated Plasmodium falciparum malaria. In vitro studies of P. falciparum parasitized erythrocytes demonstrate that inhibitors of the protein tyrosine kinase SYK prevent malaria parasite egress from infected red blood cells and thereby terminate the parasite's life cycle. Although no potent syk kinase inhibitors were approved for human use at the time of initiation of this study, a bcr-abl tyrosine kinase inhibitor (imatinib mesylate (Gleevec®)) that also exhibits off-target inhibition of syk tyrosine kinase, has been FDA-approved for treatment of a number of human malignancies including chronic myelogenous leukemia and GIST. Because imatinib can be taken daily for many years without significant toxicity, it can be used to obtain a preliminary indication of whether inhibition of erythrocyte syk kinase can suppress parasitemia in patients with P. falciparum malaria. In a phase 1 clinical trial on the same patient population, anti-malaria activity was observed with imatinib, with little or no accompanying toxicity. Because dihydroartemisinin plus piperaquine constitute the currently used standard-of-care therapy for malaria in Southeast Asia, the above trial will test the safety and efficacy of the combination of imatinib plus dihydroartemisinin and piperaquine in treatment of uncomplicated malaria. In this pilot study, the rate of decrease in peripheral blood parasitemia in 30 adult male patients with uncomplicated malaria will be compared to the same rate of decrease in parasitemia in 30 adult male patients treated solely with dihydroartemisinin plus piperaquine.
#Intervention
- DRUG : Imatinib combination therapy
- Imatinib plus dihydroartemisinin plus piperaquine
- Other Names :
- Gleevec, Glivec
- DRUG : Dihydroartemisinin-piperaquine
- Standard of care
- Other Names :
- Artekin, Eurartesim, Diphos, Timequin, Duocotecxin, Malacur, Ridmal
|
#Eligibility Criteria:
Inclusion Criteria:
* Gender: only adults are selected for the trial; note that female subjects cannot be women of child-bearing age.
* Age: 18 <= age <= 50 years.
* Target disease: Uncomplicated Plasmodium falciparum malaria
Exclusion Criteria:
* symptoms and signs of complicated malaria
* including continuous high fever of over 390C, psychiatric disorders, confusion, other neurological symptoms, symptoms and signs of functional impairment of the organs such as lungs, kidneys or cardiovascular system;
* symptoms and signs of liver damage or kidney damage
* symptoms and signs of another complicating infection such as pneumonia, dengue fever, and other bacterial infection.
* P. falciparum > 25.000 / mm3
* WBC <4000 and >10.000 /mm3
* RBC < 3.5x106/mm3
* Platelets < 40.000 /mm3
* Hemoglobin < 10 g/dL
* ALT more than 200% of the upper limit (56 units/L)
* AST more than 200% of the upper limit (40 units/L)
* Blood creatine more than 75% of the upper limit (men: 1.2 mg/dL, women 1 mgdL)
* Serum total protein < 6 g/L
* Glycemia < 50 mg/dL> 200 mg/dL
* Standard urine test Serious alterations
* Concomitant treatments
Antimalarial Drugs Anticoagulant therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02614404
|
{
"brief_title": "Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria",
"conditions": [
"Plasmodium Falciparum Malaria"
],
"interventions": [
"Drug: Dihydroartemisinin-piperaquine",
"Drug: Imatinib combination therapy"
],
"location_countries": [
"Vietnam"
],
"nct_id": "NCT02614404",
"official_title": "Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-02",
"study_completion_date(actual)": "2017-02-02",
"study_start_date(actual)": "2015-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-11",
"last_updated_that_met_qc_criteria": "2015-11-23",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-25",
"first_submitted": "2015-11-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive training - that have been shown to be effective in promoting active and healthy aging. The objective is to study the molecular and neural mechanisms of these strategies to stimulate brain plasticity and improve brain health and cognitive functioning.
Detailed Description
It is a randomized controlled study with three intervention groups - physical, cognitive and combined - and a control group. The intervention is carried out over 3 months, with a frequency of 5 weekly sessions of 45 minutes each. Cognitive training is applied through a computerized program, physical training consists of a walking aerobic program, and combined training arises from the addition of the two previous ones.
140 participants will undergo an exhaustive pre- and post-intervention evaluation that includes neuropsychological, neuroimaging, genetic and biochemical analysis before and after the intervention as well as physical and health status assessment.
The present project aims to examine the independent and combined effects of exercise and cognitive stimulation in functional and structural brain plasticity, cognitive performance, emotional state and quality of life, and will determine the demographic and clinical factors that can modulate neuroplasticity. It will allow us to study the neurophysiological mechanisms by which the different types of intervention have an effect on the structure and functioning of the brain and cognition within an omics framework.
#Intervention
- BEHAVIORAL : Physical exercise
- The structured physical activity plan consists of a walking program with an initial progressive phase (first week: 30 minutes/session and second week: 45 minutes/session, with a Borg scale of perceived exertion between 9 and 10) and an improvement and maintenance phase (10 weeks, 45 minutes/session with a Borg scale of perceived exertion between 11 and 14).
- BEHAVIORAL : Cognitive training
- We use a computerized cognitive training tele-medicine tool, designed by the Guttmann Institute: Guttmann Neuro Personal Trainer (PREVIRNET). Sessions will consist in activities of attention, memory and executive functions, also put in place progressively and parallel to the physical activity.
- BEHAVIORAL : Combined training
- Subjects included in this group receive both types of intervention.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 50 and 70
* Underactive or sedentary (<2 hours a week of physical activity).
* Adequate visual, auditory and fine motor skills.
* Able to speak and understand Catalan or Spanish language.
* Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.
Exclusion Criteria:
* Mini mental State examination < 24 and Montreal Cognitive Assessment- Short (MoCA -S) < 6.
* Diagnosis of mild cognitive impairment, dementia or other serious neurological, psychiatric, or systemic illness.
* Presence of another illness that render them unable to engage in physical activity (signs or symptoms of chronic heart disease, chronic obstructive pulmonary disease, orthopedic problems).
* History of drug abuse or alcoholism.
* Psychotropic consumption
* Contraindication to magnetic resonance imaging
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03123900
|
{
"brief_title": "Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project",
"conditions": [
"Aging",
"Cognitive Function 1, Social"
],
"interventions": [
"Behavioral: Cognitive training",
"Behavioral: Physical exercise",
"Behavioral: Combined training"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT03123900",
"official_title": "Neuroplasticity in Adulthood: Physical Exercise and Cognitive Training; Integrative Omics Study on the Neurobiological Effects of Physical Activity and Cognitive Stimulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-08",
"study_completion_date(actual)": "2018-04-08",
"study_start_date(actual)": "2015-11-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-23",
"last_updated_that_met_qc_criteria": "2017-04-17",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-21",
"first_submitted": "2017-03-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.
#Intervention
- DRUG : Derris scandens Benth extracts
- Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
- DRUG : naproxen
- Naproxen 500 mg/day for 4 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=50 yr
* Known case of primary knee osteoarthritis
* WOMAC pain subscale (item1) >= 5
* signed informed consent
Exclusion Criteria:
* hypersensitive to NSAIDs
* history of peptic ulcer or melena
* unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
* history of intra-articular injection of knee within 3 months
* status post knee replacement
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00503828
|
{
"brief_title": "Derris Scandens Benth Extract VS Naproxen in Knee OA",
"conditions": [
"Knee Osteoarthritis"
],
"interventions": [
"Drug: naproxen",
"Drug: Derris scandens Benth extracts"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT00503828",
"official_title": "The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis",
"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)": "2007-07"
},
"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)": "2010-01-13",
"last_updated_that_met_qc_criteria": "2007-07-18",
"last_verified": "2009-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-07-19",
"first_submitted": "2007-07-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the influenza immunity of age 3 and older population. Phase III clinical study was conducted in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.
In order to monitor and evaluate the safety and protective effect against influenza administered on age 3 and older population, therefore we conduct the phase IV clinical trial of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).
Detailed Description
Select three sites to conduct this study in Henan, china. In the principle of informed consent and voluntary participation, adopt randomized and control design and include 6000 healthy subjects, among them, trial group 3000 persons, blank control group 3000 persons respectively and randomized dividing into 4 age groups.
The evaluation of safety: For all the vaccinated subjects, monitor general reaction and post-vaccination AEFI by mean of active soliciting and passive report. The evaluation of safety data mainly includes summary of clinical reaction endpoint, local and systemic adverse events of all subjects during the observation period and incidence rate of relevant ADR/AE.
The evaluation of immunogenicity: Respectively and randomly sample 600 persons from vaccination group and blank control group. Collect venous blood on the first day or 28 day of vaccination. Adopt international universal HI testing method(SRID) to carry out serology test.
The criteria for HI antibody test result:
* Take 1:10 serum as the lowest dilutability. For subjects whose HI antibody \<1:10 before immunization, calculate as 1:5 and their post-vaccination HI antibody titer≥1:40 will be as the seroconversion. For subjects HI antibody ≥1:10 before the vaccination, take post-vaccination HI antibody titer increases 4 times as seroconversion;
* Take HI antibody titer≥1:40 as threshold of positive protection;
* Take statistics of subject number whose serum HI antibody titer reach protective level (HI antibody titer≥1:40). Calculate protection rate of vaccine and 95% CI;
* GMT titer and 95% CI. Evaluation of immune protective effect: Monitor Influenza Like Illness(ILI) to all subjects in monitoring place and conduct epidemiological survey to ILI. Collect nasopharyngeal swab and blood specimen during acute and recovery period for the laboratory test.
ILI refers to fever (body temperature≥38℃) with cough or pharyngalgia. Test influenza virus nucleic acid in nasopharyngeal swab. Isolate serum of blood specimen and carry out the test of serum antibody.
Evaluation indicator:
* Statistics of ILI incidence rate in immune population
* Statistics of incidence rate in monitoring place
#Intervention
- BIOLOGICAL : Inactivated influenza split vaccine
- 3000 participants (750 of above 60,750 of age 19-60, 750 of age 13-18 and 750 of age 3-12) to receive influenza split vaccine of 15 μg HA; one dose regime
- Other Names :
- Hualan Bio
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
* Be able to abide by the requirement of clinical trial protocol to participate in follow up;
* Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
* Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
* Be able to comply with the requirement of clinical trial protocol;
* Have no history of vaccination and vaccination with other product in latest 1 week;
* Axillary temperature <=37℃.
Exclusion Criteria:
* Any history of severe illness, such as tumor, autoimmune disease, etc.;
* Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
* History of neurological symptom or physical signs;
* Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
* Bleeding physique or prolonged bleeding;
* History of influenza infection or vaccination at least once within the past 6 months;
* History of administration of other vaccine or injection of immunoglobulin, or any research drug within the past 1 week;
* Any acute disease that needs usage of antibiotics or antiviral therapy on the whole body within the past 7 days;
* Fever (axillary temperature>=38℃) within the past 3 days;
* Participating in another clinical trial;
* History of Guillain-Barre Syndrome, severe birth defect or severe disease, allergy, eclampsia, epilepsy, encephalopathy or psychosis or family disease;
* Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection;
* Known or suspected other diseases at the same time, including respiratory system disease, acute infection or active period of chronic disease, HIV infection of infant or mother, cardiovascular disease, during of treatment of cancer and skin disease;
* Any condition that, in the judgment of investigator, may affect trial assessment.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01511744
|
{
"brief_title": "Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine",
"conditions": [
"Human Influenza"
],
"interventions": [
"Biological: Inactivated influenza split vaccine"
],
"location_countries": [
"China"
],
"nct_id": "NCT01511744",
"official_title": "A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2011-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-08-14",
"last_updated_that_met_qc_criteria": "2012-01-18",
"last_verified": "2012-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-19",
"first_submitted": "2012-01-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, multi-center observational survey study to uncover how antibiotic differences can influence utilization decisions. The purpose is to assess the trade-offs between drug side effects and infection prevention that patients are willing to make when taking prophylactic antibiotics. Misuse of antibiotics or non-adherence to prescribed regimens is a public health issue that may be due to a variety of reasons including unclear instructions, symptom improvement and adverse events Subjects will be healthcare providers (physician or nurse) and individuals 18+ years of age in the dermatologic surgery waiting area (including patients and accompanying individuals). Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.
