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#Study Description
Brief Summary
The study is a prospective, 1-arm, open label, nonrandomized, single center study designed to evaluate label comprehension, device usability and safety of the FERTI·LILY Conception Cup. The primary safety endpoint will be an assessment of reported adverse events.
Subjects will be screened -10 (±3) days prior to the baseline visit. At baseline, 15-20 subjects meeting the inclusion/exclusion criteria will be provided with a FERTI·LILY Conception Cup device and instructions for using the device. Subjects will participate in a label comprehension protocol that includes the physician confirmation that they have adequate comprehension to enroll. If not, a screen failure form is completed.
Subjects will agree to try and use the device within 2 weeks of disposition therefore at baseline a two-week visit is scheduled. In the event they do not use the device within the two-week period the follow up visit can be rescheduled based on the visit window of +14 days. If it is not used within 4 weeks, the PI will have the subject return to the site to authorize another two-week period that will be captured as unscheduled follow up visit. The subject should complete the Device Experience Survey after each device use. The Device Experience Survey will be returned at this time, and adverse events will be assessed.
#Intervention
- DEVICE : FERTI LILY Conception Cup
- The FERTI-LILY Conception Cup is indicated for over-the-counter (OTC) home use by couples trying to conceive. The FERTI·LILY device OTC contains a cervical cap attached to a stem. The FERTI-LILY Conception Cup is intended to push semen towards the cervix as an aid in conception. It is designed to be inserted vaginally after intercourse and left in place for 20-60 minutes. The device is recommended to be used during the ovulatory phase of the menstrual cycle. It is not to be left in place for longer than six hours. The device may be re-used up to 18 times or over 6 cycles.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is a female volunteer, age >= 18 years.
* Subject is willing and able to provide written informed consent for study participation.
* Subject agrees to use the FCC device as directed.
* Subject agrees to complete all study-related assessments.
* Subject agrees to try to use the cup within two weeks of disposition.
* PI confirms that the subject had the adequate label comprehension to enroll in the study.
Exclusion Criteria:
* Subject has a medical condition or other factor that, in the opinion of the investigator, would contraindicate participation in the study.
* Subject has active bacterial vaginosis infection or vaginismus.
* Subject has an abnormal clinically significant Pap Smear diagnosis.
* Subject has a history of endometriosis.
* Subject has any contraindications with the Instructions for Use.
* Subject has an allergy to silicone.
* Subject is pregnant or lactating.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05529160
|
{
"brief_title": "FERTI-LILY Safety Study",
"conditions": [
"Natural Conception",
"Label Comprehension",
"Device Usability",
"Safety Issues"
],
"interventions": [
"Device: FERTI LILY Conception Cup"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05529160",
"official_title": "A Prospective, 1-Arm, Open Label, Non-Randomized Study of the FERTI-LILY Conception Cup Device to Assess Label Comprehension, Device Usability and Safety in Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-20",
"study_completion_date(actual)": "2022-09-21",
"study_start_date(actual)": "2022-07-29"
},
"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)": "2023-04-06",
"last_updated_that_met_qc_criteria": "2022-09-01",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-06",
"first_submitted": "2022-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).
Detailed Description
Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).
Hypothesis:
The study aims at evaluating the potential clinical impact of a highly sensitive urinary marker, Uromonitor, regarding possible reduction in number of cystoscopies.
We hypothesize that the use of a sensitive urinary marker regarding recurrent tumor will enable us to reduce the number of follow-up cystoscopies without risk of delaying diagnosis of recurrence and progression cystoscopies compared to flexible cystoscopy alone.
We hypothesize that number of tumors missed at follow-up cystoscopy alone or urinary marker alone is identical or in favor of a sensitive urinary marker that can detect sub-visible lesions and the examinations combined identify all tumor recurrences.
Moreover, we hypothesize that tumors missed at follow-up at a given time point are very small and will be identified at next follow-up without increasing the risk of progression and that regular follow-up with cystoscopy alone therefore can be replaced by follow-up with a sensitive urinary biomarker alone - where cystoscopy only is performed if the biomarker is positive.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who previously had low grad NMIBC.
* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up.
Exclusion Criteria:
* Clinical suspicion of muscle invasive bladder cancer
* Upper urinary track tumours
* Patients undergoing neoadjuvant chemotherapy based on local protocols
* Metastatic urothelial carcinoma
* Patients recived installation therapy within the last 4 weeks
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03962933
|
{
"brief_title": "Urine-based Detection of Non-muscle Invasive Bladder",
"conditions": [
"Bladder Cancer"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT03962933",
"official_title": "Urine-based Detection of Non-muscle Invasive Bladder Cancer Recurrence",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-01",
"study_completion_date(actual)": "2023-08-01",
"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)": "2024-01-30",
"last_updated_that_met_qc_criteria": "2019-05-23",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-24",
"first_submitted": "2019-05-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
Detailed Description
Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).
The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos.
The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization.
The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.
An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.
#Intervention
- PROCEDURE : Embryo transfer
- Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
|
#Eligibility Criteria:
Inclusion Criteria:
* female patients undergoing IVF procedures
* age less than 39 years
Exclusion Criteria:
* less than 4 fertilized eggs in day 1 after IVF
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 38 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02639000
|
{
"brief_title": "Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years",
"conditions": [
"Infertility"
],
"interventions": [
"Procedure: Embryo transfer"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT02639000",
"official_title": "Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2010-07"
},
"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)": "2016-10-04",
"last_updated_that_met_qc_criteria": "2015-12-22",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-23",
"first_submitted": "2015-12-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study involves two parts: a randomised controlled trial, and a nested qualitative study.
The main aim of the trial is to evaluate the effectiveness of a pharmacist-led, medications-focused patient counselling on reducing the frequency of hypoglycaemia in older adults diagnosed with type 2 Diabetes Mellitus within 12 weeks in Jordan.
The study hypothesis is that individualised patient counselling which is provided by pharmacists and involves recommendations about anti-diabetic medications will reduce the risk of hypoglycaemia by preventing further episodes in the elderly Jordanians with type 2 Diabetes Mellitus.
The qualitative study aims at evaluating the experience of participants in both groups with the study (process evaluation). This involves exploring which components are effective and which are not with the reasons, the contextual factors affecting the delivery and implementation of the study and the intervention, and how the study and the intervention can be scaled up in the future.
Detailed Description
Hypoglycaemia is the most serious adverse effect of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in clinical trials that evaluate the impact of such type of interventions on hypoglycaemia risk, especially in older adults. Despite the increasing prevalence of chronic diseases such as diabetes in Jordan, pharmacists still provide traditional services rather than patient-centred services.
The purpose of this research is to investigate the effect of pharmacist-led, individualised, and medications-focused patient counselling on reducing episodes of hypoglycaemia compared to the usual care in older Jordanians with type 2 Diabetes Mellitus within 12 weeks.
This research is a prospective, open-label, randomised controlled trial that is conducted in the outpatient endocrinology and cardiology clinics at King Abdullah University Hospital in Jordan, with 204 elderly patients who had been diagnosed with type 2 diabetes. Participants will be randomised in a 1:1 ratio into either the intervention (SUGAR Handshake) or the usual care groups. Each participant in the SUGAR Handshake group will receive a face-to-face individualised educational session with a pharmacist at the inclusion visit, a pictogram containing the main educational information, and a reinforcement of the educational session through a phone call at week 6 of the inclusion visit. They will also receive the usual care provided by the health care professionals at the outpatient clinics. On the other hand, patients in the usual care group will only receive the routine care provided at the outpatient clinics. The duration of the trial for each participant is 12 weeks.
The qualitative study is performed through phone interviews with 8-12 participants of each group at week 6 of the inclusion visit. Participants are to be approached according to convenience sampling and the data will be analysed using content analysis.
#Intervention
- BEHAVIORAL : SUGAR Handshake
- An interactive patient counselling session delivered by a pharmacist which mainly focuses on medication-related instructions towards preventing hypoglycaemia in addition to recommendations about hypoglycemia early recognition, causes, and treatment. The SUGAR Handshake is individualised according to shared decision making and each participant's characteristics.
Components of the SUGAR Handshake intervention will be covered under five main domains:
1. Signs and symptoms of hypoglycemia.
2. Understanding the underlying causes of hypoglycaemia such as misuse of anti-diabetic medications.
3. Good glycaemic control and self-monitoring, which mainly includes instructions on handling the anti-diabetic medications.
4. Acknowledgement by the patient
5. Recap and summary
The pictogram contains the main recommendations for easy recall by the participant. Moreover, the intervention will be reinforced by a phone call at week 6 of the inclusion visit.
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of type 2 Diabetes Mellitus
* Have been taking a sulfonylurea, insulin, or any three or more anti-diabetic medications
Exclusion Criteria:
* Unable to understand instructions or to give consent.
* Impaired mental capacity
* On palliative care for cancer, with advanced-stage or end-stage diseases, who have psychosis or severe depression, who are terminally-ill, or with life expectancy < 6 months
* Have been diagnosed with haemolytic anaemia or hemoglobinopathies as being self-reported or according to the patient's electronic record.
* Unwilling to take home glucose measurements or to use the glucometer (for example because of severe hearing or visual impairment and without a caregiver to measure the blood glucose level by the glucometer)
* Unwilling to return for follow up.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04081766
|
{
"brief_title": "Pharmacist-Led Study in Controlling Hypoglycemia in Older Adults With Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes Mellitus Type 2 With Hypoglycemia"
],
"interventions": [
"Behavioral: SUGAR Handshake"
],
"location_countries": [
"Jordan"
],
"nct_id": "NCT04081766",
"official_title": "Randomized Controlled Trial of Pharmacist-Led Patient Counselling in Controlling Hypoglycemic Attacks in Older Adults With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-31",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2020-02-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-22",
"last_updated_that_met_qc_criteria": "2019-09-04",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-09",
"first_submitted": "2019-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.
Detailed Description
This is a double-blind, multicentre, randomized, parallel group, dose-finding study of the efficacy, safety and tolerability of a once-daily 3-day regimen of PA with a 3:1 weight/weight ratio for patients with acute, symptomatic, uncomplicated P. falciparum malaria. Patients will be recruited from 5 to 7 study sites in endemic regions of South East Asia and Africa and will be randomized to 1 of 3 treatment groups differing in dosage, with 160 patients per group (n-480). Randomization will be balanced within each study site across all 3 study groups in pre-assigned treatment blocks.
The first dose will be administered on Day 0 and patients will remain hospitalized for at least 4 days whilst undertaking the 3-day regimen. Patients will remain near the study site for a minimum of 7 days or once fever and parasite clearance is confirmed (assessed by 3 negative readings of fever and/or slide).
The primary efficacy end point is the cure rate on Day 28 - the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR). Despite this Day 28 end point, the relatively long half-life of pyronaridine necessitates follow-up until Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.
#Intervention
- DRUG : pyronaridine/artesunate
- Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.
- Other Names :
- Pyramax
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients between the age of 15 and 60 years inclusive
* Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations
* Absence of severe malnutrition (defined as the weight-for-height being below -3 standard deviations or <70% of the median of the NCHS/WHO normalized reference values)
* Weight of between 35 kg and 75 kg inclusive
* Presence of acute symptomatic uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only (i.e. no mixed infection) plus history of fever within the previous 24 hours or a measured temperature of >=37.5°C (depending on method of measurement):
* the acceptable range is between 1,000 and 100,000 asexual parasite count/μl of blood and
* axillary/tympanic temperature of >= 37.5°C or oral/rectal temperature of >= 38.0°C
* Ability to swallow oral medication
* Ability to comply with study visit schedule: patients will be hospitalised for at least 4 days and will be required to remain in the vicinity of the trial site for a minimum of 7 days or until clearance of fever and parasite for at least 24 hours, whichever is the later. The patient is to return to the study site or to make themselves available for all scheduled follow up visits, until discharge at Day 42.
* Females must not be pregnant or lactating and be willing to take measures to not become pregnant during the study period
* Willingness and ability to comply with the study protocol for the duration of the study
Exclusion Criteria:
* Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000
* Mixed Plasmodium infection
* Severe vomiting, defined as >3 times in the 24 hours prior to inclusion in the trial or inability to tolerate oral treatment
* Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other clinically important abnormality (including head trauma).
* Presence of febrile conditions caused by diseases other than malaria
* Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
* Evidence of use of any other antimalarial agent within 2 weeks prior to the start of the study confirmed by a negative urine test or using Eggelte dipsticks
* Positive urine pregnancy test or lactating
* Received an investigational drug within the past 4 weeks
* Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
* Known seropositive HIV antibody
* Liver function tests [ASAT/ALAT levels] >2.5 times upper limit of normal values
* Known significant renal impairment as indicated by a serum creatinine of >= 1.4 mg/dl
* Previous participation in this clinical trial
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01594931
|
{
"brief_title": "Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria",
"conditions": [
"Plasmodium Falciparum Malaria"
],
"interventions": [
"Drug: pyronaridine/artesunate"
],
"location_countries": [
"Gambia",
"Senegal",
"Thailand",
"Cambodia",
"Uganda",
"Indonesia"
],
"nct_id": "NCT01594931",
"official_title": "A Randomised, Multi-Centre, Phase II, Dose-ranging Clinical Study to Assess the Safety and Efficacy of Fixed Dose, Orally Administered Pyronaridine and Artesunate (3:1) in Adult Patients With Acute Uncomplicated Plasmodium Falciparum Malaria",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-03",
"study_completion_date(actual)": "2006-04",
"study_start_date(actual)": "2005-07"
},
"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)": "2021-11-02",
"last_updated_that_met_qc_criteria": "2012-05-08",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-09",
"first_submitted": "2012-05-07",
"first_submitted_that_met_qc_criteria": "2021-08-20"
}
}
}
|
#Study Description
Brief Summary
This study aims to compare the effects of ShotBlocker, virtual reality glasses and cold application on pain and patient satisfaction in patients who were applied subcutaneous low molecular weight heparin (LMWH) injection in adult patients.
Detailed Description
The research being carried out in Ankara City Hospital Clinic of Orthopedics. The research sample is expected to consist of 150 adult patients, who will be randomly divided into three groups. First group will be applied ShotBlocker (n=50); second group will be applied Virtual Reality Glasses (n=50) and third group will be applied subcutaneous LMWH via cold application (n=50). So as to assess the effect of the injection, it will be applied on patients' left side within abdomen site via standard method (control) while the same will be done on patients' right side according to method of intervention (intervention). Therefore, each patient will form both intervention and control groups. Prior to subcutaneous LMWH injection, 'Descriptive Characteristics Form', which includes participants' socio-demographic attributes (gender, marital status, age, level of education, etc.), will be filled out by the researcher by means of face-to-face interview. Following the injection, in order to evaluate patients' pain, 'Visual Analog Scale for Pain' will be filled while 'Visual Analog Scale for Satisfaction' will be used in order to identify patients' satisfaction with the application. It is expected that compared to standard injection, ShotBlocker, virtual reality glasses and cold application will reveal more positive results on pain and patient satisfaction during subcutaneous LMWH injection in adult patients. Besides, the method that has the more effect will be determined by comparing different methods. It is thought the data collected by the research will contribute to literature.
#Intervention
- DEVICE : Group 1
- In each group, patients will be applied both standard subcutaneous heparin injection and with ShotBlocker.
- Other Names :
- ShotBlocker
- DEVICE : Group 2
- In each group, patients will be applied both standard subcutaneous heparin injection and with virtual reality glasses.
- Other Names :
- Virtual Reality Glasses (VRG)
- DEVICE : Group 3
- In each group, patients will be applied both standard subcutaneous heparin injection and with cold application.
- Other Names :
- Cold Application
|
#Eligibility Criteria:
Inclusion Criteria:
* Open to communication
* 18 or over years of age
* Received 1x0,4 ml enoksaparin sodium treatment
* Experienced no complications during or after operation
* Normal values of thrombocyte (150.000 <= age <= 300.000), aPTT (25 <= age <= 35 sec) and INR (0.8 <= age <= 1.2) (Thrombocyte, INR and aPTT tests will be assessed in accordance with reference values of the kits that the hospital uses.)
* No infection, scar tissue or incision in abdomen site
* Received no parenteral treatment other than this site
* Not diagnosed with any sort of coagulation disorder
* No visual impairment to be able to wear VR glasses
* No allergy to cold
* No mental or neurological disability
* No audio-visual impairment disability to be able to watch the video
* Turkish speaking and comprehending
* Non-pregnant
* No hematological or allergic disease
* Willing to be hospitalized for 2 days
* Volunteer to participate in the research will constitute the research sample.
Exclusion Criteria:
During data collection, those who;
* Renounce from participating in the research
* Remove virtual reality glasses during or after operation
* Fail to hold the cold pack for necessary period of time
* Show signs of cold allergy during operation
* Change institutions or were discharged early during research
* Change dose of drugs within drug system
* Develop drawbacks in the abdomen site will be excluded from the research.
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
|
NCT05833646
|
{
"brief_title": "Comparison of the Effects of ShotBlocker, Virtual Reality Glasses and Cold Application in Subcutaneous Heparin Injection",
"conditions": [
"Subcutaneous Injection"
],
"interventions": [
"Device: Group 2",
"Device: Group 1",
"Device: Group 3"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05833646",
"official_title": "Comparison of the Effects of ShotBlocker, Virtual Reality Glasses and Cold Application on Pain and Patient Satisfaction in Subcutaneous Heparin Injection Application in Adult Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-15",
"study_completion_date(actual)": "2023-07-25",
"study_start_date(actual)": "2023-03-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-01",
"last_updated_that_met_qc_criteria": "2023-04-16",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-27",
"first_submitted": "2023-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Sexual health is one the important components of life quality. The aim of this study is to compare sexual dysfunction of women who survived Covid-19 and who didn't undergo Covid-19.
Detailed Description
With identifying a new type of coronavirus, the infection disease known as Coronavirus disease-2019 (Covid-19) is still effective worldwide. Within the frame of the description that the health is 'a complete physical, mental and social welfare,' many physical and mental modality may be expected due to the pandemic and the measures against pandemic. Among them, sexual health is one of the basic indicative factors of human welfare. There are few data on sexual dysfunctions from the previous clinic pandemic experiences. From the very early stages of Covid-19 pandemic, health systems and researches focused on mortalities and short-term morbidities. Although there are similar studies about effects of pandemic on sexual behaviors of general community, there is no comparative study about the effects on sexual functions of women survived from Covid-19 and women having no Covid-19 history, yet. This study aims to compare women survived from Covid-19 and women having no Covid-19 history and having similar characteristics in terms of sexual dysfunctions.
#Intervention
- BEHAVIORAL : Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
- sexual dysfunction assesment
|
#Eligibility Criteria:
Inclusion Criteria:
* previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
* being sexually active
Exclusion Criteria:
* having psychiatric disease
* having any malignity
* having endometriosis
* having a gynecologic surgery history
* having a previous sexual dysfunction
Sex :
FEMALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05018065
|
{
"brief_title": "Sexual Functions and Covid-19",
"conditions": [
"Covid19",
"Sexual Behavior"
],
"interventions": [
"Behavioral: Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05018065",
"official_title": "Evaluation of Women's Sexual Functions After Having Covid-19",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-01",
"study_completion_date(actual)": "2020-12-30",
"study_start_date(actual)": "2020-05-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-27",
"last_updated_that_met_qc_criteria": "2021-08-23",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-24",
"first_submitted": "2021-08-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the feasibility of a smartphone-based measurement on badminton footwork. The performance of footwork will be collected utilizing a smartphone app and further investigate the validity, reliability and discrimination of the measurement.
#Intervention
- OTHER : footwork
- six-point footwork
|
#Eligibility Criteria:
Inclusion Criteria:
* adults familiar with badminton six points foot work.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04546139
|
{
"brief_title": "Feasibility of Smartphone-based Measurement on Badminton Footwork",
"conditions": [
"Sports Physical Therapy"
],
"interventions": [
"Other: footwork"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT04546139",
"official_title": "Feasibility of Smartphone-based Measurement on Badminton Footwork",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-15",
"study_completion_date(actual)": "2021-10-15",
"study_start_date(actual)": "2020-08-01"
},
"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)": "2022-09-14",
"last_updated_that_met_qc_criteria": "2020-09-04",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-11",
"first_submitted": "2020-08-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP) antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a higher rate of erosion and a higher risk of progressive and severe RA.
The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more effective.
The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial studies from patients with early arthritis suggest that UA and RA may share common immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early arthritis demonstrates synovitis in more than half of the joints samples with prominent T cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).
Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence the clinical outcome.
Recently, Methotrexate has been demonstrated to improve the course of undifferentiated arthritis and prevent the development of RA. Short regimen of more intensive therapy with Infliximab could alter the radiological, immunopathological and clinical outcome.
Detailed Description
not necessary
#Intervention
- DRUG : Infliximab
- Infliximab 3 mg/kg wk 0,2,6
- Other Names :
- FR-BR7794
- DRUG : sodium chloride
- Group II : Placebo wk 0,2,6
|
#Eligibility Criteria:
Inclusion Criteria:
Diagnosis of UA Absence of American College of Rheumatology (ACR) criteria Active UA defined by a swollen joint count >= 1 and < 4 Positive anti-CCP Disease duration < 2 years DMARDs naive No chronic treatment with steroids (> 3 months), if needed washout of 4 weeks NSAIDs stable
Exclusion Criteria:
Other rheumatic inflammatory diagnosis Contraindication to MRI (pace-maker, etc.) Congestive heart disease Active or latent tuberculosis
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01245361
|
{
"brief_title": "A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit",
"conditions": [
"Undifferentiated Arthritis"
],
"interventions": [
"Drug: sodium chloride",
"Drug: Infliximab"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01245361",
"official_title": "A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001'.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2007-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-10-31",
"last_updated_that_met_qc_criteria": "2010-11-19",
"last_verified": "2013-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-22",
"first_submitted": "2010-11-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.
Detailed Description
A previous animal study has indicated that rice bran extract provided inhibition of MAO-B enzyme activity and ROS formation in a corticosterone-induced depression-like animal model. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. The Investigators examine the Korean version of the Hamilton Depression Rating Scale, the Korean Version of the Beck-II Depression Inventory, the Korean version of the Patient Health Questionnaire-9, the Perceived Stress Scale, the Korean version of the Beck Anxiety Inventory and biomarkers at baseline and after 8 weeks of intervention. One hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.
#Intervention
- DIETARY_SUPPLEMENT : Rice bran extract group
- Rice bran extract 1,000 mg/day for 8 weeks
- DIETARY_SUPPLEMENT : Control group
- Placebo 1,000 mg/day for 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* the Korean version of the Hamilton Depression Rating Scale score between 7 <= age <= 24
Exclusion Criteria:
* No depressive symptom (K-HRSD <= 6) or severely depressed (K-HRSD >= 25)
* Those are taking hormone therapy such as estrogen within the past 6 months
* Those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.)
* Those with a history of treatment for depression
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
* Uncontrolled hypertension (>160/100 mmHg)
* Uncontrolled thyroid diseases.
* Those who are taking drugs, functional foods, herbs, etc. that may affect depression
* Alcohol abuser
* Allergic reaction to this test food
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05180136
|
{
"brief_title": "Efficacy of Rice Bran Extract in Mildly to Moderately Depressed Adults",
"conditions": [
"Depression"
],
"interventions": [
"Dietary Supplement: Rice bran extract group",
"Dietary Supplement: Control group"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05180136",
"official_title": "Efficacy and Tolerability of Rice Bran Extract in Mildly to Moderately Depressed Patients: a Double-blind, Randomized, Placebo-controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-30",
"study_completion_date(actual)": "2022-12-31",
"study_start_date(actual)": "2022-01-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-02",
"last_updated_that_met_qc_criteria": "2021-12-17",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-06",
"first_submitted": "2021-12-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The GLEAM study aims at assessing the potential of electrical impedance tomography (EIT) for noninvasive glucose measurement.
Detailed Description
Within the GLEAM study, paired samples of EIT and blood glucose measurements will be collected in individuals with type 1 diabetes during standardized euglycemia, hypoglycemia and hyperglycemia. These samples will be used to assess the potential of EIT for noninvasive glucose measurement and/or dysglycemia detection.
#Intervention
- OTHER : Controlled euglycemia, hypoglycemia and hyperglycemia
- EIT measurements are collected in different glycemic states (euglycemia, hypoglycemia and hyperglycemia). Venous blood glucose is measured using a gold-standard glucose analyzer.
|
#Eligibility Criteria:
Inclusion Criteria:
* Written, informed consent
* Type 1 Diabetes mellitus as defined by WHO for at least 6 months
* Aged 18 - 60 years
* HbA1c <= 9.0 %
* Insulin treatment with good knowledge of insulin self-management
* Use of a continuous (CGM) or flash glucose monitoring system (FGM)
* Native language German or Swiss German
Exclusion Criteria:
* Incapacity to give informed consent
* Contraindications to insulin aspart (NovoRapid®)
* Known allergies to adhesives of the EIT device (e.g., gel electrodes)
* Pregnancy, breast-feeding or lack of safe contraception
* Active heart, lung, liver, gastrointestinal, renal or psychiatric disease
* Patients with implantable electronic devices (e.g., pacemaker or implantable cardioverter defibrillator (ICD)) or thoracic metal implants
* Epilepsy or history of seizure
* Active drug or alcohol abuse
* Chronic neurological or ear-nose-and-throat (ENT) disease influencing voice or history of voice disorder
* Thoracic or back deformities
* Body mass index (BMI) >35.0 kg/m2
* Open wounds, burns, or rashes on the upper thorax
* Active smoking
* Medication known to interfere with voice or to induce listlessness (e.g., opioids, benzodiazepines, etc.)
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
|
NCT06223204
|
{
"brief_title": "GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Other: Controlled euglycemia, hypoglycemia and hyperglycemia"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT06223204",
"official_title": "GLEAM: Noninvasive Glucose Measurement Using Impedance Tomography - a Pilot Project",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-10",
"study_completion_date(actual)": "2024-04-10",
"study_start_date(actual)": "2024-01-31"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-02",
"last_updated_that_met_qc_criteria": "2024-01-15",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-25",
"first_submitted": "2023-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.
Detailed Description
The aim of this study is to determine if the Sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.
#Intervention
- DEVICE : Sharklet Catheter insertion
- DEVICE : Silicone Foley Catheter insertion
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient requires a chronic indwelling Foley catheter for at least 3 days.
* Catheters will not remain indwelling greater than 30 days at a time
* Patient is more than 18 years
* Patient is able to give informed consent
* Patient is able to attend follow-up sessions
Exclusion Criteria:
* Patient is less than 18 years
* Patient is pregnant
* Patient with a known allergy to silicone
* Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
* Patient unable to accommodate the catheter
* Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated.
* Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
* Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
* Patient is unable to feel and/or communicate their symptoms
* Informed consent is unable to be obtained
* Patient is unable or unwilling to comply with the study follow-up schedule
* Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
* Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02835456
|
{
"brief_title": "Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?",
"conditions": [
"Catheter Associated Urinary Tract Infections"
],
"interventions": [
"Device: Silicone Foley Catheter insertion",
"Device: Sharklet Catheter insertion"
],
"location_countries": [
"Hungary"
],
"nct_id": "NCT02835456",
"official_title": "Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2016-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-04",
"last_updated_that_met_qc_criteria": "2016-07-15",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-18",
"first_submitted": "2016-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was planned as a randomized controlled double-blind experimental study to examine the effect of aromatherapy on newborn pain, stress and behaviors. The main questions it aims to answer are:
* Lavender oil massage applied to newborns has an effect on pain, stress and behavior of newborns.
* Lavender oil bath applied to newborns has an effect on pain, stress and behavior of newborns.
* There is a difference between lavender oil massage and lavender oil bath applications applied to newborns in reducing the pain and stress level of the newborn and regulating their behavior.
Randomization method will be used in the determination of the study groups (Lavender massage, lavender bath and control group), and the study group to which the newborns will be included will be determined in the computer environment. Gender, gestational age, postnatal age and body weight will be considered as matching criteria for newborns included in lavender massage, lavender bath and control groups. For ALPS-Neo and ABSS evaluations, 10 minutes (20 minutes in total) of newborns will be recorded with a video camera before and after the study.
Detailed Description
Newborns have to receive treatment and care for a long time in the neonatal unit. Newborns admitted to neonatal intensive care units (NICUs) have to cope with stressors such as numerous environmental stimuli (bright light, loud noise, frequent touch, etc.) and repetitive painful interventions when they are not developmentally ready. A care environment devoid of parental contact and stimuli, disturbing the newborn, and encountering stress and excessive stimuli negatively affects the delicate physical condition and immature organ systems of the newborn, and physiological and behavioral stress symptoms can be observed. However, in neonatal units; It is known that there may be many undesirable stimuli such as excessive noise, light, and intense activity in the unit, as well as situations where sensory stimuli such as monotonous sounds, inactivity, and silence from some medical equipment are rare. In these cases, sensory deprivation or sensory overload problems may develop as a result of the decrease or increase in the quality and quantity of sensory stimuli . Precautions should be taken to prevent these problems from occurring. Complementary care practices such as aromatherapy can be used to reduce sensory stimulus problems and stress.
Aromatherapy, which is the most widely used in complementary care applications; It is defined as the use of essential oils obtained from flowers, plants and trees to increase health and well-being. Essential oils can be administered orally, by touch, and by inhalation. The aim of aromatherapy by touch (massage, bath, compress) is to benefit from the anti-inflammatory, antispasmadic, antiviral, antifungal and antibacterial effects of essential oils and to allow the muscles to return to a resting tone. Since the sense of touch is developed in newborn babies at birth, the application of aromatic oils with the sense of touch is important in reducing the stress of the baby in the first days of his life.
Among the essential oils used in aromatherapy, the most studied fragrance is lavender. Lavender generally has antiseptic, anti-inflammatory, pain-relieving, relaxing and sleep-inhibiting effects. In line with this information, it is aimed to examine the effect of aromatherapy on the pain, stress and behavior of newborns.
#Intervention
- OTHER : Lavender application
- Lavender application
|
#Eligibility Criteria:
Inclusion Criteria:
* Postnatal age of 1 <= age <= 5 days,
* Gestational age is 38 <= age <= 42 weeks,
* Tolerant of enterally given food (without NEC, digestive system and chromosomal abnormalities),
* Not connected to respiratory support device,
* No skin disease,
* No surgical intervention,
* Newborns with written consent from at least one of the parents will be included in the study.
Exclusion Criteria:
* Findings such as tachypnea, fever
* Newborns with Rh and AB0 incompatibility
* Newborns undergoing surgical intervention
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 5 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05770999
|
{
"brief_title": "The Effect of Aromatherapy Application on Pain, Stress and Behaviors of the Newborn",
"conditions": [
"Newborn, Infant, Disease"
],
"interventions": [
"Other: Lavender application"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05770999",
"official_title": "The Effect of Aromatherapy Application on Pain, Stress and Behaviors of the Newborn",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-20",
"study_completion_date(actual)": "2022-10-20",
"study_start_date(actual)": "2022-05-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-13",
"last_updated_that_met_qc_criteria": "2023-03-04",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-03-16",
"first_submitted": "2022-10-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Randomisation between postoperative administration of an ACE-inhibitor or not.
Detailed Description
Children that are undergoing elective surgery for the creation of a Fontan circulation will be randomised to postoperative administration of an ACE-inhibitor or not.
Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days postoperatively.
#Intervention
- DRUG : Administration of an ACE-inhibitor or not
|
#Eligibility Criteria:
Inclusion Criteria:
* All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation
* Parents have agreed with the study after informed consent
Exclusion Criteria:
* Urgent / Emergent surgery
* Preoperative use of an ACE-inhibitor
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00263406
|
{
"brief_title": "Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation",
"conditions": [
"Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation"
],
"interventions": null,
"location_countries": [
"Belgium"
],
"nct_id": "NCT00263406",
"official_title": "Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2002-12"
},
"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)": "2007-12-28",
"last_updated_that_met_qc_criteria": "2005-12-06",
"last_verified": "2007-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-08",
"first_submitted": "2005-12-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group.
