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#Study Description
Brief Summary
Fracture-dislocation of the carpometacarpal (CMC) joints of the ring and little finger are the most affected CMC joints and the dislocation may be accompanied by other hand injuries. Fracture-dislocation of the CMC joints of the ring and little finger are extremely mobile because of their saddle shape anatomy and loose ligamentous attachments. Missed and incorrect diagnosis is very frequent in metacarpal base injuries of the hand and results in impaired function and weak grip. In these lesions immediate reduction is imperative. Treatment options for these injuries include non-operative management, closed reduction with Kirschner wire fixation (K-wire) and open reduction with internal fixation (ORIF). In chronic CMC fracture-dislocations ORIF is mandatory. Although operative treatment is recommended in the literature in fracture-dislocation of the CMC joints of the ring and little finger, other authors, in specific cases, performed conservative treatment through immediate reduction and splint immobilization and this treatment can be sufficient.
Detailed Description
Physical examination in carpometacarpal injuries reveals ulnar-sided pain, swelling, diffuse edema, a palpable lump and tenderness of the hand.
Radiological examination include hand-wrist radiographs in the posteroanterior (PA), true lateral and 45º oblique views. A true lateral view of the hand may demonstrate the dislocation, although overlapping of the joints can mask the dislocation. On PA radiographs, Fisher et al. propose using the so-called M-line parallelism of the CMC joints. A break in this M-line suggests a dislocation. Another method is to draw metacarpal cascade lines on a PA radiographs.
It is important to recognise the associate lesions, for example hamate fractures, because this fracture can change the prognosis, surgical planning and treatment. The investigators hypothesized that there is an interobserver variability to evaluate the carpometacarpal fracture-dislocation and associated lesions in x-rays are underestimated. The investigators propose a protocol with a CT scan to asses this lesions. The researchers hypothesised that surgical reconstruction would result in better clinical result and lower complications rate than non-surgical treatment.
#Intervention
- PROCEDURE : Osteosynthesis
- Reduction and fixation of the carpometacarpal fracture dislocation of the hand with osteosynthesis (Kirschners wires, plate and screws)
- Other Names :
- Cast
|
#Eligibility Criteria:
Inclusion Criteria:
* Closed carpometacarpal fracture dislocation of the hand
* Adults from 18 <= age <= 80 old
Exclusion Criteria:
* history of fractures or tendon lesions in the same hand
* Children
* Open fracture dislocations
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
|
NCT04668794
|
{
"brief_title": "Carpometacarpal Fracture-dislocations",
"conditions": [
"Carpometacarpal; Dislocation"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT04668794",
"official_title": "Carpometacarpal Fracture-dislocation of the Hand: Interobserver and Intraobserver Variability for Identify Associate Hamate Fractures and Its Implications in Surgical Planning and Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-10",
"study_completion_date(actual)": "2022-11-14",
"study_start_date(actual)": "2020-11-02"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-08",
"last_updated_that_met_qc_criteria": "2020-12-14",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-16",
"first_submitted": "2020-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
Detailed Description
The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).
#Intervention
- DEVICE : CRT-D
- Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
* In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
* Moderate to severe heart failure (NYHA Class III-IV) with EF <= 35% and QRS duration >= 120 ms
* Left bundle branch block (LBBB) with QRS duration >= 130 ms, EF <= 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
* Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
* Subject is willing and capable of providing informed consent
* Subject is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion Criteria:
* Subjects with documented permanent complete AV block
* Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
* Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
* Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
* Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...)
* Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
* Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
* Women of childbearing potential who are or plan to become pregnant during the course of the trial
* Subjects currently requiring dialysis
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
|
NCT03089281
|
{
"brief_title": "Strategic Management to Optimize Response To Cardiac Resynchronization Therapy",
"conditions": [
"Heart Failure"
],
"interventions": [
"Device: CRT-D"
],
"location_countries": [
"France",
"Japan",
"Netherlands",
"United States",
"Germany",
"Canada",
"Spain",
"Ireland",
"Switzerland",
"Italy",
"United Kingdom"
],
"nct_id": "NCT03089281",
"official_title": "Strategic Management to Optimize Response To Cardiac Resynchronization Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-15",
"study_completion_date(actual)": "2020-09-15",
"study_start_date(actual)": "2017-08-01"
},
"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)": "2022-04-05",
"last_updated_that_met_qc_criteria": "2017-03-19",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-24",
"first_submitted": "2017-03-19",
"first_submitted_that_met_qc_criteria": "2022-04-01"
}
}
}
|
#Study Description
Brief Summary
Purpose of study is to assess perioperative functional parameters of the anterior abdominal wall muscles and postural control status in patients with large and giant incisional hernias in a controlled diagnostic study.
The study involved 95 patients (100% completed) with a large or giant incisional hernia of the anterior abdominal wall. The participants were divided into three groups by type of hernia repair: bridged hernia repair, Rives-Stoppa procedure, or TAR technique. Perioperative functional parameters of the anterior abdominal wall muscles were assessed by tension dynamometry. The postural balance assessments were made by raster photostereography.
#Intervention
- DIAGNOSTIC_TEST : Dynamometric tension assessment
- Tension dynamometry was carried out using the 'Back-Check 600' diagnostic complex by Dr.WOLFF® (GmbH, Germany). The dynamometric stress assessment included tasks for flexion and extension of the body. The functional assessment of the abdominal wall muscles was assessed when preparing the patient for surgery (1-10 days before AWR-abdominal wall reconstruction) and 6 months after AWR.
- Other Names :
- DT
- DIAGNOSTIC_TEST : Postural balance
- Postural balance was assessed using raster photostereography and baropodometry on the 'DIERS' diagnostic complex by Formetric-4D (GmbH, Germany). When analyzing the topography of the optical field, muscle imbalance is revealed in the form of lateral deviation and inclination of the trunk and pelvis, as well as the values of the angle of kyphosis and lordosis. When conducting baropodometry, the level of displacement of the pressure area on the feet of patients in a static and dynamic position was assessed. Diagnosis of postural balance in patients with incisional ventral hernia was performed a few days before surgical treatment and 6 months after AWR.
- Other Names :
- PB
- DIAGNOSTIC_TEST : Assessment of the hernia defect size
- Parameters of the hernial defect, including the volume of the hernial sac, the diameter of the hernial orifice, the ratio of hernia volume to the abdominal cavity volume, were performed using preoperative (1-10 days before AWR) multispiral computed tomography on a GE 'BrightSpeed 16' tomograph (General Electric©, USA)
- DIAGNOSTIC_TEST : Physical activity of patients
- To analyze the physical activity of patients, the measurement of the number of steps was used. The measurements of steps and the amount of distance traveled were carried out using a physical activity monitor - a fitness bracelet 'MiBAND' (China). Measurements were taken 10 days before AWR and within 6 months after AWR.
- Other Names :
- PAP
|
#Eligibility Criteria:
Inclusion Criteria:
* big and giant incisional hernia
* hernia without recurrence
* age 18 <= age <= 75
Exclusion Criteria:
* acute infection diseases
* cancer
* orthopedic diseases
* terminal status
* BMI>39,9
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
|
NCT05990647
|
{
"brief_title": "Impact Evaluation of Incisional Hernia on Muscular and Postural Function",
"conditions": [
"Incisional Hernia"
],
"interventions": [
"Diagnostic Test: Postural balance",
"Diagnostic Test: Dynamometric tension assessment",
"Diagnostic Test: Assessment of the hernia defect size",
"Diagnostic Test: Physical activity of patients"
],
"location_countries": [
"Uzbekistan"
],
"nct_id": "NCT05990647",
"official_title": "Incisional Hernia Impact on Muscular and Postural Function",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-31",
"study_completion_date(actual)": "2023-05-15",
"study_start_date(actual)": "2018-01-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-14",
"last_updated_that_met_qc_criteria": "2023-08-06",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-14",
"first_submitted": "2023-07-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at multiple sites. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2 placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined safety criteria in the preceding cohort. Each subject's participation will take place over approximately 150 days, not including the screening visit. There are no hypotheses for this phase I study. The primary objective will be to determine the safety of single ascending intravenous (IV) infusions of SAR440894 when administered in healthy adults.
Detailed Description
A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at multiple sites. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2 placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined safety criteria in the preceding cohort. Each subject's participation will take place over approximately 150 days, not including the screening visit. There are no hypotheses for this phase I study. The primary objective will be to determine the safety of single ascending intravenous (IV) infusions of SAR440894 when administered in healthy adults. The secondary objectives are: 1) to determine the pharmacokinetics (PK) of single ascending doses of 60-minute IV infusions SAR440894 in healthy adults and 2) to asses the immunogenicity of single ascending doses of 60-minute IV infusions SAR440894 in healthy adults.
#Intervention
- OTHER : Placebo
- One time 60-minute IV infusion of lyophilized placebo for SAR440894
- BIOLOGICAL : SAR440894
- One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be a healthy adult 18 <= age <= 45 of age, inclusive, with a body mass index (BMI) greater than 18 or less than 35 kg/m^2, inclusive.
* Participants of childbearing potential* having vaginal intercourse must use an effective method of contraception** from 45 days before study product administration through the final study visit.
*Not sterilized via hysterectomy or bilateral oophorectomy and/or salpingectomy or be less than 1 year from the last menses if menopausal.
**Includes any of the following (a) exclusive non-male sexual relationships; (b) monogamous relationship with vasectomized partner (greater than or equal to 180 days between procedure and subject receipt of investigational product); (c) bilateral tubal ligation or tubal occlusion (eg., Essure(R)); (d) effective intrauterine device (IUD); (e) hormonal implants (eg., Implanon(R)); (f) other hormonal contraceptives (such as birth control pills, vaginal rings, patches or injections); (g) barrier methods (condom, diaphragm, cervical cap) PLUS spermicide (gel or foam)
* Women of childbearing potential must agree not to donate ova or oocytes (ie, human eggs) during the study.
* Male subjects (including those with vasectomies) whose partners are of childbearing potential should use condoms with spermicide and not donate sperm for the duration of the study.
* Must have adequate venous access for IV infusions and blood draws.
* Agrees to be available for all study visits and willing to cooperate fully with the requirements* of the study protocol.
*Requirements include remaining in confinement for at least 72 hours after receiving study product and other activities outlined in the protocol's Schedule of Events.
* Is able to understand the informed consent process and procedures and signs the consent form.
* Will agree not to donate any blood or blood products* for the duration of the study.
* Includes whole blood, red blood cells, platelets, plasma, or plasma derivatives.
* Will agree to avoid travel to endemic areas (as defined by the Center for Disease Control (CDC)) for Chikungunya Virus (CHIKV) at any point during the Follow-up period (https://www.cdc.gov/chikungunya/geo/index.html).
Exclusion Criteria:
* Has any medical condition (renal dysfunction) that, in the opinion of the site PI or appropriate sub-investigator listed on Form Food and Drug Administration (FDA) 1572, is a contraindication to study participation.
* Has any clinically significant (CS) electrocardiogram (ECG) abnormalities in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator been listed on Form FDA 1572.
* Use of any prohibited prescription medication (excluding contraceptives in females) within 14 days before study product administration, through Day 56** *Prohibited medications include immunosuppressives; immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); prescription Non-Steroidal Anti-inflammatory Drugs (NSAIDs); anti-neoplastic agents; any vaccine (licensed or investigational). If study activities overlap with the influenza season, subjects will be instructed to obtain influenza vaccine at least 45 days prior to proposed dosing or delay vaccination until after Day 56. Subjects will be instructed to obtain the last dose of any vaccine for SARS-CoV-2 (COVID-19) at least 45 days prior to proposed dosing or delay vaccination until after Day 56.
* Use of nonprescription systemic drugs within 7 days before study product administration (includes vitamins, antacids*, over-the-counter drugs**, herbal/dietary supplements, etc.) through Day 28***
*Nonprescription drugs and supplements may be allowed before Day 28 at the discretion of the site PI.
**Includes proton pump inhibitors and H2-blockers (Histamine-2 blockers)
***Nonprescription drugs and supplements may be allowed before Day 28 at the discretion of the site PI. In the event an OTC oral contraceptive becomes available during the course of the study, it must be reviewed and approved by the site PI.
* Hypertension, with confirmed systolic blood pressure (BP) greater than 140 mm Hg or confirmed diastolic BP greater than 90 mm Hg, measured after 5 minutes of rest at Screening.
* Hypotension, with confirmed systolic BP less than 90 mm Hg.
* Resting heart rate (HR) less than 45 bpm or greater than 100 bpm at Screening.
* Body weight less than 50 kg.
* History of a significant illness, per the investigators' clinical judgment, within 2 weeks before dosing (subjects can screen after illness is resolved for 2 weeks).
* Known diagnosis of prolonged QT interval, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
* Males with a mean QTcF greater than 450 msec or females with a mean QTcF greater than 470 msec (Fridericia's correction) at Screening.*
*ECG tracings should be recorded at least 1 minute apart, after at least 5 minutes of rest in the supine position. If the mean QTcF value from the 3 tracings exceeds the limits stated, the subject is disqualified.
* Any history of malignancy ever, except low-grade skin cancer (ie, basal cell carcinoma thought to be cured).
* History of drug abuse, alcohol abuse, or significant psychiatric history according to the investigators' judgment within 12 months before Screening.
* Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody at Screening.
* Excessive consumption of beverages containing xanthine bases, or more than 400 mg of caffeine per day within 1 week of study product administration through the final study visit.
* Consumption of alcohol within 24 hours before study product administration.
* Use of nicotine-containing products within 45 days before study product administration through the final study visit.
* Positive drug screen*, positive cotinine screen, or positive breathalyzer test for alcohol at Screening or admission (Day -1).
*Cannabinoids, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and phencyclidine. Subjects should be notified by phone not to consume any poppy seeds within 24 hours before the Screening urine test to avoid a false positive opioid test result.
* If female, serum positive pregnancy test at Screening or serum positive pregnancy test on Day -1.
* Breastfeeding throughout the duration of the study
* Total WBC and platelet counts, hemoglobin*, total bilirubin*, alanine/aspartate aminotransferase* and sodium* are Grade 1 or higher** at Screening visit***.
*For sodium; potential subjects excluded prior to Protocol Version 6.0 with Grade 1 sodium values may be rescreened.
For hemoglobin; a lower limit within 0.5 g/dL of the lower limit of normal (LLN) is allowable at Screening.
For total bilirubin; ULN values will be allowed at Screening and Day -1/baseline provided the AST and ALT are within normal limits. Potential subjects excluded prior to Protocol Version 6.0 with bilirubin values below the Version 6.0 upper limit may be rescreened.
* For ALT/AST; subjects who screened prior to Protocol Version 11.0 were excluded if AST/ALT results were Grade 1 or higher at Screening. Subjects who screen with Protocol Version 11.0, AST/ALT is exclusionary if Screening results are 1.5 × ULN or if assessed as CS by the site PI.
* Grade 1 or higher toxicity, see Appendix C and Appendix D for subjects who screened and enrolled prior to Protocol Version 11.0. Subjects who screen and enroll with Protocol Version 11.0, toxicity will be assessed with the NCI CTCAE, Version 5.0 - November 2017. Safety laboratory tests drawn on Day -1 or Screening if within 48 hours of planned dosing will serve as baseline values. Day -1 laboratory tests with a Grade 1 severity, other than those noted above, will not exclude subjects from participation.