Detailed Description
This is a prospective, multi-center observational survey study to uncover how antibiotic differences can influence utilization decisions. The purpose is to assess the trade-offs between drug side effects and infection prevention that patients are willing to make when taking prophylactic antibiotics. Misuse of antibiotics or non-adherence to prescribed regimens is a public health issue that may be due to a variety of reasons including unclear instructions, symptom improvement and adverse events Subjects will be healthcare providers (physician or nurse) and individuals 18+ years of age in the dermatologic surgery waiting area (including patients and accompanying individuals). Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.
Adults in the dermatologic surgery department waiting room with age greater than or equal to 18 years (this includes both patients and accompanying individuals (family members, friends, caregivers)) and healthcare providers in dermatologic surgery. A member of the study team will approach patients in the Perelman Dermatology Clinic to determine if they meet inclusion criteria and educate them about the study using the verbal script. If interested, patients will receive a link to the online survey, which will contain an informed consent page. Dermatology healthcare providers will be identified in clinic or from academic center staff directories. Individuals meeting inclusion criteria will also be recruited from the dermatologic surgery waiting rooms of other collaborating institutions (Penn State Health, University of Missouri Health Care, Indiana University Health, University of Minnesota, Oregon Health \& Science University, Washington University in St. Louis, UT Southwestern, UC Davis and Ohio State University) once approved by their IRB.
All data will be collected and stored in a secured password-protected conjoint.ly account managed by the Penn Dermatologic Surgery Clinical Research Team. Collaborating institutions will not have access to the survey responses. Data analysis: Multivariate random parameters logit will be used to estimate preference weights for each attribute level. These preference weights will be used to estimate the maximum acceptable risk of various side effects that subjects would be willing to accept in exchange for infection prevention. Collaborating researchers from other institutions will not be involved in data analysis.
#Intervention
- OTHER : Survey
- The study will involve a 22 question online survey, administered through the online survey platform conjoint.ly. Conjoint.ly is a web-based survey tool used to conduct survey research, evaluations and other data collection activities. Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Individual in the dermatologic surgery waiting room: patient, caregiver, family member or accompanying individual to patient receiving dermatologic surgery service, or dermatology healthcare provider
Exclusion Criteria:
* Age less than 18 years.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04150523
|
{
"brief_title": "Perspectives on Prophylactic Antibiotic Use in Dermatologic Surgery",
"conditions": [
"Medication Adherence"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04150523",
"official_title": "Perspectives on Prophylactic Antibiotic Use in Dermatologic Surgery: a Prospective Multi-center Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-01",
"study_completion_date(actual)": "2021-08-25",
"study_start_date(actual)": "2019-10-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-30",
"last_updated_that_met_qc_criteria": "2019-10-31",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-04",
"first_submitted": "2019-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.
Detailed Description
Although there may be no direct benefit to the subjects under study, the investigation will assess the stability which determines the efficacy for future toric optics and the amount of glistening and PCO formation of the IPure and ZCB00 hydrophobic acrylic IOLs.
25 eyes of 25 patients will be recruited for each IOL, that is 50 eyes of 50 patients. The randomization will be done with a binomial law. The IOL have a priori the same IOL constants which eliminates the necessity to know which IOL is going to be implanted at the preoperative time. A clinically relevant difference for rotational stability will be 2°. The reasonable standard deviation of the position of an IOL in the eye is 2.4°. A total of 48 patients is necessary for a probability of 80% to measure a clinically relevant difference concerning the IOL stability.
In the week before surgery, the eye to be operated is examined at the slit-lamp and by indirect fundoscopy and measurement of intraocular pressure (IOP) will be performed routinely. Additionally, routine biometry is performed using the IOLMaster (Zeiss Meditec AG, Jena, Germany) for axial length measurement, K-readings and anterior chamber depth (ACD) measurements.
Randomisation will be performed using online randomisation and patients will be allocated 1:1 either to the study group (iPure group), or to the control group (ZCB00).
A self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed in a standardised fashion. The IOL is implanted via injector into the capsular bag. Following the implantation of the IOL, the viscoelastic substance is aspirated thoroughly from the anterior chamber, as well as retro-lentally, to assure complete removal of the OVD.
Any deviation from the standard protocol will be recorded peroperatively. Follow-ups will be performed 1-2 hours, 1 month, 12 months and 24 months after cataract surgery.
#Intervention
- DEVICE : Cataract surgery
- Cataract surgery with implantation of an intraocular lens (IOL)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age-related cataract
* Age 21 and older
* Visual Acuity > 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Exclusion Criteria:
* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
* Previous ocular surgery or trauma.
* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04329754
|
{
"brief_title": "Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study",
"conditions": [
"Cataract"
],
"interventions": [
"Device: Cataract surgery"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT04329754",
"official_title": "Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-02",
"study_completion_date(actual)": "2015-02",
"study_start_date(actual)": "2012-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-17",
"last_updated_that_met_qc_criteria": "2020-03-30",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-01",
"first_submitted": "2013-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations.
Detailed Description
This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).
#Intervention
- DRUG : Doravirine/lamivudine/tenofovir disoproxil fumarate
- FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.
- Other Names :
- MK-1439A, DELSTRIGO™
|
#Eligibility Criteria:
Inclusion Criteria:
* Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment.
* Is naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
* Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A.
* Is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
* Is highly unlikely to become pregnant or to impregnate a partner
Exclusion Criteria:
* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
* Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
* Has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir)
* Has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
* Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
* Requires or anticipates requiring any of the prohibited medications
* Has significant hypersensitivity or other contraindication to any of the components of the study drug
* Has a current (active) diagnosis of acute hepatitis due to any cause
* Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9
* Is pregnant, breastfeeding, or expecting to conceive
* Is female and expecting to donate eggs, or is male and is expecting to donate sperm at any time during the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02629822
|
{
"brief_title": "Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)",
"conditions": [
"HIV-1 Infection"
],
"interventions": [
"Drug: Doravirine/lamivudine/tenofovir disoproxil fumarate"
],
"location_countries": null,
"nct_id": "NCT02629822",
"official_title": "A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-28",
"study_completion_date(actual)": "2020-10-28",
"study_start_date(actual)": "2016-01-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-26",
"last_updated_that_met_qc_criteria": "2015-12-10",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-14",
"first_submitted": "2015-12-10",
"first_submitted_that_met_qc_criteria": "2019-12-12"
}
}
}
|
#Study Description
Brief Summary
To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.
#Intervention
- PROCEDURE : Blood sample
- PROCEDURE : Radiography
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female aged of more than 4 years.
* GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities
Exclusion Criteria:
* Previous treatment with GH
* Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00145457
|
{
"brief_title": "IGF1 Generation Test",
"conditions": [
"Growth Hormone Deficiency"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00145457",
"official_title": "A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-01",
"study_start_date(actual)": "2001-04"
},
"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)": "2007-06-06",
"last_updated_that_met_qc_criteria": "2005-09-01",
"last_verified": "2007-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-05",
"first_submitted": "2005-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
Detailed Description
The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.
#Intervention
- DRUG : Fed Cohort PBT2
- PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
- DRUG : Fasted Cohort PBT2
- PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or females with a BMI between 19 and 30kg/m2
* No clinically significant abnormalities
Exclusion Criteria:
* Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2)
* Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry
* Significant history of depression or other psychiatric illness
* Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
* unable to swallow capsules
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
|
NCT02107313
|
{
"brief_title": "Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Fed Cohort PBT2",
"Drug: Fasted Cohort PBT2"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT02107313",
"official_title": "A Phase 1, Single Centre, Randomised, 2 Period Crossover Study to Determine the Effect of Food on the Pharmacokinetic Profile of a Single Dose of PBT2 Administered Orally to Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2014-07",
"study_start_date(actual)": "2014-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-30",
"last_updated_that_met_qc_criteria": "2014-04-07",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-08",
"first_submitted": "2014-04-03",
"first_submitted_that_met_qc_criteria": "2016-02-28"
}
}
}
|
#Study Description
Brief Summary
Introduction: Electrical Impedance Tomography (TIE) consists of an equipment that enables the visualization / quantification in real time of the regional distribution of ventilation and pulmonary perfusion, as well as of ventilatory mechanics. Used on the edge of the bed, it is easy to move, non-invasive, allowing a momentary or continuous assessment, guiding the conduct in a safe and precise way through the electrical impedance technology. It is important to note that, in addition to ensuring the efficacy of the patient's behavior, the TIE supports the most diverse types of studies to be performed. These include those based on the effectiveness of the use of the method in the most diverse pulmonary dysfunctions, in the adjustment of the mechanical ventilation and in the average time of hospitalization. Objective: To evaluate the pulmonary function of patients in invasive mechanical ventilation through SIT. Method: This research was carried out in compliance with the National Health Council's Guidelines for Research Involving Human Beings (466/12). The study was a prospective longitudinal clinical-experimental type in which all patients (occasional sampling) used mechanical ventilation and were hospitalized in the Adult Intensive Care Unit (ICU) of the Santa Casa de Misericórdia Foundation of Pará, and they developed sepsis with pulmonary repercussions; (DEHG) / HELLP Syndrome and Adult Respiratory Distress Syndrome (ARDS) and who met the inclusion criteria were evaluated and monitored with TIE to perform ventilatory therapy according to the research objectives. The research was carried out in the city of Belém, in the state of Pará, in the adult ICU of the FSCMP. As inclusion criterion, the patient should be in the FSCMP adult Intensive Care Unit (ICU), under mechanical invasive ventilation, previously authorized by the family through the Informed Consent Form to participate in the study.
Detailed Description
A prospective longitudinal clinical-experimental study was carried out in which 30 postpartum / postpartum women who developed complications of their clinical condition, needing support by invasive mechanical ventilation, development of sepsis with pulmonary repercussion, Specific Pregnancy Disease ( SDP), HELLP syndrome or ARDS were evaluated and monitored with Electrical Impedance Tomography for conduction of ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two tapes with 16 electrodes were connected by means of an adhesive tape, one for each band, around the thorax and aligned in a plane corresponding to a cross section with emission of an electric current imperceptible and harmless to the patient, generating, according to the pulmonary dynamics, a variation of electrical impedance, consequently a gradient of electrical resistivity. A flow sensor positioned between the endotracheal tube and the 'Y' of the ventilator circuit, responsible for capturing ventilatory mechanic information, and a reference cable positioned by an electrocardiographic monitoring electrode, in the abdominal region or in the region from the shoulders. The data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as its correlation in patients under mechanical ventilation. All experimental values were presented as mean ± standard deviation (SD). The study was of the experimental type, and the descriptive statistic was used to characterize the sample. Statistical analysis was performed with GraphPad Prism 5.0. The P value \<0.05 was considered statistically significant. The results were placed in spreadsheets and graphs created with GraphPad Prism 5.0 (GraphPad Software, San Diego, California, USA).
#Intervention
- OTHER : Sepsis
- Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
- OTHER : HELLP Syndrome
- Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
- OTHER : Respiratory Distress Syndrome Adult
- Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
|
#Eligibility Criteria:
Inclusion Criteria: the patient should:
* To be admitted to the Adult Intensive Care Unit (ICU) of the FSCMP;
* Being in the postpartum/puerperium period;
* To evolve with complications of its clinical condition: sepsis with pulmonary repercussions, Specific Disease of Pregnancy (SDP), HELLP syndrome or ARDS;
* Support by invasive mechanical ventilation;
* To be previously authorized by the family to participate in the study through the WICF.
