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#Study Description
Brief Summary
The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 \[no pain\] to 10 \[maximum pain\]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p \< 0.05).
#Intervention
- DEVICE : Acupuncture
- DEVICE : Sham acupuncture
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 40
* male and female volunteers
Exclusion Criteria:
* history of neurological disorders
* neck surgery
* chronic neck pain resulting from a traumatic incident
* chronic musculoskeletal condition
* medical diagnosis of fibromyalgia; systemic disease
* connective tissue disorder
* non-tolerance of needles; current pregnancy
* having undergone physical therapy use of analgesic, muscle relaxant.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01984021
|
{
"brief_title": "Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.",
"conditions": [
"Nonspecific Neck Pain"
],
"interventions": [
"Device: Sham acupuncture",
"Device: Acupuncture"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT01984021",
"official_title": "Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2013-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-02",
"last_updated_that_met_qc_criteria": "2013-11-13",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-14",
"first_submitted": "2013-11-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.
Detailed Description
The study will be conducted at the Department of Pediatric Medicine unit 1, KEMU / Mayo Hospital Lahore. Total of 140 neonates fulfilling the eligibility criteria will be enrolled. They will be randomly divided into two groups - A and B. Mothers of the neonates in group A will be advised massage with sunflower oil while mothers of the neonates in group B will be advised massage without any emollient. Babies will closely be followed up and their weight and length will be measured at six months of age and will be analyzed using SPSS v 23.0.
#Intervention
- OTHER : Emollient (sunflower oil)
- In group A, mothers will be advised to massage their babies with sunflower oil at a dose of 10 mL/kg/day twice a day in equally divided amounts. They will be called for follow up after six months of application of sunflower oil.
|
#Eligibility Criteria:
Inclusion Criteria:
* Neonates of both genders
* Both breast fed and non-breast fed infants
* Neonates with birth weight between 1.5 and 2.5 kg
* Preterm neonates born between 28 and 37 completed weeks of gestation
Exclusion Criteria:
* Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 28 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04619758
|
{
"brief_title": "Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial",
"conditions": [
"Weight Gain"
],
"interventions": [
"Other: Emollient (sunflower oil)"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT04619758",
"official_title": "Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-30",
"study_completion_date(actual)": "2018-06-30",
"study_start_date(actual)": "2018-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-06",
"last_updated_that_met_qc_criteria": "2020-11-02",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-06",
"first_submitted": "2020-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to explore the relationship between the onset of fall and the time taken to complete the Timed Up and Go test (TUG) in this CMT1A patient population.
The investigators hypothesize that patients with balance disorders and therefore a risk of major fall will require a longer time to perform the Timed Up and Go test. In addition, it seems important to confirm that the severity of the disease has a negative impact on the frequency of balance disorders.
Detailed Description
Charcot-Marie Tooth disease is the most frequent and common inherited neuropathy with the various forms and subtypes. The CMT-1A is the most frequent form of the disease and represents more than eighty percent of the all subtypes. In view of different clinical elements (muscular strength deficit, walking and balance disorders, podological impairment), patients with CMT seem to be able to present an increased risk of fall. In 2017 pilot study supports this. More recently, a study by Ramdharry et al. appears to confirm this with a cohort of 252 patients with CMT, 86% of whom have experienced at least one major fall or loss of balance. This increased incidence of falls is also found in children and adolescents with CMT with consequences in terms of injury and management.
Systematic screening of the risk of falls in this population is necessary, but no prospective studies on the occurrence of falls and its detection have yet been carried out in this population.
A study focusing on this issue in order to standardize the assessment of postural control disorders using a simple test of common clinical practice seems necessary.
#Intervention
- DIAGNOSTIC_TEST : Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with Charcot-Marie-Tooth disease type 1A
- The data of the gait analysis, posturography and strength analyses as well as the questionnaires' scores will be taken into account in this research. At 6 months and at 1 year, occurrence of a fall will be recorded in order to prospectively monitor this parameter. A final analysis will be carried out at 1 year from the first according to the same methods as the initial assessment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years
* Diagnosis of Charcot Marie Tooth disease, type 1A confirmed by molecular biology (duplication 17.p11.2) and by a pathological electromyogram, that is to say with demyelinating impairment (+/- axonal) dependent length
* Listening and written French
* Strength of the quadriceps superior to 2/5 MMT MRC
* Agreement after written information, clear and honest about the purpose of the study, the nature of the tests and their possible side effects or bothersome
* Health insurance cover
Exclusion Criteria:
* Presence of other neurological comorbidity
* Presence of coronary artery disease unstabilized
* Peripheral neuropathy of other causes: diabetes, monoclonal gammopathy, malignancy, solid cancer, systemic autoimmune disease (lupus, Sjögren's disease, Wegener sarcoidosis ...), infectious disease (viral hepatitis, HIV ...), drugs known to be responsible for iatrogenic neuropathy.
* Gait trouble of other origin
* Patients unable to give their consent.
* Intellectual deficit that does not allow to comply with tests
* Patient under guardianship, or protection of justice.
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
|
NCT05142059
|
{
"brief_title": "Fall Risk Assessment in a Population of Charcot-Marie-Tooth Disease Type 1A (CMT 1A) by Timed Up and Go Test",
"conditions": [
"Charcot-Marie-Tooth Type 1A Neuropathy"
],
"interventions": [
"Diagnostic Test: Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with Charcot-Marie-Tooth disease type 1A"
],
"location_countries": [
"France"
],
"nct_id": "NCT05142059",
"official_title": "Fall Risk Assessment in a Population of Charcot-Marie-Tooth Disease Type 1A (CMT 1A) by Timed Up and Go Test",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-18",
"study_completion_date(actual)": "2024-12-13",
"study_start_date(actual)": "2020-09-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-27",
"last_updated_that_met_qc_criteria": "2021-11-18",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-02",
"first_submitted": "2021-10-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to see how antibodies (proteins that fight infection) are made after you receive the new H5N1 flu vaccine. The new H5N1 vaccine will be given to 50 healthy adult lab workers, aged 18 years and older. Subjects will receive two 90mcg injections (shots in the arm) of the vaccine about 1 month apart. Subjects will maintain a memory aid to record oral temperature and any response to the vaccine for 7 days after each immunization. Subjects will be contacted by telephone 1 to 3 days after vaccination. They will return to the clinic on Day 7. Blood will be drawn before each vaccination and on Days 56 and 180. Subjects may be involved in the study for about 6 months. It is anticipated that the vaccine will provide safe protection against influenza H5N1.
Detailed Description
The purpose of this open-label, phase I/II study is to investigate the safety and immunogenicity of two 90-mcg doses of intramuscular inactivated influenza A/H5N1 vaccine in healthy adults, aged 18 years and older. Subjects will receive 2 doses of the vaccine separated by approximately 28 days. Subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 7 days after each immunization. Subjects will be contacted by telephone 1 to 3 days after vaccination (approximately Day 2) to assess concomitant medications and the occurrence of AEs, and they will return to the clinic on Day 7 for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. Serum for immunogenicity evaluations will be obtained prior to the first vaccination (Day 0) and prior to the second vaccination (at Day 28), and on Days 56 and 180. Primary objectives are to determine the safety of subvirion inactivated A/H5N1 vaccine in healthy adults and to determine the immunogenicity of subvirion inactivated H5N1 vaccine in healthy adults approximately 1 month following receipt of each of two 90 mcg doses of vaccine. The secondary objective is to evaluate immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. Primary endpoints are: AE or serious adverse event information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment); geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of the vaccine; and GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers against the influenza A/H5N1 virus 28 days after receipt of the second dose of the vaccine. The secondary endpoints are GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; and development of serum antibody responses against antigenically drifted variants of H5N1 influenza viruses.
#Intervention
- BIOLOGICAL : Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in single-dose vials containing 90-mcg/mL A/H5N1 HA. Dosage is two 90 mcg doses administered intramuscularly separated by approximately 28 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Laboratory personal with potential exposure to live H5N1 viruses.
* Male or nonpregnant female (as indicated by a negative urine pregnancy test prior to each dose of vaccine), aged 18 years and older.
* Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
* Is in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
* Able to understand and comply with planned study procedures.
* Provides informed consent prior to any study procedures and is available for all study visits.
Exclusion Criteria:
* Has a known allergy to eggs or other components of the vaccine.
* Has a known allergy or sensitivity to latex (in the stopper).
* Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
* Is undergoing immunosuppression as a result of an underlying illness or treatment.
* Has an active neoplastic disease or a history of any hematologic malignancy.
* Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
* Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
* Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
* Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 6-month study period.
* Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00311675
|
{
"brief_title": "St. Jude Open Label H5 Trial",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00311675",
"official_title": "A Single Center, Open-Label, Phase I/II Study of Two 90-µg Doses of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2006-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-08-27",
"last_updated_that_met_qc_criteria": "2006-04-05",
"last_verified": "2008-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-04-06",
"first_submitted": "2006-04-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.
Detailed Description
Mannan Binding Lectin (MBL) is a member of the lectin pathway of the complement system and plays an important role in the innate immune system. MBL replacement in MBL-deficient children with chemotherapy-induced neutropenia represents a new approach to lower the risk of febrile episodes, of hospital admission, of prolonged use of intravenous antibiotics and of severe infections.
The aim of the Phase II study is to find evidence for the correct prediction of plasma levels of MBL necessary for clinical effects and biological efficacy, to confirm the dosage regimen needed to reach the required MBL plasma levels, and reconfirm the safety and lack of side-effects.
#Intervention
- DRUG : Mannan Binding Lectin (MBL)
- DRUG : Mannan Binding Lectin
- MBL dose at a twice weekly dose interval (3 or 4 days):
0.2 mg/kg, for a 3-day interval; 0.3 mg/kg, for a 4-day interval
- Other Names :
- MBL SSI
|
#Eligibility Criteria:
Inclusion Criteria:
* Children ages 0 - 12 years, during chemotherapy, and expected to become neutropenic
* MBL deficiency by genotype or phenotype (< 100 ng/ml)
* Informed consent and assent of patient and/or legal representative
Exclusion Criteria:
* Inability or unwillingness to comply with the protocol or likely inability to complete the study period
* Known allergic reactions to MBL and other human plasma products
* Participation in other investigational drug studies within the last month
* Clinically relevant abnormalities in: serum immunoglobulins IgG, IgA, IgM; blood counts; complement factors measured by AP50, CH50; urine protein and cell counts; serum creatinine and liver enzymes, as routinely determined for regular patient care.
Sex :
ALL
Ages :
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00138736
|
{
"brief_title": "Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia",
"conditions": [
"MBL-Deficient",
"Neutropenia"
],
"interventions": [
"Drug: Mannan Binding Lectin (MBL)",
"Drug: Mannan Binding Lectin"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT00138736",
"official_title": "Phase II Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-10",
"study_start_date(actual)": "2004-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-08-30",
"last_updated_that_met_qc_criteria": "2005-08-29",
"last_verified": "2007-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-08-30",
"first_submitted": "2005-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Prostate cancer is one of the most common types of malignancy in men. Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is considered the current gold standard method in the diagnosis of prostate cancer. Some patients experience serious discomfort during the procedure because the ultrasound probe is placed in the rectal area. Although no anesthetic or analgesic is used in some centers during the prostate biopsy procedure, in some centers lidocaine gel, cream or spray is applied before entering the rectal area, and lidocaine ampoule is injected during the procedure. However, most patients experience pain and discomfort due to the way the procedure is performed.
Today, in addition to pharmacological methods, non-pharmacological methods are also used to control pain. Cold application has an important place among non-pharmacological methods. In this randomized controlled intervention study, the effect of cold lidocaine gel application on pain level in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) will be evaluated. In this study, it is thought that application of cold lidocaine gel will reduce the pain level of patients.
The research will be conducted at the Urology Polyclinic of Çukurova University Faculty of Medicine Balcalı Practice and Research Hospital. The sample of the research; Ç.Ü.T.F. Volunteer patients who have undergone prostate biopsy at the Urology Polyclinic of Balcalı Practice and Research Hospital and meet the research criteria will be recruited. Patients consisting of 3 groups: control, experiment 1 (Lidocaine Gel) and experiment 2 (Cold Lidocaine Gel) will be determined by randomization. A power analysis was carried out by obtaining statistical support for the sample size. As a result of the sample calculation calculated with power with a confidence interval of 95%, beta value of 95% and alpha value of 0.05, a total of 114 patients will be included, 38 each in the control group, Lidocaine gel and Cold Lidocaine Gel groups. . Data will be collected with the 'Personal Information Form' and 'Pain Assessment Form'. The data will be analyzed in the SPSS (Statistical Package for the Social Sciences) package program.
In this context, in our study, the effect of lidocaine gel and cold lidocaine gel applied to the rectal area on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy will be evaluated and the effect of cold application on pain control will be compared. This result will make great contributions to patient benefit in terms of pain management.
Detailed Description
Prostate cancer is one of the most common types of malignancy in men. According to GLOBOCAN (Global cancer statistics) 2020 data, the age-standardized incidence rate of prostate cancer varies between 11.3-37.5 per hundred thousand in the world, depending on the development level of the countries, and it is seen to be 42.5 per hundred thousand in our country. It ranks second after lung cancer in terms of incidence in men in our country and in the world. Prostate cancer screening aims to reduce mortality and morbidity by detecting prostate cancer at an early stage. Digital rectal examination (DRE), prostate specific antigen (PSA) value, transrectal ultrasonography (TRUS) and biopsy are used to diagnose prostate cancer. Ultrasound-guided prostate biopsy has been used since 1981 and is one of the most important urological diagnostic methods. Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is currently considered the gold standard method in the diagnosis of prostate cancer. In the TRUSG-guided biopsy procedure, after the patients are placed in the left lateral or lithotomy position, the needle-guided rectal probe is inserted into the anal canal with the help of lubricating gel, and the prostate tissue is monitored under USG guidance and a biopsy is taken. The procedure takes approximately 20 minutes, and approximately 15 minutes pass during the entry and exit of the probe into the rectal area. In recent years, the importance of pain control has increased due to prostate biopsy being performed on younger patients, biopsies being taken from more quadrants, and repeated prostate biopsies. Due to severe pain, the rate of tolerance of the procedure by the patient decreases, and this may lead to a decrease in the number of biopsy samples taken from the planned quadrant and a decrease in cancer detection rates. Therefore, ensuring pain control and increasing patient tolerance in TRUSG-PBx is extremely important. Many different methods are used to reduce pain and discomfort. In recent studies, local anesthesia is used in transrectal ultrasound-guided prostate biopsies; Methods such as periprostatic nerve block (PPSB), lidocaine injection, intrarectal lidocaine gel, transperineal periprostatic block (TPPB with gel combination), low-dose spinal anesthesia and intravenous (IV) sedation application have been used and results have been reported showing that these methods increase the pain tolerance in the patient. One of the most important obstacles to the biopsy process is anal area pain. The pain felt during the biopsy occurs for 2 reasons:
1. Pain felt when the biopsy needle penetrates the prostate capsule and enters the stroma.
2. Pain caused by stretching of the anal sphincter as the transrectal ultrasound probe enters the anus (passing the ultrasound probe through the anus, advancing it into the rectum, and manipulating it within the rectum).
For periprostatic nerve blockade before biopsy, penetration into the rectum with a rectal probe is required before anesthesia, and this first penetration is the main cause of the patients' complaints. Due to pain resulting from anal canal sensation during biopsy, intrarectal local anesthesia, which is highly absorbed through the rectal mucosa, is frequently used. Although the procedure is easy to perform and causes very low mortality, efforts to reduce the discomfort and pain that patients may feel lead to the development of new protocols for pre-procedure preparations and anesthesia and analgesia. Most patients who will undergo transrectal biopsy experience anxiety due to the possibility of the result being cancer, the psychological discomfort caused by the fact that the procedure will be performed rectally, and the procedure is painful for the patient. Nurses have an important and indispensable role in pain control and within the team. To reduce pain, nurses; They should inform patients about pain preventive approaches and pain control methods and give the message to patients that everything necessary has been done before painful procedures. Nurses should also apply non-pharmacological methods to reduce the consumption of analgesic drugs or increase their effect by providing adequate analgesia. The patient, whose anxiety decreases, will perceive the intensity and duration of pain as decreased as his sense of pain control will improve.
Non-pharmacological methods are used alone or together with pharmacological methods in order to reduce the use of analgesics and at the same time improve the quality of life of the patient by relieving the patient's pain as much as possible. Cold application also has an important place among non-pharmacological methods.
Cold application is effective in reducing pain, indirectly or directly. It indirectly reduces pain by eliminating edema, swelling and muscle spasm resulting from inflammation or trauma, and has a direct effect by changing the conduction properties of peripheral nerves. In this context, evidence-based studies should be examined and pharmacological and non-pharmacological methods that reduce pain should be used in patient care areas.
A study in the literature showed that applying intrarectal lidocaine gel by massaging the anal area increases patient tolerance and provides balanced and adequate anesthesia at every stage of the biopsy.
In another study in the literature, they compared the application of three intrarectal anesthesia methods along with periprostatic nerve block (periprostatic nerve block with intrarectal lidocaine gel, lidocaine cream and indomethacin suppository) during transrectal ultrasonography-guided prostate biopsy. They stated that intrarectal lidocaine cream application together with PPSB provided more effective pain control.
In the literature, studies conducted to evaluate the effect of cold application on pain during removal of mediastinal and thorax tubes have observed that the application reduces pain, and it has been stated that applying cold to the entry point of the chest tubes reduces the pain and the amount of analgesic consumption during movement and coughing.
As can be seen, various studies have been conducted to determine which anesthesia technique will reduce pain and to evaluate the rectal pain and sensitivity caused by the probe. However, it is still controversial which local anesthesia method is more suitable and will cause less pain. However, although there are many national and international studies on the subject in the literature, no experimental study has been found on the effect of cold lidocaine gel application on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy. The purpose of our research, which we planned in the light of this information, is to compare the effect of applying cold lidocaine gel to the rectal area on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy.
#Intervention
- OTHER : LIDOCAINE GEL
- To LG group patients, 20 ml lidocaine gel will be applied intrarectally (double application: 5cc to the perianal region, covering the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed in the rectum.
- OTHER : COLD LIDOCAINE GEL
- In CLG group patients, 20 ml of cold lidocaine gel kept in the refrigerator at +4 0C will be applied intrarectally (double application: 5cc to the perianal region, including the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed into the rectum.
|
#Eligibility Criteria:
Inclusion Criteria:
* Being able to communicate effectively,
* Being > 40 years,
* Being literate,
* Volunteering to participate in the research.
Exclusion Criteria:
* Having a previous history of chronic pain,
* Having alcohol and drug addiction,
* Having bleeding diathesis and active urinary tract infection,
* Having a cognitive disorder, neurological or psychiatric disease,
* Having a disease in the anal and rectal area (wound, fistula, fissure, hemorrhoids, etc.).
* Not agreeing to participate in the research.
Sex :
MALE
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06429046
|
{
"brief_title": "Effect of Lidocaine Gel and Cold Lidocaine Gel on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound",
"conditions": [
"Prostate Cancer XXX",
"TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY"
],
"interventions": [
"Other: COLD LIDOCAINE GEL",
"Other: LIDOCAINE GEL"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06429046",
"official_title": "Effect of Lidocaine Gel and Cold Lidocaine Gel Applied to the Rectal Area on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound: Randomized Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-29",
"study_completion_date(actual)": "2023-09-12",
"study_start_date(actual)": "2020-01-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-24",
"last_updated_that_met_qc_criteria": "2024-05-20",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-05-24",
"first_submitted": "2024-05-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A two phase trial to understand the personal, behavioral, environmental, and contextual factors that underpin sedentary behavior and to systematically test a series of contextual prompt characteristics that may lead to subsequent change in sedentary behavior.
Detailed Description
Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (\<30 min) and long (≥30 min) bouts of sedentary behavior.
Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.
#Intervention
- BEHAVIORAL : Prompt sent
|
#Eligibility Criteria:
Inclusion Criteria:
* Full-time employees
* Males or females
* Ages 18 <= age <= 65
* Sedentary working habits (as indicated by >7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
* Willing to engage in the study assessment and intervention for 10 weeks.
Exclusion Criteria:
* Non-ambulatory, pregnant
* Non-English speaking
* Diagnosis of psychiatric problems or taking psychiatric medications
* Medical history that prohibits prolonged standing.
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
|
NCT03399916
|
{
"brief_title": "Ecological Momentary Determinants of Sedentary Behavior",
"conditions": [
"Sedentary Behavior"
],
"interventions": [
"Behavioral: Prompt sent"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03399916",
"official_title": "TranSITion: Ecological Momentary Determinants of Sedentary Behavior",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02",
"study_completion_date(actual)": "2017-02",
"study_start_date(actual)": "2016-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-31",
"last_updated_that_met_qc_criteria": "2018-01-08",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-17",
"first_submitted": "2017-12-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research is to study new ways of classifying mental disorders in children based on observable behavior and genetics to ultimately diagnose these disorders better.
Detailed Description
The NIMH Research Domain Criteria (RDoC) initiative seeks to further a long-range goal of contributing to diagnostic systems as informed by research on genetics, neuroscience, and behavior. The RDoC approach is based on identifying the most elemental units of analysis relevant to psychiatric disorders (such as genes and molecules) and using this matrix as a framework for investigation. In this case-control family study, the investigators will be using self-report questionnaires and computer-based tests to develop diagnostic methods for neuropsychiatric disorders in children, their siblings, and their parents. They will do this by recruiting 'normal' and 'affected' children, their siblings, and their parents. They will look at the subject, sibling, and parents to determine if psychiatric disorders are inherited. 'Affected' children, ages 6-12, are those who have been diagnosed with a psychiatric disorder. Participants will undergo a battery of questionnaires/evaluations and a blood draw. The investigators will determine if the questionnaires and tests that reflect the constructs (such as reward prediction and willingness to work) predict psychopathology and impairment. The blood draw will be genotyped to determine if the measured constructs are associated with neuropsychiatric candidate genes, cross-disorder candidate gens and a cross-disorder polygenic score.
|
#Eligibility Criteria:
Inclusion Criteria:
* male or female, ages 6 <= age <= 12.
* biological child of parent(s) participating in testing.
Exclusion Criteria:
* taking psychotropic medications.
* free of uncontrolled medical problems.
* major sensorimotor disability (e.g., deafness, blindness).
* diagnosed neurological condition.
* inadequate command of the English language.
* history of head injury with loss of consciousness lasting longer than 10 minutes.
* IQ estimated at below 80.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02415647
|
{
"brief_title": "Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria",
"conditions": [
"Mental Disorders",
"Psychological Disorders",
"Psychiatric, Diagnosis",
"Mental Disorders Diagnosed in Childhood"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02415647",
"official_title": "Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-13",
"study_completion_date(actual)": "2020-05-31",
"study_start_date(actual)": "2014-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-16",
"last_updated_that_met_qc_criteria": "2015-04-08",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-14",
"first_submitted": "2015-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.
#Intervention
- OTHER : POHIM-CCRT
- postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
|
#Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed cervical cancer
* radical hysterectomy and pelvic lymph node dissection was done
* histologically indicated adjuvant chemoradiotherapy (more than one as below)
* positive pelvic lymph node metastasis
* positive parametrial invasion
* positive tumor involvement on surgical margin
* ECOG performance status 0 or 1
* Bone marrow function: granulocyte >=1.0 x 1000/µl, platelet >=30 x 1000/µl, hemoglobin >=10 g/dl
* Kidney function: Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl
Exclusion Criteria:
* positive distant metastasis (including retroperitoneal lymph node metastasis)
* previous history of pelvic radiotherapy
* more than 3 months after radical surgery for cervical cancer
* neoadjuvant chemotherapy was done
* previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
Sex :
FEMALE
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:
Yes
|
NCT03239613
|
{
"brief_title": "Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer",
"conditions": [
"Cervix Cancer",
"Radiotherapy, Adjuvant",
"Radiotherapy, Intensity-Modulated",
"Hypofractionated Dose",
"Chemotherapy, Concurrent"
],
"interventions": [
"Other: POHIM-CCRT"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03239613",
"official_title": "Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_CCRT Trial)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-28",
"study_completion_date(actual)": "2023-04-28",
"study_start_date(actual)": "2017-08-31"
},
"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)": "2025-01-03",
"last_updated_that_met_qc_criteria": "2017-08-03",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-04",
"first_submitted": "2017-08-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Up to half of autistic people experience anxiety symptoms, which can have a significant impact on everyday wellbeing. However, there are currently very few effective, evidence-based interventions to support autistic people in managing anxiety; and many autistic people face barriers in accessing inperson health and social care services. Therefore, developing new interventions (and/ or adapting existing ones) that improve anxiety, in a way that meets the needs of autistic people, represents the autism community's number one priority for research and clinical practice.
Addressing this priority, the investigators will test the acceptability and feasibility of a new, app-based therapeutic approach for anxiety ('Molehill Mountain') that has been developed with, and adapted for, autistic people aged 12-years and over using adapted Cognitive Behavioural therapy principles. This means that information will be collected from autistic people accessing clinical services on whether they would choose to use the anxiety app, whether the app is simple to administer and use, how it is used, how it can be improved, and whether it is effective in reducing anxiety symptoms and/ or enhancing other outcomes, such as everyday wellbeing and functioning.
The evidence from this project will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, with the ultimate aim of transforming long-term healthcare delivery for autistic people.
#Intervention
- BEHAVIORAL : Molehill Mountain app
- The Molehill Mountain app (currently Version 2) was developed jointly by King's College London (Lead: Prof Emily Simonoff; Advisors: Dr Ann Ozsivadjian and Dr Rachel Kent) and UK autism charity Autistica (Product Owner: Andy Clarke; Product Designer: Joanna Alpe) for use by autistic people aged ≥12-years (https://www.autistica.org.uk/molehill-mountain).
The app was designed based on a self-guided paper-and-pencil CBT toolkit adapted for autism by Professor Emily Simonoff. Since the first version of Molehill Mountain (a two-week long programme) was launched in 2016, and based on surveys of autistic people and five rounds of prototype testing, the Molehill Mountain V2 app was relaunched in April 2021 as a three-month long app-based programme with enhanced interactive features. This 3-month V2 Molehill Mountain app, with enhanced interactive features supporting short daily logins, that will be implemented in the current study.
- DEVICE : Molehill Mountain app
- As above.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 16-years.
* Autism diagnosis.
* Current mild-to-severe anxiety symptom severity, as assessed at screening (and currently in touch with mental health services e.g., referred, on the waitlist).
* Able and willing to provide verbal and written informed consent to take part in the study.
* Access to Molehill Mountain app via SmartPhone or other Smart device.
Exclusion Criteria:
* Difficulties with reading/ writing to the extent that the app is inaccessible.
* High risk of self-harm that make participation in the study inappropriate for the individual's current level of clinical need (as assessed by clinical team).
* Attended >= 6 sessions of individual or group therapy (e.g., cognitive behavioural therapy) in the past 6-months, which would make it impossible to parse out the effects of the app from existing therapy.
* If using psychotropic medication, this medication/ dose must have been stable for a minimum of 8-weeks on entry to the study.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05302167
|
{
"brief_title": "Molehill Mountain Feasibility Study.",
"conditions": [
"Anxiety",
"Autism"
],
"interventions": [
"Device: Molehill Mountain app",
"Behavioral: Molehill Mountain app"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05302167",
"official_title": "Feasibility Study of an Adapted App-based Anxiety Intervention ('Molehill Mountain') for Autistic People.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-10-24",
"study_completion_date(actual)": "2024-10-24",
"study_start_date(actual)": "2022-09-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-26",
"last_updated_that_met_qc_criteria": "2022-03-29",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-31",
"first_submitted": "2022-02-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.
#Intervention
- DEVICE : Transcranial Direct Current Stimulation (tDCS)
- Other Names :
- tDCS, Low intensity transcranial DC stimulator, Soterix 1x1
- DEVICE : Placebo sham
- Other Names :
- tDCS sham
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
* Cognitive function sufficient enough to understand experiments and follow instructions
* Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion Criteria:
* Botox treatment within 6 weeks of enrollment
* Fixed contraction of the affected limb
* Complete flaccid paralysis of the affected limb
* History of hemorrhagic stroke
* Ongoing use of CNS active medications
* Ongoing use of psychoactive medications
* Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures
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
|
NCT01726673
|
{
"brief_title": "Robots Paired With tDCS in Stroke Recovery",
"conditions": [
"Stroke"
],
"interventions": [
"Device: Transcranial Direct Current Stimulation (tDCS)",
"Device: Placebo sham"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01726673",
"official_title": "Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01",
"study_completion_date(actual)": "2018-06",
"study_start_date(actual)": "2012-09"
},
"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)": "2021-05-14",
"last_updated_that_met_qc_criteria": "2012-11-14",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-15",
"first_submitted": "2012-10-26",
"first_submitted_that_met_qc_criteria": "2018-07-18"
}
}
}
|
#Study Description
Brief Summary
Currently, selective cervical nerve root injections are recommended under the guidance of fluoroscopy, ultrasonography and computed tomography in patients with chronic cervical radicular pain who do not respond to conservative treatments and are not planned for surgery. Various serious complications, mainly vascular, have been reported in the literature. These complications include vertebral artery injury, spinal cord and brain stem infarction. The arteries of the cervical spinal cord are the vertebral, ascending, and deep cervical arteries arising from the aorta.The arteries arising from these main arteries and reaching the intervertebral foramen are called segmental arteries, the arteries reaching the epidural region from the intervertebral foramen and the radicular arteries, and the branches reaching the spinal cord are called the medullary artery. These small arteries supplying the spinal cord lie close to the spinal nerve in the foramen between the anterior and posterior trabercules. Vasospasm or embolism, which occurs as a result of direct needle trauma to these vascular structures around the target nerve or injection of particulate steroids, are the most common causes of complication development.
The aim of our study is to identify the vascular structures around the foramen in selective cervical root injection, which has proven effectiveness in cervical radicular pain, to determine the most reliable method for positioning the needle while reaching the target nerve under US guidance and to prevent possible complications.
Detailed Description
A total of 50 healthy volunteers and 10 patients with cervical radicular pain, between the ages of 18-70, height above 155 cm and body mass index 25 and below, in the Algology Clinic of the University of Health Sciences Dışkapı Yıldırım Beyazıt Training and Research Hospital will be included in the study. Those who have structural disorders in the neck region and who have undergone neck surgery will not be included in the study. 7 cadavers will be included in the study in Ankara University Faculty of Medicine, Department of Anatomy.
2 Algology specialists from Health Sciences University Dışkapı Yıldırım Beyazıt Training and Research Hospital Algology Clinic and 3 doctors from Ankara University Medical Faculty Anatomy Department will participate in the study. Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG. Again, two Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure. Seven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries.