Detailed Description
Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of this injury and the often residual symptoms, there is a large variety in diagnostic approach and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a challenge to minimize injury consequences on short and long term.
In this study we investigate the immediate effect of two therapeutic techniques: fascia therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint position sense are measured before and after treatment.
The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.
#Intervention
- OTHER : fascia therapy or transcutaneous fibrolysis
- fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion
|
#Eligibility Criteria:
Inclusion Criteria:
* acute ankle sprain
Exclusion Criteria:
* none
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
|
NCT01249573
|
{
"brief_title": "The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain",
"conditions": [
"Acute Ankle Distortion"
],
"interventions": [
"Other: fascia therapy or transcutaneous fibrolysis"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01249573",
"official_title": "The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain in Young Adults.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-03",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-10",
"last_updated_that_met_qc_criteria": "2010-11-25",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-30",
"first_submitted": "2010-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the safety evaluation, efficacy evaluation, long-term aesthetics and psychological satisfaction of single-port and multiport laparoscopy for children and adolescents with BOT in China.
#Intervention
- PROCEDURE : single-port laparoscopy surgery
- The two groups underwent different surgical procedures.
- PROCEDURE : multiport laparoscopy surgery
- The two groups underwent different surgical procedures.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients <=18 years
* Postoperative pathological diagnosis confirmed benign ovarian tumor
* Multi-hole laparoscopic or single-hole laparoscopic surgery
* Medical records and pathological data were complete and available
Exclusion Criteria:
* Patients with malignant pathological diagnosis
* Patients undergoing open surgery
* Incomplete medical records or pathological data
Sex :
FEMALE
Ages :
- Minimum Age : 1 Year
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06201221
|
{
"brief_title": "Single-port Laparoscopy in Children and Adolescents",
"conditions": [
"Benign Ovarian Tumors"
],
"interventions": [
"Procedure: single-port laparoscopy surgery",
"Procedure: multiport laparoscopy surgery"
],
"location_countries": [
"China"
],
"nct_id": "NCT06201221",
"official_title": "Advantages of Single-port Laparoscopy in the Treatment of Benign Ovarian Tumors in Children and Adolescents: A Multicenter Retrospective Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-01",
"study_completion_date(actual)": "2023-12-01",
"study_start_date(actual)": "2019-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-11",
"last_updated_that_met_qc_criteria": "2023-12-29",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-11",
"first_submitted": "2023-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
#Intervention
- DRUG : Zevalin (SH L 749 , BAY86-5128)
- 0,3mCi/kg
- DRUG : Zevalin (SH L 749 , BAY86-5128)
- 0,4mCi/kg
|
#Eligibility Criteria:
Inclusion Criteria:
* Platelet counts of >= 100,000/mm3
* Absolute neutrophil counts of >= 1,200/mm3
* Bone marrow involvement < 25%
Exclusion Criteria:
* Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc.
* Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy)
* Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction
* Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00220285
|
{
"brief_title": "Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma",
"conditions": [
"Non-Hodgkin's Lymphoma",
"Lymphoma, B-Cell",
"Lymphoma, Low-Grade"
],
"interventions": [
"Drug: Zevalin (SH L 749 , BAY86-5128)"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00220285",
"official_title": "A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-10",
"study_start_date(actual)": "2004-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-30",
"last_updated_that_met_qc_criteria": "2005-09-21",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-22",
"first_submitted": "2005-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This experimental study will compare impact forces and metabolic cost in runners (N=20; ages 18-45 years, who already use a forefoot strike running gait) in two treadmill running test sessions (shod vs barefoot running)
Detailed Description
Specific Aim 1: To identify if differences in metabolic cost exist between barefoot versus cushioned shod FM strikers during an acute bout of running exercise. Hypothesis: The metabolic cost will be higher in the cushioned shod runners with forefoot and midfoot strike compared to the barefoot runners.
Specific Aim 2: To identify if differences in peak impact forces exist between barefoot versus cushioned shod runners in forefoot-midfoot (FM) strikers.
Hypothesis: Peak impact forces will be higher in the barefoot runners with a forefoot and midfoot striking running style compared to the cushioned shod runners with a forefoot and midfoot striking running style.
#Intervention
- OTHER : running with normal running shoes and barefoot
- shod condition: normal running shoes barefoot condition: running with no shoewear
|
#Eligibility Criteria:
Inclusion Criteria:
* trained runners with a running foot striking style of either initial forefoot or midfoot strike.
* run on average at least 20 miles/week
* be able to run for at least 20 minutes at one session
* free of any orthopedic limitation
Exclusion Criteria:
* history of lower extremity injury within the last 6 months prior to testing
* rear-foot strike running style
* does not run in a cushioned shoe on any occasion
* runs on average < 20 miles/week
* unable to run for 20 minutes or greater
* presence of any open wound or deformity on the feet which would prevent participant from running barefoot
* neurologic injury that would preclude normal running activity.
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
|
NCT01536171
|
{
"brief_title": "Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners",
"conditions": [
"Healthy"
],
"interventions": [
"Other: running with normal running shoes and barefoot"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01536171",
"official_title": "Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-07",
"study_completion_date(actual)": "2012-07",
"study_start_date(actual)": "2011-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-04-21",
"last_updated_that_met_qc_criteria": "2012-02-15",
"last_verified": "2014-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-20",
"first_submitted": "2011-11-02",
"first_submitted_that_met_qc_criteria": "2014-03-17"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. The 650 participants will be divided into the following age groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents 10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each age level. Study procedures include: medical history, targeted physical exam based on history, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.
Detailed Description
Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Data from several cohorts in different age groups that received licensed trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to provide protection against the new virus. In addition, adults are more likely to have measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody than are children. These data indicate the need to develop vaccines against the new H1N1 strain and suggest that different vaccine strategies (e.g., number of doses, need for adjuvant) may be appropriate for persons in different age groups. If the novel influenza H1N1 2009 virus continues to circulate, it is possible that it will co-circulate with the non-pandemic seasonal influenza strains. In this situation, it might be beneficial to co-administer an H1N1 vaccine concurrent with the seasonal inactivated influenza vaccine. This protocol will explore if vaccination with the 2009-2010 licensed seasonal trivalent influenza vaccine (TIV) has an effect on antibody response to the novel influenza H1N1 2009 virus. This protocol will also examine if receiving the H1N1 vaccine either concurrent with, prior to, or following the seasonal influenza vaccine affects the antibody response to the seasonal influenza vaccine. A randomized Phase II study in infants, toddlers, children and adolescents. This study is designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine when given concurrent with seasonal TIV, or sequentially with (before or after) seasonal influenza vaccine. Primary objectives are: safety, to assess the safety of the unadjuvanted, inactivated H1N1 vaccine when administered either concurrent with, prior to, or following licensed seasonal influenza vaccination; and immunogenicity, to assess the effect of TIV administration on antibody response to unadjuvanted, inactivated H1N1 vaccine as assessed by HAI, stratified by age of recipient. The secondary objective is: immunogenicity, to assess the effect of H1N1 vaccine administration on antibody response to TIV as assessed by HAI, stratified by age of recipient. Subjects will be randomized into 4 groups, stratified by age (150 subjects per group with 50 subjects per age stratum: greater than or equal to 6-\<36 months, greater than or equal to 36 months-9 years, and 10-17 years), to receive two 15 mcg doses of inactivated influenza H1N1 vaccine at Days 0 and 21 followed by TIV on Day 42 (Group 1), two 15 mcg doses of H1N1 vaccine of which the first dose is administered concurrently with TIV (Group 2), two 15 mcg doses of H1N1 vaccine of which the second dose is administered concurrently with TIV (Group 3), or TIV administered on Day 0 followed by two 15 mcg doses of H1N1 vaccine on Days 21 and 42 (Group 4). Following immunization, safety will be measured by assessment of adverse events for 21 days following the last vaccination (Day 42 for those who do not receive the second dose), serious adverse events and new-onset chronic medical conditions for 8 months post first vaccination (Day 201 for Groups 2 and 3 or Day 222 for Groups 1 and 4), and reactogenicity to the vaccines for 8 days following each vaccination (Day 0-7). Immunogenicity testing will include HAI and neutralizing antibody testing prior to vaccination, on the day of each vaccination (Days 0, 21 and 42) and 21 days following the third vaccine.
#Intervention
- BIOLOGICAL : Inactivated H1N1 Vaccine
- Inactivated influenza H1N1 vaccine, 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm or in the anterolateral thigh muscle (1 injection in each arm or each thigh if receiving 2 doses).
- BIOLOGICAL : Trivalent Inactivated Influenza Vaccine
- Licensed seasonal trivalent influenza vaccine (TIV) (2009-2010 season). For subjects greater than or equal to 6 - \<36 months, licensed TIV will be administered as a single 0.25 mL intramuscular (IM) injection in the deltoid muscle of the arm or in the anterolateral thigh muscle. For subjects greater than or equal to 36 months - 17 years, licensed TIV will be administered as a single 0.5 mL IM injection in the deltoid muscle of the arm or in the anterolateral thigh muscle.
|
#Eligibility Criteria:
Inclusion Criteria:
* Are males or non-pregnant females aged 6 months to 17 years, inclusive.
* All subjects 6 months to 9 years must be 'primed'.
* Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
* The subject must be in good health, as determined by axillary (<10 years) or oral temperature (axillary temperature <100 degrees Fahrenheit or oral temperature <101 degrees Fahrenheit), medical history, and targeted physical examination based on medical history.
* Subject and/or parent(s)/legal guardian(s) must be willing and able to comply with planned study procedures and be available for all study visits.
* Subject and/or parent(s)/legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.
Exclusion Criteria:
* Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal and chicken protein).
* Have a positive urine or serum pregnancy test within 24 hours prior to vaccination or are breastfeeding.
* Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
* Have an active neoplastic disease or a history of any hematologic malignancy.
* Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
* Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis or major depression.
* Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others.
* Are receiving any psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate) or any drugs for treatment of depression.
* Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
* Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during the study period (prior to Day 180 after the last vaccination).
* Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the last vaccination. This is inclusive of routine childhood immunizations provided outside the scope of this study. The initiation of this protocol does not take precedence over routine immunizations.
* Has received a licensed 2009 <= age <= 2010 seasonal influenza vaccine.
* Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses.
* Have a history of severe reactions following previous immunization with influenza virus vaccines.
* Have an acute illness, including an axillary temperature greater than 100 degrees Fahrenheit or an oral temperature greater than or equal to 101 degrees Fahrenheit, within 3 days prior to vaccination.
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
* Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have a history of novel influenza H1N1 2009 infection prior to enrollment.
* Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
* Have a history of alcohol or drug abuse.
* Plan to travel outside of North America in the time between the first vaccination and 63 days following the first vaccination.
* Have a history of Guillain-Barré Syndrome.
* Have any condition that the investigator believes may interfere with successful completion of the study.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00943202
|
{
"brief_title": "Sanofi Pasteur, TIV + H1N1, Pediatric Population",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Inactivated H1N1 Vaccine",
"Biological: Trivalent Inactivated Influenza Vaccine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00943202",
"official_title": "Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Infants and Toddlers (Greater Than or Equal to 6 - <36 Months), Children (Greater Than or Equal to 36 Months - 9 Years), and Adolescents (10 - 17 Years)",
"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)": "2009-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-04-22",
"last_updated_that_met_qc_criteria": "2009-07-21",
"last_verified": "2010-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-22",
"first_submitted": "2009-07-21",
"first_submitted_that_met_qc_criteria": "2011-04-28"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither investigator nor participant knows the treatment that the participant receives), multicenter (study conducted at multiple sites), and placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and active comparator (an established effective treatment that is compared with a medication to test whether the medication has a real effect in a clinical study) controlled study (placebo or active comparator is compared with the study medication to test whether the study medication has a real effect in clinical study). The study consists of 4 phases: screening phase (45 days before administration of study medication); pre-dosing run-in phase (a phase before a clinical study is commenced when no treatment is given. In this study, participant's glucose level will be observed during run-in-phase: days 15 to 1 before administration of study medication); treatment phase, and follow-up phase (7 to 10 days after the last dose of the study medication). Approximately 88 participants will be enrolled in this study. All participants will be randomly assigned to 4 treatment arms: JNJ-41443532 250 mg; JNJ-41443532 1000 mg; pioglitazone arm; and placebo. Safety evaluations will include assessment of adverse events including ocular assessments, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The maximum study duration for each participant will be approximately 12 weeks.
#Intervention
- DRUG : JNJ-41443532
- Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
- DRUG : Pioglitazone 30 mg
- Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.
- DRUG : Placebo
- Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
* On a stable treatment regimen for at least 2 months prior screening
* Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
* Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
* Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
* History of other types of diabetes and complications or secondary forms of diabetes
* History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
* Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
* Clinically significant abnormal electrocardiogram
* History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
* Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01230749
|
{
"brief_title": "A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: JNJ-41443532",
"Drug: Pioglitazone 30 mg",
"Drug: Placebo"
],
"location_countries": null,
"nct_id": "NCT01230749",
"official_title": "A Double-Blind, Randomized, Placebo- and Active Comparator-Controlled, 4-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of JNJ-41443532 in Subjects With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2010-12"
},
"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)": "2013-12-11",
"last_updated_that_met_qc_criteria": "2010-10-28",
"last_verified": "2013-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-29",
"first_submitted": "2010-10-22",
"first_submitted_that_met_qc_criteria": "2013-10-17"
}
}
}
|
#Study Description
Brief Summary
This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.
Detailed Description
This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO.
Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2).
#Intervention
- COMBINATION_PRODUCT : SB11 PFS
- SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
- Other Names :
- Ranibizumab
|
#Eligibility Criteria:
Inclusion Criteria:
* Neovascular AMD or macular oedema secondary to RVO in the study eye
* Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the ophthalmologist (e.g., retina specialist)
* Aged 18 years and older at the time of signing the informed consent form (ICF)
* Written ICF must be obtained from the subject prior to any study-related procedure (if the subject cannot read ICF, an impartial witness will be present during the entire informed consent discussion)
* Willingness and ability to undertake all scheduled visits and assessments
Exclusion Criteria:
* Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse [i.e., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
* History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past ITV injections with any agent in either eye
* Active or suspected infectious disease, or active disorder that preclude safe use of IP at the discretion of the Investigator, in either eye or adnexa of either eye at Screening or at Day 1
* History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after ITV injection or intraocular procedures in either eye
* History of massive subconjunctival haemorrhages of concern reported by the subject after an ITV injection in either eye
* Uncontrolled intraocular pressure (IOP) greater than (>=) 25 mmHg in the study eye at Screening or at Day 1
* Treatment with any ITV injection within the 30 days prior to Day 1 in the study eye
* Any invasive ocular surgery including retinal detachment surgery, long-acting ocular therapeutic agent/implant including corticosteroid, or ocular drug release device implant (approved or investigational) in the study eye within 90 days prior to Day 1 or planned intraocular surgery within next 28 days after Day 1
* Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1
* Treatment with any ocular IP in either eye within 90 days prior to Day 1
* Treatment with systemic anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
* Receipt of any systemic (non-ocular) IP within 180 days prior to Day 1
* Use of therapies that are known to be toxic to ocular tissue within the 180 days prior to Day 1, including, but not limited to, deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, or ethambutol
* Known ocular or non-ocular conditions that per the ophthalmologist (e.g., retina specialist) represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk
* Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg while sitting confirmed after repeated measurement) at Screening or Day 1
* Current systemic infectious disease or therapy for active infectious disease
* Pregnant or lactating women at Screening or at Day 1
Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06176963
|
{
"brief_title": "A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO",
"conditions": [
"Neovascular Age-related Macular Degeneration",
"Macular Edema",
"Retinal Vein Occlusion"
],
"interventions": [
"Combination Product: SB11 PFS"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT06176963",
"official_title": "An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-30",
"study_completion_date(actual)": "2023-12-12",
"study_start_date(actual)": "2023-11-21"
},
"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)": "2024-12-30",
"last_updated_that_met_qc_criteria": "2023-12-11",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-12-20",
"first_submitted": "2023-12-11",
"first_submitted_that_met_qc_criteria": "2024-12-05"
}
}
}
|
#Study Description
Brief Summary
When a child is diagnosed with cancer the family's world is turned upside down. Parents have high levels of stress because they must learn important information about their child's diagnosis,medications and treatments. They must also learn how to care for their child once they have left the safety of the hospital. Parents have voiced that during this time they receive too much information, have paper overload, and hear and read different information causing them to feel confused. Parents have shared that small amounts of information that can be repeated when they want and as often as they want helps them to feel more confident to care for their child. This study will ask parents if they like and can easily learn information about how to care for their child with cancer from short videos that highlight key points, have visual cues, and provide case examples. If parents find short videos useful and helpful for learning, with the goal that they will feel more confident to care for their child and have lower levels of anxiety.
Detailed Description
A diagnosis of childhood cancer is overwhelming for both the child and family. Parents/caregivers of newly diagnosed pediatric oncology patients need specialized education to provide safe care for their child at home. Previous research and clinical experience have highlighted that current strategies are not successful. Families report challenges with paper, information overload and teaching provided at a time when they are unable to focus. They describe inconsistent messages between different providers and sources of information.Parents/caregivers have expressed that information that is concise, consistent, with visual cues, and can be repeated, positively influences their ability to understand. Poor quality of discharge teaching in pediatrics is associated with increased emergency room visits and readmissions to hospital. Predictors of readmission include medical complexity and 4 or more medications prescribed at time of discharge. Pediatric oncology patients are medically complex and at risk for significant life-threatening complications. Multiple home medications are the standard for children receiving cancer therapy. Current parent/caregiver education is often driven by checklists of content that health careproviders (HCP) believe must be delivered prior to first hospital discharge. Timing of education is planned according to HCP schedules and not consistently at a time chosen by and suitable for parents/caregivers.
Methods for providing parent/caregiver education currently include verbal discussion with HCPs and written information. Evaluation of educational video strategies in pediatric oncology has been limited to taped diagnostic discussions. It is reported that 90% of parents/caregivers of pediatric cancer patients search the internet for information. Video education developed by pediatric oncology experts has the advantage of providing consistent information, being available for repeat viewing, and available at times chosen by the parents/caregivers.
Goals and Objectives The overarching goal is to improve consistency and quality of education provided to parents/caregivers of newly diagnosed pediatric oncology patients.
Primary Objective:
To develop two short video-based education modules for parents/caregivers of children with newly diagnosed cancer which are acceptable and understandable.
Secondary Objectives:
1. To determine the feasibility of a trial of providing education in video modules as demonstrated by the ability to recruit 20 parents/caregivers of newly diagnosed children with cancer within 8 months and by having at least 90% of enrolled parents/caregivers watch the two videos and answer 10 knowledge and confidence questions
2. To obtain qualitative feedback about the videos
3. To describe change in knowledge and confidence before and after viewing the two videos
Impact and Relevance Statement This study is proposing a novel video-based education program for parents/caregivers which hypothesize will lead to improved understanding and confidence to care for their child newly diagnosed with cancer post first discharge from hospital. Learning in this fashion can be conducted at a time best suited to each individual caregiver and allow for repetition of the materials as often as desired. It ensures that different caregivers for the same child receive the same information. The greatest impact will be on the parents/caregivers with a goal to increase knowledge, preparedness and confidence and minimize distress and anxiety.
Methods:
In this pilot study the investigators plan to develop and evaluate two video modules focused on two essential 'prior-to-first-discharge' topics: the approach to fever and giving medications at home. The video modules will be short, concise and will include case-based scenarios allowing parents/caregivers to review and consolidate teaching.
The content of the videos will be developed by pediatric oncology nurses, physicians and pharmacists from across POGO centers. The review panel will consist of 8-12 HCPs with representation by discipline and center. The script will be developed in a series of teleconferences in which first the content will be developed and refined using a consensus approach. Once the content is agreed upon, a script will be developed and refined among the review panel. When finalized, the investigators will begin to test acceptability and understandability with respondents. For this phase, eligible respondents will be any parent or caregiver of a child with cancer irrespective of type or timing of diagnosis. The investigators will exclude respondents who do not understand English. The investigators will then test the script with consecutive parent/guardian respondents using one-on-one cognitive interviews. The investigators will ask the respondent to read the script and the investigators will ask them to rate acceptability and understandability on 5 Point Likert scales which the investigators have used previously for instrument development.
Using a semi-structured interview, the investigators will ask probing questions to clarify their understanding of content. A second interviewer will be present who will rate understandability on a 4 point Likert scale ranging from 1=completely incorrect to 4=completely correct. After every 5 interviews, the results will be shared with the review panel who will decide whether to modify the script. Iterations will continue until at least 4 of the last 5 respondents are correct in their interpretation, state the script is understandable and acceptable and further modifications are not required based upon qualitative comments.
The finalized scripts will be developed into short videos, less than 5 minutes in length. The videos will be tested in new groups of 5 respondents and similarly evaluated for acceptability and understandability using cognitive interviews. Respondents will be specifically asked about length and clarity of information presented.
The videos will be considered satisfactory when at least 4 of the last 5 respondents are correct in their interpretation, state the video is understandable and acceptable and further modifications are not required based upon qualitative comments.
Confidence and knowledge questions will be developed in a similar method with consensus among the Pediatric Oncology HCPs and then with parents. This will allow both clinical expert consensus and parent validation.
Next, the investigators will test the feasibility of a trial of the educational video modules by conduct of a pilot study based at SickKids. Eligible respondents will be parents or caregivers of children newly diagnosed with cancer within the past 4 weeks. The investigators will exclude parents who do not understand English. Only one parent per child will be eligible. For eligible and consenting parents/caregivers, the investigators will ask them to watch the two videos, summarize the content of the video and provide feedback similar to the development phase. The investigators will also ask them to answer the confidence survey and the knowledge questions which will measure their knowledge and confidence in different domains of fever management and medication administration. The questions will be administered before and after watching the videos.
|
#Eligibility Criteria:
Inclusion Criteria:
* for the first phase - review of script, eligible respondents will be any parent or caregiver of a child with cancer irrespective of type of timing of diagnosis.
* for the video review phase - must be a parent/caregiver of a child diagnosed with cancer in the last 8 months
Exclusion Criteria:
* must have written and spoken English
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03752801
|
{
"brief_title": "Improving Quality and Consistency in Family Education Prior to First Discharge Following Pediatric Cancer Diagnosis",
"conditions": [
"Oncology"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT03752801",
"official_title": "Improving Quality and Consistency in Family Education Prior to First Discharge Following Pediatric Cancer Diagnosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-30",
"study_completion_date(actual)": "2019-09-30",
"study_start_date(actual)": "2018-05-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-10",
"last_updated_that_met_qc_criteria": "2018-11-20",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-26",
"first_submitted": "2018-11-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
It is now estimated that the number of adults with congenital heart disease in the U.S is over 800,000. Unfortunately, these patients, in some way, have become a lost population. They have congenital abnormalities familiar to a children's hospital, yet have surpassed the age cutoff for admission.
Recently, we have developed a specialized program to care for this unique patient population. Dedicated programs such as ours hope to optimize patient care, consolidate specialized resources, provide sufficient patient numbers for training and maintain expertise and facilitate research in this unique population.
Detailed Description
In the United States, approximately 30,000 children are born with congenital heart disease every year. As technology, operative technique, and critical care medicine have improved significantly over the years, more of these children are surviving into adulthood.
Care of the congenital cardiac surgical patient requires a concerted effort on the part of the surgeons, perfusionists, anesthesiologists, intensivists, nurses, respiratory therapists, rehabilitation services and social workers. It is hoped that the same excellent care received in a children's congenital heart surgery program can be continued as these patients graduate into an adult program.
This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University between January 1, 2000 and December 31, 2006. We will review approximately 225 charts for this study.
The first aim of the study would be to examine the demographics of the adult congenital heart surgery program itself. The following information will be collected:
* Location of the surgery - children's hospital vs adult hospital
* Surgeon - adult cardiac surgeon vs congenital cardiac surgeon
The second aim of the study would be to analyze the types of surgeries being performed. The following information will be collected:
* Pathologic diagnosis
* Number of re-operative sternotomies
* Number of open-heart surgeries
The third aim of the study would be to analyze our outcomes. The following information will be collected:
- Number of surgical mortalities
|
#Eligibility Criteria:
Inclusion Criteria:
* surgery at Children's Healthcare of Atlanta or Emory University between 1.1.2000 and 12.31.2007
* surgery on patients after 18 years to approximately 65 years
Exclusion Criteria:
* Those who do not meet inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00446160
|
{
"brief_title": "Adult Congenital Heart Disease Surgery",
"conditions": [
"Congenital Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00446160",
"official_title": "Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07-01",
"study_completion_date(actual)": "2016-07-01",
"study_start_date(actual)": "2000-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-21",
"last_updated_that_met_qc_criteria": "2007-03-09",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-03-12",
"first_submitted": "2007-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.
#Intervention
- DRUG : THR-687 dose level 1
- single intravitreal injection of THR-687 dose level 1
- DRUG : THR-687 dose level 2
- single intravitreal injection of THR-687 dose level 2
- DRUG : THR-687 dose level 3
- single intravitreal injection of THR-687 dose level 3
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female aged >= 18 years
* Type 1 or type 2 Diabetes Mellitus
* Central-involved DME with central subfield thickness of >= 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or >= 305µm on non-Spectralis SD-OCT, in the study eye
* Best-corrected visual acuity (BCVA) <= 62 and >= 23 ETDRS letter score in the study eye
* Written informed consent obtained from the subject prior to screening procedures
Exclusion Criteria:
* Macular edema due to causes other than DME
* Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
* Previous confounding treatments / procedures, or expected to require confounding treatments / procedures at any time during the study period
* Presence of neovascularization at the disc (NVD) in the study eye
* Uncontrolled glaucoma in the study eye
* Any active ocular / intra-ocular infection or inflammation in either eye
* Poorly controlled Diabetes Mellitus
* Uncontrolled hypertension
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
|
NCT03666923
|
{
"brief_title": "A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)",
"conditions": [
"Diabetes Mellitus",
"Diabetic Retinopathy",
"Diabetic Macular Edema"
],
"interventions": [
"Drug: THR-687 dose level 3",
"Drug: THR-687 dose level 2",
"Drug: THR-687 dose level 1"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03666923",
"official_title": "A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-687 for the Treatment of Diabetic Macular Edema (DME)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-20",
"study_completion_date(actual)": "2019-11-20",
"study_start_date(actual)": "2018-09-17"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-22",
"last_updated_that_met_qc_criteria": "2018-09-07",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-12",
"first_submitted": "2018-09-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.
|
#Eligibility Criteria:
Inclusion Criteria:
* Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure >140 or diastolic >90 mmHg + day-time systolic blood pressure >135 or day-time diastolic blood pressure >85 mmHg)
* Metabolic syndrome (ATP III criteria)
Exclusion Criteria:
* Secondary arterial hypertension
* Severe liver or kidney disease
* Immunological disease
* Cardiac arrhythmias
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01541566
|
{
"brief_title": "Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring and Assessment of Psychological Determinants",
"conditions": [
"Arterial Hypertension",
"Metabolic Syndrome"
],
"interventions": null,
"location_countries": [
"Italy"
],
"nct_id": "NCT01541566",
"official_title": "Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2007-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-26",
"last_updated_that_met_qc_criteria": "2012-02-29",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-03-01",
"first_submitted": "2012-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
Detailed Description
This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.
#Intervention
- DRUG : Betamethasone - ACTIVE
- antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
- Other Names :
- antenatal corticosteroid, dexamethasone
- OTHER : Normal Saline - PLACEBO
- normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
- Other Names :
- NS
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants age >= 18 years
* 24w0d to 32w6d weeks gestation
* Singleton pregnancy
* Received first course of ACS at or prior to 31w6d gestation
* Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization
* Expectant management planned
* Premature Ruptured membranes (PROM) before onset of labor
Exclusion Criteria:
* Known major fetal anomalies
* Multiple gestation
* Not a candidate for expectant management
* Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9
* Already receiving corticosteroids for another condition
* Any contraindications to the maternal use of corticosteroids
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02469519
|
{
"brief_title": "Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes",
"conditions": [
"Premature Birth"
],
"interventions": [
"Drug: Betamethasone - ACTIVE",
"Other: Normal Saline - PLACEBO"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02469519",
"official_title": "A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-15",
"study_completion_date(actual)": "2022-10-31",
"study_start_date(actual)": "2016-03-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-15",
"last_updated_that_met_qc_criteria": "2015-06-08",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-11",
"first_submitted": "2015-06-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.
#Intervention
- DEVICE : Intra-bronchial valve (Spiration IBV)
- Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
- Other Names :
- Spiration IBV
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 80 years
* Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
* Moderate to severe airflow obstruction FEV1 <50% Predicted
* Severe dyspnoea - mMRC >=2
* Hyperinflation - total lung capacity (TLC) >=100% predicted, RV >=150% predicted
* SWT >=75m
* Optimum COPD treatment for at least 6 weeks
* No COPD exacerbation for at least 6 weeks
* Less than 4 admissions for exacerbation in the preceding 12 months
Exclusion Criteria:
* Patient unable to provide informed consent
* Patient without clear targets for airflow re-distribution
* Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
* pO2 on air <6.0kPa
* pCO2 on air >8.0kPa
* Neurological, rheumatological or other cause of exercise limitation
* Other major medical illness, e.g. lung cancer that will limit participation
* Production of purulent sputum more often than not (more than 50% of days)
* Clinically significant bronchiectasis
* Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
* Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise
* Prednisolone dose greater than 15mg a day
* Significant pulmonary hypertension - RVSP >=45mmHg
* Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23%
* Prior LVRS or lobectomy
* Lung nodule requiring surgery
* Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
* Female of childbearing age with positive pregnancy test
* Subject participated in a research study of investigational drug or device in prior 30 days
* Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
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
|
NCT00825578
|
{
"brief_title": "Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema",
"conditions": [
"Heterogeneous Emphysema"
],
"interventions": [
"Device: Intra-bronchial valve (Spiration IBV)"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00825578",
"official_title": "Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-06",
"last_updated_that_met_qc_criteria": "2009-01-20",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-01-21",
"first_submitted": "2009-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Space flight simulation study to study effects of microgravity through bedrest coupled with flight exercise counter-measures.
Detailed Description
Flight Analogs/Bed Rest Research Project (FA/BRRP) provides NASA with a ground-based research platform to complement space research. By mimicking on Earth the conditions of weightlessness experienced by the human body in space, NASA can test and refine scientific theories and procedures to develop countermeasures to protect humans from the effects of the space travel. The use of ground analogs, such as bed rest, are essential because access to the resources required to conduct studies in space is very limited, and the expense of studies significantly greater than those conducted using flight analogs. Future space exploration will challenge NASA to answer many critical questions about how humans can live and work for extended missions away from Earth.
Flight analog testing is critical to NASA to validate countermeasures, given the few opportunities to use flight platforms as the Shuttle retires; also, the US has only 1-2 International Space Station (ISS) crewmembers per Expedition. The Flight Analogs/Bed Rest Research Project is one way NASA will devise ways to ensure astronaut safety and productivity on extended missions to the moon and Mars.
In the Flight Analogs Project (FAP), volunteers spend many days in a controlled research environment in the Flight Analog Research Unit (FARU) in Galveston, TX. In the current campaigns, volunteers will undergo three phases in the bedrest projects: 1) pre-bedrest baseline testing, 2) a bedrest phase, and 3) the recovery period. Bed rest results in many physiologic changes similar to those seen in astronauts. Pre bed rest is used to gather baseline data against which the bed-rest phase data will be compared. Researchers then monitor how the volunteers' bodies change over the course of the study and how quickly they recover once they are allowed to resume normal activities. Post bed rest is used to monitor recovery from bed rest. In longer campaigns, return to the unit for follow-up testing may be requested after 1, 3, 6, and/or 12 months.