Exclusion Criteria:
* Being a cardiac pacemaker;
* Pregnant women in any period of gestation who develop complications of their clinical condition and need support through invasive ventilation.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03715647
|
{
"brief_title": "Correlation of Survival in Puerperae by Electrical Impedance Tomography",
"conditions": [
"Postpartum Period",
"Sepsis",
"Respiratory Distress Syndrome,Adult",
"HELLP Syndrome"
],
"interventions": [
"Other: Respiratory Distress Syndrome Adult",
"Other: HELLP Syndrome",
"Other: Sepsis"
],
"location_countries": null,
"nct_id": "NCT03715647",
"official_title": "Correlation of the Driving Pressure With the Survival of Puerperae Under Mechanical Ventilation by Electrical Impedance Tomography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-06",
"study_start_date(actual)": "2017-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-06",
"last_updated_that_met_qc_criteria": "2018-10-19",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-23",
"first_submitted": "2018-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary aim this prospective longitudinal observational outcomes study is to compare 18 month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot fractures with major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL will be measured using well established self reported measures, including the Veterans Rand Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).
Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss will have similar functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with an injury that meets at least one of the following:
1. Gustilo type III pilon fractures consistent with one of the following OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C
2. Gustilo type III B or C ankle fractures
3. Gustilo type III mid and/or hind foot fractures consistent with one of the following OTA codes: 81B2-B3, 82B and 82C
4. Open foot crush or blast injuries from high energy mechanism involving the mid and /or hind foot with significant soft tissues damage
5. Other severe foot injury (including closed foot crush or blast injuries)
* Ages 18 <= age <= 60 inclusive.
* Admitted to the hospital prior to definitive wound closure.
Inclusion notes:
* Patients may have other injuries except as noted below under exclusion criteria.
* Foot crush and blast injuries are eligible if they are considered to be at significant risk for impaired outcome with moderate to severe disability and typically include one of the following associated injuries:
1. ankle dislocation (80A)
2. subtalar dislocation (80B)
3. extruded talus
4. chopart dislocation (80C)
5. multiple midfoot dislocations (80C)
6. three or greater proximal metatarsal fractures
7. heel pad/plantar degloving
8. extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome
* These injuries may include 'toe-pan' injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.
Exclusion Criteria:
* Patient has a Glasgow Coma Scale motor score of 0 <= age <= 4 or a Glasgow Coma Scale motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6) at time of consent
* Patient has third degree burns on >10% total surface area affecting the study limb
* Patient has a previous leg or foot amputation of either limb
* Patient is non-ambulatory due to an associated complete spinal cord injury
* Patient non-ambulatory pre-injury
* Patient speaks neither English nor Spanish
* Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
1. Patient has been diagnosed with a severe psychiatric condition
2. Patient is intellectually challenged without adequate family support
3. Patient lives outside the hospital's catchment area
4. Follow-up is planned at another medical center
5. Patients who are prisoners or homeless
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
|
NCT01606501
|
{
"brief_title": "Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol",
"conditions": [
"Severe Distal Tibia Injury",
"Severe Ankle Injury",
"Severe Foot Injury",
"Major Soft Tissue Loss",
"Major Bone Articular Surface Loss",
"Major Ankle Articular Surface Loss"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01606501",
"official_title": "Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-20",
"study_completion_date(actual)": "2019-09-20",
"study_start_date(actual)": "2012-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-24",
"last_updated_that_met_qc_criteria": "2012-05-23",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-25",
"first_submitted": "2012-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In layperson's language state the purpose of the study in 3-5 sentences.
Previous research has demonstrated that intimate partners can positively influence those with PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study will provide Veterans with PTSD and their partners with a mobile app designed to promote engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and improve relationship quality in Veterans and their intimate partners.
b) State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of this new knowledge.
Understanding ways to improve the public health impact of public-facing, evidence-based mobile apps is critical. This study will test a low-cost, 'high-touch' approach to improving the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which are already available to the general public and used by over 55,000 new users per year.This study will test whether the involvement of an intimate partner in the use of a mobile app for PTSD will result in changes in how the mobile apps are used and in relationship quality and PTSD symptoms over time. Additionally, this study will test whether the addition of a discussion board can improve engagement with the apps and/or outcomes. The study will also provide useful qualitative data that can inform the development of subsequent dyadic interventions using mobile technologies.
c) Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of investigational device in individuals with specific condition; purpose of study is to examine specific behavioral traits in humans in classroom or other environment)
The purpose of this study is to evaluate how Veterans and their partners interact with evidence-based mobile apps for improving PTSD symptoms.
Detailed Description
Please SUMMARIZE the research procedures, screening through closeout, which the human subject will undergo. Refer to sections in the protocol attached in section 16, BUT do not copy the clinical protocol. Be clear on what is to be done for research and what is part of standard of care.
In brief, the study team will attempt to recruit 100 couples in which one partner is a community-dwelling Veteran with significant, untreated symptoms of posttraumatic stress disorder (PTSD) symptoms. All participants will receive access to a mobile app designed by Veterans Affairs (VA). Veterans will receive access to the PTSD Coach mobile app, and their partners will receive access to the PTSD Family Coach mobile app. Potential participants will be identified from targeted Facebook and other social media outreach efforts. Those who view an advertisement will be directed to the study website, hosted by Stanford's Qualtrics domain, where they will be provided with information about the study, screened for eligibility,and then provided with an informed consent document. Upon completing the informed consent process, participants will be asked to complete a baseline survey and then to share information about the study with their partner. Veterans and their partners will be connected only by a subject identification number. After completing the baseline survey, all participants will then be encouraged to use the PTSD Coach app or the PTSD Family Coach app as often or as little as they like.
Using random assignment, half of the dyads will also be provided with a) access to a secure, confidential discussion board, where they will be able to post new messages and respond to messages posted by others and b) mailed information packages that contain information about coping with PTSD, coping with a spouse's PTSD, and strategies for managing relationship distress associated with PTSD. Those dyads who do not receive access to the discussion board will still receive access to the mobile apps but will not have access to either the discussion board or the mailed information packages.
Outcomes will be evaluated using objective measures of engagement with the apps, changes in attitudes toward use of mental health services, relationship quality,changes over time in PTSD and stress symptoms, and qualitative experiences associated with use of the apps. Barriers to implementation and identified strategies for overcoming barriers will be catalogued over the duration of the study.
Description of PTSD Coach:
Participants will be provided with a link to download PTSD Coach (freely available on iTunes and Google Play Stores or through myvaapps.com) and brief recommendations for how to use the app over the subsequent 8 weeks of the study. PTSD Coach is a mobile app for iPhone and Android, developed by the VA National Center for PTSD in collaboration with National Center for Telehealth and Technology (T2) and the Department of Veterans Affairs Patient Care Services. PTSD Coach was initially developed and launched in March, 2011, with usability and focus group data derived from a sample of 80 veterans with PTSD, many of whom were explicitly requesting 'something I can do when I'm stressed, wherever I am.' The app provides 4 primary treatment components: 1) psychoeducation about PTSD, 2) self-monitoring tools, 3) immediate tools for symptom management, and 4) immediate access to public and private support resources. The psychoeducation component provides text and audio informational topics about PTSD, with an emphasis on normalizing the condition, and information about ways to begin engaging with mental health services. The self-monitoring tools component administers the PTSD Checklist Civilian version (PCL-C), provides tailored feedback on symptom level and changes since the last assessment, and allows and encourages users to create reminders to self-monitor their symptom levels. The symptom management component provides specific tools tailored for managing reminders of trauma, avoiding trauma-related triggers, overcoming feelings of being disconnected from others, overcoming feelings of being disconnected from reality,improving sleep, and reducing feelings of sadness, hopelessness, worry, anxiety, or anger.These tools include audio-based relaxation exercises, guided deep breathing, making plans for social activities, engaging in pleasant activities, tips for distraction from unpleasant sensations, and other simple exercises. The support component encourages users to create a personal support network (from their phone's contact list) and provides users with information about additional resources for veterans (e.g., crisis and help-line numbers). Evidence for PTSD Coach is described in detail in the Preliminary Studies section. In brief, use of PTSD Coach alone is associated with significant within-session changes in ratings ofdistress43 and demonstrates a small but clinically meaningful effect on PTSD symptoms(d=.30, f\~.15) relative to a wait-list control group.
Partners will be provided with a link to the PTSD Family Coach app. PTSD Family Coach provides four main intervention elements: Learn, Support, Tools for Managing Stress, and Self-Assessment. The 'Learn' section of the app provides extensive, mobile-friendly information about the basics of PTSD and how to best support their loved one with PTSD, how to take care of on self while living with someone with PTSD, how to take care of relationships with children and with one's partner, and how to most effectively encourage their partner to engage in professional care. The 'Support' section of the app provides information about how to get immediate crisis help (e.g., for medical emergencies, suicidal thoughts, or threats of violence), how to get help in talking with a partner about PTSD, how to find family-specific services, resources for parents and children, and resources for the Veteran. The 'Tools for Managing Stress' section of the app contains interactive relaxation tools, cognitive strategies for managing stress, mindfulness exercises, encouragement to engage in pleasant activities and to engage in social activities, safety-planning tools, tips for good sleep hygiene, and grounding techniques. Finally, the 'Self-Assessment' section of the app provides tools for self-monitoring stress symptoms and tracking these symptoms over time.Description of the Discussion Boards to be used in this study:All discussion boards will be privately hosted on the secure https://www.health-space.net sight maintained by the PI and can only be accessed with a unique API key and valid invitation code stored in the mobile app, so that only those who have been provided with both a research version of the study app and a valid invitation code will be able to access the discussion board. There will be 2 unique discussion boards: one for family members (i.e., accessed from the PTSD Family Coach app) and one for Veterans (i.e., accessed from the PTSD Coach app). Those who choose to post a message to the discussion board will be identified only by their invitation code (a random string of 6 characters and/or digits), and all messages will be reviewed by the investigators in order to ensure safety and appropriateness before they can be viewed by any other participants. As soon as a message is posted, an automated email will be sent to each of the investigators, who will be asked to log-in to a secure website in order to approve the submitted message so that it can viewed by other participants. Should any safety or privacy-related concerns arise, or the message is deemed inappropriate for any other reason, the participant who submitted the message will be contacted and provided with additional information necessary for either obtaining additional assistance or modifying the message to make more appropriate or private as necessary.
Every 2 weeks for 8 weeks, each participant will be mailed an information packet (i.e., 4 packets in total for each participant) that will provide additional information on managing stress and conflict in relationships,increasing positive interactions in the relationship, problem-solving in relationships, and increasing positive communication in relationships. Information packets will contain general information, a list of available resources that can provide additional information, and suggested exercises to practice with their partner or by using the mobile app.
Ten weeks after being randomized, Veterans and their partners will be asked to complete a follow-up survey using the Qualtrics web survey tool. Those participants who are willing to take part in a telephone interview will be contacted by telephone to participate in a 30-minute qualitative interview about the app, communication with their partner about PTSD symptoms,and suggestions for optimizing partner-based interventions using mobile apps.
#Intervention
- BEHAVIORAL : Mobile App + Mailed Materials for managing stress associated with PTSD
- PTSD Coach and PTSD Family Coach mobile apps plus mailed 'Couples Coach' intervention materials and discussion board added to PTSD Family Coach app
- BEHAVIORAL : Mobile App for managing stress associated with PTSD
- PTSD Coach and PTSD Family Coach mobile apps
|
#Eligibility Criteria:
Inclusion Criteria:
To be eligible to participate, participants must be either a Veteran with PTSD or living with a partner who is a Veteran with PTSD.
Veterans must be:
* A veteran of the U.S. Armed Forces
* Must have a previous diagnosis of PTSD
* Must have access to a smart phone using the iOS operating system
* Must not have previously used PTSD Coach.