Demographic characteristics (age, gender, BMI, body height) of 50 volunteers and 10 patients with cervical radicular pain will be recorded. The pain intensity of 10 patients with cervical radicular pain will be determined and recorded with the VAS (visual analog scale) score before the procedure and at 1,2,3 and 4 weeks after the procedure, by calling the patients for control.
The cadavers will be dissected after being placed in the supine position and bilaterally from C4 to C7. Neurovascular complexes will be defined.
Efforts will be made to determine the most appropriate needle pathway to reach the target cervical nerve.
#Intervention
- PROCEDURE : Ultrasound-guided selective cervical nerve root block
- The volunteer will be placed in the lateral decubitus position with the examined side up and the ultrasonographic examination will be started. Using a high frequency 6-18 MHz linear transducer, scanning in the cephalad and caudal direction until the cervical tubercles are identified in the short axis of the vertebra at the cricoid level, the localization and number of the target nerve root and vascular structures in the foraminal opening between the anterior and posterior tubercles of the transverse process from C4 to C8. will be defined as Unlike healthy volunteers, local anesthetic and steroid injections will be administered to the target nerve.
|
#Eligibility Criteria:
Inclusion Criteria:
healthy volunteers patients with cervical radicular pain
Exclusion Criteria:
Patients who have structural disorders in the neck region and who have undergone neck surgery
*
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
|
NCT05450926
|
{
"brief_title": "Selective Cervical Root Block for Chronic Pain",
"conditions": [
"Neck Pain"
],
"interventions": [
"Procedure: Ultrasound-guided selective cervical nerve root block"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05450926",
"official_title": "Appropriate Sonoanatomical Approach in Ultrasound-guided Selective Cervical Root Block",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-01",
"study_completion_date(actual)": "2023-06-01",
"study_start_date(actual)": "2022-02-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-30",
"last_updated_that_met_qc_criteria": "2022-07-08",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-11",
"first_submitted": "2022-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a single blind, randomized parallel controlled experimental study planned to determine the effect of distant reiki, which is one of the non-pharmacological methods, on fatigue and comfort level in hemodialysis patients. The hypothesis of the study is that distant reiki increases patients comfort and reduces fatigue.
Detailed Description
Methods: In order to determine the sample size of the study, before starting the research, power analysis was performed by taking the information of the statistician and previous studies as a reference in order to determine the number of patients to be included in the reiki and control groups. As a result of the analysis performed by taking effect size 0.35, type 1 error 0.05, power 0.80 and correlation between repeated measurements 0.50, it is planned to study with a total of 46 patients, including at least 31 patients in each group. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed. Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group. The control group will be filled in the questionnaire after the first measurement, in the 4th (1st month) and 8th (2nd month) weeks. At the end of the study, remote reiki sessions will be applied by the researcher, since the patients in the control group have equal ethical rights. The primary expected result of the study is the effect of distant reiki on fatigue in hemodialysis patients. The second expected result of the study is to determine the effect of distant reiki on comfort.
#Intervention
- OTHER : Distant reiki
- In order to determine the sample size of the study, it is planned to study with a total of 62 patients, including at least 31 patients in each group, in the power analysis based on the statistics of the statistician and previous studies. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Over the age of 18
* In patients over the age of 65, the Standardized Mini Mental Test (SMMT) score is 26 and above,
* Having hemodialysis three days / times a week for 6 months or longer with the diagnosis of chronic renal failure,
* Can speak and understand Turkish,
* General condition is good and comfortable (whose life findings are within normal limits)
* Do not have any problem that prevents cognitive, affective and verbal communication,
* Do not use any sedative drugs,
* Do not have any psychiatric illness,
* Those who sign the informed consent form will be included in the sample.
Exclusion Criteria:
* - who do not agree to participate in the study,
* younger than 18,
* In patients > 65 years, whose SMMT value is below 24 points
* Patients undergoing hemodialysis without a diagnosis of chronic renal failure,
* Receiving hemodialysis treatment for less than 6 months and once or twice a week,
* Can't speak Turkish,
* General condition unstable (shortness of breath, arrhythmia, fluctuations in blood pressure),
* Diagnosed with anxiety, panic attack and using medication for anxiety,
* Using any sedative medication,
* Have any problem that prevents cognitive, affective and verbal communication,
* Any psychiatric illness,
* Those who do not sign the informed volunteer consent form will not be included in the study.
Study termination criteria:
* Who want to leave the research,
* Changing institution / province,
* If the patient dies, the study will be terminated.
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
|
NCT04830657
|
{
"brief_title": "The Effect of Reiki on Fatigue and Comfort",
"conditions": [
"Hemodialysis",
"Fatigue"
],
"interventions": [
"Other: Distant reiki"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04830657",
"official_title": "The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-02",
"study_completion_date(actual)": "2022-03-02",
"study_start_date(actual)": "2020-12-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-13",
"last_updated_that_met_qc_criteria": "2021-04-02",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-05",
"first_submitted": "2021-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive treatment. Data collection for each patient will take place at one visit. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP\<130/80 mmHg. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP\<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a therapeutic glycemic response defined as HbA1c=\<7%. To observe the proportion of patients achieving fasting plasma glucose\<110 mg%. To identify factors for not achieving BP\<130/80 mmHg. To describe percentage of patients with positive proteinuria (including microalbuminuria) by treatment groups .
|
#Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent
* Patient was diagnosed with type 2 diabetes
* Patient is on antihypertensive treatments for at least 3 months, with the same regimen for a minimum of 4 weeks prior to survey
Exclusion Criteria:
* Patients are critically ill, had mental health problems or difficulty in communication
* Patients who are unwilling or unable to provide informed consent
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
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
|
NCT00803660
|
{
"brief_title": "Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes",
"conditions": [
"Hypertension",
"Type 2 Diabetes"
],
"interventions": null,
"location_countries": [
"Vietnam"
],
"nct_id": "NCT00803660",
"official_title": "In Practice Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2009-05",
"study_start_date(actual)": "2008-11"
},
"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)": "2009-07-09",
"last_updated_that_met_qc_criteria": "2008-12-04",
"last_verified": "2009-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-05",
"first_submitted": "2008-12-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A double-blinded randomized control study using a pulsed electromagnetic field therapy to establish whether this device decreases patient pain and decreases narcotic use in women who have undergone cesarean delivery.
Detailed Description
This prospective, double-blind, randomized, sham-controlled clinical trial will investigate the effectiveness of PEMF using the Ivivi SofPulse on postoperative pain severity and narcotic use in women after cesarean delivery at Jacobi Medical Center. On admission to labor and delivery or in the obstetrical outpatient office, potential subjects will complete questions related to inclusion / exclusion criteria and sign a consent to participate in the study. If eligible, patients will receive a Ivivi Sofpulse device which will be placed over the incisional area and turned on. The devices are randomized into functional and sham groups. The device will be left around the incision site unless the patient needs to shower. In an effort to minimize bias, the patients, providers and investigators will not be aware if the device is functional or not. Lot numbers will accompany the device. After completion of the study, the Lot numbers, which will be provided by the manufacturer, will reveal which devices were functional devices or shams. These lot numbers will only be provided on completion of the trial. Wong-Baker Faces pain assessment tool will be evaluated by the Principal Investigator (PI) or co-investigator for determination of subjective postoperative pain at 0, 2, 6, 12, 24, 48, and 72 hours after cesarean delivery. Amount of oxycodone in milligrams consumed by patients will be recorded 24, 48, 72 hours after cesarean delivery. Postoperative anesthesia type (Duramorph or morphine patient controlled anesthesia pump) will be recorded as well. Subjects will be randomized to PEMF treatment (functional), or sham treatment. All subjects will be followed for the duration of their stay in the hospital following their cesarean delivery.
No follow-up is required. The goal is to recruit one hundred patients over the course of four months. Patient data will be identified by use of medical record number and will be kept private on the Jacobi Medical Center Obstetrics and Gynecology server which is password protected. Access will only be for the investigator and co-investigators in the study. Nurse on labor and delivery have already received an in-service on the proper use of this device.
#Intervention
- DEVICE : SofPulse
- Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 45
* Female
* Undergoing lower transverse cesarean delivery or cesarean delivery with bilateral tubal ligation.
* Pfannenstiel Skin incision
* Consent to the study and willing to comply with study methods
Exclusion Criteria:
*
* Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)
* Patients undergoing additional procedures at the time of their cesarean delivery such as cesarean hysterectomy or myomectomy.
* Patients with vertical skin or uterine incisions.
* Patients who forget to, or decide not to, replace PEMF device
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02365753
|
{
"brief_title": "Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Device: SofPulse"
],
"location_countries": null,
"nct_id": "NCT02365753",
"official_title": "Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-17",
"study_completion_date(actual)": "2018-10-31",
"study_start_date(actual)": "2015-01"
},
"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)": "2019-04-04",
"last_updated_that_met_qc_criteria": "2015-02-18",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-19",
"first_submitted": "2015-02-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Schizophrenia patients in comparing to normal controls show decreased ability to identify objects with decreased level of fragmentation, a task that is associated with magnocellular pathway function.
|
#Eligibility Criteria:
Inclusion Criteria:
* Schizophrenia
Exclusion Criteria:
* Ophthalomological or Neurological problems
* Left handed
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
|
NCT01378403
|
{
"brief_title": "Evaluation of Dorsal Visual Stream in Patients With Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT01378403",
"official_title": "Evaluation of Dorsal Visual Stream in Patients With Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2007-09"
},
"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)": "2011-06-22",
"last_updated_that_met_qc_criteria": "2011-06-21",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-06-22",
"first_submitted": "2011-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
#Intervention
- DRUG : tacrolimus
- oral
- Other Names :
- FK506, Prograf
|
#Eligibility Criteria:
Inclusion Criteria:
* Hospitalized patient
* Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02159651
|
{
"brief_title": "A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia",
"conditions": [
"Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis"
],
"interventions": [
"Drug: tacrolimus"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT02159651",
"official_title": "Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-23",
"study_completion_date(actual)": "2019-12-23",
"study_start_date(actual)": "2014-04-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-22",
"last_updated_that_met_qc_criteria": "2014-06-06",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-10",
"first_submitted": "2014-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to evaluate the concerns of university students who are involved in sports on more than one subject related to sports injuries (anxiety of losing ability, anxiety of suffering, anxiety of losing social support, etc.). In addition, in this study, the awareness of protection from sports injuries was evaluated in order to minimize sports injuries and create awareness of injury prevention, based on the idea that the athlete will be injured less with less anxiety in sports life.
Detailed Description
Regardless of the sport branch, athletes are likely to encounter many injury stories during their active sports life. Stories of sports injuries cause anxiety in athletes. Therefore, sports injury prevention awareness is important. This study aimed to evaluate and compare the anxiety about sports injuries and sports injury prevention awareness of university students studying in different faculties and practicing regular sports. Personal Information Form, Sports Injury Anxiety Scale (SIAS) and Sports Injury Prevention Awareness Scale (SIPAS) were used. There was no difference between university students from three different faculties who participated in sports in terms of the total scores of the SIAS and SIPAS (p\>0.05). It was determined that there was a significant difference between the students from three faculties in terms of the Anxiety of Losing Ability (ALA) parameter, which is one of the subscales of the SIAS (p\<0.05). In pairwise comparisons between the groups, a significant difference was found between the students of health sciences and medical faculties in the subscale of the SIAS-ALA (p=0.001). University students who participated in sports from all three faculties included in the study had normal levels of anxiety about sports injuries and high levels of sports injury awareness. High sports injury awareness of students participating in sports may be an important factor for injury prevention. Low levels of anxiety may also be associated with high levels of awareness.
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteering to participate in the research
* To be a student in one of the Faculties of Sports Sciences, Health Sciences, Engineering and Medicine
* Participating in a regular sport branch
Exclusion Criteria:
* - Being diagnosed with a chronic disease or regular medication use
* Not being a student in one of the Faculties of Sports Sciences, Health Sciences, Engineering and Medicine
* Voluntary separation from employment
* Failure to complete the questionnaires to be applied within the scope of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06766344
|
{
"brief_title": "Examınatıon of Sports Injury Anxıety Level and Sports Injury Preventıon Awareness of Unıversıty Students Partıcıpatıng in Sports",
"conditions": [
"Sport Injuries"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT06766344",
"official_title": "Examınatıon of Sports Injury Anxıety Level and Sports Injury Preventıon Awareness of Unıversıty Students Partıcıpatıng in Sports",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-10",
"study_completion_date(actual)": "2023-09-10",
"study_start_date(actual)": "2023-06-26"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-09",
"last_updated_that_met_qc_criteria": "2025-01-04",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-09",
"first_submitted": "2024-12-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with primary central nervous system lymphoma (PCNSL) are treated with high-dose-methotrexate-based chemotherapy, which requires hospitalization and extensive expertise to manage related toxicity. Treatment with R-CHOP, the most commonly used combination against aggressive lymphomas, could overcome these difficulties, but CNS bioavailability of related drugs is poor due to their limited capability to cross the blood-brain barrier (BBB). Tumor necrosis factor (TNF) induces selective BBB permeabilization and enhances CNS access of anticancer drugs in animal models. The addition of NGR peptide improves biological properties of TNF, resulting in increased drug availability and antitumor synergistic effect, without increased toxicity. Thus, the addition of NGR-hTNF to R-CHOP may result in improved CNS drug availability and activity in patients with relapsed/refractory PCNSL; this hypothesis is being tested in this ongoing phase II trial called 'INGRID'. This trial will consider HIV-negative patients (age 18-80 ys; ECOG PS ≤3) with relapsed/refractory PCNSL previously treated with high-dose-methotrexate-based chemotherapy± radiotherapy, and with measurable disease.
Detailed Description
There are three planned analyses:
1. An exploratory analysis (proof of principle) on the first 10 enrolled patients. In the case the experimental treatment will be safe and some tumor responses will be recorded, the chairman, after due multidisciplinary discussion, could propose to proceed with an open, non-comparative phase II trial, with overall response rate (complete and partial responses) as primary endpoint. The maximum overall response rate considered of low interest will be 30%, and the minimum response rate considered of interest will be 50%; to demonstrate that difference, a total of 28 patients will be needed (one-sided test; trype I error .10; power .9). Importantly, BBB permeabilization will be investigated using different methods. Variations in tumor microvasculature and vessel permeability will be assessed by DCE- and DSC-MRI. Permeability will be assessed in contrast-enhanced lesions, perilesional areas and normal appearing brain; results will expressed as KTRANS values normalized using contralateral normal appearing white matter, and compared by Wilcoxon Signed Rank Test. Concentrations of R-CHOP drugs were assessed on matched CSF and serum/plasma samples.Moreover, BBB permeability will be also assessed by 99mTc-diethylene-triamine-pentacetic acid (99mTc-DTPA) brain scintigraphy.
2. First of the two stages of Simon Minimax design, where 12 patients will be entered (including the 10 patients of the exploratory phase) and, if at least 4 responses will be observed, the study will be continued until a total of 28 patients will be entered.
3. Second stage of Simon Minimax design: final analysis of activity on the whole series (n=28); the experimental treatment will be declared active if at least 12 responses will be observed.
#Intervention
- DRUG : NGR-hTNF
- dose of 0.8 mcg/sqm
- OTHER : RITUXIMAB
- dose of 375 mg/mq
- Other Names :
- mabthera
- DRUG : Doxorubicin
- dose of 50 mg/mq
- Other Names :
- adriamicina
- DRUG : Cyclophosphamide
- dose of 750 mg/mq
- Other Names :
- endoxan
- DRUG : Vincristine
- dose of 1.4 mg/mq (max 2 mg)
- DRUG : Prednisone
- 75 mg
- Other Names :
- deltacortene
|
#Eligibility Criteria:
Inclusion criteria
* Histological or cytological diagnosis of (D)LBCL
* Disease exclusively localized into the CNS (brain, meninges, cranial nerves, eyes and/or spinal cord) both at first diagnosis and failure
* Progressive or recurrent disease
* Previous treatment with high-dose-methotrexate-based chemotherapy ± WBRT
* Presence of at least one target lesion, bidimensionally measurable
* Age 18 - 80 years
* ECOG performance status 0 <= age <= 3
* Adequate bone marrow (platelets >75.000/mm3, hemoglobin >8 g/dl, ANC >1.000/mm3), renal (serum creatinine <2 times UNL and creatinine clearance >=40 mL/min), cardiac (VEF >=50%), and hepatic (SGOT/SGPT <3 times UNL, bilirubin and alkaline phosphatase <2 times UNL) function.
* Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without any prejudice. Informed consent signed by a patient's guardian is acceptable if the patient is not able to decide inclusion in the study due to cognitive impairment
*3 Exclusion criteria
* Known HIV disease or other chronic immunodeficiency
* Patients with positive flow cytometry examination of the CSF, but negative results in CSF conventional cytology, and without any other evidence of CNS disease
* Patients with concomitant extra-CNS disease at presentation or relapse
* Symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
* Any other serious medical condition which could impair the ability of the patient to participate in the trial
* Concurrent treatment with other antineoplastic drugs
* Therapy with PPI (Proton Pump Inhibitors, that may interfere with chromogranine levels, see above). For gastroprotective therapy H2-blockers (i.e. ranitidine) are allowed.
* Pregnant and lactating female patients. Sexually active patients of child bearing potential must implement adequate contraceptive measures during study participation.
* Previous or concurrent malignancies at other sites diagnosed or relapsed within the last 3 years of follow-up. Patients with surgically cured in situ carcinomas and basal cell carcinoma of the skin are allowed.
* Presence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
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
|
NCT03536039
|
{
"brief_title": "RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor",
"conditions": [
"Lymphoma, Large B-Cell, Diffuse"
],
"interventions": [
"Drug: Prednisone",
"Other: RITUXIMAB",
"Drug: NGR-hTNF",
"Drug: Doxorubicin",
"Drug: Cyclophosphamide",
"Drug: Vincristine"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03536039",
"official_title": "Monoinstitutional Phase II Trial Addressing Tolerability and Activity of RCHOP Chemoimmunotherapy Preceded by BBB Permeabilization by t-NGR Necrosis Factor in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-27",
"study_completion_date(actual)": "2020-01-27",
"study_start_date(actual)": "2016-01-27"
},
"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)": "2022-08-03",
"last_updated_that_met_qc_criteria": "2018-05-23",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-24",
"first_submitted": "2017-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Yet, the studies that have tested this are extremely limited in number and even fewer explore any acute effects of exercise training on subjects who meet diagnostic criteria. Thus, the investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia.
Detailed Description
Limited experimental research has explored the effects of acute exercise training (\< 1 week of exercise) on sleep and daytime impairment in samples of adults who meet diagnostic criteria for insomnia. In response to the current literature, the investigators aim to better understand the short-term clinical benefit of adopting exercise training in insomnia. Including multiple bouts of exercise in a short time span while measuring sleep with objective and self-reported measures may be more reflective of capturing true acute effects of exercise implementation on insomnia. The investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia. This project will address prior limitations in the area of acute exercise research by utilizing a sample with diagnosed insomnia, assessing multiple nights of sleep, and implementing multiple bouts of exercise stimuli. This project will examine the following aims:
Aim 1: To examine if implementing 1 week of moderate-intensity aerobic exercise improves objective and subjective sleep compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.
Aim 2: To examine if implementing 1 week of moderate-intensity aerobic exercise reduces severity of daytime impairment compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.
#Intervention
- BEHAVIORAL : Outdoor Walking
- Unsupervised outdoor walking will be the mode used for moderate-intensity aerobic exercise. The walking intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.
- OTHER : Quiet Rest
- The quiet rest condition will consist of watching a nature documentary in a quiet room. The quiet rest intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.
|
#Eligibility Criteria:
Inclusion Criteria:
* ISI >= 10
* Age 18 <= age <= 55 years
* Clinically defined Insomnia (i.e., meeting DSM-5 criteria for insomnia disorder)
* Psychiatric health, aside from treated anxiety and depression determined by participant self-report and instruments described below.
Exclusion Criteria:
* Unstable acute or chronic medical conditions. Examples include, but are not limited to, central nervous system disorders (e.g., head injury, seizure disorder, multiple sclerosis, tumor), cardiovascular or hemodynamically significant cardiac disease, renal failure, diabetes. Individuals with well-controlled health conditions that do not affect sleep or well-being (e.g., asthma, high blood pressure, diabetes, or ulcers) will not be excluded.
* Women who are pregnant, nursing, or are planning on becoming pregnant in the next three months.
* Current untreated major syndromal psychiatric disorders:
Specific exclusionary self-reports include:
* Major depressive disorder
* Dysthymic disorder
* Bipolar disorder
* Panic disorder
* Obsessive compulsive disorder
* Generalized anxiety disorder
* Any psychotic disorder
* Any current substance use disorder
The investigators will NOT exclude participants for:
* Untreated subsyndromal symptoms of depression or anxiety and currently treated and stable depression or anxiety disorder.
* Past episodes of major depressive or anxiety disorder, provided the most recent episode ended at least six months before the diagnostic assessment
* Simple phobia
* Social phobia
* Past eating disorders
* Past substance use disorders
* Specific learning disabilities
* Other current sleep disorders, such as:
* Insufficient sleep syndrome
* Circadian rhythm sleep disorders
* Narcolepsy
* Restless legs syndrome
* Obstructive sleep apnea
* Current night shift work
Other sleep disorders are diagnosed according to criteria listed in the DSM-5 and the International Classification of Sleep Disorders, 2nd Edition, 2005. These disorders are evaluated using a clinical interview with the Structured Interview for Sleep Disorders.
* > 0 on the Physical Activity Readiness Questionnaire (PAR-Q+), which represents an inability to safely perform exercise without medical approval or supervision.
* High risk of sleep-disordered breathing indicated by >= 5 'Yes' responses on the STOP-Bang questionnaire, or >= 2 + male sex, >=2 + BMI > 35, or >=2 + a neck circumference >16 inches (females) or >17 inches (males).
* Obesity (BMI >= 30)
* Indication of moderate/severe depressive or anxiety symptoms (score >= 10 on the Patient Health Questionnaire-9 [PHQ-9] or score >= 10 on the 7-item Generalized Anxiety Disorder Questionnaire [GAD-7], respectively)
* Current treatment for insomnia
* Suspected circadian rhythm disorder (delayed sleep phase: habitual bedtime >= 2:00 am or wake time >= 10:00 am; advanced sleep phase: habitual bedtime <= 9:00 pm or wake time <= 5:00 am)
* Nocturnal shift-work (i.e., working between 12:00 am and 6:00 am)
* Physically active (self-report of > 2 sessions/week of structured physical activity or >150 minutes/week of accelerometer-measured bouted moderate to vigorous physical activity)
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
|
NCT04402021
|
{
"brief_title": "Exercise and Insomnia Study: The Effects of 1 Week of Exercise Training on Insomnia Severity",
"conditions": [
"Insomnia Chronic",
"Insomnia, Primary"
],
"interventions": [
"Other: Quiet Rest",
"Behavioral: Outdoor Walking"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04402021",
"official_title": "The Effect of Short-term Exercise on Sleep and Daytime Impairment in Adults With Insomnia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-01",
"study_completion_date(actual)": "2020-12-01",
"study_start_date(actual)": "2020-08-11"
},
"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)": "2021-01-14",
"last_updated_that_met_qc_criteria": "2020-05-20",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-26",
"first_submitted": "2020-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research is being done to evaluate the effects of a sleeping pill (eszopiclone, Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in patients with knee pain.
#Intervention
- DRUG : Placebo
- 3mg placebo capsule, once daily at bedtime
- DRUG : Eszopiclone
- 3mg capsule, once daily at bedtime
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 64
* Diagnosed with and under physicians care for osteoarthritis of the knee according to American College of Rheumatology Criteria with radiographic evidence demonstrating at least grade 1 osteoarthritis (OA)
* Report at least typical arthritic pain>4 out of 10 (0=no pain, 10=the most extreme pain imaginable)
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Sleep Disorders, Revised definition (ICSD-R) criteria for either primary (psychophysiologic) insomnia or insomnia secondary to osteoarthritis
* Insomnia symptoms must include problems with middle of the night awakenings
* Insomnia symptom duration > 6 months
* Baseline, 2-week, sleep diary average wake after sleep onset time >30 minutes
* Baseline self-reported total sleep time < 6.5 hours per night
* Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study
Exclusion Criteria:
* Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc)
* Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc)
* Major medical disease (including, hepatic impairment, chronic obstructive pulmonary disease/compromised respiratory function, cancer, dementia, diabetes, congestive heart failure, cerebrovascular disease, raynaud's syndrome)
* Active major psychiatric disorders (including dementia or cognitive impairment) and history of schizophrenia or bipolar I disorder
* History of serious suicide attempt; 6) history of alcohol or substance (including prescription medications) abuse
* Pregnancy or plans to become pregnant within 6 months
* Intraarticular steroid injection within the past month
* Regular (>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers, within the past two months
* Regular (> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and anticonvulsants within the past one month
* Unwilling or unable to discontinue all use of the medications listed in #10 for two weeks prior to starting the study
* Unwilling or unable to discontinue all centrally acting agents and all analgesic usage within 24 hours of pain testing sessions
* Refusal to provide consent to contact patient's physician to establish diagnosis and obtain medical record information
* Regular tobacco or nicotine use
* Heavy caffeine use [(>2 cups of coffee/day (equivalent)
* History of previous allergic reaction or severe side effects to sedative hypnotics
* Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir)
* In addition, subjects will undergo in-laboratory blood tests prior to receiving drug and will be excluded from further participation if they exhibit: a) positive pregnancy test, b) positive toxicology (benzodiazepine, opioids, Tetrahydrocannabinol (THC), alcohol, and stimulants), c) abnormal liver enzyme panel
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00374556
|
{
"brief_title": "Insomnia and Osteoarthritis Study",
"conditions": [
"Osteoarthritis",
"Insomnia"
],
"interventions": [
"Drug: Placebo",
"Drug: Eszopiclone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00374556",
"official_title": "The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2006-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-14",
"last_updated_that_met_qc_criteria": "2006-09-08",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-11",
"first_submitted": "2006-09-08",
"first_submitted_that_met_qc_criteria": "2017-10-10"
}
}
}
|
#Study Description
Brief Summary
The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy.
Detailed Description
The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy. There were three aims of this study: AIM 1: Self-Efficacy - To examine the ability of a six-week, manualized, cognitive-behaviorally based group educational intervention (Re-Inventing Yourself after SCI-Bridge) to improve both SCI-specific and general self-efficacy for people who are early in the process of community reintegration; AIM 2: Psychosocial Adjustment - To assess the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve psychosocial adjustment of people with SCI who are early in the community reintegration process; and, Aim 3: Participation - To determine the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve societal participation for people with SCI who are early in the community reintegration process.
#Intervention
- BEHAVIORAL : ReInventing Yourself after SCI
- 6-week, manualized, cognitive-behaviorally based group educational intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* History of SCI at any level;
* completed initial inpatient rehabilitation but are no more than 6 months post-discharge;
* 18 years or older at the time of study enrollment;
* English speaking in order to complete study measures and participate in group interactions; and
* able to provide informed consent to participate.
Exclusion Criteria:
* History of moderate or severe traumatic brain injury;
* current participation in another RCT;
* live beyond a reasonable commuting distance from Craig Hospital;
* unable to verbally communicate;
* unable to attend group sessions;
* active participation in another formal clinical group or psychological therapy;
* are currently experiencing severe depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 20 or higher on the Personal Health Questionnaire-9;
* report any current suicidal ideation on the Personal Health Questionnaire-9; or
* have any condition that, in the judgment of the investigators, precludes successful participation 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:
Yes
|
NCT03554733
|
{
"brief_title": "Bridge Reinvention",
"conditions": [
"Spinal Cord Injuries"
],
"interventions": [
"Behavioral: ReInventing Yourself after SCI"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03554733",
"official_title": "A Bridge From Rehabilitation to Real-World: Re-Inventing Yourself After SCI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-30",
"study_completion_date(actual)": "2018-04-30",
"study_start_date(actual)": "2014-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-13",
"last_updated_that_met_qc_criteria": "2018-06-11",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-13",
"first_submitted": "2018-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this randomized controlled trial is to compare the efficacy of extended high dose letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent 3 days ) with short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an adjuvant to GnRH antagonist protocol in the management of patients with poor ovarian response undergoing IVF-ET.
Detailed Description
Poor response to controlled ovarian stimulation (COH) is estimated to occur in 9-24 % of all IVF cycles. Although there is no consensus on the definition of poor response to COH, inability to produce adequate number of mature follicles( ≤ 2-5) or to recruit adequate number of oocytes ( ≤ 3 oocytes ) in response to standard stimulation protocols are the main criteria used for diagnosis of poor responders .
Patients with poor response to COH usually have higher cyclical cancelation rate , poor embryo quality and less number of embryos suitable for transfer or cryopreservation .
During the past decade gonadotropin releasing hormone antagonists (GnRHant) were widely used in the treatment of patients with poor response to standard gonadotropin releasing hormone agonist (GnRHa) protocols .In contrast to GnRHa, GnRHant is administered at the late follicular phase and therefore don't suppress the early follicular phase endogenous gonadotropins and has no suppressive effect on ovarian function at the stage of follicular recruitment.Several studies comparing GnRHant protocol with the standard GnRHa long protocol revealed a reduction in the duration of stimulation , dose of required gonadotropins , and the costs of IVF cycle with GnRHant as well as equivalent pregnancy rates .
In 2001, Mitwally and Casper introduced letrozole ( a third generation non steroidal aromatase inhibitor licensed for treatment of hormonally-responsive breast cancer after surgery ) as new ovulation induction agent in clomiphene citrate resistant patients with polycystic ovary syndrome (PCOS) . Subsequent studies confirmed the effectiveness of letrozole in induction of ovulation in women with PCOS and in superovulation (either alone or in combination with gonadotropins ) .
In patients with poor response undergoing IVF, several studies revealed that the combination of letrozole ( 2.5 mg or 5 mg/day for 5 consecutive days in early follicular phase ) with GnRHant protocol improved the ovarian response and reduced the gonadotrophin dose required. On the other hand , Schoolcraft et al reported that letrozole(2.5 mg/day from cycle day 3 to 7)/GnRHant protocol has no advantages over microdose flare GnRHa protocol.
The ideal dose and duration of letrozole administration for ovulation and superovulation is still not clear. Several studies comparing two doses of letrozole (2.5 mg or 5 mg) in superovulation suggested that the higher dose might be associated with more follicles developing.
In almost all studies to date , letrozole was administered for five consecutive days in early follicular phase . In only one study , letrozole (2.5 mg/day) was administered for ten consecutive days starting on day 1 of menstrual cycle . In that study , prolonged administration of letrozole produced more mature follicles and pregnancies than short letrozole therapy regimen in patients with clomiphene citrate resistant polycystic ovary syndrome .
The investigators designed this randomized controlled trial to compare the efficacy of extended high dose letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent 3 days ) with conventional short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an adjuvant to GnRHant protocol in the management of patients with poor ovarian response undergoing IVF-ET.