THE COUNTERMEASURE AND FUNCTIONAL TESTING STUDY (CFT) will test the effectiveness of exercise on loss of muscle, bone and cardiovascular function. Participants will perform an exercise program in a system called the standalone Zero Gravity Locomotion Simulator (sZLS), a 'vertical treadmill' that removes the weight from the long axis of the body to simulate exercise as it is done in space. Resistance (weight lifting) exercise will be performed on special weight machines. Before and after 70 days of bedrest, participants will be tested on a corresponding set of physiological measures. Specific exercises and intensities are rotated such that each workout is different, with some days being heavier and some lighter. Results of the study will help understand which mission tasks might be affected by changes in physiology during space flight and design countermeasures to prevent or minimize impairment to these physiological systems
The ALTERNATE COMPRESSION GARMENT STUDY (ACG) will determine effectiveness of compression garments on regulating blood pressure and other body systems after extended periods of head-down bed rest. Participants in the experimental group will wear custom-fit compression garments and undergo evaluation on their response to an upright tilt test and a corresponding set of physiological measures before and after 14 days of bed rest. These participants will be compared to another group of participants who did not wear the compression garments. Results of the study will help scientists determine the time it takes for the cardiovascular system to re-adapt to upright posture, determine whether wearing compression garments during recovery is necessary to protect against dizziness and loss of consciousness often experienced after space missions, and determine the effect of wearing custom fit compression garments on the amount of time needed to readjust to a normal, upright posture.
|
#Eligibility Criteria:
Inclusion Criteria:
* US Citizen
* Must be able to pass physical
Exclusion Criteria:
* tobacco use
* menopausal
* prescription drug use
* food allergies
* joint injuries
* Thrombosis
* Reflux
* High blood pressure
* Diabetes
Sex :
ALL
Ages :
- Minimum Age : 24 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00891449
|
{
"brief_title": "Space Flight Simulation to Study Effects of Micro-gravity Through Bed Rest",
"conditions": [
"Weightlessness"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00891449",
"official_title": "Countermeasure and Functional Testing Study (CFT-70)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": "2014-12",
"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)": "2015-11-17",
"last_updated_that_met_qc_criteria": "2009-04-30",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-01",
"first_submitted": "2009-04-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A French, multicenter, prospective, observational, 'real life' assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms
Detailed Description
This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care.
The purpose of this study is to collect data on safety of the devices used since the French reimbursement.
130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.
#Intervention
- DEVICE : LVIS and LVIS JR
- Braided coil assist stents used for aneurysm embolization
- Other Names :
- Low Profile Visualized Intraluminal Support
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency (' Bail-out stenting ')
* Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03553771
|
{
"brief_title": "Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms",
"conditions": [
"Intracranial Aneurysm"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT03553771",
"official_title": "A French, Multicenter, Prospective, Observational, 'Real Life' Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-01",
"study_completion_date(actual)": "2021-07-01",
"study_start_date(actual)": "2018-02-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-24",
"last_updated_that_met_qc_criteria": "2018-05-30",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-12",
"first_submitted": "2018-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.
#Intervention
- OTHER : Citric Acid
- Subjects will undergo cough reflex sensitivity testing to citric acid.
|
#Eligibility Criteria:
Inclusion criteria:
* Adult patients (ages 18 <= age <= 75 years)
* Cough for more than 8 weeks
* Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
* Ability to understand the purpose and nature of the study
* Willingness to participate and provide consent form
Exclusion criteria:
* Actively smoke in the preceding 6 months.
* Recent respiratory tract infection (<4 weeks).
* Drink above the recommended safe alcohol limit (21 units per week).
* History of respiratory or gastrointestinal malignancies.
* Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
* Subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel
* Use of angiotensin converting enzyme inhibitors
* Use of H2 blockers or proton pump inhibitors in the seven days prior to reflux testing (impedance/pH), or inability to withhold such medications for the duration of the study
* Women of childbearing potential, using adequate birth control. Adequate birth control includes: (i) hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; (ii) barrier methods (such as, a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); (iii) intrauterine device (IUD); or (iv) abstinence (no sex). Adequate birth control must be maintained for the duration of the study. Women not using adequate birth control will be excluded from the study, as funding for the pregnancy tests was not included in the small grant awarded for this study.
* Nursing mothers will be excluded.
* Persons with allergies to citrus will be excluded.
* Inability to understand the purpose and nature of the study
* Unwillingness to participate and provide consent form
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
|
NCT02492126
|
{
"brief_title": "Esophageal Motility in Reflux Induced Cough",
"conditions": [
"Cough"
],
"interventions": [
"Other: Citric Acid"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02492126",
"official_title": "Chronic Cough and Reflux: Is Esophageal Motility the Key?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-06",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-30",
"last_updated_that_met_qc_criteria": "2015-07-02",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-08",
"first_submitted": "2015-07-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the efficacy and safety of the QuikClot® Radial® pad on hemostasis after transradial access (TRA), compared to the standard of care TR Band®, to hopefully develop a safe and efficacious technique to achieve more rapid patent hemostasis after TRA, and improve patient care by optimizing radial hemostasis management.
Detailed Description
The QuikClot® Radial® (QC) pad will be applied over the radial artery access site covered with either a Coban™ bandage or a Tegaderm™ dressing after TRA. Firm manual compression will then be applied over the QC pad after the sheath is removed for 5 minutes. The Coban™ cohort will then have the Coban™ bandage removed after an additional 25 minutes, then be covered with a Tegaderm™ dressing. The Tegaderm™ only cohort will be closely observed for 25 minutes after release of manual pressure. Both cohorts will remove the Tegaderm™ dressing the following morning.
Consented subjects will be randomly assigned in the cardiac cath lab upon completion of their procedure into one of the following arms:
Arm 1 - Standard of Care with a TR Band®
Arm 2 - QC pad combined with a Coban™ bandage
Arm 3 - QC pad combined with a Tegaderm™ dressing. This arm was stopped after the enrollment of 73 patients and replaced by the QC/TR Band® arm
Arm 4- QC pad was applied on the radial arterial access site with 30 minutes of compression under a TR Band® inflated with 8-10 mL of air. Then the TR Band® was removed, leaving the QC pad covered with a Tegaderm™ dressing.
#Intervention
- DEVICE : Quikclot Radial (QC) Pad
- The QC pad will be applied over the radial artery access site covered with either a Coban™ bandage, a Tegaderm™ dressing, or a TR Band after TRA.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing cardiac catheterization (CC) and/or percutaneous coronary intervention (PCI) via the radial artery as part of their standard of care treatment
* Patients able and willing to give written informed consent
* Patient > 18 years
Exclusion Criteria:
* Patients presenting with acute ST-segment elevation myocardial infarction (STEMI)
* Oral anticoagulation therapy as described below:
1. If on a DOAC (direct-acting oral anticoagulants - ie dabigatran, rivaroxaban, apixaban, edoxaban), patients will be excluded if DOAC taken within 48 hours and eGFR > 30 ml/min or DOAC taken within 72 hours and eGFR < 30 ml/min.
2. If the patient is on warfarin, excluded if INR > 1.5
* Liver Failure
* Life-threatening illness that the patient would not be expected to live more than 6 months post-procedure
* Major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but before randomization, where the operator believes participation in this trial is now inappropriate.
* Thrombocytopenia, with a platelet count of < 75,000.
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
|
NCT03535597
|
{
"brief_title": "Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access",
"conditions": [
"Coronary Artery Disease"
],
"interventions": [
"Device: Quikclot Radial (QC) Pad"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03535597",
"official_title": "A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-28",
"study_completion_date(actual)": "2022-12-28",
"study_start_date(actual)": "2018-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-24",
"last_updated_that_met_qc_criteria": "2018-05-22",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-24",
"first_submitted": "2018-05-02",
"first_submitted_that_met_qc_criteria": "2024-08-29"
}
}
}
|
#Study Description
Brief Summary
Molecular nuclear imaging in prostate cancer has made significant progress in the last few years. The introduction of tracers that target the prostate-specific membrane antigen (PSMA) has profoundly influenced imaging diagnostics in prostate cancer. In case of relapse after curative treatment (especially after radical prostatectomy), PSMA positron emission tomography (PET) has the ability to detect lesions already at very low prostate-specific antigen (PSA) levels. The improved detection of relapses increases the interest of individualized targeted therapies in patients with prostate cancer recurrence. Thus, this development led to the acceptance of PSMA PET for diagnostics in prostate cancer patients with biochemical relapses in national and international guidelines.
Detailed Description
As mentioned before, current data on salvage lymphadenectomy in prostate cancer is very limited and stems mainly from retrospective series. Prospective studies are not available. Furthermore, most of these analyses are based on choline-based positron emission tomography, which by now has been progressively replaced with the significantly more sensitive and specific PSMA-based PET. Diagnostic advantages are especially obvious in early biochemical recurrence with low PSA levels . The high specificity of a PSMA Tracer in diagnosing prostate cancer tissue is further demonstrated by the introduction of PSMA-radioguided surgery. Here, patients are injected intravenously before surgery with 111In- or 99mTc-labeled PSMA ligands in order to enhance intraoperative detection of affected lymph nodes that show radiotracer accumulation.
Regarding biomarkers used in prostate cancer, besides PSA and PSA-associated variations, there also exists a multiple number of different biomarkers. However, most of these biomarkers are used in the primary diagnostic setting or in advanced metastatic tumor stages with a castration-resistant stage. However, especially in early biochemical recurrences there is a need for biomarkers to help determine whether or not local salvage treatment can or should be considered. Circulating tumor cells (CTCs) are promising candidates as a biomarker, that could support the decision-making process. While the prognostic relevance of CTCs for patients with a metastatic castration-resistant stage prostate cancer has been shown in many studies, far less data exists for patients with hormone-sensitive metastatic prostate cancer. Regardless of the fact, survival is associated with the number of CTCs measured in peripheral blood. Recently, we were able to show that CTCs in patients with limited metastatic prostate cancer exhibited higher prognostic relevance, before and after cytoreductive radical prostatectomy, than conventional biomarkers (PSA, LDH =lactate Dehydrogenase and BAP). Even when the conventional biomarkers were combined with routine markers and CTCs, the prognostic relevance did not increase. Although the case numbers were very small, in the future, CTCs could still help identify patients that would most profit from a cytoreductive radical prostatectomy.
Therefore, this project will investigate whether or not CTCs can preoperatively provide prognostic information on the postoperative oncological response, as described in the study protocol. The plan is to withdraw blood (7,5 ml) before surgery from 150 limited metastatic prostate cancer patients. These patients have to qualify for salvage surgery according to the PSMA-PET. The blood will be examined with the Cell-Search-Systems for CTCs and their PSMA Expression.
Plasma samples and peripheral blood mononuclear cells (PBMCs) from peripheral blood will also be stored. These samples will be used later for a further project on prostate cancer-specific exosomes where PSMA positivity and cell-free circulating nucleic acids will be examined. The expertise for such analyses, standard operating procedures (SOPs) and necessary equipment are available.
Furthermore, the Institute for Tumor Biology has recently established a new blood test for detecting breast cancer. This test will also be used on prostate cancer patients within the scope of this project. This test measures the serum concentration of Cyr61-Proteins. The Institute has established an Enzyme-Linked Immunosorbent Assay (ELISA), which has already been successfully implemented for the analysis of blood plasma in 527 breast cancer patients. Consequently, this newly developed blood test presents an important improvement in the diagnosis of breast cancer (International patent System 2018/054052). It would also like to test this method for its adequacy and improvement in the diagnosis of prostate cancer within the context of this project.
Furthermore, in a subset of patients additionally tissue from metastatic lymph nodes will be collected for molecularpathologic analysis if tissue sampling does not affect routine pathological examination.
#Intervention
- OTHER : Blood sample
- Additional blood sample of about 30 ml that will be drawn for biomarker analyses (2 EDTA = ethylenediaminetetraacetic acid and 1 Cell-search-tubes).The drawn blood for CTC-Analysis and biomarker identification will be promptly processed ac-cording to the established standards at the Institute for Tumor Biology (see below).
The histological analysis of the resected tissue during salvage surgery is carried out according to clinical routine (conventional haematoxylin and eosin stained and PSMA-Immunohistochemistry). Additionally, tissue samples will undergo molecularpathological analysis if this does not affect routine pathological examination.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients in good general health and an expected life expectancy of > 10 years
* Diagnosis of prostate cancer relapse
* Evidence of positive lymph nodes or soft tissue metastases as seen in PSMA PET
Exclusion Criteria:
* Contraindication for a surgical procedure
* Clinical suspicion of systemic disease as determined by PSMA PET
* PSMA PET examination older than 4 months at time of surgery
Sex :
MALE
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
|
NCT04324983
|
{
"brief_title": "Identification of Predictive Biomarkers",
"conditions": [
"Prostate Cancer Recurrent"
],
"interventions": [
"Other: Blood sample"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04324983",
"official_title": "Identification of Predictive Biomarkers for Successful Salvage Surgeries on PSMA-PET-positive Limited Metastatic Prostate Cancer Relapses",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-05",
"study_completion_date(actual)": "2023-04-05",
"study_start_date(actual)": "2020-03-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-04-12",
"last_updated_that_met_qc_criteria": "2020-03-26",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-27",
"first_submitted": "2020-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).
#Intervention
- DRUG : LIK066
- LIK066 15 mg, 50 mg and 150 mg
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients, age 18 <= age <= 65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
* Fasting plasma glucose <=250mg/dL at screening.
* If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
Exclusion Criteria:
* Patients with type 1 diabetes mellitus.
* Patients with history of acute diabetic complications within the 6 months prior to screening.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
* Patients with signs or symptoms of significant diabetic complications.
* Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01915849
|
{
"brief_title": "Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Placebo",
"Drug: LIK066"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01915849",
"official_title": "A Randomized, Double-blinded, Placebo-controlled, Crossover Trial to Assess the Effect of Orally Administered LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-02-06",
"last_updated_that_met_qc_criteria": "2013-08-01",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-05",
"first_submitted": "2013-08-01",
"first_submitted_that_met_qc_criteria": "2015-01-22"
}
}
}
|
#Study Description
Brief Summary
This study is a randomized, double-blind clinical trial in a Chinese population.
Detailed Description
This study is a randomized, double-blind clinical trial in a Chinese population. Active drug and placebo were used as controls to observe the relative efficacy of X0002 spray.
#Intervention
- DRUG : X0002 Spray
- According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
- Other Names :
- Test drug
- DRUG : Ibuprofen Tablet
- Ibuprofen Tab 400mg, tid.
- Other Names :
- Active drug
- DRUG : Ibuprofen Placebo Tab
- Ibuprofen Placebo Tab 400mg, tid.
- Other Names :
- Placebo Oral Tablet
- DRUG : X0002 Placebo Spray
- According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
- Other Names :
- Placebo Spray
|
#Eligibility Criteria:
Inclusion Criteria:
* 1. Ability to read and provide written, personally signed, and dated informed consent to participate in the study, in accordance with the GCP and applicable regulations, before completing any study related procedures.
2. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
3. Subject must be a male or female between 40 and 75 years, inclusive.
4. Female subjects must either not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or be willing to practice at least 1 of the following medically acceptable methods of birth control: Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the subjects usual menstrual cycle period) before study drug administration.
1. Intrauterine device.
2. Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
5. Subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria, and fulfillment of at least four of the 6 criteria: age of >=50 years stiffness lasting <30 minutes after getting up in the morning crepitus Bone tenderness Bone enlargement No joint fever
6. Subject must have a history of clinically symptomatic OA of the knee for >=6 months.
7. Subject must have had knee pain while standing, walking, and/or in motion for at least 14 days during the month prior to screening.
8. Subject must have a knee pain score >=40 mm and <90 mm on a 100 mm VAS (without analgesic medication) on at least 7 of the 10 days prior to randomization(according to the subject's diary card records).
9. Subject must have a WOMAC pain average score of knee >=40 mm and <90 mm starting on the first screening visit.
10. Subject must be willing to discontinue any NSAIDs or other analgesic (e.g. aspirin) or potentially confounding concomitant treatments (e.g. physiotherapy, acupuncture) starting on the first screening visit until completing participation in the study. (The use of <=325 mg acetylsalicylic acid per day as cardiac prophylaxis is permitted.) The subject will be allowed to take rescue medication (acetaminophen) for pain during the study except during the 24 hours prior to the Second Screening Visit, Baseline (Day1), Week 2, Week 4, Week 8, Week 12, Week 14.
11. Subject must be willing to discontinue applying any topical preparations containing Vitamin A acids [including all trans-retinoic-acid (tretinoin), 13-cis-retinoic-acid (isotretinoin), 9-cis-retinoic-acid (alitretinoin), vitamin A (retinol), retinal, and their derivatives] to the lower limbs starting on the first screening visit until completing participation in the study. (Topical preparations containing Vitamin A acids or retinol may be applied to areas of the skin above the waist, but should not be applied to areas of the skin exposed to study medication.) 12. Subject must be willing to avoid unaccustomed physical activity (e.g. starting a new weight lifting routine) for the duration of the study starting on the first screening visit.
13. With the exception of OA of the knee, the subject must be in good general health with no clinically significant findings from medical history, vital signs, physical examination, ECG, and routine laboratory tests that could interfere with subject safety, or pain and functional assessments, as determined by the Investigator.
Exclusion Criteria:
* 1. The subject had a history of trauma, and the injury affected the knee joint.
2. Subject who has secondary OA of the knee or OA of lower limb joints other than the knee that in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee.
3. Subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee.
4. Subject who has had significant injury, as estimated by the Investigator, involving the target knee within the 6 months before screening.
5. Subject who has skin lesions or wounds on or near the knees to be treated at Screening or on Day 1 prior to the first administration of study medication.
6. Subject who has used opiates or corticosteroids within 30 days before screening for the target knee or who requires treatment with chronic opiates or corticosteroids.
7. Subject who has had intra articular injections of corticosteroids, hyaluronic acid, or viscosupplements (e.g. Synvisc®) to a knee to be treated within the 3 months before screening.
8. Subject who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen.
9. Subject who has had an active peptic ulceration in the 6 months prior to screening or a history of gastrointestinal (GI) bleeding within 5 years of screening.
10. Subject who has used an anticoagulant (except aspirin up to 325 mg/day for cardiac prophylaxis) in the month prior to Screening.
11. Subject who has positive results on fecal occult blood testing at screening or on Day 1 prior to the first administration of study medication.
12. Subject who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (e.g. osteonecrosis, chondrocalcinosis).
13. Subject is an asthmatic requiring treatment with systemic corticosteroids. Asthmatic subjects using inhaled corticosteroids are eligible.
14. Subject has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigators opinion, could compromise the subjects welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
15. Subject has a significant renal or hepatic disease, as indicated by clinical laboratory assessment,defined as
1. aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase>=3 × the upper limit of normal
2. creatinine >=1.5 × ULN
3. hemoglobin<10g/dL.
16. Subject has any other clinically significant laboratory finding at Screening that in the investigators opinion contraindicates study participation.
17. Subject is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding squamous or basal cell carcinoma of the skin).
18. Subject has clinically significant abnormality on 12-lead ECG, including a QTc interval >450 msecs for males and 470 msecs for females.
19. Subject has uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at baseline (may be repeated after 5 minutes rest to verify).
20. Subject is female and pregnant, planning to become pregnant during the study, or nursing.
21. Subject participated in a previous clinical study with bromine hydrochloride spray.
22. Subjects with known alcohol or other substance abuse.
23. Subject participated in any other clinical trial within the past 3 months or 5 half-lives, whichever is longer.
24. Subject is a participating Investigator, sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned.
25. Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
26. Subjects without access to telephone and/or ability to gain technology access.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03691818
|
{
"brief_title": "Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis",
"conditions": [
"KNEE OSTEOARTHRITIS"
],
"interventions": [
"Drug: Ibuprofen Placebo Tab",
"Drug: X0002 Placebo Spray",
"Drug: X0002 Spray",
"Drug: Ibuprofen Tablet"
],
"location_countries": [
"China"
],
"nct_id": "NCT03691818",
"official_title": "A Phase 2, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Initial Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-21",
"study_completion_date(actual)": "2019-10-21",
"study_start_date(actual)": "2018-07-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-13",
"last_updated_that_met_qc_criteria": "2018-09-27",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-02",
"first_submitted": "2018-09-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
More and more laparoscopic hepatectomy were performed due to increasing experience, well designed instruments and energy device. But the localization of tumor and resection line design are still relative difficult comparing open approach due to limit space. Intraoperative liver segmentation can be obtained by ultrasound-guide intraportal injection of a fluorophore and illuminating with a Near-Infrared light source for positive staining and by intravenous injection after ligation of segmental vessels for negative staining .The ultrasound guide intraportal injection approach is challenging in the minimally-invasive setting. However hepatocelluar carcinoma(HCC) was supplied by hepatic artery mainly. The investigators aimed to evaluate the feasibility of arterial base positive staining for fluorescence liver segmentation in human by superselective intra-hepatic artery injection of Indocyanine Green (ICG) .
Detailed Description
Materials and Methods
1. Participants The present prospective, single-center, feasibility study of fluorescence demarcation of hepatic segment including HCC by means of direct super-selective intrahepatic artery ICG injection. Patients were enrolled according to the following criteria: single HCC, scheduled for laparoscopic hepatectomy for curative resection, age ranging from 20 to 85 years old, absence of proven or suspected allergies to iodine or ICG, absence of coagulopathy, absence of diseases contraindicating general anesthesia, and absence of pregnancy.
All the bio-chemical test, cardiac echo , cardiac thalium test, ICG clearance test, Liver CT or MRI were obtained before operation
2. Equipment Endovascular procedure was performed in the conventional angiography room and laparoscopic hepatecotmy was done in operating room at the Kaohsiung Chang Gung memorial hospital. Near infra-red fluorescence laparoscopy was used to acquire the fluorescence signal arising from the liver parenchyma after Indocyanine Green (ICG) injection.
3. Procedures
1. Celiac trunk angiography and super-selective hepatic angiography:
A 4 Fr angiography sheath (Terumo Europe NV, Belgium) was placed under aseptic conditions in the right femoral artery, using the Seldinger technique. A 4 Fr Cobra-2 catheter (Terumo Europe NV, Belgium) was positioned at the origin of the celiac trunk. A selective celiac trunk digital subtraction angiographic (DSA) run was performed, after injection of a contrast medium (Visipaque 270, GE Healthcare; Buckinghamshire, United Kingdom), 28mL at a rate of 4mL/sec. A 2.7 French micro-catheter (Progreat™, Terumo Europe NV; Belgium) was used to super-selectively catheterize different hepatic segmental arteries supplying the target hepatic segment including HCC. In all cases, the position was controlled by performing DSA and angio computer tomography runs with selective micro-catheter injections. The micro-catheter was then perfused with saline and left in place until surgery. Then the patients were transferred to operative room while operative room available.
2. Evaluation of hepatic segmental demarcation using NIR real-time imaging during laparoscopic hepatectomy:
The patients underwent a standard 5-port laparoscopic hepatectomy, which was performed by 2 experienced laparoscopic surgeons .
Stage I : the liver mobilization was performed for preparing the hepatectomy. The intraoperative ultrasound was used for localization of HCC. The resection line was defined as principle of laparoscopic hepatectomy such as surgical margin, surgical volume and etc. The pringle control device was prepared.
Stage II : Rea-time enhanced visualization of the hepatic segment which were supplied feeding artery was achieved by means of fluorescence imaging using a direct selective intrahepatic artery injection of a 5 mL bolus of ICG (DiagnoGreen®, Taiwan, ROC) at a concentration of 0.125mg/mL. The demarcation of enhanced hepatic segment were defined. The correspondence between the fluorescence margin and ultrasound(US) guide resection line were analized.
Stage III: The surgical resection line was chose by real time clinical judgement including analysis of information of US, artery-base CT, fluorescence image, liver anatomy and patient condition. The laparoscopic hepatectomy was performed with pringle vascular control.
Stage IV: the specimen information including tumor size and margin in vitro was recoded. The distance between surgical margin and enhanced liver were measured.
#Intervention
- PROCEDURE : Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining
- The patients with single HCC which is planned to received laparoscopic hepatectomy were involved. Procedures were performed in conventional angiography room. The celiac trunk was catheterized and a microcatheter was advanced into segmental hepatic artery branches which supplied the HCC. The 5cc 0.125 mg/cc ICG was injected from super-selective hepatic artery in operative room. A Near-Infrared laparoscope was used to detect the fluorescent signal to assess the correspondence between arterial-based fluorescence demarcation and ultrasound-based surgical demarcation.
|
#Eligibility Criteria:
Inclusion Criteria:
* Single Hepatocellular carcinoma.
* plan of Laparoscopic hepatectomy.
* Age between 20 to 85 y/o.
Exclusion Criteria:
* allergies to iodine or ICG
* Liver cirrhosis
* coagulopathy
* chronic kidney disease
* pregnancy
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04266548
|
{
"brief_title": "Arterial Base Fluorescence Segmental Positive Staining",
"conditions": [
"Hepatic Carcinoma"
],
"interventions": [
"Procedure: Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT04266548",
"official_title": "Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-06",
"study_completion_date(actual)": "2020-01-06",
"study_start_date(actual)": "2018-07-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-12",
"last_updated_that_met_qc_criteria": "2020-02-10",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-12",
"first_submitted": "2020-02-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study in adults with advanced solid tumors including non-small cell lung cancer.
The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer. Such medicines are called immune checkpoint inhibitors.
The study has two parts. In the first part, doctors want to find out the highest dose of 2 medicines that people with solid tumors can tolerate. This dose is then used for the second part of the study.
In the second part, the combination of the two medicines is tested in patients with non-small cell lung cancer and other types of solid cancer. These patients had gotten treatment with anti-PD-1 or anti-PD-L1 medicines but their tumors have come back. The doctors check whether the combination of BI 754111 and BI 754091 makes tumors shrink.
Both medicines are given as an infusion into the vein every 3 weeks. If there is benefit for the patients and if they can tolerate it, the treatment is given for maximum of 1 year. During the entire study doctors will regularly check the health of the patients.
#Intervention
- DRUG : BI 754111
- Day 1 of 3 week cycle
- DRUG : BI 754091
- Day 1 of 3 week cycle
|
#Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated, written Informed consent form (ICF) prior to any trial-specific procedures, sampling, or analyses
* Patients >=18 years at the time of signature of the ICF
* Part I (dose escalation):
--Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
* For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.
* Must have measurable lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
* Previous treatment with an anti-programmed cell death 1 (receptor) (PD-1) monoclonal antibody (mAb) is allowed as long as the last administration of the anti-PD-1 mAb on the previous treatment is a minimum of 60 days prior to starting treatment in this trial.
* Part II (dose expansion):
* Patients must have measurable disease per RECIST v1.1 criteria, must have at least 1 tumour lesion amenable to biopsy, and must be medically fit and willing to undergo a biopsy before first treatment (if adequate archival tissue is not available) and, unless clinically contraindicated, after 6 weeks on therapy.
* Dose Expansion Cohorts: Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours of one of the following types:
* Second and 3rd line Non-small cell lung cancer (NSCLC) patients:
* Must have progressed on anti-PD-1 or anti-programmed cell death ligand 1 (PD-L1) treatment after having achieved radiologically confirmed benefit (minimum of stable disease)
* Must have had a minimum duration of benefit of 4 months and minimum treatment duration of 2 months on the previous anti- PD-1 or anti-PD-L1 treatment without experiencing disease progression during that period.
* The anti-PD-1- or anti-PD-L1-containing treatment must have been the latest treatment regimen prior to enrolling in this trial
* Must be within >4 and <12 weeks since the latest treatment and their first dose in this trial. Patients who have had anti-PD-1 or anti-PD-L1 monotherapy as their first-line NSCLC treatment regimen must have a PD-L1 expression level of >=1% at baseline (local validated testing).
* Anti-PD-1 or anti-PD-L1 treatment-naïve patients with microsatellite stable Metastatic colorectal Cancer (mCRC):
* Patients must have had >= 1 line treatment
* Must have microsatellite stable disease (identified using any validated test)
* Must be anti-PD-1 and anti-PD-L1 treatment naïve
* Anti-PD-1 or anti-PD-L1 pretreated patients with any high Tumour mutational burden (TMB) (>=10 mutations/Mb) and/or Microsatellite instability high (MSI-H) and/or DNA MMRd solid tumours
* Patients must have high TMB (>= 10 mutations/Mb) and/or MSI-H and/or DNA mismatch repair deficient (MMRd) (measured using any validated test).
* Patients must have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.
* 1st-line squamous or non-squamous NSCLC patients:
* Patients must be treatment naïve
* Must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type (only applicable to patients with non-squamous NSCLC)
* Regardless of PD-L1 expression level. However, the number of patients with high level of PD-L1 expression (>=50% PD-L1) will be limited to a maximum of 10 patients
* Eastern Cooperative Oncology Group (ECOG, R01 <= age <= 0787) score: 0 to 1
* Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial participation and for at least 6 months after the last administration of trial medication. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion Criteria:
* Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to first trial treatment or planned within 12 months after screening, e.g., hip replacement
* Patients who must or wish to continue the intake of restricted medications (see Section 4.2.2.2) or any drug considered likely to interfere with the safe conduct of the trial
* Previous enrolment in this trial
* Any investigational or anti-tumour treatment, except BI 754091, within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 neuropathy due to prior platinum-based therapy
* Prior treatment with anti-Lymphocyte-activation gene 3 (LAG-3) agents
* Patients with NSCLC that has EGFR mutations or ALK rearrangements (only applicable to patients with non-squamous NSCLC).
* Presence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening, with the exception of appropriately treated basal-cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment
* Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of PD by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases.
* Inadequate organ function or bone marrow reserve as demonstrated by the laboratory values presented in Table 3.3.3: 1.
* Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) >470 msec
* Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
* Patients with an ejection fraction (EF) <55% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF, will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram, multi-gated acquisition scan). A historic measurement of EF no older than 6 months prior to first administration of study drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both.
* History of pneumonitis within the last 5 years
* History of severe hypersensitivity reactions to other mAbs
* Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
* Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
* Active infection requiring systemic treatment (antibacterial, antiviral, or antifungal therapy) at start of treatment in this trial
* Known history of human immunodeficiency virus infection or an active hepatitis B or C virus infection
* Interstitial lung disease
* Chronic alcohol or drug abuse or any condition that, in the Investigator's opinion, makes him/her an unreliable trial subject, unlikely to complete the trial, or unable to comply with the protocol procedures.
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
|
NCT03156114
|
{
"brief_title": "This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.",
"conditions": [
"Neoplasms",
"Carcinoma, Non-Small-Cell Lung"
],
"interventions": [
"Drug: BI 754111",
"Drug: BI 754091"
],
"location_countries": [
"Poland",
"United States",
"Canada",
"Spain",
"United Kingdom"
],
"nct_id": "NCT03156114",
"official_title": "An Open Label, Phase I Dose-finding Study of BI 754111 in Combination With BI 754091 in Patients With Advanced Solid Cancers Followed by Expansion Cohorts at the Selected Dose of the Combination in Patients With Non-small Cell Lung Cancer and Other Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-09",
"study_completion_date(actual)": "2023-06-06",
"study_start_date(actual)": "2017-06-13"
},
"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)": "2023-06-29",
"last_updated_that_met_qc_criteria": "2017-05-15",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-17",
"first_submitted": "2017-05-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.
PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.
Detailed Description
OBJECTIVES:
Primary
* Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer (defined by \> 20 pack years of smoking and sputum atypia) treated with iloprost vs placebo.
* Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these patients.
* Determine whether this drug affects prostaglandin metabolism in these patients.
* Determine the toxicity profile of this drug in these patients.
Secondary
* Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), apoptotic index, and microvessel density, in these patients.
* Determine the genes whose expression is altered by this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral iloprost twice daily.
* Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.
Patients are followed at 1 month and then annually thereafter.
PROJECTED ACCRUAL: A total of 152 patients (76 \[38 current smokers and 38 former smokers\] per treatment arm) will be accrued for this study within 2 years.