Partners of Veterans must be:
* An intimate partner of a Veteran
* Living with that partner
* Must have access to a smart phone using the iOS operating system
* must be experiencing significant stress
Exclusion Criteria:
a) actual or threatened interpersonal violence in the home
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02780635
|
{
"brief_title": "Use of Mobile Apps for Those With PTSD and Their Partners",
"conditions": [
"Ptsd"
],
"interventions": [
"Behavioral: Mobile App for managing stress associated with PTSD",
"Behavioral: Mobile App + Mailed Materials for managing stress associated with PTSD"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02780635",
"official_title": "Use of Mobile Apps for Those With PTSD and Their Partners",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12",
"study_completion_date(actual)": "2018-12",
"study_start_date(actual)": "2015-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-26",
"last_updated_that_met_qc_criteria": "2016-05-18",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-23",
"first_submitted": "2016-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The term \"heel pain\" is used to describe a common, painful condition that is localized in the plantar part of the heel and worsens when weight is placed on the heel. Patients with heel pain are more likely to have thickened plantar fascia, abnormal plantar fascia tissue, thicker plantar heel fat pad, and calcaneal spur. Calcaneal spurs are bony protrusions that typically occur just in front of the medial calcaneal tuberosity. Systemic medical treatments, physical therapy agents, exercise and local injections are often applied for heel pain caused by plantar fasciitis and calcaneal spur.
This study is to examine the effects of ESWT and kinesio taping on pain and other clinical outcomes in patients with calcaneal spurs.
Detailed Description
The responses of patients who underwent ESWT or kinesio taping due to calcaneal spur before and after treatment will be compared. Pain, functionality and quality of life are the clinical parameters compared.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and over with heel pain
* A calcaneal spur seen on foot radiographs
Exclusion Criteria:
* Those who had received a steroid injection into the heel within the past three months
* Those who had experienced trauma or surgery to the foot and ankle within the past six months
* Those with a rheumatic disease affecting the foot and ankle (e.g., spondyloarthritis)
* Those with open wounds or infections in the area to be treated with lesions.
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
|
NCT06533683
|
{
"brief_title": "Effects of Kinesio Taping and Extracorporeal Shock Wave Therapy in the Calcaneal Spur",
"conditions": [
"Calcaneal Spur",
"Plantar Fasciitis",
"Heel Pain"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT06533683",
"official_title": "Effects of Kinesio Taping Versus Extracorporeal Shock Wave Therapy on Pain in the Treatment of Calcaneal Spur: A Retrospective Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-01",
"study_completion_date(actual)": "2024-03-01",
"study_start_date(actual)": "2023-09-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-01",
"last_updated_that_met_qc_criteria": "2024-07-30",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-08-01",
"first_submitted": "2024-07-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the effectiveness of the Person-First - Please (PFP) intervention in supporting nurse's competence and collective competence of Person-Centred Care (PCC) in older people Long-Term Care (LTC). The goal is to promote PCC culture in older people LTC.
Research question 1:
What is the effectiveness of the PFP intervention on the PCC collective competency of nurses in older people LTC?
Hypothesis for research question 1 are:
1. Nurses in intervention group will have higher level of competence of PCC than control.
Research question 2:
How PCC climate has been maintained in older people LTC from the point of view of the nurses, next of kin and older people?
Hypothesis for research question 2 are:
1. PCC climate will be better in intervention group than control from point of view of the nurses, next of kin and older people.
2. The higher competence of nurses the higher level of PCC climate from point of view of the next of kin and older people.
3. The higher collective competence of the nurses the higher level of the PCC climate from point of view of the next of kin and older people.
Detailed Description
The study takes place in older people long-term care on two cities in western part of Finland. The long-term care units are similar as stuff structure, nurse/resident ration, working ideology and quality management.
The research design is quasi-experimental research with pre- and post- test measurements in the intervention and control groups. The intervention group will follow the protocol and the control group participants will follow the usually care. Data are being collected at baseline, immediately after 10 weeks intervention and at follow-up 6 weeks after intervention.
Continuing education named 'Person First - Please' (PFP) based on Person-Centered Care (PCC) Practice Framework and Theory of Collective Competence and it consist of four modules: Information, Person, Autonomy and Dignity. Information module will take one hour in the first intervention week, and it will include information about the study; informed consent; short clarification about concept PCC and prerequisites for PCC. Tree other modules takes 4 hours contact with researcher in every three weeks.
Power analyses for the sample size showed that for 0.8 effect size, power of 0.8 and statistical significance of 0.05 with three main hypotheses, for intervention group n=64 and for control group n=128. ICC of 0.1 was used based on previous sample of the primary outcome measurement.
The sampling based on cluster sampling. Two cities will be constituting the clusters in western part of Finland. From these cities will be selected first all public long-term care units for the older people. To avoid contamination, one of the cities will be selected to participate in the intervention and the other in the control.
Participants in the study consist of nurses (Registered Nurses, Licensed Practice Nurses, Caregiver Assistants) who work in older people LTC and older people from the same units participate alone or with their next of kin.
Nurses background questions are age, education, working experience. Older people and next of kin background questions are age, length of the living in LTC, relationship, number of visits per week in LTC. The effectiveness of an intervention is measured by validated measurements that have been properly licensed.
The data will be analysed by latest version of the Software Platform for Statistical Analysis (SPSS). Descriptive statistic will be calculated for the numerical and categorical data. The normal distribution of the data and 95% confidence intervals will be calculated for the numerical and categorical data. Intervention and control group will be statistically compared, and differences will be measured at each time point. At the baseline will be ensure the similarity of intervention and control group for background variables. Cross-tabulations will be done for categorical and numerical variables. The sum variable of the measurements during the three different measurement time will be analysed using hierarchical linear mixed models will compare the changes over time between the groups.
Each participant will be informed before about the purpose of the study, issues related to research ethics, reporting of the findings and they will sign informed consent. Since the study involves research participants who are vulnerable due to cognitive impairment, researcher have clear protocol and special attention will be paid to ethical issues during the study.
#Intervention
- BEHAVIORAL : Person-First - Please (PFP)
- PFP takes 10 weeks and consist of four modules: Information, Person, Autonomy and Dignity. Information module takes 1 hour contact on first week. The other modules will follow every third weeks, starting from week 2. So that on week 2, 5 and 8 researcher meet nurses in 4 hours education session. Between the modules, nurses can take contact online to the researcher.
|
#Eligibility Criteria:
Inclusion Criteria:
* Nurses (RNs, Licensed Practice Nurses, Caregiver Assistants) who works in older people LTC. The inclusion criteria for nurses are that they work permanently or on a long-term deputy (at least 6 months) in units.
* The criteria for older people participating alone are that older people have enough cognitive capacity assessed by managers of the units. The criteria for next of kin participating is they will visit at least weekly in LTC.
Exclusion Criteria:
* short- time deputy nurses
* older people in terminal care
Sex :
ALL
Ages :
- Maximum Age : 110 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04833153
|
{
"brief_title": "Continuing Education Intervention Named 'Person First - Please'",
"conditions": [
"Nurse-Patient Relations"
],
"interventions": [
"Behavioral: Person-First - Please (PFP)"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT04833153",
"official_title": "Continuing Education Intervention 'Person First - Please' of Person-Centred Care Targeted to Nurses in Older People Long-term Care",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-02",
"study_completion_date(actual)": "2022-03-31",
"study_start_date(actual)": "2021-08-30"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-10",
"last_updated_that_met_qc_criteria": "2021-04-03",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-06",
"first_submitted": "2021-03-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. Behavioral disorders associated with them can have serious social repercussions. However, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.
Fifteen subjects will be included after collection and signed their informed consent.
The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. Furthermore the rTMS treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The LEFT stimulation site will be established through a anatomofunctional imaging before treatment (between D-7 and D0).
Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.
#Intervention
- DEVICE : Transcranial magnetic stimulation: rTMS
- 4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with schizophrenic disorders aged from 18 <= age <= 60 old
* Patients suffering from auditory hallucinations undergoing antipsychotic treatments
* Written signed consent
Exclusion Criteria:
* Pregnancy or breastfeeding
* Counter-indication to MRI or to rTMS
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
|
NCT02525315
|
{
"brief_title": "Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations",
"conditions": [
"Schizophrenic Disorders"
],
"interventions": [
"Device: Transcranial magnetic stimulation: rTMS"
],
"location_countries": [
"France"
],
"nct_id": "NCT02525315",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2007-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-17",
"last_updated_that_met_qc_criteria": "2015-08-14",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-17",
"first_submitted": "2015-08-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Previous clinical studies have indicated that finafloxacin is well-tolerated with few treatment-related adverse events. As a part of the clinical development of finafloxacin, other PK studies are required to determine the effect of other variables on the PK profile of finafloxacin. This study aims to determine the effect of age and gender on the pharmacokinetic profile of finafloxacin.
#Intervention
- DRUG : 400 mg finafloxacin (2 x 200 mg tablets)
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male and/or female, 18 <= age <= 35 of age (inclusive), or 65 years or over(>= 65 years).
* Body mass index (BMI) >= 18 and <= 30 kg/m2.
* No clinically significant abnormal findings, as judged by the Principal Investigator (PI), on the physical examination, ECG, medical history, or clinical laboratory results during screening.
* Negative screen for human immunodeficiency virus (HIV), hepatitis B, C and/or positive hepatitis B surface antigen (HBsAg), and anti-Hepatitis C virus (HCV) antibodies.
* Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or were using one of the following acceptable birth control methods:
1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) for a minimum of 6 months.
2. Intrauterine device (IUD) in place for at least 3 months.
3. Barrier methods (condom and diaphragm) plus spermicide for at least 14 days prior to the first dose and throughout the study.
4. Surgical sterilization of the partner (vasectomy for 6 months minimum).
5. Hormonal contraceptives for at least 3 months prior to the first dose of the study and throughout the study.
* Females of non-childbearing potential were either postmenopausal for at least 2 consecutive years prior to Day 1, with a follicle-stimulating hormone (FSH) level > 40 IU/mL or had undergone one of the following sterilization procedures at least 6 months prior to Day 1:
1. Bilateral tubal ligation.
2. Hysterectomy.
3. Hysterectomy with unilateral or bilateral oophorectomy.
4. Bilateral oophorectomy.
* Male subjects were either sexually inactive (abstinent) or using a barrier method for 14 days prior to the first dose and throughout the study.
* In addition, male subjects and female subjects of childbearing potential were advised to remain sexually inactive or to keep the same birth control method for at least 30 days in the case of females and 90 days in the case of males, following the last dose. Male subjects were additionally advised not to donate sperm for 90 days following the last dose.
* Was able to understand and willing to sign an ICF.
Exclusion Criteria:
* Subject with psychiatric, neurological, or behavioral disorders that may have interfered with the conduct or interpretation of the study.
* Subject with a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematological disorders that were capable of significantly altering the absorption, metabolism, or elimination of drugs, or were considered a risk with the study medication or could have interfered with the interpretation of data.
* Subject who had an abnormality in the 12-lead ECG that, in the opinion of the PI, increased the risks associated with participating in the study.
* Subject with clinically relevant abnormal laboratory data or vital signs at screening, or any abnormal laboratory value which, in the opinion of the PI, could have interfered with the assessment of safety.
* Subject with exposure to any investigational drug within 30 days prior to screening.
* Subject with a known hypersensitivity or other contraindication to the use of fluoroquinolones.
* Subject with a history of tendon rupture or tendonitis.
* Subject who received corticosteroid therapy in the 4 weeks prior to study drug administration.
* Subject with prior participation in a finafloxacin investigational study.
* Subject who had current diagnosis or known history of drug and/or alcohol abuse.
* Subject who smoked > 10 cigarettes per day and was unable or unwilling to refrain from nicotine during study confinement.
* Subject who received any drugs known to strongly inhibit or induce any of the enzymes within the cytochrome P-450 (CYP) system within 30 days prior to the first dose.
* Subject who had exposure to any medication (with the exception of hormone replacement therapy [HRT] for the elderly subjects), including over-the-counter (OTC) medications, 7 days prior to dosing.
* Subject who had exposure to antacid medication 24 hours prior to study drug administration until collection of the last PK sample.
* Subject who had consumed grapefruit 10 days prior to study drug administration until collection of the last PK sample.
* Subject with any clinically significant illness 3 months before the study.
* Subject who had donated blood or plasma during the previous 56 days prior to dosing.