* All other abnormal laboratory values collected at Screening and on Day -1 will be exclusionary at the discretion of the PI.
* Potassium, bicarbonate or creatinine/eGFR* results are Grade 1 or higher at either Screening or Day -1/Baseline visits.
*For creatinine; subjects who screened prior to Protocol Version 11.0 were excluded if creatinine results were Grade 1 or higher. Subjects who screen with Protocol Version 11.0, creatinine is not an exclusionary criterion, instead subjects should have a calculated eGFR using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (CKD-EPI) of >= 90 mL/min/1.73m2 to be enrolled in the study.
* Received an experimental agent (vaccine, drug, biologic, device, or medication) within 45 days or 5 half-lives (whichever is longer) before study product administration.*
*Prior participation at any time in noninvasive methodology trials in which no drugs were given is acceptable.
* Is participating in or plans to participate in another clinical trial with an interventional agent that will be received during this trial.
* Has donated more than 500 mL of blood or blood products* within the month before Screening.
*Includes whole blood, red blood cells, platelets, plasma, or plasma derivatives.
* Has a history of serologically-proven Chikungunya virus (CHIKV) exposure at any point, or positive anti CHIKV antibodies (ie., positive IgM or IgG) at Screening.
* Has received blood products within 120 days prior to Screening.
* Has received mAb in the past 3-months or 5 half-lives (whichever is longer) prior to Screening, whether licensed or investigational, or plans to receive a mAb outside of this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04441905
|
{
"brief_title": "Phase 1 Study of SAR440894 vs Placebo",
"conditions": [
"Chikungunya Virus Infection"
],
"interventions": [
"Other: Placebo",
"Biological: SAR440894"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04441905",
"official_title": "A Phase 1, Randomized, Double-Blind, Multi-Site, Single Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of SAR440894 vs Placebo in Healthy Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-22",
"study_completion_date(actual)": "2024-08-22",
"study_start_date(actual)": "2020-10-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2020-06-19",
"last_verified": "2023-09-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-22",
"first_submitted": "2020-06-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.
#Intervention
- DRUG : Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
- Magnevist at a dose of 0.1 mmol/kg
- DRUG : Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
- Magnevist at a dose of 0.2 mmol/kg
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
Exclusion Criteria:
* Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
* Patients with allergy to contrast media
* Patients with serious hepatic impairment
* Patients with serious renal impairment
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00652418
|
{
"brief_title": "Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography",
"conditions": [
"Magnetic Resonance Angiography",
"Peripheral Vascular Diseases",
"Peripheral Arterial Diseases"
],
"interventions": [
"Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00652418",
"official_title": "Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-10",
"study_completion_date(actual)": "2004-10",
"study_start_date(actual)": "2004-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-10-14",
"last_updated_that_met_qc_criteria": "2008-04-02",
"last_verified": "2013-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-03",
"first_submitted": "2008-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).
The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.
#Intervention
- DRUG : Colistin (Polymyxin E) 100mg x 4/d
- Colistin (Polymyxin E) 100mg x 4/d
- DRUG : both medications
- PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
- DRUG : will not receive PO treatment
- will not receive PO treatment - will receive plecebo treatment
- DRUG : PO Garamycin 80mg x 4/d
- PO Garamycin 80mg x 4/d
|
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria
1. Patient identified as a KPC carrier.
2. Patient capable to understand and sign informed consent
3. Age > 18
4. Patient capable to receive oral medication
Exclusion Criteria:
* Exclusion Criteria:
1. Patient unable to sign informed consent
2. Age <= 18
3. Pregnant/lactating female
4. Patient not expected to survive > 2 weeks.
5. Patient unable or not allowed to receive oral medications
6. A known allergy to study drugs.
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
|
NCT01266499
|
{
"brief_title": "A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).",
"conditions": [
"Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia"
],
"interventions": [
"Drug: Colistin (Polymyxin E) 100mg x 4/d",
"Drug: will not receive PO treatment",
"Drug: PO Garamycin 80mg x 4/d",
"Drug: both medications"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT01266499",
"official_title": "A Randomized Open Label Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-28",
"last_updated_that_met_qc_criteria": "2010-12-23",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-12-24",
"first_submitted": "2010-12-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a phase 1, first in human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult male and female subjects 18 to 55 years of age, inclusive.
Detailed Description
Subjects will provide written informed consent and undergo a screening visit within 28 days of receiving study drug. Eligible subjects must have a negative urine drug screen (UDS) and a negative naloxone challenge test at Screening and at the check-in visit (Day -1). Upon completion of screening, eligible subjects will be admitted to the clinical research unit (CRU) on Day -1 and remain confined in the CRU through completion of all scheduled procedures on Day 4 to allow for safety labs, pharmacokinetic (PK) blood draws, ECGs, injection site assessments, and adverse event monitoring.
Study medication dosing will occur in the morning on Day 1 and serial blood samples for plasma concentration determination for PK analysis will be taken during this time at pre-dose and 0.25, 0.50, 1, 1.5, 2, 4, 8, 10, 12, 24 (day 2), 48 (day 3), and 72 (day 4) hours post dose. Additional blood PK samples will be taken at follow-up visits. A Safety Review Committee (SRC) will review blinded, preliminary data from Cohort 1 to make recommendations regarding escalation to Cohorts 2 and 3.
#Intervention
- DRUG : NRS-033
- A single dose of NRS-033 will be administered
- DRUG : Placebo
- A single dose of matching placebo will be administered
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female >=18 and <=55 years at time of consent
* Body mass index >=18.0 to <=35.0 kg/m2
* Medically healthy based on the absence of clinically significant abnormal vital sign
* Females must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission; also, females of childbearing potential must agree to use a highly effective means of contraception from Screening until 9 months after receiving the study medication.
* Male subjects with female partners of childbearing potential must agree to use a male condom and will be advised of the benefit for a female partner to use a highly effective method of contraception
* Agree to stay within National Institute on Alcohol Abuse and Alcoholism (NIAAA) low risk drinking criteria. For women, low-risk drinking is no more than 3 drinks on any single day and no more than 7 drinks per week. For men, it is defined as no more than 4 drinks on any single day and no more than 14 drinks per week.
* Agree not to take opioid analgesics.
Exclusion Criteria:
* Clinically significant medical or psychiatric diagnosis (assessed on history, physical exam, ECG, and/or blood tests; includes significant history of cardiovascular, pulmonary, hepatic, gallbladder, or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease).
* Significant neuropsychiatric diagnosis (e.g., major depression, suicidal ideation, multiple sclerosis, dementia) as reported by the subject, or a past history of suicide attempt.
* Females who are pregnant, lactating, or likely to become pregnant during the study.
* History over last 30 days of consuming alcohol >3 drinks day per day or >7 drinks per week if female; if male >4 drinks per day or >14 drinks per week.
* Currently uses tobacco or nicotine containing products, including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum.
* Reported history of a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
* Subject reported history of any use of long-term use of opioids agonists or antagonists; e.g., methadone, oxycodone, hydrocodone, naltrexone, buprenorphine.
* Subject reported history of any medications to treat opioid use disorder (MOUD); e.g., methadone, naltrexone, buprenorphine, kratom.
* Subject reports anticipated need for opioid analgesia in the next 12 months (e.g., planned surgery).
* Subject reports history or presence of allergic or adverse response (including rash or anaphylaxis) to naloxone, naltrexone, nalmefene, morphinan opioid agonists, benzyl alcohol or sesame oil.
* Positive urine drug screen (UDS) for barbiturates, benzodiazepines, cocaine, methamphetamine, or opioids.
* Positive alcohol breath test.
* Received an investigational drug within the last 30 days or 5 half-lives of the drug, whichever is longer, prior to administration of study medication.
* Has taken exclusionary prohibited medications within the last 30 days or 5 half-lives of the drug, whichever is longer.
* Subjects with a history of syncope, or have a history of symptomatic hypotension or symptomatic hypoglycemia.
* Subjects who test positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg), or Hepatitis C virus (HCV) antibody.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05724797
|
{
"brief_title": "Single Ascending Dose Study of NRS 033 in Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Placebo",
"Drug: NRS-033"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05724797",
"official_title": "A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of NRS 033 in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-04",
"study_completion_date(actual)": "2024-12-04",
"study_start_date(actual)": "2023-04-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-01",
"last_updated_that_met_qc_criteria": "2023-02-10",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-13",
"first_submitted": "2023-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea
#Intervention
- DRUG : Sitagliptin 100mg
- Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
- DRUG : Pioglitazone 30 mg
- Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes according to the American Diabetes Association
* Baseline level of 7% <= A1C < 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)
Exclusion Criteria:
* Acute or chronic diseases of heart, lung, kidney,
* Active or past infectious conditions
* Malignancy
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03125694
|
{
"brief_title": "Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea",
"conditions": [
"Uncontrolled Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Sitagliptin 100mg",
"Drug: Pioglitazone 30 mg"
],
"location_countries": [
"Iran, Islamic Republic of"
],
"nct_id": "NCT03125694",
"official_title": "Efficacy, Durability, Safety, and Tolerability of Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea: a 52-week, Randomized, Open-label, Parallel-group, Phase 3 Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-01",
"study_completion_date(actual)": "2017-04-01",
"study_start_date(actual)": "2015-02-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-24",
"last_updated_that_met_qc_criteria": "2017-04-19",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-24",
"first_submitted": "2017-03-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3 different partner antibiotics, and the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate.
Detailed Description
This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime, piperacillin/tazobactam, and aztreonam) in healthy volunteers. Participants will be administered a single dose of SPR741 alone, a single dose of SPR741 in combination with 1 of the 3 different partner antibiotics, and a single dose of the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase.
The 3 treatment arms will be enrolled and dosed in parallel or in a staggered manner, as needed for scheduling.
All participants in the study will be monitored for safety after administration of the last dose of investigational product.
#Intervention
- DRUG : SPR741
- 400 mg IV over 1 hour
- DRUG : Ceftazidime
- 1.0 gram IV over 1 hour
- DRUG : Piperacillin/tazobactam
- 4.5 grams IV over 1 hour
- DRUG : Aztreonam
- 1.0 gram IV over 1 hour
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males and/or females (of non-childbearing potential), 18 <= age <= 55 of age (inclusive) at the time of screening;
* BMI >= 18.5 and <= 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive);
* Medically healthy without clinically significant abnormalities at the screening visit or Day -1, including:
1. Physical examination, vital signs. Vital signs include temperature, heart rate, respiratory rate, and blood pressure;
2. Triplicate ECGs taken at least 1 minute apart with QTcF interval duration less than 450 msec obtained as an average from the triplicate screening and pre-dose Day 1 ECGs after at least 5 min in a semi-supine quiet rest;
3. Hemoglobin/hematocrit, white blood cell (WBC) count, and platelet count equal to or greater than the lower limit of normal range of the reference laboratory;
4. Creatinine, BUN, ALT and AST equal to or less than the upper limit of normal for the reference laboratory; results of all other clinical chemistry and urine analytes without any clinically significant abnormality.
Discussion between the PI and the Medical Monitor (MM) is encouraged regarding the potential significance of any laboratory value that is outside of the normal range during the pre-dose period.
* Be non-smokers (including tobacco, e-cigarettes or marijuana) for at least 1 month prior to participation in the study;
* Willing and able to provide written informed consent;
* Be willing and able to comply with all study assessments and adhere to the protocol schedule;
* Have suitable venous access for drug administration and blood sampling;
* If female, be of non-childbearing potential (e.g. post-menopausal as demonstrated by FSH or surgical sterilization i.e., tubal ligation or hysterectomy). Provision of documentation is not required for female sterilization, verbal confirmation is adequate;
* If male, a willingness not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective method of birth control (such as an intrauterine device, diaphragm, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation). This criterion applies to males (and/or female partners) who are surgically sterile and must be followed from the time of first study drug administration until 90 days after the final administration of study drug.
Exclusion Criteria:
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
* History of known or suspected Clostridium difficile infection;
* History of seizure disorders;
* Positive urine drug/alcohol testing at screening or check-in (Day -1);
* Positive testing for HIV, HBsAg or HCV;
* History of substance abuse or alcohol abuse (defined as those who consume more than 14 units of alcohol per week, and where this consumption is spread over less than 3 days, or those who regularly (weekly) consumed excessive amounts of alcohol (>8 units for men and >6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics) within the previous 5 years;
* Use of any prescription medication or any over-the-counter medication, herbal products, vitamins, diet aids or hormone supplements within 7 days prior to randomisation;
* Documented hypersensitivity reaction or anaphylaxis to any medication;
* Donation of blood or plasma within 30 days prior to randomisation, or loss of whole blood of more than 500 mL within 30 days prior to randomisation, or receipt of a blood transfusion within 1 year of study enrollment;
* Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
* Any other condition or prior therapy, which, in the opinion of the PI, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03376529
|
{
"brief_title": "Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Aztreonam",
"Drug: Ceftazidime",
"Drug: SPR741",
"Drug: Piperacillin/tazobactam"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03376529",
"official_title": "A Single-center, Multi-arm, Open-label, Randomized, 3-period, Crossover, Phase 1 Study to Evaluate the DDI, PK, Safety, and Tolerability of Single Doses of SPR741 Co-administered With Three Different Antibiotics in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-19",
"study_completion_date(actual)": "2017-12-20",
"study_start_date(actual)": "2017-11-10"
},
"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)": "2018-01-05",
"last_updated_that_met_qc_criteria": "2017-12-12",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-18",
"first_submitted": "2017-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients.
The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy. In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy. This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment. The purpose of the phase II portion of the study, is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo. A skeletal-related event is defined as:
* Pathologic fracture
* Spinal cord compression
* Requirement for either radiation or surgery to bone due to:
* Pain
* Prevention of imminent fracture
* Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine. Charges in serum DKK1 levels will be characterized. The size and number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and at selected sites with QCT scans.
Detailed Description
The study was originally planned to have two phases. Phase II, the dose expansion phase, was not conducted.
#Intervention
- DRUG : BHQ880
- DRUG : Zoledronic acid
- Other Names :
- ZOL446
|
#Eligibility Criteria:
Inclusion Criteria:
* Relapsed or refractory multiple myeloma patients requiring treatment with a non-bortezomib-containing regimen (prior treatment with bortezomib is acceptable)
* The diagnosis of symptomatic multiple myeloma (International Myeloma Working Group)
* Patients with multiple myeloma who do not have measurable serum M-protein or measurable urine M-protein must have measurable increased concentrations of free light chains (using FreeLite™)
* At least one prior SRE defined as one of the following:
* Pathologic fracture
* Spinal cord compression
* Requirement for either radiation or surgery to bone due to:
* Pain
* Prevention of imminent fracture
* Stabilization of a fracture
* Current or planned treatment with zoledronic acid
* Ambulatory patients aged >= 18 years
* Adequate organ function
Exclusion Criteria:
* Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism and/or Paget's disease of bone.