#Intervention
- DRUG : Extended high dose letrozole regimen /GnRH antagonist protocol
- Letrozole (Femara; Novertis pharma AG, Basle, Switzerland) is administered starting on cycle day one for 8 consecutive days . The dose of letrozole is 5mg /day during the first 5 days of cycle and 2.5 mg/day during the subsequent 3 days .
Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol.
GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration .
- Other Names :
- Extended letrozole/GnRHant
- DRUG : Short low dose letrozole regimen /GnRH antagonist protocol
- Letrozole (Femara; Novertis pharma AG, Basle, Switzerland)2.5 mg /daily is administered for 5 consecutive days starting on cycle day 3.
Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 3 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol.
GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration .
- Other Names :
- Short Letrozole/GnRHant
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who produced less than three mature follicles in response to standard GnRH agonist long protocol in their first IVF cycle
Exclusion Criteria:
* Age > 42 years
* FSH> 12 IU/L
* Irregular menstrual cycles
* Unilateral ovary
* Polycystic ovary syndrome
* Endometriosis
* Male factor of infertility requiring ICSI
* History of recurrent miscarriage
* Endocrinologic disorders
* Systemic disease contraindicating pregnancy
Sex :
FEMALE
Ages :
- Minimum Age : 30 Years
- Maximum Age : 42 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01219153
|
{
"brief_title": "Extended High Dose Letrozole Regimen Versus Short Low Dose Letrozole Regimen as an Adjuvant to GnRH Antagonist Protocol in the Management of Poor Responders Undergoing IVF-ET",
"conditions": [
"Infertility"
],
"interventions": [
"Drug: Short low dose letrozole regimen /GnRH antagonist protocol",
"Drug: Extended high dose letrozole regimen /GnRH antagonist protocol"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT01219153",
"official_title": "Extended High Dose Letrozole Regimen Versus Short Low Dose Letrozole Regimen as an Adjuvant to GnRH Antagonist Protocol in the Management of Patients With Poor Ovarian Response Undergoing IVF-ET, a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-07-12",
"last_updated_that_met_qc_criteria": "2010-10-12",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-13",
"first_submitted": "2010-10-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project involves the delivery of education and training sessions to Seven Oaks General Hospital (SOGH) staff, with the goal of workplace injury prevention. Education will include review of provincial safe patient handling and back injury prevention guidelines and review of core fitness competencies required to comply with injury prevention standards. Training sessions will include exercises to improve core, gluteal and quadricep strength, hip/knee mobility and hamstring flexibility. Training will also be an opportunity to provide feedback on functional movement performance. Outcomes will include questionnaires on: low back pain/dysfunction; movement confidence; work injury rates and participant satisfaction with program. The project will advise stakeholders of the benefits and challenges associated with implementation of a fitness program to support safe patient handling techniques, as outlined in the provincial guidelines for healthcare workers.
Detailed Description
The Fit for Work Project is an educational and training program outcome evaluation. It is a two-part education and practical program designed to evaluate the effects of training on movement confidence, low back dysfunction and changes in rates of lower back injury. In the first part, participants will attend the education session developed by physiotherapists who specialize in return to work programs. In the second part participants will participate in a 4-week practical program, where they will stretch, lengthen and strengthen key muscles used in squatting, weight shifting and the hip hinge movement. Feedback and movement coaching are an important element in performing and mastering these movements correctly and this workplace wellness training program will provide staff the support needed.
#Intervention
- OTHER : An Educational and Training Program
- Education and practical training program designed to evaluate the effects of training on movement confidence, low back dysfunction and changes in rates of lower back injury
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, age >= 18 years
* Staff of Seven Oaks General Hospital during the time of the program
* Able to communicate in English and provide written informed consent
Exclusion Criteria:
* An acute injury, a medical condition, or other personal reason inhibiting participation in all 4 weeks of exercise training sessions
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
|
NCT05834959
|
{
"brief_title": "Implementation of a Fitness Education and Training Program to Support Safe Patient Handling and Safe Lifting",
"conditions": [
"Lower Back Injury"
],
"interventions": [
"Other: An Educational and Training Program"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT05834959",
"official_title": "Implementation of a Fitness Education and Training Program to Support Safe Patient Handling and Safe Lifting in a Community Based Hospital (The Fit for Work Project)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-11",
"study_completion_date(actual)": "2023-10-30",
"study_start_date(actual)": "2023-03-14"
},
"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)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2023-04-17",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-28",
"first_submitted": "2023-03-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Males develop more severe SARS-CoV-2 infection related disease outcome than females. Herein, sex hormones were repeatedly proposed to play an important role in Covid-19 pathophysiology and immunity. However, it is yet unclear whether sex hormones are associated with Covid-19 outcome in males and females. In this study, we analyzed sex hormones, cytokine and chemokine responses as well as performed a large profile analysis of 600 metabolites in critically-ill male and female Covid-19 patients in comparison to healthy controls and patients with coronary heart diseases as a prime Covid-19 comorbidity. We here show that dysregulated sex hormones, IFN-γ levels and unique metabolic signatures are associated with critical illness in Covid-19 patients. Both, male and female Covid-19 patients, present elevated estradiol levels which positively correlates with IFN-γ levels.
Male Covid-19 patients additionally display severe testosterone and triglyceride deficiencies as compared to female patients and healthy controls. Our results suggest that male Covid-19 patients suffer from multiple metabolic disorders, which may lead to higher risk for fatal outcome. These findings will help to understand molecular pathways involved in Covid-19 pathophysiology.
#Intervention
- DIAGNOSTIC_TEST : Sex Hormones
- A panel of 13 hormones was measured in plasma samples of COVID-19 patients (total testosterone, free testosterone, dihydrotestosterone, androstenedione, 17-β-estradiol, estrone, sex hormone-binding globulin, thyroid-stimulating hormone, free triiodothyronine (T3), free thyroxine (T4), luteinizing hormone, follicle-stimulating hormone and cortisol).
|
#Eligibility Criteria:
Inclusion Criteria:
* Admission on ICU
* Covid-19
Exclusion Criteria:
* none
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
|
NCT04979091
|
{
"brief_title": "Sex Hormone Dysregulations Are Associated With Critical Illness in COVID-19 Patients",
"conditions": [
"Covid19",
"Critical Illness"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT04979091",
"official_title": "Low Testosterone and High Estradiol Are Associated With Disease Severity in Critically Ill COVID-19 Patients - a Retrospective Analysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-26",
"study_completion_date(actual)": "2021-05-31",
"study_start_date(actual)": "2020-03-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-06",
"last_updated_that_met_qc_criteria": "2021-07-25",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-27",
"first_submitted": "2021-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to determine whether the AggreGuide platelet aggregometer can discern the effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the agonist.
|
#Eligibility Criteria:
Inclusion Criteria:
* adults
Exclusion Criteria:
* aspirin contraindications
* anticoagulants
* aspirin past week
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
|
NCT01603966
|
{
"brief_title": "Low Dose Aspirin Studied With the AggreGuide",
"conditions": [
"Platelet Aggregation"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01603966",
"official_title": "Low Dose Aspirin Study With the AggreGuide",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2012-06",
"study_start_date(actual)": "2012-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-17",
"last_updated_that_met_qc_criteria": "2012-05-22",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-23",
"first_submitted": "2012-05-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
Detailed Description
The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.
#Intervention
- DRUG : EG017 3mg
- EG017 3mg/day Oral administration for 12 weeks, once daily
- DRUG : EG017 6mg
- EG017 6mg/day Oral administration for 12 weeks, once daily
|
#Eligibility Criteria:
Inclusion Criteria:
SUI symptoms of at least 6 months duration Urinary incontinence in the 1-hour pad test weight>=5g and<30 g Moderate to severe urinary incontinence evaluated by ICIQ-SF
Exclusion Criteria:
Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.) Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery before prior to study entry Patient has a serious illness or medical condition
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05674045
|
{
"brief_title": "A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence",
"conditions": [
"Stress Urinary Incontinence"
],
"interventions": [
"Drug: EG017 3mg",
"Drug: EG017 6mg"
],
"location_countries": [
"China"
],
"nct_id": "NCT05674045",
"official_title": "A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploration Phase II Trial to Evaluate the Efficacy and Safety of EG017 Tablets in Postmenopausal Women With Stress Urinary Incontinence",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-06",
"study_completion_date(actual)": "2022-09-26",
"study_start_date(actual)": "2022-01-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-06",
"last_updated_that_met_qc_criteria": "2022-12-30",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-06",
"first_submitted": "2022-12-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.
Detailed Description
After approval from hospital ethical committee, patients fulfilling the inclusion \& exclusion criteria were recruited after taking informed written consent for surgery. Patients were allocated to group A and B using computer generated random sample allocation.
In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters.
In group B, B-lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.
#Intervention
- PROCEDURE : Balloon Tamponade or B-Lynch
- In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.
|
#Eligibility Criteria:
Inclusion Criteria:
* Singleton pregnancy
* Late Third Trimester pregnancy (35+ weeks to 39 weeks)
* Placenta Previa confirmed by ultrasonography
* Elective Caesarean Section.
Exclusion Criteria:
* Multiple gestation
* Placenta accreta Spectrum (accrete/increta/percreta)
* Bleeding diathesis
* Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.
* Serious medical or surgical diseases.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05133167
|
{
"brief_title": "Balloon Tamponade Vs B-Lynch In Placenta Previa",
"conditions": [
"Placenta Previa"
],
"interventions": [
"Procedure: Balloon Tamponade or B-Lynch"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05133167",
"official_title": "Comparison of Efficacy of Surgical Interventions (Balloon Tamponade Versus B-lynch Suture) to Prevent Postpartum Hemorrhage in Patients With Placenta Previa",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-01",
"study_completion_date(actual)": "2021-10-01",
"study_start_date(actual)": "2021-04-01"
},
"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)": "2021-11-24",
"last_updated_that_met_qc_criteria": "2021-11-15",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-24",
"first_submitted": "2021-11-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open label phase I/II clinical trial to assess safety, tolerability and potential effect on SMN mRNA and protein in vivo of a compound in which preliminary evidence supports a potential effect on SMN levels in vitro.
Detailed Description
This is an open label phase I/II trial of valproic acid in 40 SMA subjects \> 2 years of age with severe, intermediate, and mild phenotypes. Primary outcome measures includes laboratory and physical examination assessments to monitor effects on liver, hematologic, metabolic and nutritional status. Secondary outcomes includes measures of gross motor function; electrophysiologic measures of denervation; DEXA estimates of body composition, bone mineral density and content; measures of pulmonary function; and quantitative SMN mRNA and protein levels in blood cells. Subjects will need 2-3 baseline visits over a 3 -6 month period prior to enrollment. Follow-up visits will be scheduled at 3, 6 and 12 months on treatment.
#Intervention
- DRUG : Valproic Acid
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have a diagnosis of SMA, confirmed by genetic testing
* Only patients 2 years and older at enrollment will be eligible
Exclusion Criteria:
* Patients taking any medications with known hepatotoxicity, congenital metabolic disorders or on multiple anticonvulsant medications
* Patients taking medications which may interact with VPA
* Patients on ventilatory support for more than 16 hours per day
* Patients currently enrolled in other treatment trials
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00374075
|
{
"brief_title": "Study of Safety and Dosing Effect on SMN Levels of Valproic Acid (VPA) in Patients With Spinal Muscular Atrophy",
"conditions": [
"Spinal Muscular Atrophy"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00374075",
"official_title": "In Vivo Study of Safety, Tolerability and Dosing Effect on SMN mRNA and Protein Levels of Valproic Acid in Patients With Spinal Muscular Atrophy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-02",
"study_start_date(actual)": "2003-09"
},
"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)": "2023-05-10",
"last_updated_that_met_qc_criteria": "2006-09-06",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-08",
"first_submitted": "2006-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Hematopoietic cell transplantation (HCT) is the only curative treatment modality for many hematologic malignancies. Morbidity and mortality rates have declined drastically over the years, secondary to improvements in both transplant techniques and pharmacotherapies, including immunosuppressants, anti-infectives, analgesics and other supportive care medications. Despite advances in patient care, toxicities associated with HCT (e.g., graft-versus-host disease (GVHD), infection, pain, anxiety, depression, mucositis, nausea/vomiting) continue to pose challenges in patient care and have a significant impact on quality of life. (QOL). A recent study demonstrated subjects randomized to intensive supportive care had a clinically significant improvement in their QOL during hospitalization and up to 3 months post-transplant compared to those receiving standard care.
Further follow up evaluations have evaluated the impact of focused palliative care/symptom management on QOL metrics - inclusive of Edmonton Symptom Assessment surveys (ESAS). In other malignant settings, i.e. solid tumor, ESAS has been noted as an effective measure of symptoms control and the utilization of this assessment is linked to positive outcomes. The American Society of Clinical Oncology (ASCO) has designated QOL as the second most relevant metric for post-transplant patient care behind survival, making the optimization of supportive care pharmacotherapy a clinically relevant subject to investigate. Pharmacogenetics (PGx) uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose selection. SNPs encode drug-metabolizing enzymes, transporters, and targets that can significantly impact drug efficacy and toxicity. With the growing complexity of both antineoplastics and supportive care, oncologists have less time to manage each subject's myriad of supportive care concerns by trial and error. Suboptimal management of symptoms compromises potential benefits from cancer therapy, disrupts clinic workflow, increases emergency room visits, and affects both patient satisfaction and reimbursement. Genetic variation is well documented across the human genome and affects a subject's response to medications regarding efficacy and toxicity. The genome is quickly becoming a pragmatic tool that can assist oncologists and other providers in optimizing supportive care for subjects with cancer.
Detailed Description
The investigators hypothesize that the implementation of a pharmacist-driven precision medicine service guided by HCT clinical pharmacists and Specialty Pharmacy pharmacists using preemptive pharmacogenomic (PGx) testing will identify drug-gene interactions relevant to the supportive care of HCT subjects. This approach to care may improve symptom management and QOL as interpreted via ESAS in adult HCT subjects treated at our institution. With the experience of past studies and a customized genetic panel, the investigators will genotype subjects prior to transplant and identify actionable drug-gene pairs and utilize these to direct supportive therapies. To date no studies have highlighted the significance of incorporating preemptive PGx testing to personalize therapy selection and dosing into the management of adult HCT subjects as a means of improving QOL and symptom management. The primary aim is to estimate the frequency of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on their test results during the study period (from admission for HCT to HCT D100). Secondarily the investigators will measure improvement in aggregate and individual scores on the ESAS survey and will further use the ESAS in its totality to assess the impact of PGx-guided care as compared to pre-implementation/non-PGx driven strategies through aggregate ESAS scores, individual ESAS scores, and differences between HCT admission (or baseline) and HCT Day 30 scores before and after the intervening program. In the outpatient setting the investigators will utilize planned medication reconciliation (with PGx guidance) by Specialty Pharmacy Service pharmacists to adhere to PGx-recommendations and capture insight into the implementation of this program to share with other practitioners. The implementation of this study will personalize pharmacotherapy, improve symptom management and QOL in adult HCT subjects treated at our institution, and offer guidance globally in supporting the role of the pharmacist in pharmacogenomics (PGx) and management of HCT subjects.
#Intervention
- OTHER : Pharmacogenomic-guided supportive care
- Patients undergoing hematopoietic stem cell transplantation will be genotyped and supportive care therapies tailored to identified drug-gene pairs and guideline recommendations
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent and HIPAA authorization for release of personal health information
* Age >= 18 years at the time of consent
* Scheduled HCT (allogeneic and autologous, any conditioning regimen) treatment for any malignant or non-malignant indications (i.e. aplastic anemia)
* Ability to read and understand English or Spanish
* Able to provide a buccal sample for DNA extraction and genotyping
Exclusion Criteria:
* Psychiatric illness/social situations, or active/recent (within 30 days) history of elicit substance abuse that would limit compliance with study requirements as determined by the investigator
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
|
NCT04727827
|
{
"brief_title": "Pharmacogenomic-Guided Supportive Care in Hematopoietic Cell Transplantation",
"conditions": [
"Hematopoietic Cell Transplantation",
"Oncology"
],
"interventions": [
"Other: Pharmacogenomic-guided supportive care"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04727827",
"official_title": "A Prospective Interventional Trial of Pharmacogenomic-Guided Supportive Care in Hematopoietic Cell Transplantation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-09",
"study_completion_date(actual)": "2023-06-09",
"study_start_date(actual)": "2021-02-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-03",
"last_updated_that_met_qc_criteria": "2021-01-26",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-27",
"first_submitted": "2021-01-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical cardioversion. Ankle brachial index will be measured three times with oscillometric method and three times with doppler method. Two study sessions will be performed: the first before and the second after electrical cardioversion. The first session will be ended before anesthesia. The second session will be started before a conscious patient will be transported from intensive care unit to general ward.
All the measurements will be taken in the intensive care unit at an ambient temperature of 21° C, after patients will give their written informed consent to participate in the study. All patients will be awake, fasting and in the supine position. ABI will be measured according to the guidelines issued by AHA. Systolic blood pressure will be measured using a Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau, Switzerland). The appropriate cuff size will be used with the width of the cuff being at least 40% of the limb circumference. The arm with higher systolic blood pressure will be used to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI measurements will be repeated 3 times with each method in the reverse order of the preceding measurement e.g., in the case of the initial counterclockwise sequence: right arm, right popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm, the clockwise sequence will be used, starting and ending with the left arm. The same sequence of limb pressure measurements will be used used during the study.
A sample size calculation was based on the preliminary observations made by the study team. It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size of 115 patients incorporated an assumption of dropout due to non-effective electrical cardioversion, patient decision to quit study or failure to obtain adequate ABI.
The measurements will be repeated three times with each method and for the each method the mean will be used for the calculations. Investigator - study nurse, trained at the vascular department, will perform all ABI measurements.
#Intervention
- DEVICE : ABI measurement using both doppler and oscillometric method
- Other Names :
- doppler method (Echo Sounder ES-101EX, Hadeco, Japan and Minimus II, Rister, Germany), oscillometric method (Microlife WatchBP AG, Widnau, Switzerland)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing electrical cardioversion due to atrial fibrillation
Exclusion Criteria:
* Circulatory instability
* Use of vasoconstrictive agents
* Limb trauma
* Upper limb artery stenosis
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02986282
|
{
"brief_title": "Ankle - Brachial Index Measurement in Atrial Fibrillation",
"conditions": [
"Atrial Fibrillation Fluttering"
],
"interventions": [
"Device: ABI measurement using both doppler and oscillometric method"
],
"location_countries": null,
"nct_id": "NCT02986282",
"official_title": "Ankle - Brachial Index Measurement in Patients With Atrial Fibrillation Before and After Electrical Cardioversion",
"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)": "2012-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-18",
"last_updated_that_met_qc_criteria": "2016-12-05",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-08",
"first_submitted": "2016-12-02",
"first_submitted_that_met_qc_criteria": "2017-06-19"
}
}
}
|
#Study Description
Brief Summary
The study is a pilot study (phase 2) that includes a usability study (phase 1).
The aim of the study is to investigate the feasibility and usability of the healthy nutrition application and the effects on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge among patients with cardiovascular disease in a cardiac rehabilitation setting. Furthermore, it studies the overall user experience when using the healthy nutrition application.
Detailed Description
The study can be divided in two phases, each one addressing a specific research question:
1. Usability: Is the developed healthy nutrition application user-friendly and does it seem motivating for cardiac patients in a cardiac rehabilitation setting to use the application to eat more healthily?
2. Pilot study: Is the developed healthy nutrition application feasible and acceptable for cardiac patients? Does the healthy nutrition application have an effect on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge in cardiac patients in a cardiac rehabilitation setting and what is the user experience?
#Intervention
- BEHAVIORAL : A gamified smartphone app-based eating behaviour intervention
- All patients gained access to the healthy nutrition application and were encouraged to make full use of its feature, and they were also required to maintain a logbook through the application at home to follow-up on their diet. The intervention last for six weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* History of cardiovascular disease with or without intervention (PCI/CABG/conservative/pacemaker implantation/ablation)
* History of current or past cardiac rehabilitation in Jessa Hospital Hasselt
* Current treatment must require them to follow the Mediterranean diet plan
* Age >=18 years
* Willing and physically able to follow a application-based healthy nutrition program and other study procedures in a six-week follow-up period
* Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
* Possession of and/or able to use an Android based smartphone (version 6 or higher)
* Possession of internet connectivity
* Dutch speaking and understanding
Exclusion Criteria:
* Pregnant females
* Combined with diabetes or severe kidney disease
* Participation in other cardiac rehabilitation program trials, focusing on diet outcome
* Current or recent participation in other technology-supported programs, even when not directly targeting nutrition
* Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than six weeks based on investigators judgment
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
|
NCT05884489
|
{
"brief_title": "Usability and Feasibility of the NutriQuest Application",
"conditions": [
"Gamification",
"Nutrition",
"Behavior Change"
],
"interventions": [
"Behavioral: A gamified smartphone app-based eating behaviour intervention"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT05884489",
"official_title": "Gamified Smartphone Application to Improve the Adherence to the Mediterranean Diet in Cardiac Patients: a Usability and Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-12",
"study_completion_date(actual)": "2022-10-12",
"study_start_date(actual)": "2022-06-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-01",
"last_updated_that_met_qc_criteria": "2023-05-22",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-01",
"first_submitted": "2023-05-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background:
Fournier's gangrene it's a necrotizing infection of the genital area, with high morbidity and mortality. The site of infection its the origin of the necrotizing fasciitis. There are 4 well known origins of Fournier's gangrene: Testicular, Intestinal, Urinary and cutaneous, and its prognostic value has not been established yet, that's because the lack of case series with adequate number of patients. This is a retrospective study in which we evaluate the prognostic factors of every patient and its mortality compared with its origin area and multiple scores with their survival rates and hospital stay.
Detailed Description
Objective:
To evaluate origins of Fournier's gangrene as a prognostic value in the morbidity and mortality.
Patients and methods:
This is a retrospective study where patients from a single hospital from 2007 to 2016 were included. They were categorized in 4 groups matching the origin of infection. In every group categorizing with the origin of infection and determined severity factors, days of hospital stay, Fournier's gangrene severity index and mortality. A statistic analysis will be done using lineal multivariable analysis.
#Intervention
- PROCEDURE : Aggressive debridement
- Aggressive debridement of the tissues undergoing fascitis
|
#Eligibility Criteria:
Inclusion Criteria
* Male Patient
* Fournier's Gangrene
* All patients treated with two antibiotics
* All patients undergone with aggressive debridement
Exclusion Criteria
* Female
* Not having Fournier's Gangrene
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03443544
|
{
"brief_title": "Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients",
"conditions": [
"Fournier Gangrene",
"Fournier's Gangrene of Penis",
"Fournier's Gangrene of Scrotum"
],
"interventions": [
"Procedure: Aggressive debridement"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT03443544",
"official_title": "Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-01",
"study_completion_date(actual)": "2018-02-01",
"study_start_date(actual)": "2017-11-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-23",
"last_updated_that_met_qc_criteria": "2018-02-22",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-23",
"first_submitted": "2018-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2) Explore the durability of the effects of MBSR over one year.
#Intervention
- BEHAVIORAL : Mindfulness-based Stress Reduction
- Other Names :
- MBSR
- BEHAVIORAL : MS Education Control
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 years or older
* Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
* Expanded Disability Severity Scale <= 8 at baseline;
* Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
* Mild to moderate stress defined by a score of >= 10 on the Perceived Stress Scale at screening;
* Ability to read and write in English;
* Willingness to provide informed consent and comply with study activities, including weekly MBSR sessions and daily practice or weekly Education Control classes.
Exclusion Criteria:
* MBSR or cognitive behavioral therapy training within the last 5 years;
* Current regular meditation or yoga practice (weekly or more often);
* MS exacerbation within 30 days of Baseline Visit;
* Mini-Mental Status Examination (MMSE) score of <= 26 at Screening Visit;
* Active suicidal ideation (Beck Depression Inventory) at Screening Visit;
* Reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
* Other current life-threatening or severely disabling physical disorders;
* Positive pregnancy urine test at Baseline and women planning pregnancy during the study period (contraception not required);
* Cancer, other than basal or squamous skin cancers; or
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02340754
|
{
"brief_title": "Mindfulness-based Stress Reduction for Multiple Sclerosis",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Behavioral: Mindfulness-based Stress Reduction",
"Behavioral: MS Education Control"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02340754",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-30",
"study_completion_date(actual)": "2017-05-30",
"study_start_date(actual)": "2015-05"
},
"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)": "2018-04-09",
"last_updated_that_met_qc_criteria": "2015-01-13",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-19",
"first_submitted": "2015-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary endpoint of this phase II trial is the objective response rate of the regimen. The secondary endpoints include treatment-related toxicity, progression free survival and overall survival and breast conserving rate.
Detailed Description
This is an open-label phase II trial designed to test the effect and toxicity profile of combination of docetaxel, cisplatin, and capecitabine in locally advanced breast cancer patients.Breast cancer is one of the leading causes of cancer death for women in Taiwan. Despite the advance in multidisciplinary treatment, a significant number of patients eventually develop metastatic disease, especially those who present with locally advanced breast cancer (LABC). LABC remains an important and challenging problem in practice. In LABC, treatment strategies that include neoadjuvant chemotherapy have several potential advantages: early initiation of systemic therapy, in vivo assessment of response, and downstaging of primary tumor and regional lymphatic metastases, which makes breast-conserving surgery an option for many. The potential theoretical shortcomings include delay in local treatment, introduction of drug resistance, and unreliability of clinical staging. In practice, the advantages have exceeded the disadvantages. Clinical trial has demonstrated that docetaxel and capecitabine is highly effective in the treatment of metastatic breast cancer. On the other hand, our previous study has demonstrated that combination of taxane and cisplatin is highly effective in the treatment of locally advanced and metastatic breast cancer. We design a combination chemotherapy using docetaxel with cisplatin and capecitabine in the treatment of locally advanced breast cancer.
#Intervention
- DRUG : Docetaxel , Cisplatin , Capecitabine
|
#Eligibility Criteria:
Inclusion Criteria:
* Women with histological proven LABC, without metastasis, and no prior therapy. LABC is defined as follows：
1. Tumor more than 5 cm in diameter
2. Tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
3. Clinical evident inflammatory carcinoma
4. Ipsilateral fixed axillary adenopathy
* Measurable disease by physical examination, breast sonography and other image study
* KPS≧ 70%
* Adequate bone marrow reserve, defined as white blood cell (WBC)≧ 3,500/ mm3, absolute neutrophil count (ANC)≧ 1,500/mm3, platelets ≧ 100,000/mm3
* Adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (ALT) and aspartate transaminase (AST) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
* Patients must be ≦ 65 years
* Signed informed consent
Exclusion Criteria:
* Patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for LABC. Concomitant use of above therapy will no be allowed.
* Pregnant or lactating woman
* Metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
* Prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
* Secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
* Active infection (at the discretion of the investigator)
* Significant neurological (such as seizures) or psychiatric disorder
Sex :
FEMALE
Ages :
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00155259
|
{
"brief_title": "Docetaxel, Cisplatin and Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Drug: Docetaxel , Cisplatin , Capecitabine"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT00155259",
"official_title": "Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2004-10"
},
"study_design": {
"allocation": "NON_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)": "2007-07-25",
"last_updated_that_met_qc_criteria": "2005-09-08",
"last_verified": "2005-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-12",
"first_submitted": "2005-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status.
The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.
Detailed Description
The Society of Cardiothoracic surgeons suggest that 50% of patients undergoing cardiac surgery have a blood transfusion.
Several studies indicate an increase in morbidity and mortality related to blood transfusions.
Traditionally, the coagulation tests are performed in the hematology laboratory.
Rotational thromboelastrometry is a useful method of assessing perioperative coagulation function in patients undergoing cardiac surgery.
The presence of significant amounts of heparin in blood samples during cardiopulmonary bypass induces artifactual errors when thromboplastin is used as a reagent. For this reason, whole blood coagulation monitoring with ROTEM® has not been feasible during cardiopulmonary bypass with heparin anticoagulation. Recently recombinant thromboplastin has come available. It's stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to 5UI/l .
Three of the available ROTEM®-tests are EXTEM (activation by recombinant thromboplastin), INTEM (activation by elagic acid) and HEPTEM. In the latter, heparinase, added to the INTEM reagent, eliminates heparin to reveal underlying coagulopathies.
The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high concentration of heparin and to evaluate whether heparinase could reverse heparin's effect on EXTEM and INTEM during cardiopulmonary bypass.
Arterial blood samples were drawn for analysis after induction of anesthesia (T0),10 minutes after the administration of heparin (T1), at unclamping of the aorta (T2) and after heparin reversal with protamine (T3). The following tests will be performed: EXTEM, INTEM, HEPTEM and a heparinase modified EXTEM. For the latter, recombinant thromboplatin instead of the elagic acid is used in the HEPTEM test. Heparin concentrations are measured at T1 and at the end of bypass (T2). HEPCON® was used for heparin management.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass
* Patients from 18 <= age <= 85 old.
Exclusion Criteria:
* Patients incapable to consent.
* Known coagulopathies or platelet dysfunction.
* Patients treated with antiplatelet drugs other than aspirin.
* Patients treated with anti vitamine K anticoagulants.
* Patients treated with heparin less than 6 hours prior to surgery.
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
|
NCT01455454
|
{
"brief_title": "Heparin's Influence on ROTEM® Analysis",
"conditions": [
"Coronary Artery Disease"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01455454",
"official_title": "Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2011-09",
"study_start_date(actual)": "2010-09"
},
"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)": "2011-10-20",
"last_updated_that_met_qc_criteria": "2011-10-19",
"last_verified": "2011-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-20",
"first_submitted": "2011-10-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims at examining muscle strength capacity in neck and shoulder muscles in children and adolescents with and without tension-type headache, and furthermore examining the effect of a 10 week specific strength training programme for neck and shoulder muscles compared to a multi-disciplinary approach in 10 weeks.
Detailed Description
Frequent and chronic tension type headache are the most frequent pain illnesses in children with a prevalence of 0.5-7,6%. Frequent or daily headache leads to constraints in the child's life in relation to school and social activities.
The underlying pathophysiological mechanisms are not yet fully examined. In several studies in adults and in children it is found that the shoulder muscles are tense and tender, but it is not known whether this phenomenon is primary or secondary to tension-type headache. A decrease in muscle capacity is furthermore found in studies. We therefore aim at examining parameters for muscle function in order to compare the differences between children with and without headache, and at examining the effect of a 10 week progressive specific strength training programme on headache compared to an in time comparable multidisciplinary intervention based on lifestyle counseling.
#Intervention
- DEVICE : Specific Strength Training
- 10 weeks of progressive specific strength training for neck and shoulder muscles.