* Subject who was unlikely to comply with the clinical study protocol.
* Subject who was a member of the clinical site or Sponsor personnel or their immediate family, defined as spouse, parent, sibling, child, grandparent, or grandchild.
* Any other condition that, in the opinion of the PI, precluded participation in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01904162
|
{
"brief_title": "Effect of Age and Gender on the PK and Tolerability of Finafloxacin",
"conditions": [
"Pharmacokinetic and Tolerability of Finafloxacin"
],
"interventions": [
"Drug: 400 mg finafloxacin (2 x 200 mg tablets)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01904162",
"official_title": "Determination of the Effect of Age and Gender on the Pharmacokinetics and Tolerability of a Single Dose of Finafloxacin-HCL in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02",
"study_completion_date(actual)": "2010-02",
"study_start_date(actual)": "2010-02"
},
"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)": "2024-03-13",
"last_updated_that_met_qc_criteria": "2013-07-17",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-22",
"first_submitted": "2013-07-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.
Detailed Description
Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life. Currently, there are no treatments for restoring nipple sensitivity and the associatedto improve lower sexual quality of life this condition. It would thus be of great clinical benefit to post breast surgery patients if a provide a new safe and , effective , topical , on-demand, treatment for this condition can be developed.
#Intervention
- DRUG : AB-101
- Apply approximately 1 hour prior to sexual activity
- Other Names :
- Phenylephrine
- DRUG : Placebo
- Apply approximately 1 hour prior to sexual activity
- Other Names :
- Vehicle Solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Female breast cancer survivor
* Age: 18 to 70
* First diagnosed with Stage I or II breast cancer
* Have had breast surgery: nipple sparring mastectomy or lumpectomy
* At least 3 years post surgery
* Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)
* Baseline nipple sensitivity <=5 (likeartLikert scale)
* QoL-BC (>=7)
* Delayed orgasm (CTCAE v4.0) Grade 2
* One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
* Able to give informed consent
* Currently in a monogamous heterosexual relationship for at least 12 months
* Sexually active within the last 30 days
* Willing to engage in sexual activity at least once a month during the duration of the study
* Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
* Willing to use an adequate method of birth control
* Able to comply with the study requirements for 8 consecutive weeks
* Able to give informed consent
Exclusion Criteria:
* Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
* Currently pregnant
* Nursing within the last 6 months prior to beginning the study
* History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
* Actively being treated for breast cancer
* Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
* Uncontrolled or severe hypertension
* Decreased oxygen in the tissues or blood
* Active inflammation of the liver
* Acute inflammation of the pancreas
* Overactive thyroid gland
* Acidosis
* Diabetes
* Spinal cord injury
* Nipple dermatitis
* Regional complex pain syndrome
* Use of any hypertensive drugs
* Use of MAO inhibitors
* Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I
* In partners: sexual dysfunction or erectile dysfunction
* Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
* Nipple dermatitis
* Regional complex pain syndrome
* Unable to provide consent or make allotted clinical visits
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:
Yes
|
NCT03592121
|
{
"brief_title": "Study to Investigate the Effect of AB-101 in Breast Cancer Survivors",
"conditions": [
"Sexual Dysfunction",
"Sexual Arousal Disorder",
"Sexual Dysfunction, Physiological",
"Breast Cancer",
"Nipple Disorder",
"Neuropathy",
"Cancer of Breast"
],
"interventions": [
"Drug: AB-101",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03592121",
"official_title": "Study to Investigate the Effect of AB-101 in Breast Cancer Survivors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-12",
"study_completion_date(actual)": "2019-10-12",
"study_start_date(actual)": "2018-07-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-12",
"last_updated_that_met_qc_criteria": "2018-07-18",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-19",
"first_submitted": "2018-07-08",
"first_submitted_that_met_qc_criteria": "2020-03-03"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the mechanisms leading to rapid postoperative improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and compare the changes in glucose level, beta-cell function, and insulin resistance induced by a week of very low calorie liquid diet and those induced by a week of matched very -low calorie liquid diet occuring in the context of routine postoperative care following RYGB.
Detailed Description
Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and controlled diet and activity, separated by a 4-10-week washout period.
Study Period #1:
This first study period is 9 days/nights long and requires you to be closely supervised at our Clinical and Translational Research Center (CTRC). During this time you will receive the same diet and are expected to have the same activity level you will be prescribed in the immediate post-operative period.
Wash-out period:
During this study period you are expected to return to your usual diet and exercise level.
Study Period #2:
This last study period is also 9 days/nights long, includes the EXACT same diet you have received during the first study period, and in addition you will undergo the planned gastric by-pass surgery.
Procedures during the research:
Mixed Meal Challenge test will be done four times during the entire study: days 1 and 9 for each study period. This test allows the investigators to evaluate how much insulin your body is producing and how well this insulin is processed.
Measurement of resting energy expenditure will be done four times during the entire study. This test tell us how much energy your body is burning up in a resting state.
|
#Eligibility Criteria:
Inclusion Criteria:
* volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.
Exclusion Criteria:
* abnormal renal function
* significant anemia
* difficult venous access
* treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
* recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance.
* pregnancy
* non -English speakers
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
|
NCT01153516
|
{
"brief_title": "Diabetes and Gastric By- Pass",
"conditions": [
"Type 2 Diabetes"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01153516",
"official_title": "Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2010-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-27",
"last_updated_that_met_qc_criteria": "2010-06-28",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-30",
"first_submitted": "2010-06-24",
"first_submitted_that_met_qc_criteria": "2018-11-08"
}
}
}
|
#Study Description
Brief Summary
To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
Detailed Description
The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers
#Intervention
- DRUG : HCP1105
- DRUG : HCP0918
- DRUG : HCP0816
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
* Healthy male volunteers, aged 19 <= age <= 55.
* The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2
Exclusion Criteria:
*
*Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
* Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2
Sex :
ALL
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
|
NCT02941796
|
{
"brief_title": "Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers",
"conditions": [
"Hyperlipidemias"
],
"interventions": [
"Drug: HCP0816",
"Drug: HCP1105",
"Drug: HCP0918"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02941796",
"official_title": "An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics and Safety After Administration of HCP1105 Alone and Co-administration of HGP0918 and HGP0816 in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2016-06"
},
"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)": "2016-10-21",
"last_updated_that_met_qc_criteria": "2016-10-19",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-21",
"first_submitted": "2016-10-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years
Detailed Description
This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.
#Intervention
- BIOLOGICAL : Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
- The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml
- BIOLOGICAL : Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
- The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml
- OTHER : Two doses of placebo at the schedule of day 0,28
- The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy children and adolescents aged 3 <= age <= 17 years;
* The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8 <= age <= 17 years);
* Proven legal identity.
Exclusion Criteria:
* Travel history / residence history of communities with case reports within 14 days;
* History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
* Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
* Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
* History of SARS-CoV-2 infection;
* History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
* Autoimmune disease or immunodeficiency / immunosuppression;
* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
* Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase I clinical trials):
1. Blood routine test: white blood cell count, hemoglobin, platelet count;
2. Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;
3. Urine routine index: urine protein (PRO);
* History of alcohol or drug abuse;
* Receipt of blood products within in the past 3 months;
* Receipt of other investigational drugs in the past 30 days;
* Receipt of attenuated live vaccines in the past 14 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
* Axillary temperature >37.0°C;
* Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04551547
|
{
"brief_title": "Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19",
"conditions": [
"COVID-19"
],
"interventions": [
"Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28",
"Other: Two doses of placebo at the schedule of day 0,28",
"Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28"
],
"location_countries": [
"China"
],
"nct_id": "NCT04551547",
"official_title": "A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-30",
"study_completion_date(actual)": "2023-02-08",
"study_start_date(actual)": "2020-10-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-02",
"last_updated_that_met_qc_criteria": "2020-09-15",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-16",
"first_submitted": "2020-09-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for the symptomatic treatment of fever and pain in mild to moderate. It comes in different formulations for oral, intravenous and rectal. The IV route allows rapid passage of paracetamol in the systemic arterial circulation and thus the brain, faster distribution evidenced a higher plasma concentration compared with oral and rectal. However the IV route also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy, unpleasant and painful.
The way per-Albus not to date used for the administration of paracetamol. It is a path nonetheless very interesting for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows a very rapid action. Furthermore, the terminal per-oral mucosa, less restrictive than IV administration and faster than oral administration, requires a simple medical gesture without special surveillance after administration, produces no pain or risk of infection for the patient (in contrast to the IV). It is interesting to test a new dosage form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and pharmacodynamics) with the only dosage form of reference used by the IV route.
Detailed Description
Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
#Intervention
- DRUG : Kinetics of plasma concentrations of paracetamol
- Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
- DRUG : Placebo
- Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers
* Aged > 18 years and not more than 50 years
* Males
* Values of vital signs before administration of the test products:
* NOT between 100 <= age <= 140 mm Hg
* PAD between 50 <= age <= 90 mm Hg
* Radial pulse between 45 <= age <= 90 beats per minute
* Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatories)
Exclusion Criteria:
* Contraindications to the administration of paracetamol
* Hypersensitivity to paracetamol
* History of hepatitis B or C
* Severe renal impairment
* Hepatic insufficiency
* Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
* Pathology evolutionary time of the review for inclusion
* Binge drinking, smoking (more than 10 cigarettes/day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse
* Subject does not meet the selection criteria regarding their ability to discriminate the sensations resulting from noxious stimuli during psychometric testing
* Topic having all breaches of the oral mucosa (aphthae)
Sex :
MALE
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
|
NCT00982215
|
{
"brief_title": "Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00982215",
"official_title": "Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2009-10",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-01-30",
"last_updated_that_met_qc_criteria": "2009-09-22",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-23",
"first_submitted": "2009-09-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Risk factors for cardiovascular disease are poorly controlled even for patients who frequently visit their physician, leading to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The investigators are confident that a pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to markedly reduce cardiovascular events in the United States.
Detailed Description
Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. A gap in the literature is that it is not known whether a comprehensive CVRS model would be implemented in typical office practices in un-integrated settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including disease management apps have found no trial that has incorporated communication with a pharmacist and this lack of evidence is a major gap in the mHealth literature.
The objective of this application is to develop and test a mobile app enabled, pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice. In addition to developing the app with patients as design partners, the investigators will conduct a multi-center individually randomized study nested within an ongoing NIH trial in medical offices with large geographic, racial and ethnic diversity. The study team will randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site + pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic minorities. The central hypothesis is that the mHealth CVRS designed with patients as partners will be implemented and significantly improve patient engagement, leading to improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage metrics. The rationale for this proposed study is that a novel mHealth model that improves secondary prevention of CVD with pharmacist assistance will lead to broader adoption by health systems throughout the US.
The primary Aim is: to examine the feasibility of mHealth technology to disseminate evidence-based risk reduction guidelines in a prospective randomized controlled trial among diverse primary care offices. The investigators postulate that system engagement (primary hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary hypothesis) will be significantly greater in patients randomized to the mHealth intervention compared to the control group.
This study is expected to produce the following outcomes: unique mobile app features that complement the standard CVRS, increased engagement with a CVRS and increased achievement of guideline-concordant therapy.
#Intervention
- OTHER : Pharmacist-led cardiovascular risk service (CVRS)
- CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.
- OTHER : Mobile access to study Personal Health Record
- Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.