* Current active dental problems including
* Ongoing infection of the teeth or jawbone (maxilla or mandibula)
* Current exposed bone in the mouth
* Dental or fixture trauma
* Current or previous osteonecrosis of the jaw
* Slow healing after dental procedures
* Recent (within 6 weeks) or planned dental or jaw surgery during the study (extraction, implants)
* Patients who are allergic to/ intolerant of bisphosphonate therapy
* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled diarrhea) that could cause unacceptable safety risks or compromise compliance with the protocol
* Other clinically significant heart disease (e.g. symptomatic congestive heart failure, uncontrolled arrhythmia, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 78 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00741377
|
{
"brief_title": "A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients",
"conditions": [
"Multiple Myeloma Bone Disease"
],
"interventions": [
"Drug: Zoledronic acid",
"Drug: BHQ880"
],
"location_countries": [
"United Kingdom",
"United States"
],
"nct_id": "NCT00741377",
"official_title": "A Phase Ib/II Multicenter Dose-determination Study, With an Adaptive, Randomized, Placebo-controlled, Double-blind Phase II, Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-18",
"last_updated_that_met_qc_criteria": "2008-08-25",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-26",
"first_submitted": "2008-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.
Detailed Description
Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on CYP2C9 genotype may improve antidiabetic treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* nonsmokers and in good health
Exclusion Criteria:
* family history of diabetes mellitus
* taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study
Sex :
MALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 27 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00806013
|
{
"brief_title": "Study the Effects of CYP2C Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT00806013",
"official_title": "Study the Effects of CYP2C9 and CYP2C19 Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide in Healthy Chinese Subject",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2008-12",
"study_start_date(actual)": "2008-08"
},
"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)": "2010-01-27",
"last_updated_that_met_qc_criteria": "2008-12-09",
"last_verified": "2008-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-10",
"first_submitted": "2008-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration.
Detailed Description
B. Braun Medical Inc. intends to conduct human PK studies and obtain marketing approval for Cefazolin 2g in the United States with identical indications of those already approved for the 1g strength. A pharmacokinetic study will be conducted with the Cefazolin 2g product manufactured by B. Braun Medical Inc. Cefazolin 1.5g dose will be prepared using 10g Cefazolin pharmacy bulk with 5% Dextrose. The clinical study proposed in this protocol is designed to evaluate the pharmacokinetic characteristics of 2g and 1.5g Cefazolin in Dextrose in healthy subjects at the maximum recommended infusion dose of 6g per day per FDA's recommendation.
The study is designed to simulate clinical practice and overall experience with cephalosporin administration. Cefazolin may be reconstituted with dextrose (or a number of other diluents as recommended in the innovator's package insert) in order to achieve an osmolality appropriate for intravenous infusion.
According to B. Braun's approved package insert for Cefazolin 1g, the maximum dose of 1.5g Cefazolin for Injection USP and Dextrose Injection USP is 1.5 grams every 6 hours for severe, life-threatening infections. In rare instances, doses of up to 12 grams of Cefazolin per day have been used. Lower doses are stated in the B. Braun package insert.
#Intervention
- DRUG : Cefazolin 2g for Injection USP and Dextrose Injection USP
- Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
- Other Names :
- Cefazolin 2g in DUPLEX (50ml)
- DRUG : Cefazolin 1.5g
- Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
- Other Names :
- Cefazolin 1.5g (50ml)
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects, male and female
* Age: 18 - 70 years (inclusive) at the time of screening.
* Females of non-child bearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal >= 1 year with follicle stimulating hormone [FSH] > 40 U/L).
* Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory evaluations).
* Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent and the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to performing any of the screening procedures.
Exclusion Criteria:
* Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn products or any of the other ingredients of the Investigational Products
* Subjects with impaired renal function based on the Cockcroft-Gault formula using actual body weight, i.e. estimated creatinine clearance <= 80 mL/min (performed at Screening only)
* Body Mass Index (BMI) < 20.0 or > 30.0 kg/m^2
* Body Weight < 50.0 kg
* White Blood Count (WBC) < 3.5 x10^3/uL or > ULN
* absolute neutrophil count (ANC) < 1.5 x10^3/uL or > ULN
* Alarine aminotransferase and aspartate aminotransferase > upper limit of normal
* Other laboratory tests that are outside the normal limits, considered by the investigator, to be clinically significant.
* Use of any medication on a chronic basis.
* Takes any medication which interferes with the study drug or study procedures including aminoglycosides, anticoagulants, and probenecids.
* Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies from 14 days prior to Day -1 until end of study. By exception, acetaminophen <= 1 gram per day is permitted.
* Tobacco use during the last 2 months prior to enrollment.
* Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
* Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1
* Positive blood test for ethanol at screening or Day -1.
* At screening, the subject has a clinically relevant ECG change, as assessed by the PI or designee.
* Concurrent acute or chronic infections (e.g. viral infections, except chronic recurrent herpes infections)
* History of or ongoing alcohol abuse or drug abuse (within last 2 years).
* Received an Investigational drug or device within 30 days of first dose of study drug
* Clinically relevant medical conditions which are likely to interfere with the evaluation of the trial drug, e.g. COPD, metabolic disorders (such as clinical and sub-clinical diabetes mellitus), history of malignant diseases (within last 5 years), autoimmune diseases, and cardiovascular disease
* Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
* Any condition that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
* Unable or unwilling to adhere to the study-specified procedures and restrictions
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
|
NCT01121354
|
{
"brief_title": "Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX",
"conditions": [
"Infection"
],
"interventions": [
"Drug: Cefazolin 2g for Injection USP and Dextrose Injection USP",
"Drug: Cefazolin 1.5g"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01121354",
"official_title": "A Phase I Multiple-Dose Two-Arm Study to Evaluate the PK and Safety of Cefazolin 2g for Inj. USP and Dextrose Inj. USP in the DUPLEX® Drug Delivery System and Cefazolin for Inj. 1.5g in Daily Doses of 6g in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-02",
"study_completion_date(actual)": "2010-02",
"study_start_date(actual)": "2009-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-07-16",
"last_updated_that_met_qc_criteria": "2010-05-11",
"last_verified": "2013-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-12",
"first_submitted": "2010-05-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study aims to evaluate the efficacy, safety and tolerability of FF/UMEC/VI compared with FF/VI via ELLIPTA® inhaler in Chinese participants with inadequately controlled asthma. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
#Intervention
- DRUG : FF/VI
- FF/VI will be administered.
- DRUG : FF/UMEC/VI
- FF/UMEC/VI will be administered.
- DEVICE : ELLIPTA
- FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler.
|
#Eligibility Criteria:
Inclusion criteria:
* Participant must be >= 18 years at the time of signing the informed consent.
* Documented history asthma diagnosis as defined by the Global Initiative for Asthma (GINA) at least one year prior to Visit 0.
* Participants with inadequately controlled asthma (ACQ-6 score >=1.5) despite Inhaled Corticosteroids/Long-Acting Beta-2-Agonists (ICS/LABA) maintenance therapy at Visit 1.
* Participants who require daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of greater than [>]250 micrograms (mcg) per day fluticasone propionate [FP, or equivalent]).
* A best pre-bronchodilator morning (AM) FEV1 >=30 percent (%) and less than (<) 85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative.
* Airway reversibility defined as >=12% and >=200 milliliters (mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
* All participants must be able to replace their current Short-Acting Beta-2-Agonists (SABA) inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Participants must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
* Male or female participants following contraceptive/barrier requirements and it should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the study.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
* Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
* Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1.
* Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including all of the following:
1. History of exposure to risk factors (especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels).
2. A post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of less than or equal to (<=)70% of predicted normal values.
3. Onset of disease >=40 years.
* Participants with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
* Immune suppression (e.g., Human Immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Participants at potentially high risk (e.g., very low Body Mass Index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
* Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
* Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Clinically significant Electrocardiogram (ECG) abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the participant's medical history and exclude participants who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
1. Atrial Fibrillation with rapid ventricular rate >120 beats per minute (bpm).
2. Sustained or non-sustained ventricular tachycardia.
3. Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted).
4. QT interval corrected for heart rate by Fridericia's formula (QTcF) >=500 milliseconds (msec) in participants with QRS <120 msec and QTcF >=530 msec in participants with QRS >=120 msec.
* Participants with any of the following at Screening (Visit 1):
1. Myocardial infarction or unstable angina in the last 6 months.
2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months.
3. New York Heart Association (NYHA) Class IV Heart failure [American Heart Association, 2016].
* Participants with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
* Participants with carcinoma that has not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.
* Participants with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
* Participants who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
* Participants who are:
1. Current smokers (defined as participants who have used inhaled tobacco products within the 12 months prior to Visit 1, e.g. cigarettes, electronic-cigarettes/vaping, cigars or pipe tobacco).
2. Former smokers with a smoking history of >=10 pack years (e.g. >=20 cigarettes per day for 10 years).
* Participants with a known or suspected history of alcohol or drug abuse within the last 2 years.
* A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate.
* Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
* Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
* In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
Inclusion criteria for randomization:
* Participants with inadequately controlled asthma (ACQ-6 score >=1.5) at Visit 2.
* A best pre-bronchodilator morning (AM) FEV1 >=30% and <90% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative (Quanjer).
* Liver function tests at Visit 1:
1. Alanine aminotransferase (ALT) <2 times upper limit of normal (ULN).
2. Alkaline phosphatase <=1.5 times ULN.
3. Bilirubin <=1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
* Compliance with completion of the Electronic diary reporting defined as completion of all questions/assessment on >=4 of the last 7 days during the run-in period.
Exclusion criteria for randomization:
* Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the participant's asthma status or the participant's ability to participate in the study.
* Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
* Changes in asthma medication (excluding run-in medication and albuterol/salbutamol inhalation aerosol provided at Visit 1).
* Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
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
|
NCT04937387
|
{
"brief_title": "Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: FF/VI",
"Drug: FF/UMEC/VI",
"Device: ELLIPTA"
],
"location_countries": [
"China"
],
"nct_id": "NCT04937387",
"official_title": "A Phase III, 12 Week, Randomized, Double-blind, 4 Arm Parallel Group Bridging Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI Once-daily Via a Dry Powder Inhaler With Dual Combination of FF/VI, Administered in Chinese Participants With Inadequately Controlled Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-05",
"study_completion_date(actual)": "2024-08-05",
"study_start_date(actual)": "2021-07-29"
},
"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)": "2025-01-17",
"last_updated_that_met_qc_criteria": "2021-06-22",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-24",
"first_submitted": "2021-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A study in patients with depression
#Intervention
- DRUG : Duloxetine Hydrochloride
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients at least 18 years who have previously completed satisfactorily the Lilly sponsored previous clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator
* All females must test negative for a urine pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study.
* Must sign the informed consent document (ICD).
Exclusion Criteria:
* Have received treatment within the last 30 days with a drug ( not including study drug) that has not received regulatory approval for any indication at the time of study entry.
* Patients who have entered the optional tapering period of the previous study.
* In the opinion of the investigator, patients judged to be at serious suicidal risk.
* Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use MAOI during the study or within 5 days of discontinuation of the study drug.
* Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician
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
|
NCT00191594
|
{
"brief_title": "Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials",
"conditions": [
"Major Depressive Disorder"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT00191594",
"official_title": "Open-Label Duloxetine Extension Phase in Patients Who Have Completed the HMDG Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2005-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-01-26",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2007-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-19",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goals of our research project are to study the relationship, if any, between the success of a TB injection (measured by pain relief and general patient satisfaction) and the method in which it was placed. Because fluoroscopy places patients requires a slight risk from radiation exposure and increased cost versus blind injection, it is important to know if there is an advantage to using this technique. The investigators will randomize 64 patients to receive either trochanteric bursa injections with corticosteroid and local anesthetic guided by fluoroscopy, or trochanteric bursa patients to receive trochanteric bursa injections based on landmarks on palpation. The investigators will then determine which method is superior, and whether injecting steroid and local anesthetic into the bursa itself is superior or inferior to injecting it into a tender area outside the bursa.
Detailed Description
This will be a randomized, controlled study evaluating the value of fluoroscopy in trochanteric bursa injections. Subjects will be recruited solely from the patients we normally see at the Blaustein Pain Treatment Center with a clinical diagnosis of GTPS. Sixty-four patients will be randomized in a 1:1 ratio using sealed envelopes to receive either TB corticosteroid injection done blind or with fluoroscopy. All patients who provide informed consent will be brought into the fluoroscopy suite and placed in the lateral decubitus position. In the patients randomized to receive fluoroscopically guided injections, a 22-gauge needle will be placed into the TB and correct position confirmed by fluoroscopy and contrast injection (1 ml per attempt) before corticosteroid and local anesthetic injection (60 mg of depomedrol and 2.5 ml of 0.5% bupivacaine). In the blinded group, one sham, pulsed fluoroscopic image will be taken of the femur, and the injection will be done based only on physical exam (overlying the area of maximal tenderness) and landmarks. Prior to the injection, 1 ml of contrast will be administered and another image taken to determine whether or not the needle is within the bursa, but this will not alter the injection. After contrast administration, the same corticosteroid and bupivacaine injection will be administered. The 2 main questions we propose to answer are: 1) whether using fluoroscopy for TB injections results in improved outcomes (comparison of the 32 patients in each group); and 2) whether injecting into the bursa provides superior results than performing non-bursal injections into the area of maximal tenderness (comparison of 32 patients who receive fluoroscopically-guided bursa injections + those patients whose blinded injection was noted to be intra-bursal vs. those patients whose blinded injection was extra-bursal).
#Intervention
- PROCEDURE : trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
- Depomedrol 60 mg + bupivacaine 2.5 ml
- PROCEDURE : Trochanteric bursa injection with depomedrol and bupivacaine
- Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years
* Clinical diagnosis of trochanteric bursitis
Exclusion Criteria:
* Pregnancy
* Allergy to contrast
* Untreated coagulopathy
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
|
NCT00480675
|
{
"brief_title": "Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections",
"conditions": [
"Bursitis"
],
"interventions": [
"Procedure: Trochanteric bursa injection with depomedrol and bupivacaine",
"Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00480675",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05",
"study_completion_date(actual)": "2008-05",
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-01-28",
"last_updated_that_met_qc_criteria": "2007-05-30",
"last_verified": "2009-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-05-31",
"first_submitted": "2007-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk for iron deficiency. Studies in our laboratory have shown that this is mainly the result of reduced dietary iron absorption because of increased hepcidin concentrations. During pregnancy, women have a large increase in iron needs because of the expansion of maternal blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive development. Whether maternal adiposity impairs absorption and transfer of iron to the fetus, and thereby increases risk of iron deficiency in the mother and the infant is unclear.
Detailed Description
In obese subjects, hepcidin concentrations are increased and iron absorption is believed to be reduced, leading to iron deficiency over time. How all this will influence iron supply of the fetus in obese pregnancy has not been well investigated to date. Even if maternal and fetal iron uptakes are regulated separately, it is unclear to what extent maternal subclinical inflammation might influence this process. A small study by Dao et al. indicated that maternal-fetal iron transfer was impaired in obese pregnant women, possibly due to hepcidin up-regulation. In this study, both maternal BMI as well as hepcidin were negatively correlated with cord blood iron status. Maternal hepcidin and c-reactive protein were significantly higher and cord blood iron was significantly lower in the obese compared to the normal weight. Hepcidin was shown to have an effect on iron transfer across the placenta in the study by Young et al.: the transfer was increased in women with undetectable hepcidin at delivery compared to those with higher levels. As of now, clear associations between maternal BMI or maternal hepcidin concentration and fetal iron status were not shown.