- Other Names :
- A
- BEHAVIORAL : Lifestyle Counseling
- 10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
- Other Names :
- B
|
#Eligibility Criteria:
Inclusion Criteria:
* primary tension-type headache with no more than one episode of migraine pr. month
Exclusion Criteria:
* post-trauma headache
* co-morbidity
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01155557
|
{
"brief_title": "The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years",
"conditions": [
"Tension-Type Headache"
],
"interventions": [
"Device: Specific Strength Training",
"Behavioral: Lifestyle Counseling"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT01155557",
"official_title": "Strength Capacity of Neck and Shoulder Muscles in Children and Adolescents 9-17 Years With Tension Type Headache and the Effect of Specific Strength-Training on Tension-Type Headache",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2009-08"
},
"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)": "2015-03-19",
"last_updated_that_met_qc_criteria": "2010-07-01",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-02",
"first_submitted": "2010-06-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery.
In this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.
#Intervention
- PROCEDURE : Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block
- Two different catheter techniques with same doses local anesthetic infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 65 old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective thoracotomy surgery
Exclusion Criteria:
* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
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
|
NCT05083832
|
{
"brief_title": "Effect of Two Different Plane Blocks on Post-thoracotomy Pain",
"conditions": [
"Pain, Postoperative",
"Thoracotomy",
"Erector Spinae Plane Block",
"Serratus Anterior Plane Block"
],
"interventions": [
"Procedure: Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05083832",
"official_title": "Effects of Ultrasound-guided Continuous Erector Spina Plane Block and Continuous Serratus Anterior Plane Block on Post-thoracotomy Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-09",
"study_completion_date(actual)": "2024-02-20",
"study_start_date(actual)": "2021-06-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-06",
"last_updated_that_met_qc_criteria": "2021-10-06",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-19",
"first_submitted": "2021-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.
Detailed Description
Interpretation of fetal heart rate monitoring during labor is one of the most common procedures performed in the practice of obstetrics. Continuous monitoring of the fetal heart rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for intervention to prevent this terrible complication. The quality of the fetal heart rate signal is critical for appropriate interpretation of the characteristics that identify risk.
This is a prospective, randomized pragmatic trial comparing the Novii Fetal ECG/EMG system to external fetal heart rate and tocometry (standard of care) for the amount of time of interpretable fetal heart rate during labor. Randomization will occur in blocks based on BMI to control for the potential effect of BMI.
Fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by experienced Maternal Fetal Medicine (MFM) physicians who will assess the tracing for quality and interpretability. In addition, both approaches will be compared with respect to the need for additional monitoring modalities, amount of nursing intervention, cost and satisfaction of the patients and healthcare providers.
#Intervention
- DEVICE : Novii ECG/EKG System
- External fetal heart rate monitoring
- DEVICE : External fetal heart rate monitoring
- External fetal heart rate monitoring
|
#Eligibility Criteria:
Inclusion Criteria:
* Pregnant women >= 18 years; gestational age >= 37 weeks
* Singleton pregnancy.
* These women will be those presenting to Labor and Delivery for one of the following:
* Rule out labor
* Spontaneous labor
* Induction of labor
Exclusion Criteria:
* Age < 18 years; multiple gestation pregnancy; gestational age < 37 weeks
* Fetal distress or vaginal bleeding prior to monitor placement
* Previous cesarean section
* Planned cesarean delivery.
* Women who are enrolled in the study but have less than 1 hour of fetal heart rate monitoring after randomization will be excluded from analysis.
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
|
NCT03156608
|
{
"brief_title": "Novii External Fetal Monitoring Device",
"conditions": [
"Pregnancy Related",
"Fetal Distress"
],
"interventions": [
"Device: Novii ECG/EKG System",
"Device: External fetal heart rate monitoring"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03156608",
"official_title": "Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06-28",
"study_completion_date(actual)": "2017-06-28",
"study_start_date(actual)": "2017-03-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-11-01",
"last_updated_that_met_qc_criteria": "2017-05-16",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-17",
"first_submitted": "2017-03-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.
#Intervention
- DRUG : Methylene blue (1%)
- DRUG : Rhenium sulfure
- PROCEDURE : Surgical procedure
- PROCEDURE : Anatomo-pathologic procedure
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy)
* approval and informed consent
Exclusion Criteria:
* chemotherapy
* locoregional radiotherapy
* prevalent axillary lymph node
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
|
NCT00314405
|
{
"brief_title": "Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope",
"conditions": [
"Infiltrative Breast Cancer"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00314405",
"official_title": "Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-04",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-04"
},
"study_design": {
"allocation": "NON_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)": "2008-08-08",
"last_updated_that_met_qc_criteria": "2006-04-11",
"last_verified": "2008-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-04-13",
"first_submitted": "2006-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This prospective observational study aimed to investigate whether there is a relationship between weight, height, BMI, abdominal circumference (AC), hip circumference (HC), and AC-to-hip ratio with the incidence of hypotension in patients undergoing cesarean section under spinal anesthesia.
Detailed Description
This prospective observational study was conducted over eight months from March 2021 to October 2021 at the Anesthesiology and Reanimation Department of Erzurum Regional Training and Research Hospital, Erzurum, Turkey, a tertiary care hospital. Before commencing the study, the Institute ethics committee approval was taken from the Ethical Committee of Health Sciences University, Erzurum Regional Training and Research Hospital, Erzurum, Turkey. This study was carried out in accordance with the Declaration of Helsinki and written informed consent was obtained from all participants.
The study population comprised 60 women who agreed to participate with uncomplicated term pregnancies, BMI \< 30 kg/m2, aged between 18-45 years, ASA I and II undergoing elective cesarean section under spinal anesthesia. Participants with a complicated pregnancy, such as diabetes, hypertension, fetal anomaly, a history of allergy to study drugs, psychiatric diseases, coagulation abnormalities, and mul¬tiple pregnancies were excluded from the study. Also, patients who required conversion to general anesthesia were excluded.
A day before surgery, patients were informed about the study, and written informed consent was obtained from participants. On the day of the operation, all participants were preloaded with 500 milliliters of Ringer's lactate through a 16-18 gauge intravenous cannula. In the operating room, standard monitorization including non-invasive blood pressure, electrocardiography, and pulse oximetry was provided. Before the spinal anesthesia, patients' age, weight, height, abdominal and hip circumferences, ASA physical status, baseline values of noninvasive blood pressure, and heart rate (HR) were recorded.
Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration. Hip circumference was measured at the widest circumference over the buttocks. All the measurements were carried out by the trained anesthesia technician using standard non-stretch tape with the parturients wearing light clothes. To minimize errors, three consecutive measurements were obtained; results were averaged and the AC-to-hip ratio was calculated by dividing the values of the abdominal (cm) and hip circumference (cm).
Spinal anesthesia in the sitting position was performed on all patients. Following skin sterilization, a 27-gauge Quincke-tip spinal needle was advanced through the midline L3-4 intervertebral space. After free cerebrospinal fluid flow was observed, 2.4 ml 0.5% hyperbaric bupivacaine (12 mg) was injected over 30 seconds. Then, the spinal needle was removed and patients were placed in the supine position for the operation, and the operating table was tilted 20° to the left. A pinprick test was used to evaluate the sensory block level and surgery was initiated when the sensory block reached the T6 dermatome. Spinal anesthesia was considered to have failed when the sensory block was not consistent within the first 20 minutes following the spinal injection. In this instance, general anesthesia was performed and these patients were excluded from the study. A Modified Bromage scale was used to evaluate the motor block level. After delivery of the baby, 20 IU oxytocin in 1000 ml Ringer's lactate solution was given intravenously over 5 hours. Hypotension (a 20% decrease in systolic blood pressure compared to preoperative values), was treated by uterine displacement and rapid infusion of fluid. Intravenous ephedrine (5 mg) was given in case of persistent hypotension. Intravenous atropine (1 mg) was injected to treat bradycardia (the HR \< 45 beats/minute). In our clinic, ephedrine is routinely used as the first choice in the treatment of hypotension. Intravenous ondansetron (4 mg) was used to treat persistent nausea and vomiting. Following spinal injection, systolic, diastolic, and mean arterial pressure and HR values were recorded every 2 minutes for 20 minutes and then every 5 minutes until the end of the operation. The operation time (the time from the beginning of the surgical incision until the end of surgery), anesthetic complications, such as nausea or vomiting, the number of patients requiring ephedrine and atropine, the total amount of intravenous fluid used, and the total amount of ephedrine used during surgery were recorded. Neonatal Apgar scores at 1 and 5 minutes after delivery and the weight and height of the neonates were recorded. After surgery, patients were transferred to the recovery room. Pain severity was assessed via the Visual analog scale (VAS, 0 cm=no pain, 10 cm=worst pain). In the case of VAS \> 3, 1 gr paracetamol was given to patients intravenously. Anesthesia-related side effects (e.g., nausea, vomiting, and headache), sensory block time (from the spinal injection to the recovery of T10 dermatome), and the time requiring supplemental analgesics was recorded by an independent observer blinded to the group assignment at 30 min and 1st and 2nd hours post-operatively. When the motor block had regressed to the T10 level, patients were sent to the clinics.
Statistical Analysis The sample size calculation was performed based on the data gained from the study's preliminary results using Russ Lenth's power and sample size calculation application (13). Fifty-eight patients were needed to detect an anticipated effect size of 0.37 with a power of 85% and an alpha of 5%.
The statistical analysis of all data was performed with SPSS 20 software (SPSS Inc., Chicago, IL, USA), and P\<0.05 was considered statistically significant. Data were expressed as mean values ± standard deviation (SD), median (min-max), or number and percentage values. Kolmogorov-Smirnov test was used to detect the distribution of data.
Pearson correlation analysis was performed to assess the association between anthropometric measures (i.e., BMI, AC-to-hip ratio) with the incidence of hypotension and the total amount of ephedrine used. Correlation analysis was performed to find the correlations between the total amount of ephedrine used and the AC, HC, and AC-to-hip ratio. The correlation between the total amount of ephedrine used and the weight of the fetus was also investigated. The regression equations were obtained by using the linear regression method and the coefficients (r2) were compared.
#Intervention
- PROCEDURE : Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration.
- The operation time (the time from the beginning of the surgical incision until the end of surgery), anesthetic complications, such as nausea or vomiting, the number of patients requiring ephedrine and atropine, the total amount of intravenous fluid used, and the total amount of ephedrine used during surgery were recorded.
- Other Names :
- Hip circumference was measured at the widest circumference over the buttocks., Three consecutive measurements were obtained; results were averaged and the AC-to-hip ratio was calculated by dividing the values of the abdominal (cm) and hip circumference (cm)., Spinal anesthesia in the sitting position was performed on all patients., After surgery, patients were transferred to the recovery room.
|
#Eligibility Criteria:
Inclusion Criteria:
* women who agreed to participate
* with uncomplicated term pregnancies
* BMI < 30 kg/m2
* aged between 18 <= age <= 45 years
* ASA I and II
* undergoing elective cesarean section under spinal anesthesia
Exclusion Criteria:
* a complicated pregnancy, such as diabetes, hypertension, fetal anomaly
* a history of allergy to study drugs
* psychiatric diseases
* coagulation abnormalities
* multiple pregnancies
* patients who required conversion to general anesthesia
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05382624
|
{
"brief_title": "The Relationship Between Abdominal Circumference: Hip Ratio and Ephedrine Requirement",
"conditions": [
"Hypotension",
"Anesthesia, Local",
"Cesarean Section Complications"
],
"interventions": [
"Procedure: Abdominal circumference was measured at the umbilical level in the standing position at the end of a normal expiration."
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05382624",
"official_title": "The Relationship Between Abdominal Circumference: Hip Ratio and Ephedrine Requirement in Spinal Anesthesia for Elective Cesarean: A Prospective Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-30",
"study_completion_date(actual)": "2021-01-01",
"study_start_date(actual)": "2020-04-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-19",
"last_updated_that_met_qc_criteria": "2022-05-17",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-19",
"first_submitted": "2022-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study the investigators propose to pilot test a brief, mindfulness shared decision making intervention that begins shortly after receiving a diagnosis of breast cancer. A mindfulness instructor will conduct an hour long session with consented participants before the scheduled surgical appointment. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety. To measure this endpoint, participants will complete three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys will include questions on quality of life, anxiety, and participant satisfaction with the mindfulness program.
Detailed Description
The primary aim of this study is to identify if a mindfulness intervention is feasible before the participant has their surgical consultation. The secondary aim is to measure the impact of the mindfulness intervention on participant reported outcomes including anxiety, quality of life and decisional satisfaction. Newly diagnosed female breast cancer patients will be contacted over the phone after the patient learns of their diagnosis but prior to their surgical appointment to discuss surgical options. Verbal consent will be obtained over the phone and the participant will be directed to complete an online survey to answer baseline questions on their anxiety and quality of life as well as to provide their contact information and availability in order to schedule a mindfulness session with a certified mindfulness teacher. The participant will then proceed to an hour-long mindfulness exercise geared to help women apply these techniques to the decisional making process. The goal is to empower women to approach their diagnosis and treatment decisions with greater stability and improve their ability to focus on their values and preferences instead of just focusing on the diagnosis. This will be measured by administering patient reported outcomes (PROs) via REDCap online surveys at three timepoints. The first PRO 'baseline survey' is administered after the participant enrolls but before the mindfulness session. The second PRO 'before surgery survey' is completed after the surgical consultation but prior to the scheduled surgery. The final PRO '6-month survey' is administered 6 months after the surgery to measure quality of life, anxiety, and participant satisfaction with the mindfulness program. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety.
#Intervention
- BEHAVIORAL : Mindfulness Session
- one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient
|
#Eligibility Criteria:
Inclusion Criteria:
* Females >20 and < 70 years
* History of contralateral breast cancer in the past is acceptable
* Patients seeking second opinion for diagnosis are eligible
* Clinical AJCC stage 0-III breast cancer
* Patients who have an in breast tumor recurrence are eligible
* English Speaking
* Willing to fill out surveys required for the study
* Gene mutation carriers are eligible
* Neoadjuvant therapy patients are eligible
Exclusion Criteria:
* AJCC Stage IV breast cancer
* Unwilling to fill out surveys for the study
* Patients with a distant recurrence
* Patients unaware of their diagnosis
Sex :
FEMALE
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:
Yes
|
NCT03880799
|
{
"brief_title": "The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer",
"conditions": [
"Breast Cancer",
"Surgery"
],
"interventions": [
"Behavioral: Mindfulness Session"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03880799",
"official_title": "The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-08",
"study_completion_date(actual)": "2020-02-10",
"study_start_date(actual)": "2018-11-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-22",
"last_updated_that_met_qc_criteria": "2019-03-15",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-19",
"first_submitted": "2018-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.
Detailed Description
About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice.
In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity.
There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients.
On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.
#Intervention
- DRUG : Carboplatin
- Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks
- DRUG : Gemcitabine
- Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=70 years
* Cytologically or histologically documented NSCLC
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
* World Health Organisation (WHO) performance status 0 <= age <= 2
* Non-frail patients according to Comprehensive Geriatric Assessment
* Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part)
* No prior chemotherapy (for phase II part)
* Life expectancy of at least 12 weeks
* Serum bilirubin less than 1.5 times the upper normal limit
* Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
* Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance >60 ml/min
* Neutrophil count more than 1.5x 109 /L
* Platelet count more than 100x 109 /L
* Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.
Exclusion Criteria:
* Hemoptysis
* Central nervous system metastases
* Clinically significant cardiovascular disease
* Medically uncontrolled hypertension
* Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
* Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
Sex :
ALL
Ages :
- Minimum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02175381
|
{
"brief_title": "Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC",
"conditions": [
"NSCLC"
],
"interventions": [
"Drug: Gemcitabine",
"Drug: Carboplatin"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT02175381",
"official_title": "A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04",
"study_completion_date(actual)": "2014-04",
"study_start_date(actual)": "2011-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-15",
"last_updated_that_met_qc_criteria": "2014-06-25",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-26",
"first_submitted": "2014-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will assess compassion fatigue among healthcare providers in a single emergency department (ED) using the Professional Quality of Life (ProQoL) scale.
#Intervention
- BEHAVIORAL : Professional Quality of Life (ProQoL) scale
- COMPASSION SATISFACTION AND COMPASSION FATIGUE (PROQOL) measures how compassion for those who are cared for can affect providers in positive and negative ways. Questions about experiences, both positive and negative, as a provider reflecting the frequency experiences within the last 30 days. 1=Never 2=Rarely 3=Sometimes 4=Often 5=Very Often
|
#Eligibility Criteria:
Inclusion Criteria:
* Currently employed as a health care provider in the emergency department. All eligible individuals will be 18 years and older.
Exclusion Criteria:
* Individuals that are not currently employed in the emergency department
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
|
NCT03070249
|
{
"brief_title": "Compassion Fatigue in ED Providers",
"conditions": [
"Compassion Fatigue"
],
"interventions": [
"Behavioral: Professional Quality of Life (ProQoL) scale"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03070249",
"official_title": "Compassion Fatigue Among Emergency Department Healthcare Providers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-25",
"study_completion_date(actual)": "2017-10-10",
"study_start_date(actual)": "2017-04-13"
},
"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)": "2017-10-24",
"last_updated_that_met_qc_criteria": "2017-02-28",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-03",
"first_submitted": "2017-02-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this protocol is to assess the sensitivity and specificity of a photoplethysmography (PPG)-based algorithm for the detection of atrial fibrillation as compared to a gold-standard assessment (wearable ECG patch) among a population of individuals with known atrial fibrillation and without known atrial fibrillation over a 7-day study period.
Detailed Description
Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States, affecting up to one in four individuals across the lifespan, and is associated with substantial morbidity and mortality. Fifteen percent of strokes in the United States are attributable to Afib, and nearly 20% of these occur in individuals with no prior Afib history. Because Afib is often paroxysmal, one-time screening is unlikely to capture those at risk. Thus, there has been an increasing interest in leveraging monitoring for Afib via wearable devices, which provide a novel method to detect Afib and determine the burden of Afib in the general population. Devices such as the WHOOP 4.0 strap use advanced sensors to detect pulse rate and other physiologic metrics in real-time. Given the high degree of pulse-rate variability in Afib, it is clear that algorithms evaluating data from these devices may be able to detect asymptomatic Afib. However, the sensitivity and specificity of the algorithm operating on data from the WHOOP 4.0 strap have not been formally evaluated in a clinical setting.
The WHOOP strap measures changes in blood flow via photoplethysmography (PPG), from which timing between successive heartbeats ('beat-to-beat intervals') is measured. While normal sinus rhythm tends to display beat-to-beat intervals of similar magnitude, those of cardiac arrythmias are characterized by higher variability and may follow particular patterns.
The primary objective of this study is to assess the sensitivity and specificity of the WHOOP Strap ANF 1.0 classification algorithm for the detection of Afib as compared to a gold-standard assessment (one-week ECG patch monitoring using the BioTel ePatch).
#Intervention
- DEVICE : WHOOP 4.0 Strap
- Subjects will receive both the WHOOP 4.0 Strap and the BioTel ePatch and will continuously wear each for one week. Data will be collected and analyzed by the study team upon return of the both devices from the subject.
- DEVICE : BioTel ePatch
- Subjects will receive both the WHOOP 4.0 Strap and the BioTel ePatch and will continuously wear each for one week. Data will be collected and analyzed by the study team upon return of the both devices from the subject.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 22 years
* Known diagnosis of atrial fibrillation OR no history of arrhythmia as documented in the patient medical record
* Seen in a Yale New Haven Hospital-associated Primary Care or Cardiology Clinic
* Cell phone (IOS 15.0 or greater or Android 10 or greater) with an active data plan and willing to install the WHOOP Mobile Application software
* Full-time US resident
* Able to read, understand, and provide written informed consent in English
* Willing and able to participate in the study procedures as described in the consent form
* Able to communicate effectively with and follow instructions from the study staff
Exclusion Criteria:
* Pre-existing WHOOP user with active account
* Has implantable cardiac device (e.g., pacemaker, ICD, LVAD)
* Solid organ transplant
* Sensitivity or allergy to ECG patch or skin glue
* Unwilling to wear WHOOP 4.0 strap for one week
* Unwilling to wear BioTel (ECG patch) ePatch for one week
* WHOOP strap should be the only wearable on the arm. Individuals unwilling to adhere to the proper usage of the WHOOP strap will be excluded.
* Unwilling to install the WHOOP Mobile Application software
* Unable to provide informed consent
* Non-English speaking (as the WHOOP Mobile Application software is English only)
* Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to polyamide, polyester, or elastane bands primarily used in wrist worn fitness devices
* Symptomatic (or active) allergic skin reactions
* Significant tremor that prevents the subject from being able to hold still.
* Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, increases the risk to the subject or renders data uninterpretable.
* Pregnant women: Women who report being pregnant at the time of study participation.
* Subjects taking rhythm control drugs including amiodarone, dronedarone, dofetilide, sotalol, flecainide, ibutilide, lidocaine, procainamide, propafenone, quinidine, tocainide.
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05809362
|
{
"brief_title": "WHOOP Abnormal Rhythm Notification",
"conditions": [
"Atrial Fibrillation"
],
"interventions": [
"Device: WHOOP 4.0 Strap",
"Device: BioTel ePatch"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05809362",
"official_title": "Validation of a Photoplethysmography-Based Algorithm for Detection of Atrial Fibrillation Via a Wearable Device - WHOOP Abnormal Rhythm Notification",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-25",
"study_completion_date(actual)": "2024-01-25",
"study_start_date(actual)": "2023-04-10"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-23",
"last_updated_that_met_qc_criteria": "2023-03-29",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-12",
"first_submitted": "2023-03-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To date the effect of AIMS on medical interventions has not been studied. We seek to retrospectively evaluate paper and electronic anesthesia records among a single surgical population (esophageal surgery) to ascertain any differences that may exist between cohorts with regards to chart completion, anesthetic management and medical care.
Detailed Description
Anesthesia information systems (AIMS) are increasingly used to electronically capture physiologic and management data during anesthesia. Proponents tout an improved accuracy of data yet this has not been formally evaluated. Furthermore, whether AIMS is associated with changes in medical care is unknown. Studies with newer technologies have demonstrated increased medical interventions as a result of implementation. The pulmonary artery catheter was shown to increase medical interventions when used yet no improvement in outcomes are observed and some suggest a deleterious effect. 1 Several studies suggest improved patient care with electronic anesthesia records. 2,3 These all center around clinical decision support that reminds clinicians to give certain medications or ensure chart completion. Despite these advantages there are no studies evaluating the 'hawthorne effect' of AIMS. Physiologic data is now recorded at each data point using AIMS. This differs significantly from paper anesthesia records in which clinicians often chart physiologic trends choosing to omit spurious values. It is possible that a Hawthorne effect may occur in this scenario with increased data collection and an increased ability to scrutinize the medical record. Given the litigious nature of medical practice today, there is concern about the impact of AIMS on medicolegal liability. 4 Yet, to date the effect of AIMS on medical interventions has not been studied. We seek to retrospectively evaluate paper and electronic anesthesia records among a single surgical population (esophageal surgery) to ascertain any differences that may exist between cohorts with regards to chart completion, anesthetic management and medical care.
#Intervention
- OTHER : Electronic Medical Record
- Advent of EMR use for documentation of anesthetic care
|
#Eligibility Criteria:
Inclusion Criteria:
* Underwent esophageal surgery and had anesthetic documented in medical record
Exclusion Criteria:
* Cases less than one hour
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02258100
|
{
"brief_title": "Anesthesia Information System vs Paper Anesthesia Records for Care Congruency",
"conditions": [
"Paper Versus EMR Generated Anesthesia Records"
],
"interventions": [
"Other: Electronic Medical Record"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02258100",
"official_title": "Retrospective Review of an Anesthesia Information System and Paper Anesthesia Records for Care Congruency in a Single Surgical Population.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2014-09"
},
"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)": "2019-09-11",
"last_updated_that_met_qc_criteria": "2014-10-02",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-07",
"first_submitted": "2014-10-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to obtain a better understanding of how stress is related to health risks.
Detailed Description
Participants complete up to two study visits of approximately 3-4 hours each. The first study visit involves an interview about life experiences and emotions. If the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days. The second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions. No further follow-up of participants is conducted beyond the two study visits.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pre-menopausal
* Must be able to speak and read English fluently
Exclusion Criteria:
* Specific medications and chronic diseases
* History of heart attack (myocardial infarction)
* Pregnant or given birth in last 3 months
* Peri-menopausal or post-menopausal
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01208844
|
{
"brief_title": "Study of Physical Health for Women With Posttraumatic Stress or Depression",
"conditions": [
"Healthy",
"Stress, Psychological",
"Depression",
"Posttraumatic Stress Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01208844",
"official_title": "Cardiovascular Risk in Relation to Posttraumatic Stress Disorder in Young Women",
"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)": "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)": "2015-04-29",
"last_updated_that_met_qc_criteria": "2010-09-23",
"last_verified": "2015-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-24",
"first_submitted": "2010-08-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
At least 25 volunteers with a diagnosis of coronary artery disease in the Department of Cardiology of Dokuz Eylul University and who meet the criteria for follow-up and inclusion will participate in the study. Demographic and clinical information of the participants will be questioned. Active video games and exercise sessions will be randomized to last 25 minutes. Before and after the sessions, heart rate, blood pressure, shortness of breath, oxygen saturation and arterial stiffness will be measured. In addition, energy expenditure, heart rate, perceived exertion, shortness of breath and oxygen saturation will be recorded during the sessions. At the end of the sessions, the person will be asked if they enjoy active video games.
Detailed Description
Individuals etiology, demographic information (age, gender,marital status, education,occupation),risk factors (smoking,alcohol use,exercise habit),height,weight,curriculum vitae, family history, medications used, and effort test results will be recorded.
Evaluation of energy expenditure: Energy expenditure during active video games and exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement.
Evaluation of hemodynamic and pulmonary responses:
Blood pressure: It will be measured with a sphygmomanometer. Perceived effort: The degree of perceived effort will be evaluated with the Modified Borg scale.
Shortness of breath: Shortness of breath will be assessed with the Modified Borg scale.
Heart rate and Oxygen saturation: It will be evaluated by pulse oximetry. Evaluation of vascular responses: Arterial stiffness will be assessed to assess vascular responses to active video games and exercise. Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. The patient's age, gender, blood pressure, height, weight, carotid-sternal notch distance between the artery, carotid-femoral artery as the distance between the entered data to the computer after increasing pressure over the brachial artery through a transducer (augmentation index) and again, carotid-femoral pulse wave velocity via the artery (pulse wave velocity) measurements will be made.
The pleasure received from both interventions will be evaluated according to the visual analogue scale (0-10).
Active Video Game Intervention The active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and a sensor.
Active video games consist of Bowling, River Rush, Rally Ball and Reflex Ridge games.
Participants will exercise for a total of 25 minutes with light-paced games for warm-up for the first 5 minutes, then brisk games with different body movements until the 15 minutes are complete, and light-paced games for 5 minutes to cool down.
Participants will complete active video games in the same order. Aerobic Exercise Intervention The exercise intervention will consist of a continuous moderate-intensity walking session on the treadmill. After the first 5 minutes of warm-up, at 55-70% of the peak heart rate reserve(HRR)with a 15-minute walking session, and 5 minutes of cooling down a total of 25 minutes of exercise will be performed.
Blood pressure, heart rate, oxygen saturation, dyspnea, and perceived general fatigue (Mod.Borg 0-10) of the participants will be evaluated before the interventions, at the end of the loading, after the exercise, and 5 minutes after the intervention. Before and after the sessions arterial stiffness will be measured.
#Intervention
- OTHER : Active video game
- With the closed envelope method, the order in which the participants will perform active video games and aerobic exercise will be determined. It will be applied with 2 weeks between interventions.
- OTHER : aerobic exercise
- With the closed envelope method, the order in which the participants will perform active video games and aerobic exercise will be determined. It will be applied with 2 weeks between interventions.
|
#Eligibility Criteria:
Inclusion Criteria:
* Having been diagnosed with coronary artery disease
* Being clinically stable
* Becoming a volunteer
Exclusion Criteria:
* The presence of unstable angina
* The presence of a pacemaker
* The presence of cardiomyopathy
* The presence of a high cardiovascular risk
* The presence of November severe neurological, pulmonary and musculoskeletal system diseases
* The patient wants to quit the study
Sex :
MALE
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
|
NCT05722366
|
{
"brief_title": "Investigation of Acute Responses of Active Video Games Practice Compared to Exercise in Coronary Artery Patients",
"conditions": [
"Coronary Artery Disease"
],
"interventions": [
"Other: aerobic exercise",
"Other: Active video game"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05722366",
"official_title": "Comparison of Acute Responses of Aerobic Exercise and Active Video Games in Coronary Artery Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-14",
"study_completion_date(actual)": "2023-08-01",
"study_start_date(actual)": "2022-11-20"
},
"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)": "2023-09-08",
"last_updated_that_met_qc_criteria": "2023-02-01",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-10",
"first_submitted": "2022-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the effects of Mindfulness-based Interventions (MBI) on the neuropsychological profile of individuals with mild cognitive impairment (MCI). It will also investigate changes in fMRI activity, such as resting-state functional connectivity networks and changes in activity in attention networks in task-related fMRI using graph theory analysis after Mindfulness-based Interventions. Participants will be randomly assigned to receive either the Mindfulness-Based Intervention, Cognitive Rehabilitation Training or Treatment as Usual as the passive control group comparison.
Detailed Description
As the population of Singapore ages rapidly, cognitive decline associated with both normal aging and disease is becoming a frequently encountered health challenge. In our proposed study, we will investigate the effects of mindfulness-based interventions (MBI), which have shown significant promise in halting and even reversing age-related cognitive impairment. MBI enhances the quality and frequency of mindfulness, defined as a mental state achieved by focusing one's attention and awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. In this study, we will administer a standardized MBI program or Cognitive Rehabilitation Therapy to a group of 60 patients diagnosed with mild cognitive impairment (MCI), a condition marked by deficits in language, memory and attention that often leads to dementia; an additional 30 patients will be assigned to the control group. There will be 3 runs with 30 persons per run; each group will have 10 randomly assigned participants. By comparing the 3 groups across the 3 runs, we seek to test the following hypotheses: 1) MBI will result in significantly greater improvements in neuropsychological testing outcomes across multiple cognitive domains, including attention, memory, language and processing speed, 2) MBI will strengthen cortical connectivity as measured by functional magnetic resonance imaging (fMRI), and 3) MBI will lead to changes in fMRI activation on a test of facets of attention. Neuropsychological testing will take place in SGH, while fMRI and EEG scanning will take place in the Center for Cognitive Neuroscience at Duke-NUS. Both the MBI and CRT will be facilitated by trained personnel. Our proposed experiment comprises one of the most comprehensive interrogations of the effects of MBT on patients to date, and if successful, could rapidly translate into a program with both clinical and economic impact.