- OTHER : Web access to study Personal Health Record
- Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.
|
#Eligibility Criteria:
INCLUSION CRITERIA:
* Patients age 55 and older;
* Owns and uses a smartphone;
* Any ONE of the following guideline-related needs in the past 18 months:
1. Most recent encounter LDL >= 100 mg/dl
2. Most recent encounter BP > 140/90 mmHg (or > 150/90 for persons age 60+)
3. Most recent encounter not taking recommended post-stroke medications
4. Most recent encounter not taking recommended post-MI medications
5. Diabetics with most recent encounter not on ACE inhibitor or ARB blocker
6. Any patient with most recent A1c > 8.0%
7. Diabetics with no urine microalbumin screening, past 18 months
EXCLUSION CRITERIA:
* Non-English speaking (app available only in English for this study)
* No encounter in the past 18 months (they may be receiving care elsewhere and guideline-related needs may not be reliably assessed) at the clinic itself
* Most recent systolic BP >200 or diastolic BP > 110 mm Hg
* Any history of significant hepatic disease, including cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 3 times normal (either AST above 96 U/L or ALT above 99 U/L or total bilirubin > 2.0 mg/dl))
* History of hemorrhagic stroke
* Pulmonary hypertension
* Stage 4 or metastatic cancer
* Current nursing home residence or has plans to move to one within the next 12 months
* Has plans to transfer care from the current clinic within the next 6 months
* Inability to give informed consent or impaired cognitive function
* Currently pregnant (females only)
* Currently a prisoner
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03081871
|
{
"brief_title": "Mobile Cardiovascular Risk Service Trial",
"conditions": [
"Cardiovascular Diseases",
"Personal Health Records",
"Pharmaceutical Care",
"Mobile Apps"
],
"interventions": [
"Other: Mobile access to study Personal Health Record",
"Other: Web access to study Personal Health Record",
"Other: Pharmacist-led cardiovascular risk service (CVRS)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03081871",
"official_title": "Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-31",
"study_completion_date(actual)": "2018-08-31",
"study_start_date(actual)": "2017-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-11",
"last_updated_that_met_qc_criteria": "2017-03-10",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-16",
"first_submitted": "2017-03-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.
#Intervention
- DRUG : Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects having understood and signed an informed consent form.
* Either sex
* Healthy subjects, 18 <= age <= 65 of age
* Subjects with skin types I to IV according to Fitzpatrick Scale
* Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.
Exclusion Criteria:
* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
* Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
* Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
* Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
* Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
* Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
* Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
* Known or suspected hypersensitivity to any component of the investigational products
* Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01105234
|
{
"brief_title": "An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects",
"conditions": [
"Irritation"
],
"interventions": [
"Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues."
],
"location_countries": [
"France"
],
"nct_id": "NCT01105234",
"official_title": "An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-05",
"study_completion_date(actual)": "2010-05",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-26",
"last_updated_that_met_qc_criteria": "2010-04-15",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-16",
"first_submitted": "2010-02-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.
Detailed Description
Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.
#Intervention
- OTHER : Gua Sha
|
#Eligibility Criteria:
Inclusion Criteria:
* non-specific low back pain at least once weekly for at least the previous 3 months
* average back pain intensity hat least 40mm on a 100mm visual analog scale (VAS)
Exclusion Criteria:
* specific low back pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, or oncologic disease
* dystonia
* pregnancy
* invasive treatment of the spine or spinal surgery within the previous 4 weeks
* oral steroids or anticoagulants
* hemophilia or a skin condition in the area to be treated
* started a new treatment for low back pain within the previous month or planning to start a new treatment within the next month
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
|
NCT03333213
|
{
"brief_title": "Gua Sha Therapy for Chronic Low Back Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Other: Gua Sha"
],
"location_countries": null,
"nct_id": "NCT03333213",
"official_title": "Gua Sha Therapy for Chronic Low Back Pain: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12-01",
"study_completion_date(actual)": "2010-12-01",
"study_start_date(actual)": "2009-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-06",
"last_updated_that_met_qc_criteria": "2017-11-02",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-06",
"first_submitted": "2017-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.
Detailed Description
After subjects have signed informed consent voluntarily, they go through screening period for within 28 days.
As period I, subjects of Cohort1 take fimasartan and Amlodipine for 10 days and subjects of Cohort2 take rosuvastatin for 6 days.
And then, as period II, subjects of both Cohorts take fimasartan, Amlodipine and rosuvastatin in Cohort1 case for 6 days and in Cohort2 case for 10 10days.
For Fimasartan, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24hour after medication(32 times in total).
For Amlodipine, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before medication, 10th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24hour after medication(30 times in total).
For Rosuvastatin and N-desmethyl rosuvastatin, subjects of Cohort2 have blood sampling 4th, 5th, 14th, 15th day before medication, 6th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24hour after medication(28 times in total).
#Intervention
- DRUG : Fimasartan
- DRUG : Amlodipine
- DRUG : Rosuvastatin
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject, aged 19- 50 years at screening.
* Body weight within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
Exclusion Criteria:
* History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
* Hypotension (systolic <= 100 mmHg or diastolic <= 65 mmHg) or hypertension (systolic >= 140 mmHg or diastolic >= 90 mmHg), measured at screening
* Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.25 x the upper limit of normal
* History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)]
* Participation in any other study within 3 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02397538
|
{
"brief_title": "Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects",
"conditions": [
"Hypertension"
],
"interventions": [
"Drug: Rosuvastatin",
"Drug: Amlodipine",
"Drug: Fimasartan"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02397538",
"official_title": "An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2015-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-23",
"last_updated_that_met_qc_criteria": "2015-03-24",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-25",
"first_submitted": "2015-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to identify biomarkers allowing the distinction between invasive and non-invasive strains of Staphylococcus epidermidis. This distinction is important to determine if the patient is infected and, as a consequence, if an antibiotic treatment is required.
Detailed Description
In the hospital, a large proportion of bacteraemia and implantable medical device infections are caused by Staphylococcus epidermidis. This microorganism is the most abundant on human skin and all patients are carriers. Its remarkable ability to form biofilms on most materials explains that catheter-related infections are by far the most common.
S. epidermidis infections are difficult to treat because most strains are multi-resistant and antibiotics are less effective in the presence of biofilms.
In addition, S. epidermidis poses a major diagnostic problem because it is also the first source of contamination of blood culture sample and intraoperative samples (in case of suspected infection of orthopedic material in particular). Thus, when a sample is positive for S. epidermidis, there is less than a 25% chance that it reflects true bacteremia in the patient and 30% of patients would inappropriately receive vancomycin following contaminated blood cultures. Differentiating a contamination of a blood or intraoperative sample from true S. epidermidis infection is therefore crucial for patient management because unnecessary antibiotic therapy is potentially responsible for the emergence of resistant strains, toxicity and additional costs.
The objective of this study is to identify the genetic markers that make it possible to differentiate the strains causing infections from the strains causing contamination by comparing their genomes using high throughput sequencing.
#Intervention
- DIAGNOSTIC_TEST : high-throughput sequencing
- technique of high-throughput sequencing of the markers present in the genome of the S. epidermidis strains responsible for infection in order to help to discriminate the true infections of the contaminations
|
#Eligibility Criteria:
Inclusion Criteria:
CASE Inclusion Criteria:
Population 1: nosocomial bacteraemia associated with intravascular devices
* Hospitalized patient with intravascular device (peripheral or central, venous or arterial, short or long duration) for at least 48 hours before the development of bacteraemia
* Presenting a definite infection with S. epidermidis according to the categorization criteria,
Sub-Population 1A:
3a) Aged less than 28 days (New-born)
Sub-population 1B:
3b) Aged 28 days or more
Population 2: nosocomial infections of implanted material
* An operated patient carrying implanted equipment following orthopaedic surgery, following cardiac surgery or following neurosurgery,
* Presenting a definite infection with S. epidermidis according to the categorization criteria occurring in the year following surgery
CONTROL Inclusion Criteria:
Population 1: carrier of intravascular devices
* Hospitalized patient with intravascular device (peripheral or central, venous or arterial, short or long duration) for at least 48 hours before positive blood culture with S. epidermidis
* Certain contamination with S. epidermidis according to the categorization criteria,
Sub-Population 1A:
3a) Aged less than 28 days (Newborn)
Sub-population 1B:
3b) Aged 28 days or more
Population 2: carrier of implanted material
* An operated patient carrying implanted equipment following orthopedic surgery, following cardiac surgery or following neurosurgery,
* Presenting a certain contamination to S. epidermidis according to the categorization criteria occurring in the year following surgery
Exclusion Criteria:
CASE Exclusion Criteria Population 1: nosocomial bacteremia associated with intravascular devices
* Opposition of the patient or the holders of parental authority (minor patients)
* Patient with polymicrobial infection
* Patient with a colonized catheter (positive catheter end culture <103UFC / mL) with no clinical signs of local or general infection and with sterile peripheral blood cultures
* Patient with local catheter infection (positive catheter end culture> 103UFC / mL) with local inflammatory signs only and with sterile peripheral blood cultures
Population 2: nosocomial infections of implanted material
* Opposition of the patient or the holders of parental authority (minor patients)
* Patient with an infection of material concomitant with a catheter-related infection
CONTROL Exclusion Criteria
Populations 1 and 2:
Opposition of the patient or the holders of parental authority (minor patients)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03374371
|
{
"brief_title": "Invasive Markers of Staphylococcus Epidermidis",
"conditions": [
"Staphylococcus Epidermidis Positive Blood Culture"
],
"interventions": [
"Diagnostic Test: high-throughput sequencing"
],
"location_countries": [
"France"
],
"nct_id": "NCT03374371",
"official_title": "Identification of Genomic Markers Associated With the Invasiveness of Staphylococcus Epidermidis Strains Responsible for Infections",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-18",
"study_completion_date(actual)": "2020-12-18",
"study_start_date(actual)": "2018-03-01"
},
"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)": "2021-12-10",
"last_updated_that_met_qc_criteria": "2017-12-11",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-15",
"first_submitted": "2017-12-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.
#Intervention
- DRUG : catridecacog
- Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).
|
#Eligibility Criteria:
Inclusion Criteria:
* Documental congenital FXIII deficiency
* Normal platelet count and clotting parameters
* Adequate renal and hepatic function
* If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
* If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
* Negative drug and alcohol screens
Exclusion Criteria:
* Received blood products or FXIII concentrates within 4 weeks of study enrollment
* Known antibodies to FXIII
* Hereditary or acquired coagulation disorder other than FXIII deficiency
* Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
* Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
* Received treatment with any experimental agent within 30 days of study enrollment
* Any surgical procedure in the 30 days prior to enrollment
* Donated blood within 30 days prior to 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
|
NCT00056589
|
{
"brief_title": "Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency",
"conditions": [
"Congenital Bleeding Disorder",
"Congenital FXIII Deficiency"
],
"interventions": [
"Drug: catridecacog"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00056589",
"official_title": "A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-10",
"study_completion_date(actual)": "2003-10",
"study_start_date(actual)": "2003-03"
},
"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)": "2017-01-11",
"last_updated_that_met_qc_criteria": "2003-03-19",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-03-20",
"first_submitted": "2003-03-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.
#Intervention
- BEHAVIORAL : aerobic exercise
- 12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
- BEHAVIORAL : Health Education Control
- 12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
|
#Eligibility Criteria:
Inclusion Criteria:
* are between 18 and 65 years
* are current smokers (i.e., smoking at least 10 cigarettes per day)
* are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months.
Exclusion Criteria:
* current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP
* Substance abuse or dependence (excluding nicotine dependence) within the past 6 months
* lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP
* lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP
* current suicidality or homicidality
* marked organic impairment
* physical disabilities or medical problems (such as a history of diabetes, hypertension, seizure disorder, coronary heart disease, valvular heart disease, and pulmonary disease) or use of medications (such as beta blockers) that would prevent or hinder participation in a program of moderate intensity exercise
* current pregnancy of intent to become pregnant during the next 12 weeks, and i) current use of any pharmacotherapy, including transdermal nicotine replacement, for smoking cessation
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
|
NCT00713063
|
{
"brief_title": "Behavioral Exercise Intervention for Smoking Cessation",
"conditions": [
"Nicotine Dependence"
],
"interventions": [
"Behavioral: Health Education Control",
"Behavioral: aerobic exercise"
],
"location_countries": null,
"nct_id": "NCT00713063",
"official_title": "Behavioral Exercise Intervention for Smoking Cessation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2006-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-30",
"last_updated_that_met_qc_criteria": "2008-07-09",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-11",
"first_submitted": "2008-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study will investigate an association between ankle dorsiflexion and altered frontal knee kinematics during step down test in patients with PFPS.