#Intervention
- OTHER : Stable iron isotope 57 (57Fe) labeled iron solution
- test meal labeled with 12 mg 57Fe
- OTHER : Stable iron isotope 58 (58Fe) labeled iron solution
- test meal labeled with 12 mg 58Fe
|
#Eligibility Criteria:
Inclusion Criteria:
* Pregnant women with either normal pre-pregnancy BMI (BMI 18.5 - 24.9kg/kg2) or with overweight or obesity (BMI > 27.5kg/m2) before pregnancy (assessed based on data reported by the women at their first visit at the hospital)
* 18 <= age <= 45 old
* singleton pregnancy
* week of pregnancy 14±3
Exclusion Criteria:
* underlying malabsorption disease
* chronic illness, which influences iron absorption
* inflammatory status other than obesity
* medical problems known to affect iron homeostasis
* smoking during pregnancy
* no regular use of medication, which influences iron absorption
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
|
NCT02747316
|
{
"brief_title": "Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status",
"conditions": [
"Overweight",
"Obesity",
"Pregnancy"
],
"interventions": [
"Other: Stable iron isotope 57 (57Fe) labeled iron solution",
"Other: Stable iron isotope 58 (58Fe) labeled iron solution"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT02747316",
"official_title": "Maternal Iron Absorption and Utilization and Iron Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infant Iron Status",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04",
"study_completion_date(actual)": "2020-09",
"study_start_date(actual)": "2016-02"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-23",
"last_updated_that_met_qc_criteria": "2016-04-18",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-21",
"first_submitted": "2016-01-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.
#Intervention
- PROCEDURE : Transvaginal natural orifice endoscopic surgery for endometrial cancer staging
- Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES
|
#Eligibility Criteria:
Inclusion Criteria:
* Extreme obese patients
* Early stage type-1 endometrial cancer proved by endometrial sampling
Exclusion Criteria:
* any contraindication for pneumoperitoneum
* any contraindication for the dorsal lithotomy position
* any contraindication for general anesthesia,
* any contraindication for v-NOTES
* suspicion of pelvic adhesions
* presence or suspicion of obliteration of the pouch of Douglas
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04240730
|
{
"brief_title": "Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer",
"conditions": [
"Endometrial Cancer",
"Extreme Obesity"
],
"interventions": [
"Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04240730",
"official_title": "Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer",
"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)": "2019-01-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-11",
"last_updated_that_met_qc_criteria": "2020-01-22",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-27",
"first_submitted": "2020-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
#Intervention
- PROCEDURE : Descemet's stripping endothelial keratoplasty
- Small incision corneal transplant procedure to treat dysfunctional endothelium.
|
#Eligibility Criteria:
Inclusion Criteria:
* candidate for Descemet's stripping with endothelial keratoplasty
* at least 21 years
* willing and able to return for scheduled follow-up visits
* reads and signs Informed Consent document
Exclusion Criteria:
* visual acuity of less than 20/400 in fellow eye
* known sensitivity to planned study concomitant medications
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00624221
|
{
"brief_title": "Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty",
"conditions": [
"Fuchs Endothelial Dystrophy",
"Corneal Edema"
],
"interventions": [
"Procedure: Descemet's stripping endothelial keratoplasty"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00624221",
"official_title": "A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-10",
"study_completion_date(actual)": "2007-11",
"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)": "2016-04-27",
"last_updated_that_met_qc_criteria": "2008-02-19",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-27",
"first_submitted": "2008-02-19",
"first_submitted_that_met_qc_criteria": "2010-03-02"
}
}
}
|
#Study Description
Brief Summary
30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. Accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). Two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. The two versions will differ only in palatability and will be equicaloric. Subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. Each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. The quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.
#Intervention
- OTHER : Low Acceptability Meal
- OTHER : High acceptability meal
|
#Eligibility Criteria:
Inclusion Criteria:
* Gender: Male
* Age: 18 <= age <= 50 years
* Body Mass Index (BMI): 18.5 <= age <= 24.9 kg/m2
* Stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status)
Exclusion Criteria:
* Smoking
* Substance abuse such as alcohol or drugs
* Medical or psychological illness
* Use of medications
* Previous gastrointestinal surgery
* History of weight fluctuation (weight loss of greater than 5% within the past 3 months)
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02615613
|
{
"brief_title": "The Effect of Food Hedonics on Appetite Hormones Levels",
"conditions": [
"Eating Behavior"
],
"interventions": [
"Other: High acceptability meal",
"Other: Low Acceptability Meal"
],
"location_countries": null,
"nct_id": "NCT02615613",
"official_title": "Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-30",
"last_updated_that_met_qc_criteria": "2015-11-25",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-26",
"first_submitted": "2015-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
Detailed Description
This is a randomized, double-blind, placebo-controlled, sequential cohort, single escalating dose study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of sevuparin in healthy volunteer adult male and female subjects. The study will consist of three subcutaneous dose cohorts (3, 6 and 9 mg/kg sevuparin). Each dosing cohort will consist of 8 subjects who will be randomized to receive either a single dose of sevuparin or matching placebo in a 3:1 ratio (6 active/2 placebo).
#Intervention
- DRUG : Sevuparin
- The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent form is signed and dated
* Adult male or female subjects, aged >=18 to <=65 years inclusive;
* Body mass index >=19.0 to <=29.0 kg/m2 and a body weight 50.0 <= age <= 100.0 kg
* Subjects must have a negative pregnancy test and subjects of childbearing potential must either be surgically sterile or be willing to practice a highly effective method of contraception
* Subjects must be in good health, as determined by a medical history, physical examination
* Subjects with no clinically significant and relevant history that could affect the conduct of the study.
Exclusion Criteria:
* Recent trauma or injury or history of clinically significant bleeding.
* Clinical evidence of significant or unstable medical illness
* Subjects who have received any prescribed systemic or topical medication
* Subjects who have received aspirin, anti-platelet therapy, anticoagulant therapy and prophylactic and therapeutic LMWH or un-fractioned heparin.
* Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies)
* Subjects who have received any medications known to chronically alter drug absorption or elimination processes
* Subjects who are still participating in a clinical study
* Subjects who have donated any blood, plasma or platelets
* Subjects with a significant history of drug allergy
* Subjects who have any clinically significant allergic disease
* Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively
* Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcF interval > 470 ms, or with sinus rhythm with PR interval <110 ms or >210 ms, confirmed by a repeat ECG.
* Screening transaminases (AST, ALT, GGT) >= 1.5 times the ULN; estimated glomerular filtration rate (GFR, MDRD equation) < 60 mL/min; APTT above the normal range, INR above 1.4; absolute platelet count <150,000/μL.
* Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
* Subjects with a positive urine drug screen/alcohol test result
* Subjects who smoke more than 6 cigarettes
* Subjects who have positive hepatitis B or hepatitis C antibody or HIV antibodies.
* Subjects who test positive for HIT antibodies at Screening.
* Any relevant condition, behavior, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study.
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:
Yes
|
NCT03853421
|
{
"brief_title": "Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin",
"conditions": [
"Safety and Tolerability"
],
"interventions": [
"Drug: Sevuparin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03853421",
"official_title": "A Double-blind, Placebo-controlled Study in Healthy Volunteers to Determine the Safety and Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-06",
"study_completion_date(actual)": "2019-05-06",
"study_start_date(actual)": "2019-02-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-16",
"last_updated_that_met_qc_criteria": "2019-02-22",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-25",
"first_submitted": "2019-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.
In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.
This study will be in 2 parts, as follows:
Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.
A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.
#Intervention
- DRUG : AUT00201
- Oral dose of AUT00201
- DRUG : Placebo
- Oral dose of placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
* Must have body mass index (BMI) of 18.0 <= age <= 31.0 kg/m2
* Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* Must be able to give fully informed written consent.
Exclusion Criteria:
History or presence of
* Epilepsy
* Severe head injury, or any other chronic neurological condition or any psychiatric disorder
* Abnormal screening EEG (Part A1 and Part B only)
* Positive tests for hepatitis B & C, HIV
* Severe adverse reaction to any drug
* Sensitivity to trial medication
* Drug or alcohol abuse
* Use of over-the-counter medication within previous 7 days (with the exception of Paracetamol [acetaminophen])
* Prescribed medication during previous 28 days
* Participation in other clinical trials of unlicensed medicines
* Loss of more than 400 mL blood, within the previous 3 months
* Vital signs or QTcF interval outside the acceptable range
* Clinically relevant abnormal findings at the screening assessment
* Acute or chronic illness
* Clinically relevant abnormal medical history or concurrent medical condition
* Positive result for suicidal ideation or behaviour using the Colombia suicide severity rating scale (C-SSRS)
* Possibility that volunteer will not cooperate
* Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
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
|
NCT04158453
|
{
"brief_title": "Safety, Blood Levels and Effects of AUT00201",
"conditions": [
"Healthy Volunteer"
],
"interventions": [
"Drug: AUT00201",
"Drug: Placebo"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04158453",
"official_title": "A Randomised, Double-blind, Placebo-controlled, Single and Repeated Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AUT00201 in Healthy Male and Female Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-14",
"study_completion_date(actual)": "2020-12-24",
"study_start_date(actual)": "2019-10-10"
},
"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)": "2021-01-13",
"last_updated_that_met_qc_criteria": "2019-11-07",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-08",
"first_submitted": "2019-11-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed research program will investigate the changes in brain chemistry and circuitry that 're-wire' the brain during chronic cocaine use, promote relapse, and complicate treatment efforts. Currently-using and non-treatment-seeking individuals with a cocaine use disorder will undergo a cocaine self-administration paradigm 2-5 days prior to completing positron emission tomography (PET) and functional magnetic resonance imaging (fMRI).
Detailed Description
Cocaine use disorder (CUD) remains a significant public health concern that is resistant to current treatments. Challenges to treating CUD include an imbalance in neurobiological systems that 're-wire' the brain such that appetitive and habitual processes influence decision-making and behavior. This research project aims to provide insight into this reorganized circuitry in CUD by investigating neurofunctional systems related to glutamatergic plasticity and functional brain networks during initial (2-5 days) abstinence. To target this potentially critical period of recovery, currently-using and non-treatment-seeking individuals with CUD will undergo a cocaine self-administration paradigm 2-5 days prior to completing \[18F\]FPEB positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Healthy comparison (HC) subjects that have participated in \[18F\]FPEB PET as part of other Yale approved protocols will be recruited to participate in the fMRI portion of this study.
Aim 1: To determine the availability of mGluR5 using \[18F\]FPEB PET during initial abstinence in individuals with CUD. The investigators hypothesize individuals with CUD, relative to HC, will exhibit concurrently and regionally specific increases (e.g., in the striatum) and decreases (e.g., in the prefrontal cortex) in mGluR5 availability.
Aim 2: To determine patterns of resting-state, response-inhibition, an automaticity related connectivity within and between large-scale functional networks using fMRI during initial abstinence in individuals with CUD. The investigators hypothesize network-based analyses of fMRI will reveal lower frontoparietal and greater limbic network modulation in CUD as compared to HC.
Aim 3: To explore the relationships between mGluR5 availability and functional network activity during initial abstinence in individuals with CUD. The investigators will perform multi-modal analysis of PET and fMRI data to examine links between molecular and functional systems in CUD using emerging 'fusion' approaches. While exploratory in nature, the investigators expect to find links between alterations in mGluR5 systems and functional reorganization in CUD (e.g., greater dorsostriatal mGluR5 may be linked to blunted frontoparietal inhibition).
Aim 4: To explore the relationships between mGluR5 availability, functional network activity (and their linkages) with cocaine self-administration, disease severity and chronicity, and psychometric assessments of impulsivity and compulsivity. While exploratory in nature, the investigators expect more substantial neurofunctional alterations during initial abstinence will be associated with greater cocaine self-administration, disease severity, impulsivity and compulsivity in individuals with CUD.
#Intervention
- BEHAVIORAL : Psychiatric and Cognitive Testing
- Interviews, questionnaires, and computer testing.
- DRUG : Cocaine Self-adminstration
- The intervention will include a training and safety session that consists of physician/nurse-administered cocaine followed by a self-regulated cocaine administration period under carefully controlled and closely monitored conditions.
- Other Names :
- cocaine hydrochloride
- RADIATION : Positron Emission Tomography
- PET scans will be performed on a High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available. Antecubital venous catheters will be used for IV administration of the radiotracer and for venous blood sampling. A radial artery catheter may also be inserted by an experienced physician before the PET scan. At the beginning of each scan, the participants's head will be immobilized and a 6-minute transmission scan, using an orbiting 137Cs point-source, is obtained and used for attenuation correction. PET scans will be acquired using bolus or bolus plus constant infusion administration of \[18F\]FPEB.
- Other Names :
- PET
- OTHER : Magnetic Resonance Imaging
- Structural and functional MRI data will be acquired using a Siemens Trio TIM 3.0T system at the Yale Magnetic Resonance Research Center. High-resolution structural MRI data will be acquired to facilitate analysis of PET data and may be used in additional analysis of tissue volume and brain structure. Resting-state and task-based functional MRI data will be acquired using state-of-the-art multiband echo-planar imaging (EPI) gradient-echo sequences. Diffusion-weighted MRI data will also be acquired using multiband imaging sequences to investigate anatomical connectivity.
- Other Names :
- MRI, functional MRI
|
#Eligibility Criteria:
Inclusion Criteria:
* All participants:
* Age 21 - 60 years
* Provide voluntary, written, informed consent
* Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
* For females: non-lactating, no longer of child-bearing potential or agreeing to practice effective contraception during the study (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine system [IUS]; barrier methods: condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence when this is in line with the preferred and usual lifestyle of the subject), and a negative serum pregnancy test
* Participants with a cocaine use disorder:
* DSM-5 criteria for moderate or severe cocaine-use disorder
* Recent street cocaine use in excess of quantities used in the current study
* Intravenous and/or smoked (crack/freebase) cocaine use
* Positive urine toxicology screen for cocaine
* Healthy comparison participants:
* Successful completion of an [18F]FPEB scan as part of another Yale approved protocol as a healthy control/comparison subject
Exclusion Criteria:
* All participants:
* Any condition that, in the opinion of investigators, would prevent compliance with the study protocol
* A history of significant medical or neurological illness (e.g., coronary artery disease, significant anemia, seizures)
* Current use of psychotropic and/or potentially psychoactive medications
* Physical or laboratory evidence of pregnancy
* Meet any additional PET/MR imaging-related exclusion criteria, including:
* Presence of MRI incompatible implants and other contraindications for MRI (e.g., pacemaker, artificial joints, non-removable body piercings, etc.)
* Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the participant to exceed the yearly dose limits
* History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
* Claustrophobia
* Severe motor problems that prevent the subject from lying still for PET/MR imaging
* Complaints of chronic pain (e.g., as the result of rheumatoid arthritis)
* Current, past or anticipated exposure to radiation in the work place
* Participants with a cocaine use disorder:
* Other drug use disorder (except for tobacco-use disorder)
* Less than 1 year of cocaine use disorder
* A DSM-5 major psychiatric diagnosis (schizophrenia, bipolar disorder, etc.) unrelated to cocaine
* Healthy comparison participants:
* Any DSM-5 major psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), except tobacco-use disorder
* Positive drug screen
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03471182
|
{
"brief_title": "Investigation of Cocaine Addiction Using mGluR5 PET and fMRI",
"conditions": [
"Cocaine Dependence"
],
"interventions": [
"Other: Magnetic Resonance Imaging",
"Behavioral: Psychiatric and Cognitive Testing",
"Radiation: Positron Emission Tomography",
"Drug: Cocaine Self-adminstration"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03471182",
"official_title": "Investigation of Cocaine Addiction Using mGluR5 PET and fMRI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-18",
"study_completion_date(actual)": "2022-08-18",
"study_start_date(actual)": "2018-02-26"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-29",
"last_updated_that_met_qc_criteria": "2018-03-13",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-20",
"first_submitted": "2018-02-26",
"first_submitted_that_met_qc_criteria": "2023-10-05"
}
}
}
|
#Study Description
Brief Summary
Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous injection between a retractable fixed syringe needle and the technique involving needle exchange; Comparing bruise formation following administration of insulin subcutaneous injections between RFS and the conventional technique.