#Intervention
- DRUG : iloprost
- Given orally
- OTHER : placebo
- Given orally
|
#Eligibility Criteria:
Inclusion Criteria:
* Current or former smoker with >= 20 pack-year history of smoking with no tobacco use within the past 6 months
* Mild atypia or worse on sputum cytology, or
* Bronchial biopsy with mild or worse dysplasia within the past 12 months
* Age 18 and over
* SWOG (Southwest Oncology Group)0 <= age <= 2
* Life expectancy at least 6 months
* Granulocyte count > 1,500/mm^3
* Platelet count > 100,000/mm^3
* Alkaline phosphatase <= 2.5 times upper limit of normal (ULN)
* Transaminases <= 2.5 times ULN
* Bilirubin <= 2.0 mg/dL
* Albumin >= 2.5 g/dL
* Creatinine <= 1.5 mg/dL
* Well-controlled atrial fibrillation OR rare (< 2 minutes) premature ventricular contractions allowed
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able and willing to undergo bronchoscopy
Exclusion Criteria
* Clinically apparent bleeding diathesis
* Ventricular tachycardia
* Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response
* Pneumonia or acute bronchitis within the past 2 weeks
* Hypoxemia (< 90% saturation with supplemental oxygen)
* Pregnant or nursing
* Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Serious medical condition that would preclude bronchoscopy or study participation
* Clinically active coronary artery disease
* Myocardial infarction within the past 6 weeks
* Chest pain
* Congestive heart failure
* Cardiac dysrhythmia that is potentially life-threatening
Exclusion for PRIOR CONCURRENT THERAPY:
* Biologic therapy (Not specified)
* More than 5 years since prior chemotherapy
* More than 6 weeks since prior inhaled steroids
* More than 5 years since prior thoracic radiotherapy
* Surgery (Not specified)
* No prior prostacyclin
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00084409
|
{
"brief_title": "Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease",
"conditions": [
"Lung Cancer",
"Precancerous Condition"
],
"interventions": [
"Drug: iloprost",
"Other: placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00084409",
"official_title": "A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-01",
"study_completion_date(actual)": "2009-01",
"study_start_date(actual)": "2001-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-14",
"last_updated_that_met_qc_criteria": "2004-06-10",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2004-06-11",
"first_submitted": "2004-06-10",
"first_submitted_that_met_qc_criteria": "2013-01-09"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to gather data to see if so-called enriched forms of exercise programs such as dance is more effective in improving balance and quality of life in patients with idiopathic Parkinson's disease than regular exercise programs that are currently provided by physical therapists.
Detailed Description
Comparison of traditional PT to dance in people who have parkinsons disease to measure which is better for gait, balance and QOL.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PD at least 3 years ago
* < 80 years
* Have gait and balance issues
Exclusion Criteria:
* Diagnosis of PD for less than 3 years
* 80 years or older
* Not have gait and balance issues
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01163344
|
{
"brief_title": "Dance Exercise as Novel Complementary Therapy for Parkinson's Disease",
"conditions": [
"Parkinsons Disease"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01163344",
"official_title": "Dance Exercise as Novel Complementary Therapy for Parkinson's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2010-07"
},
"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)": "2017-03-16",
"last_updated_that_met_qc_criteria": "2010-07-14",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-15",
"first_submitted": "2010-07-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.
#Intervention
- DRUG : Stannous fluoride toothpaste
- product containing 0.45% stannous fluoride
- Other Names :
- experimental
- DRUG : Colgate Dental Cream
- product containing 0.76% sodium monofluorophosphate
- Other Names :
- control
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects, ages 18 <= age <= 70, inclusive.
* Subject is available during study duration and has no allergies to oral hygiene formulations.
* A minimum of 20 natural teeth with facial and lingual scorable surfaces.
* A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
* Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].
Exclusion Criteria:
* Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
* History of dental prophylaxis or treatments in the past month or during study duration.
* History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
* Subjects scheduled for medical procedures for the duration of the study.
* Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
* History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
* History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
* Oral soft tissue pathology.
* History of active or severe periodontal disease and loose teeth.
* Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
* Fixed or removable orthodontic appliance or removable partial dentures.
* Self-reported pregnancy or lactation.
* Subjects known to be an alcoholic, or a recovering alcoholic.
* History or current use of recreational drugs or other habit promoting products.
* Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
* Ability to refrain from oral hygiene for twelve (12) hours prior to scheduled visit.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06353165
|
{
"brief_title": "Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva",
"conditions": [
"Plaque, Dental"
],
"interventions": [
"Drug: Stannous fluoride toothpaste",
"Drug: Colgate Dental Cream"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT06353165",
"official_title": "A Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-12",
"study_completion_date(actual)": "2023-04-12",
"study_start_date(actual)": "2023-03-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-15",
"last_updated_that_met_qc_criteria": "2024-04-05",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-08",
"first_submitted": "2024-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Subjects with histologically proven glioblastoma (GBM) who are suspected to have progression and are candidates for a surgical resection according to standard of care may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age.
Positron emission tomography (PET/CT) imaging will be used to evaluate fluciclovine uptake at sites of suspected progression before planned surgery. In addition, clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions.
Investigators anticipate enrolling up to 30 subjects who will undergo a clinical brain MRI examination with and without contrast and a research 18F-Fluciclovine PET/CT scan of the brain prior to surgery. They will also have a blood draw preoperatively to collect samples for cfDNA analysis. PET/CT imaging sessions will include an injection of approximately 5 mCi (range for most studies is anticipated to be 5 mCi +/- 20%) of 18F-Fluciclovine.
Detailed Description
This is a pilot study in subjects with a histologically proven diagnosis of glioblastoma (GB) who have completed chemoradiation and now have new contrast enhancing lesions or lesions showing increased enhancement ( 25% increase) who are recommended for a clinical surgical resection. Subjects may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Subjects who come to the University of Pennsylvania for diagnosis and/or treatment of GB and who meet the study inclusion criteria may be approached by study personnel for recruitment into this study. Subjects will be approached about study participation regardless of race or ethnic background. Investigators anticipate enrolling up to 30 participants. Subjects who consent but do not complete the study imaging will be considered not evaluable and will be replaced. Accrual will likely occur over approximately 1-2 years. After undergoing screening assessments and verifying eligibility for study participation subjects will undergo a research 18FFluciclovine PET/CT scan of the brain and a clinical brain MRI with and without gadolinium contrast, all baseline imaging will be done prior to (within 1 week) of the surgical procedure. The PET-CT and MRI can be performed in any order.
#Intervention
- DRUG : Axumin, Intravenous Solution
- To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression versus pseudoprogression
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants will be >= 18 years
* Initial diagnosis of glioblastoma (histologic or molecular proof)
* Completion of chemoradiation
* New contrast-enhancing lesion or lesions showing increased enhancement (>25% increase) on standard MRI after completion of chemoradiation
* Recommended for clinically surgical resection
* Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
* Karnofsky performance status >= 60
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
Exclusion Criteria:
* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
* Contraindications to MRI or use of gadolinium contrast
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
|
NCT03990285
|
{
"brief_title": "[18F]Fluciclovine in Post-treatment Glioblastoma ( Axumin )",
"conditions": [
"Glioma Glioblastoma Multiforme"
],
"interventions": [
"Drug: Axumin, Intravenous Solution"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03990285",
"official_title": "Multimodality 18F-Fluciclovine PET, MRI and Cell Free Circulating DNA to Differentiate Tumor Progression From Pseudoprogression in Patients With Glioblastoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-18",
"study_completion_date(actual)": "2021-11-18",
"study_start_date(actual)": "2019-06-12"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-12-22",
"last_updated_that_met_qc_criteria": "2019-06-17",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-18",
"first_submitted": "2019-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the possible effects of uvulopalatopharngoplasty (UPPP) -which is a a therapy used on patients with Obstructive sleep apnea syndrome (OSAS- on oxidative damage.
Detailed Description
Obstructive sleep apnea syndrome (OSAS) is a sydrome which has characteristic upper way obstruction and a decrease in blood oxygen saturation as sleeping. uvulopalatopharngoplasty (UPPP)is one of the surgical approaches applied to the patients with OSAS, since the oxidative damage markers have been found high in patients with OSAS. Although antioxidant levels were higher in patients with OSAS than those in normal population, there is report about the effect of UPPP on antioxidant status in patients with OSAS. We performed this study to confirm whether is there a We performed the present study to confirm whether there is a relationship between the OSAS and oxidative damage before and after UPPP.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who underwent uvulopalatopharngoplasty (UPPP)for Obstructive sleep apnea syndrome (OSAS)
Exclusion Criteria:
* Anormal nasopharyngeal computed tomography, chronic diseases such as diabetes mellitus, hypertension etc.
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
|
NCT01635699
|
{
"brief_title": "Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE (OSAS)",
"conditions": [
"Sleep Apnea, Obstructive"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT01635699",
"official_title": "Effect of Modified Fujita Technique Uvulopalatoplasty on Oxidative DNA Damage Levels in Patients With Obstructive Sleep Apnea SyndromE",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06",
"study_completion_date(actual)": "2011-03",
"study_start_date(actual)": "2008-06"
},
"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)": "2012-07-09",
"last_updated_that_met_qc_criteria": "2012-07-06",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-09",
"first_submitted": "2012-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available, however, on the effects of 'exergaming' , interactive technology- mediated approaches to increasing physical activity in children and youth. This project involves a partnership between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing, prevention and behavioral sciences and exercise physiology and is designed to examine the effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity, risk factors for cardiometabolic disease and self-competence in Boston Public School children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60 minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition Education) group.Results of this pilot study will guide and inform a larger study of exergaming in children from the Boston Public Schools.
#Intervention
- BEHAVIORAL : EXCEL
- Children in the EXCEL intervention will receive 12 weeks of supervised physical activity, guided by principles of behavior change, in the form of exergaming (technology-mediated interactive physical activity)3 times per week for 12 weeks and will also receive weekly group nutrition education sessions
- BEHAVIORAL : EXCEL
- Participants in the EXCEL intervention will receive 12 weeks of supervised physical activity in the form of exergaming (technology-mediated physical activity). Sessions will be held 3 times per week with 60 minutes of supervised physical activity.
- Other Names :
- EXERGAMING
- BEHAVIORAL : Nutrition Education ONLY
- Children in the nutrition education group will receive 30 minutes per week of group nutrition education in the school environment and delivered by a registered dietitian The nutrition education sessions will be identical to those provided for the EXCEL group.
|
#Eligibility Criteria:
Inclusion Criteria:
* enrolled in grades 3 <= age <= 5
* able to attend GoKids and school-based weekly educational sessions for 12 weeks and complete baseline and follow-up testing
* informed consent from a parent or legal guardian and written assent from the child
* English speaking child
* free from medical conditions that would prohibit exercise as indicated by permission to participate in school physical education, and by review of screening questions with clearance from primary care provider as necessary.
Exclusion Criteria:
* abnormalities on screening/baseline evaluation that could pose a significant risk for exercise
* illness that would limit participation
* plans to move out of the area or change schools in the next 6 months
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01104038
|
{
"brief_title": "EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program",
"conditions": [
"Cardiovascular Disease"
],
"interventions": [
"Behavioral: Nutrition Education ONLY",
"Behavioral: EXCEL"
],
"location_countries": null,
"nct_id": "NCT01104038",
"official_title": "EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-07",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-05-26",
"last_updated_that_met_qc_criteria": "2010-04-14",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-15",
"first_submitted": "2010-04-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
GSK2982772 is a first-in-class, highly selective, receptor-interacting protein-1 (RIP1) kinase inhibitor being developed for the treatment of inflammatory bowel disease, plaque psoriasis (PsO), rheumatoid arthritis (RA) and other disease conditions. PK data from the first time in human (FTIH) study for GSK2982772 showed that the half life of GSK2982772 was short (approximately 2 to 3 hours). A once daily (QD) formulation would be more convenient from a subject perspective and could offer the advantage of providing a flatter GSK2982772 concentration time profile. Following completion of Parts A and B, it was determined that the slowest minitab formulation provided a PK profile suitable for QD dosing but this formulation was susceptible to a food effect. This study will evaluate the pharmacokinetics of GSK2982772 following administration of different minitab MR formulations in a capsule relative to an IR reference tablet formulation, the pharmacokinetics of selected MR formulation in capsule following repeat doses for 3 days and to compare the pharmacokinetics of GSK2982772 following administration of MR tablet formulations in the fed and fasted state relative to an IR tablet formulation. The study is divided into three parts: Part A will be a non-randomized 6 periods, sequential, 6-way fixed sequence design in which up to 4 MR minitab formulations in a capsule will be evaluated. Periods 1, 2, and 3 will evaluate a slow MR release duration (nominally 24 hours), a fast MR release duration (nominally 10 hours), and IR tablet respectively. Periods 4, 5 and 6 will have flexible dose regimen and it will depend on the outcomes of Period 1 to 3. Subjects will be admitted to the clinic the previous day before dosing. Each in-patient period will consist of 3 days and 2 nights followed by a minimum washout period of 7 days between doses, for both Part A and C. In Part A and C, 16 healthy subjects will be enrolled such that at least 12 evaluable subjects complete the study. Part B will be an open-label, repeat dose study in which the selected MR minitab formulation in capsule will be evaluated. Each in-patient period will consist of 5 days and 4 nights. There will be a minimum of 7 days washout period between the last morning dose of one period and the first dose of the next period. In Part B, 10 healthy subjects will be enrolled such that at least 6 evaluable subjects complete the study. Part C of the study will be a non-randomised 6 period, sequential, fixed sequence crossover design in which MR tablet formulations will be evaluated. Periods 1 and 2 will evaluate single dose administration of a 240 milligram (mg) MR tablet and the 240 mg IR tablet (reference), respectively. Periods 3, 4, 5 and 6 will be flexible and the dosing regimen will be dependent on the outcome of Periods 1 and 2.
#Intervention
- DRUG : GSK2982772 Modified Release
- GSK2982772 MR will be available as prototype MR minitablet in capsules with unit dose strength of 60 mg in Part A. In Part B, GSK2982772 MR minitablet in capsules with unit dose strength of 15, 30 or 60 mg will be administered by subjects for Days 1 to 3. In Part C, GSK2982772 MR tablet with unit dose strength of 240, 360 or 480 mg will be administered by subjects. GSK2982772 MR will be administered orally with 240 mL of water.
- DRUG : GSK2982772 Immediate Release
- In part A, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 120 mg (4 tablets of dose strength 30 mg) orally with 240 mL of water. In part C, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 240 mg (8 tablets of dose strength 30 mg) orally with 240 mL of water.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject must be 18 <= age <= 65 of age inclusive, at the time of signing the informed consent.
* Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body weight greater than and equal to 50 kilogram (kg) and body mass index within the range 19.0 to 32.0 kilogram per meter square (kg/m^2) (inclusive).
* A male subject must agree to use a highly effective contraception during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
* A female subject is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive during the treatment period and for at least 30 days before and 30 days after the last dose of study treatment.
* Capable of giving signed informed consent.
Exclusion Criteria:
* History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
* Parts A and C only: Any history of suicidal behavior within the past 6 months or any history of attempted suicide in a subject's lifetime.
* Part B only: Subjects with current history of suicidal ideation behavior as measured using the columbia-suicide severity rating scale (C-SSRS) or a history of attempted suicide.
* History of clinically significant psychiatric disorders as judged by the investigator. Depression requiring treatment in the last 2 years.
* History of herpes zoster (shingles) reactivation.
* History or diagnosis of obstructive sleep apnea.
* History of a significant respiratory disorder. Childhood asthma that has fully resolved is permitted.
* History or current evidence of febrile seizures, epilepsy, convulsions, significant head injury, or other significant neurologic conditions.
* A positive diagnostic tuberculosis (TB) test at screening defined as a positive QuantiFERON-TB Gold test or T-spot test. In cases where the QuantiFERON or T spot test is indeterminate, the subject may have the test repeated once, but they will not be eligible for the study unless the second test is negative.
* History of GI surgery (with exception of appendectomy).
* History of cholecystectomy or gall stones.
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
* ALT greater than 1.5 times upper limit of normal (ULN).
* Bilirubin greater than 1.5 times ULN (isolated bilirubin greater than 1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percentage of total).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
* Corrected QT interval (QTc) greater than 450 millisecond (msec).
* Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen [up to 2 gram (g) per day], hormone replacement therapy and hormonal contraception are permitted).
* Live or attenuated vaccine(s) within 30 days of enrolment, or plans to receive such vaccines during the study or plans to receive a vaccine within 30 days + 5 half-lives of the last dose of study medication.
* Subject in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within a 56 day period; therefore donation or loss of greater than 400 mL of blood within the previous 3 months.
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
* Current enrolment or past participation within the last 3 months before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.
* Subjects who have previously been enrolled in this study. Subjects in Part A of this study are not permitted to participate in Part B. Subjects in Parts A or B of this study are not permitted to participate in Part C.
* Current or history of renal disease or estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation calculation less than 60 mL/minutes(min)/1.73m^2 at screening.
* Presence of Hepatitis B surface antigen (HBsAg) at screening Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose. As potential for and magnitude of immunosuppression with this compound is unknown, subjects with presence of hepatitis B core antibody (HBcAb) should be excluded. Subjects positive for HBsAg and/or positive for anti-HBc antibody (regardless of anti-HBs antibody status) are excluded.
* An elevated C-reactive protein (CRP) outside the normal reference range.
* Part B only: A positive anti-nuclear antibody (ANA) outside the normal reference range.
* Confirmed positive pre-study drug/alcohol screen.
* Positive human immunodeficiency virus (HIV) antibody test.
* Regular use of known drugs of abuse, or history of drug or alcohol abuse in the past 5 years.
* Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* Current use or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening. A carbon monoxide breath test reading of greater than 10 parts per million (ppm).
* Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
* Unwilling or unable to swallow multiple size 0 <= age <= 00 capsules as part of study participation.
* Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator at screening.
* Total cholesterol greater than or equal to 300 milligram/deciliter (mg/dL) (greater than or equal to 7.77 millimoles per liter [mmol]/L]) or triglycerides greater than or equal to 250 mg/dL (greater than or equal to 2.82 mmol/L).
* Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
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
|
NCT03266172
|
{
"brief_title": "A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses",
"conditions": [
"Autoimmune Diseases"
],
"interventions": [
"Drug: GSK2982772 Immediate Release",
"Drug: GSK2982772 Modified Release"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03266172",
"official_title": "A Three Part, Non-randomized, Open Label Study Designed to Assess the Pharmacokinetics of GSK2982772 Following Administration of Minitab Modified Release Formulations in a Capsule Relative to an Immediate Release Reference Tablet Formulation (Part A), the Pharmacokinetics of Escalating, Repeat Doses of a Selected Minitab Modified Release Prototype (Part B) , and the Pharmacokinetics of GSK2982772 Following Administration of Modified Release Tablet Formulations in the Fed and Fasted State (Part C) in Healthy Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-21",
"study_completion_date(actual)": "2018-11-21",
"study_start_date(actual)": "2017-09-27"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-13",
"last_updated_that_met_qc_criteria": "2017-08-25",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-30",
"first_submitted": "2017-08-25",
"first_submitted_that_met_qc_criteria": "2019-12-18"
}
}
}
|
#Study Description
Brief Summary
Type 2 diabetes mellitus has been associated with an about 2-fold increase in risk of Alzheimer's disease (AD). Patients with AD have been reported to have reduced insulin sensitivity. It may be hypothesized that, compared to insulin sensitive subjects otherwise similar in general health and body habitus, insulin resistant subjects are more likely to have cerebrospinal fluid (CSF) indicators of incipient AD pathology, abnormalities in CSF peptides related to insulin signaling and glucose homeostasis, and possibly other metabolites that are associated with a risk of AD. The objective of this study is to examine the relation of insulin resistance and the concentrations of CSF biomarkers. The results of this study may be useful in the detection of the subjects who are at risk for cognitive decline and AD.
Detailed Description
Type 2 diabetes mellitus has been associated with an approximately 2-fold increase in risk of Alzheimer's disease (AD). Patients with AD have been reported to have reduced insulin sensitivity, and to have insulin concentrations that are elevated in plasma and decreased in cerebrospinal fluid (CSF). Cognitively normal individuals with insulin resistance are thus of interest in our effort to gain an understanding of the antecedents of this problem. It may be hypothesized that, compared to insulin sensitive subjects otherwise similar in general health and body habitus, insulin resistant subjects are more likely to have CSF indicators of incipient Alzheimer pathology, abnormalities in CSF peptides related to insulin signaling and glucose homeostasis, and possibly other metabolites that are associated with a risk of AD.
The objectives are to 1) assess the concentrations of biomarkers of Alzheimer pathology in the CSF of cognitively normal men with and without insulin resistance, and 2) assess the concentrations of other CSF biomarkers of potential relevance to insulin resistance and AD in the CSF of cognitively normal men with and without insulin resistance.
All subjects with eligibility will have had an oral glucose tolerance test performed within the past 3 months that revealed a normal fasting blood level and normal glucose tolerance. In addition, they will have had no history of significant cognitive disorders, no prior diagnosis of diabetes mellitus, and will not be receiving insulin or oral hypoglycemic. Eligibility for inclusion in the insulin-resistant group will be defined by scores on the Matsuda Index; non-insulin resistant controls will have normal values on the Matsuda Index. An effort will be made to ensure that both groups (i.e., those with insulin resistance and those without insulin resistance) will be similar in age, weight, BMI, and Apo E4 genotype (APOE).
All procedures will be performed on a single visit. The subjects will undergo a Mini-Mental Status Examination (MMSE) performed by a qualified examiner. In addition, a blood sample will be obtained for measurements of basic blood chemistry (electrolytes, creatinine, glucose, total protein, and albumin), hematology, thyroid function, metabolic function (e.g. fasting plasma glucose and insulin levels) and for proteomic analysis. The APOE genotype will be determined from the blood samples, if it has not been assessed earlier. A lumbar puncture will be performed to obtain CSF samples that will be used to determine concentrations of biomarkers of AD pathology and to find out new biomarkers that may reflect AD pathology.
All materials will be used according to national ethical guidelines for Good Clinical Practice. Analyses of the CSF for levels of beta-Amyloid biomarkers, total tau and phosphorylated tau will be done using a sandwich ELISA. Descriptive statistics will be provided for each analyte, comparing the 2 groups of subjects.
All participants will provide written informed consent. Blood and CSF samples will be analysed also by collaborators in other European countries. Before analysis and sending data and blood/CSF samples to partners of the project, all clinical information and sample information will be made anonymous (coded data). Personal information, i.e., name and personal identity number, is removed from data/samples, and separate codes are given to them before delivering them to other partners for the purposes of the project. Methods for database maintenance and data delivery will be used that have proved to be functional in previous research projects. A formal description of the different data formats, access routines and tools for basic processing will be created at the start of the project.
|
#Eligibility Criteria:
Inclusion Criteria:
* Males 55 <= age <= 70 years in age
* Normal cognitive function, as evidenced by the following: 1. Living independently in the community, 2. No memory complaints; Score on Mini Mental State Examination >= 25 (Folstein 1975), 3. Score on Functional Activities Questionnaire < 9
* Has had oral glucose tolerance test including determination of plasma glucose and insulin levels at baseline and 30 and 120 minutes within the past 3 months, meeting the following criteria: 1. Normal fasting blood glucose (<7.0 mmol/l), 2. Normal glucose tolerance at 120 minutes (<11.1 mmol/l), 3. Meets criteria for either normal insulin sensitivity or insulin resistance, based upon the Matsuda insulin sensitivity index
* Willing to have lumbar puncture
Exclusion Criteria:
* Evidence of significant neurological disease, including 1. Abnormal neurological examination, 2. History of stroke (other than lacunar infarction), 3. prior diagnosis of mild cognitive impairment, significant head injury with impairment of consciousness > 24h, brain tumor, multiple sclerosis, epilepsy, or hydrocephalus, 4. Diagnosis or family history consistent with autosomal dominantly inherited AD
* Prior diagnosis of diabetes mellitus type 1 or 2
* Evidence of significant metabolic or endocrine disorder associated with risk of cognitive impairment, e.g., hypothyroidism or B12 deficiency
* Major psychiatric disorder, including psychosis
* Evidence of significant systemic disease, including: congestive heart failure, renal failure, hepatic cirrhosis, significant chronic obstructive pulmonary disease, cancer within the past 5 years (other than nonmetastatic basal cell and squamous cell carcinoma of the skin)
* Excluded concomitant medications: 1. Acetylcholinesterase inhibitors, Memantine (Alzheimer's disease medications), 2. Insulin or oral hypoglycemics, 3. Anticoagulants (excluding aspirin, clopidogrel, dipyridamole, or other antiplatelet drugs), 4. Neuroleptic drugs, including risperidone, olanzapine, quetiapine, and ziprasidone, 5. Receipt of an investigational drug within the past 30 days (or within 5 half-lives of an investigational drug, whatever is longest)
Sex :
MALE
Ages :
- Minimum Age : 55 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02010476
|
{
"brief_title": "Alzheimer's Disease Biomarkers in Cerebrospinal Fluid in Insulin-resistant Men",
"conditions": [
"Alzheimer's Disease"
],
"interventions": null,
"location_countries": [
"Finland"
],
"nct_id": "NCT02010476",
"official_title": "Cerebrospinal Fluid Changes in Insulin-Resistant Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2013-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-05-12",
"last_updated_that_met_qc_criteria": "2013-12-11",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-12",
"first_submitted": "2013-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate how common gene mutations are in benign and malignant thyroid lesions.
Detailed Description
The overall objective of this study is to evaluate the prevalence of molecular markers in patients with benign and malignant thyroid lesions. This study consists of:
Retrospective review of archived surgical pathology specimens at Oregon Health \& Science University (OHSU) from patients with thyroid cancer or benign thyroid disease (nodules or goiter) who underwent thyroidectomy and/or neck dissection as standard of care. Molecular markers will be evaluated on archived tissue.
Molecular markers will be correlated with clinical information extracted from OHSU medical records: histologic subtype of cancer, measures of tumor aggressiveness (capsular and angiolymphatic invasion, local invasion, lymph node and distant metastases, TNM stage(TNM Classification of Malignant Tumours)) and clinical outcome (recurrence, distant metastases and death).
Patients with other malignancies presenting for standard of care services will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a 'positive' control for the DNA/RNA isolation techniques and mutation assays, as other cancers commonly express some of the same mutations. Normals will have peripheral blood collected for DNA, RNA and buffy coat/white blood cells as a 'negative' control for the DNA/RNA isolation techniques and mutation assays.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 1 - 100
* Benign or malignant thyroid lesion, other malignancy or no thyroid abnormality
* Pathologic specimen available for analysis
* Ability to provide informed consent (for prospective study, Part Two)
* Age greater than age 18 (for normal controls)
Exclusion Criteria:
* Patients without adequate data for analysis
* Histopathologic or cytopathologic diagnosis of for medullary thyroid carcinoma (not derived from the thyroid follicular epithelium), thyroid lymphoma
* Unwilling to participate or unable to provide informed consent
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00598364
|
{
"brief_title": "Molecular Markers in Thyroid Cancer",
"conditions": [
"Thyroid Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00598364",
"official_title": "Molecular Markers in the Diagnostic and Prognostic Evaluation of Thyroid Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2007-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-08",
"last_updated_that_met_qc_criteria": "2008-01-10",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-21",
"first_submitted": "2008-01-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to collect data that will help researchers better understand the various causes of obesity and diabetes; particularly to understand how consumption of NCASs affects the way the body uses nutrients.
#Intervention
- OTHER : Dietary: saccharin
- Assess the glycemic and hormonal responses to an oral glucose load preceded by an oral solution of NCASs (saccharin).
- OTHER : Estimate glucose absorptions
- Indirectly estimate the rate of glucose absorption and gastric emptying by using 3-O-methyglucose (3-OMG) and acetaminophen, respectively.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 65 years inclusive;
* Men and women;
* Able to provide written, informed consent;
* Weight stable (± 3 kg) during the 3 months prior to enrollment;
* BMI <= 25 kg/m2
Exclusion Criteria:
* Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or chronic obstructive pulmonary disorder, g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder;
* Consumption of more than a can of diet beverage or a spoonful of non-caloric artificial sweeteners weekly (or each equivalent from foods) during the past month.
* Pregnant or nursing women;
* Current smokers (smoking within the past 3 months);
* Known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients;
* History of difficult blood sample collections or unfavorable anatomy of venous access;
* Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.
* Blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.
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
|
NCT02835859
|
{
"brief_title": "Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners",
"conditions": [
"Diabetes"
],
"interventions": [
"Other: Estimate glucose absorptions",
"Other: Dietary: saccharin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02835859",
"official_title": "Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2017-09",
"study_start_date(actual)": "2014-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-14",
"last_updated_that_met_qc_criteria": "2016-07-13",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-18",
"first_submitted": "2016-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.
#Intervention
- BEHAVIORAL : Active and Healthy Families
- Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 5 <= age <= 12 years
* Body mass index greater than or equal to the 85th percentile for age and sex
* Patients seen at Contra Costa County clinics participating in Active and Healthy Families
* Spanish speaking
* Parent of participant
Exclusion Criteria:
* Previous participation in Active and Healthy Families
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02044705
|
{
"brief_title": "Impact of Active and Healthy Families",
"conditions": [
"Overweight",
"Obesity"
],
"interventions": [
"Behavioral: Active and Healthy Families"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02044705",
"official_title": "Impact of Active and Healthy Families (Familias Activas y Saludables): A Family-Based Group Medical Appointment Model for Childhood Obesity in Federally Qualified Health Centers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2014-05",
"study_start_date(actual)": "2012-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-10",
"last_updated_that_met_qc_criteria": "2014-01-22",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-24",
"first_submitted": "2014-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.
Detailed Description
The aim of the study is to compare the content of exosomes between two goups of 20 patients, with and without endothelial dysfucntion.
the endothelial function will be evaluated after polysomnography, on obese patients with OSA (AHI \>15).
#Intervention
- DIAGNOSTIC_TEST : ENDOPAT
- digital plethysmography
|
#Eligibility Criteria:
Inclusion Criteria:
* adult subject
* Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent
* Subject with OSA (defined by AHI >15/h)
Exclusion Criteria:
* cardiac or vascular desease
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
|
NCT04459182
|
{
"brief_title": "Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome",
"conditions": [
"Endothelial Dysfunction"
],
"interventions": [
"Diagnostic Test: ENDOPAT"
],
"location_countries": [
"France"
],
"nct_id": "NCT04459182",
"official_title": "Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-06",
"study_completion_date(actual)": "2023-07-06",
"study_start_date(actual)": "2021-01-14"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-11",
"last_updated_that_met_qc_criteria": "2020-07-03",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-07",
"first_submitted": "2020-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.
Detailed Description
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. A random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. Descriptive statistics will be used to analyze demographic data.
#Intervention
- DRUG : ibuprofen
- Other Names :
- motrin, advil
- DRUG : acetamin w codeine
- Other Names :
- tylenol with codeine, T3
|
#Eligibility Criteria:
Inclusion Criteria:
* Children ages 4 <= age <= 18 years with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting
Exclusion Criteria:
* A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00520442
|
{
"brief_title": "Acute Pediatric Fracture Analgesia Study",
"conditions": [
"Fracture"
],
"interventions": [
"Drug: acetamin w codeine",
"Drug: ibuprofen"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00520442",
"official_title": "Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-09",
"study_completion_date(actual)": "2007-09",
"study_start_date(actual)": "2003-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-03-07",
"last_updated_that_met_qc_criteria": "2007-08-22",
"last_verified": "2008-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-08-24",
"first_submitted": "2007-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.
In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.
#Intervention
- BIOLOGICAL : Evaluate the improvement in response from the end of anti-PD-1 monotherapy
- Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).
|
#Eligibility Criteria:
Inclusion Criteria:
* Initial diagnosis of classical HL
* Optional histopathology confirmation of relapse/refractory HL, (2) age >= 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2
* Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,
* Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study
* Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.