Detailed Description
Altered frontal and transverse plane hip kinematics during single leg weight-bearing tasks are thought to be important contributors to patellofemoral pain (PFP). The closed chain nature of single leg tasks means that hip kinematics can be influenced by more distal mechanics, such as foot pronation.
One of the often-studied distal movements theorized to cause PFPS is pronation of the subtalar joint. Pronation is a tri-planar movement that includes dorsiflexion, eversion, and abduction of the foot. Many studies have examined eversion characteristics of PFPS patients, but the dorsiflexion aspect of the movement has been shown to be a possible risk factor, restricting dorsiflexion was shown to increase medial knee displacement in young healthy adults. Conversely, when available dorsiflexion ROM is increased, medial knee displacement is thought to decrease.
Patients with PFPS were observed to have a decreased DFROM (dorsiflexion range of motion) as compared to normal individuals, though this topic has not thoroughly been investigated.
#Intervention
- OTHER : frontal projection angle, ankle dorsiflexion
- Dorsiflexion measurements will be taken in 4 different positions and repeated and recorded 3 times in each position, Prone bent, straight knee and Standing bent, straight knee. Prior to the measurement, the participants completed two 30-second calf stretches The FPPA was determined as the angle at the knee formed by lines connecting the anterior superior iliac spine, the midpoint of the femoral condyles and the midpoint of the malleoli at the deepest part of the squat
|
#Eligibility Criteria:
Inclusion Criteria:
* Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.
* Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6weeks.
* VAS equal to or greater than 3.
* Age of the subject 18 <= age <= 35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates.
* BMI under 30 kg/m2, both gender
For the control group, subjects were recruited to this study if they had:
* No previous history or diagnosis of knee pathology.
* No pain with any of the above-mentioned provocative activities.
* No history of lower limb or spinal pathology.
Exclusion Criteria:
* A history of any of the following condition: meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
* A history of traumatic patellar subluxation or dislocation.
* Previous surgery in the lower extremities within the 12 months prior to participation in the study.
* Any balance impairments are secondary to a vestibular or neurological disorder or secondary to the use of medication.
* Any lower limb bony/congenital deformity
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03897569
|
{
"brief_title": "Association Between Ankle Dorsiflexion and Frontal Projection Angle in PFPS",
"conditions": [
"Patellofemoral Pain Syndrome"
],
"interventions": [
"Other: frontal projection angle, ankle dorsiflexion"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03897569",
"official_title": "Association Between Ankle Dorsiflexion and Frontal Projection Angle During a Functional Task in the Patellofemoral Pain Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-01",
"study_completion_date(actual)": "2019-07-01",
"study_start_date(actual)": "2019-03-30"
},
"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)": "2019-07-30",
"last_updated_that_met_qc_criteria": "2019-03-29",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-01",
"first_submitted": "2019-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage.
The peripheral perfusion index (PPI) reflects changes in peripheral perfusion and laser doppler flowmetry allows measurement of bowel tissue perfusion.
The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.
Detailed Description
An important goal of haemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation, but in clinical practice, monitoring and resuscitation is routinely based on measuring of blood pressure and heart rate, which might be inadequate endpoints for optimal resuscitation. Haemodynamic management targeting cardiac output and stroke volume (SV), and to some extent, flow and tissue perfusion is feasible when applying minimally-invasive or non-invasive methods, but has been limited to a narrow number of critically ill patients and to the intraoperative setting. Another approach to resuscitation is aimed at flow and perfusion of vital organs. Ideally, measurements would be done directly on these organs, but no feasible methods exist. Assuming blood flow is diverted from the peripheral tissue and the gastrointestinal tract to vital organs, during circulatory shock, an objective, simple and non-invasive method of detecting peripheral tissue perfusion impairment might detect this at an early stage. The peripheral perfusion index (PPI) is derived from the photoelectric plethysmographic pulse oximetry signal, which all patients are monitored by perioperatively to assess arterial oxygen saturation. The PPI is a numerical non-invasive measure representing the ratio between the pulsatile (arterial) and non-pulsatile component of the light reaching the pulse oximeter, and PPI decreases in states of hypoperfusion. PPI reflects changes in peripheral perfusion and blood volume and decreased peripheral perfusion determined by PPI predicts surgical complications and morbidity in acute surgical and septic shock patients.
The mesenteric haemodynamic response to circulatory shock is complex, and diagnosis of bowel ischaemia poses significant difficulty for the clinicians due to its non specific presentations and lack of a simple diagnostic test. In patients undergoing colorectal surgery for malignancy, laser doppler flowmetry allows measurement of bowel tissue perfusion.
The aim of this study is to explore the association between changes in peripheral and intestinal perfusion in patients undergoing elective colorectal surgery exposed to intraoperative haemodynamic challenges.
#Intervention
- OTHER : Haemodynamic monitoring
- see Group description
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult
* Elective colorectal surgery, low anterior resection of the colon, sigmoid colectomy or right hemicolectomy
* Written informed consent
Exclusion Criteria:
* No consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03395483
|
{
"brief_title": "Peripheral and Mesenteric Perfusion in Elective Surgical Patients",
"conditions": [
"Peripheral Perfusion",
"Bowel Ischemia",
"Colorectal Surgery",
"Haemodynamic Instability"
],
"interventions": [
"Other: Haemodynamic monitoring"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03395483",
"official_title": "Investigating the Peripheral Perfusion Index; Correlations Between Peripheral and Mesenteric Perfusion in Elective Surgical Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-01",
"study_completion_date(actual)": "2019-10-01",
"study_start_date(actual)": "2018-04-10"
},
"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)": "2019-11-01",
"last_updated_that_met_qc_criteria": "2018-01-03",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-10",
"first_submitted": "2017-12-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals. This exploratory project proposes to address this scientific gap by introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease Prevention Program to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations.
Detailed Description
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes. Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals. Few studies have examined the feasibility of using brief physician advice and multi-level, clinic-based interventions to change poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among these culturally diverse populations that comprise the clinic population. This exploratory project proposes to address this scientific gap by introducing and piloting a Self-Care Stimulating Disease Prevention Program (SCSDPP) to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations (primarily Latinos) served by the community clinics of the Venice Family Clinic (VFC) health center in Los Angeles County. The program will include the development of 1) a simple-to-use patient Health Priority Assessment (HPA) tool designed to assess patient preferences for behavior change; 2) a standard protocol for physicians to provide brief health advice using motivation interviewing (\< 2 minutes per visit); 3) a protocol for distributing self-help aids for patient use (e.g., pedometer, exercise videos); and 4) a series of monthly follow-up counseling sessions by lay health educators (e.g., promotores) to help patients address their lifestyle change priorities over time. We will conduct a randomized controlled pilot of the SCSDPP in approximately 100 patient cases at two community health clinics within the VFC health center system. The pilot will utilize precise outcome measures, including commonly-accepted biomarkers (e.g., HgbA1c, fasting blood glucose) and psychometrically-validated measures of process and health status, to accurately assess the magnitude of changes in diet and physical activity among patients over a 12-month observation period. The feasibility of integrating the SCSDPP into the community health clinic setting will be evaluated, and is the primary aim of this project. The results will inform efforts to plan a larger, successor study. Relevance to Public Health: this study evaluates a clinic-based brief intervention to help prevent overweight/obesity, a public health problem that has been linked to the development of the metabolic syndrome and other precursors of diabetes.
#Intervention
- BEHAVIORAL : Self-Care Stimulating Disease Prevention Program
- The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.
- BEHAVIORAL : Fighting Cancer with Advice
- Patient health counseling program by lay health educators entitled 'Fighting Cancer with Advice.'
|
#Eligibility Criteria:
Inclusion Criteria:
* Ages 18 and older
* English or Spanish-speaking
* Accessible by telephone or in person over time
* Willing to cooperate with data collection
* Planning to be in the Los Angeles area for the next 6 to 12 months so they can complete the study period
Exclusion Criteria:
* Women who are pregnant
* History of cancer, except non-melanoma skin cancer or in situ cancers
* Medical conditions preventing free choice of foods (e.g., colitis, poorly-controlled diabetes)
* Medical conditions precluding participation in common forms of aerobic or resistance exercise (e.g., uncontrolled angina, asthma or hypertension; severe physical impairment; and end-stage disease conditions such as congestive heart failure, nephropathy from any cause, or advanced chronic pulmonary disease)
* Does not show any desire to change any of their health behaviors (i.e., healthy eating, physical activity, sedentary behavior, or control their weight)
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
|
NCT00569595
|
{
"brief_title": "Improving Health Habits in Impoverished Populations",
"conditions": [
"Diabetes",
"Chronic Diseases"
],
"interventions": [
"Behavioral: Fighting Cancer with Advice",
"Behavioral: Self-Care Stimulating Disease Prevention Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00569595",
"official_title": "Improving Health Habits in Impoverished Populations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-07",
"last_updated_that_met_qc_criteria": "2007-12-06",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-12-07",
"first_submitted": "2007-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
Detailed Description
Subjects will be screened within 28 days prior to enrollment into the study. After qualifying for the study subjects will visit the clinical unit on Day l and will have pre-dose blood samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs) immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then be given the vaccine.
Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and 181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and alcohol testing), vital signs, 12-lead electrocardiogram and physical examination.
Adverse events (AEs) will be monitored throughout the study.
#Intervention
- BIOLOGICAL : Licensed seasonal influenza vaccine
- 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 <= age <= 50 of age, inclusive
* Good general health status, as determined by the Investigator
* Adequate venous access for repeated phlebotomies
* Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Bilirubin may be Grade 2 if associated with no1mal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant (e.g. vigorous exercise or Gilbert's syndrome)
* Negative drug and alcohol screen at Screening and pre-dose on Day I
* For women of child bearing potential, negative pregnancy test
* Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex,monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the Fluzone Intramuscular Quadrivalent vaccine dose.
Exclusion Criteria:
* Pregnant, possibly pregnant, or lactating women
* Body mass index> 35.0 kg/m2
* Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening
* Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
* Daily symptoms
* Daily use of short acting beta 2 agonists
* Use of inhaled steroids or theophylline
* Use of pulse systemic steroids
* Emergency care or hospitalization related to asthma or other chronic lung disease
* Systemic steroids for asthma exacerbation
* History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
* History of coronary artery disease, arrhythmia, or congestive heart failure
* Clinically significant ECG abnormality
* Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or pre-dose on Day I
* History of anaphylaxis or angioedema
* Known allergy to any of the ingredients in the vaccine formulation including egg allergy
* History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
* Previous nasal surgery or nasal cauterization
* Any symptoms of upper respiratory infection or temperature> 38°C within 3 days before Day I
* Significant nasal congestion or rhinorrhea as assessed by the investigator.
* Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
* Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
* Use of statin medication within 30 days before Day I (including atorvastatin, fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)
* Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
* Receipt of any IP within 30 days before Day 1
* Receipt of any vaccine within 30 days before Day I
* Receipt of intranasal vaccine within 90 days before Day I
* Receipt of any influenza vaccine within 6 months before Day I
* Any change in medication for a chronic medical condition within 30 days before Day I
* Past regular use or current use of intranasal illicit drugs or any regular use of illicit drugs by any other route.
* Use of tobacco products or electronic cigarettes within 30 days before Day l. Any other smoking products including marijuana will be excluded.
* Any medical, psychiatric, or social condition or any occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including immunogenicity), or a subject's ability to give informed consent
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
|
NCT03163342
|
{
"brief_title": "Immune Response Following Seasonal Influenza Vaccination",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Licensed seasonal influenza vaccine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03163342",
"official_title": "Extent and Durability of Immune Response Following Seasonal Influenza Vaccination in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-21",
"study_completion_date(actual)": "2018-06-15",
"study_start_date(actual)": "2017-05-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-26",
"last_updated_that_met_qc_criteria": "2017-05-19",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-23",
"first_submitted": "2017-05-19",
"first_submitted_that_met_qc_criteria": "2019-04-04"
}
}
}
|
#Study Description
Brief Summary
This phase II trial studies how well selumetinib sulfate works in treating patients with pancreatic cancer with Kirsten rat sarcoma (KRAS) G12R mutations that has spread from where it started to nearby tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the objective response rate to selumetinib sulfate (selumetinib) administered as 75 mg orally twice daily on a continuous schedule in patients with advanced pancreas cancer harboring Kirsten rat sarcoma (KRAS) G12R mutations.