Method Study site A clinical trial was conducted in two medical-surgical units in a hospital in the period from June 15th to November 30th, 2009, after approval by the Ethics and Research Committee.
Intervention In a group of patients the investigators used syringes with retractable fixed needle to administer subcutaneous and intramuscular injections. In the group of control, the investigators used the standard technique to administer medications.
Population of study Patients were sequentially enrolled through a lottery system of exposure using random numbers kept in sealed, opaque envelopes.
Sampling design and sample size Subcutaneous injection The sample size was based on the expected proportion of bruising following the injection. It was expected that 40% of patients would show bruising with the conventional technique and 20% with the technique under study for subcutaneous applications. With an alpha error of 5% (p = 0.05) and power of study of 80% (beta error of 20% or 0.2) 240 patients were included, 120 in each group.
Intramuscular injection The sample size was based on the proportion of patients with moderate to severe pain. It was considered normal the incidence of moderate to severe pain in 30% with a needle exchange, whereas it was considered an increase of up to 40% with the retractable fixed needle. The investigators included 500 patients in each group.
#Intervention
- DEVICE : needle exchange
- Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous injection between a retractable fixed syringe needle and the technique involving needle exchange; Comparing bruise formation following administration of insulin subcutaneous injections between retractable fixed needle and the conventional technique.
|
#Eligibility Criteria:
Inclusion Criteria:
* The investigators included all patients over 18 who agreed to participate in the study for subcutaneous and intramuscular injections. The monitoring was done after the reading, comprehension check, and signing of the Term of Free Consent and Clarification.
Exclusion Criteria:
* The investigators excluded patients taking anticoagulants or those who had coagulation disorders, injuries, or skin changes.
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
|
NCT01271608
|
{
"brief_title": "Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.",
"conditions": [
"Knowledge, Attitudes, Practice",
"Injection Site Reactions"
],
"interventions": null,
"location_countries": [
"Brazil"
],
"nct_id": "NCT01271608",
"official_title": "Intramuscular and Subcutaneous Injections: is it Necessary to Have Needles Exchanged?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-01-07",
"last_updated_that_met_qc_criteria": "2011-01-06",
"last_verified": "2009-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-07",
"first_submitted": "2011-01-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
Detailed Description
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. Irinotecan will be administered once every 14 days, the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels: 200mg/w, 400mg/w, 600mg/w, weekly. The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks, when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.
#Intervention
- DRUG : Nimotuzumab
- 200,400,600 or 800mg weekly until progression or AEs
- DRUG : Irinotecan
- 180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent form signed before performing any of the study's specific procedures.
* ECOG performance status 0 <= age <= 2.
* Age > 18，both genders.
* Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
* Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
* At least 1 measurable lesions ,( longest diameter>= 1 cm by spiral computed tomography (CT) scan or MRI)
* Life expectancy more than 3 months.
* K-ras is wild type
* Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
* Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
* Haemoglobin>=90g/L , granulocyte>=1.5×109/L ,WBC >=3×109/L, platelet count>=100×109/L
* TBIL<= 1.5 x ULN ,ALK<= 2.5 x ULN or <= 5ULN（Liver metastasis），AST and ALT<= 2.5 x ULN or <= 5ULN（Liver metastasis）,Creatinine <= 1.5 x ULN
* No brain metastasis
Exclusion Criteria:
* Previous radiotherapy at lesions within three months
* Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
* Received other anti EGFR monoclonal antibody treatment
* Complete or incomplete intestinal obstruction
* Participation in other interventional clinical trials within 1 month
* Psychiatric disease affected cognitive ability, including brain metastasis
* Peripheral neuropathy lesion is more than I stage.
* History of serious allergic or allergy
* Pregnant or breast-feeding women
* Patients with the history of Serious lung or hear disease
* Other malignant tumor
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
|
NCT05278728
|
{
"brief_title": "Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer",
"conditions": [
"Colorectal Cancer"
],
"interventions": [
"Drug: Irinotecan",
"Drug: Nimotuzumab"
],
"location_countries": [
"China"
],
"nct_id": "NCT05278728",
"official_title": "Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-14",
"last_updated_that_met_qc_criteria": "2022-03-03",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-14",
"first_submitted": "2015-08-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
Detailed Description
Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d.
Secondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL \> 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.
#Intervention
- DRUG : Darunavir
- to assess efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
- Other Names :
- Prezista
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected adults,
* age >= 18 years,
* with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (>= 6 months),
* virologically controlled (VL <= 50 cp/ml,
* >= 1 year,
* at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count >= 300/mm3 >= 6 months,
* virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and
* with no history of virological failure (VL > 200 cp/mL after >= 6 months under PI and/or used NRTI),
* no current opportunistic infection,
* renal clearance >= 60 mL/min if tenofovir is used,
* transaminases (SGOT, SGPT) plasma levels < 2N,
* hemoglobin > 11 g/dL,
* platelets count > 150 000/mm3,
* negative pregnancy test in women with childbearing potential,
* informed written consent signed by both the investigator and the subject,
* national insurance scheme (article L1121 <= age <= 11 of the French Public Health code),
* no participation to any other clinical trial
Exclusion Criteria:
* HIV-2 infection,
* current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,
* virus genotypically resistant to darunavir and the used NRTIs,
* history of virological failure (VL > 200 cp/mL after >= 6 months under PI and/or used NRTI),
* irregular follow-up and/or history of lack of adherence to ART <= 12 months,
* current pregnancy,
* current opportunistic infection,
* associated treatment containing one or more drugs interacting with hepatic cytochromes,
* any addictive behaviors (alcohol consumption, drugs ...) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02384967
|
{
"brief_title": "Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients",
"conditions": [
"HIV INFECTION"
],
"interventions": [
"Drug: Darunavir"
],
"location_countries": [
"France"
],
"nct_id": "NCT02384967",
"official_title": "Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-24",
"last_updated_that_met_qc_criteria": "2015-03-04",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-10",
"first_submitted": "2015-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment.
This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility.
The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.
Detailed Description
Constipation is a common condition. Perception of a healthy bowel movement varies widely within and among populations but the Rome III Criteria is a standardised tool that diagnoses functional constipation on the basis of the following symptoms for the last 3 months with symptom onset at least 6 months prior to diagnosis:
1. Must include two or more of the following:
* Straining during at least 25% of defecations
* Lumpy or hard stools in at least 25% of defecations
* Sensation of incomplete evacuation for at least 25% of defecations
* Sensation of anorectal obstruction/blockage for at least 25% of defecations
* Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
* Fewer than three defecations per week
2. Loose stools are rarely present without the use of laxatives
3. Insufficient criteria for irritable bowel syndrome
Additional to being extremely uncomfortable, untreated constipation can lead to faecal impaction (with resulting faecal incontinence), particularly in elderly and confused people and is believed to be a risk factor for haemorrhoids (piles) and diverticular disease. However even without a medical diagnosis the undesired symptoms can reduce perceived quality of life and successful management may involve a number of factors. Standard treatment consists of disimpaction and the administration of laxatives to achieve a normal bowel habit of passing a soft stool without pain. The daily use of laxatives long term is often advised against as it can make your body dependent on them, causing your bowel to no longer function normally.
Stool softening is a physician's first step in the management of chronic constipation. Psyllium has been shown to soften stools by increasing stool water content, far more than most common dietary fibres. It forms a soft gel which eases the stool along the lower digestive tract ready for evacuation. This bulkier faeces presses on the wall of the intestine, stimulating the muscles to contract and force the contents forward, a process known as 'peristalsis'. If there is insufficient fibre in the diet, the faeces will move more slowly and there will be more time for water to be absorbed from the ingested food into the rest of the body, leaving the faeces smaller and harder, which in turn is more difficult to move. Psyllium has the advantage of being much gentler than some common fibres (such as wheat bran) that can be irritating to a sensitive bowel.
Studies using psyllium in a range of doses of 7g up to 24g a day show positive results in relation to increasing stool frequency and weight, and improving stool consistency, in turn improving associated abdominal pain and discomfort. These results were applicable in both adults and the elderly. Although psyllium works in a much more gentle natural way, in some studies it was seen to be superior to or comparative to commonly used laxatives.
Probiotics had the added advantage of improving stool frequency and consistency and accompanying abdominal pain, most likely by their positive effects on the gut microflora often seen to be imbalanced in those with constipation. These effects were seen in infants, adults and the elderly with no adverse events such inducing loose stools.
Lastly, inulin in a range of doses of 1.5g up to 50g a day was seen to improve not only beneficial bacteria counts but also bowel transit in infants, adults and the elderly and in one study was again seen to be more effective than a common laxative but without the side effects.
This study aims to increase the body of scientific data on psyllium by way of a randomised, placebo-controlled study.
#Intervention
- DIETARY_SUPPLEMENT : Natural Fibre Supplement
- Natural Fibre Supplement 2 doses per day for 4 weeks
- Other Names :
- Lepicol
|
#Eligibility Criteria:
Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must;
* Be able to give written informed consent,
* Be between 18 and 80 years,
* Subject has chronic functional constipation according to the Rome III Diagnostic Criteria, where (f) is mandatory.
i. Must include two or more of the following:
1. Straining during at least 25% of defæcations
2. Lumpy or hard stools in at least 25% of defæcations
3. Sensation of incomplete evacuation for at least 25% of defæcations
4. Sensation of anorectal obstruction / blockage for at least 25% of defaecations
5. Manual manœuvers to facilitate at least 25% of defæcations (e.g., digital evacuation, support of the pelvic floor)
6. Fewer than 3 defæcations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis
* Subjects will continue on his/her normal diet,
* The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
* Are less than 18 and greater than 80 years,
* Females are pregnant, lactating or wish to become pregnant during the study.
* Are hypersensitive to any of the components of the test product,
* Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
* Subject has an obstructive or metabolic aetiology for constipation,
* Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
* Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit,
* Subject has a history of drug and/or alcohol abuse at the time of enrolment
* Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
* Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
* Subjects may not be receiving treatment involving experimental drugs,
* If the subject has been in a recent experimental trial, these must have been completed not less than 90 days prior to this study.
* Have a malignant disease or any concomitant end-stage organ disease
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:
Yes
|
NCT02073006
|
{
"brief_title": "A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation",
"conditions": [
"Constipation"
],
"interventions": [
"Dietary Supplement: Natural Fibre Supplement"
],
"location_countries": [
"Ireland"
],
"nct_id": "NCT02073006",
"official_title": "A Randomised, Double-blind, Placebo-Controlled, Parallel Study to Evaluate the Effects of Lepicol® in Adults With Chronic, Functional Constipation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-07",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-15",
"last_updated_that_met_qc_criteria": "2014-02-25",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-27",
"first_submitted": "2014-02-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease
#Intervention
- PROCEDURE : Transcutaneous levator recession
- recession of the upper and lower eyelid retractors can improve the upper eyelid contour if the patient has lateral flare (common in TED). The choice of procedure depends on severity of lid retraction and associated features like proptosis, status of extraocular muscles, and corneal condition
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease
Exclusion Criteria:
* Patients refused to participate in the study, patients with systemic diseases causing lid retraction (such as Guillain-Barré syndrome), pseudo retractions, contralateral ptosis, local skin condition (as scar adherence), medication (such as sympathomimetic drugs, lithium, and steroid), neurological conditions (such as dorsal midbrain syndrome and hydrocephalus) and thyroid related lid retraction
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05671120
|
{
"brief_title": "Transcutaneous Levator Recession for Non-thyroid Lid Retraction",
"conditions": [
"Eye Diseases"
],
"interventions": [
"Procedure: Transcutaneous levator recession"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05671120",
"official_title": "Transcutaneous Levator Recession for Non-thyroid Lid Retraction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-06-01",
"study_completion_date(actual)": "2021-08-02",
"study_start_date(actual)": "2019-01-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-04",
"last_updated_that_met_qc_criteria": "2023-01-01",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-04",
"first_submitted": "2023-01-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A study was designed with two specific aims: (1) to assess the effect of soy bread, compared with wheat bread, on markers of bone metabolism and cardiovascular health, and (2) to evaluate whether soy bread consumption affects the metabolism of phytoestrogens. To answer Aim 1, a double-blind randomized crossover trial was conducted. Individuals with an ability to metabolize a specific isoflavone, daidzein, consumed 3 slices of bread (either soy or wheat) daily over a 12-week period. After a 4-week wash-out period, subjects consumed 3 slices/day of the other type of bread. Markers of bone metabolism and cardiovascular health were evaluated before and after each time period. To answer Aim 2, individuals who did not metabolize daidzein at baseline entered a double-blind randomized trial of soy bread with or without fructooligosaccharide (a type of dietary fiber) over an 8-week period. Subjects were evaluated regarding their ability to metabolize daidzein to equol.
Detailed Description
Soy beans are rich in isoflavones, such as genistein and daidzein, which exhibit estrogenic activity. While the cardiovascular benefits of isoflavones in soy have been recognized, the effects on bone metabolism are less well known. The National Aeronautics and Space Administration expressed an interest in the effects of soy on bone loss and a former NASA scientist developed a soy product, soy bread, which may be more palatable for most Americans than currently available soy foods. A two-treatment two-period crossover trial was conducted to assess the effects of soy bread consumption on deoxypyridinoline, N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, calcium, leptin, insulin-like growth factor-1, luteinizing hormone, follicle-stimulating hormone, testosterone, cholesterol (total, HDL, LDL), triglycerides, apolipoprotein AI, apolipoprotein B, C-reactive protein, and glycosylated hemoglobin. The crossover trial was conducted in subjects identified as having the ability to metabolize daidzein to equol. The treatment was 3 servings of soy bread daily over a 12-week period. The control period included 3 servings of a placebo wheat bread over a 12-week period. For subjects who did not metabolize daidzein to equol at baseline, a pretest-posttest trial of soy bread consumption over an 8-week period was conducted to examine whether 3 servings/day of soy bread increased urinary equol concentrations and whether the addition of fructooligosaccharide enhanced this excretion.
#Intervention
- BEHAVIORAL : Soy bread
|
#Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women and men who were 50 years or older.
Exclusion Criteria:
* Allergy to soy, wheat, and/or nuts. Use of hormone replacement therapy within the past 6 months. Diagnosis of osteoporosis or use of bone loss medications. Use of drugs within the past 3 months which increase the risk of osteoporosis. End-stage renal disease or other nephropathies. Chemotherapy within the past 6 months. Active gastrointestinal disorders. Diagnosis of thyroid disorder. Use of cholesterol-lowering medications within the past month. Vitamin, mineral, protein, and/or calorie deficiency. Alcoholism, acute or chronic hepatitis, cirrhosis. Use of systemic antibiotics within the past 6 months. Currently under dietary restrictions that would conflict with the intervention. Anticipated mental or physical incapability of adhering to the dietary protocol during the time period of the study (e.g. expected travel).