Exclusion Criteria:
* radiotherapy in the treatment after anti-PD1
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
|
NCT03664323
|
{
"brief_title": "Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma",
"conditions": [
"Hodgkin Lymphoma"
],
"interventions": [
"Biological: Evaluate the improvement in response from the end of anti-PD-1 monotherapy"
],
"location_countries": [
"France"
],
"nct_id": "NCT03664323",
"official_title": "Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-31",
"study_completion_date(actual)": "2018-06-30",
"study_start_date(actual)": "2018-01-31"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-10",
"last_updated_that_met_qc_criteria": "2018-09-07",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-10",
"first_submitted": "2018-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.
#Intervention
- DRUG : LAF237 = vildagliptin
|
#Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00952991
|
{
"brief_title": "The Effects of LAF237 on Gastric Function in Type 2 Diabetes",
"conditions": [
"Diabetes Mellitus, Non-Insulin-Dependent"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00952991",
"official_title": "A Double Blind, Cross Over, Placebo Controlled, Multiple-dose Study to Evaluate the Effects of LAF237 on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-02",
"study_completion_date(actual)": "2006-02",
"study_start_date(actual)": "2005-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-03-23",
"last_updated_that_met_qc_criteria": "2009-08-05",
"last_verified": "2011-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-08-06",
"first_submitted": "2009-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Asthma is the most common chronic respiratory disease in children and has much effect on their life and study, which leads to huge economic burden and pressure to the whole families. Some children will develop into adult patients so that asthma can be the life-long vigorous trouble. In recent years, the prevalence rate of children asthma is increasingly going up worldwide. The prevalence rate in last 12 months reported in USA, United Kingdom, Australia, New Zealand was between 12% to 30%.
Center for Asthma Prevention and Education of Capital Institute of Pediatrics investigated the national asthma prevalence in 900 thousands children in 27 provinces and cities, which average rate was 0.11% to 2.03% in 1990. In 2000, we investigated it again in 31 provinces(43 cities) and the average national children asthma prevalence rate was 1.97%(0.25% to 4.63%) which was much higher than that in 1990.
Detailed Description
1. Objectives
1. To investigate the national children(0-14 years old)asthma prevalence;
2. To compare the prevalence rate between that in 1990 and 2000;
3. To analyse the asthma manifestations including the ages, seasons, causes, trigger and hereditary factors and their impact on the asthma patients, families and society;
4. To identify the risk factors by questionnaires in case-control research.
2. Study Design / Clinical Plan
1. The screening stage: to distinguish suspected asthma from the children age from 0 to 14 years old.
2. To obtain identified asthma from the suspected asthma.
3. To evaluate the prevalence and severe degree of 0 to 14-year-old children asthma and gain the main risk factors by case-control research.
|
#Eligibility Criteria:
Inclusion Criteria:
* children age from 0 <= age <= 14
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01319292
|
{
"brief_title": "To Investigate the Prevalence of Children Asthma in China",
"conditions": [
"Asthma"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01319292",
"official_title": "To Investigate the Prevalence of Children Asthma in China and Compare With That of the Last 20 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2011-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-04",
"last_updated_that_met_qc_criteria": "2011-03-18",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-21",
"first_submitted": "2011-03-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.
Detailed Description
Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with focal dermal hypoplasia
* between the ages of 3 and 18 years
* ability to fast overnight, and
* weight at least 9 kg
Exclusion Criteria:
* pregnant individuals,
* weight less than 9 kg
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02463656
|
{
"brief_title": "Growth Arrest in Focal Dermal Hypoplasia",
"conditions": [
"Focal Dermal Hypoplasia"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02463656",
"official_title": "Growth Arrest in Focal Dermal Hypoplasia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03-30",
"study_completion_date(actual)": "2018-05-31",
"study_start_date(actual)": "2015-07-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-18",
"last_updated_that_met_qc_criteria": "2015-06-03",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-04",
"first_submitted": "2015-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy.
Initial Treatment Period:
Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab, higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an open-label fashion.
The starting pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of pembrolizumab.
Switch-to-Pembrolizumab Treatment Period:
Participants who were initially randomized to receive ICC and experienced progressive disease (PD) may have been eligible to switch to receiving pembrolizumab provided they met protocol-specified requirements for switching. Qualified participants were re-randomized to receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03, all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.
Detailed Description
Two interim and one final statistical analyses were planned for and conducted during this study:
* Interim Analysis 1 (futility analysis),
* Interim Analysis 2 (\~18 months into study): database cutoff date 12-May-2014, and
* Final Analysis (\~36 months into study): database cutoff date 16-Nov-2015. The End of Trial Analysis for the study was conducted at \~75 months into the study: database cutoff date 31-Jan-2019.
#Intervention
- BIOLOGICAL : Pembrolizumab
- IV infusion
- Other Names :
- SCH 900475, MK-3475, KEYTRUDA®
- DRUG : Carboplatin
- Carboplatin per institutional standard
- Other Names :
- PARAPLATIN®
- DRUG : Paclitaxel
- Paclitaxel per institutional standard
- Other Names :
- TAXOL®
- DRUG : Dacarbazine
- Dacarbazine per institutional standard
- Other Names :
- DTIC
- DRUG : Temozolomide
- Temozolomide per institutional standard
- Other Names :
- TEMODAR®
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
* Participants must be refractory to ipilimumab
* Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor
* Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting)
* Radiographically measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
* Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier
* Disease progression within 24 weeks of last dose of ipilimumab
* Participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug
* Expected to require any other form of systemic or localized antineoplastic therapy while on study
* Chronic systemic steroid therapy within 2 weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication
* Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
* Prior treatment with any other anti-programmed cell death (PD) agent
* Active infection requiring systemic therapy
* Known history of Human Immunodeficiency Virus (HIV)
* Active Hepatitis B or Hepatitis C
* Regular user (including recreational use of) illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study through 120 days after last dose of study drug
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01704287
|
{
"brief_title": "Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)",
"conditions": [
"Malignant Melanoma"
],
"interventions": [
"Drug: Dacarbazine",
"Biological: Pembrolizumab",
"Drug: Temozolomide",
"Drug: Paclitaxel",
"Drug: Carboplatin"
],
"location_countries": null,
"nct_id": "NCT01704287",
"official_title": "Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11-16",
"study_completion_date(actual)": "2019-01-31",
"study_start_date(actual)": "2012-11-20"
},
"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)": "2020-05-18",
"last_updated_that_met_qc_criteria": "2012-10-08",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-11",
"first_submitted": "2012-10-08",
"first_submitted_that_met_qc_criteria": "2017-02-08"
}
}
}
|
#Study Description
Brief Summary
Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours.
Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury.
Therefore the investigators hypothesize:
Continued low dose steroids given three times over a 24 hour period will:
1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
2. Decrease urinary desmosine levels, and hence be protective of lung injury.
#Intervention
- DRUG : Hydrocortisone
- Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
- DRUG : Saline
- Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for bilateral total knee replacement
* Between 50 <= age <= 90 years
Exclusion Criteria:
* Patients on steroid therapy
* Patients that require stress-dose steroid pre-operatively
* Patients that smoke
* Patients that are diabetic
* Patients younger than >= 50 years than 90 years
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01399268
|
{
"brief_title": "Steroids in Bilateral Total Knee Replacement",
"conditions": [
"Postoperative Inflammatory Response"
],
"interventions": [
"Drug: Hydrocortisone",
"Drug: Saline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01399268",
"official_title": "Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-08",
"study_completion_date(actual)": "2011-02",
"study_start_date(actual)": "2009-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-31",
"last_updated_that_met_qc_criteria": "2011-07-20",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-21",
"first_submitted": "2011-07-14",
"first_submitted_that_met_qc_criteria": "2017-07-27"
}
}
}
|
#Study Description
Brief Summary
Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed.
However administration of Cystadrops® in patients below 2 years old could be of value for these patients and prevent the crystal deposit. It is the reason why as part of the Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric population from 6 months to less than 2 years old.
#Intervention
- DRUG : Mercaptamine
- Patients will be treated with 1 drop in each eye 4 times a day, at the same dose and regimen than the one indicated in adults and children from 2 years of age.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient aged from 6 months to less than 2 years
* Cystinosis diagnosed patients confirmed by the physician and with presence of corneal cystine crystal deposits assessed during ophthalmic examination
* Evidence of a signed and dated informed consent document indicating that parents/ legally acceptable representatives had been informed of all pertinent aspects of the study (if required by regulation)
* Parents/ legally acceptable representatives who are willing to comply with regular visits and ophthalmic exams
Exclusion Criteria:
* Contraindications to any of the Cystadrops® components
* Participation in another ophthalmic investigational study or intent to participate during the course of the study
* Any medical condition that would, in the opinion of the Investigator, interfere with the evaluation of the study objectives
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04125927
|
{
"brief_title": "Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)",
"conditions": [
"Cystinosis"
],
"interventions": [
"Drug: Mercaptamine"
],
"location_countries": [
"France",
"Germany",
"Italy",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT04125927",
"official_title": "Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients From 6 Months to Less Than 2 Years Old",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-23",
"study_completion_date(actual)": "2022-12-23",
"study_start_date(actual)": "2020-09-01"
},
"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)": "2024-02-05",
"last_updated_that_met_qc_criteria": "2019-10-11",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-14",
"first_submitted": "2019-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.
Detailed Description
This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study.
This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.
#Intervention
- DRUG : NKTR-181 BID tablets
- NKTR-181 tablets 100-600 mg twice daily (BID)
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-nursing female aged 18 <= age <= 75 old
* Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months
* Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
* Opioid analgesia is necessary
* Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry
* Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
* Willing and able to provide informed consent
Exclusion Criteria:
* History of hypersensitivity, intolerance, or allergy to opioids
* Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period
* Untreated moderate to severe sleep apnea
* Chronic migraines as the primary pain condition
* Cancer related pain
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
|
NCT02367820
|
{
"brief_title": "Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain",
"conditions": [
"Low Back Pain",
"Chronic Pain"
],
"interventions": [
"Drug: NKTR-181 BID tablets"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02367820",
"official_title": "A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2015-04-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-22",
"last_updated_that_met_qc_criteria": "2015-02-13",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-20",
"first_submitted": "2015-02-09",
"first_submitted_that_met_qc_criteria": "2020-09-14"
}
}
}
|
#Study Description
Brief Summary
This study aimed to evaluate the effect of three forms of continuing medical education (CME) on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices.
Detailed Description
Practice-based, randomized controlled trial. Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0-3 years. Interventions: Group A practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Group B practices (n=41) received the same as Group A and were offered weekly conference calls providing advice and support. Group C practices (n=41) received the same as Group B and were offered in-office visit providing hands-on advice and support. Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance. Primary outcome measure: rate of preventive dental services provision per 100 well-child visits. Secondary outcome measure: % of practices providing 20 or more preventive dental visits.
#Intervention
- BEHAVIORAL : Continuing medical education
- Group A practices took part in a 90 minute lecture with slides, case-based presentations and discussions of the clinical interventions, instruction in children's dental development, common dental diseases and prevention, screening, referral, counseling and fluoride varnish application. Group B practices received the same as group A and additionally were offered support through telephone conference calls using 'learning collaborative' methods where staff receive ongoing support from CME instructors and learn from one another as they begin to implement systems for preventive care in their practices. The conference calls were moderated by research staff with clinical expertise in primary health care who had assisted in other interventions among NC pediatric and family medicine offices. Group C received the same intervention as Group B and were offered additional in-office support for implementation of preventive dental procedures provided by a dental hygienist.
|
#Eligibility Criteria:
Inclusion Criteria:
* pediatric or family physician Medicaid practice in North Carolina
Exclusion Criteria:
* participation in related pilot study
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00464009
|
{
"brief_title": "Development and Evaluation of a Medical Intervention for Early Childhood Caries",
"conditions": [
"Early Childhood Dental Caries"
],
"interventions": [
"Behavioral: Continuing medical education"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00464009",
"official_title": "Development and Evaluation of a Medical Intervention for Early Childhood Caries",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2002-04",
"study_completion_date(actual)": "2007-11",
"study_start_date(actual)": "2001-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-01-29",
"last_updated_that_met_qc_criteria": "2007-04-19",
"last_verified": "2009-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-04-20",
"first_submitted": "2007-04-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Comparison of the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients
Detailed Description
laparotomy benign gynecological surgery is the most common gynecologic operation worldwide because is major operation for surgery and can affect to bowel movement after operation and turn to postoperative ileus , clinically severe postoperative ileus affects up to 14% of patients after laparotomy for gynecologic surgery that leaded to more complication, slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.
Preclinical studies has considered to use preventative therapeutic options for prevent ileus including coffee
The investigators used the coffee reduces postoperative ileus However, no good quality of evidence base supports the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients
#Intervention
- OTHER : caffeine coffee
- drank 3 cups of caffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda.
Coffee was prepared with a conventional coffee machine
- OTHER : decaffiene coffee
- drank 3 cups of decaffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda.
Coffee was prepared with a conventional coffee machine
- OTHER : still water
- drank 3 cups of still water daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda.
Coffee was prepared with a conventional coffee machine
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients were asked to participate if they were scheduled to undergo laparotomy for a benign gynecologic condition
* Ever drink coffee before
* can speak or communication Thai language
Exclusion Criteria:
1 hypersensitivity or allergy to caffeine/ coffee 2.ever intraabdominal sugery before 3. had an active intra-abdominal malignancy, bowel perforation, pre-existing bowel disease, or a history of abdominal or pelvic irradiation.
*pregnancy woman 5.thyroid disease 6 Inflammatory bowel disease 7.liver disease 8.cardiac arrhythmia 9.history of difficult to defecation ( feces only 2 times per week) 10.after operation need to stay in ICU more than 24 hr 11.need to put Ng tube after operation
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03660267
|
{
"brief_title": ">The Purpose of This Study Was to Determine Whether Consuming a 100-mL Cup of Coffee is Effective in Preventing or Reducing Postoperative Ileus After Laparotomy of Benign Gynecological Patients",
"conditions": [
"Effects of Coffee Ingestion on Recovery of Bowel Function"
],
"interventions": [
"Other: still water",
"Other: decaffiene coffee",
"Other: caffeine coffee"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT03660267",
"official_title": "The Effects of Coffee Ingestion on Recovery of Bowel Function in Patients Undergoing Benign Gynecologic Operation : A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-30",
"study_completion_date(actual)": "2019-09-30",
"study_start_date(actual)": "2018-09-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-30",
"last_updated_that_met_qc_criteria": "2018-09-05",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-06",
"first_submitted": "2018-09-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.
#Intervention
- DIETARY_SUPPLEMENT : iridoid enriched mixed fruit beverage
- Mixed fruit beverage consisting of noni (Morinda citrifolia) juice, Cornelian cherry (Cornus mas \& Cornus officinalis) puree and juice, olive (Olea europea) leaf extract, and other fruit juices and natural flavors
- Other Names :
- TruAge Max
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females age 25 <= age <= 60.
* Overweight or obese, defined as BMI 23.0 to 39.9 kg/m2.
* Impaired fasting glucose, defined as fasting blood glucose 100 to 125 mg/dl.
* Prehypertension or Grade 1 hypertension, defined as systolic blood pressure 120 <= age <= 159 mm Hg AND diastolic BP 80 <= age <= 99 mm Hg.
* Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
* Consent to the study and willing to comply with study procedures.
Exclusion Criteria:
* Prescription medication use for hypertension, high cholesterol, diabetes, heart disease, cancer, liver disease, or AIDS/HIV 2.
* Intake of foods and/or dietary supplements that may confound study outcomes including any use of a noni-based dietary supplement in the last month.
* Regular use (> 3 times per week over the past month) of any dietary supplement that contains 'super fruits' or high antioxidant concentrations.
* Regular use (> 3 times per week over the past month) of any dietary supplement intended to alter or regulate blood glucose levels.
* Any medical conditions or diseases that may affect subject safety or confound study results (in the opinion of the investigator).
* Pregnant or lactating female.
* History of alcohol, drug, or medication abuse.
* Current heavy smokers (1 or more packs/day).
* Allergies to any ingredient in the investigational products.
* Participation in another study with any investigational product.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01597076
|
{
"brief_title": "Effect of an Iridoid Enriched Beverage on Skin Autofluorescence",
"conditions": [
"Oxidative Stress",
"Quality of Life",
"Metabolic Syndrome"
],
"interventions": [
"Dietary Supplement: iridoid enriched mixed fruit beverage"
],
"location_countries": [
"Indonesia"
],
"nct_id": "NCT01597076",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2012-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-04",
"last_updated_that_met_qc_criteria": "2012-05-10",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-11",
"first_submitted": "2012-05-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary aim of this project is to test the efficacy of an inpatient congestive heart failure (CHF) educational intervention compared with usual care among inpatients at Griffin Hospital, who are largely drawn from the population of the Naugatuck Valley in Connecticut.
The educational intervention will utilize:
* written educational materials suitable for patients with low health literacy - alternatives to written materials (e.g., video- and audiotapes) that may more effectively communicate health information to elderly patients and those with low health literacy
* a one-on-one educational session with a nurse patient educator. The educational session will use as its framework guidelines provided by the America Medical Association (AMA) to improve communication between healthcare providers and low health literacy patients. The investigators hypothesize that CHF patients who receive this educational intervention will have fewer hospital readmissions or deaths than the usual care group. The investigators further hypothesize that patients with low health literacy will derive more benefit from the intervention than patients with higher literacy.
The secondary aims of the project are to:
* assess whether patients in the education and usual care groups differ on post-discharge CHF knowledge and on satisfaction with hospital care. Compared with usual care, the investigators hypothesize that CHF patients who receive the educational intervention will have better knowledge of CHF and will be more satisfied with the care they received in the hospital.
The potential impact of the proposed project may be to increase disease knowledge and health literacy, and improve adherence to CHF treatments. This, in turn, may contribute to improved medical outcomes and reduced hospital readmissions for CHF patients. In addition, if this preliminary study provides evidence of a promising educational intervention suitable for patients with low health literacy, th investigators will endeavor to test the intervention in ethnically diverse populations throughout Connecticut.
Detailed Description
Variables and Measures
We will assess health literacy with the Short Test of Functional Health Literacy in Adults (STOFHLA). The STOFHLA is a brief version of the widely used instrument, the Test of Functional Health Literacy in Adults (TOFHLA) that measures patients' ability to comprehend situations often encountered in the health care setting; e.g., reading registration forms and instructions for diagnostic tests. It is a 36-item reading comprehension test written in 14-point font that requires 7 minutes to complete.
Primary Outcome The primary outcome is readmission or death from any cause within 90 days of discharge. This outcome will be ascertained by: 1) reviewing electronic and written medical records to identify patients re-admitted to Griffin Hospital; 2) monitoring obituaries; and 3) conducting three-month post-discharge follow-up phone calls to determine if the patient was admitted elsewhere since discharge from Griffin.
Secondary outcomes
* Change in knowledge of CHF from study enrollment to two weeks post-discharge will be measured by the Knowledge of CHF Questionnaire.
* Patient satisfaction with hospital care will be examined two weeks post-discharge with the 27-item Hospital Consumer Assessment of Health Plans Survey (HCAHPS) Telephone Survey Instrument.
* Feedback on educational materials will be obtained in narrative from patients.
Other variables of interest Through review of electronic and written medical records, we will ascertain subject characteristics including demographics and socioeconomic factors and disease-related variables
Procedures Following IRB review and approval, Dr. Dorothea Wild, a study co-investigator, will review and screen new admissions to identify potentially eligible patients. Within 24 hours of admission, she will contact the attending of record to request permission to enroll the patient in the study; if permission is granted, Dr. Wild will approach the patient to describe the study and obtain consent to participate.
Obtaining consent Dr. Wild will obtain written informed consent from each patient who agrees to participate. She will inform patients that they will: 1) receive either the standard educational material provided by the Hospital for CHF patients or a more intensive educational intervention developed for this study; 2) have a 50% chance of being assigned to each group; and 3) not know whether they are receiving standard or intensive education.
Randomization, allocation concealment, and blinding Dr. Haq Nawaz will use software developed by the Johns Hopkins Division of Oncology Biostatistics to randomize patients to the usual care and educational intervention groups. Dr. Nawaz will keep group assignments in consecutively numbered opaque envelops and will reveal the assignment only to the nurse patient educator when the intervention is assigned. All other study personnel who collect and manage data will remain blind to study assignment. Patients will also be blind to group assignment throughout the trial.
Each patient in the group receiving the educational intervention will:
* view the HFSA videotape;
* receive a copy of 'Managing Your Health with Heart Failure' to review in hospital and to take home;
* receive pre-printed charts on which to record daily weigh, evidence of swelling, and whether or not s/he took prescribed diuretics, with instructions on when to inform the doctor about weight or swelling problems;
* receive a copy of 'Following a Low-Salt Diet' to review and take home;
* participate in a 45 - 60 minute one-on-one session with a nurse patient educator that reviews the above information using as a framework the 6-step strategy recommended by the AMA; and
* be encouraged to take written/pictorial notes to augment the above materials.
The nurse educator will elicit feedback from patients on the quality and accessibility of the written materials.
Each patient in the educational intervention and usual care groups will receive and review with a staff nurse:
* written information on diagnosis and treatment of CHF that is not designed for low literacy patients; and
* a pre-printed discharge instruction sheet that explains the patient's medications and dietary instructions, identifies symptoms that should be reported to the primary care physicians, and provides a physician follow-up appointment.
Post-discharge assessments The data manager will administer the Knowledge of CHF Questionnaire and the measure of patient satisfaction by telephone two weeks post-discharge. She will also regularly review obituaries and place a follow-up phone call three months post-discharge to ask about any subsequent hospitalizations, including to facilities other than Griffin.
Data safety and monitoring Because the proposed study involves an educational intervention, potential risks of participation are minimal. Nonetheless, the PI, Dr. Calvocoressi, and one co-investigator, Dr. Nawaz, will conduct monthly data and safety reviews to assess risk and monitor adverse events. An additional review will be conducted following the report of any adverse event. We will also assess whether the event can be attributed to the research (i.e., definite, possible, unrelated). Any adverse events graded 2 or higher will immediately be reported to the Griffin Hospital IRB and to the funding agency.
Data Analysis Plan The analysis plan will include univariate, bivariate, and multivariate analyses conducted with SAS software. We will conduct all analyses according to the intent-to-treat principle and will use a 0.05 (two-tailed) level of significance.
Assessing subject characteristics and the adequacy of the randomization procedure We will examine whether the control and intervention groups significantly differ on subject characteristics (e.g., socio-demographic factors, features of the disease, involvement of caregivers) that may impact the relationship between treatment group and study outcomes. For categorical variables, we will use the Chi square test for this purpose; for continuous variables, we will use the Student's t-test.
Primary outcome We will use the t-test for proportions to examine the difference in the proportions of patients in the educational and usual care groups who are re-hospitalized or die within 90 days of discharge. In addition, we will employ logistic regression to examine whether the educational and usual care groups differ on re-hospitalization/death (yes/no) at 90 days adjusted for pertinent covariates. We will conduct a secondary analysis to test the robustness of these findings. That analysis will examine whether time to re-hospitalization/death differs between the educational and usual care groups using the log rank test and the proportional hazard (Cox) model.
We will examine the interaction between treatment group (educational versus usual care) and health literacy (i.e., low versus adequate) in relation to readmission/death at 90 days post-discharge to assess whether the impact of the educational intervention differed by health literacy level.
Secondary outcomes We will examine the difference between the educational and usual care groups in knowledge of CHF at study enrollment and following discharge by calculating a continuous change score based on the two administrations of the knowledge of CHF questionnaire. We will use the paired t-test for the bivariate analysis. To control for covariates, including knowledge score at the time of enrollment, we will conduct a linear regression analysis.
The difference between the educational and usual care groups in satisfaction with treatment, measured post-discharge on a continuous scale, will be examined using the t-test and linear regression to adjust for covariates.
Power and Sample Size Calculations We have based these calculations on our primary outcome, the proportions of CHF patients in the educational and usual care groups who either die or are re-admitted to the hospital for any cause within 90 days of discharge.
A review of the Griffin Hospital database over the past three years indicates that 33.5% of CHF patients meeting our inclusion criteria were re-admitted to Griffin Hospital within 90 days. Though the patient population is quite stable and most CHF patients needing readmission probably return to this facility, we assume that an additional 5% were admitted elsewhere during the 90 days following discharge from Griffin Hospital. In addition, based on previously conducted studies of educational interventions in CHF (19), we expect that an additional 6% will die within this period. Thus, we base our calculations on 45% of the usual care group experiencing all-cause readmission or death within 90 days of discharge. For the educational group we based our calculations on a 25% absolute decrease in these events during the same time period (i.e., 20% will be re-admitted or die). This is a clinically meaningful decrease and is consistent with the difference in readmissions/deaths between control and educational intervention groups in a recent CHF outpatient study.
We used the following formula for our calculations:
n = {\[p1(q1) + p2(q2)\]/ (p2-p1)}(f(alpha,beta))
where n = number of subjects needed in each group p1 = percentage of patients in the control group who were not re-hospitalized q1 = percentage of patients in the control group who were re-hospitalized p2 = percentage of patients in the intervention group who were not re-hospitalized q2 = percentage of patients in the control group who were re-hospitalized f(alpha,beta) = 7.9 when alpha = .05 (two-sided) and beta = .20
The number of patients per group needed to detect a 25% decrease in 90 day all-cause readmission/death is 52; the total sample needed for this study is 104. Assuming that 10% of patients will refuse to participate or will be lost to follow-up, we will need to enroll 116 eligible patients.
Over the past three years, there were, on average 174 patients admitted to Griffin annually with a primary diagnosis of CHF. Seventy-three of these patients per annum would have been excluded from participation (e.g., discharged to a skilled nursing facility, too ill to participate), leaving an average of 101 patients per year meeting inclusion criteria. We should, therefore, be able to recruit the 116 subjects need for this study in approximately 14 months.
#Intervention
- BEHAVIORAL : Health Literacy-Tailored Education
- Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.
|
#Eligibility Criteria:
Inclusion Criteria:
* Eligible consecutive patients aged 50 years and over admitted with a primary diagnosis of CHF at Griffin Hospital will be invited to participate regardless of age, gender, race, or education level.
* Because dietary and medication non-compliance affect patients with both systolic and diastolic heart failure, the investigators will include patients with both of these conditions, regardless of their ejection fraction.
Exclusion Criteria:
* The investigators will exclude patients with clinical conditions and communication barriers that would limit their ability to participate in and/or benefit from this educational intervention.
* The investigators will also exclude patients whose planned discharge is to another hospital or to a structured setting in which medical personnel are responsible for their care (e.g., a skilled nursing facility), thus limiting their ability to implement a largely self-directed self-care regimen upon leaving the hospital.
* In addition, the investigators will exclude any patient who does not have a telephone and cannot, therefore, be contacted to obtain post-discharge follow-up data.
Specific exclusion criteria include:
* A diagnosis of dementia or other severe mental disorder (e.g., acute delirium, psychosis)
* Clinical instability or need for transfer to another hospital for acute intervention (e.g., experiencing cardiogenic shock, or needing valve surgery or acute coronary intervention)
* Terminal illness or intubation
* Moderate to severe uncorrected vision or hearing problems
* Inability to speak English or to provide informed consent
* Lack of access to a telephone
* Planned discharge to a structured facility (e.g., skilled nursing facility, intermediate care facility)
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
|
NCT00508716
|
{
"brief_title": "Health Literacy in Patients With Congestive Heart Failure",
"conditions": [
"Congestive Heart Failure"
],
"interventions": [
"Behavioral: Health Literacy-Tailored Education"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00508716",
"official_title": "A Randomized-Controlled Trial of a Health Literacy Tailored Educational Intervention for Hospitalized Congestive Heart Failure Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-04-15",
"last_updated_that_met_qc_criteria": "2007-07-27",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-07-30",
"first_submitted": "2007-07-26",
"first_submitted_that_met_qc_criteria": "2015-03-15"
}
}
}
|
#Study Description
Brief Summary
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.
Detailed Description
The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses (stented and stentless biological valves) using conventional open-heart surgery. As a result of the sutureless implant procedure, in fact, patients could benefit from:
Reducing aortic clamp times, with subsequent overall reduction of surgical timing and therefore reduction in related risks; Avoiding to pass the stitches through the annulus and sutures knotting, with consequent less risk of tearing aortic annulus and wall, damaging the bundle of His, embolizing foreign material in the vascular system.
#Intervention
- DEVICE : Aortic valve replacement with Perceval aortic heart valve
- Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects of >= 75 years;
* Subjects with aortic valve stenosis or steno-insufficiency;
* Subjects at high surgical risk and candidates for aortic valve replacement with a biological prosthesis;
* Subjects in NYHA functional classes III and IV with the Logistic EuroSCORE greater than 5%.
* Subjects who have agreed to participation in the clinical evaluation and who have signed the informed consent;
* Subjects who are willing to undergo all the medical follow-ups and echocardiographic examinations and laboratory tests that form part of this present protocol.
Exclusion Criteria:
* Subjects involved in any other clinical study for drugs or devices;
* Subjects who have previously undergone implantation with the Perceval S prosthesis being assessed;
* Subjects with previous implantation of valve prostheses or annuloplasty ring in mitral position;
* Subjects requiring simultaneous procedures, apart from septal myectomy and/or coronary by-pass;
* Subjects with aneurysmal dilation or dissection of the ascending aortic wall needing surgical correction;
* Subjects needing non elective intervention;
* Subjects with aortic annulus (after procedure for decalcification) of dimensions such that the implantation of a valve of size 21 or 23 mm is not possible (direct intra-operative measurement with sizer), in accordance with the indications reported in the Investigator's Brochure;
* Subjects with active endocarditis;
* Subjects with active myocarditis;
* Subjects with any anomaly of the coronary ostia determined through pre-operative coronary angiogram or during intervention itself;
* Subjects with congenital bicuspid aortic valve;
* Subjects with aortic root enlargement, where the ratio between observed and expected diameters (calculated as a function of age and patient body surface area) is > 1.3;
* Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is > 1.3;
* Subjects with myocardial infarct < =90 days;
* Subjects with known hypersensitivity to nickel alloys.
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00860730
|
{
"brief_title": "PERCEVAL Pivotal Trial",
"conditions": [
"Aortic Valve Replacement"
],
"interventions": [
"Device: Aortic valve replacement with Perceval aortic heart valve"
],
"location_countries": [
"France",
"Germany",
"Belgium",
"Switzerland"
],
"nct_id": "NCT00860730",
"official_title": "PERCEVAL Pivotal Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-08",
"last_updated_that_met_qc_criteria": "2009-03-11",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-12",
"first_submitted": "2009-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the present study was to evaluate the effects of aerobic interval training versus strength training or a combination of these regimes on factors comprising the metabolic syndrome in order to find the most effective exercise regime for patients with metabolic syndrome.
Detailed Description
In the Western world, approximately 25% of young to middle-aged adults have metabolic syndrome. There seem to be a strong age-dependence in the prevalence of the metabolic syndrome, but the incidence rises rapidly within adolescents and middle-aged groups and follows the development of obesity in the general population. Metabolic syndrome confers an increased risk of coronary heart disease, cardiovascular disease, and premature death; therefore, effective and affordable strategies to combat the syndrome would be of great individual and social importance.
Despite the general agreement that moderate-intensity physical activity for a minimum of 30 min five days per week or vigorous-intensity aerobic physical activity for a minimum of 20 min three days a week promote and maintain health, the optimal training regime to treat metabolic syndrome and its associated cardiovascular abnormalities remains uncertain.
#Intervention
- BEHAVIORAL : aerobic exercise
- carried out 3 times per week for 12 weeks
- BEHAVIORAL : strength training
- carried out 3 times per week for 12 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Having metabolic syndrome according to international diabetes foundations definition (IDF).