SECONDARY OBJECTIVES:
I. To determine the progression free survival of patients with locally advanced, unresectable and stage IV pancreas cancer treated with selumetinib monotherapy.
II. To evaluate the safety of selumetinib in patients with advanced pancreas cancer.
III. To determine the impact of additional genetic alterations on the response to selumetinib in pancreas cancer harboring KRAS G12R mutations.
IV. To develop a clinically applicable biomarker predicting response to selumetinib in pancreas cancer harboring KRAS G12R mutations.
OUTLINE:
Patients receive selumetinib sulfate orally (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 52 weeks.
#Intervention
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Selumetinib Sulfate
- Given by mouth (PO)
- Other Names :
- AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Selumetinib Sulphate
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed locally advanced or metastatic pancreas cancer
* Patients must have received at least 6 months fluorouracil (5-FU)- or gemcitabine-based treatments for pancreas cancer (fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin [FOLFIRINOX], fluorouracil, leucovorin calcium and oxaliplatin [FOLFOX], 5-FU+ nal-IRI [MM-398; nanoliposomal irinotecan], or 5-FU [including capecitabine], gemcitabine-based gemcitabine plus abraxane, gemcitabine monotherapy among others)
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Patients must have Clinical Laboratory Improvement Act (CLIA) confirmed somatic Kirsten rat sarcoma (KRAS) G12R mutation as determined by sequence analysis of matched normal deoxyribonucleic acid (DNA) from any specimen obtained from the individual; patients must provide tumor sample for KRAS analysis or be willing to undergo mandatory screening biopsy
* Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least 4 weeks prior to starting study medication; patients who received FOLFIRINOX must be 6 weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified
* Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky >= 70%
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 75,000/mcL
* Hemoglobin (Hgb) >= 9.0 g/dL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3 x institutional upper limit of normal
* Creatinine =< institutional upper limit of normal OR
* Creatinine clearance > 60 mL/min/1.73 m^2 by either Cockcroft-Gault formula or 24-hour urine collection analysis
* Patients must be willing to return to the clinic for follow-up visits
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 weeks after dosing with selumetinib sulfate (AZD6244) ceases; women of child-bearing potential must have a negative pregnancy test within 14 days prior to study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform her treating physician immediately; please note that the AZD6244 manufacturer recommends that adequate contraception for male patients should be used for 12 weeks post-last dose due to sperm life cycle; NOTE: breastfeeding should be discontinued if the mother is treated with selumetinib
* Ability to understand and the willingness to sign a written informed consent document or patients with Impaired Decision Making Capacity (IDMC) if they are represented by a Legally Authorized Representative (LAR)
* Patient must be able to reliably swallow oral medications
Exclusion Criteria:
* Patients who have received prior treatment with tyrosine kinase inhibitors (e.g. erlotinib), or anti-Epidermal growth factor receptor (EGFR) agents (e.g. cetuximab, panitumumab)
* Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous
* Patients with active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events
* Patients who are receiving any other investigational agents
* Patients with known brain metastases should be excluded from this clinical trial; no additional workup is needed to exclude brain metastases if the patient is asymptomatic or has no history of brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Selumetinib (AZD6244) or other agents used in study
* Previous Mitogen-activated protein kinase kinase (MEK), RAS, or Rapidly Accelerated Fibrosarcoma (RAF) inhibitor use
* Patients with the following cardiac conditions are excluded:
* Uncontrolled hypertension (blood pressure [BP] of >= 150/95 despite medical support/management)
* Acute coronary syndrome within 6 months prior to starting treatment
* Uncontrolled angina - Canadian Cardiovascular Society grade II-IV despite medical support/management
* Heart failure New York Heart Association (NYHA) class II or above
* Prior or current cardiomyopathy (within 6 months) including but not limited to the following:
* Known hypertrophic cardiomyopathy
* Known arrhythmogenic right ventricular cardiomyopathy
* Abnormal ejection fraction (echocardiogram [ECHO]) =< 53% (if a range is given then the upper value of the range will be used) or cardiac magnetic resonance imaging (MRI)
* Previous moderate or severe impairment of left ventricular systolic function (left ventricular ejection fraction [LVEF] < 45% on echocardiography or equivalent on multi-gated acquisition scan [MUGA]) even if full recovery has occurred; echocardiogram (Echo) and additional cardiac studies not indicated unless clinically symptomatic or patient has significant cardiac history
* Severe valvular heart disease
* Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest
* Fridericia's corrected QT interval (QTcF) >= 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) are excluded; the use of medication(s) that can prolong QTc interval is prohibited while treated on this study
* Patients with known ophthalmologic conditions, such as:
* Current or past history of central serous retinopathy
* Current or past history of retinal vein occlusion
* Known intraocular pressure (IOP) > 21 mmHg (or upper limit of normal [ULN] adjusted by age) or uncontrolled glaucoma (irrespective of IOP); patients with controlled glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) may be eligible after discussion with the study chair
* Subjects with any other significant abnormality on ophthalmic examination (performed by an ophthalmologist) should be discussed with the study chair for potential eligibility
* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
* Patients with refractory nausea and vomiting, chronic gastrointestinal (GI) diseases (e.g., inflammatory bowel disease) or significant bowel resection
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; HIV-positive patients not on antiviral therapy with undetectable viral loads and cluster of differentiation 4 (CD4) counts > 300, and after confirmation of eligibility after discussing with the study chair are eligible
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
|
NCT03040986
|
{
"brief_title": "Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations",
"conditions": [
"KRAS NP_004976.2:p.G12R",
"Stage III Pancreatic Cancer AJCC v6 and v7",
"Stage IV Pancreatic Cancer AJCC v6 and v7"
],
"interventions": [
"Other: Laboratory Biomarker Analysis",
"Drug: Selumetinib Sulfate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03040986",
"official_title": "A Phase II Study of Selumetinib (AZD6244) for the Treatment of Advanced Pancreas Cancer Harboring KRAS G12R Mutations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-10",
"study_completion_date(actual)": "2020-10-15",
"study_start_date(actual)": "2017-07-21"
},
"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)": "2021-02-09",
"last_updated_that_met_qc_criteria": "2017-02-01",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-02",
"first_submitted": "2017-02-01",
"first_submitted_that_met_qc_criteria": "2020-12-16"
}
}
}
|
#Study Description
Brief Summary
This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.
#Intervention
- DRUG : Azithromycin
- Treatment with Azithromycin single dose - weight based dosing max 2gm
- DRUG : Albendazole
- Single dose of Albendazole weight based dosing
- 400mg
- Other Names :
- IDA
- DRUG : Ivermectin
- Ivermectin weight based dosing - max 21mg
- Other Names :
- IDA
- DRUG : Diethylcarbamazine
- Diethylcarbamazine weight based dosing - max 500mg
- Other Names :
- IDA
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult aged 18 <= age <= 65
* Able to give informed consent
Exclusion Criteria:
* Known chronic illness
* Hb <7 at baseline
* Liver function or Creatinine * 1.5 Upper Limit of Normal
* Urinary tract infection at baseline
* Pregnancy (female participants only)
* Routine medications which interact with study drugs
* Lactose/Gluten intolerance
* Permanent disability impeding study participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03664063
|
{
"brief_title": "PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )",
"conditions": [
"Lymphatic Filariasis",
"Yaws",
"Trauma"
],
"interventions": [
"Drug: Azithromycin",
"Drug: Ivermectin",
"Drug: Albendazole",
"Drug: Diethylcarbamazine"
],
"location_countries": [
"Papua New Guinea"
],
"nct_id": "NCT03664063",
"official_title": "A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-01",
"study_completion_date(actual)": "2019-01-01",
"study_start_date(actual)": "2018-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-28",
"last_updated_that_met_qc_criteria": "2018-09-06",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-10",
"first_submitted": "2018-09-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the blood of patients with severe persistent asthma.
Detailed Description
Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.
Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.
|
#Eligibility Criteria:
Inclusion Criteria:
* Physician diagnosis of severe persistent asthma;
* Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;
* Male or female age 12 <= age <= 65 years;
* Non-smoker.
Exclusion Criteria:
* Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;
* Respiratory infection within 30 days prior to the study;
* Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;
* Having been treated with Xolair within the past year;
* Requiring chronic immunosuppressive therapy;
* Having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study;
* Having taken an investigational drug within 30 days prior to the study;
* Have a history of drug or alcohol abuse;
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02659618
|
{
"brief_title": "Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma",
"conditions": [
"Severe Persistent Asthma"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02659618",
"official_title": "Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-26",
"study_completion_date(actual)": "2020-12-16",
"study_start_date(actual)": "2016-04"
},
"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)": "2022-02-11",
"last_updated_that_met_qc_criteria": "2016-01-19",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-20",
"first_submitted": "2015-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research will implement a novel habit formation intervention among people living with hypertension and an indication of medication non-adherence to help maintain high anti-hypertensive (AH) medication adherence by leveraging the power of routines and unconsciously triggered habitual behaviors. The investigators will test whether high AH medication adherence can be maintained using contextually-cued medication adherence habits that mitigate the negative effects of declining motivation, forgetfulness, and the cognitive burden of performing repeated daily behaviors. The use of mHealth tools will help to make this a scalable and sustainable intervention approach for addressing an important healthcare issue in Arizona.
#Intervention
- OTHER : Wellth app
- The Wellth app will be provided to treatment groups 1 and 2 for free and it is available for download through all common mobile app stores for both iOS and Android phones. The Wellth App is a private company that serves over five million clients that range from patients of healthcare providers and beneficiaries of various health insurance companies to employees of large corporations, where the Wellth App is offered as a behavioral tool for increasing meditation adherence among individuals who are managing chronic conditions through daily meditations, e.g. chronic obstructive pulmonary disease, asthma, high blood pressure, coronary artery disease, and HIV. The Wellth App has already been offered to some members of Arizona Complete Health, so both Wellth and Arizona Complete Health are familiar with implementing this program among this target population.
- BEHAVIORAL : Habit training
- Participants in treatment groups 1 and 2 will be asked to identify an existing routine behavior that will act as a 'cue' for their daily pill-taking behavior to. However, only participants in treatment group 2 will have to submit visual evidence of their cue to the Wellth app in addition to photos of their medication in order to receive credit for the medication check-in (i.e., financial incentives conditional on using their cue).
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older
* Currently diagnosed with hypertension (either stage I or stage II hypertension)
* Able to read/write/understand English
* Have daily access to a smartphone
* Engaged in hypertension care (i.e., already been prescribed antihypertensive medication for a minimum of 12 months at the time of study enrollment)
* Demonstrated antihypertensive medication nonadherence by having over 73 days without documented antihypertensive medication prescription coverage (observable in Arizona Health Care Cost Containment System (AHCCCS) prescription drugs claims) in the past 12 months (i.e., >80% mean adherence)
Exclusion Criteria:
* Less than 18 years
* Does not have current hypertension diagnosis
* Unable to read/write/understand English
* Does not have daily access to a smartphone
* Not currently engaged in hypertension care
* Has not demonstrated antihypertensive medication nonadherence within the past 12 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05672797
|
{
"brief_title": "Habitual Hypertension Medication Adherence in Arizona",
"conditions": [
"Medication Adherence",
"Habits",
"Hypertension"
],
"interventions": [
"Other: Wellth app",
"Behavioral: Habit training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05672797",
"official_title": "Habitual Hypertension Medication Adherence in Arizona",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-31",
"study_completion_date(actual)": "2024-03-31",
"study_start_date(actual)": "2022-12-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-02",
"last_updated_that_met_qc_criteria": "2023-01-03",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-05",
"first_submitted": "2022-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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