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00366860
|
{
"brief_title": "Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease",
"conditions": [
"Osteoporosis",
"Cardiovascular Diseases"
],
"interventions": [
"Behavioral: Soy bread"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00366860",
"official_title": "Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05",
"study_completion_date(actual)": "2008-05",
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-02",
"last_updated_that_met_qc_criteria": "2006-08-17",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-21",
"first_submitted": "2006-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.
Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.
Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.
Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Detailed Description
Background: With appropriate treatment, lung cancer patients can be a long-term survivor. However, many patients suffered from post-operative pulmonary complications, limited activity tolerance, and poor quality of life. Nurses in a great position to provide individualized health education regarding exercise for these patients; therefore to develop and test cost-effective nurses-lead lung rehabilitation exercise education programs deserver further scientific efforts.
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.
Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.
Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.
Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Significance: The study results will provide evidence for the efficacy of pulmonary rehabilitation and a home exercise program for enhancing exercise tolerance and quality of life in lung cancer survivors.
#Intervention
- BEHAVIORAL : Home rehabilitation exercise program
- After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.
|
#Eligibility Criteria:
Inclusion Criteria:
* aged 20 and older,
* diagnosed with stage I-IIIB non-small cell lung cancer
* completed initial cancer treatments and no planned cancer treatment in three months
* Karnofsdy Performance Status equal or greater then 50
* estimated survival time greater than six months
* with the permission of the patient's physician
Exclusion Criteria:
* having a medical condition precluding exercise (i.e. uncontrolled arrhythmias, uncontrolled hypertension, third-degree heart block, myocardial infarction within six months, unstable angina, acute congestive heart failure and taking anticoagulation for valve diseases).
* poor controlled diabetics (HbA1C>9%)
* regularly exercising in moderate or higher intensity three time a week within three month
* unable to walk independently
* unable to communicate
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03918538
|
{
"brief_title": "A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors",
"conditions": [
"Lung Cancer"
],
"interventions": [
"Behavioral: Home rehabilitation exercise program"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03918538",
"official_title": "A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-17",
"study_completion_date(actual)": "2017-03-17",
"study_start_date(actual)": "2015-09-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-17",
"last_updated_that_met_qc_criteria": "2019-04-16",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-17",
"first_submitted": "2019-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to measure the amount of movement between the bones of the shoulder joint when mobilization techniques are applied by a physical therapist.
Detailed Description
The purpose of this study is to image the articular joint movement of the glenohumeral joint utilizing ultrasound imaging (USI). Specific aims include: 1) measurement of the distance between the articular surfaces at rest; 2) measurement of the distance between the articular surfaces during manually applied glides of those surfaces; and 3) analysis of any association between the amount of glide and reported joint mobility, force application, or joint position.
Subjects will be recruited from a population of convenience. After consenting to participate, eligible subjects will complete a demographic questionnaire and pretesting of scapular and shoulder mobility. Two days of testing will be scheduled. On the first day, three grades of glenohumeral mobilization will be applied in the following directions: distraction, posterior and inferior. A handheld dynamometer will measure force; ultrasound imaging will record glenohumeral joint position. Each grade and direction will be repeated three times on the right and the left shoulder. On the second day, the mobilizations will be repeated. Measurements of humeral movement will be calculated from the ultrasound images.
#Intervention
- DEVICE : Manual Mobilization
- Stabilization of the glenoid fossa with movement of the humerus using varying degrees of force as applied by a physical therapist. Subject is positioned with the shoulder in 55 degrees of abduction and 30 degrees of horizontal adduction. Manual force is applied by a physical therapist on the proximal humeral head moving the humeral head posterior, inferior or lateral (distraction). An ultrasound transducer placed over the anterior shoulder joint provides imaging of the humeral head and the glenoid fossa. This manual intervention is repeated three times in each direction on each arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* asymptomatic subjects with no history of neck, shoulder, or arm pain; full active pain free range of motion at the cervical spine and shoulders
Exclusion Criteria:
* neuromuscular or musculoskeletal disorders; connective tissue disorders such as rheumatoid arthritis; inflammatory conditions such as Crohns disease; Down's syndrome; Marfan's syndrome; medically diagnosed hypermobility; history of neck, shoulder or arm trauma, pain, or surgery including dislocation and rotator cuff tears; pregnancy; and metal implants
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
|
NCT02338791
|
{
"brief_title": "Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder",
"conditions": [
"Disorder of Shoulder"
],
"interventions": [
"Device: Manual Mobilization"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02338791",
"official_title": "Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-26",
"study_completion_date(actual)": "2019-03-26",
"study_start_date(actual)": "2012-04"
},
"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)": "2019-04-22",
"last_updated_that_met_qc_criteria": "2015-01-09",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-14",
"first_submitted": "2015-01-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment approaches may not be suitable. Recently there has been a growing interest in positive psychology - the study of wellbeing, positive emotions and characteristics, and personal growth. The investigators believe that positive psychotherapy interventions may be beneficial after acquired brain injury, to reduce psychological morbidity. Because such interventions have not previously been applied in this population, the investigators propose to conduct a pilot randomised controlled trial to examine the feasibility of a brief positive psychotherapy intervention in an out-patient setting. This project will produce essential information to allow us to plan future full-scale clinical trials in this area.
#Intervention
- OTHER : Psychotherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or over;
* Diagnosis of stroke or acquired brain injury (confirmed clinically and/or radiologically);
* Between 3 and 12 months post-injury at time of recruitment;
* Presence of emotional distress (score in moderate or above range on at least one sub-scale of the Depression Anxiety Stress Scales; DASS-21);
* Medically stable;
* Able to consent to research.
Exclusion Criteria:
* Significant communication impairments that would preclude participation;
* Diagnosis of mild traumatic brain injury (due to the known additional complexities contributing to outcome in this population);
* Comorbid developmental learning disability or degenerative neurological condition.
Pre-injury history of mood disorder will not lead to exclusion.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01867684
|
{
"brief_title": "Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation",
"conditions": [
"Acquired Brain Injury",
"Emotional Distress"
],
"interventions": [
"Other: Psychotherapy"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01867684",
"official_title": "Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-05",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2013-07"
},
"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)": "2015-01-08",
"last_updated_that_met_qc_criteria": "2013-06-03",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-04",
"first_submitted": "2013-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed multiple myeloma.
Detailed Description
The protocol was originally designed as a Simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the International Uniform Response Criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.
#Intervention
- DRUG : Ruxolitinib 25 mg
- Ruxolitinib was supplied as 5 and 25 mg tablets.
- Other Names :
- INCB018424
- DRUG : Dexamethasone 40 mg
- Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma with evidence of measurable disease.
* Relapsed or refractory disease with at least one line of prior therapy.
* Adequate bone marrow reserve.
Exclusion Criteria:
* Received anti-cancer medications or investigational therapy in the past 28 days.
* Intracranial disease or epidural disease.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00639002
|
{
"brief_title": "A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Drug: Ruxolitinib 25 mg",
"Drug: Dexamethasone 40 mg"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00639002",
"official_title": "A Phase 2, Two Stage, Open-label, Clinical Trial to Determine the Therapeutic Effect and Safety of an Oral JAK2-inhibitor (INCB018424) in Patients With Relapsed or Refractory Multiple Myeloma",
"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)": "2008-03"
},
"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)": "2018-02-13",
"last_updated_that_met_qc_criteria": "2008-03-12",
"last_verified": "2018-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-19",
"first_submitted": "2008-03-12",
"first_submitted_that_met_qc_criteria": "2011-12-16"
}
}
}
|
#Study Description
Brief Summary
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).
Detailed Description
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.
#Intervention
- DEVICE : Multifocal Contact Lens
- The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
- DEVICE : Single Vision Contact Lens
- The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Visual acuity of 20/25 or better in both eyes with habitual contact lenses
* -0.75 D or more myopic in both eyes
* -0.75 D or less astigmatism in both eyes
* Current single vision contact lens wearer who does not require a reading aid
* CLDEQ-8 score of 12 or more points with habitual contact lenses
* No history of ocular surgery or medication
* Reports digital device use of at least 3 hours per day
* No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
* No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03544216
|
{
"brief_title": "Accommodative Relief for Uncomfortable Non-Presbyopes",
"conditions": [
"Asthenopia"
],
"interventions": [
"Device: Multifocal Contact Lens",
"Device: Single Vision Contact Lens"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03544216",
"official_title": "Accommodative Relief for Uncomfortable Non-Presbyopes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-06",
"study_completion_date(actual)": "2018-05-06",
"study_start_date(actual)": "2017-02-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-15",
"last_updated_that_met_qc_criteria": "2018-05-21",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-01",
"first_submitted": "2017-01-12",
"first_submitted_that_met_qc_criteria": "2019-01-24"
}
}
}
|
#Study Description
Brief Summary
This pilot study will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences in knee osteoarthritis. Basic clinical demographic information will be obtained as well as preoperative functional and pain assessment scores, functional tests, and pressure pain threshold measurement. The purpose of the study will be to investigate if any sex differences can be identified in these tissues and to investigate if there appears to be any relationship between these differences and functional scores and tests.
Detailed Description
The goal of this study is to determine if sex differences can be identified in the knee joint that can contribute to the differences in incidence and severity of knee osteoarthritis observed in men and women, particularly over the age of 50. Recent studies assessing the responses of articular chondrocytes to systemic factors suggest that there are underlying differences in the biochemical and molecular characteristics of male and female cells. It is also known that immune responses differ in males and females, suggesting that there may be important differences in the levels of immune modulators in the joint tissues, including the synovial membrane, the synovial fluid, and the cartilage itself. Responses to the vitamin D metabolite 1_,25(OH)2D3 are upregulated in osteoarthritic cartilage, raising the possibility that males and females differ in their circulating levels of vitamin D, in the content of vitamin D metabolites in the synovial tissues, or in the ability of the cells to respond to this steroid. Similarly, in post-menopausal women, circulating estrogen is reduced relative to testosterone, but it is not known if this might impact the knee. Most importantly, it is not known if potential sex differences can be correlated with severity of disease.
This study is based on the hypothesis that sex differences exist in different tissues of the knee joint, which contribute to the increased incidence and severity of knee osteoarthritis in older women as compared to older men.
To test this hypothesis, the investigators will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences.
#Intervention
- OTHER : musculoskeletal
- Many musculoskeletal conditions are impacted by the chromosomal sex of the patient. While osteoarthritis (OA) is predominant in men younger than 50 years of age, after age 50 the condition is more prevalent in women, particularly post-menopause. This has implications for diagnosis and treatment of OA, as well as for joint replacement.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient demographics (age, sex, BMI). 2. Clinical background material
* Post menopausal female
* List of all medications and supplements
1. Use of vitamin D supplements (duration and amount)
2. Use of bisphosphonates (past and current)
3. Use of estrogen (past and current)
* Prior trauma or knee surgery
1. Have you ever injured the operative knee so badly that it was difficult for you to walk for at least one week?
2. Have you ever had any kind of knee surgery? Please include arthroscopy (where they put a scope in your knee), ligament repair surgery, or a meniscectomy (where they repaired or cut away a torn meniscus or cartilage)?
* Prior intraarticular injections
1. Steroid
2. Hyaluronic acid
* SF 12
* WOMAC
* PASE functional scale
* Pain scale: The 11 question OARSI-OMERACT pain scale will be used. Patients will complete the pain scale within 2 weeks prior to surgery and at 3 months following surgery
* Knee pain map: Patients will complete this within 2 weeks prior to surgery and at 3 months following surgery
* Pressure pain thresholds at knee. This will be completed within 2 weeks prior to the surgery and at 3 months following surgery (see attachment for details) 3. Preoperative blood tests
a. Vitamin D level 25 D3 should be measured 4. Standard preoperative radiographs: AP, lateral, standing flexion AP and patellar sunrise
Exclusion Criteria:
* Patients with inflammatory arthritis
* Patients with osteonecrosis
* Patients with prior upper tibial osteotomy
* Premenopausal women
* Patients under age 65 years, older than 75 years
* Patients who are insulin dependent or diabetic
* Patients with a BMI>30
* Patients with a history of knee infection
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01403207
|
{
"brief_title": "An Analysis of Potential Sex Differences in Knee Osteoarthritis",
"conditions": [
"Degenerative Joint Disease",
"Osteoarthritis"
],
"interventions": [
"Other: musculoskeletal"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01403207",
"official_title": "An Analysis of Potential Sex Differences in Knee Osteoarthritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-03-14",
"last_updated_that_met_qc_criteria": "2011-07-25",
"last_verified": "2014-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-27",
"first_submitted": "2011-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.
Detailed Description
Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).
#Intervention
- DRUG : Intranasal Placebo
- Intranasal placebo
- DRUG : Intranasal Morphine 15 mg
- Intranasal Morphine 15 mg
- DRUG : Immediate Release Oral Morphine 60 mg
- Immediate Release Oral Morphine 60 mg
- DRUG : Intravenous morphine
- Intravenous morphine 7.5 mg
- DRUG : Intranasal morphine 7.5 mg
- Intranasal morphine 7.5 mg
- DRUG : Oral placebo
- Oral placebo
- DRUG : Intravenous placebo
- Intravenous placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 <= age <= 40 years
* Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
* Moderate or severe pain within 6 hours of completion of surgery
Exclusion Criteria:
* Other oral surgical procedures during the same session except the removal of supernumerary third molars
* Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
* Allergy to shellfish
Additional Inclusion/Exclusion Criteria May Apply
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
|
NCT00390312
|
{
"brief_title": "Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction",
"conditions": [
"Post-Operative Pain",
"Third Molar Extraction"
],
"interventions": [
"Drug: Oral placebo",
"Drug: Intravenous morphine",
"Drug: Intranasal Morphine 15 mg",
"Drug: Intravenous placebo",
"Drug: Intranasal Placebo",
"Drug: Immediate Release Oral Morphine 60 mg",
"Drug: Intranasal morphine 7.5 mg"
],
"location_countries": null,
"nct_id": "NCT00390312",
"official_title": "Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2001-11",
"study_completion_date(actual)": "2001-11",
"study_start_date(actual)": "2001-09"
},
"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)": "2008-01-04",
"last_updated_that_met_qc_criteria": "2006-10-17",
"last_verified": "2007-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-19",
"first_submitted": "2006-10-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.
Detailed Description
Because of a considerable increase in streptococcus pneumoniae meningitis with penicillin nonsusceptible strains, it is now largely recommended to add vancomycin to the third-generation cephalosporin antibiotic regimen. It has also been recently shown that use of dexamethasone reduces mortality and unfavorable outcome in adults with pneumococcal meningitis. However, concern has arisen, that dexamethasone may impair penetration of vancomycin in cerebrospinal fluid.
We therefore thought to measure in a purely observational study, blood and CSF vancomycin concentrations in adult patients with pneumococcal meningitis hospitalized in medical intensive care unit that received third-generation cephalosporin, vancomycin and dexamethasone. The aim of the study was to observe whether or not sufficient concentrations of vancomycin could be measured in the CSF despite the concomitant use of dexamethasone. Patients were cared for in a perfectly routine manner. There was no randomization. All patients received routine, recommended care (IDSA guidelines). There was no invasive procedure. Dexamethasone was administered according to the de Gans study (NEJM 2002). In these patients with severe meningitis, a second lumbar puncture was performed as recommended(IDSA Guidelines, CID 2004). At the same time, peripheral blood was taken. In both samples, vancomycin concentration was determined.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults (> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit
Exclusion Criteria:
* Allergy to one of the antibiotics used 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
|
NCT00162578
|
{
"brief_title": "Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis",
"conditions": [
"Pneumococcal Meningitis"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00162578",
"official_title": "Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-11",
"study_start_date(actual)": "2002-12"
},
"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)": "2007-07-23",
"last_updated_that_met_qc_criteria": "2005-09-09",
"last_verified": "2007-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-13",
"first_submitted": "2005-09-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This prospective, controlled study will compare the 3D cephalometric analysis of bone and craniofacial soft tissues in young (18-35 years) non-overweight apneic adults phenotype between a test group (with AHI 15) and a control group (healthy subjects with AHI \< 15).