Exclusion Criteria:
* Unstable angina pectoris
* Uncompensated heart failure
* Myocardial infarction during the past 4 weeks
* Complex ventricular arrhythmias
* Kidney failure
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00986024
|
{
"brief_title": "Resistance and/or Endurance Training, What is Most Effective in Prevention of Cardiovascular Diseases?",
"conditions": [
"Metabolic Syndrome"
],
"interventions": [
"Behavioral: aerobic exercise",
"Behavioral: strength training"
],
"location_countries": null,
"nct_id": "NCT00986024",
"official_title": "Strength Training Versus Aerobic Interval Training to Modify Risk Factors of the Metabolic Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-03",
"study_completion_date(actual)": "2007-03",
"study_start_date(actual)": "2006-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-12-13",
"last_updated_that_met_qc_criteria": "2009-09-28",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-29",
"first_submitted": "2009-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this multicenter, randomized, double-blind, active control, non-inferiority clinical trial is to evaluate the efficacy of epinastine hydrochloride eye drops for the treatment of seasonal allergic conjunctivitis using azelastine hydrochloride eye drops as a positive control in Chinese patients. The main question it aims to answer are:
• Is the efficacy for of epinastine hydrochloride eye drops for the treatment of seasonal allergic conjunctivitis non-inferior to azelastine hydrochloride eye drops?Participants will be randomly assigned to the test group or control group in a 1:1 ratio. The test group was treated with epinastine hydrochloride eye drops + azelastine hydrochloride simulating eye drops, and the control group was treated with azelastine hydrochloride eye drops + epinastine hydrochloride simulating eye drops, which were used twice a day for 14 consecutive days.
#Intervention
- DRUG : Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln
- Epinastine Hydrochloride Eye Drops + Simulating Azelastine Hydrochloride Eye Drops are used: both eyes are administered twice daily, once in the morning and once in the evening, with an interval of 8-12 hours between administrations; each time, 1 drop of each of the two eye drops is placed in each eye into the conjunctiva, and the two eye drops are applied at intervals of more than 5 minutes.
- DRUG : Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln
- Azelastine Hydrochloride Eye Drops + Simulating Epinastine Hydrochloride Eye Drops are used: both eyes are administered twice daily, once in the morning and once in the evening, with an interval of 8-12 hours between administrations; each time, 1 drop of each of the two eye drops is placed in each eye into the conjunctiva, and the two eye drops are applied at intervals of more than 5 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to understand and voluntarily sign the informed consent form, and able to comply with the treatment plan, visits, and laboratory tests stipulated in the study. subjects under 18 years and without full capacity for civil behavior are required to sign the informed consent form in writing, and a legal guardian is also required to sign the informed consent form;
* The age on the date of signing the informed consent is equal to or greater than 12 years, gender is not limited;
* Have any one of the following three laboratory report records prior to randomization:
1. Positive eosinophil cytology results;
2. Positive specific immunoglobulin E (IgE) test;
3. Positive skin prick test;
* Clinician-diagnosed seasonal allergic conjunctivitis in both eyes based on history, symptoms, and signs.
Exclusion Criteria:
* Presence of ocular diseases that may affect the study results at the time of screening in either eye, such as blepharitis, blepharitis, dacryoadenitis, dacryocystitis, infectious conjunctivitis, keratitis, moderate-to-severe dry eye (according to the diagnostic grading of the Chinese expert consensus on dry eye), and uveitis;
* Conjunctival inflammatory proliferative lesions (including giant papillary hyperplasia, paving stone-like hyperplasia, jelly-like hyperplasia, etc.) within 2 years prior to screening in either eye;
* Best corrected visual acuity (BCVA) of less than 4.4 (five-point visual acuity) in either eye at screening;
* Intraocular pressure>21 mmHg or <8 mmHg in either eye at screening;
* Current or previous glaucoma or other optic nerve disease, or suspected glaucoma and other optic nerve disease, in either eye;
* current or previous retinal detachment, diabetic retinopathy, or the presence of any progressive retinal disease in either eye;
* Either eye has had internal eye surgery within 6 months prior to screening or has had laser eye surgery and external eye surgery within 3 months prior to screening or plans to have eye surgery during the study period;
* Ocular trauma within 3 months prior to Screening in either eye (except where, in the judgment of the Investigator, there is no impact on the study validity and safety results);
* Presence of a systemic disease at the time of screening that may affect the results of the study, e.g., dry syndrome, rheumatoid arthritis, graft-versus-host disease, systemic lupus erythematosus, scleroderma, and tuberculosis;
* Presence of severe, unstable, or uncontrolled cardiovascular, cerebral, pulmonary, hepatic, renal, autoimmune, and other relevant systemic diseases at the time of screening, e.g., severe chronic obstructive pulmonary disease (COPD), severe asthma, severe cardiac arrhythmia, significant heart failure (New York Heart Association classification >= Class III), uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 90 mmHg ), uncontrolled diabetes, etc;
* History of medical conditions that, in the judgment of the investigator, may interfere with the safe administration of topical antihistamines/mast cell stabilizers, such as hepatic or renal impairment (ALanine aminoTransferase(ALT) or ASpartate aminoTransferase(AST) >= 2.5 times the upper limit of normal; total bilirubin >= 1.5 times the upper limit of normal; and serum creatinine or urea/urea nitrogen >= 1.2 times the upper limit of normal), in the 6 months prior to screening;
* The following topical (ophthalmic) prohibited drugs have been used or are planned to be used during the study period within the time period specified prior to randomization (the number of days is the pre-randomization period of prohibition and does not include experimental drugs):
* Ocular immunosuppressive drugs (e.g. cyclosporine, tacrolimus, etc.): 60 days;
* Ocular corticosteroid drugs (dexamethasone, flumethasone, prednisone acetate, rimexolone, difluprednate, loteprednol, etc.): 45 days;
* Ocular mast cell stabilizing drugs: 14 days;
* Ocular antihistamine and decongestant drugs: 3 days;
* Ocular artificial tears: 1 day;
* Other ophthalmic drugs: 3 days.
* The following topical (dermal or nasal spray) prohibited medications have been used for the time specified prior to randomization or are planned to be used for the duration of the study (the number of days is the duration of prohibition prior to randomization):
* Antihistamines and corticosteroids for periocular skin: 7 days;
* Nasal spray immunosuppressive drugs: 60 days;
* Nasal spray corticosteroid drugs: 45 days;
* Nasal spray mast cell stabilizing drug: 14 days;
* Nasal spray antihistamine and decongestant drugs: 3 days.
* The following systemically prohibited drugs have been used or are planned to be used during the study period within the time period specified prior to randomization (the number of days is the time of prohibition prior to randomization):
* Immunotherapy and immunosuppressive agents (including biologics): 60 days;
* Long-acting corticosteroids (dexamethasone, betamethasone): 30 days;
* Leukotriene receptor antagonists (e.g., montelukast sodium): 30 days;
* Non-long-acting corticosteroids, mast cell stabilizers: 14 days;
* Antihistamines, decongestants, monoamine oxidase inhibitors: 7 days;
* Aspirin-containing drugs, non-steroidal anti-inflammatory drugs(NSAIDs): 3 days.
* Non-pharmacological treatments to reduce the signs or symptoms of seasonal allergic conjunctivitis such as cold compresses to the eyes, desensitization therapy, and saline rinsing of the eyes are planned for the duration of the study;
* Known allergic reaction to epinastine hydrochloride eye drops, azelastine hydrochloride eye drops, or any of the components of the simulated medications;
* inability to avoid wearing contact lenses for the duration of the study;
* participation in another clinical research trial within 30 days prior to randomization or planned during the study period;
* women who are pregnant or breastfeeding; subjects who have a positive pregnancy test result at screening; do not consent to the use of an effective method of contraception from the start of the study until 4 weeks after the end of the study (including hormonal methods - oral, implanted, injectable, or transdermal birth control pills; physical barrier methods - - spermicide in combination with a physical barrier method such as a diaphragm or condom; an intrauterine device; or surgical sterilization of a partner, etc.) to avoid pregnancy in themselves or their partner within 4 weeks of study start to study end for subjects of childbearing age;
* Presence of other factors that, in the opinion of the investigator, make participation in this study inappropriate, including inability or unwillingness to comply with the protocol (e.g., alcoholism, drug dependence, or psychological disorders, etc.).
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06212973
|
{
"brief_title": "A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients",
"conditions": [
"Seasonal Allergic Conjunctivitis"
],
"interventions": [
"Drug: Epinastine Hcl Oph Soln+Simulating Azelastine Hcl Oph Soln",
"Drug: Azelastine Hcl Oph Sol+Simulating Epinastine Hcl Oph Soln"
],
"location_countries": [
"China"
],
"nct_id": "NCT06212973",
"official_title": "A Phase 3, Multicenter, Randomized, Double-masked, Active Controlled Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops 0.05% in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-02",
"study_completion_date(actual)": "2023-11-02",
"study_start_date(actual)": "2023-03-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-19",
"last_updated_that_met_qc_criteria": "2024-01-15",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-19",
"first_submitted": "2024-01-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors.
Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)
#Intervention
- DRUG : Torisel
- 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.
- Other Names :
- temsirolimus
|
#Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria:
Part 1 only:
* Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system [CNS] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brain stem gliomas and optic pathway tumors)
Part 2 only:
* Subjects with histologically confirmed diagnosis of refractory or relapsed: Neuroblastoma, High-grade gliomas: glioblastoma multiforme, anaplastic astrocytomas, and other high-grade gliomas (histological confirmation waived for brain stem gliomas), Rhabdomyosarcoma.
* Measurable disease (for subjects with neuroblastoma, evaluable disease as determined by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted).
Exclusion Criteria:
Exclusion Criteria:
* Subjects receiving enzyme-inducing anticonvulsants.
* Pulmonary hypertension or pneumonitis
* Active infection or serious intercurrent illness
* Other exclusions apply
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00106353
|
{
"brief_title": "Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors",
"conditions": [
"Adenocarcinoma",
"Neoplasms"
],
"interventions": [
"Drug: Torisel"
],
"location_countries": [
"France",
"Mexico",
"United States",
"Poland",
"Germany",
"Canada",
"Russian Federation"
],
"nct_id": "NCT00106353",
"official_title": "A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2005-03"
},
"study_design": {
"allocation": null,
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-08",
"last_updated_that_met_qc_criteria": "2005-03-22",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-03-23",
"first_submitted": "2005-03-22",
"first_submitted_that_met_qc_criteria": "2010-12-10"
}
}
}
|
#Study Description
Brief Summary
The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004_050, MK0653A-043; NCT00092677).
Detailed Description
The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050, MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. No patient visits will occur. National cancer and death registries exist in 5 of the 7 countries that participated in the base SEAS trial. At the time of Follow-up study initiation, accessing the registry data in Ireland was not feasible due to local regulations and Cancer and Death registries did not exist in Germany. As a result, data will be collected only for all SEAS patients known to be alive at the end of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
|
#Eligibility Criteria:
Inclusion Criteria:
* The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01077830
|
{
"brief_title": "An Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Trial (MK-0653A-043-10)",
"conditions": [
"Cancer"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01077830",
"official_title": "A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-02",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2010-03"
},
"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)": "2022-02-09",
"last_updated_that_met_qc_criteria": "2010-02-26",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-01",
"first_submitted": "2010-02-26",
"first_submitted_that_met_qc_criteria": "2013-12-16"
}
}
}
|
#Study Description
Brief Summary
This study evaluated the motor and sensory block duration and the postoperative analgesic effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block Anesthesia. Motor and sensory block duration were considered as a primary endpoint.
Detailed Description
The supraclavicular approach to the brachial plexus provides more consistent and effective regional anesthesia to the upper extremity than other approaches to brachial plexus blockade. However, the fear of pneumothorax is often cited by anesthetists as a reason to avoid this approach. With increasing affirmation on patient safety and better patient outcomes, ultrasound guided regional anesthesia (UGRA) is becoming more widely popular. Ultrasound provides clinicians with a real time image suitable for visualizing anatomical structures, needle placement, and local anesthetic spread. Ultrasound-guidance to supraclavicular brachial plexus block has shown to increase success rates, reduce the volume of local anesthetic (LA) used and has the potential to minimize the risk of complications.
Although there are many treatment choices for postoperative pain, a gold standard has not been established. Prolonging the duration of peripheral nerve blocks using long-acting Local Anesthesia or perineural catheters can be used. However, perineural catheters are more time-consuming, costly, has possible higher complication rates (e.g. Infection), and needs more postoperative care.
Several adjuvants such as fentanyl, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), tramadol, and magnesium have been used to extend the duration of peripheral nerve blocks. 5-7 Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.
The investigators designed this study to evaluate the effect of adding magnesium sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block anesthesia. The sensory and motor block durations were evaluated as primary endpoints and the postoperative analgesic effects as a secondary endpoint.
#Intervention
- DRUG : Magnesium Sulphate
- Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells.
- Other Names :
- Bupivacaine HCL 0.5%
|
#Eligibility Criteria:
Inclusion Criteria:
* - ASA physical status I to II,
* - Patients listed for elective forearm or hand surgery using supraclavicular brachial plexus block anesthesia
Exclusion Criteria:
1 - evidence of severe cardiovascular, renal, or hepatic diseases, preexisting neurological or psychiatric illnesses.
2- patients have allergy to the study drugs. 3 - patients who have any contraindications to brachial plexus block anesthesia.
4- pregnant or lactating women, or 5- if the BMI was > 35 kg/m2.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02752334
|
{
"brief_title": "Magnesium Sulphate in the Ultrasound-guided Supraclavicular Brachial Plexus Block",
"conditions": [
"Pain"
],
"interventions": [
"Drug: Magnesium Sulphate"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT02752334",
"official_title": "The Effect on Outcome of Adding Magnesium Sulphate to Bupivacaine in the Ultrasound-guided Supraclavicular Brachial Plexus Block Anesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02",
"study_completion_date(actual)": "2019-03",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-08",
"last_updated_that_met_qc_criteria": "2016-04-21",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-26",
"first_submitted": "2016-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
Detailed Description
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.
#Intervention
- DRUG : Alogliptin and metformin
- Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
- Other Names :
- SYR-32, Glycoran
- DRUG : Alogliptin and metformin
- Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
- Other Names :
- SYR-322, Glycoran
- DRUG : Metformin
- Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
- Other Names :
- Glycoran
|
#Eligibility Criteria:
Inclusion Criteria:
* Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
* Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
* Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
* Was receiving specific diet and exercise (if any) therapies during the observation period.
Exclusion Criteria:
* Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
* With a history or symptoms of lactic acidosis.
Sex :
ALL
Ages :
- Minimum Age : 26 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01318109
|
{
"brief_title": "Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Alogliptin and metformin",
"Drug: Metformin"
],
"location_countries": null,
"nct_id": "NCT01318109",
"official_title": "A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin in Subjects With Type 2 Diabetes in Japan",
"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)": "2008-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-02-03",
"last_updated_that_met_qc_criteria": "2011-03-17",
"last_verified": "2012-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-18",
"first_submitted": "2011-03-16",
"first_submitted_that_met_qc_criteria": "2011-06-08"
}
}
}
|
#Study Description
Brief Summary
This study aims to apply baseline MRI and neuropsychological measures to predict patient responses to behavioral cognitive rehabilitation. Training will take place over 12 weeks, 1 hour per day, 5 days per week.
The investigator hypothesizes the following:
\[1a\] The investigator expects that individuals with low baseline Conscientiousness will experience a lower magnitude of overall cognitive improvement following rehabilitation
1. b\] The investigator expects the impact of Conscientiousness on fidelity of rehabilitation will in part be moderated by individual differences in program adherence and executive function
2. a\] The investigator expects that individual differences in structural and functional connectome disturbances will in part explain differences in participant responses to cognitive rehabilitation.
This study will also serve to supplement the sample of participants for the current IRB approved study ((IRB: 603069, Title: A case-control, 5-year follow-up study of cardiovascular, environmental and genetic risk factors for disease progression in patients with multiple sclerosis.
Detailed Description
The participant will be asked to make a total of two (2) visits, approximately 90 days apart. Each visit will involve: neuro-performance testing, and self-report questionnaires. Each study visit is expected to take approximately 1-2 hours. Between the two visits, the participant will be asked to complete a 12 week, computer-based cognitive training program. This includes 1 hour of training each day for 5 days each week.
On Visit 1, the participants will undergo a full battery of neuro-performance tasks including tests and questionnaires that will measure their memory, thinking speed, fatigue, and personality. This visit is expected to take approximately 1-2 hours. The participants will be also asked to have a close friend or family member to complete similar surveys. A self-addressed envelope containing these questionnaires will be provided to take home with them. The participant will need to pass it onto a close friend or family member to be completed and mailed back.
In addition, the participant will be asked to take part in the 12 week computerized cognitive training program. This can be done at home, or anywhere the participant has access to a computer and internet. This cognitive training has been shown to improve cognitive performance in people with multiple sclerosis. The training involves a variety of interactive exercises which adapt to their abilities. The participants will need complete 1 hour of training each day, for 5 days each week.
At 90 days, the participant will return for the 1-2 hours' follow-up visit where they will complete the same cognitive testing and questionnaires which they had completed during visit 1.
All study visits will take place at Buffalo General Hospital. All of the procedures described above will be performed by a trained member of the research team as part of the research study.
If an individual is ineligible for participation, their screening information will be discarded (i.e., shredded). If participants are deemed eligible (either in person or over the phone), they will be scheduled to come in to the hospital for neuropsychological testing. Written consent will be obtained prior to administration of tests. As part of the consent process, participants will be asked for permission to use any data collected as part of the screening process as well.
#Intervention
- BEHAVIORAL : Cognitive Training
- Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.
|
#Eligibility Criteria:
Inclusion Criteria:
For all subjects:
* males and females above age 18
* fluent in English
* education >9 years
Additional inclusion criteria for MS patients are as follows:
* Clinically definite MS diagnosis
* Expanded Disability Status Scale (EDSS) <= 6.5
* MS patients must be relapse-free and stable from the time of their MRI acquired for the CEG-MS study
* Willing and able to comply with the study procedures for the duration of the trial
Exclusion Criteria:
* history of serious medical or psychiatric illness (other than MS in the patient group) that may affect cognitive functioning
* color-blindness
* history of developmental disability
* past or current alcohol or substance dependence
* History of major depressive disorder, bipolar disorder, or psychotic disorder predating the onset of MS
* History of traumatic brain injury as defined by trauma causing loss of consciousness or transient post-traumatic or retrograde amnesia exceeding 5 min
* Other pathology related to MRI abnormalities
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
|
NCT03306875
|
{
"brief_title": "Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Behavioral: Cognitive Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03306875",
"official_title": "Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-30",
"study_completion_date(actual)": "2018-10-20",
"study_start_date(actual)": "2017-11-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-26",
"last_updated_that_met_qc_criteria": "2017-10-05",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-11",
"first_submitted": "2017-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether a computer-driven system (Smartcare/PS) decreases weaning duration from mechanical ventilation when compared to usual care in children.
Detailed Description
Baseline data: All subjects included into this RCT will undergo routine examination upon admission to the hospital. These examinations include physical, medical/medication history (on the last year for medical history and the last 3 months for medication history (if available), vital signs, radiologic data and laboratory tests.
Intervention: A pre-inclusion test (pressure support test) with a level of pressure support of ± 5 cmH2O of the P plateau, but no greater than 30 cmH2O (pressure-support level plus positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this ventilation mode; the test is repeated daily until positive. The test could be stopped before 30 minutes if the patient showed evidence of respiratory distress (respiratory rate \> 40 breaths per minute and FiO2 \> 60% in order to obtain pulse oxymetry ≥ 95%). The test is considered positive when, after 30 minutes, the patient remained clinically stable with a respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than 6 ml per kilogram of body weight within the authorized pressure-support range, with pulse oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than 60 percent. When the pressure-support test is positive, the patient is randomized either to Arm 1 where the intervention is weaning with the support of Smartcare/PS or to Arm 2 where the intervention is weaning based on usual care. Both group are ventilated with the same ventilator: Evita XL.
#Intervention
- DEVICE : Smartcare/PS
- computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status
- Other Names :
- Weaning from mechanical ventilation with Smartcare/PS
|
#Eligibility Criteria:
Inclusion Criteria:
* The attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously.
* No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (< 5 µg/kg/min)
* Slight or no endotracheal tube gas-leakage ([Vti - Vte]/Vti <= 20%)
* Mechanical ventilation with a plateau pressure <= 25 cmH2O over PEEP
* PEEP <= 8 cmH2O
* FiO2 <= 60% in order to obtain pulse oxymetry >= 95%
* PaCO2 < 70 mmHg on the last blood gases
* Extubation not expected the day of inclusion
Exclusion Criteria:
* N/A
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00678912
|
{
"brief_title": "Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care",
"conditions": [
"Respiratory Failure"
],
"interventions": [
"Device: Smartcare/PS"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00678912",
"official_title": "Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2007-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-19",
"last_updated_that_met_qc_criteria": "2008-05-15",
"last_verified": "2012-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-16",
"first_submitted": "2008-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research study, conducted by Truth Initiative, will help us learn how text messaging can help young adults between 18 and 24 years of age quit vaping.
Detailed Description
The Quit Vaping Study (QVS)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 18-24. This study is a 2-arm randomized controlled trial conducted among young users aged 18-24 recruited through online channels. Participants will be randomized to a quit vaping text message intervention or to an assessment-only control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.
#Intervention
- OTHER : This is Quitting
- Text message-based intervention for quit vaping support.
- OTHER : Assessment only Control
- Assessment only
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 24
* Past 30-day use of e-cigarettes containing nicotine
* Interest in quitting e-cigarette use in the next 30 days
* US residence
Exclusion Criteria:
* Failure to confirm mobile number after initial sign-up
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 24 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04251273
|
{
"brief_title": "Text Message Quit Vaping Intervention for Young Adults",
"conditions": [
"Tobacco Cessation"
],
"interventions": [
"Other: Assessment only Control",
"Other: This is Quitting"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04251273",
"official_title": "A Randomized Trial of a Text Message Quit Vaping Intervention for Young Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-12",
"study_completion_date(actual)": "2020-11-12",
"study_start_date(actual)": "2019-12-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-10",
"last_updated_that_met_qc_criteria": "2020-01-29",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-31",
"first_submitted": "2020-01-23",
"first_submitted_that_met_qc_criteria": "2022-05-17"
}
}
}
|
#Study Description
Brief Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.
Detailed Description
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.
#Intervention
- DRUG : Atorvastatin10mg, Ezetimibe10mg
- Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
- Other Names :
- CKD-391
- DRUG : Atorvastatin10mg, Ezetimibe placebo
- Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
- Other Names :
- Lipitor
- DRUG : Atorvastatin20mg, Ezetimibe10mg
- Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
- Other Names :
- CKD-391
- DRUG : Atorvastatin20mg, Ezetimibe placebo
- Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
- Other Names :
- Lipitor
- DRUG : Atorvastatin40mg, Ezetimibe10mg
- Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
- Other Names :
- CKD-391
- DRUG : Atorvastatin40mg, Ezetimibe placebo
- Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
- Other Names :
- Lipitor
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult, at least 19 years.
* Hyperlipidemia patient of LDL-C<=250 mg/dl and TG <=400 mg/dl
* Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
* Drug compliance during Run-in period >=70%
* Patients must willing to the study and signed an informed consent
Exclusion Criteria:
* Patients with myopathy included rhabdomyolysis or CPK level>=2xULN
* Patients with acute arterial disease
* Patients with renal dysfunction or Serum creatinine level >=2x ULN
* Patients with liver dysfunction or ALT, AST level > 2xULN
* Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
* Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP>=180mmHg or DBP>=110mmHg, hypothyroidism as TSH>=1.5xULN)
* Patients who have a history or presence of active malignancy within 5 years
* Patients with difficulty of stop taking lipid-lowering agents during run-in period.
* Patients who have taken another investigational drug within 4 weeks prior to screening visit.
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
|
NCT02451098
|
{
"brief_title": "Clinical Trial to Evaluate the Efficacy and Safety of CKD-391",
"conditions": [
"Hyperlipidemia"
],
"interventions": [
"Drug: Atorvastatin40mg, Ezetimibe placebo",
"Drug: Atorvastatin20mg, Ezetimibe10mg",
"Drug: Atorvastatin40mg, Ezetimibe10mg",
"Drug: Atorvastatin10mg, Ezetimibe10mg",
"Drug: Atorvastatin20mg, Ezetimibe placebo",
"Drug: Atorvastatin10mg, Ezetimibe placebo"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02451098",
"official_title": "A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2015-03"
},
"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)": "2016-01-28",
"last_updated_that_met_qc_criteria": "2015-05-20",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-21",
"first_submitted": "2015-05-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study investigated the effect of facilitated tucking in the early postpartum period on preterm neonate comfort and breastfeeding performance.
Detailed Description
Individualized Developmental Care (IDC) offered by NICUs yields positive outcomes in preterm neonates and neonates. Those positions should be comfortable and safe to promote physiological stability and optimal neuromotor development. The facilitated tucking position is the position of the baby in its mother's womb. It calms the neonate and helps it feel safe and maintain body control. It also improves sleep quality, stabilizes physiological parameters, gives a sense of security, supports motor development, and optimizes energy use. The facilitated tucking position makes it easier for preterm neonates to undergo invasive procedures (heel blood collection, aspiration etc.). However, there is no published research examining the effect of the facilitated tucking position in the early postpartum period on physiological parameters, comfort, and breastfeeding performance in preterm neonates.
#Intervention
- BEHAVIORAL : Facilitation Tuchking Position
- The nurse placed the neonate in the facilitated tucking position by rolling up a sizeable sterile towel in a U-shape and covering it with covers available in the unit and then placed the neonate in a supine position. The physiological parameters at admission and in the 15th and 30th minutes of facilitated tucking were recorded. In the 30th minute of facilitated tucking, the researcher and the observer nurse completed the COMFORTneo simultaneously but separately. The neonate was in the facilitated tucking position until delivered to its mother. The researcher and the observer nurse had a full view of the neonate's face and body when completing the COMFORTneo, which took them about two minutes. After the neonate stabilized (within the first half an hour to an hour), it was delivered to its mother for breastfeeding based on specialist consent. The first breastfeeding was performed and completed the LATCH by researcher and the observer nurse.
|
#Eligibility Criteria:
Inclusion Criteria:
* Born at 35 <= age <= 37 weeks of gestation,
* Appropriate weight for the week of gestation,
* 1-min and 5-min Apgar score of >= 8,
* No oxygen therapy,
* No anatomical and physiological problems,
* Showing no signs of illness,
* No congenital disorder,
* No breastfeeding problems
Exclusion Criteria:
* No parental consent
* Medical intervention other than the follow-up
Sex :
ALL
Ages :
- Minimum Age : 35 Weeks
- Maximum Age : 37 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04704180
|
{
"brief_title": "Facilitated Tucking Position's Effect on Comfort and Breastfeeding",
"conditions": [
"Breastfeeding, Exclusive",
"Position",
"Preterm Birth"
],
"interventions": [
"Behavioral: Facilitation Tuchking Position"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04704180",
"official_title": "The Effect of Facilitated Tucking in the Early Postpartum Period on Preterm Neonatal Comfort and Breastfeeding Performance: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-29",
"study_completion_date(actual)": "2019-07-03",
"study_start_date(actual)": "2018-11-29"
},
"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)": "2021-01-11",
"last_updated_that_met_qc_criteria": "2021-01-07",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-11",
"first_submitted": "2021-01-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Comorbid chronic lung disease (CLD) increases mortality in heart failure (HF) patients. Understanding the predictors and pathophysiology of HF can improve the efficacy of HF treatment. This study evaluated the cardiopulmonary exercise test (CPET) results to identify significant predictors on long-term outcomes in HF patients with CLD.
Detailed Description
The CPET was administered in a cohort of 169 HF outpatients with exercise intolerance at a tertiary referral center between May 2007 and July 2010. A CLD was defined as abnormal spirometry accompanied by clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease criteria. The primary endpoint was defined as CV mortality or the first HF hospitalization. Totally 49 events occurred before the end of follow up in January 2018.
#Intervention
- DIAGNOSTIC_TEST : cardiopulmonary exercise test
- Patients performed an upright graded bicycle exercise using a personalized protocol or performed a motorized treadmill exercise using a modified Bruce protocol. Peak VO2 and peak respiratory exchange ratio (RER) were defined as the highest 30-second average value obtained during exercise. The anaerobic threshold (AT) was determined by V-slope method. The VE(minute ventilation)/VCO2 (carbon dioxide production) at AT was calculated as the average VE/VCO2 for 1 minute during AT and immediately after AT. If AT could not be determined, the lowest VE/VCO2 was determined by averaging the three lowest consecutive 0.5-minute data points.
|
#Eligibility Criteria:
Inclusion Criteria:
* outpatients >= 18 years, male or female.
* Patients with a diagnosis of heart failure with clinical symptoms and echocardiography evidence
* Patients received cardiopulmonary exercise test exams
Exclusion Criteria:
* Cannot tolerance exercise test due to muscular-skeletal disorder
* Cannot co-operate all functional studies
* Family reject to participate in this project
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
|
NCT04141345
|
{
"brief_title": "Comorbid Chronic Lung Disease on Heart Failure",
"conditions": [
"Comorbid Chronic Lung Disease on Heart Failure"
],
"interventions": [
"Diagnostic Test: cardiopulmonary exercise test"
],
"location_countries": null,
"nct_id": "NCT04141345",
"official_title": "Influence of Comorbid Chronic Lung Disease on Heart Failure Long-Term Outcomes: Relevance of Ventilatory Inefficiency",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2007-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-28",
"last_updated_that_met_qc_criteria": "2019-10-24",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-28",
"first_submitted": "2019-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.
Detailed Description
Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.
#Intervention
- BEHAVIORAL : Observational
- No intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* 50 <= age <= 85 of age, able to communicate in English, history of heart disease
Exclusion Criteria:
* history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00320905
|
{
"brief_title": "Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation",
"conditions": [
"Cardiovascular Disease"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00320905",
"official_title": "Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-02",
"study_completion_date(actual)": "2008-03",
"study_start_date(actual)": "2006-03"
},
"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)": "2010-07-20",
"last_updated_that_met_qc_criteria": "2006-05-01",
"last_verified": "2010-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-03",
"first_submitted": "2006-05-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. The null hypothesis was that there was no difference in satisfaction with length of hospital stay.
Detailed Description
Objective: To determine whether women having day-case laparoscopic supracervical hysterectomy (LSH) are as satisfied with the length of stay in hospital as women who stay overnight following the procedure.
Design: randomised controlled trial (RCT).
Setting: Ulleval university hospital, Oslo, Norway.
Population: 49 women scheduled for LSH were enrolled and 45 patients completed the study (22 in the inpatient group and 23 in the day-case group).
Methods: Women were randomised to either day-case care or overnight hospital stay following a routine supracervical hysterectomy. The primary outcome measure was satisfaction with the length of stay in the hospital (measured on a 10-point visual analogue scale) and secondary measures were health-related quality of life (measured using the EuroQol EQ5D), anxiety (measured using the State-Trait Anxiety Inventory for Adults (STAI) and general questions about their experiences of having the operation. Readmissions, prolonged hospitalisations, complications and any contact with a health professional after discharge were also recorded. Measures were taken on the day of surgery (postoperatively), and on days 1, 2, 4 and 7 following surgery. The data were analysed based on an intention to treat.
#Intervention
- PROCEDURE : day-case laparoscopic supracervical hysterectomy
- patients discharged home the same day of the operation
- Other Names :
- day surgery, day-case, outpatient surgery
- PROCEDURE : inpatient LSH
- patients discharged home the day after the operation
- Other Names :
- inpatient, overnight stay
|
#Eligibility Criteria:
Inclusion Criteria:.
* women requiring a hysterectomy for benign conditions
Exclusion Criteria:
* previous history of cervical dysplasia, an abnormal smear test within the last two to three years,
* abnormal histology or cytology at endometrial sampling,
* a history of endometriosis,
* advanced endometriosis diagnosed intra-operatively,
* previous major abdominal or pelvic surgery (patients with previous caesarean section were considered as eligible),
* a mental disorder or somatic disease that would interfere with a normal recovery pattern such as substance dependence disorder,
* psychosis, or American Society of Anaesthesiologists (ASA) rating 3 and 4 patients, and
* inability to understand and execute oral and written Norwegian language.