#Intervention
- BEHAVIORAL : Mindfulness Based Training (MBT) Program
- Participants in the MBT program will meet weekly for 8 weeks. Each session will last one-and-a-half hours. Mindfulness, defined as caring moment-to-moment awareness, will be cultivated through the teaching and formal practice of sitting and walking meditation, body scan, and mindful movement (e.g. yoga). Participants will also be taught how to practice mindfulness informally when eating, engaging in pleasurable activities and through interactions with others. Participants will be encouraged to practice approximately 30 minutes a day, and will be provided handouts as well as guided audio recordings of formal practices taught in session to aid their practice at home.
- Other Names :
- MBT
- BEHAVIORAL : Cognitive Rehabilitation Training
- Participants in the CRT program will meet weekly for 8 weeks. Each session will last one-and-a-half hours. The 8 week-program will consist of the following components: (i) identifying and working on at least one personal rehabilitation goal related to everyday life that is associated with cognitive difficulties; (ii) reviewing and building on the use of practical memory strategies, and or introducing and teaching the use of a new strategy or memory aid; (iii) introducing techniques for learning new information and associations, identifying the preferred strategy, and encouraging the application of this strategy in daily life; (iv) providing practice in maintaining attention and concentration; and (v) exploring current ways of coping with stress and anxiety as well as providing relaxation techniques to help aid with coping (Clare, 2007). Participants will be provided with instructional hand-outs as well as logs to record, monitor and evaluate their progress.
- Other Names :
- CRT
|
#Eligibility Criteria:
Inclusion Criteria:
* Fluent in English
* Mild Cognitive Impairment: Fulfill Diagnostic and Statistical Manual of Mental Disorders version five (DSM-V) diagnostic criteria for Minor Neurocognitive Disorder
* MMSE score = 20 <= age <= 30
* Clinical Dementia Rating Score (CDR) = 0.5
* Age: <=75 years
Exclusion Criteria:
* Presence of major neurological conditions such as epilepsy, stroke, Parkinson's Disease and or brain injury
* Presence of major psychiatric conditions such as major depression or schizophrenia
* Unsuitability for fMRI scanning (e.g. pacemakers, metallic implants, claustrophobia)
* Unable to give or no consent available
* Left-handed participants may take part in the study but will not undergo fMRI scanning
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04000984
|
{
"brief_title": "Beneficial Effects of Mindfulness-based Training on Neuropsychological Outcomes in Mild Cognitive Impairment",
"conditions": [
"Mild Cognitive Impairment"
],
"interventions": [
"Behavioral: Cognitive Rehabilitation Training",
"Behavioral: Mindfulness Based Training (MBT) Program"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT04000984",
"official_title": "Investigating the Beneficial Effects of Mindfulness-based Training on Neuropsychological Outcomes in Mild Cognitive Impairment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-01",
"study_completion_date(actual)": "2019-12-01",
"study_start_date(actual)": "2016-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-27",
"last_updated_that_met_qc_criteria": "2019-06-26",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-27",
"first_submitted": "2019-05-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate whether recanalization and stenting for symptomatic subacute and chronic veterbrobasilar artery occlusion is technically feasible, can prevent from recurrent ischemic events and promotes functional recovery of disability.
Detailed Description
Ischemic stroke accounts for 87% of cerebrovascular accidents. Of these, a part is the result of intracranial veterbrobasilar occlusion. Acute veterbrobasilar artery occlusion is a devastating disease with high mortality without successful treatment. A subset of patients can survive the acute phase and develop subacute or chronic veterbrobasilar artery occlusion. Due to the adequacy of collaterals, some patients can live without any or just very mild symptoms. On the contrast, lack of enough collaterals, another patients still presented with recurrent ischemic events and progressive disability despite intensive medical therapy. Prognosis is extremely poor. It is in this cohort that subacute or chronic revascularization is often considered. The optimal treatment in this cohort with non-acute veterbrobasilar artery occlusion is unknown, and there is little literature to guide therapy. Extracranial-intracranial bypass may revascularize the intracranial artery occlusion. However, bypass procedures are technically challenging and are associated with significant risk of morbidity and mortality. Recurrent ischemic symptoms despite best medical treatment be indication for endovascular revascularization and stent remodeling. This study was to evaluate the technical feasibility, safety and treatment effects of recanalization and stenting for veterbrobasilar subacute-chronic intracranial artery occlusion。
#Intervention
- DEVICE : stenting
- Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.
|
#Eligibility Criteria:
Inclusion Criteria:
* Stroke or TIA (transient ischemic attack) due to the intracranial veterbrobasilar artery occlusion.
* Occlusions may be diagnosed by TCD (transcranial cerebral doppler), MRA (magnetic resonance angiography), or CTA (computed tomographic angiography) to qualify for angiogram performed as part of the study protocol but must be confirmed by catheter angiography for enrollment in the trial
* Time from imaging-documented occlusion and/or from aggravation of clinical symptoms (aggravation was defined as change in mRS [modified rankin scale]>=1 and/or NIHSS [national institutes of health stroke scale]>=4) to recanalization was greater than 24 hours. The reasons for delayed intervention were due to delayed diagnosis, interhospital transfer, or unsuccessful initial trial of anticoagulation and antiplatelet therapy.
* Etiology was suitable for stenting, which was judged by at least a neurologist, a neurosurgeon and a neuro-interventionalist.
Exclusion Criteria:
* Unsuitable etiology.
* Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
* Any aneurysm without treatment proximal to or distal to occluded intracranial artery
* Intracranial tumor (except meningioma) or any intracranial vascular malformation
* CT or angiographic evidence of severe calcification at target lesion
* Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting
* Any hemorrhagic infarct within 14 days prior to enrollment
* Any hemorrhagic infarct within 15 - 30 days that is associated with mass effect
* Any history of a primary intracerebral (parenchymal) hemorrhage (ICH)
* Any other intracranial hemorrhage (subarachnoid, subdural, epidural) within 30 days
* Any untreated chronic subdural hematoma of greater than 5 mm in thickness
* Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%
* Known allergy or contraindication to aspirin, clopidogrel, heparin, metal, local or general anesthesia
* History of life-threatening allergy to contrast dye.
* Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, INR [international normalized ratio] > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (AST [aspartate transaminate]or ALT [alanine transaminase]> 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis)
* Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
* Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
* Life expectancy<1 year due to other medical conditions.
* Enrollment in another study that would conflict with the current study
* Other special conditions considered by neurological physician, neurosurgeon and neuro-intervention doctors, weren't suitable for recanalization procedure.
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
|
NCT01632865
|
{
"brief_title": "Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion",
"conditions": [
"Stroke"
],
"interventions": [
"Device: stenting"
],
"location_countries": [
"China"
],
"nct_id": "NCT01632865",
"official_title": "Recanalization and Stenting for Subacute and Chronic Veterbrobasilar Artery Occlusion",
"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)": "2013-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-25",
"last_updated_that_met_qc_criteria": "2012-06-28",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-03",
"first_submitted": "2012-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to investigate relationship between CTS diagnosis with electrodiagnostic studies and median nerve's cross-sectional area measered by US and MRI in PsA patients.
Detailed Description
Carpal tunnel syndrome (CTS) is a type of entrapment neuropathy, caused by compression of the median nerve in the carpal tunnel at the wrist1. It accounts for about 90% of all entrapment neuropathies. But there is no gold standard technique for diagnosing CTS. Electrodiagnostic studies (EDS) are generally used in differential diagnosis because the symptoms may be difficult to interpret. Unfortunetely EDS has some limitations. The factors can limit EDS are that it is not comfortable for patients and physicians, may require interventional procedures, need patient cooperation, provide limited information on the etiology of CTS, time consuming, and can not be used in some patient groups such as patients with dermatological contraindications. Recent years, magnetic resonance imaging (MRI) and ultrasonography (US) have facilitated the diagnosis of CTS. The median nerve cross-sectional area (CSA) measured by US or MRI has been found to be associated with CTS. However, there are studies with conflicting results regarding the median nerve CSA in patients with rheumatic diseases. Psoriatic arthritis (PsA), a kind of rheumatic disease, occurs in up to 30% of people with psoriasis and can have serious debilitating effects on the peripheral joints, spine, tendon insertions, and fingers. To our knowlage, any study didn't assess MRI measurements of median nerve CSA in PsA patients. In this study we aimed to assess CTS's US and MRI findings in patients with PsA and compare them healty controls.
#Intervention
- DIAGNOSTIC_TEST : Ultrasonography, Magnetic resonance imaging
- The cross-sectional area of the median nerve was measured with US and MRI.
|
#Eligibility Criteria:
Inclusion Criteria:
* PsA patients according to the CASPAR criteria who consecutively applied to the FTR outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR outpatient clinic enrolled in the study.
Exclusion Criteria:
* Patients were excluded from the study if they had history of conditions associated with an increased incidence of CTS except PsA (diabetes mellitus, pregnancy, hypothyroidism, renal failure or other severe systemic diseases); history or clinical/electrophyscologic finding of radiculopathy, plexopathy, polyneuropathy or any nervous system diseases; history of fractures, severe trauma or surgical interventions involving the wrist; bifid median nerve on wrist imaging and under the age of 18, over the age of 65. There was no history of rheumatic disease in the healthy volunteer group.
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
|
NCT05086042
|
{
"brief_title": "Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings",
"conditions": [
"Carpal Tunnel Syndrome",
"Psoriatic Arthritis"
],
"interventions": [
"Diagnostic Test: Ultrasonography, Magnetic resonance imaging"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05086042",
"official_title": "Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-15",
"study_completion_date(actual)": "2020-03-15",
"study_start_date(actual)": "2019-03-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-20",
"last_updated_that_met_qc_criteria": "2021-10-07",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-20",
"first_submitted": "2021-10-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
25 to 50% of endometriotic patients are infertile and use medically assisted procreation. In general, the assessment of pain in medically assisted procreation is very little studied. Pain assessment studies in endometriotic patients remain limited to a quantitative assessment of pain symptomatology, without contextualization of painful manifestations. The primary objective of our study is the qualitative and contextualized assessment of pain during In Vitro Fertilization (IVF) protocol in endometriotic and non-endometriotic patients. The secondary objectives of our study are the quantitative study of pain, the measurement of the impact of personal efficiency on painful symptomatology, evaluation of depression, the results of IVF (implantation, pregnancy and live birth rates), and compare pain between endometriotic or non-endometriotic patients and between primary infertility and secondary infertility. According to the results obtained in this study, therapeutic strategies for the management of pain could be proposed, with the aim of improving the quality of life and the results of IVF in these patients.
#Intervention
- OTHER : Using different survey to evaluate pain
- Survey will be at different time of the IVF protocol (at the first medical appointment in the medically assisted department, after stimulation, after oocytes retrieval, after embryo transfer, one month after the IVF protocol)
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)
Exclusion Criteria:
* Refusal to participate in the study
* Minor patient
* Patient > 43 years
* BMI patient > 35
* Pregnant woman
* Unable to provide clear information to the patient
* Patient under guardianship or lack of health cover
* Patient in IVF with donation of oocyte
* IVF patients for oocyte preservation
* Patient who had already participated in the study
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 43 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04103320
|
{
"brief_title": "Evaluation of Pain in the Course of in Vitro Fertilization",
"conditions": [
"Infertility"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04103320",
"official_title": "Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-04",
"study_completion_date(actual)": "2021-08-04",
"study_start_date(actual)": "2019-11-18"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-29",
"last_updated_that_met_qc_criteria": "2019-09-23",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-25",
"first_submitted": "2019-08-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
Detailed Description
This was a 12-week randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multi-center study to assess the efficacy of ESN364 in postmenopausal women suffering from vasomotor symptoms (hot flashes).
This study consisted of a screening period (Days -35 to -1, including the screening visit \[Visit 1\] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity assessments), a 12 week treatment period (Day 1 \[Visit 2\] to Week 12 \[Visit 5\]), and a follow up visit (Week 15 \[Visit 6\]) 3 weeks after the last dose of study drug.
The study was performed on an ambulatory basis. The screening visit (Visit 1) occurred up to 35 days prior to randomization. Eligibility was assessed via physical examination, clinical laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy. Subjects received an electronic diary to record daily vasomotor symptoms during the duration of the screening period. Subjects who had ≥7 consecutive days of vasomotor symptom recordings participated in the study. Subjects are encouraged to continue recording for the duration of the whole screening period. The electronic diary was reviewed by study site staff on Day 1 (Visit 2) to confirm study eligibility. Subjects were rescreened 1 time upon approval of the medical monitor.
During the treatment period, subjects returned to the study site every 4 weeks for assessments.
The follow-up visit occurred approximately 3 weeks following the last dose of study drug.
#Intervention
- DRUG : Fezolinetant
- Oral Capsule
- Other Names :
- ESN364
- DRUG : Placebo
- Oral Capsule
|
#Eligibility Criteria:
Inclusion Criteria:
* Women >40 years and <=65 years at the screening visit;
* A body mass index between 18 kg/sqm to 38 kg/sqm (extremes included);
* Spontaneous amenorrhea for >=12 consecutive months; or spontaneous amenorrhea for >=6 months with biochemical criteria of menopause (follicle-stimulating hormone [FSH] >40 IU/L); or having had bilateral oophorectomy >=6 weeks prior to the screening visit (with or without hysterectomy);
* At least 50 moderate to severe vasomotor symptoms per week (ie, 7 consecutive days), as recorded in the daily diary during the screening period;
* In good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations, as judged by the Investigator;
* Women >40 years who have documentation of a normal/negative or no clinically significant findings mammogram (obtained at Screening or within the prior 9 months of trial enrollment.) Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings;
* Willing to undergo a transvaginal ultrasound to assess endometrial thickness at Screening and at Week 12 (end-of-treatment, - and subjects) who are withdrawn from the study prior to completion, at the Early Termination (ET) Visit. This is not required for subjects who have had a partial (supracervical) or full hysterectomy;
* Willing to undergo an endometrial biopsy at Screening (in the event that the subject's transvaginal ultrasound shows endometrial thickness >=4 mm) and at Week 12 (end--of--treatment) - all subjects), for subjects with uterine bleeding, and for subjects who are withdrawn from the study prior to completion, at the ET Visit if study drug exposure is >=10 weeks. This is not required for subjects who have had a partial (supracervical) or full hysterectomy;
* Negative alcohol breath test and negative urine test for selected drugs of abuse (amphetamines, tricyclic antidepressants, cocaine, or opiates) at the screening visit;
* Negative urine pregnancy test;
* Negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody screens);
* Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; and
* Documentation of a normal Pap smear (or equivalent cervical cytology) or of no clinical significance in the opinion of the Investigator within the previous 9 months or at Screening.
Exclusion Criteria:
* Use of a prohibited therapy (hormone therapy, hormonal contraceptive, or vasomotor symptom medication [prescription, over the counter, or herbal]) or not willing to wash out drugs
* History (in the past year) or presence of drug or alcohol abuse;
* Previous or current history of a malignant tumor, except for basal cell carcinoma;
* Uncontrolled hypertension and a systolic blood pressure >=140 mmHg and/or a diastolic blood pressure >=90 mmHg;
* Judged by the Investigator to be unsuited to participate in the study based on findings observed during physical examination, vital sign assessment, or 12-lead electrocardiogram (ECG);
* History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients;
* Exclusion criterion 7 has been removed in Amendment 1;
* An unacceptable result from endometrial biopsy (performed when endometrial thickness is >= 4mm measured by transvaginal ultrasound) of endometrial hyperplasia, endometrial cancer, or inadequate specimen at Screening (1 repeat biopsy permitted if technically possible);
* History of endometrial hyperplasia or uterine/endometrial cancer;
* History of unexplained uterine bleeding;
* History of seizures or other convulsive disorders;
* Medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [eg, moderate asthma], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome;
* Presence or sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion (ADME) mechanisms of drugs as judged by the Investigator;
* Active liver disease or jaundice, or values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 x the upper limit of normal (ULN); or total bilirubin >1.5 x ULN; or creatinine >1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula <=59 mL/min/1.73 sqm at the screening visit;
* Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study);
* Suicide attempt in the past 3 years;
* Unable or unwilling to complete the study procedures; or
* Subject is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof, who is directly involved in the conduct of the study.
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03192176
|
{
"brief_title": "A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)",
"conditions": [
"Menopause",
"Hot Flashes"
],
"interventions": [
"Drug: Placebo",
"Drug: Fezolinetant"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03192176",
"official_title": "A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09-19",
"study_completion_date(actual)": "2018-09-19",
"study_start_date(actual)": "2017-07-19"
},
"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)": "2024-11-26",
"last_updated_that_met_qc_criteria": "2017-06-15",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-19",
"first_submitted": "2017-06-15",
"first_submitted_that_met_qc_criteria": "2021-09-01"
}
}
}
|
#Study Description
Brief Summary
To test the efficacy of a group prenatal care intervention to reduce the risk of obesity related health conditions during and after pregnancy in obese mothers and their infants.
Detailed Description
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a group prenatal care (GPNC) intervention designed to reduce the risk for obesity related health conditions during and after pregnancy in overweight/obese mothers and their infants in American Samoa.
#Intervention
- BEHAVIORAL : Group Prenatal Care (GPNC)
- GPNC participants will attend 11 group sessions total: 10 during pregnancy and one postpartum. Each session will be 90-100 minutes long. Groups will collectively identify the preferred time of day for these sessions. Groups of 10 women will be led by a locally trained, Samoan nurse-midwife with the study Project Director as a co-facilitator. At each of the visits participants will engage in self-assessments of weight and blood pressure, including learning to take their blood pressure with a digital cuff, calculating BMI, and plotting their weight gain on a graph), receive short individual clinical examinations from a midwife, and participate in group discussions about prenatal care, childbirth preparation, and their postpartum care. The session at 6-weeks postpartum will allow women to introduce their babies to the group and share childbirth stories.
- BEHAVIORAL : Standard of Care
- Standard of prenatal care
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years. We will exclude younger pregnant women because adolescents may still be experiencing their own growth and development, which would be a source of confounding for our study outcomes.
* Self-reported Samoan ethnicity. Based on all four grandparents (of the participant) being reported as Samoa. Other ethnic groups make up approximately 2% of the American Samoan population but we are specifically interested in determining the efficacy of this intervention fro Samoan women, who have considerably poorer health outcomes in this setting.
* English speaking. The intervention will be delivered primarily in English, as is usual for standard prenatal care in this setting, with some Samoan language likely to be used in group discussions. Take home materials will be provided in both English and Samoan.
* Planning to reside in American Samoa for the duration of pregnancy and until at least 6 weeks postpartum. Some women travel from the neighboring country of Samoa (Independent/Western Samoa) to receive prenatal care at LBJTMC. These women will be excluded based on the need to receive all intervention sessions and a postpartum follow up.
* Singleton, viable pregnancy. A twin pregnancy reduced to singleton before 140 weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there must be no evidence of more than one fetus on the most recent pre-randomization ultrasound. Including multiple pregnancies would confound study outcomes.
* Completed LBJTMC prenatal care enrollment visit. Participants must have enrolled in standard prenatal care and received a standard of care physical exam, ultrasound, confirmation of pregnancy dating, pregnancy history, and preliminary gestational diabetes screen to ensure that no pregnancy health-based exclusion criteria (see below) are met. Participants must obtain written documentation from their provider of this visit, and permission from them to participate in the GPNC study.
* Gestational age at randomization no earlier than 11 weeks 0 days and no later than 14 weeks 0 days based on an algorithm that compares the last menstrual period date and data from the enrollment ultrasound. This will ensure that each participant is exposed to the intervention for the same amount of time.
* Body mass index >= 26kg/m2 based on measured weight at enrollment and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used. A BMI cutpoint of 26 kg/m2 is used in line with the usual upward-adjusted criteria for overweight in populations of Polynesian descent.
Exclusion Criteria:
* Age less than 18 years because of the potential for growth during pregnancy and the need for participant informed consent.
* Diagnosis of diabetes prior to pregnancy or an HbA1C >= 6.5% or other glucose tolerance test result suggestive of pre-pregnancy diabetes. All potential participants will have HbA1C or an alternative test performed prior to randomization at their standard prenatal care enrollment visit.
* Gestational diabetes or preeclampsia in a previous pregnancy
* Known fetal anomaly/pregnancy health condition known to require specialist monitoring/treatment
* Planned termination of pregnancy
* Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder (BED) is not an exclusion criterion.
* Current eating disorder diagnosed by a clinician
* Prior bariatric surgery
* Current use of one or more of the following medications:
* Metformin
* Systemic steroids
* Antipsychotic agents (e.g. Abilify, Haldol, Risperdal, Seroquel, Zyprexa)
* Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g Depakote, Lamictal, Lithium, Neurontin, Tegretol, Topamax, Keppra)
* Medications for Attention Deficit Hyperactivity Disorder (ADHD) including amphetamines and methylphenidate
* Continued use of weight loss medication including Over The Counter (OTC) and dietary supplements for weight loss (e.g. Adipex, Suprenza, Tenuate, Xenical, Alli, conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, Hydroxycut, Sensa, Corti-Slim, Chromium, Chitosan, Bitter Orange)
* Contraindications to aerobic exercise in pregnancy specified by the American College of Obstetrics and Gynocology (ACOG) committee Opinion #267, 2002 (re-affirmed 2009)
* Participation in another interventional study that influences weight control
* Participants unwillingness or inability to commit to a six-week postpartum follow up of herself or her child, including planning to move away
* Untreated medical or psychiatric condition (e.g. depression, bipolar disorder) that could impede study participation
* Hospitalization for hyperemesis
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
|
NCT04025268
|
{
"brief_title": "Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa",
"conditions": [
"Obesity"
],
"interventions": [
"Behavioral: Standard of Care",
"Behavioral: Group Prenatal Care (GPNC)"
],
"location_countries": null,
"nct_id": "NCT04025268",
"official_title": "Development of a Group Prenatal Care Intervention to Address Maternal and Child Non-Communicable Disease (NCD) Risk in American Samoa",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-30",
"study_completion_date(actual)": "2019-06-30",
"study_start_date(actual)": "2016-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-15",
"last_updated_that_met_qc_criteria": "2019-07-17",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-18",
"first_submitted": "2019-07-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without any structural abnormalities. Despite extensive research, the pathogenesis of IBS has not been clearly elucidated yet. Recent studies have shown that disturbed gut microbiota may promote the development and maintenance of IBS. Significant changes in the microbial communities of healthy controls vs IBS patients have been reported in several studies. These findings promoted the research on probiotics for the treatment of IBS. Probiotics are live microorganisms which, when administered at the right dose, have a positive effect on human health. The currently published systemic reviews and meta-analyses of randomized clinical trials have indicated that probiotics have beneficial clinical effects and can help to reduce global and specific IBS symptoms significantly. However, the effect depends on the specific composition of the probiotic preparation, and some meta-analyzes indicate that multi-strain preparations are more effective than single-strain preparations. Therefore, further research is highly anticipated. The purpose of the current clinical trial is to assess the effectiveness of multi-strain probiotic preparation in patients with diarrhea predominant IBS (IBS-D).
#Intervention
- DIETARY_SUPPLEMENT : Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo
- Oral supplementation with multi-strain probiotic preparation
- DIETARY_SUPPLEMENT : Maltodextrin
- Maltodextrin as placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* diarrhea-predominant irritable bowel syndrome (IBS-D)
* at least moderate form of IBS-D assessed using IBS-SSS, i.e. with score >175
* male and female subjects of Caucasian race
* age between 16 and 70 years (inclusive)
* good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination
* results of laboratory tests (hematology, clinical chemistry, serology, and urinalysis) within the normal range of the local laboratory or considered non-clinically significant by the investigator
* patients who have provided freely their own written informed consent
* patients available for the whole study period
* patients who are able to follow strictly the instructions of the investigational team regarding the study procedures and to fulfil the requirements of the protocol
* the following medications are permitted during the course of the study, as long as they are used at a constant dosage and are commenced at least 1 month prior to study start: birth control pill, or depot intramuscular contraceptive preparation, estrogen-progesterone replacement therapy, L-thyroxine, low-dose antidepressants (up to 25 mg day of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), low-dose antihypertensives in the diuretic, angiotensin-converting enzyme inhibitor or angiotensin II inhibitor classes
* patients are allowed to take spasmolytic drugs on an ad hoc basis
Exclusion Criteria:
* other than IBD-D types of IBD
* mild type of IBS-D (<175 points in IBS-SSS scale)
* the use of probiotics within last three months
* the treatment with antibiotics within last three months
* a concurrent severe illness (malignancies, uncontrolled hypertension and diabetes mellitus, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyper- or hypothyroidism)
* chronic bowel disorders other than IBS, including inflammatory bowel diseases, gastroenteritis, stomach and duodenal ulcers, celiac diseases;
* pregnancy or lactation
* diagnosed lactose intolerance
* the use of motility drugs or dietary fiber supplements within 2 weeks before study start
* plan to have surgery during the time of the study
* a history of alcohol or drug abuse
* taking anti-coagulant medications
* participation in another clinical trial within last three months
* patients who will receive antibiotics during the study
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04662957
|
{
"brief_title": "Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome",
"conditions": [
"Irritable Bowel Syndrome With Diarrhea",
"Effects of Probiotics"
],
"interventions": [
"Dietary Supplement: Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo",
"Dietary Supplement: Maltodextrin"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT04662957",
"official_title": "The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-31",
"study_completion_date(actual)": "2020-05-31",
"study_start_date(actual)": "2019-11-02"
},
"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)": "2020-12-16",
"last_updated_that_met_qc_criteria": "2020-12-09",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-10",
"first_submitted": "2020-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
Detailed Description
Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. In addition, medication non-compliance is common among patients with schizophrenia.
Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia. A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders. Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents, improving negative symptoms and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable medication addresses issues of noncompliance, while avoiding peak blood levels of oral preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia. Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system.
This study is an open, randomized, controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use. Patients with schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled.
#Intervention
- DRUG : Risperidone Long Acting
- Dose 25.00, 37.50 or 50.00 mg q two weeks
- Other Names :
- Risperdal Consta
- DRUG : oral risperidone
- 0.50-6.00 mg oral risperidone daily
- Other Names :
- Risperdal
|
#Eligibility Criteria:
Inclusion Criteria:
* Ages 18 <= age <= 65
* Schizophrenia or schizoaffective disorder
* Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use disorder
* Alcohol use on at least 5 days during the 4 weeks prior to randomization
* Patient is medically stable to start either form of risperidone.
Exclusion Criteria:
* Current treatment with clozapine.
* Current treatment with injectable risperidone long-acting.
* Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
* Change in medications (dose of current medication, discontinuation of medication, or new medication) in past 30 days.
* History of or current breast cancer.
* History of intolerance of or allergy to risperidone or risperidone long-acting.
* Currently residing in a residential program designed to treat substance use disorders.
* Current treatment with long-acting, injectable antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
* Past treatment with risperidone long-acting will require a review by the medication adjustment group before entering the client into the study.
* Treatment at baseline with a second antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
* Treatment at baseline with a psychotropic agent proposed to curtail substance use will require a review by the medication adjustment group before entering the client into the study.
* Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00130923
|
{
"brief_title": "Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder",
"conditions": [
"Schizophrenia",
"Psychotic Disorders",
"Substance Abuse",
"Alcohol Abuse"
],
"interventions": [
"Drug: oral risperidone",
"Drug: Risperidone Long Acting"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00130923",
"official_title": "Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2005-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-09",
"last_updated_that_met_qc_criteria": "2005-08-15",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-08-16",
"first_submitted": "2005-08-15",
"first_submitted_that_met_qc_criteria": "2012-09-23"
}
}
}
|
#Study Description
Brief Summary
This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)
Detailed Description
No study medication was administered in this study.
#Intervention
- DRUG : Placebo
- Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
- DRUG : ATX-101 (1 mg/cm^2)
- Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
- DRUG : ATX-101 (2 mg/cm^2)
- Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
- DRUG : ATX-101 (4 mg/cm^2)
- Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
|
#Eligibility Criteria:
Inclusion Criteria:
* Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06 <= age <= 03, 07 <= age <= 07, 09 <= age <= 15)
* Signed informed consent
* Willingness to comply with schedule and procedures of the study
Exclusion Criteria:
* Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded
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
|
NCT02159729
|
{
"brief_title": "Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101",
"conditions": [
"Submental Fat",
"Healthy"
],
"interventions": [
"Drug: ATX-101 (4 mg/cm^2)",
"Drug: ATX-101 (2 mg/cm^2)",
"Drug: Placebo",
"Drug: ATX-101 (1 mg/cm^2)"
],
"location_countries": [
"United Kingdom",
"Canada",
"Australia",
"United States"
],
"nct_id": "NCT02159729",
"official_title": "Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area",
"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)": "2009-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-17",
"last_updated_that_met_qc_criteria": "2014-06-06",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-10",
"first_submitted": "2014-06-06",
"first_submitted_that_met_qc_criteria": "2020-02-04"
}
}
}
|
#Study Description
Brief Summary
This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.
Detailed Description
This study will evaluate Bio-Germanium's efficacy on immune function and immune cell activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).
#Intervention
- DIETARY_SUPPLEMENT : Investigational Product (Bio-Germanium)
- * Ingredient: Bio-Germanium
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
* Storage: Room temperature (below 25℃)
* Duration of use: 8 weeks
- DIETARY_SUPPLEMENT : Control Group - Placebo Product
- * Ingredient: Corn starch
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day
* Storage: Room temperature (below 25℃)
* Duration of use: 8 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers between the ages of 25 <= age <= 75
* Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
* Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
Exclusion Criteria:
* Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as psychiatric, infectious, hematologic and neoplastic diseases (exceptions can be made under the discretion of the researcher)
* Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
* Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
* Those received vaccination within 3 months before screening
* Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
* Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
* Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
* Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
* Those who are pregnant, breastfeeding or planning to become pregnant during this study
* Those who are oversensitive or allergic to the investigational product
* Those who plan to participate in other researches during this study
* Those who participated in other researches within 4 weeks of the start of this study
* Those who are deemed inappropriate by the researcher
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03677921
|
{
"brief_title": "A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function",
"conditions": [
"Normal Healthy Subjects"
],
"interventions": [
"Dietary Supplement: Investigational Product (Bio-Germanium)",
"Dietary Supplement: Control Group - Placebo Product"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03677921",
"official_title": "A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-10",
"study_completion_date(actual)": "2018-09-10",
"study_start_date(actual)": "2017-12-10"
},
"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)": "2018-09-20",
"last_updated_that_met_qc_criteria": "2018-09-17",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-19",
"first_submitted": "2018-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The mental health of the French population in response to covid-19 pandemic is of concern.
Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.
|
#Eligibility Criteria:
Inclusion criteria:
* Being a DES intern (Occitanie-Est)
* Being on internship as of November 1, 2020
Exclusion criteria:
* Refusal to participate
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
|
NCT04669054
|
{
"brief_title": "Hospital Interns Psychological State During the COVID-19",
"conditions": [
"COVID 19",
"Depression",
"Stress Disorders, Post-Traumatic"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04669054",
"official_title": "Hospital Interns Psychological State During the COVID-19 Pandemic",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-30",
"study_completion_date(actual)": "2021-07-30",
"study_start_date(actual)": "2020-12-01"
},
"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)": "2021-10-25",
"last_updated_that_met_qc_criteria": "2020-12-14",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-16",
"first_submitted": "2020-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies.
Detailed Description
Preeclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. Fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE .
Both syndromes share some pathophysiologic features, with a variable involvement of placental insufficiency and cause fetal cardiovascular remodeling and adaptations . Fetal adaptations as metabolic and cardiovascular programming occur in response to adverse intrauterine conditions as PE and FGR . Offspring from preeclamptic pregnancies showed cardiac structural and functional changes and greater blood pressure in childhood and adolescence .
Most of the studies on FGR included pregnancies complicated by PE and vice versa, which fails to adequately assess the independent effect of each condition on the fetal cardiac functions.
#Intervention
- PROCEDURE : Ultrasound
- Fetal echocardiography using ultrasound device
|
#Eligibility Criteria:
Inclusion criteria:
* Pregnant women more than or equals 28 weeks
* Preeclampsia defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg
* Fetus with normal growth or with growth restriction
Exclusion criteria:
* congenital malformations
* intrauterine infection
* multiple pregnancies
* fetuses of mothers treated with a tocolytic agent
* fetuses with abnormal heart rates (tachycardia or bradycardia)
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06381258
|
{
"brief_title": "Fetal Cardiac Function",
"conditions": [
"Fetal Growth Retardation"
],
"interventions": [
"Procedure: Ultrasound"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06381258",
"official_title": "Fetal Systolic and Diastolic Cardiac Function Assessment in Mothers with Preeclampsia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-01",
"study_completion_date(actual)": "2024-12-12",
"study_start_date(actual)": "2024-04-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-24",
"last_updated_that_met_qc_criteria": "2024-04-23",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-24",
"first_submitted": "2024-04-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of the most common complication of PCI and adversely affect in-hospital, short- and long-term outcome.As bivalirudin proved its effectiveness in decreasing haemorrhagic events during PCI, its administration may be advocated in subjects deemed at high risk of bleeding.Objective of the present trial is to compare the safety and effectiveness of procedural use of bivalirudin in comparison to unfractionated heparin (UFH) in patients undergoing PCI deemed at high risk of procedural bleeding.
Detailed Description
Antithrombotic and antiplatelet therapies have been the focus of extensive clinical investigations over the past 2 decades. In PCI settings all therapies inhibiting coagulation and primary hemostasis may limit ischaemic event rates, but are associated with an increased risk of bleeding. Retrospective and registry data indicates that haemorrhage is associated with mortality in patients undergoing PCI, emphasizing the potential importance of minimizing bleeding, as well as ischemic events, bleeding has now emerged as one of the most common complication of PCI. Major bleeding and blood transfusion have been strongly associated with increased rates of in-hospital and late mortality, MI and repeat revascularization after PCI. Also minor bleeding, although represent a complication significantly less dangerous than major haemorrhages, are associated with prolonged hospitalization, increased cost and adversely affect short- and long-term outcome.
UFH is the most commonly used anticoagulant drug during PCI. Bleeding events during PCI may be in part due to the use of this drug. Bivalirudin (The Medicine's Co., Parsippany, NJ) is a synthetic direct thrombin inhibitor approved for patients with stable and unstable coronary syndromes undergoing PCI. Favourable properties of bivalirudin may minimize bleeding.
Several clinical and procedural factors have been evaluated to identify patients exposed to a higher risk of hemorrhages. Nikolsky et al. have developed a risk score (validated on REPLACE-1 and REPLACE-2 data) based on clinical variable useful to predict the incidence of major peri-procedural bleeding after contemporary PCI using the femoral approach. The clinical variables considered into this algorithm are age \>55 years (integer score 4 for every 10 years over 55), female gender (integer score 3), eGFR \<60 ml/min/1.73 m2 (integer score 2), pre-existing anaemia (integer score 2), and administration of low-molecular weight heparin within 48 hours (integer score 2). Global risk score 0-1 anticipated a major bleeding rate of 1.3%; a risk score 2-6 was associated with a 1.8% risk of major bleeding; a risk score 7-9 associated with a 2.7% risk if major bleeding, whereas a risk score \>=10 was associated with a 5% rate of major bleeding.
Our hypothesis is that bivalirudin, compared with UFH, may provide significant benefits in term of bleeding in the selected population of patients deemed at high risk of bleeding. Our aim is thus to prove, in a double-centres, randomized, blind controlled trial enrolling patients undergoing PCI via the femoral approach, the efficacy in term of haemorrhagic events and, secondarily, the effectiveness and safety of bivalirudin by means of the study drug vs UFH.
Sample size estimation: in this high risk population we expect a rate of major and minor bleeding of \>5% for the UFH group vs a 3% event rate in the bivalirudin group. Aiming for a 0.05 alpha and 0.80 power, a total of 662 patients will need to be enrolled (331 patients per group). This will be increased by about 25% (leading to a total of 830 patients) because of considerable uncertainty about expected end-point rates.
#Intervention
- DRUG : Bivalirudin
- Patients randomized to Bivalirudin group will be treated by bivalirudin before and during the procedure. Bivalirudin will be given as bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.The infusion will be lowered to 1.0 mg/kg per hour in patients with eGFR \<30 ml/min/1.73 m2.
- Other Names :
- Bivalirudin (Angiox; The Medicine Company - NJ 07054 U.S.A)
- DRUG : Unfractionated Heparin
- Patients randomized to the Control group will receive unfractionated heparn (UFH) before and during the procedure. UFH bolus will be of 70 UI/kg. If the activated clotting time measured 5 minutes after the study drug administration is lower than 270 seconds, an additional bolus of the randomised drug (UFH 20 U/kg) will be given.
|
#Eligibility Criteria:
Inclusion Criteria:
*
* Male or female able to understand and sign a witnessed informed consent
* Age >= 18 ys
* Patients with stable (CCS 1 <= age <= 4) or unstable angina pectoris (but with the most recent anginal episode occurring >48 hours before the procedure) or documented silent ischemia
* Stable Hemodynamic conditions (systolic BP > 100 HR > 40 < 100).
* No clinical and ECG changes suggestive of ongoing acute or recent (<48 hours) myocardial infarction.
* Bleeding risk score >= 10
* Procedure planned via femoral approach
* Double antiplatelet therapy.
*2.2 Angiographic inclusion criteria
* Angiographic evidence of a de novo lesion > 50% requiring intervention
Exclusion Criteria:
*
* Female sex with childbearing potential
* Age <18 years
* Ongoing or recent episode (<48 hours) of unstable coronary artery disease (including both ST-elevation and non-ST-elevation acute coronary syndromes)
* Chronic kidney disease (estimated glomerular filtration rate <30mL/min/1.73 m2).
* Ongoing serious bleeding or bleeding diathesis
* Previous stroke in the last 6 months
* Platelet count <=100,00 per mm3
* History of heparin- induced-thrombocytopenia
* Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or sensitivity to contrast which cannot be adequately pre-medicated.
* Hemodynamic instability (systolic blood pressure < 100 mm Hg; heart rate < 40 bpm or >100 bpm; complex ventricular arrhythmias; AV block) requiring balloon counterpulsation or inotropic support.
* The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this study.
* Positive clinical history for intracranial neoplasia, AV malformation, aneurysm.
* INR >= 2.0 or prothrombin time 1.2 times upper limit of normality
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
|
NCT01465503
|
{
"brief_title": "Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients",
"conditions": [
"Bleeding"
],
"interventions": [
"Drug: Unfractionated Heparin",
"Drug: Bivalirudin"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT01465503",
"official_title": "Bivalirudin in Patient at High Risk of Bleeding Undergoing Percutaneous Coronary Interventions.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2008-01"
},
"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)": "2014-04-08",
"last_updated_that_met_qc_criteria": "2011-11-03",
"last_verified": "2014-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-04",
"first_submitted": "2011-11-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the alpha/beta ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the alpha/beta ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the alpha/beta ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.
Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.
#Intervention
- RADIATION : Hypofractionation
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with T1 <= age <= 4 N0 M0 prostate cancer
Exclusion Criteria:
* other no skin cancer diagnosed within 5 years prior to enrolment
* no informed consent
Sex :
MALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02311049
|
{
"brief_title": "Hypofractionated Radiotherapy for Prostate Cancer",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Radiation: Hypofractionation"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02311049",
"official_title": "Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer: Randomised Trial Comparing Toxicity Between 2 Different Hypofractionated Schedules",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-14",
"study_completion_date(actual)": "2020-06-14",
"study_start_date(actual)": "2013-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-29",
"last_updated_that_met_qc_criteria": "2014-12-04",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-08",
"first_submitted": "2013-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
* Ketamine seems an obvious choice in the setting of an emergency department
* Ketamine leads to increased production of salivary and tracheal secretions
* Antisialagogues(atropine)therefore have been recommended as a routine adjunct
* We compare atropine with placebo as an adjunct to ketamine sedation in children undergoing primary closure of lacerated wound
Detailed Description
The degree of secretion was significantly less in the atropine group compared with the control group at the end of the procedure (VAS score: 16.5 ± 9.9 vs. 27.0 ± 15.9, atropine vs. control, p = 0.00). The change in the degree of secretion between the start and end of the procedure was significantly greater in the atropine group than in the control group (p = 0.00) (Fig. 2). However, the frequency of hypersalivation as predefined (VAS score ≥50) did not differ between the groups (p = 0.06).
The only complication that differed significantly between the two groups was tachycardia (p \> 0.05). Complications such as aspiration, laryngospasm, and apnea were not documented in the hospital. There were fewer interventions for hypersalivation in the atropine group, but the difference was not significant (p \> 0.05). As interventions, O2 administration and endotracheal intubation were not needed. After discharge, the control patients tended to have more complaints of nausea, vomiting, and ataxia, although the difference was not significant (p \> 0.05) Heart rate was increased significantly in the atropine group (p = 0.00). The frequency of tachycardia according to patient age was also significantly higher in the atropine group than in the control group (p = 0.00)
#Intervention
- DRUG : Atropine
- Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Pediatric lacerated patients
Exclusion Criteria:
* Contraindication of ketamine or atropine
Sex :
ALL
Ages :
- Minimum Age : 12 Months
- Maximum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00834470
|
{
"brief_title": "Adjunctive Atropine During Ketamine Sedation",
"conditions": [
"Conscious Sedation"
],
"interventions": [
"Drug: Atropine"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT00834470",
"official_title": "Is Atropine Needed With Ketamine Sedation?",
"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)": "2008-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-08-06",
"last_updated_that_met_qc_criteria": "2009-02-01",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-03",
"first_submitted": "2009-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.
Detailed Description
To healthy male subjects of 16, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Group 1: CKD-395 0.5/1000mg 1T(Fasting) / CKD-395 0.5/1000mg 1T(Fed) Group 2: CKD-395 0.5/1000mg 1T(Fed) / CKD-395 0.5/1000mg 1T(Fasting) Pharmacokinetic blood samples are collected up to 48hrs. Investigate the effect of food on the pharmacokinetic characteristics of CKD-395
#Intervention
- DRUG : CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
- administered CKD-395 0.5/1000mg 1T to oral (fasting condition)
- Other Names :
- CKD-395 0.5/1000mg
- DRUG : CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
- administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)
- Other Names :
- CKD-395 0.5/1000mg
|
#Eligibility Criteria:
Inclusion Criteria:
* A healthy male whose age is > 19 years when visiting for initial screening test
* Body mass index (BMI) between 17.5 ~ 30.5 kg/m^2 and the body weight must be over 55kg
* Body mass index (BMI) = weight (kg) / height (m)^2
* A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
* Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
* The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
* The participants must have an ability and willingness to participate throughout the entire trials
Exclusion Criteria:
* A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease.
* Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
* Who had following results after examination
a. ALT or AST > twice higher than normal value
* Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g)
* Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial
* Whose blood pressure > 140 mmHg (systolic blood pressure) or > 90 mmHg (diastolic pressure)
* Who had a medical history of alcohol and drug abuses.
* Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug
* Who smokes more than 20 cigarettes per day
* Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug
* Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
* Who has a potent to increase a danger by participating in the clinical trials or who can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
* Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain the ingredients of Metformin or biguanidine drugs
* Who has a serious heart failure or a congestive heart failure that must be drug-treated
* A patient with hepatopathy
* A patient with severe nephropathy
* Who has diabetic ketoacidosis or a diabetic coma, or type 1 diabetes, or has history of acute metabolic acidosis or ketoacidosis
* A patient with serious infectious disease or severe injuries before and after a surgery
* Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
* A patient who has kidney disease or renal insufficient that are caused by cardiovascular collapse (shock) and acute myocardial infarction (a male with higher serum creatinine of 1.5mg / dL, or less creatinine clearance of 80 mL / min)
* A patient who is being tested to inject radiological iodine contrast agent into blood vessels (ex: intravenous urography, intravenous cholangiography, angiography, using contrast medium computer tomography, etc.)
* Who has severe systematic infection or severe trauma
* Who has nutritional status, starvation, debilitating condition, pituitary dysfunction, or adrenal insufficiency patients
* Who has respiratory dysfunction, gastrointestinal disease
* Who is unable to take high fat foods
* Who cannot limit intake of grapefruit or grapefruit containing foods in 7 days from the first dosing of clinical testing drug to collect pharmacokinetic blood samples
* Test subjects who is not willing or unable to comply with guidelines described in this protocol
* A person who is not determined unsuitable to participate in this test by the researchers
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02648854
|
{
"brief_title": "Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers",
"conditions": [
"Diabetes Mellitus, Type II"
],
"interventions": [
"Drug: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02648854",
"official_title": "A Randomized, Open-label, Single Dose, 2-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-08",
"last_updated_that_met_qc_criteria": "2016-01-05",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-07",
"first_submitted": "2015-12-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood 'clinical samples'.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
* Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
* Subject is between 18 <= age <= 95 years.
Exclusion Criteria:
* Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
* Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
* Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02535468
|
{
"brief_title": "T2Bacteria Panel Pivotal Study",
"conditions": [
"Bacteremia"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02535468",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2015-12"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-17",
"last_updated_that_met_qc_criteria": "2015-08-27",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-28",
"first_submitted": "2015-08-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.
Detailed Description
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.
#Intervention
- BEHAVIORAL : TIPS Intervention
- A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
|
#Eligibility Criteria:
Inclusion Criteria:
* Singleton baby born at GA >37 weeks
* baby 8 hours to 7 days old
* Mother age 16 <= age <= 50 years
* Normal, healthy infant as described in newborn examination
* First time parents living in the Greater Toronto Area
* Mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home
Exclusion Criteria:
* Maternal or infant complications requiring prolonged hospital stay
* Previous stillbirth or neonatal death
* Maternal chronic illness
* Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
* Known drug or alcohol use beyond occasional social use
* Smoking two packs a day or more
* Either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
* Mother's partner is working night shifts
* Mother unable to read or understand English
* No telephone in the home
* Involvement in another research protocol involving sleep
Sex :
ALL
Ages :
- Minimum Age : 8 Hours
- Maximum Age : 7 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00228215
|
{
"brief_title": "Tips for Infant and Parent Sleep (TIPS)",
"conditions": [
"Sleep Deprivation"
],
"interventions": [
"Behavioral: TIPS Intervention"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00228215",
"official_title": "Tips for Infant and Parent Sleep (TIPS) Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-12",
"study_completion_date(actual)": "2005-12",
"study_start_date(actual)": "2005-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-13",
"last_updated_that_met_qc_criteria": "2005-09-26",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-28",
"first_submitted": "2005-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.
Detailed Description
Fibromyalgia (FM) is a chronic pain condition with significant morbidity. Current research suggests a primarily central mediation of the widespread pain including central sensitization at the spinal level and abnormal pain processing at the cerebral level. Findings in FM patients include abnormal neurotransmitter levels in cerebrospinal fluid (CSF), abnormal activation of cerebral pain processing areas and abnormal peripheral pain and sensory thresholds. Continuous low level spinal cord activation by primary nociceptive afferents (C and A delta fibers) is believed to significantly drive the central sensitization. One major spinal neurotransmitter released by these pain fibers is substance P (SP). Several studies have shown that FM patients have up to three times higher baseline SP levels in the CSF compared to controls. Since spinal neurotransmitter release and therefore nociceptive afferent activity is also regulated via a descending inhibitory pathway releasing norepinephrine (NE) and serotonin (5HT), decreased activity of this pain modulating system could also be involved in abnormal pain processing in FM. Indeed, there is support in the literature for decreased CSF levels of both NE and 5HT or their metabolites. Milnacipran, a NE and 5HT reuptake inhibitor, has been shown to potentially effectively reduce FM pain and symptoms of FM by affecting the above pathologies.
The investigators propose an open label clinical trial with milnacipran 200 mg over 12-weeks in order to investigate the pain pathway in FM patients at peripheral and spinal levels before and after treatment. In addition, the investigators will assess pain intensity and symptoms of FM before, during and after treatment. To determine if there are peripheral effects, the investigators will characterize the systemic neurotransmitter release and their metabolites in plasma. The investigators will also measure the heart rate variability using an electrocardiogram to look for effects on the sympathetic nervous system.
#Intervention
- DRUG : Milnacipram
- Titration to 200mg PO daily
- Other Names :
- Savella
|
#Eligibility Criteria:
Inclusion Criteria:
* Female age >= 18 years
* Written informed consent and written release of health and research study information
* Diagnosis of Fibromyalgia
* Participant has pain greater than 4 on the NRS of 0 to 10 on average over the last week prior to initial evaluation that interferes with function most days per week
* Pain duration greater than 6 months
* Negative urine pregnancy test on experimental day 1 and 2 and on first day of treatment prior to administration of study medication and fluoroscopy
* Ability to speak and understand English, to follow instructions, and fill out study questionnaires
* Likely to complete all required visits
* Must be ambulatory and able to lay prone for 30 minutes
Exclusion Criteria:
* Any condition or situation that in the investigator's opinion may put the participant at significant risk, confound the study results, or interfere significantly with the participant's participation in the study
* Serious, unstable medical illness that could lead to hospitalization over the next three months; and/or a DSM-IV diagnosis(es) with active problems within the last six months, such as: schizophrenia, bipolar disorder, antisocial personality disorder, or substance use disorder
* Known, uncontrolled, serious systemic disease, including: hypertension and/or tachyarrythmia
* Females who are pregnant, breast feeding, or who plan to become pregnant, or who may potentially become pregnant
* Allergy or sensitivity to any component of the study medication or to contrast dye
* Patients on coumadin, heparin, or any other known increase risk of bleeding
* Signs of increased intracranial pressure
* Patients who are unable to continue current pain medication
* Allergy or contraindication to acetaminophen
* Use of monoamine oxidase inhibitors
* Uncontrolled narrow-angle glaucoma
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
|
NCT01288807
|
{
"brief_title": "Effect of Milnacipran on Pain in Fibromyalgia",
"conditions": [
"Fibromyalgia"
],
"interventions": [
"Drug: Milnacipram"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01288807",
"official_title": "Effects of a 12 Week Milnacipran 200 mg Treatment on Pain Perception and Pain Processing in Fibromyalgia - An Open Label Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2011-02"
},
"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)": "2019-09-24",
"last_updated_that_met_qc_criteria": "2011-02-01",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-02",
"first_submitted": "2011-02-01",
"first_submitted_that_met_qc_criteria": "2019-09-04"
}
}
}
|
#Study Description
Brief Summary
The main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. Patient will be recruited during an hospitalisation due to COPD exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. The rate of exacerbations will be determined every three months up to one year follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of them, the following information will be obtained:
* Number/severity of exacerbations or hospitalisation since last clinic visit
* Compliance and side effects
* Blood sample
* Plasma levels of theophylline
* Sputum (induced)
* MMRC
* SGRQ
* Forced spirometry + inspiratory capacity
- At the beginning and at the end of the study
* 6MWT
* BMI
* BODE
#Intervention
- DRUG : theophylline
- theophylline 100 mg, twice at day
- OTHER : placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Ability to understand study procedures and to comply with them for the entire length of the study.
* Any gender. No contraception is required neither pregnancy expected in the range of age
* Age > 45 years
* Smoking history > 10 pack-years (current or ex-smokers)
* Clinical diagnosis of COPD
* Presence of severe airflow obstruction on forced spirometry (FEV1/FVC < 0.7 and post-BD FEV1 < 50% of reference value) staged as GOLD III or IV
* Diagnosis of COPD exacerbation on discharge.
Exclusion Criteria:
* Presence or history of other chronic respiratory diseases (asthma, bronchiectasis, TB lesions)
* Cancer
* Heart failure
* Pregnancy, or risk of pregnancy
* Other inflammatory diseases
* Previous treatment with theophylline
* For drug studies: allergy/sensitivity to study drugs or their ingredients.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01599871
|
{
"brief_title": "Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Drug: theophylline",
"Other: placebo"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01599871",
"official_title": "Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2011-01"
},
"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)": "2017-08-29",
"last_updated_that_met_qc_criteria": "2012-05-15",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-16",
"first_submitted": "2012-05-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to investigate the sensitivity and specificity of the Red Reflex Test (RRT), with and without dilation, for early detection of ocular abnormalities in children and newborns. The RRT functions by shining a light from an ophthalmoscope into a participant's eye and noting the presence or absence of a red glow. Despite its use in pediatric clinics for years, this test at times fails to detect significant ocular diseases, especially located in the back of the eye, threatening visual development in this population. Therefore, the investigators aim to quantify the utility of this test as a tool for screening by comparing these findings on RRT with those of retinal photography.
The investigators hypothesize that the sensitivity and specificity of the RRT will be sufficient for detecting anterior segment pathology but will be insufficient for detecting posterior segment pathology with or without dilation.
Detailed Description
Pediatric patients will be recruited through clinical practice at the designated study sites. Participants with known anterior segment or posterior segment pathology will be eligible for inclusion. Patients who have a history of disease, treatments and/or surgical procedures affecting the ability for normal pupillary reaction are excluded. An equal number of age matched participants with a normal anterior and posterior segment exam will be recruited from routine outpatient ophthalmology clinic appointments. Informed consent will be obtained and will include an option to be considered for medical photography. Participants may opt out of photography and still be included in the study. For Spanish speaking participants, an interpreter will be used for study recruitment and informed consent. A Spanish informed consent (developed by a Spanish medical translator from our English written consent) will be provided. Current estimated number of subjects required for the study is 200 total including 100 controls. Patient charts will be accessed from date of birth to patient's current age using either Cerner or Epic depending on the study site location. Examiners will include ophthalmology residents with one completed year of ophthalmology training. They will be blinded to participants' ophthalmologic history.
Pupil size will be recorded under ambient lighting conditions and the red reflex test (RRT) performed at 18 cm using a direct ophthalmoscope (Welch Allyn 11710 or similar). Each eye will then be inspected individually at 1 cm. Examiner description of the pupillary reflex in terms of color, brightness, and the presence or absence of potential anterior/posterior segment abnormality will be recorded using a standardized survey tool. The exam room lights will then be turned off and the pupils examined again with the direct ophthalmoscope according to the standard RRT procedure and results recorded.
Next, pharmacological dilation will be achieved according to standard practices. For all patients, one drop of proparacaine hydrochloride ophthalmic solution will be instilled in each eye to achieve anesthesia. For patients under 1 year old, one drop of Cyclomydril will then be instilled in each eye and followed second drop in each eye 5 minutes later. For children over 1 year of age, pharmacologic dilation will be achieved with 1 drop of Cyclopentolate 1% and 1 drop of Phenylephrine 2.5% in each eye. The RRT will be repeated by the same examiner, including the lights on and lights off portions of the exam, and the results recorded.
Subjects will be de-identified and results will be stored on a password protected Children's National Hospital computer and pertinent statistical analyses will be perform to asses our hypothesis. All statistical tests will be performed at the 5% level of significance unless otherwise stated.
#Intervention
- DIAGNOSTIC_TEST : Direct ophthalmoscope
- Red reflex test
|
#Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients recruited in clinical practice with known anterior or posterior segment pathology as well as patients without anterior or posterior segment pathology
Exclusion Criteria:
* Patients who have a history of disease, treatments and/or surgical procedures affecting the ability for normal pupillary reaction
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04125043
|
{
"brief_title": "Accuracy of the Red Reflex Test in the Pediatric Population",
"conditions": [
"Abnormal Vitreous Humor Morphology",
"Abnormal Choroid Morphology",
"Optic Nerve Diseases",
"Retinal Disease",
"Retinal Hemorrhage"
],
"interventions": [
"Diagnostic Test: Direct ophthalmoscope"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04125043",
"official_title": "Sensitivity and Specificity of the Red Reflex Test for Detecting Anterior and Posterior Segment Ophthalmic Pathology in the Pediatric Population",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-01",
"study_completion_date(actual)": "2023-08-01",
"study_start_date(actual)": "2020-03-01"
},
"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)": "2023-10-23",
"last_updated_that_met_qc_criteria": "2019-10-10",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-14",
"first_submitted": "2019-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase I study aiming at:
* establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes) at 18 MIU;
* investigating the possible impact of albumin on pharmacokinetic profile by comparing 3 different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif® from Merck-Serono, a registered IFN beta-1a solution containing HSA;
* establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals against Rebif® using the same regimen.
#Intervention
- DRUG : Interferon beta-1a HSA-free biosimilar
- 6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution without albumin
- Other Names :
- Bioferon®
- DRUG : Interferon beta-1a HSA+ biosimilar
- 6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution combined with albumin solution
- Other Names :
- Bioferon®
- DRUG : Interferon beta-1a original
- 6 MIU/0.50 mL in pre-filled glass syringe solubilized in HSA and mannitol solution (marketed formulation)
- Other Names :
- Rebif®
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female subjects aged between 18 and 45 years
* Weight range between 55 and 95 kg for males, 45 and 80 kg for females, providing body mass index (BMI) was between 18 and 29 kg/m2
* Absence of significant findings in the medical history and physical examination
* Absence of significant laboratory abnormalities as judged by the investigator.
* 12-lead ECG without significant abnormalities
* Negative urine drug screen
Exclusion Criteria:
* History of major renal, hepatic, immunological, haematological, gastrointestinal, genitourinary, neurological, or rheumatological disorders
* Active diseases of any type, even if mild, including inflammatory disorders and infections.
* Pregnant or lactating women or women contemplating becoming pregnant during study. Female subjects of child-bearing potential who did not practice efficient contraception during the study. A pregnancy test in blood was performed at screening and before each period with β-human chorionic gonadotropin for females of child-bearing potential. If pregnancy test was positive, the subject had to be immediately excluded from study and followed until delivery
* History of severe allergy or of asthma at any time.
* History of cardiovascular dysfunction
* Hypertension
* Sick sinus syndrome or known long QT syndrome
* Presence of QTc  > 440 msec or pronounced sinus bradycardia (<40 bpm/min), even if elicited by sport
* Dark skin preventing local tolerance assessment or abnormal cutaneous reaction e.g. urticaria or papular dermographism
* Intense sport activities.
* Any clinically significant laboratory value on screening that were not within normal range on single repeat
* Positive hepatitis B & C antigen screen
* Positive HIV antibody screen or screen not performed
* Any recent acute illness or sequelae thereof which could expose the subject to a higher risk or might confound the results of the study
* Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
* History of hypersensitivity to any drug if considered as serious
* History of alcohol or drug abuse
* Positive qualitative urine drug test at screening
* Use of any medication in 2 weeks prior to study and throughout study, including aspirin or other over-the-counter preparation.
* Blood (500 mL) donation or hemorrhage during the previous three months
* Participation in a clinical trial in the previous 3 months
* Smoking
* Consumption of a large quantity of coffee, tea or equivalent
* Present consumption of a large quantity of alcohol or wine or equivalent
* Psychological status which could have had an impact on subject's ability to give informed consent or behavioral tests
* Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate its interpretation, or represent a potential risk for the subject
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
|
NCT02517788
|
{
"brief_title": "Phase I BP Interferon (IFN) Beta-004",
"conditions": [
"Multiple Sclerosis, Relapsing-Remitting"
],
"interventions": [
"Drug: Interferon beta-1a HSA-free biosimilar",
"Drug: Interferon beta-1a HSA+ biosimilar",
"Drug: Interferon beta-1a original"
],
"location_countries": null,
"nct_id": "NCT02517788",
"official_title": "Comparative Pharmacokinetic Profile of Interferon Beta-1a (Bioferon®) Administered as Single i.v. Doses in HSA-free Formulation and HSA+ Solution and as Multiple s.c. Doses in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": "2006-07",
"study_start_date(actual)": "2006-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-10",
"last_updated_that_met_qc_criteria": "2015-08-05",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-07",
"first_submitted": "2015-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56.
As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period.
Detailed Description
Krill powder is a food supplement rich in active ingredients such as fatty acids, phospholipids, protein and antioxidants like astaxanthin. It is considered to be more effective in lowering triglyceride values than fish oils and it may have positive effect on cholesterol values as well. Krill proteins may have positive effect on blood pressure and astaxanthin has anti-oxidative and anti-inflammatory properties. Thus, krill powder has a lot of potential in improving lipid values and having other positive health effects on cardiovascular system. However, there haven't been many clinical studies done with krill powder and thus systematic data on human safety is limited.
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56.
A total of 6 study visits were included. At pre-screening visit the study subjects were requested to sign pre-screening visit informed consent form. A structured interview on demographics (age, sex, ethnicity), previous and current diseases, current medication, alcohol and tobacco consumption and use of dietary supplements (especially fish oil and other n-3 fatty acid (FA) supplements, plant sterols and cholesterol lowering fiber supplements (guar gum, glucomannan, oat fiber etc.) and use of fish foods was carried out at the screening visit and replicated at the day 56 visit. Study included one test product: krill powder derived from antarctic krill (Euphausia Superba) (Rimfrost Pristine®, Rimfrost AS, PO box 234, 6099 Fosnavaag, Norway) and placebo product and both were given in capsule form, 4 capsules in the morning and 4 in the evening.
Nutritional counselling regarding the consumption of fish, omega-3 and -6 fatty acids, food supplements and investigational product for the duration of the study were given for the study subjects at the screening visit by a study nurse or registered dietitian and compliance was followed throughout the study. The subjects were advised to keep their medication, lifestyle, background diet and body weight constant during the study and deviation were recorded into the diary.
As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period. Any unfavourable and unintended sign, symptom or medical complaint and worsening of a pre-existing condition was regarded as adverse event (AE). Study subjects kept diary for the whole duration of the study and were requested to write down all unfavourable symptoms and medical complaints not existing at baseline or significantly worsened from baseline situation. Completeness of diaries was checked at each study visit. All reported adverse events were recorded, coded and analysed carefully to determine severity, possible relation to study products, onset and outcome of the event. In addition, safety laboratory values, cholesterol and triglyceride values and blood pressure was measured.