Detailed Description
Objectives The goal of this study is to determine an accurate bone and soft tissue phenotype for the non-overweight apneic young adult.
Materials and Methods This study was approved by the ethics medical committee of the University hospital of Liege.
This prospective, controlled study will compare cephalometric 3D analysis of bone and craniofacial soft tissue phenotype of young, non-overweight apneic adults using cephalometric 3D analysis between a test group (with AHI 15) and a control group (healthy subjects with AHI \< 15).
The inclusion criteria were : (1) patients aged between 18 and 35 years ; (2) Body Mass Index (BMI) lower than 30kg/m² ; (3) alcohol consumption less than 4 unit per day ; (4) tabacco use less than 6 cigarettes per day ; (5) no illicit drug use ; and (6) absence of chronic pathology or medication.
The exclusion criteria were : (1) presence of an acute illness on the day of admission ; (2) patients treated with orthognathic surgery after apnea screening ; (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).
The test group consisted of 23 patients (9 girls and 14 boys) recruited in polysomnography in sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april 2023.
Concerning the control group, the participants, healthy adults volunteers are recruited among friends and families of students who collaborate with sleep center for scientific projects. These subjects have no complaints related to OSA and will have to undergo a sleep examination (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients (14 girls and 9 boys).
This study takes place in two stages. First, all patient are invited to an initial consultation where question about demographics (age, weight, height, gender) and medical history will be asked. At the end of this consultation, only patient of the control group leave with a sleep monitor to record their sleep for one night.
Afterwards, all patients (test and control group) will be invited to undergo a super low dose CBCT in the supine position at CHU Sart Tilman University Hospital.
Demographics and orthodontics data A general history will be taken, including gender, age, height, weight, medical and surgical history (e.g. presence/absence of tonsils and vegetations), current or past regular medication use, presence of allergies associated with allergic rhinitis, presence of asthma and presence of parafunctions.
Cephalometric data An ultra low dose CBCT ( 300μm resolution) will be performed in each patient with a field of 16x18 cm. A computerized 3D analysis will be performed with Dolphin Imaging 11.95 software. All these tools will allow the collection of the following data: parameters concerning the morphological typology and growth potential, the base of the skull, the maxilla, the mandible, the inter-maxillary relationship, the pharynx, the airways as well as the volumes of the different structures.
Sleep data The data will be collected by means of the epworth sleepiness scale (ESS) and a sleep recording of the polysomnography at the hospital type (AASM type 1 sleep recording) for the test group and of the ventilatory polygraph type (AASM type 3 sleep recording) for the control group.
#Intervention
- OTHER : CBCT
- CBCT examination in supine position A computerized 3D-analysis using Dolphin Imaging 11.95 software was performed in each CBCT.
|
#Eligibility Criteria:
Inclusion Criteria:
* (1) patients aged between 18 and 35 years ;
* (2) Body Mass Index (BMI) lower than 30kg/m² ;
* (3) alcohol consumption less than 4 unit per day ;
* (4) tabacco use less than 6 cigarettes per day ;
* (5) no illicit drug use ; and
* (6) absence of chronic pathology or medication.
Exclusion Criteria:
* (1) presence of an acute illness on the day of admission ;
* (2) patients treated with orthognathic surgery after apnea screening ;
* (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).
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
|
NCT06022679
|
{
"brief_title": "CBCT Analysis of the Craniofacial Architecture in Young, Non-overweight Apneic Adult Phenotype",
"conditions": [
"OSA"
],
"interventions": [
"Other: CBCT"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT06022679",
"official_title": "CBCT Analysis of the Craniofacial Architecture in Young, Non-overweight Apneic Adult Phenotype",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-01",
"study_completion_date(actual)": "2023-04-01",
"study_start_date(actual)": "2022-04-01"
},
"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)": "2023-09-05",
"last_updated_that_met_qc_criteria": "2023-08-31",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-05",
"first_submitted": "2023-08-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia providers, which in turn prevents their patients from having organ injury.
Detailed Description
Blood pressure management is an important part of anesthesia. Many factors contribute to a change in blood pressure during a surgical procedure, such as blood loss, manipulation by surgeons, and there are several mechanisms through which anesthesia itself changes blood pressure. Although a high blood pressure also occurs during anesthesia, most of these factors lower a patient's blood pressure. When a patient's blood pressure becomes too low, the internal organs become at risk of receiving not enough blood (low perfusion or hypoperfusion). This low perfusion state can result in organ damage (ischemia) because of an insufficient supply of oxygen and glucose. Hence the important task of anesthesia providers to maintain the blood pressure of patients, using a wide range of drugs and other interventions.
A big challenge in blood pressure management is to know when a low blood pressure indeed results in low perfusion of organs. There is a large variation between patients in how susceptible they are to low blood pressure, as well as a difference between the organs in how easily they are damaged because of low perfusion. Elder patients, or patients with preexisting hypertension, heart problems or other cardiovascular diseases are more prone to a low blood pressure and are more likely to develop organ ischemia when there is a low blood pressure. The kidneys, the heart and the brain are the organs that are most at risk of organ damage. As one cannot measure the perfusion states of individual organs in individual patients, it is very difficult to know 'how low to go' with a patient's blood pressure.
Recent studies have used large datasets of patients to demonstrate that there is statistical association between low blood pressure during surgery and various types of organ injury. As patients are already treated for low blood pressure by anesthesia providers, this suggests that patients have low organ perfusion states despite the current treatment standards. A patient's blood pressure is not simply a dial that can be adjusted to a specific level. Finding the right level of interventions can be difficult in some patients. Consequently, lower blood pressures are common in anesthesia, even with the current standards of blood pressure management.
In this proposed study the investigators will implement two forms of decision support to assist anesthesia providers in blood pressure management. The decision support aims to educate anesthesia providers about the risks of low blood pressures in direct relation to the patients that they treat. One form of decision support will provide automated notifications through pagers and through the anesthesia information management system. These automated notifications pop up when the patient's blood pressure drops below a level that is associated with a risk of organ injury, and thus alerts the anesthesia provider of the blood pressure and its associated risk. The second form of decision support will send a postoperative email the day after the procedure when the patient has had a low blood pressure for particular duration. This email then provides feedback to the anesthesia provider by informing them of the increased risks of organ injury that are associated with that low blood pressure.
The study will look at both a change in patient outcome and a change in blood pressure management and will be performed at the Vanderbilt University Medical Center (VUMC). The change in patient outcome will primarily be studied through the occurrence of acute kidney injury in the first days following the procedure at the VUMC. The change in blood pressure management (provider behavior) will be studied by observing the depth and duration of low pressures during anesthesia, and the number of interventions that have been used to treat the blood pressure. Patient outcome will be studied by comparison of a baseline phase - before the decision support is implemented and uses historic data- and the intervention phase - the period during which the intervention is active. Only routinely collected clinical data will be used for these analyses: no additional data collection is required.
As it is impossible to know which form of decision support will be the most effective, the first three months of the intervention period will be a 'nested cluster-randomized trial'. The anesthesia providers (not the patients) will be randomized to either the automated notifications or the feedback emails. After three months all anesthesia providers will receive both forms of decision support for the remainder of the intervention period. The reason why anesthesia providers are randomized only during the first three months is that cross-over or contamination between the two groups is expected. This contamination could make it impossible to study the effect of the decision support on patient outcome, as there will be no longer any difference between the study groups.
#Intervention
- PROCEDURE : Attending real-time decision support
- Near real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia.
- PROCEDURE : In-room real-time decision support
- Near real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia.
- PROCEDURE : Attending feedback emails
- Attending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
- PROCEDURE : In-room provider feedback emails
- In-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
- DEVICE : Anesthesia Information Management System (AIMS)
- The anesthesia electronic record keeping system
- DEVICE : Perioperative Data Warehouse (PDW)
- The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails.
- PROCEDURE : General anesthesia
- Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
- DEVICE : Pager system
- The mobile pager system through which alerts can be sent
- PROCEDURE : Central neuraxial anesthesia
- Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.
- Other Names :
- Regional anesthesia, Spinal anesthesia, Intrathecal anesthesia, Subarachnoid anesthesia, Epidural anesthesia, Central neuraxial blockade
- PROCEDURE : Non-cardiac surgery
- Any surgical intervention that is not aimed at surgical correction of the heart
- DRUG : Propofol
- Anesthetic drug used to maintain general anesthesia
- DRUG : Sevoflurane
- Anesthetic drug used to maintain general anesthesia
- DRUG : Desflurane
- Anesthetic drug used to maintain general anesthesia
- DRUG : Isoflurane
- Anesthetic drug used to maintain general anesthesia
- DRUG : Ephedrine
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Phenylephrine
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Norepinephrine
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Epinephrine
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Dobutamine
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Dopamine
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Isoproterenol
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Milrinone
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Atropine
- Cardiovascular drugs used to treat intraoperative hypotension
- DRUG : Glycopyrrolate
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Vasopressin
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Terlipressin
- Cardiovascular drug used to treat intraoperative hypotension
- DRUG : Sodium Chloride 0.9%
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Ringer's lactate
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Hydroxyethyl starch solutions
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Fresh Frozen Plasma
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Packed Red Blood Cells
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Albumin solutions
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Plasma-Lyte
- Intravenous fluid used to treat intraoperative hypotension
- DRUG : Lidocaine
- Local anesthetic used for central neuraxial anesthesia.
- Other Names :
- Lignocaine
- DRUG : Bupivacaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Levobupivacaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Ropivacaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Mepivacaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Tetracaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Prilocaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Procaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Chloroprocaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Benzocaine
- Local anesthetic used for central neuraxial anesthesia.
- DRUG : Articaine
- Local anesthetic used for central neuraxial anesthesia.
|
#Eligibility Criteria:
Inclusion Criteria:
* 60 years and older
* Inpatients
* Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia
Exclusion Criteria:
* Pre-existing end-stage renal disease: operationalized as a preoperative need for dialysis
* The following surgical procedures: renal surgery, cardiac surgery, organ transplantation, ophthalmic surgery, endoscopic gastrointestinal procedures, and (interventional) radiologic procedures.
* small non-invasive or minimally-invasive procedures will also be excluded, operationalized as excluding procedures with a surgical time of less than twenty minutes.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02726620
|
{
"brief_title": "Decision Support for Intraoperative Low Blood Pressure",
"conditions": [
"Hypotension"
],
"interventions": [
"Drug: Mepivacaine",
"Drug: Ropivacaine",
"Procedure: General anesthesia",
"Drug: Albumin solutions",
"Drug: Dobutamine",
"Drug: Lidocaine",
"Procedure: In-room provider feedback emails",
"Drug: Prilocaine",
"Drug: Norepinephrine",
"Device: Anesthesia Information Management System (AIMS)",
"Procedure: Central neuraxial anesthesia",
"Drug: Packed Red Blood Cells",
"Drug: Isoproterenol",
"Procedure: Attending real-time decision support",
"Drug: Fresh Frozen Plasma",
"Drug: Atropine",
"Device: Pager system",
"Procedure: Non-cardiac surgery",
"Drug: Phenylephrine",
"Drug: Ephedrine",
"Drug: Milrinone",
"Drug: Terlipressin",
"Procedure: Attending feedback emails",
"Drug: Hydroxyethyl starch solutions",
"Drug: Benzocaine",
"Drug: Ringer's lactate",
"Drug: Desflurane",
"Drug: Glycopyrrolate",
"Drug: Tetracaine",
"Drug: Propofol",
"Device: Perioperative Data Warehouse (PDW)",
"Drug: Epinephrine",
"Drug: Procaine",
"Procedure: In-room real-time decision support",
"Drug: Isoflurane",
"Drug: Plasma-Lyte",
"Drug: Vasopressin",
"Drug: Articaine",
"Drug: Bupivacaine",
"Drug: Sodium Chloride 0.9%",
"Drug: Levobupivacaine",
"Drug: Sevoflurane",
"Drug: Chloroprocaine",
"Drug: Dopamine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02726620",
"official_title": "Decision Support for Intraoperative Low Blood Pressure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-31",
"study_completion_date(actual)": "2018-12-29",
"study_start_date(actual)": "2017-01-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-16",
"last_updated_that_met_qc_criteria": "2016-03-28",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-04",
"first_submitted": "2016-03-28",
"first_submitted_that_met_qc_criteria": "2019-04-24"
}
}
}
|
#Study Description
Brief Summary
Ten subjects will be enrolled in the study. Each subject will have their left and right forehead randomly assigned to receive 4 units of PrabotulinumtoxinA-xvfs or OnabotulinumtoxinA. Subjects will be reassessed at 2 weeks for evaluation of rhytide diminution around each injection point to assess relative diffusion of each drug in the forehead.
Detailed Description
This is a prospective, single-center, blinded, randomized, split-face study to investigate the area of spread or diffusion of onabotulinumtoxinA and prabotulinumtoxinA at the same dilution and dose in the treatment of forehead lines in adult subjects.
Ten adult subjects, 18 years or older, with moderate-to-severe dynamic and none-to-minimal static forehead lines will be enrolled. Upon enrollment and after a thorough review of the inclusion and exclusion criteria as well as obtaining written and informed consent, each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of prabotulinumtoxinA 2.5 cm above the orbital rim. As a control, the contralateral forehead half will receive 4 units or 0.1 cc of onabotulinumtoxinA at the same dilution. If applicable, a urine pregnancy test will be obtained prior to treatment. Subjects may be treated on the same day that they are screened and provide informed consent. Given the small volume of injection, tuberculin hubless syringes will be used to ensure accuracy of specific injection volumes. Injections will be delivered intramuscularly with the needle at a 90-degree angle or perpendicular to the skin surface. The left and right-side assignment will be determined based on the treating physician's selection of a sealed envelope using random numbers on the treatment day.
Following initial treatment, the subjects will be re-evaluated at a Day 14. Surface area of rhytide reduction will be measured in centimeters squared (incorporating length and width measurements) two-weeks post-injection to assess differences, if any, in rhytid reduction on each side of the forehead by a blinded investigator. The field of rhytid reduction (visual absence of horizontal forehead rhytids) will be measured while the frontalis fully contracted. Any adverse events will be recorded at the 2-week follow up. After the Day 14 assessment subjects will exit the study after which the investigator will assess the patient for any asymmetry and if the investigator deems it appropriate and the subject desires it, a touch up correction will be performed.
Subjects will be photographed at baseline and two weeks after treatment using Visia and 2D photography. Photos will be taken before and after marking the points of injection. Moreover, photos will be taken both with the frontalis muscle fully relaxed and fully contracted.
#Intervention
- DRUG : PrabotulinumtoxinA-Xvfs
- All subjects will receive one injection of 4 units or 0.1 cc of prabotulinumtoxin A into the frontalis at a single point 2.5 cm above the orbital rim at the mid-pupillary line.