* women were also excluded from the study if they did not have an adult carer (a relative or a friend) staying with them during the first night after discharge; or they were living or staying at a hotel more than an hour's drive from the hospital; and if they did not have access to a telephone.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01127243
|
{
"brief_title": "Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy",
"conditions": [
"Hysterectomy"
],
"interventions": [
"Procedure: inpatient LSH",
"Procedure: day-case laparoscopic supracervical hysterectomy"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01127243",
"official_title": "Do Women Prefer to Stay in Hospital Following Hysterectomy? A Randomised Trial of Day-case Versus Inpatient Laparoscopic Supracervical Hysterectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-05-20",
"last_updated_that_met_qc_criteria": "2010-05-19",
"last_verified": "2009-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-20",
"first_submitted": "2010-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.
#Intervention
- DRUG : metformin
- metformin tablets 2 g x 2
- Other Names :
- glucophage
- DRUG : insulin detemir
- insulin as requested
- Other Names :
- Levemir
- DRUG : insulin aspart + insulin aspart protamin
- insulin as requested
- Other Names :
- novomix
- DRUG : Insulin aspart
- insulin as requested
- Other Names :
- NovoRapid
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females > 30 years
* Type 2 diabetes
* Body mass index (BMI): 25.0 <= age <= 39.9 kg/m2
* HbA1c above 7.5 %
* Antidiabetic tablet-treatment during 1 year minimum AND / OR
* Insulin treatment during a minimum of 3 months
* Negative pregnancy test
* Signed, informed consent
Exclusion Criteria:
* MI, coronary revascularization, TCI,or apoplexy within the last 3 months
* TCI with verified stenosis of above 70%
* Heart failure (NYHA class III or IV)
* Former cancer patient, unless disease-free period of more than 5 years
* estimated creatinine clearance < 60 ml/min Liver disease
* Alcohol abuse
* Drug abuse
* Retinopathy with on-going laser treatment at start of study
* Other acute or chronic serious disease leading to hypoxia
* Pregnant or breastfeeding women
* Women of child-bearing potential, not using contraceptives
* Allergy to medication used in the study
* Incapable of understanding the nature of the informed consent
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00657943
|
{
"brief_title": "The Copenhagen Insulin and Metformin Therapy Trial",
"conditions": [
"Type 2 Diabetes",
"Atherosclerosis",
"Arteriosclerosis"
],
"interventions": [
"Drug: Insulin aspart",
"Drug: insulin aspart + insulin aspart protamin",
"Drug: metformin",
"Drug: insulin detemir"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT00657943",
"official_title": "The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-02-04",
"last_updated_that_met_qc_criteria": "2008-04-11",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-14",
"first_submitted": "2008-04-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg (Reference, R) following oral administration.
Secondary Objective:
To investigate the safety and tolerability of meloxicam following a single dose of meloxicam capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese subjects.
#Intervention
- DRUG : Meloxicam capsule
- DRUG : Meloxicam tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study
* Healthy adult male, aged between 20 and 40 years
* Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram [kg]/height in meters2 [m2]).
* Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
* No significant deviation from biochemistry including: aspartate transaminase (SGOT/AST), alanine transaminase (SGPT/ALT), gamma-glutamyl-transferase (GGT), alkaline phosphatase, total bilirubin, albumin, glucose, blood urea nitrogen (BUN), creatinine, uric acid, total cholesterol and triglyceride.
* No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
* No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.
Exclusion Criteria:
* History of drug or alcohol abuse within the past one year
* Medical history of allergic asthma or sensitivity to analogous drug
* Evidence of chronic or acute infectious diseases from 4 weeks before the study
* Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
* Ongoing peptic ulcer and constipation
* Planned vaccination during the time course of the study.
* Taking any clinical investigation drug from 3 months before the study
* Use of any medication, including herb medicine or vitamins from 4 weeks before the study
* Blood donation of more than 500 ml within the past 3 months
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
* A positive test for HIV antibody
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02183181
|
{
"brief_title": "Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Meloxicam capsule",
"Drug: Meloxicam tablet"
],
"location_countries": null,
"nct_id": "NCT02183181",
"official_title": "A Randomized, Single-dose, Two-way Crossover Study to Assess the Bioequivalence of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) Administered to Healthy Adult Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-01",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-08",
"last_updated_that_met_qc_criteria": "2014-07-04",
"last_verified": "2014-07"
},
"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
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. We aim to investigate the efficacy and safety of remote programming.
Detailed Description
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated to guarantee proper functioning. In France, the follow-up of approximately 400 000 patients implanted with a CIED is performed by cardiologists. Remote monitoring allows for interrogation of contemporary CIEDs and has revolutionized the care for implanted patients. Early detection of arrhythmias, lead issues, battery depletion and algorithm side effects decreases both morbidity and mortality of CIED patients which is why today remote monitoring enjoys a class IA recommendation. While remote interrogation is advancing steadily, remote programming is not at all possible today. CIED problems may be quickly solved by changing the parameters but this is only possible when the patient visits a cardiologist capable of performing CIED programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists (in small clinics or diagnostic centers) and the possibility to offer expert support at remote locations or developing countries. At Bordeaux University, we have developed a method which enables remote programming of a CIED. The method requires the patient to be in direct vicinity of a CIED programmer, while the cardiologist specialized in CIED programming can operate the programmer from any remote location. We aim to investigate the efficacy and safety of remote programming by applying our method to implanted patients to perform remote interrogation and programming changes.
#Intervention
- OTHER : Interrogation/programming
- As the study investigates remote programming, we will describe two locations: local (patient side) and remote (expert side). Local support is defined by a physician or a technician under the direct responsibility of a nearby physician who connect the patient to the remote programming system. Similar to a conventional check-up, an external defibrillator will be located in the near vicinity of the patient. The patient will first be connected to the programmer as during a conventional follow-up. The programmer will then be connected to a local PC which captures the programmer VGA video output and controls the programmer through a mouse emulator. This local PC will be remotely controlled by the remote PC using Cisco Webex, a communication software used worldwide to support telemedicine.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient of both sexes over the age of 18
* Patients implanted with a cardiac pacemaker or an automatic defibrillator and an indication for device check-up (interrogation ± programming) which may be periodic as part of their follow-up, postoperative, following a remote monitoring alert, pre/post MRI or following symptoms.
* Person beneficiary of social security insurance.
* Informed consent confirmed in writing (at the latest on the day of inclusion and before any examination required by the research).
* Women of procreating age with effective contraception
Exclusion Criteria:
* Patients younger than 18 years
* Patients who are incapable to understand the study design or to give informed consent.
* Pregnant or breastfeeding women
* Persons placed under judicial protection, curatorship, tutorship.
* Subject deprived of liberty on judicial or administrative decision
* Persons participating in another study who are still in their period of exclusion
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
|
NCT05366660
|
{
"brief_title": "Remote Programming of Cardiac Implantable Electronic Device",
"conditions": [
"Defibrillators, Implantable",
"Follow-Up Studies",
"Pacemaker, Artificial",
"Telemedicine",
"Algorithms"
],
"interventions": [
"Other: Interrogation/programming"
],
"location_countries": [
"France"
],
"nct_id": "NCT05366660",
"official_title": "Remote Programming of Cardiac Implantable Electronic Device",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-04",
"study_completion_date(actual)": "2022-04-04",
"study_start_date(actual)": "2021-06-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-29",
"last_updated_that_met_qc_criteria": "2022-05-05",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-09",
"first_submitted": "2022-05-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project aims to help Veterans who are in medical treatment and have untreated alcohol problems. First, the investigators adapted a Decision Aid that explains alcohol-related treatment options and their risks and benefits. Then, the investigators are determining the effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and to improve drinking- and medical-related outcomes over time. It may also decrease Veterans' use of expensive health services such as hospitalizations and emergency visits. Finally, the investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The project should increase patient-centered health care for Veterans with alcohol problems to benefit their recovery.
Detailed Description
In fiscal year 2014, over 57,000 Veterans with diagnosed alcohol use disorders (AUDs) received VHA inpatient medical-surgical services. This likely underrepresents the prevalence of AUDs among Veteran inpatients, because these conditions often go undiagnosed during hospital stays. The high prevalence of AUDs among VHA medical and surgical patients is of critical concern because AUDs and medical conditions exacerbate one another, and their co-occurrence increases the use of costly health services. Yet, there are no evidence-based strategies that improve outcomes in this patient population by means of increased utilization (initiation, engagement) of AUD treatment services. The investigators have identified Drinking Options: Motivate, Shared Decisions, Telemonitor (DO-MoST) as a potential solution to the critical need for evidence-based strategies.
This project is evaluating DO-MoST as a new and innovative intervention to facilitate the transition from medical-surgical care to AUD treatment in primary and specialty care settings, thereby improving Veterans' AUD and medical outcomes. DO-MoST entails use of motivational interviewing and a decision aid during the inpatient stay to facilitate informed choices about drinking options and resources for help to change drinking, if desired, followed by telephone calls with the patient to continue to motivate and support decisions. In addition to determining the effectiveness of DO-MoST, this project includes a process evaluation - that is, will gather information from providers and patients on DO-MoST's implementation at the two project sites - to inform VA's potential widespread implementation of DO-MoST with medical-surgical patients with AUDs.
Using an effectiveness/implementation Hybrid Type 1 design, incorporating a randomized controlled trial (RCT) and process evaluation to facilitate future implementation, this project has three Specific Aims.
Aim 1: Adapt a decision aid being implemented with AUD patients in non-VA primary care settings to be appropriate for Veterans with AUDs in medical-surgical treatment settings. With this prototype, the investigators will conduct alpha testing with patients and providers, and adapt and pilot the decision aid to finalize it for use in the RCT.
Aim 2: Conduct DO-MoST at two VA facilities (Ann Arbor and Palo Alto) and evaluate its effectiveness.
The primary hypotheses are: Patients in DO-MoST, compared to patients in usual care (UC), will be more likely to (1) utilize AUD help (initiate, engage), (2) have better AUD (fewer heavy drinking days) and medical (physical status) outcomes, and (3) have fewer and more delayed acute care episodes (Emergency Department visits, rehospitalizations). Patients will be assessed at baseline, and 3, 6, and 12 months post-baseline, for outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and DO-MoST groups on course of outcomes.
Aim 3: Conduct a qualitative process evaluation to inform the wider implementation of DO-MoST, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The purpose is to provide guidance for VA facilities' broader adoption of DO-MoST in the future, including its possible adaptation for diverse subpopulations of Veterans, such as patients with mental health diagnoses (e.g., PTSD).
In summary, this project will develop a decision aid and comprehensively examine DO-MoST as a novel and groundbreaking approach to providing a bridge between medical-surgical treatment and AUD treatment. Decision Aids have been used successfully in a number of contexts, but never with medical-AUD patients. The investigator's operations partners from VHA Office of Mental Health and Suicide Prevention, and Medical Service, are committed to directly addressing the dangerous, costly pattern of Veterans obtaining medical-surgical services but not receiving the AUD treatment they need. The project is focused on priorities in the VA Blueprint for Excellence, of HSR\&D Service, and of the PIs' HSR\&D Centers of Innovation.
#Intervention
- BEHAVIORAL : Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)
- Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
|
#Eligibility Criteria:
Inclusion Criteria:
Medical-surgical inpatients with alcohol use disorder at the Ann Arbor or Palo Alto VA. Specifically:
* in a current episode of medical-surgical care,
* meet DSM 5 criteria for an AUD
* no specialty addiction treatment or weekly mutual-help group attendance within 60 days prior to the inpatient episode,
* no restricted access due to infection control requirements (e.g., TB, MRSA, C. diff),
* no significant cognitive impairment,
* ongoing access to a cell or land line telephone,
* at least one contact who will continue to know the patient's contact information, and (8) not having participated in an interview for Aim 1 of this project.
Exclusion Criteria:
See inclusion criteria.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03258632
|
{
"brief_title": "Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders",
"conditions": [
"Alcohol Use Disorder"
],
"interventions": [
"Behavioral: Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03258632",
"official_title": "Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-26",
"study_completion_date(actual)": "2022-05-31",
"study_start_date(actual)": "2018-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-17",
"last_updated_that_met_qc_criteria": "2017-08-21",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-23",
"first_submitted": "2017-08-15",
"first_submitted_that_met_qc_criteria": "2024-04-16"
}
}
}
|
#Study Description
Brief Summary
The article presents the results of a randomized, placebo-controlled study of the conservative treatment with Daflon (Detralex) in female patients with Pelvic congestion syndrome .
#Intervention
- DRUG : Daflon
- All consecutive patients were randomly allocated into 2 groups to receive Daflon (Detralex) at a dose of 1000 mg once daily (study group) or placebo (control group).
|
#Eligibility Criteria:
Inclusion Criteria:
*The presence of pelvic varicose veins verified by transvaginal and transabdominal duplex ultrasound scanning
Exclusion Criteria:
* Severe disease of the gastrointestinal tract or hematopoietic system
* Terminal stage of cardiovascular, respiratory, renal or hepatic failure
* Grade IV malignancy
* Peripheral artery disease (PAD) of the lower extremities, any type of diabetes, or mental disease.
* Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04512443
|
{
"brief_title": "Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome",
"conditions": [
"Pelvic Congestion Syndrome"
],
"interventions": [
"Drug: Daflon"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT04512443",
"official_title": "Clinical Efficacy of Conservative Treatment in Female Patients With Plevic Congestion Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-28",
"study_completion_date(actual)": "2020-03-28",
"study_start_date(actual)": "2019-12-28"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-13",
"last_updated_that_met_qc_criteria": "2020-08-12",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-13",
"first_submitted": "2020-08-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.
Detailed Description
Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.
#Intervention
- OTHER : Plant- based, olive oil diet
- used as part of daily diet, followed for 8 weeks
- Other Names :
- plant-based, olive oil diet
- OTHER : Prostate Cancer Foundation diet
- followed for 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* prostate cancer, BMI 25.0 to 40.0 kg/m2
Exclusion Criteria:
*
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03084913
|
{
"brief_title": "Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Other: Prostate Cancer Foundation diet",
"Other: Plant- based, olive oil diet"
],
"location_countries": null,
"nct_id": "NCT03084913",
"official_title": "Comparing Diets for Weight Loss and Improvement in Cancer Biomarkers in Men With Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11-30",
"study_completion_date(actual)": "2016-11-30",
"study_start_date(actual)": "2015-01-01"
},
"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)": "2017-03-21",
"last_updated_that_met_qc_criteria": "2017-03-20",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-21",
"first_submitted": "2017-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to investigate the feasibility and efficacy of a high intake of milk and/or cheese products compared to phosphate tablets in patients with hypophosphatemic rickets when evaluating the S-phosphate levels as a main effect parameter. The study was designed as a randomized, multiple crossover study.
Detailed Description
Objectives:
Standard treatment of hypophosphatemic rickets consists of oral phosphate tablets and vitamin D analogous. Due to their rapid absorption, serum-phosphate fluctuations can occur and secondary hyperparathyroidism may be a consequence. Our aim was to evaluate, if phosphate supplement administered as milk or cheese is superior or equal to phosphate tablets in patients with hypophosphatemic rickets
Study population:
Patients with genetic verified hypophosphatemic rickets were included in the period from August 2015 to June 2016. Patients were excluded from the study if they presented with tertiary hyperparathydoism, were treated with Cinacalcet or suffered from milk allergy.
Study design:
The study was designed as a randomized, multiple crossover study with three treatment periods consisting of the regular oral phosphate supplement, a high milk intake or a high cheese intake (randomization.com). Patients were instructed to discontinue their regular treatment, except for their usual doses of D vitamin analogs, three days prior to sample collection and instead engage in the study treatment. Furthermore, they should follow their normal eating habits while undergoing the study treatment, which was controlled by food and liquid registrations.
At the phosphate supplement session, the patients were treated with an 800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose. At the cheese session, the patients were treated with an estimated phosphate content of 800 mg distributed over 5 meals. At the milk session, the patients were treated with 800 ml of milk daily corresponding to approximately 800 mg phosphor per day.
Sampling:
After three days of treatment, the patients visited our clinic for anaerobically handled blood samples, which were collected 5 times through out one day for calcium, phosphate, parathyroid hormone, fibroblast growth factor 23 and basic phosphatase. Urine samples for calcium and phosphate was collected in containers from 0800 to 1200 and from 1200 to 1600. A 24-hour urine samples was obtained from the day before the sampling from 0800 to 0800 hours the following morning.
#Intervention
- DIETARY_SUPPLEMENT : Phosphate tablets.
- DIETARY_SUPPLEMENT : High cheese intake.
- DIETARY_SUPPLEMENT : High milk intake.
|
#Eligibility Criteria:
Inclusion Criteria:
* Genetic verified hypophosphatemic rickets.
* In treated with oral phosphate tablets.
Exclusion Criteria:
* Tertiary hyperparathydoism.
* In treatment with Cinacalcet.
* Suffered from milk allergy.
Sex :
FEMALE
Ages :
- Minimum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03348644
|
{
"brief_title": "Milk Products in the Treatment of Hypophosphatemic Rickets",
"conditions": [
"Hypophosphatemic Rickets"
],
"interventions": [
"Dietary Supplement: High cheese intake.",
"Dietary Supplement: High milk intake.",
"Dietary Supplement: Phosphate tablets."
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03348644",
"official_title": "Milk Products in the Treatment of Hypophosphatemic Rickets: A Randomised Crossover Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-01",
"study_completion_date(actual)": "2016-06-01",
"study_start_date(actual)": "2015-08-01"
},
"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)": "2017-11-21",
"last_updated_that_met_qc_criteria": "2017-11-15",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-21",
"first_submitted": "2017-10-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and therapeutic effectiveness of tolvaptan when administered to slow the progression of cyst development and renal function insufficiency in adult Korean patients diagnosed with rapidly progressive ADPKD who have chronic kidney disease (CKD) stages 1-3 at initiation of treatment.
#Intervention
- DRUG : Tolvaptan
- 30mg and 15mg of Tolvaptan Tablet
- Other Names :
- Samsca
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who voluntarily participate by giving written informed consent on this trial
* Male and female patients aged >= 19 to <= 50 years
* Subjects diagnosed with ADPKD based on the Unified Criteria for Ultrasonographic diagnosis of ADPKD (Pei-Ravine Criteria)
* Subjects with confirmed CKD stages 1 <= age <= 3 at the screening visit
* Subjects with confirmed rapidly progressive typical ADPKD 'Typical ADPKD'
* refers to bilateral and diffuse distribution, with mild, moderate or severe replacement of kidney tissue by cysts, where all cysts contribute similarly to TKV.
'rapidly progressive ADPKD'
* Patients will be defined as 'rapidly progressive ADPKD' if they meet any of the following criteria:
* Mayo class 1C, 1D or 1E
* Truncating PKD1 mutation confirmed by genetic testing before participating this trial ③ PRO-PKD score > 6 ④ Patients with ADPKD with a decline in Estimated glomerular filtration rate(eGFR) >= 5 mL/min/1.73 m2 within 1 year from the screening visit or with an average annual decline in eGFR >= 2.5 mL/min/1.73 m2 over a period of 5 years (excluding patients with an eGFR decline due to factors other than ADPKD, such as uncontrolled type 2 diabetes, early diabetic glomerular disease or immune-mediated glomerulonephritis)
Exclusion Criteria:
* Patients with hyponatremia or hypernatremia
* Patients with anuria
* Patients with volume depletion
* Patients who are unable to sense or appropriately respond to thirst
* Patients with contraindications to MRI assessment [e.g., ferromagnetic metal prosthesis, aneurysm clips, severe claustrophobia, large tattoo on the abdomen or back, etc.]
* Patients with severe renal impairment [e.g., patients with currently active glomerulonephritis, kidney cancer, having a single kidney, history of renal surgery within the last 3 years, etc.]
* Patients with severe hepatic impairment [e.g., cirrhosis, viral hepatitis, unspecified liver function test abnormalities (ALT or Aspartate aminotransferase(AST)) > 3 x ULN or Total Bilirubin > 2 x ULN), etc.]
* Patients with eGFR decline due to factors other than ADPKD (e.g., uncontrolled type 2 diabetes, early diabetic glomerular disease or immune-mediated glomerulonephritis, etc.)
* Patients with a history of hypersensitivity and/or specific reactions to benzazepine or benzazepine derivatives (such as Benazepril), or tolvaptan
* Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption, etc.
* Patients who need chronic diuretic use
* Patients who are receiving any experimental (not marketed) or approved therapies that may affect the treatment of ADPKD within 6 months from the screening visit [e.g., anti-sense RNA therapy, rapamycin, sirolimus, everolimus and somatostatin analogs (octreotide, sandostatin), vasopressin antagonist (mozavaptan, conivaptan), vasopressin agonist (desmopressin)]
* Patients who have received cyst decompression or sclerotherapy within 3 years from the screening visit
* Patients with a history of taking tolvaptan within 6 months from the screening visit
* Patients who received any investigational medicinal product in another trial within 30 days from the screening visit
* Fertile women who are currently pregnant or breat feeding, or not willing to use or capable of using acceptable contraceptive methods (abstinence, oral, implanted or injected hormonal methods of contraception, intrauterine device or barrier methods of contraception, such as condom, contraceptive diaphragm and spermicidal agents) to avoid pregnancy until completion of the trial
* Patients who are, in the opinion of the investigator, unable to comply with the administration of the Investigational Medicinal Product(IMP) or the trial procedures
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03949894
|
{
"brief_title": "Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease",
"conditions": [
"Autosomal Dominant Polycystic Kidney Disease (ADPKD)"
],
"interventions": [
"Drug: Tolvaptan"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03949894",
"official_title": "Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-25",
"study_completion_date(actual)": "2022-05-25",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-16",
"last_updated_that_met_qc_criteria": "2019-05-13",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-14",
"first_submitted": "2019-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The majority of cystic fibrosis (CF) patients die from a progressive pulmonary disease.Airway inflammation plays a major role for the pathogenesis of CF lung disease, and ultimately leads to lung destruction. The release of oxidants during the inflammation process leads to a chronic imbalance of oxidants and antioxidants and may be a central component leading to irreversible lung damage in CF patients. The antioxidant glutathione, which is a naturally occurring tripeptide, is depleted in the extracellular epithelial lining fluid of the CF lung. The elevation of reduced level to normal and also the augmentation of glutathione concentrations above the normal level, as observed in smokers and during defence of Pseudomonas infection, may be desirable to avoid lung damage. Data from pilot studies in humans and animals have indicated that the glutathione concentrations in epithelial lining fluid can be elevated by aerosol application.
The main objective of this trial is to evaluate the effect of a 24-week treatment with inhaled glutathione compared with control inhalations (normal saline) on pulmonary function in adult and pediatric CF patients. Secondary objectives are to determine the effects of inhaled glutathione on inflammatory variables, glutathione levels and free elastase in induced sputum and to evaluate the safety and tolerability of the 24-week treatment with inhaled GSH.
There is considerable hope within the CF community that the addition of anti-oxidative therapy to an already comprehensive program for treating the lungs will decrease morbidity and improve the quality of life for patients with CF.
#Intervention
- DRUG : reduced glutathione sodium salt
- 646 mg GSH-Na powder per vial to prepare a 4ml solution, twice daily for 24 weeks.
- Other Names :
- TAD 600
- DRUG : 0.9% normal saline (control)
- 4 ml of a 0.9% normal saline solution (9mg/ml NaCl), twice daily for 24 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patient, 8 years (pediatric 8 - 17 years inclusive; adult 18 years)
* Confirmed diagnosis of CF (positive sweat chloride, 60 mEq/liter by pilocarpine iontophoresis and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype)
* Patient is able to perform acceptable spirometric maneuvers according to ATS standards
* FEV1 > 40% predicted and < 90% predicted
* The patient is clinically stable fulfilling the following:
No evidence of acute upper or lower respiratory tract infection within 4 weeks of screening.
No pulmonary exacerbation requiring an use of i.v./oral/inhaled antibiotics, or oral corticosteroids within 4 weeks of screening.
FEV1 at Visit 2 is within a range of ± 10% of FEV1 from the Visit 1. (If FEV1 at V2 is not within that range, V2 may be re-scheduled once within 7 days)
* Concomitant or chronic medication is planned to be continued unchanged for the entire study duration
* The patient or the patient's legally acceptable representative is able to give informed consent in accordance with ICH and GCP guidelines and local legislation
* Patient is able to comply with the study visit schedule and willing and able to complete the assessments specified in the protocol.
Exclusion Criteria:
* History of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial by the investigator. 'Relevance' in this context refers to any increased risk of hypersensitivity reaction to trial medication. (Specific concerns currently identified with respect to the use of inhaled glutathione in allergic patients per se are not existing)
* Concomitant inhaled thiol-containing medications (e.g., inhaled N-acetylcysteine).
Such medication had to be finished at least 2 weeks before the screening visit. Oral N-acetylcysteine may be continued.
* New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
* Patient with a known relevant substance abuse, including alcohol or drug abuse.
* Pregnant or lactating woman or female patient of child bearing potential who is sexually active and not using a medically approved form of contraception such as oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms.
* Patient with a documented persistent colonization with B. cepacia (defined as more than one positive culture within the past year).
* Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
* Existing cycling medication regimen without completion of at least 3 cycles prior to the screening visit or the drug cycles of other therapies are not in accordance with the 4-week time-schedule for the single visits of this study
* Clinically relevant diseases or medical conditions other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This includes, but is not limited to, significant hematological, hepatic,renal, cardiovascular, and neurological diseases (diabetic patients may participate if their disease is under good control prior to screening).
* Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
* The patient is an employee of the investigator or the institution with direct involvement in the trial or other trials under the direction of the investigator or their members.
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00506688
|
{
"brief_title": "Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients",
"conditions": [
"Cystic Fibrosis"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT00506688",
"official_title": "Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients",
"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)": "2007-07"
},
"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)": "2012-07-10",
"last_updated_that_met_qc_criteria": "2007-07-24",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-07-25",
"first_submitted": "2007-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Traumatic brachial plexus lesions may lead to permanent impairment of hand function despite brachial plexus surgery. In selected cases the affected forearm can be amputated and replaced by a bionic hand. It is unclear how cortical activation patterns change after the injury and after acquisition of the hand prosthesis considering the complex changes in sensory and motor feedback. The aim of the study is to measure cortical activity with fMRI during actual and imagery movements with the affected and healthy arm in a group of patients after traumatic brachial plexus injury and a group in whom this was followed by replacement with a bionic hand. In this prospective study three groups of patients will participate: 1) 3 adult patients with a traumatic brachial plexus lesion eligible for a bionic arm but prior to its acquisition, 2) 3 patients with a traumatic brachial plexus lesion who have acquired the bionic arm already, and 3) 10 healthy subjects. The investigators will measure cortical activity using fMRI BOLD tasks of closing the hand and motor imagery of this movement. Cortical activity will be compared between the three groups. Additionally, regional gray matter volume, resting-state, and DTI networks will be studied. Written informed consent will be provided prior to the investigation. The complete examination has a duration of approximately 45 minutes.
#Intervention
- DIAGNOSTIC_TEST : MRI
- MRI scan
- Other Names :
- functional MRI, fMRI
|
#Eligibility Criteria:
Inclusion Criteria:
* age above 18 years
* participants should understand German or English
* patients with a bionic hand are selected who are able to open and close the hand prosthesis.
Exclusion Criteria:
* the standard contraindications for MRI will be checked for according to hospital protocol (ferromagnetic devices such as clips, claustrophobia, etc.) and, if necessary, patients will be excluded from participation.
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
|
NCT04649749
|
{
"brief_title": "Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury",
"conditions": [
"Brachial Plexus Neuropathies",
"Traumatic Brachial Plexus Lesion",
"Bionic Hand Reconstruction"
],
"interventions": [
"Diagnostic Test: MRI"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT04649749",
"official_title": "Central Programming in Patients With a Bionic Hand After Traumatic Brachial Plexus Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-01",
"study_completion_date(actual)": "2022-09-01",
"study_start_date(actual)": "2020-10-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-28",
"last_updated_that_met_qc_criteria": "2020-11-25",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-02",
"first_submitted": "2020-10-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.
|
#Eligibility Criteria:
Inclusion Criteria:
* active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings
* healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients
Exclusion Criteria:
* pregnant woman
* positive result of human immunodeficiency virus examination
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01269268
|
{
"brief_title": "Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis",
"conditions": [
"Active Tuberculosis"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01269268",
"official_title": "Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05-14",
"study_completion_date(actual)": "2014-05-14",
"study_start_date(actual)": "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)": "2019-03-18",
"last_updated_that_met_qc_criteria": "2011-01-03",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-04",
"first_submitted": "2011-01-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to collect longitudinal data on outcomes of neuraxial or neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that we may contribute to the growing evidence for or against these therapies and to provide data for ongoing quality improvement activities.
|
#Eligibility Criteria:
Inclusion Criteria:
* treated for intractable pain by the UW Interventional Pain Treatment program
* inpatient or outpatient
Exclusion Criteria:
* 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:
No
|
NCT00167726
|
{
"brief_title": "Neuraxial and Neurolytic Analgesia for Intractable Pain",
"conditions": [
"Pain"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00167726",
"official_title": "Neuraxial and Neurolytic Analgesia for Intractable Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2005-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-09",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-14",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Stroke is the leading cause of disability in adults in the United States. Despite advances in hyperacute stroke care, advancements in stroke rehabilitation are lagging. We have previously shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic conditioning (IC), can improve paretic leg strength, reduce muscle fatigue, and increase walking speed in chronic stroke survivors (\>1 year post-stroke). The IC procedure makes the paretic leg transiently ischemic (5 minutes) using a cuff inflated to 225 mmHg, and repeats the occlusion 5 times with 5 minute periods of rest between cycles (45 total minutes). It is well accepted that the response to IC is complex and involves local, humoral and neural factors. The mechanism by which IC can confer motor benefit in stroke survivors is unknown. The aim of this study is to examine if IC can increase sympathetic nervous system (SNS) activity, which would promote an increased cardiovascular response to exercise and increased muscle strength. We hypothesize that plasma epinephrine and norepinephrine levels will increase more during a cold pressor test (a well-tolerated test to induce a sympathetic response) in chronic stroke survivors who undergo a single session of IC vs. IC-Sham. To accomplish the goals of this study, 15 chronic stroke survivors will each make two visits to the adult translational research unit at Medical College of Wisconsin (MCW) to have either IC or IC-Sham performed on their paretic leg in a counterbalanced order. Venous blood will be drawn before and after the IC or IC-Sham procedure and after a two-minute cold pressor test where the study participants submerge their hand into a bucket of ice water. This will cause an increased sympathetic response, which will be assessed by measuring blood pressure and the relative increase in the levels of circulating catecholamines (epinephrine and norepinephrine, assessed by high performance liquid chromatography).
#Intervention
- PROCEDURE : Ischemic Conditioning
- Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants will receive one session of the intervention (45 minutes total).
- PROCEDURE : Sham Ischemic Conditioning
- There will also be an IC Sham group which is identical to the IC intervention, except the cuff is only inflated to 10 mmHg, which is a high enough pressure to perceive cuff tightness but not high enough to have any physiological effects.
|
#Eligibility Criteria:
Inclusion Criteria:
* Study participants must be between 18 <= age <= 85 years, able to give informed consent, >1 year post diagnosis of unilateral cortical or sub-cortical stroke, have residual lower limb paresis.