#Intervention
- DIETARY_SUPPLEMENT : Nutritional counseling A
- Krill powder capsules
- DIETARY_SUPPLEMENT : Nutritional counselling B
- Placebo capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 65 years
* Slightly obese female and male subjects (BMI between 25 <= age <= 30 kg/ m2)
* Mildly or moderately elevated blood pressure (RR systolic 130 <= age <= 159/ diastolic under 99)
* Signed written informed consent
Exclusion Criteria:
* Medication potential to affect serum lipids (lipid-lowering drugs)
* Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
* Any untreated medical condition affecting absorption of fat
* Type 1 and 2 diabetes
* Cancer or other malignant disease within the past five years
* Periodical hormone replacement therapy
* High intake of oily fish (>2 times per week as a principal meal) (i.e. salmon, herring, sardines, mackerel, vendace)
* Smoking
* Alcohol consumption >15 doses per week
* Pregnant, lactating or wish to become pregnant
* Hypersensitivity to fish or any of the components of the test products
* Regular use (> 3 times per week) of n-3 or other fatty acid supplements, plant sterols or fiber supplements 4 weeks before randomization
* Lack of suitability for participation in the trial, for any medical reason, as judged by the PI
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
|
NCT03112083
|
{
"brief_title": "Safety and Tolerability of Krill Powder Supplement in Slightly Overweight People With Moderately Elevated Blood Pressure",
"conditions": [
"Adverse Drug Event",
"Side Effects of Drugs"
],
"interventions": [
"Dietary Supplement: Nutritional counseling A",
"Dietary Supplement: Nutritional counselling B"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT03112083",
"official_title": "Prospective, Randomized, Single-center, Double-blinded, Placebo-controlled Study on Safety and Tolerability of the Krill Powder Product in Slightly Obese Study Subjects With Moderately Elevated Blood Pressure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-17",
"study_completion_date(actual)": "2016-06-17",
"study_start_date(actual)": "2015-10-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-13",
"last_updated_that_met_qc_criteria": "2017-04-07",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-13",
"first_submitted": "2017-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles.
The product being used in this study is EVOLENCE®, which is currently marketed in the United States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles), and been approved by the U.S. Food and Drug Administration (FDA).
Detailed Description
The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction.
#Intervention
- DEVICE : Evolence
- Injectable collagen
- Other Names :
- collagen, Dermicol-P35 27G
- DEVICE : Lidocaine
- admix anesthetic
- DRUG : topical anesthetic
|
#Eligibility Criteria:
Inclusion Criteria:
* Understanding and voluntary signature (including date) of an informed consent document
* Healthy male or female > 18 years
* Clinical evidence of bilateral, fully visible aging defects in the nasolabial area with grades 2.0, 2.5, or 3.0 on the Modified Fitzpatrick Wrinkle Scale (MFWS section 6.5)
* Willingness to receive EVOLENCE® injections in areas of aging defects (wrinkles)
* Willingness and ability to comply with the requirements of this protocol
Exclusion Criteria:
* History of multiple severe allergies (food, drug, or substances) and/or anaphylactic shock
* Subjects with a history of a bleeding disorder, or receiving chronic anti-platelet therapy or other chronic anticoagulant medication
* Subject on low-dose aspirin therapy or a non-steroidal anti-inflammatory drug, not interrupted at least 10 days prior to injection and/or resumed within 1 week after injection
* History of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products or natural rubber latex
* Autoimmune or collagen vascular disease, or connective tissue disease
* Active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry
* Previous tissue augmentation - permanent implants or hyaluronic acid within 6 months or EVOLENCE® within 12 months in the treatment area
* Currently being treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or has been treated within the last 3 months prior to study entry
* Botulinum-toxin A within 6 weeks in treatment area
* Received any investigational products within 30 days prior to the study enrollment
* Females of Childbearing Potential
* Any clinically significant organic disease or other medical condition that in the opinion of the PI, makes the subject a poor candidate for participation 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
|
NCT00929071
|
{
"brief_title": "Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®",
"conditions": [
"Aging",
"Pain"
],
"interventions": [
"Drug: topical anesthetic",
"Device: Evolence",
"Device: Lidocaine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00929071",
"official_title": "Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-01",
"study_completion_date(actual)": "2009-02",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "NON_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)": "2014-08-07",
"last_updated_that_met_qc_criteria": "2009-06-24",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-26",
"first_submitted": "2009-06-24",
"first_submitted_that_met_qc_criteria": "2014-06-10"
}
}
}
|
#Study Description
Brief Summary
The purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II endometrial cancer
#Intervention
- PROCEDURE : Systematic pelvic lymphadenectomy
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically proven endometrioid or adenosquamous endometrial carcinoma.
* Patients having myometrial invasion
* Age =/< 75 years
* Informed consent.
Exclusion Criteria:
* Serous papillary and clear cell tumors.
* Karnofsky index < 80 or severe diseases contraindicating surgery
* Concomitant neoplasia (basalioma cutis excluded)
* Distant metastasis or abdominal metastasis detected intraoperatively.
* Absence of myometrial invasion at frozen section.
Sex :
FEMALE
Ages :
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00482300
|
{
"brief_title": "Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer",
"conditions": [
"Endometrial Cancer"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00482300",
"official_title": null,
"recruitment_information": null,
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-06-05",
"last_updated_that_met_qc_criteria": "2007-06-04",
"last_verified": "2007-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-06-05",
"first_submitted": "2007-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
#Intervention
- DRUG : SM-13496 40mg
- once daily orally
- DRUG : SM-13496 80mg
- once daily orally
- DRUG : Placebo
- once daily orally
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient meets DSM-IV-TR criteria for schizophrenia.
* Patient is aged 18 through 74 years at informed consent.
* Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study
Exclusion Criteria:
* Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
* Patient has Parkinson's disease.
* Patient has a history or complication of malignancy.
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
|
NCT01614899
|
{
"brief_title": "A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Drug: SM-13496 40mg",
"Drug: Placebo",
"Drug: SM-13496 80mg"
],
"location_countries": [
"Japan",
"Taiwan",
"Malaysia",
"Korea, Republic of"
],
"nct_id": "NCT01614899",
"official_title": "Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11-17",
"study_completion_date(actual)": "2014-11-17",
"study_start_date(actual)": "2012-07-02"
},
"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)": "2022-04-12",
"last_updated_that_met_qc_criteria": "2012-06-07",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-06-08",
"first_submitted": "2012-06-06",
"first_submitted_that_met_qc_criteria": "2017-12-22"
}
}
}
|
#Study Description
Brief Summary
To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period.
Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.
Detailed Description
Lead migration has been a known issue/complication with spinal cord stimulation. Lead migration during the trial period can alter the success of a trial. There is no one way of securing the leads to the skin.
Our endeavor was to look at different modes of securing the leads to the skin during the trial period and present their respective lead migration rates. The three methods are
1. suturing the leads using 2.0 mono-filament nylon to the skin,
2. suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin,
3. non- suture.
In all three groups copious amounts of benzoin and steri-strips will be used.
Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray was taken and compared to the fluoroscopy pictures taken at the time of lead placement.
#Intervention
- DEVICE : Suture
- Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used.
- Other Names :
- 2.0 Mono-filament nylon suture
- DEVICE : Lead Anchor
- Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used.
- Other Names :
- 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106
|
#Eligibility Criteria:
Inclusion Criteria:
* All the patients undergoing Spinal Cord Stimulation (> 18 yearsrs)
Exclusion Criteria:
* patients whose trial period lasts less than 3 days or more than 5 days will be excluded from the study.
* patients that may require revision of leads or any complication that requires to take the leads out before the end of trial period.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01126983
|
{
"brief_title": "Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor",
"conditions": [
"Spinal Cord Stimulation"
],
"interventions": [
"Device: Suture",
"Device: Lead Anchor"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01126983",
"official_title": "Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor Securing Methods: A Randomized Single Blind Clinical Trial for Better Outcomes.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2010-05"
},
"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)": "2010-07-09",
"last_updated_that_met_qc_criteria": "2010-05-18",
"last_verified": "2010-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-20",
"first_submitted": "2010-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
Detailed Description
The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.
#Intervention
- DEVICE : Ear tube placement with the Hummingbird TTS
- Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
- Other Names :
- Preceptis Medical, Inc. Tympanostomy Tube Introducer System, Hummingbird Tympanostomy Tube Delivery System, Hummingbird TTS
|
#Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo tympanostomy tube insertion.
* At least 6 months old.
* Subject is able and willing to comply with follow-up requirements.
* Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.
Exclusion Criteria:
* Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
* Significantly atrophic tympanic membrane.
* Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
* Anatomy precludes sufficient visualization and access to the tympanic membrane.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02165384
|
{
"brief_title": "Hummingbird TTS Ear Tube Delivery Study",
"conditions": [
"Otitis Media"
],
"interventions": [
"Device: Ear tube placement with the Hummingbird TTS"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02165384",
"official_title": "Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-01",
"study_completion_date(actual)": "2018-03-01",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-03",
"last_updated_that_met_qc_criteria": "2014-06-16",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-17",
"first_submitted": "2014-06-12",
"first_submitted_that_met_qc_criteria": "2018-12-11"
}
}
}
|
#Study Description
Brief Summary
The primary aim is to prevent depression in youth and parents in a single, integrated family intervention.
Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition.
Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.
Detailed Description
Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This 'dual prevention' approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (10 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.
#Intervention
- BEHAVIORAL : Family Cognitive Behavioral Prevention
- Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
- Other Names :
- Cognitive behavioral intervention, Coping skills training, Parent training
- BEHAVIORAL : Written information
- Reading materials about depression
- Other Names :
- Psychoeducation, Self-help
|
#Eligibility Criteria:
Inclusion Criteria:
* Parent with a current or history of a depressive disorder within child's life
* Children ages 9- to 15-years-old
Exclusion Criteria:
* Bipolar I (parent or child)
* Schizophrenia (parent or child)
* Current alcohol or drug abuse (parent or child)
* Conduct disorder; developmental disability (child)
* Current diagnosis of a depressive disorder (child)
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02021578
|
{
"brief_title": "A Family Depression Prevention Program",
"conditions": [
"Depression"
],
"interventions": [
"Behavioral: Family Cognitive Behavioral Prevention",
"Behavioral: Written information"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02021578",
"official_title": "Family Cognitive Behavioral Prevention of Depression in Youth and Parents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-30",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2014-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-01",
"last_updated_that_met_qc_criteria": "2013-12-19",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-27",
"first_submitted": "2013-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The WHITE study is a multicenter, multinational, investigators-initiated, observational, prospective study conducted in a consecutive series of ambulatory patients who had completed the recommended or practicable period of anticoagulation after a first-ever episode of venous thromboembolism (VTE)
The general aim of the study is to evaluate the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulant therapy.
Detailed Description
The WHITE study is an international, non-profit, multicenter, observational, prospective and no profit study 3,200 subjects having experienced a first-ever episode of DVT of the lower limbs and/or PE, receive anticoagulation therapy for a period as recommended by international and/or local practice guidelines will be enrolled across all the countries participating to the study.
When this recommended period expires, the attending physician has to decide whether to continue with anticoagulation, switch to anti-thrombotic of another class, or stop any prophylactic pharmacological treatment.
The primary objective of the study is the evaluation of the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulation therapy.
The secondary objective is the collection of data during the follow-up: the frequency of thromboembolic complications, of bleeding complications, or death from any cause.
|
#Eligibility Criteria:
Inclusion Criteria:
* subjects who provided a written informed consent and authorization for disclosure of protected health information;
* male and female adult or elderly patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE and treated with oral anticoagulant
* for whom the center is in possession of all the data relevant to the index event;
* having a permanent reference contact.
Exclusion Criteria:
* subjects <18 years;
* subjects unable or unwilling to issue the written informed consent;
* subjects for whom the information relevant to the index event are incomplete or inaccessible to the Investigator;
* subject in whom the index event was a DVT not of the lower limbs;
* subjects with life expectancy of less than 2 years;
* subjects participating in any other clinical study, regardless of its nature;
* subjects considered, by the attending physician, unable to comply with the study 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
|
NCT04646993
|
{
"brief_title": "WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?",
"conditions": [
"Venous Thromboembolism"
],
"interventions": null,
"location_countries": [
"Czechia"
],
"nct_id": "NCT04646993",
"official_title": "Which Decision After a First Venous Thromboembolism? The WHITE Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-30",
"study_completion_date(actual)": "2022-02-28",
"study_start_date(actual)": "2018-02-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-11",
"last_updated_that_met_qc_criteria": "2020-11-21",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-11-30",
"first_submitted": "2020-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.
Detailed Description
1. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
2. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
3. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources .
4. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information .
5. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
6. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
7. Plan for missing data to address situations where variables are reported as missing, unavailable, 'non-reported,' uninterpretable, or considered missing because of data inconsistency or out-of-range results
8. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan
#Intervention
- DRUG : intraperitoneal infiltration of ropivacaine
- intraperitoneal infiltration of ropivacaine by a special equipment
|
#Eligibility Criteria:
Inclusion Criteria:
* Between 6 months and 5years.
* Laparoscopic inguinal hernia repair
* Laparoscopic testicular descent fixation
Exclusion Criteria:
* Patient who are suffering from mental disease
* Patient who suffering from neuromuscular disease
* Local anesthetic allergy
* Patient who needs directly into ICU after the operation.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 5 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01997593
|
{
"brief_title": "Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected",
"conditions": [
"Testicular",
"Colic"
],
"interventions": [
"Drug: intraperitoneal infiltration of ropivacaine"
],
"location_countries": [
"China"
],
"nct_id": "NCT01997593",
"official_title": "Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2013-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-26",
"last_updated_that_met_qc_criteria": "2013-11-22",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-28",
"first_submitted": "2013-10-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Detailed Description
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.
#Intervention
- DRUG : Didanosine
|
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
* Immunoglobulin.
* Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.
Concurrent Treatment:
Allowed:
* Blood transfusions.
Prior Medication:
Allowed:
* Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.
* Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
* Patient or guardian available to give written informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded.
* Hypersensitivity to didanosine (ddI).
* Symptomatic cardiomyopathy.
* Seizures that are not well controlled by ongoing anticonvulsant therapy.
* Symptomatic pancreatitis.
* Grade 1 or higher peripheral neuropathy.
* Active malignancy requiring chemotherapy.
Concurrent Medication:
Excluded:
* Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.
Avoid:
* Drugs with potential to cause peripheral neuropathy or pancreatitis.
Patients with the following are excluded:
* Active malignancy requiring concomitant chemotherapy.
Prior Medication:
Excluded:
* Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
* Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
* Any other experimental therapy within 1 week of entry.
* Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
Sex :
ALL
Ages :
- Minimum Age : 3 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00000963
|
{
"brief_title": "A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT00000963",
"official_title": "A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "1995-09",
"study_start_date(actual)": null
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-10-29",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg standing and in jump landing, followed by stabilization or side jumps, and to compare athletes of different levels with control subjects.
#Intervention
- OTHER : treadmill run
|
#Eligibility Criteria:
Inclusion Criteria:
* competitive level (participation in any league) for the high performance athletes group
* participation in sport for 0.5 <= age <= 4 hours per week for the recreationally active subjects
Exclusion Criteria:
* current history of a lower extremity injury requiring training cessation on the day of testing
* neurological diseases
* vestibular or visual disturbances
* cardiovascular diseases medication affecting balance
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01799434
|
{
"brief_title": "Dynamic Postural Control After Exercise",
"conditions": [
"Postural Control"
],
"interventions": [
"Other: treadmill run"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01799434",
"official_title": "Influence of an Exercise on the Dynamic Postural Control in Athletes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-02"
},
"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)": "2013-02-27",
"last_updated_that_met_qc_criteria": "2013-02-22",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-26",
"first_submitted": "2013-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.
Detailed Description
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. The study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (PF). Extracorporeal shockwave therapy (ESWT) was administered once a week for four weeks. The participants were randomly assigned to two groups (f-ESWT and r-ESWT). Pain levels were assessed using the Visual Analogue Scale, while Static and Dynamic Balance were evaluated using the Biodex Balance System.
#Intervention
- OTHER : f-ESWT
- In the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied
- OTHER : r-ESWT
- In the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied
|
#Eligibility Criteria:
Inclusion Criteria:
unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for PF in the last 6 months, 18 <= age <= 65 years, and consent to participate in the study.
Exclusion Criteria:
pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.
Sex :
ALL
Ages :
- Minimum Age : 18 Months
- Maximum Age : 63 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06685172
|
{
"brief_title": "Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial",
"conditions": [
"Plantar Fascitis",
"Pain"
],
"interventions": [
"Other: f-ESWT",
"Other: r-ESWT"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06685172",
"official_title": "Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-15",
"study_completion_date(actual)": "2024-08-15",
"study_start_date(actual)": "2023-12-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-12",
"last_updated_that_met_qc_criteria": "2024-11-11",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-11-12",
"first_submitted": "2024-11-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to investigate MER receptor tyrosine kinase (MERTK) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, acute-on-chronic liver failure (ACLF)) and in comparison to patients with acute liver failure and to healthy controls.
Detailed Description
MER receptor tyrosine kinase (MERTK) signalling cascade becomes activated on monocytes/macrophages during disease progression of liver cirrhosis from Child Pugh A to B/C, corresponding to early stages of decompensation, and before the receptor expression is increased. Factors involved in activation of the MERTK signalling cascade might be microbial products such as bacterial deoxyribonucleic acid (DNA) and other toll-like receptor (TLR)-ligands, MERTK ligands and cytokines, as shown elevated in cirrhotic patients.
Given the observation that MERTK levels peak on the day of admission with organ failure and decrease in patients surviving the episode of acute-on-chronic liver failure (ACLF), MERTK Inhibition at a time during progression of cirrhosis but before manifestation of acute decompensation with no cirrhosis (AD) or ACLF might prevent infectious complications, decompensation and improve survival in patients with cirrhosis.
This study is to investigate MER receptor tyrosine kinase (MERTK) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, acute-on-chronic liver failure (ACLF)) and in comparison to patients with acute liver failure and to healthy controls.
#Intervention
- OTHER : blood sampling for research purpose
- blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
- OTHER : clinical data collection
- clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
- OTHER : Health-related Questionnaires
- Health-related Questionnaires (Questionnaire_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
- OTHER : Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
- Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with compensated or decompensated chronic liver disease
* Patients with acute- or acute-on-chronic chronic liver failure
* Controls with no liver disease
Exclusion Criteria:
* Evidence of disseminated malignancy
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
|
NCT04116242
|
{
"brief_title": "MERTK Signalling in Monocytes/Macrophages in Patients With Liver Disease",
"conditions": [
"Liver Disease",
"Cirrhosis of the Liver",
"Acute-On-Chronic Liver Failure",
"Liver Failure"
],
"interventions": [
"Other: Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)",
"Other: Health-related Questionnaires",
"Other: blood sampling for research purpose",
"Other: clinical data collection"
],
"location_countries": [
"Switzerland",
"United Kingdom"
],
"nct_id": "NCT04116242",
"official_title": "MERTK Signalling in Monocytes/Macrophages in Patients With Liver Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-06-10",
"study_completion_date(actual)": "2024-06-10",
"study_start_date(actual)": "2015-08-27"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-25",
"last_updated_that_met_qc_criteria": "2019-10-03",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-04",
"first_submitted": "2019-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D supplementation during one year can improve bone and muscle health in post-burn period.
#Intervention
- DRUG : Cholecalciferol
|
#Eligibility Criteria:
Inclusion Criteria:
* occurrence of injury between 2005 and 2011
* burn surface area (BSA) greater than 10%
Exclusion Criteria:
* Pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin D substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet B radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02092701
|
{
"brief_title": "Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period",
"conditions": [
"Vitamin D",
"Burn Injury"
],
"interventions": [
"Drug: Cholecalciferol"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02092701",
"official_title": "Effects of a One Year Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10",
"study_completion_date(actual)": "2013-10",
"study_start_date(actual)": "2012-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": null,
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-03-20",
"last_updated_that_met_qc_criteria": "2014-03-18",
"last_verified": "2014-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-20",
"first_submitted": "2014-03-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to explore the diagnostic validity of \[18F\]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with invasive lobular breast cancer having clinically suspected or confirmed axillary lymph node metastasis.
Detailed Description
Invasive lobular carcinoma (ILC) is known to account for about 10-15% of all invasive breast cancer and is the second most common subtype of breast cancer following invasive ductal carcinoma (IDC). ILC is histologically characterized by the loss of E-cadherin involved in cell adhesion, which contributes to the growth and infiltration of tumors in the characteristic non-adhesive single cell layer pattern of ILC\]. Therefore, ILC often has no tumors detected by physical examinations and the sensitivity of mammography being reported to be 34%, which is much lower than IDC (81%). Therefore, the diagnosis of ILC is often delayed, the tumor size is larger and the stage is higher than that of IDC at the first visit. The diagnostic accuracy of breast ultrasound for axillary lymph node metastasis is reported as 55-92% for sensitivity and 80-97% for specificity. However, in the case of ILC, the diagnostic performance is significantly lower than this. According to the previous study on ILC, mammography had 7% of sensitivity, ultrasound had 26%, and MRI had 7% in diagnosing axillary lymph node metastasis with 38% of patients having false positive results for axillary lymph node metastasis. This is related to ILC-specific metastasis patterns in which only cells are replaced by cancer cells while maintaining the normal structure of the lymph node and the absence of desmoplastic reaction. The NCCN guideline recommends that during axillary lymph node resection, resection is performed up to level III if lymph node metastasis is confirmed or suspected in axillary level II or III. Preoperative chemotherapy should be considered for lymph node metastasis of cN3 or Bulky or matted cN2 stage. Considering the limited diagnostic accuracy of those standard imaging tests for diagnosis of axillary lymph node metastasis, \[18F\]FES PET/CT may help change treatment strategy, such as changing the extent of axillary lymph node resection or performing neoadjuvant chemotherapy instead of upfront surgery in patients with ILC. In addition, considering that high rate of distant metastasis and limited diagnostic accuracy of preexisting imaging modality in ILC, \[18F\]FES PET/CT is likely to help treatment decision making by discovering unexpected distant metastases. It is reported that the implementation of \[18F\]FES PET/CT contributed to the change in treatment policy in about 26% of patients compared to conventional standard imaging and \[18F\]FDG PET/CT. Currently in South Korea, reimbursement of \[18F\]FES PET/CT is limited to patients with recurrent or metastatic breast cancer whose lesions are located in the cervical spine, upper thoracic, pelvic, peritoneum, pleural, and mediastinal lymph nodes.
#Intervention
- DRUG : [18F]fluoroestradiol (FES)
- F-18 FES 111\~222 MBq(megabecquerel) injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged >= 19 years regardless of race/ethnicity.
* Subjects with histologically confirmed estrogen receptor-positive invasive lobular breast cancer within 90 days prior to [18F]FES PET/CT imaging
* Subjects whose primary tumor of cT1 <= age <= 3 according to the American Joint Committee on Cancer (AJCC) 8th tumor staging system
* Subjects with suspected or confirmed axillary lymph node metastasis clinically or in imaging test (ultrasound)
* Subjects who scheduled to undergo sentinel node biopsy or axillay lymph node dissection within 90 days of [18F]FES PET/CT imaging
* Subjects whose Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 points or less
Exclusion Criteria:
* Subject or the subject's legally acceptable representative does not provide written informed consent form
* Subjects with confirmed or suspected large, bulky, matted cN2 or cN3 axillary lymph node metastases, or distant metastases.
* Previous history of ipsilateral axillary lymph node dissection, sentinel lymph node surgery, or lymph node dissection biopsy.
* Patients who are scheduled for or have undergone chemotherapy, radiotherapy, antihormone therapy, targeted therapy, or immunotherapy between [18F]FES PET/CT and pathological diagnosis
* Subjects who are pregnant or lactating. Exclusion of the possibility of pregnancy is made by one of the following: 1) Physiologically menopausal (menstruation has stopped for more than 2 years), 2) Surgically infertility (with a history of bilateral oophorectomy or hysterectomy), 3) In the case of subjects with a possibility of pregnancy, negative serum or urine pregnancy test before administration of [18F]FES has to be negative within 24 hours, and the subjects are instructed to use contraception during her participation in this study.
* Subject has concurrent severe and/or uncontrolled and/or unstable medical condition other than cancer (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic kidney disease or chronic liver disease).
* Subject is a relative or student of the investigator or otherwise in a dependent relationship
* Subject has already participated in this study
* Subject not being able to provide intact data for this study due to personal circumstances or other reasons in the judgment of the investigator
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
|
NCT05960201
|
{
"brief_title": "Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma",
"conditions": [
"Carcinoma, Lobular"
],
"interventions": [
"Drug: [18F]fluoroestradiol (FES)"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT05960201",
"official_title": "A Phase 2, Open-label, Non-randomized, Single-center Study to Explore the Diagnostic Performance of [18F]FES PET/CT for the Assessment of Axillary Lymph Node Metastasis in Invasive Lobular Carcinoma of the Breast",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-20",
"study_completion_date(actual)": "2024-08-20",
"study_start_date(actual)": "2023-08-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-21",
"last_updated_that_met_qc_criteria": "2023-07-18",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-07-25",
"first_submitted": "2023-07-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
Detailed Description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.
#Intervention
- DEVICE : YVOIRE volume plus
- Hyaluronic acid dermal filler
- DEVICE : Restylane Lyft with Lidocaine
- Hyaluronic acid dermal filler
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female aged between 21 <= age <= 75 (inclusive)
* 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
* Desire cheek augmentation to correct volume deficit in the midface.
* Agree to use contraception
* Sign Informed Consent Form
Exclusion Criteria:
* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
* have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
* have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
* have history of bleeding disorder
* have a tendency to develop hypertrophic scarring or keloid
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04784299
|
{
"brief_title": "To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume",
"conditions": [
"Midface Volume Deficit"
],
"interventions": [
"Device: Restylane Lyft with Lidocaine",
"Device: YVOIRE volume plus"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04784299",
"official_title": "A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-11",
"study_completion_date(actual)": "2022-10-26",
"study_start_date(actual)": "2021-03-22"
},
"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)": "2024-12-19",
"last_updated_that_met_qc_criteria": "2021-03-03",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-05",
"first_submitted": "2021-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose is to compare the treatment frequency of preterm infants who developed severe ROP during the years 2015-2018 with 2020-2021 in the country, using the statistical method 'difference in differences' to investigate the potential for scientific evidence regarding the introduction of dexamethasone eye drops' effect on the development of severe treatment-requiring ROP. During these years, we assess that the recommended oxygen saturation levels for preterm infants have remained stable at each clinic, which will serve as its own reference.
Detailed Description
Retinopathy of Prematurity (ROP) can develop in premature infants and involves abnormal growth of blood vessels in the retina. It can lead to severe visual impairment or blindness if not treated in time. In Sweden, approximately 40-50 children require treatment for severe ROP each year. Children at the highest risk are screened to detect ROP at an early stage, and, if necessary, laser treatment of the retina is performed or an injection of an anti-vascular endothelial growth factor (anti-VEGF) agent is administered. However, laser treatment burns away the outermost part of the retina, and anti-VEGF carries a significant risk of recurring treatment needs, resulting in increased anesthesia and examination sessions for the child, risk of eye infection, lens damage, and uncertainty about the drug's broader effects on the child's brain or body (1-2).
Dexamethasone is a corticosteroid commonly used in eye drop form to treat inflammatory and angiogenic eye diseases. Dexamethasone is also administered systemically in neonatal care to treat lung disease and wean premature infants off ventilator support, often in relatively high doses early in the infant's life (3).
Increased inflammation in the eyes has been reported in ROP (4). According to both national and several international guidelines, dexamethasone eye drops are administered in tapering doses after laser treatment for severe ROP (1, 5). When a child begins developing severe ROP, it is classified as Type-1 ROP and Type-2 ROP. Type-1 ROP requires treatment within 72 hours, while Type-2 ROP is considered a precursor to Type-1 ROP.
In the Southern Healthcare Region of Sweden, we have initiated earlier use of dexamethasone eye drops, specifically when it appears that the child is transitioning from Type-2 ROP to Type-1 ROP. In a pilot study published in September 2021 (6), we observed that only 24% of children who received dexamethasone eye drops at Type-2 ROP progressed to Type-1 ROP, compared to 74% of children who did not receive dexamethasone eye drops for the same type of ROP.
Initially in 2019, children received the same dose recommended after laser treatment according to national guidelines. However, during 2020 and 2021, the dose was reduced to just one drop every other day or daily. As a result, only two children in 2020 and one child in 2021 required anesthesia-based treatment among those who received dexamethasone eye drops for Type-2 ROP.
In Sweden, there is a national quality registry for ROP care, SWEDROP, with approximately 98% coverage. We now aim to conduct a study based on this quality registry and compare the results from the Southern Healthcare Region with other regions in Sweden that have not used dexamethasone for Type-2 ROP. The goal is to determine whether the 'difference-in-differences' method can provide stronger scientific evidence supporting this treatment approach. The plan is to compare the number of children who progressed to laser treatment in the years before the introduction of dexamethasone for Type-2 ROP with data from 2020-2021, when all children in the Southern Healthcare Region, except for two cases at one clinic, received dexamethasone for Type-2 ROP. Specifically, we will compare the years 2015-2018 with 2020-2021. The year 2019 served as a transitional period at SUS, where only a few children were treated with varying doses, and therefore it will not be included in the primary comparison. However, trends across all regions, including 2019, will also be presented.
References:
New modifications of Swedish ROP guidelines based on 10-year data from the SWEDROP register. Holmstrom G, Hellstrom A, Granse L, Saric M, Sunnqvist B, Wallin A, Tornqvist K, Larsson E. Br J Ophthalmol. 2020 Jul;104(7):943-949
International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68
Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (\< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017.
Rivera JC, Holm M, Austeng D, et al. Retinopathy of prematurity: inflammation, choroidal degeneration, and novel promising therapeutic strategies. J Neuroinflammation. Aug 2017;14:165.
Health Rcopa. UK retinopathy of prematurity guideline. 2008
Dexamethasone Eye Drops for the Treatment of Retinopathy of Prematurity. Öhnell HM, Andreasson S, Gränse L. Ophthalmol Retina. 2022 Feb;6:181-182.