Exclusion Criteria:
* History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. wounds in the leg), chronic pain syndrome, history of head trauma, comorbid neurological disorder, any uncontrolled hypertension (>160/100 mmHg), peripheral vascular disease, a myocardial infarction in the previous year, inability to follow 2 step commands, or history of multiple strokes.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04039399
|
{
"brief_title": "Ischemic Conditioning Chronic Stroke Study",
"conditions": [
"Stroke"
],
"interventions": [
"Procedure: Ischemic Conditioning",
"Procedure: Sham Ischemic Conditioning"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04039399",
"official_title": "Ischemic Conditioning Chronic Stroke Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-23",
"study_completion_date(actual)": "2023-08-23",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-25",
"last_updated_that_met_qc_criteria": "2019-07-29",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-31",
"first_submitted": "2019-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.
Detailed Description
The present clinical study aims to investigate the clinical efficacy of 5 mouthwashes based on different active substances. The study include 180 patients divided into 6 groups of 30 patients, each group rinse with one of the following mouthwashes - mouthwash based on essential oils (menthol, thymol and eucalyptus), mouthwash based on essential oils (menthol, thymol and eucalyptus) and 0.12% chlorhexidine, mouthwash based on 0,8 % hydrogen peroxide, mouthwash based on prebiotic, water based on 0.2% chlorhexidine, placebo mouthwash. Inclusion criteria are: generalized gingival inflammation, plaque index of Turesky, 1970 \> 1.95, gingival index of Loe \& Silness, 1963 \> 0.95, no systemic diseases, no systemic medication, lack of severely damaged teeth, no large fillings, no orthodontic treatment. Patients are motivated and instructed to maintain proper and optimal personal oral hygiene. All participants undergo professional mechanical plaque removal. After instrumentation participants are instructed to rinse with 15 ml mouthwash 2 times a day for 21 days. Researchers control the amount of mouthwash used by giving a new bottle of mouthwash with the required amount for 1 patient for 1 week at the beginning of each week and taking back the bottle from the previous week. During the study period, patients are monitored on days 14 and 21, examining plaque index of Turesky, 1970, gingival index of Loe \& Silness, 1963, bleeding index of Ainamo \& Bay, 1975, side effects like staining, burning itching, oral lesions. At the end of the study (day 21), patients complete a questionnaire.
#Intervention
- DRUG : Essential oils
- Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
- DRUG : Essential oils in combination with chlorhexidine 0,12%
- Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
- DRUG : Placebo mouthwash
- Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
- DRUG : Chlorhexidine 0,20 % in combination with aroma oils
- Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
- DRUG : Prebiotic
- Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
- DRUG : Hydrogen peroxide 0,8 %
- Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Plaque Index (Turesky, 1970) > 1,95;
* Gingival Index (Loe & Silness, 1963) > 0,95;
* Bleeding Index (Animo & Bay, 1975) > 30 %;
* no systemic diseases;
* no systemic medication.
Exclusion Criteria:
* severely destroyed teeth;
* crowns;
* non correct obturation class II and V;
* orthodontic treatment;
* third molars.
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
|
NCT04733196
|
{
"brief_title": "Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis",
"conditions": [
"Gingivitis"
],
"interventions": [
"Drug: Essential oils",
"Drug: Placebo mouthwash",
"Drug: Hydrogen peroxide 0,8 %",
"Drug: Essential oils in combination with chlorhexidine 0,12%",
"Drug: Chlorhexidine 0,20 % in combination with aroma oils",
"Drug: Prebiotic"
],
"location_countries": [
"Bulgaria"
],
"nct_id": "NCT04733196",
"official_title": "Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-20",
"study_completion_date(actual)": "2020-12-20",
"study_start_date(actual)": "2020-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-01",
"last_updated_that_met_qc_criteria": "2021-01-28",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-01",
"first_submitted": "2021-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.
Detailed Description
Phase 1 study to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) given either weekly or 3-weekly.
Additionally, hints about efficacy of the combination will be looked upon.
#Intervention
- DRUG : Combination of trastuzumab and PS-341
- Trastuzumab and velcade are used according standard procedure
- Other Names :
- PS-341, velcade, trastuzumab, herceptine
|
#Eligibility Criteria:
Inclusion Criteria:
* Female gender
* Age >= 18 years
* ECOG performance status < 2
* Histologically proven diagnosis of breast cancer
* Locally advanced and/or metastatic disease
* Life expectancy of three months or longer
* No concurrent second malignancy (except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the cervix or contralateral breast cancer). Any prior second malignancy must be in remission for >= 5 years (except for contralateral breast cancer).
* No other serious illness or medical condition including:
* History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (< 6 months) transmural infarction on electrocardiogram (ECG); poorly controlled hypertension (e.g. systolic > 180 mmHg or diastolic greater than 100 mmHg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias.
* Chronic lung disease
* History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia.
* Active concurrent infection
* No symptomatic central nervous system (CNS) metastases
* No rapidly progressive visceral metastases requiring immediate chemotherapy
* No concurrent anti-cancer treatment is allowed.
* Prior investigational biological agents are allowed, with the exception of anti-HER-2 therapy for any reason.
* Previous hormonal therapy is allowed, as adjuvant and/or for metastatic breast cancer (MBC).
* Adjuvant and MBC chemotherapy allowed, provided that a minimum of 4 weeks interval has elapsed between last chemotherapy administration and first study drug dose. All patients who, in the opinion of the investigator, could benefit from single agent Herceptin® and are not considered suitable for treatment with chemotherapy plus Herceptin® can be considered for this protocol.
* A maximum cumulative dose of previous doxorubicin < 360 mg/m2 or a maximum cumulative dose of epirubicin < 720 mg/m2
* Concomitant use of bisphosphonates is allowed, however if bisphosphonates are started during the trial for worsening bone pain, patients should be assessed for possible progressive disease.
* Adequate organ function as defined by:
* Neutrophils >= 1.5 x 10^9/L
* Platelets >= 100 x 10^9/L
* Bilirubin <= 1.5 x upper limit of normal (ULN)
* Transaminases <= 2.5 x ULN or <= 5 x ULN if liver metastasis
* Creatinine <= 1.5 x ULN
* Overexpression of HER-2 in the invasive component of the primary tumor, according to one of the following definitions:
* 3+ overexpression by immunohistochemistry (IHC) or
* 2+ overexpression by IHC and fluorescence in situ hybridization (FISH) test demonstrating c-erbB2 gene amplification (ratio of c-erbB2 gene signals to centromere 17 signals > 2)
* Baseline left ventricular ejection fraction (LVEF) > 50% measured by multiple gated acquisition scan (MUGA) or echocardiography
* Evaluable or uni-dimensionally measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Women of childbearing potential must have a negative serum or urine pregnancy test and be willing to use acceptable methods of birth control.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
* Before patient registration/randomization, informed consent must be given according to International Conference of Harmonization/European Union Good Clinical Practice (ICH/EU GCP), and national/local regulations.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00199212
|
{
"brief_title": "PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2",
"conditions": [
"Carcinoma Breast Stage IV"
],
"interventions": null,
"location_countries": [
"Belgium"
],
"nct_id": "NCT00199212",
"official_title": "A Phase I, Open Label, Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin, in Patients With Advanced Breast Cancer That Overexpresses HER-2",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-12",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-02-24",
"last_updated_that_met_qc_criteria": "2005-09-19",
"last_verified": "2011-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-20",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.
#Intervention
- DIAGNOSTIC_TEST : EyeBOX device
- The EyeBOX medical device tracks a patient's eye movement and calculates a BOX Score ranging from 0-20. The BOX score is interpreted as a binary classification for eye movement abnormalities, where anything equal to or greater than 10 is a positive result for the initial evaluation of concussion and everything below 10 is negative.
|
#Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent or assent along with guardian consent.
* Have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. Only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects.
* Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
Exclusion Criteria:
* Have penetrating trauma.
* Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
* Either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available GCS score less than 13 within 24 hours.
* Be blind (no light perception), have missing or non-functional eyes.
* Be unable to open their eyes.
* Have a history of unresolved strabismus, diplopia, amblyopia.
* Have a history of unresolved cranial nerve III, IV, or VI palsy.
* Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
* Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
* Have a prior history of unresolved ocular-motor dysfunctions.
* Be intoxicated.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03966404
|
{
"brief_title": "EyeBOX Concussion Study and Registry",
"conditions": [
"Concussion, Brain",
"Mild Traumatic Brain Injury"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03966404",
"official_title": "EyeBOX Concussion Study and Registry",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-01",
"study_completion_date(actual)": "2023-06-01",
"study_start_date(actual)": "2019-08-05"
},
"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)": "2023-09-07",
"last_updated_that_met_qc_criteria": "2019-05-28",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-29",
"first_submitted": "2019-05-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.
Detailed Description
This study is a single-dose, randomized, double-blind, placebo-controlled, 2-treatment, 2-sequence, 2-way crossover, multicenter study in patients with a documented history of EIB, with or without underlying asthma. Each patient will participate in the study for approximately 5 weeks. Each patient will complete 2 screening visits (SV1 and SV2), 2 treatment visits (TV1 and TV2), and a follow-up telephone call (FV).
#Intervention
- DRUG : Albuterol Spiromax
- Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg).
- Other Names :
- Albuterol DPI, ProAir® RespiClick
- DRUG : Placebo Spiromax
- Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent/assent: For patients 18 <= age <= 50 of age, inclusive, written informed consent signed and dated by the patient before conducting any study related procedures and review of Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization; for patients 12 <= age <= 17 of age, inclusive, written informed consent signed and dated by the parent/legal guardian and written assent signed and dated by the patient before conducting any study related procedure and review of HIPAA authorization.
* Male or female patients 12 <= age <= 50 of age, inclusive, as of SV1.
* If female, is currently not pregnant, breastfeeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of non-childbearing potential.
* Documented history of EIB, with or without underlying asthma. The underlying asthma must be well-controlled (in the investigator's judgment) as per the National Asthma Education and Prevention Program, Expert Panel Report (NAEPP, EPR-3).
* Other criteria apply.
Exclusion Criteria:
* Requires a rescue bronchodilator following the exercise challenge at SV1 for a decrease in FEV1 that does not return to within 20% of their pre-exercise challenge FEV1 within 30 minutes after administration of the rescue medication.
* Pregnant, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days after the patient's last study related visit (for eligible patients only-if applicable).
* Participation in any investigational drug trial within the 30 days preceding SV1 or planned participation in another investigational drug trial at any time during this trial.
* A known hypersensitivity to albuterol or any of the excipients in the formulation.
* History of severe milk protein allergy.
* History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, otitis media, acute or chronic sinusitis, influenza, etc) that has not resolved within the 2 weeks preceding SV1.
* Other criteria apply.
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
|
NCT01791972
|
{
"brief_title": "Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)",
"conditions": [
"Exercise-Induced Bronchoconstriction (EIB)"
],
"interventions": [
"Drug: Placebo Spiromax",
"Drug: Albuterol Spiromax"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01791972",
"official_title": "A Single-Dose Study to Assess the Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2013-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-18",
"last_updated_that_met_qc_criteria": "2013-02-12",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-15",
"first_submitted": "2013-02-12",
"first_submitted_that_met_qc_criteria": "2015-05-01"
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to determine the effect of repeat oral doses of eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects. The study will comprise a screening period (between Day -45 and Day -2), treatment period 1 (Day -1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day 24 ± 1). There will be a 10-day washout between dosing of study drug in Period 1 and Period 2. The duration of each subject's participation in the study, inclusive of the screening and follow-up visits, will be approximately 10 weeks.
Detailed Description
Cohort 1 will comprise 10 subjects and Cohort 2 will comprise 18 subjects. Initiation of treatment in Cohort 1 will occur at least 6 days prior to the start of treatment for Cohort 2. In each cohort, eligible subjects will be admitted to the clinical facility on Day -1, the day prior to the start of dosing in Period 1, and will remain in the clinic until completion of study procedures on Day 18, the last day of Period 2 (an approximately 18-night inpatient stay). In Period 1, all subjects will receive a single oral dose of digoxin 0.25 mg on Day 1. In Period 2, subjects will receive repeat oral doses of eliglustat 150 mg BID (or 100 mg BID if a CYP2D6 poor metabolizer) from Day 11 to Day 17 and a single oral dose of digoxin 0AA mg on Day 15. For Cohort 2, co-administration of digoxin and eliglustat on Day 15 will occur only after review of safety data (including telemetry data) through at least Day 16 for all subjects in Cohort 1. The decision to proceed with concomitant dosing of subjects in Cohort 2 will be at the discretion of the Investigator, with consultation of the Sponsor, as appropriate.
#Intervention
- DRUG : eliglustat; digoxin
- repeat oral doses of 150 mg BID (or 100 mg BID if a CYP2D6 poor metabolizer) eliglustat (Day 11 to Day 17) plus singe dose of digoxin 0.25mg on Day 15
- Other Names :
- Genz-112638
- DRUG : digoxin
- oral 0.25mg dose of digoxin (single dose) on Day 1
|
#Eligibility Criteria:
Inclusion Criteria:
* The male or female subject is in good general health
* The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) <=32 kg/m2 at screening.
* The subject's physical examination, laboratory, vital sign, and electrocardiogram (ECG) test results are within normal limits at screening and Day -1 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.
* The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.
* The subject has not used drugs of abuse for at least 6 months prior to Day -1 and is willing and able to abstain from using drugs of abuse until completion of the safety follow-up visit.
* The subject is willing and able to abstain from alcohol for 48 hours prior to the first dose of study drug until completion of the safety follow-up visit.
* The subject is willing and able to abstain from grapefruit and grapefruit juice for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.
* The subject is willing and able to maintain a normal-fiber diet (i.e., to abstain from excess fiber-rich foods) for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.
* Female subjects of childbearing potential must have a documented negative pregnancy test at screening and Day 1, and be willing to use a medically accepted form of contraception (as defined in the protocol) from screening until 30 days after the last dose of study drug. A woman of childbearing potential is defined as any female who has not been amenorrheic for at least 2 years or has not undergone a hysterectomy or surgical sterilization.
Exclusion Criteria:
* The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree atrioventricular (AV) block, a PR interval >=210 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval >=450 msec), or sustained ventricular tachycardia.
* The subject has received antibiotics for any reason within 30 days prior to the first dose of study drug.
* The subject has received any other prescription or non-prescription medication (with the exception of nonprescription-strength ibuprofen and acetaminophen) or dietary or herbal or fiber supplement within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug without the approval of the Investigator and Genzyme.
* The subject receives an immunization within 30 days of providing informed consent.
* The subject has a history of hypersensitivity to digoxin or other digitalis glycosides, or has other drug allergies that are clinically significant in the opinion of the Investigator (e.g., significant rash or hives).
* The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition such as electrolyte disorders, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.
* The subject has digestive disorders, including malabsorption, gastroenteritis, pancreatitis, constipation, gastroesophageal reflux disease, diverticulitis, irritable bowel syndrome, or inflammatory bowel disease (including Crohn's disease).
* The subject has had a cholecystectomy.
* The subject has a screening laboratory test result >2x the upper limit of normal (ULN) for any of the following liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), and total bilirubin.
* The subject tests positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or hepatitis B surface antigen at screening.
* The subject tests positive for urine drugs of abuse, urine alcohol, or urine cotinine at screening.
* The subject received an investigational product within 30 days prior to providing informed consent or plans to receive any other investigational product at any time during the course of this study.
* The subject donated blood or blood products within 30 days prior to providing informed consent.
* The subject's schedule or travel plans prevent the completion of all required visits.
* The subject is scheduled for inpatient hospitalization, including elective surgery (inpatient or outpatient), during the study.
* The subject has a history of cancer, with the exception of basal cell carcinoma.
* The female subject of childbearing potential is pregnant or lactating.
* The subject, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
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
|
NCT01357811
|
{
"brief_title": "A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: eliglustat; digoxin",
"Drug: digoxin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01357811",
"official_title": "A Single-site, Open-label, Fixed-sequence Phase 1 Study Evaluating the Effect of Eliglustat (Genz-112638) on the Pharmacokinetics and Safety and Tolerability of Digoxin in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2011-11",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-23",
"last_updated_that_met_qc_criteria": "2011-05-19",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-23",
"first_submitted": "2011-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
#Intervention
- DRUG : MK0249
- MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
- DRUG : Concerta (methylphenidate)
- Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
- Other Names :
- CONCERTA®
- DRUG : Placebo
- For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is between 18 and 55 years (inclusive)
* Patient is an adult with a current DSM-IV diagnosis of ADHD of inattentive or combined subtype, as assessed via a structured interview using the ACDS and AISRS
* Females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy
Exclusion Criteria:
* Patient has a history of a neurological disorder resulting in ongoing impairment
* Patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder
* Patient has evidence of ongoing depression
* Patient is sensitive or allergic to methylphenidate
* Patient has glaucoma
* Patient has a previous history of narrowing or blockage of the GI tract
* Patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening
* Patient has a history of a cardiovascular disorder within 6 months prior to screening
* Patient has moderate or severe persistent asthma
* Patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to DSM-IV
* Patient has taken part in a research study within the past 30 days of signing informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00475735
|
{
"brief_title": "A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)",
"conditions": [
"Attention-Deficit/Hyperactivity Disorder (ADHD)"
],
"interventions": [
"Drug: Placebo",
"Drug: Concerta (methylphenidate)",
"Drug: MK0249"
],
"location_countries": null,
"nct_id": "NCT00475735",
"official_title": "A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Two-period, Crossover Clinical Trial to Study the Safety and Efficacy of MK0249, 10 mg, for Adult Patients, Ages 18 to 55, With Attention Deficit Hyperactivity Disorder (ADHD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04",
"study_completion_date(actual)": "2008-04",
"study_start_date(actual)": "2007-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-07-28",
"last_updated_that_met_qc_criteria": "2007-05-17",
"last_verified": "2015-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-21",
"first_submitted": "2007-05-17",
"first_submitted_that_met_qc_criteria": "2010-11-11"
}
}
}
|
#Study Description
Brief Summary
Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI \> 25).
For each patient, two consecutive PET-CT scanner will be performed using the 'Discovery MI' and 'Discovery IQ' PET-CT scanner systems.
Virtual lesions will then be created on images obtained. Images will be interpreted by two independent observers.
The study participation of each patient will be a maximum of 24 hours.
#Intervention
- OTHER : Patients with a cancer for which a FDG-PET scanner must be performed
- For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners:
* 'Discovery MI'
* 'Discovery IQ'
Only one contrast agent injection (FDG) will be given for both scanners.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years.
* A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices
* OMS <= 1, Karnofsky Index > 70.
* Negative pregnancy test at inclusion.
* Patient able to maintain a lying position in a strict supine position twice.
* Patient affiliated to a Social Health Insurance in France.
* Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.
Exclusion Criteria:
* Patient with unbalanced diabetic
* Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.)
* Pregnant or breastfeeding woman
* Any psychological, family, geographical or sociological condition that does not allow medical follow-up and/or procedures provided for in the study protocol to be respected
* Patient protected by law
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
|
NCT03956459
|
{
"brief_title": "Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer",
"conditions": [
"Cancer"
],
"interventions": [
"Other: Patients with a cancer for which a FDG-PET scanner must be performed"
],
"location_countries": [
"France"
],
"nct_id": "NCT03956459",
"official_title": "Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-04",
"study_completion_date(actual)": "2021-02-04",
"study_start_date(actual)": "2019-07-25"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-10",
"last_updated_that_met_qc_criteria": "2019-05-17",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-20",
"first_submitted": "2019-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.
#Intervention
- DRUG : Enzalutamide
- Other Names :
- MDV3100, Xtandi
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
* Presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mTc-MDP) bone scintigraphy;
* Throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or surgical castration);
* Testosterone <= 1.73 nmol/L (<= 50 ng/dL) at screening;
* Progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (PSA) values (PSA1 < PSA2 < PSA3);
* The screening PSA (PSA3) must be >= 2 μg/L (>= 2 ng/mL).
Exclusion Criteria:
* Prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium Ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the CRPC setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
* Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than LHRH analogue therapy) within 4 weeks before enrollment;
* Initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
* Use of an investigational agent within 4 weeks before the screening visit;
* Radiation therapy to bone within 4 weeks before enrollment;
* Use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;
* Screening 99mTc-MDP bone scintigraphy showing a superscan;
* Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;
* Current or previously treated brain metastasis or active leptomeningeal disease;
* History of seizure any time in the past for any reason or any condition that may predispose to seizures.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02384382
|
{
"brief_title": "A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)",
"conditions": [
"Prostate Carcinoma Metastatic to the Bone",
"Castration Resistant Prostate Cancer"
],
"interventions": [
"Drug: Enzalutamide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02384382",
"official_title": "A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY OF 18F-SODIUM FLUORIDE PET/CT BONE IMAGING IN ENZALUTAMIDE-TREATED CHEMOTHERAPY-NAÏVE PATIENTS WITH BONE-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-03",
"study_completion_date(actual)": "2019-05-03",
"study_start_date(actual)": "2015-11-30"
},
"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)": "2020-05-05",
"last_updated_that_met_qc_criteria": "2015-03-04",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-10",
"first_submitted": "2015-03-04",
"first_submitted_that_met_qc_criteria": "2020-04-20"
}
}
}
|
#Study Description
Brief Summary
COMEBACK is an investigator-initiated, 48-week study. The study will be conducted in 100 persons living with HIV (PLWH) who have been off ART for two or more weeks. All enrolled participants will be prescribed Biktarvy, if determined appropriate upon review of past historical resistance tests, for use throughout the study period. Participants will also complete a series of Patient Reported Outcomes (PROs) at screening and be assigned one of three tiers of case management intervention (Piggyback, Got Your Back, Backbone), with each tier increasing in intensity regarding intervention techniques and options provided. Participants will be assessed for virologic suppression, retention in care, and PROS throughout study follow up and at study end.
Detailed Description
In most settings in the US when patients out of care and off of ART reengage with clinical providers routine labs are collected, including CMP, CD4, VL, and HIV resistance testing when indicated, healthcare benefits are reassessed, and the most recent ART regimen is restarted if the patient agrees to treatment. There may be characteristics of these regimens that may present barriers to sufficient adherence, or perform suboptimally in patients with certain immunologic and/or viral factors, which may impact virologic suppression, including multiple pills, drug-drug interactions, variable tolerability, low CD4, high VL, or low thresholds for resistance. Biktarvy is a Single Tablet Regimen (STR) with high potency and good tolerability that can be safely used in multiple patient groups, with features, including activity in patients with a history of multi-class resistance, that may facilitate immediate ART reinitiation among a broad population of patients reengaging in care in order to promote rapid virologic suppression. Addressing this important patient population with poor retention with support mechanisms to reengage in care and reinitiate effective ART immediately may improve retention in care and accelerate virologic suppression as likewise derived in immediate ART models in treatment-naïve patients, and represent a touchstone to drive sustainability in preventing new HIV transmissions in a high burden area to meet the goals of reducing HIV as a public health threat over the next 10 years.
#Intervention
- BEHAVIORAL : Case Management
- Each tier will have a different level of case management and support, all with the goal of increasing adherence to Biktarvy for HIV management.
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-infected
* Not on ART for >2 weeks
* History of estimated eGFR > 30 ml3/min
* Baseline labs (CBC, CMP, CD4+, HIV-1 RNA) and resistance genotype test collected <2 weeks or on day of Biktarvy ART reinitiation
* >= 18 years
Exclusion Criteria:
* No history of primary integrase inhibitor mutations, >3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing
* Drug-drug interactions with Biktarvy
* Pregnancy
* Unable or unwilling to provide consent for study participation
* Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the study objective.
* Current participation in another ART adherence study
* Allergy to bictegravir, emtricitabine or tenofovir alafenamide
* Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of reinitiation of antiretroviral therapy
* Concomitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir
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
|
NCT04519970
|
{
"brief_title": "Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)",
"conditions": [
"Hiv"
],
"interventions": [
"Behavioral: Case Management"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04519970",
"official_title": "(COMEBACK): Biktarvy in PLWH But Not Retained in Care Coupled With a Strengths-based Case Management Approach to Assess Virologic Suppression Rates and Retention in Care, Along With Patient Reported Outcomes (PROS).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-06",
"study_completion_date(actual)": "2024-04-06",
"study_start_date(actual)": "2020-09-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-21",
"last_updated_that_met_qc_criteria": "2020-08-17",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-20",
"first_submitted": "2020-08-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine the efficacy of valsartan/amlodipine 80/5 mg once daily dose is reducing mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) after 8 weeks of therapy.
Detailed Description
Avsar in tablet form which contains two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland International studies are available concerning the single pill combination therapy used in Blood pressure reduction. To determine the clinical significance of single pill combination, conducted multi center real life study i.e.; 'ALERT Trial' in our local population. Through this study, observed the effect of single pill combination on BP reduction and adverse events in health care settings. Antihypertensive drugs use in a single pill combination may further enhance BP control by reducing pill burden and improve patient compliance.
#Intervention
- DRUG : Valsartan, Amlodipine -
- Valsartan is a non-peptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype used as an antihypertensive agent.
Amlodipine besylate is a dihydropyridine long-acting calcium channel blocker.
- Other Names :
- AVSAR
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient whose BP is >139/89mmHg and on monotherapy with minimum last 30 days
* Male or female aged (18 years - 70 Years)
* Signed informed consent
Exclusion Criteria:
* Secondary Hypertension
* Pregnant or Lactating mother
* Hypersensitivity to any active ingredient
* Peripheral artery disease
* Hepatic disease or biliary tract obstruction
* Chronic kidney disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03371797
|
{
"brief_title": "Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial",
"conditions": [
"Essential Hypertension"
],
"interventions": [
"Drug: Valsartan, Amlodipine -"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT03371797",
"official_title": "Efficacy and Safety of Single Pill Combination (Amlodipine/Valsartan) in Hypertensive Patients Not Controlled on Previous Monotherapy: An Observational Real Life Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-01",
"study_completion_date(actual)": "2018-11-05",
"study_start_date(actual)": "2018-02-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-08",
"last_updated_that_met_qc_criteria": "2017-12-08",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-13",
"first_submitted": "2017-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight. Conducted in a level 4 neonatal intensive care unit from March 2017 to March 2023, the study focuses on growth parameters (weight, head circumference, height), growth velocity, and the incidence of complications. The retrospective open-cohort observational design involves a sample of 284 infants, 142 in each group, considering a 95% confidence level and 80% power. The study addresses the need for a local evaluation of the efficacy of ready-to-use parenteral nutrition in this vulnerable population.
Detailed Description
Introduction:
Parenteral nutrition enhances nutrition in very low birth weight newborns (\<1500 g) who, due to gastrointestinal immaturity, experience delays in obtaining adequate nutrients enterally. Parenteral nutrition (PN) promotes better growth in all anthropometric variables in this population.
However, complications associated with its use have been documented. A commercial method developed to reduce these complications is ready-to-use parenteral nutrition, a three-chamber bag providing a complete mix of nutrients, offering immediate access, quicker initiation of nutrition, and prescription homogenization. These factors aim to achieve better metabolic stability, improved nutritional intake, and weight, height, and head circumference gain.
This study aims to evaluate outcomes with the initiation of ready-to-use parenteral nutrition.
Theoretical Framework:
Advances in favorable clinical outcomes for preterm newborns result from multiple interventions such as cardiorespiratory support and early infection identification. Despite these efforts, morbidity and mortality outcomes remain stagnant. Optimizing nutritional coverage, especially in preterm infants, is one of the objectives to improve outcomes.
Premature infants, due to their immaturity and typically critical clinical condition, require early initiation of parenteral nutrition to guarantee their nutritional needs and reduce the possibility of extrauterine growth restriction. There is also an association between early protein and energy intake and improved neurodevelopment.
While the benefits of early parenteral nutrition initiation in preterm infants are evident, it is classified as a high-risk medication due to potential errors in preparation, leading to biochemical alterations and infection risk. Standardized ready-to-use nutrition is considered a safe alternative, particularly in institutions with limited technological resources.
Commercial preparations like Numeta 13% meet the requirements recommended by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) for very low birth weight neonates (\<1500 g) and extremely low birth weight preterm infants (\<1000 g), presenting a cost-effective alternative to individualized preparations.
Despite the proven need for early parenteral nutrition in critically ill neonates, studies reveal variations in protocol adherence, with a significant percentage of units initiating late protein intake and low energy content. Institutional protocols and software utilization could address these challenges.
Continued controversy exists regarding the optimal composition of parenteral nutrition. While individualized nutrition allows adjustments, especially in preterm infants prone to electrolyte imbalances and metabolic control issues, ready-to-use preparations, though less tailored, show no significant differences in complications.
A proposed cohort study aims to assess significant differences between preterm infants receiving individualized and ready-to-use parenteral nutrition locally.
Justification for the Study:
Very low birth weight newborns require multiple supports, including thermal, respiratory, hemodynamic, and nutritional. Ready-to-use parenteral nutrition, with its immediate availability and standardized composition, reduces infection risks.
This study aims to compare clinical outcomes between individualized and ready-to-use parenteral nutrition in terms of metabolic stability, infections, and growth in preterm infants. Existing studies highlight growth delays in preterm infants, associated with poor neurodevelopment and future metabolic and cardiovascular complications. Early trophic stimulation, supported by parenteral nutrition, facilitates a smooth transition with adequate nutrient supply, aiming for appropriate weight gain.
Recognized publications such as ESPGHAN and NICE endorse the use of ready-to-use parenteral nutrition for its safety, immediate availability, and suitability for approximately 85% of patients. Only the remaining 15% may require individual adjustments for specific metabolic issues. An analytical study as proposed would allow local insights into clinical outcomes in neonates receiving individualized vs. ready-to-use parenteral nutrition.
Research Question:
What are the clinical outcomes of using ready-to-use parenteral nutrition compared to individualized parenteral nutrition in very low birth weight neonates in a level 4 Neonatal Intensive Care Unit during the period March 2017-March 2023?
Research Hypotheses:
Alternative Hypothesis: There are differences in anthropometric measurements and complication incidence between very low birth weight patients receiving individualized parenteral nutrition and Numeta G13E ready-to-use.
Null Hypothesis: There are no differences in anthropometric measurements and complication incidence between very low birth weight patients receiving individualized parenteral nutrition and Numeta G13E ready-to-use.
#Intervention
- OTHER : Ready-to-Use Parenteral Nutrition
- In newborns weighing less than 1000 grams, parenteral nutrition is initiated at volumes of 70-80 ml/kg/day up to a maximum volume of 128 ml/kg/day, with a provision of 4 grams/kg/day of protein and a metabolic rate of 12 mg/kg/minute.
For newborns weighing between 1001-1500 grams, parenteral nutrition is initiated at volumes of 70-80 ml/kg/day up to a maximum of 110 ml/kg/day.
When enteral intake exceeds 70 ml/kg/day, a gradual decrease in the volume of parenteral nutrition is initiated. We discontinue parenteral nutrition in newborns weighing less than 1000 grams with enteral volume of 120 ml/kg/day, and for those between 1000 grams and 1500 grams, enteral nutrition volume of 100 ml/kg/day.
- Other Names :
- Numeta G13E
|
#Eligibility Criteria:
Inclusion Criteria:
* Newborns admitted to the neonatal intensive care unit between March 2017 and March 2023
* Requirement for Parenteral Nutrition.
* Birth weight less than 1500 grams (very low birth weight).
Exclusion Criteria:
* Patients transferred from another hospital with more than 24 hours of life.
* Incomplete follow-up (until 36 weeks corrected age or discharge).
* Major congenital anomalies.
Sex :
ALL
Ages :
- Maximum Age : 24 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06200324
|
{
"brief_title": "Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023",
"conditions": [
"Very Low Birth Weight Infant"
],
"interventions": [
"Other: Ready-to-Use Parenteral Nutrition"
],
"location_countries": [
"Colombia"
],
"nct_id": "NCT06200324",
"official_title": "Clinical Outcomes of the Use of Ready-to-Use Parenteral Nutrition in Very Low Birth Weight Newborns in a Fourth-level Neonatal Intensive Care Unit in Cali, Colombia, March 2017-March 2023",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-31",
"study_completion_date(actual)": "2023-03-31",
"study_start_date(actual)": "2017-03-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-11",
"last_updated_that_met_qc_criteria": "2023-12-27",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-11",
"first_submitted": "2023-11-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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