#Intervention
- DRUG : Dexamethasone eyedrop
- Infants who developed stages of pretreatment-requiring severe ROP were usually given one eyedrop of dexamethasone daily until the ROP changes regressed.
|
#Eligibility Criteria:
Inclusion Criteria:
* All children born before week 30 in the Southern Healthcare Region and 3 regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP
Exclusion Criteria:
If a child has not completed the screening examinations for ROP-
Sex :
ALL
Ages :
- Minimum Age : 31 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06775353
|
{
"brief_title": "To Assess the Effect of Dexamethasone Eye Drops on the Retinopathy of Prematurity (ROP) Outcome.",
"conditions": [
"Retinopathy of Prematurity (ROP)"
],
"interventions": [
"Drug: Dexamethasone eyedrop"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT06775353",
"official_title": "The Effect of Dexamethasone Eye Drops on Retinopathy of Prematurity, a Swedish Registry-based Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-31",
"study_completion_date(actual)": "2025-01-01",
"study_start_date(actual)": "2022-12-01"
},
"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)": "2025-01-15",
"last_updated_that_met_qc_criteria": "2025-01-09",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-15",
"first_submitted": "2025-01-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Title:
The effect of dance-therapy on the functional capacity, body image and quality of life of patients with advanced obesity
Project duration:
33 months (August 2010 to June 2013)
Clinical context:
Obesity has reached epidemic proportions. The gait and balance problems in obese people and the associated decreased functional capacity and risk of falling highlight the need to evaluate the benefits of specific treatments on these problems. Attention should be paid not only to metabolic management but also to the physical rehabilitation required in cases of advanced obesity.
Objectives:
The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity (walking ability, postural control and physical activity level), body image and quality of life of patients with advanced obesity.
#Intervention
- OTHER : Dance Therapy
- overweight individuals participating in a patient education program for obese people combined with specific dance-therapy
- OTHER : patient education
- overweight individuals participating in a patient education program
|
#Eligibility Criteria:
Inclusion Criteria:
* Person with obesity (BMI >= 30)
* Aged > 18 years
* Being able to walk 10 meters without a walking aid
Exclusion Criteria:
* Foot ulcer at the moment of data acquisition
* Orthopaedic, surgical or neurological (other than diabetic neuropathy ) problems which af-fect patient's gait
* Non diabetic neuropathy (Charcot, chronic alcohol consumption, thyroid dysfunction)
* Mental diseases interfering with group therapies
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
|
NCT01451892
|
{
"brief_title": "Dance Therapy and Obesity",
"conditions": [
"Obesity"
],
"interventions": [
"Other: Dance Therapy",
"Other: patient education"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01451892",
"official_title": "The Effect of Dance Therapy on the Functional Capacity of Patients With Advanced Obesity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-02",
"study_start_date(actual)": "2010-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-16",
"last_updated_that_met_qc_criteria": "2011-10-11",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-14",
"first_submitted": "2011-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. The time on study treatment was 24 weeks.
Detailed Description
Complarate® (INN: tocilizumab) is being developed as a biosimilar to the drug Actemra®, a concentrate for the preparation of a solution for infusion.
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass of immunoglobulins. Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors.
This III phase study is aimed to compare the effectiveness, safety and immunogenicity of Complarate® and Actemra®. The study included patients aged 18-75 years at the time of signing the informed consent form with a documented diagnosis of rheumatoid artritis, established according to the 2010 ACR/EULAR classification criteria, at least 6 months before screening, with moderate or high degree of disease activity and insufficient response to methotrexate monotherapy (preservation of moderate/high disease activity for at least 3 months) and/or poor tolerability of methotrexate (including the subcutaneous form of the drug) and/or insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs (sDMARDs) with or without methotrexate inclusive, who meet all criteria for participation in the study. The study included a screening period and a treatment period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 2:1 to the study drug (Complarate®) and comparator drug (Actemra®). 465 patients (310 to the study drug group and 155 to the comparator drug group) were randomized.
#Intervention
- BIOLOGICAL : Complarate®
- The investigational drug Complarate® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks.
- Other Names :
- tocilizumab biosimilar, GNR-087
- BIOLOGICAL : Actemra®
- The reference drug Actemra® was administered as an intravenous infusion at a dose of 8 mg/kg once every 4 weeks for 24 weeks.
- Other Names :
- tocilizumab
|
#Eligibility Criteria:
Inclusion Criteria:
* Availability of written informed consent obtained from the patient before the start of any procedures related to the study.
* Men and women 18 <= age <= 75 years, inclusive, at the time of signing the informed consent form.
* Patients with a documented diagnosis of rheumatoid artritis (RA), established according to the 2010 ACR/EULAR classification criteria at least 6 months before screening, with moderate to high disease activity and an insufficient response to methotrexate monotherapy (maintaining moderate/high disease activity for at least 3 months) and/or poor tolerability of methotrexate (including the subcutaneous form of the drug) and/or insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs (sDMARDs) in combination with methotrexate or without methotrexate.
* The number of swollen and/or painful joints is 6 or more.
* No changes in the dosage regimen of standard RA therapy with oral glucocorticosteroids and NSAIDs for >= 4 weeks before screening.
* No changes in the dosing regimen of standard RA sDMARD therapy for >= 4 weeks before screening.
* Agreement to adhere to adequate methods of contraception throughout the study and for 3 months after the end of tocilizumab therapy.
Exclusion Criteria:
* A history of rheumatic autoimmune disease other than rheumatoid arthritis.
* Functional Class IV according to the ACR Functional Status Classification or wheelchair/bedridden.
* Development of pronounced extra-articular (systemic) manifestations of the disease and complications (rheumatoid vasculitis, amyloidosis, Felty's syndrome, neuropathy, damage to the organ of vision).
* Use of oral corticosteroids in doses greater than >10 mg daily prednisolone equivalent, or change in oral corticosteroid dose within 4 weeks before or during screening.
* Use of injectable corticosteroids (including intra-articular corticosteroids) or intra-articular hyaluronic acid injections within 4 weeks before or during screening.
* Therapy with tumor necrosis factor-alfa (TNF-alpha) inhibitors or any other genetically engineered biological drugs within 1 month before screening.
* History of tocilizumab therapy.
* Major surgery (including joint surgery) within 8 weeks before the start of the study or elective surgery within 6 months after the start of the study.
* A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
* Immunization with any live or live attenuated vaccine within 1 month before the first dose of the study or comparator drug.
* A history of a disease associated with the accumulation of immune complexes (including serum sickness).
* Concomitant diseases and conditions that, in the opinion of the Investigator and/or Sponsor, jeopardize the safety of the patient during participation in the study, or which will influence the analysis of safety data.
* Active systemic infection (bacterial, viral or fungal) within 14 days before signing the informed consent form or at the time of screening.
* Blood donation or blood loss (450 ml of blood or more) less than 2 months before the start of the study.
* Pregnancy or breastfeeding.
* History of demyelinating disease of the central nervous system.
* History of diverticulosis/intestinal diverticulitis or chronic ulcerative diseases of the lower gastrointestinal tract, such as Crohn's disease, ulcerative colitis.
* History of tuberculosis.
* Positive/doubtful test with tuberculosis allergen.
* Participation in clinical trials of drugs less than 3 months before signing the informed consent form.
* Positive tests for hepatitis B or C, HIV or syphilis.
* Unwillingness or inability to comply with the recommendations prescribed by this protocol.
* Identification during screening of other diseases/conditions not listed above that, in the opinion of the physician-researcher, prevent the inclusion of the patient in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06475508
|
{
"brief_title": "Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": [
"Biological: Complarate®",
"Biological: Actemra®"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT06475508",
"official_title": "Double-blind Multicenter Randomized Study of the Effectiveness and Safety of Tocilizumab Biosimilar (Complarate®) and Actemra® in Parallel Groups in Patients With Rheumatoid Arthritis With Repeated Intravenous Administration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-05",
"study_completion_date(actual)": "2024-06-11",
"study_start_date(actual)": "2023-02-13"
},
"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)": "2024-07-03",
"last_updated_that_met_qc_criteria": "2024-06-20",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-26",
"first_submitted": "2024-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of the trial is to assess the effect of radiation treatment on liver function as determined by indocyanine green extraction. The long term goal is to determine if individual assessment of liver function using the IC-Green method, either alone or in combination with other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are superior to the probabilistic method currently in use.
Detailed Description
Following intravenous injection, IC-GREEN is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). IC-GREEN is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. It undergoes no significant extrahepatic or enterohepatic circulation. Simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Therefore, the serum clearance rate (determined from serial serum concentration measurements at various times after intravenous injection) can serve as a useful index of liver function.
#Intervention
- RADIATION : Hepatic Irradiation
- Patients who take part in this study are required to be scheduled for hepatic irradiation. For the purposes of this research, they will undergo IC-GREEN testing within 2 weeks prior to the start of radiation therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years, all gender, ethnicities and races
* Life expectancy of at least 12 weeks
* Zubrod performance status <= 2
* Baseline clinical assessments of liver function by complete history and physical examination
* Laboratory tests to be done within 6 weeks prior to start of radiation: CBC and platelets, liver function tests including SGOT, SGPT, Alkaline Phosphatase, and bilirubin, albumin, BUN, creatinine, PT/PTT, INR
Exclusion Criteria:
* Pregnant
* History of allergy or are sensitive to IC-Green, iodine or to radiographic media
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
|
NCT01519219
|
{
"brief_title": "Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation",
"conditions": [
"Hepatic Irradiation"
],
"interventions": [
"Radiation: Hepatic Irradiation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01519219",
"official_title": "Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-04",
"study_completion_date(actual)": "2020-02-19",
"study_start_date(actual)": "2004-11-24"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-20",
"last_updated_that_met_qc_criteria": "2012-01-25",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-01-26",
"first_submitted": "2011-09-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: Gastric bypass is the most commonly performed type of bariatric (obesity) surgery, has dramatically increased in popularity and is now considered to be preferred treatments in severely obese patients that fail non-surgical therapy - particularly in patients with type 2 diabetes. Drug malabsorption is a potential concern post-gastric bypass because intestinal length is reduced.
Purpose: The purpose of this controlled, pharmacokinetic study is to determine whether the absorption of a single dose of metformin, the first line drug treatment in patients with type 2 diabetes, is significantly reduced after gastric bypass.
Methods: A single dose of standard release metformin 1000 mg will be administered to patients who have undergone gastric bypass and to patients who have not received surgery but are on the wait list (wait-listed controls). Blood sampling and urine sampling will occur in standardized fashion over the ensuing 24 hours to measure and compare the absorption of metformin between study arms. 34 patients total will be recruited.
Significance: Following completion of this study, we will better understand how gastric bypass affects metformin absorption. Ultimately, this information will help to ensure that this patient population is receiving optimal doses of this important drug treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients living within and around Edmonton that have been referred to the Alberta Health Services Weight Wise Program
Exclusion Criteria:
* Undergone or undergoing revision of a previous bariatric procedure
* Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting
* Currently on metformin therapy
* Any contraindications to metformin therapy such as:
1. allergy to the drug
2. chronic metabolic acidosis
3. history of lactic acidosis
4. liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal
5. congestive heart failure
6. renal failure (glomerular filtration rate < 60 ml/min)
7. alcoholism
8. acute illness
9. fatty liver disease
* Pregnant or nursing
* Not taking furosemide or nifedipine (both drugs may increase metformin absorption by 15 <= age <= 20%)the day of visit 2.
* Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol
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
|
NCT01013051
|
{
"brief_title": "Effect of Gastric Bypass on the Absorption of Metformin",
"conditions": [
"Obesity",
"Gastric Bypass"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT01013051",
"official_title": "Effect of Gastric Bypass on the Absorption of Metformin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2009-09"
},
"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)": "2011-03-03",
"last_updated_that_met_qc_criteria": "2009-11-12",
"last_verified": "2011-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-13",
"first_submitted": "2009-11-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.
#Intervention
- PROCEDURE : ultrasound guided caudal epidural block
- dynamic ultrasound imaging of the spread of local anesthetics
|
#Eligibility Criteria:
Inclusion Criteria:
* age: 6 <= age <= 24months
* ASA 1 <= age <= 3
* body weight: 5 <= age <= 20kg
Exclusion Criteria:
* patients who refuse to participate
* local site infection, pilonidal cyst, spina bifida
* spinal/meningeal abnormality
* patients who discharge after surgery without admission
* patients who is judged ineligible for other reasons by the authors
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 24 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04039295
|
{
"brief_title": "Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children",
"conditions": [
"Caudal Epidural Block"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04039295",
"official_title": "Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-13",
"study_completion_date(actual)": "2020-03-14",
"study_start_date(actual)": "2019-07-24"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-16",
"last_updated_that_met_qc_criteria": "2019-07-29",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-31",
"first_submitted": "2019-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis
Detailed Description
Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ.
Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®).
Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as 'gold standard' ) and the one made by a junior physician using the app
#Intervention
- OTHER : AOM diagnosis with app
- the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone
- OTHER : AOM diagnosis without app
- the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope
|
#Eligibility Criteria:
Inclusion Criteria:
Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained
Exclusion Criteria:
A sign (s) of vital distress Trans-tympanic drains
*
Sex :
ALL
Ages :
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04752891
|
{
"brief_title": "Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department",
"conditions": [
"Otitis Media, Suppurative"
],
"interventions": [
"Other: AOM diagnosis with app",
"Other: AOM diagnosis without app"
],
"location_countries": [
"France"
],
"nct_id": "NCT04752891",
"official_title": "Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-16",
"study_completion_date(actual)": "2023-03-16",
"study_start_date(actual)": "2021-06-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-17",
"last_updated_that_met_qc_criteria": "2021-02-11",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-12",
"first_submitted": "2021-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.
Detailed Description
This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages.
Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel.
Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.
#Intervention
- BIOLOGICAL : IMP321 (eftilagimod alpha)
- In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
- DRUG : Placebo
- In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
- DRUG : Paclitaxel
- Paclitaxel will be given in both treatment arms (classified as Non IMP)
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to give written informed consent and to comply with the protocol
* Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
* Female of age 18 years or above
* Patients who are indicated to received first line chemotherapy with weekly paclitaxel
* Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1
6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.
Exclusion Criteria:
* Prior chemotherapy for metastatic breast adenocarcinoma
* Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
* Inflammatory carcinoma
* Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
* Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
* Symptomatic known cerebral and/or leptomeningeal metastases
* Serious intercurrent infection
* Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
* Active acute or chronic infection
* Active autoimmune disease requiring immunosuppressive therapy
* Previous malignancies within the last three years other than breast carcinoma
* Patients with prior organ or stem cell transplantation
* Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
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
|
NCT02614833
|
{
"brief_title": "IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma",
"conditions": [
"Adenocarcinoma Breast Stage IV"
],
"interventions": [
"Biological: IMP321 (eftilagimod alpha)",
"Drug: Placebo",
"Drug: Paclitaxel"
],
"location_countries": [
"France",
"Netherlands",
"Poland",
"Germany",
"Hungary",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT02614833",
"official_title": "AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03",
"study_completion_date(actual)": "2021-05",
"study_start_date(actual)": "2015-12"
},
"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)": "2021-10-05",
"last_updated_that_met_qc_criteria": "2015-11-22",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-25",
"first_submitted": "2015-11-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.
#Intervention
- DRUG : Placebo
- single i.v. administration
- DRUG : NI-0801
- single i.v. administration
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged >= 18 and <= 70 years
* Either male or a female lacking childbearing potential
* Previously documented nickel allergy
Exclusion Criteria:
* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
* Known or previous diagnosis of malignancy
* Known current active tuberculosis or a history of active TB within 12 months of screening
* Known infection with HIV, Hepatitis B or C
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
|
NCT01244607
|
{
"brief_title": "NI-0801 in Allergic Contact Dermatitis",
"conditions": [
"Allergic Contact Dermatitis"
],
"interventions": [
"Drug: Placebo",
"Drug: NI-0801"
],
"location_countries": null,
"nct_id": "NCT01244607",
"official_title": "A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis",
"recruitment_information": null,
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": null,
"masking": null,
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-11-19",
"last_updated_that_met_qc_criteria": "2010-11-18",
"last_verified": "2010-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-19",
"first_submitted": "2010-11-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a 'soluble dietary fiber.' Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.
The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.
#Intervention
- DIETARY_SUPPLEMENT : NUTRIOSE FB06
- 14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day
- DIETARY_SUPPLEMENT : GLUCIIDEX 21
- 7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy people
* aged between 20 and 50 years
* BMI between 27 and 29 kg/m2
* without metabolic syndrome
* no pregnant nor nursing women
* covered by Social Security
* negative serology for hepatitis B/C and HIV
* who signed the informed consent form
Exclusion Criteria:
* persons abusing drugs (laxatives, anti-diarrheal, agents acting on satiety)
* person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
* person intolerant to gluten and / or allergic to wheat flour
* person in diet during the last 3 months
* person in vegetarian or vegan diet
* person who donated blood during the 3 months preceding the study
* Inclusion in another clinical study
* subjects receiving over 4,500 Euros in the last 12 months (including the present study)
* subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01897662
|
{
"brief_title": "Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects",
"conditions": [
"Overweight"
],
"interventions": [
"Dietary Supplement: NUTRIOSE FB06",
"Dietary Supplement: GLUCIIDEX 21"
],
"location_countries": [
"France"
],
"nct_id": "NCT01897662",
"official_title": "Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2012-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-07-12",
"last_updated_that_met_qc_criteria": "2013-07-11",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-12",
"first_submitted": "2013-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.
Detailed Description
The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.
#Intervention
- DEVICE : QuickVue Influenza A+B
- Rapid diagnostic test with IVD, QuickVue Influenza A+B
|
#Eligibility Criteria:
Inclusion Criteria:
Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:
* Male or Female of all ages (with appropriate consent).
* The subject must have had of a fever, >= 37.8º C (100º F), within the last two days.
* Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).
1. Nasal congestion
2. Rhinorrhea
3. Sore throat
4. Cough
5. Headache
6. Myalgia
7. Malaise
Exclusion Criteria:
* 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03417869
|
{
"brief_title": "QuickVue Influenza A + B Test Field Study",
"conditions": [
"Influenza A, Influenza B"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03417869",
"official_title": "QuickVue Influenza A + B Test Field Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-01",
"study_completion_date(actual)": "2018-02-01",
"study_start_date(actual)": "2017-02-16"
},
"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)": "2018-03-20",
"last_updated_that_met_qc_criteria": "2018-01-24",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-01-31",
"first_submitted": "2018-01-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Renal cell carcinoma (RCC) is the most frequently occurring primary renal neoplasm. There are several histological variants of RCC that are associated with variable prognostic outcomes. Epithelial-mesenchymal transition (EMT) is a phenomenon in which the epithelial cells acquire some mesenchymal criteria as enhanced invasive potential. There are several cell surface molecules that are implicated in EMT. Moesin is one of these molecules that is involved in EMT, which is associated with enhanced invasive potential and poor prognosis. Targeting Moesin by novel therapeutic agents may prevent EMT and improve prognosis of patients with RCC.
#Intervention
- GENETIC : Immunohistochemical detection of Moesin in Clear cell Renal Cell Carcinoma
- Formalin-fixed paraffin-embedded renal cell carcinoma tissue blocks will be sectioned and immunohistochemically stained by anti moesin antibody.
|
#Eligibility Criteria:
Inclusion Criteria:
* All cases of ccRCC.
* Tissue blocks with material adequate for immunohistochemical evaluation.
* All cases with accessible clinical data.
Exclusion Criteria:
* Cases of renal neoplasms other than ccRCC.
* Patients who received preoperative chemotherapy or radiotherapy.
* Patients with ccRCC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
* Cases with insufficient/destructed material.
* Patients with inadequate clinical data.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06055660
|
{
"brief_title": "Moesin Expression in Clear Cell Renal Cell Carcinoma",
"conditions": [
"Renal Cell Carcinoma"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT06055660",
"official_title": "Expression and Distribution of Membrane-Organizing Extension Spike Protein (Moesin/ MSN) is Associated With Epithelial-Mesenchymal Transition in Clear Cell Renal Cell Carcinoma.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2017-01-01"
},
"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)": "2023-09-28",
"last_updated_that_met_qc_criteria": "2023-09-20",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-28",
"first_submitted": "2023-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to learn more about using a home machine 'Telemonitor' to find problems people with lung cancer may have after being discharged from the hospital and help them manage problems by contacting their healthcare provider.The study hypothesis is that patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses on telemonitor data risks/implications for the first two weeks after hospital discharge, will be able to self-report their signs/ symptoms to the clinician resulting in decreased use of costly health care resources over 60 days.
Detailed Description
All patients in the study will receive usual care after hospital discharge. This study also involves an interview and review of your medical records, and uses the 'telemonitor' machine to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask you to press YES or NO buttons in response to questions on your symptoms such as difficulty breathing. Research nurses will come to your home 3 times and it will take about 30 minutes for each visit for the nurse to record the information using the telemonitor. You will also be asked to fill out a survey about your ability to do activities and your health status. This will take approximately another 30 minutes. You may or may not receive the small telemonitor (about as big as a large book) for 14 days after discharge to provide additional information to the researchers. If you receive the monitor for the full 14 days, you or someone you ask us to train will be taught to use the monitor every morning to collect information on how you will 'talk' to you to tell you to put a blood pressure cuff on your arm and an oxygen measurer on your finger. You will step on a scale to take your weight and you will use a forehead sensor to take your temperature. The blood pressure, weight, temperature, your pulse, and your oxygen level will be recorded by the monitor. It will then ask you at least 10 questions and you will push a yes or no button indicating how much difficulty you are having with your daily activities and shortness of breath. The monitor will then connect to your telephone line using a no-charge '800' number and transmit the information to the researchers. If you do not have a phone, a special antenna will be connected to the monitor to transmit the information wirelessly. The nurse will call you every day for the 14 days when you have the monitor. If you do not receive the monitor for the full 14 days, you will still have the monitor used by the nurse when you are visited at least 3 times at home to gather information on how you are doing after hospital discharge. These home monitor visits will be within 2 days after discharge, 2 weeks after discharge, and 2 months after discharge. The main difference is that the monitor will not be left in your home but will be brought by the nurse on each visit. You will also receive a phone call to ask you questions about the study at 1 month after discharge. If you do not have a phone, you will receive another home visit. Whether or not you get the monitor for the full 14 days will be determined randomly by computer before the nurse visits you at home the first time. are doing. The monitor will turn on each day at the same time; the monitor
#Intervention
- DEVICE : HomMed Telemonitor
- A 'HomMed Telemonitor' wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.
- Other Names :
- Honeywell HomMed Genesis™ DM Remote Patient Care Monitor, http://hommed.com/Products/Genesis_DM.asp
|
#Eligibility Criteria:
Inclusion Criteria:
(1) patients admitted to the hospital for lung CA as a primary or secondary diagnosis; (2) at least 45 years and up to 90 years; (3) stable mental status and ability to speak (but not necessarily read) the primary language of the region (English).
Exclusion Criteria:
* are not discharged to home settings
* are discharged to hospice
* display a verbalized inability to understand or answer the questionnaires, (4) are disqualified at the discretion of the treating physician, and/or (4) live beyond a 75 mile radius of the hospital.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01670539
|
{
"brief_title": "Home Telemonitoring for Patients With Lung Cancer",
"conditions": [
"Lung Cancer"
],
"interventions": [
"Device: HomMed Telemonitor"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01670539",
"official_title": "PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2011-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-18",
"last_updated_that_met_qc_criteria": "2012-08-21",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-22",
"first_submitted": "2012-08-09",
"first_submitted_that_met_qc_criteria": "2021-12-20"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders.
The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors.
This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).
Detailed Description
Over the past decade there have been increasing calls for the scale-up of evidence-based interventions in order to reduce the risk of violence against children in low- and middle-income countries (LMICs) (Mikton et al., 2014). In particular, parenting programs for families with young children have been shown to be effective in reducing the risk of child maltreatment and improving child wellbeing with promising evidence emerging from low- and middle-income countries (Barlow et al., 2006; Knerr et al., 2013, Chen \& Chan, 2015). These group-based programs typically aim to strengthen caregiver-child relationships through positive parenting and help parents to manage child behavior problems through effective, age-appropriate, nonviolent discipline strategies.
Despite the emerging evidence of the effectiveness of parenting interventions in reducing violence against children, many local governments and service providers in LMICs face multiple challenges implementing evidence-based parenting programs in resource poor contexts (Mikton, 2012). Parenting programs are often too expensive to deliver effectively at scale in low-resource settings due to their complexity, intensity, and length (Knerr et al., 2013). Parenting programs developed and evaluated in other contexts also may not fit the local service delivery context and may require adaptation to be relevant to the local culture of families. Additional program content may also be necessary to address acute economic deprivation, high community violence, and parental distress. The process of delivery may also need to be simplified to improve participant engagement and the quality of delivery.
As a result, it is essential that programs implemented in LMICs are
1. effective at reducing violence against children,
2. integrated within the existing service delivery system,
3. feasible and culturally acceptable to service providers and families, and
4. scalable in terms of their affordability, replicability, and sustainability while reaching a maximum number of beneficiaries.
However, there are currently very few parenting programs that meet these criteria in LMICs (such as Romania, FYR of Macedonia and Republic of Moldova), where the need is the greatest.
The present study utilizes the Multiphase Optimization Strategy (MOST) as a framework for increasing the reach and enhancing the implementation of a parenting intervention for families with 2-9 years old children (Parenting for Lifelong Health for Young Children, PLH 2-9) in three southeastern European countries with restricted resources. The MOST framework is implemented over 3 distinct phases: 1) Preparation and Adaptation, 2) Optimization, and 3) Evaluation.
The Preparation and Adaptation Phase lays the foundation for program optimisation. This may include formative research, cultural/contextual adaptation, and feasibility piloting in preparation for further testing. A key objective of the Preparation Phase is to confirm the conceptual model of RISE that informs the selection of program components to optimize. Feasibility studies are considered important steps in preparation for larger experimental studies. They allow for the assessment of intervention feasibility by examining program dosage, implementation fidelity, and participant satisfaction. Although often limited in their ability to detect significant effects due to small sample sizes, feasibility studies are also opportunities to conduct exploratory analyses of intervention effects. This is particularly important when probing for potential harmful effects prior to testing in a larger population.
The RISE Study therefore includes developing three locally adapted variants of a promising parenting program which will be focused on the needs of families from LMICs with children ages 2 to 9 years who show elevated levels of externalizing problem behavior.
This feasibility study can be located in the Preparation and Adaptation phase of MOST. It is a small-scale feasibility pilot to test the feasibility of the 12-session PLH 2-9 and the evaluation and implementation methods (including preliminary outcomes of program effects). It is planned to create a locally-developed, evidence-based parenting intervention for 40 families per country. The following activities are linked to this study:
* Interviews with officials, experts and practitioners: interviews with 12-20 officials, experts and practitioners in order to gather information relating to their perceptions of the design and adaptation of a parenting intervention in;
* Gathering input from Parenting Experts Working Group in each country: meetings with a 6-member Parenting Experts Working Group, in order to incorporate these findings and their own expert opinions into the adaptation of PLH 2-9 content, process, and structure;
* Pre-Post Feasibility Study: a small-scale, pre-post evaluation to test the feasibility of the program with 40 families with children aged 2-9 years with elevated levels of child behavior problems (assessed with the Eyberg Child Behaviour Inventory, ECBI, a parent report of child externalizing problem behaviors) in each country site to examine outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors. Moreover, the feasibility of the assessment procedures and the measures (not yet available in these regions/languages) will be tested. This means that based on the psychometric results of the feasibility study, measures may or may not be suitable for evaluation all of the listed outcomes.
* Preparation of the training materials adapted in Romanian, Moldovian, Albanian, Macedonian, and Russian, taking into account adaptation needs identified in the first three activities;
* Training of facilitators and mentor coaches in the delivery of the PLH 2-9 program in each country.
Based on the feasibility study (Adaptation and Preparation phase), the other two phases of the MOST framework will be tested in future research (studies will be registered separately):
* Phase 2: Optimization study using a factorial design testing 4 components of the parenting intervention
* Phase 3: The evaluation phase will involve testing of the optimized design (identified in phase 2) in a multisite randomised controlled trial.
A secondary objective of this project is to carefully assess barriers to implementation, integration with existing service delivery systems, and scale-ups from the outset to facilitate sustainability and real world applicability at the end of the project. When introducing such an innovative intervention in resource-limited settings, it is important to focus on the implementation processes that increase reach, efficacy, adoption, and sustainability of culturally-adapted and optimized versions of the program in addition to evaluating program effectiveness. The theoretical model for the implementation framework in the RISE project is RE-AIM (Reach, Efficacy, Adoption, Implementation, Maintenance, Glasgow et al., 2011). As a result, investigators will examine the adoption (defined as the proportion of settings willing to initiate the intervention), reach (the proportion of eligible individuals that participate in the intervention) and implementation (the fidelity, adherence, dosage assessed with multiple measures) as well as on effectiveness and sustainability of the RISE project at the organizational and participants' level. In addition, it will be examined how implementation factors influence program effectiveness, and how potential population characteristics might affect outcomes (e.g., moderators such as child age, gender, ethnicity, poverty, level of child behaviour problems, and other adversities).
#Intervention
- BEHAVIORAL : Parenting for Lifelong Health for Young Children
- In this study, the 12 sessions-PLH version for parents of young children (2-9 years) will be delivered. The PLH (2 - 9) programme is delivered in groups of parents and includes the following general content 1) One-on-one time, 2) Say what you see, 3) Talking about feelings, 4) Praising and rewarding our children, 5) Giving positive, specific, and realistic instructions, 6) Establishing household rules and routines, 7) Redirecting negative behavior, 8) Ignoring negative attention seeking and demanding behavior, 9) Using consequences to support compliance, 10) Using Cool-down as a consequence for aggressive behavior, 11) Avoiding and resolving conflicts, 12) Reflection celebration, and moving on.
- Other Names :
- PLH Programme
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#Eligibility Criteria:
Inclusion Criteria:
* for caregivers/parents:
1. age >= 18 years;
2. primary caregiver responsible for the care of a child between the ages of two and nine;
3. Report elevated levels of child behavior problems for the child he/she chooses to be part of the study (based on the Eyberg Child Behavior Inventory);
4. Have lived in the same household as this child at least four nights a week in the previous month and will continue to do so;
5. agreement to participate in the PLH 2 <= age <= 9 program;
6. Provision of Informed consent to participate in the full stud
Exclusion Criteria:
* for caregivers/parents: any adult 1) exhibiting severe mental health problems or acute mental disabilities; 2) that has been referred to child protection services due to child abuse.
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
|
NCT03552250
|
{
"brief_title": "Prevention of Child Mental Health Problems in Southeastern Europe",
"conditions": [
"Child Mental Disorder"
],
"interventions": [
"Behavioral: Parenting for Lifelong Health for Young Children"
],
"location_countries": [
"Macedonia, The Former Yugoslav Republic of",
"Moldova, Republic of",
"Romania"
],
"nct_id": "NCT03552250",
"official_title": "Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-19",
"study_completion_date(actual)": "2018-12-02",
"study_start_date(actual)": "2018-04-26"
},
"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)": "2018-12-04",
"last_updated_that_met_qc_criteria": "2018-06-08",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-11",
"first_submitted": "2018-05-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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