The preparation of the 100-unit vial of prabotulinumtoxinA will be reconstituted gently and without shaking with 2.5 cc of 0.9% preserved normal saline solution. The investigator performing the injections will reconstitute study vials.
Subjects will be injected intramuscularly using a hubless tuberculin syringe. Injections will be done at a 90-degree angle or perpendicular to the skin surface. The target sites will be the mid-line of the pupil and 2.5 cm above the orbital rim.
- Other Names :
- Jeaveau
- DRUG : OnabotulinumtoxinA
- All subjects will receive one injection of 4 units or 0.1 cc of onabotulinumtoxinA into the frontalis at a single point 2.5 cm above the orbital rim at the mid-pupillary line.
The preparation of the 100-unit vial of onabotulinumtoxinA will be reconstituted gently and without shaking with 2.5 cc of 0.9% preserved normal saline solution. The investigator performing the injections will reconstitute study vials.
Subjects will be injected intramuscularly using a hubless tuberculin syringe. Injections will be done at a 90-degree angle or perpendicular to the skin surface. The target sites will be the mid-line of the pupil and 2.5 cm above the orbital rim.
- Other Names :
- Botox
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 65 years
* Moderate-to-severe dynamic forehead rhytides and none-to-minimal static forehead rhytides (score of 3 to 4 and score of 0 to 1, respectively, using a 5-point validated grading scale for forehead lines)1
* Subjects in good general health based on investigator's judgment and medical history
* Willingness to have facial exams and photos performed
* Must be willing to give and sign an informed consent form and photographic release form
* Negative urine pregnancy test result at the time of study entry (if applicable)
* Must be willing to comply with study treatments and complete the entire course of the study
Exclusion Criteria:
* Pregnant or breastfeeding
* Previous treatment with botulinum toxin of any serotype in the forehead area within the last 6 months
* History of permanent or long-acting fillers such as silicone, Sculptra® or Radiesse® in the treatment area
* Current history of substance abuse, including alcohol or other drugs
* Concurrent use of medications that affect neuromuscular transmission such as aminoglycoside antibiotics, anticholinesterases, lincosamides and polymyxins
* Marked facial asymmetry
* History of facial nerve palsy
* Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
* Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
* Known allergy or hypersensitivity to botulinum toxin preparation
* Any planned surgical intervention to the face for the duration of the trial
* Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
* Subjects with an active bacterial, viral, or fungal infection of the treatment areas
* Subjects with tattoos or excessive scarring in the treatment areas
* Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05807412
|
{
"brief_title": "Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides",
"conditions": [
"Rhytides"
],
"interventions": [
"Drug: PrabotulinumtoxinA-Xvfs",
"Drug: OnabotulinumtoxinA"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05807412",
"official_title": "A Prospective, Single-center, Blinded, Randomized, Split-face Study Evaluating the Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-26",
"study_completion_date(actual)": "2024-02-26",
"study_start_date(actual)": "2023-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-13",
"last_updated_that_met_qc_criteria": "2023-03-28",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-04-11",
"first_submitted": "2023-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study purpose is (1) to develop the new energy expenditure equation; (2) to increase accuracy of energy cost prediction of cycle ergometer; (3) to find out some dependent factors.
Detailed Description
Oxygen consumption (ml/min) was measured while subjects were at rest and exercised at four submaximal workloads in steady state on cycle ergometer. Bioelectrical impedance analysis was used to estimate the body fats and skeletal muscle mass.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy female
* Never received bicycle training
Exclusion Criteria:
* Exercise testing contraindications
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01077219
|
{
"brief_title": "Study on Energy Cost Prediction of Cycle Ergometer",
"conditions": [
"Healthy",
"Obesity"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01077219",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-08",
"study_completion_date(actual)": "2009-08",
"study_start_date(actual)": "2009-06"
},
"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)": "2010-03-01",
"last_updated_that_met_qc_criteria": "2010-02-26",
"last_verified": "2010-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-01",
"first_submitted": "2010-02-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is looking at problems people sometimes have taking in information from their senses. Specifically, we are comparing the way in which people diagnosed with schizophrenia process sound information, compared with people who have never been diagnosed with a psychiatric disorder. When people hear a loud sound they sometimes feel startled, and when they feel startled they usually blink their eyes. However, if they hear a softer sound shortly before the loud one they may not blink their eyes - in other words, the eye-blink response is smaller. When this happens it's called prepulse inhibition of startle. In this study, we want to measure the startle response and prepulse inhibition of startle in individuals diagnosed with schizophrenia versus individuals not diagnosed with schizophrenia. We also want to find out whether people show the same amount of prepulse inhibition of startle as other members of their family.
Detailed Description
Patients with schizophrenia have difficulty screening out irrelevant stimuli, and often have the experience of sensory flooding. These 'gating deficits' may contribute to the thought disorder, cognitive fragmentation and hallucinations which are so debilitating to these individuals. The acoustic startle response is a reflex contraction of the skeletal muscles in response to a sudden acoustic stimulus. It occurs across mammalian species and can be easily measured. The modulation of this reflex by a preliminary nonstartling stimulus is termed prepulse inhibition of acoustic startle (PPI), a paradigm which is used as an operational measure of sensorimotor gating. In consonance with the schizophrenia symptoms that are suggestive of gating deficits, many patients with schizophrenia have deficits in PPI when compared to healthy controls. The brain regions that modulate PPI include the hippocampus and prefrontal cortex, areas that are implicated as being abnormal in schizophrenia. Our prior work and work from other labs suggests that PPI impairment in schizophrenia does not improve with treatment and hence may be a trait related abnormality. Work from our current funding period supports our original hypothesis, namely that impaired PPI exhibits familial association. Specifically, we are finding that PPI in first degree family members of subjects with schizophrenia is impaired. Further work is needed in order to establish that PPI impairment is heritable.
An endophenotype is a measurable trait or phenotype detectable by a biological test. Using an endophenotype rather than presence or absence of disease is a powerful tool in the study of diseases with complex polygenic etiologies such as schizophrenia. Progress in the genetics of schizophrenia is greatly confounded by the difficulty in identifying individuals who carry genes contributing to schizophrenia. Incomplete penetrance and the fact that both heritable and environmental factors interact to produce the disease add to this difficulty. This means that some individuals carrying vulnerability genes for schizophrenia who fail to exhibit robust symptoms will be classified erroneously as unaffected in genetic studies, confounding attempts to reliably define the heritable phenotype. The phenomenon of incomplete penetrance is exhibited by the finding that the risk of schizophrenia is the same for children of affected and nonaffected monozygotic twins. The polygenic etiology of schizophrenia makes it unlikely that a pooled sample of individuals defined by the presence of schizophrenia will greatly overlap in the vulnerability genes that they carry. The goal of the endophenotype approach is to narrow the defined phenotype so that a more homogeneous genotype is expected, making it much more fruitful and to conduct genetic studies.
We hypothesize that impaired PPI will prove to be a heritable endophenotype in schizophrenia. Based on our work accomplished during the current funding period, we now propose to further develop this line of research by conducting a heritability analysis of PPI. Our field is greatly in need of this work as a prelude to endophenotype-based genetic studies. We will accomplish our important goal by collecting and characterizing a cohort of healthy controls and their families, and by expanding our sample of schizophrenia subjects and their families. We will collect diagnostic, symptom, cognitive, pedigree, and PPI data all subjects, and will collect blood and extract DNA for future genetic analyses. We will use a family based strategy to investigate the pattern and degree of heritability of impaired PPI in families of schizophrenia and control probands.
This project will provide the necessary next step in advancing the use of impaired PPI as a powerful tool for the discovery of vulnerability genes contributing to schizophrenia. Currently available treatments for this devastating disorder are sadly inadequate. Our medications are virtually ineffective for a subset of our patients. The discovery of vulnerability genes and of a method for biological subtyping of patients will allow our field to develop genetically informed new treatments that specifically target particular subtypes of patients. This approach is our best hope for bringing relief to patients suffering from this disease.
#Intervention
- BEHAVIORAL : Acoustic startle testing
- recording of eyeblink component of acoustic startle reflex with small surface electrodes during presentation of acoustic stimuli through headphones
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a Schizophrenia Spectrum disorder OR no history of Psychiatric Illness
Exclusion Criteria:
* History of head injury with loss of consciousness of more than 5 minutes
* History of neurological disease (ex. meningitis, encephalitis)
* Drug or alcohol abuse within the last 3 months
* Hearing loss
* Non-correctable vision problems
* Current cancer treatment (radiation or chemotherapy currently ongoing)
* History of Post Traumatic Stress Disorder
* Diagnosis of HIV or AIDS
* Uncontrolled diabetes
* History of seizures
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:
Yes
|
NCT00561561
|
{
"brief_title": "Sensorimotor Gating in Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Behavioral: Acoustic startle testing"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00561561",
"official_title": "Sensorimotor Gating in Schizophrenia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08-26",
"study_completion_date(actual)": "2011-08-26",
"study_start_date(actual)": "2001-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-07",
"last_updated_that_met_qc_criteria": "2007-11-20",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-11-21",
"first_submitted": "2007-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
CONTEXT Vaccination has reduced mortality and morbidity by controlling many vaccine-preventable diseases. To prevent recurrence of these diseases, high vaccine coverages (VCs) (≥ 95%) are needed. But VCs for infants remain suboptimal, and four out of 10 parents doubt the safety and efficacy of vaccines in France. The Ministry of Health therefore decided in July 2017 to expand vaccination requirements to 11 valences now required to enter in young children collective structures. This measure, which went into effect in January 2018, has produced significant effects on VCs, but despite this, vaccine hesitancy (VH) persists in the general population at a prevalence level that fluctuates around 20% to 25%.
Motivational interviewing is a collaborative conversational style that reinforces a person's own motivation and commitment to behavior change. It has been successfully tested in multiple domains related to health behavior change. It has also been adapted in Quebec in the area of vaccination and tested in maternity wards with postpartum mothers (Promovac study). Having led to an increase in the VCs of infants by an average of 7 percentage points and a 40% decrease in vaccine hesitancy, this approach has been in the process of being generalized to all maternity units in Quebec since 2017 (EMMIE program). It is indeed proving to be one of the most effective at present in improving confidence in early childhood vaccines.
OBJECTIVES The main objective of this research is to provide proof of concept that, in the French context of mandatory vaccination for infants but also of high rates of VH, an educational strategy based on the principles and techniques of motivational interviewing and carried out with parents in the maternity ward in the days following delivery can reduce vaccine hesitancy (VH).
The secondary objectives are as follows:
* to verify that this reduction in VH is associated with a change in knowledge, attitudes, and beliefs regarding vaccines;
* to verify that this reduction is sustainable (at 12 months);
* to evaluate the acceptability and satisfaction of the interview for the parents
METHODS This is a pragmatic randomized controlled multicenter study with individual randomization unit comparing the impact of motivational interviewing to a standard care with a leaflet on vaccination.
Motivational interviewing will be carried out by trained midwives from the two participating maternity units (one in Marseille (Bouches-du-Rhône) and the other in Toulon (Var)), as part of the routine care provided to parturients. The midwives will be trained by the founding specialist of motivational interviewing in Quebec, during a two and a half day training course. This training will include a presentation of the theoretical foundations of this approach, its adaptation to the field of vaccination, and interactive games to put it into practice. The trained midwives will then be able to put this approach into practice during a one-month pilot period with parturients, during which they will be able to benefit from support in the form of a debriefing. The actual survey will only start at the end of this pilot phase.
In each group, a questionnaire will be offered to the women (couples) who have agreed to participate, both before the motivational interview (or delivery of the leaflet) and after the interview (or delivery of the leaflet). The second questionnaire will be completed before discharge from the maternity hospital. A third evaluation time is planned at 12 months in both groups: it will be carried out by internet or telephone.
The primary endpoint will be the change in the vaccine hesitancy score, measured by an international scale validated in French (Opel scale).
Secondary endpoints will be changes in knowledge, attitudes and beliefs about vaccination between the two groups as well as satisfaction with the ME and the brochure.
Randomization will be performed in blocks of 8, prior to acceptance for participation in this research.
EXPECTED BENEFITS If the results of this research provide proof of concept that the educational strategy based on motivational interviewing adapted to the vaccination of infants after delivery, in maternity wards, makes it possible, in the French context, to reduce VH, this will be a major advance in public health in France. Indeed, even if the vaccination obligations introduced in January 2018 have had a positive impact on infant vaccination coverage, VH remains present in parents in a proportion that remains worrying (20 to 25% according to surveys). The results of this research will then allow us to study the conditions for generalizing motivational interviewing in order to reinforce confidence in vaccination, which is lacking in a significant part of the French population.
#Intervention
- BEHAVIORAL : Motivational Interviewing
- Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a midwife. The midwife will have first received a standardized 3 days training session on the content and techniques of MI. The MI intervention will be carried out in simple and understandable language in order to allow discussion and questions from parents rather than provide prescriptive and direct information. The intervention will last approximatively 15 to 20 minutes.
- OTHER : Information flyer
- Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the midwife.
|
#Eligibility Criteria:
Inclusion Criteria:
* Mothers aged 18 years or more
* Mothers residing in the PACA region (Provence-Alpes-Côtes-d'Azur) at the time of the delivery
* Mothers who can read and speak French
* Mothers able to give a free and informed consent
* Mothers who provide written consent
Exclusion Criteria:
* Mothers of new-born needing to be transferred in a 3rd level maternity ward (because of severe condition)
* Mothers who will leave early maternity ward (<24h)
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
|
NCT05093452
|
{
"brief_title": "MOTIVAC-MATER-Confiance",
"conditions": [
"Vaccination Promotion"
],
"interventions": [
"Other: Information flyer",
"Behavioral: Motivational Interviewing"
],
"location_countries": [
"France"
],
"nct_id": "NCT05093452",
"official_title": "Motivational Interviewing of Parents in Maternity Wards About Vaccination (Entretien Motivationnel Sur la Vaccination auprès Des Parents Dans Les maternités)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-26",
"study_completion_date(actual)": "2022-12-09",
"study_start_date(actual)": "2021-11-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-03",
"last_updated_that_met_qc_criteria": "2021-10-13",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-26",
"first_submitted": "2021-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated.
Detailed Description
This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated. The study contains 3 periods: the Screening / Baseline Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment. If subjects achieve stable disease (SD), partial response (PR), or complete response (CR) at the end of the Treatment Period, they may continue Oraxol treatment in a separate extension study.
#Intervention
- DRUG : Oraxol
- * HM30181 methanesulfonate monohydrate
* Oral paclitaxel capsules
- Other Names :
- HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Women >=18 years on day of consent
* Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist.
* Measurable disease as per RECIST v1.1 criteria
* Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
* Absolute neutrophil count (ANC) >=1.5 x 109/L
* Platelet count >=100 x 109/L
* Hemoglobin (Hgb) >=9 g/dL
* Adequate liver function as demonstrated by:
* Total bilirubin of <=1.5 mg/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 x upper limit of normal (ULN) or <=5 x ULN if liver metastasis is present
* Alkaline phosphatase (ALP) <=3 x ULN or <=5 x ULN if bone metastasis is present
* Gamma glutamyl transferase (GGT) <10 x ULN
* Adequate renal function as demonstrated by serum creatinine <=1.5 x ULN
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 3 months
* Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
* Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period
* Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period (Weeks 1 and 4) through the completion of protocol-specified PK sampling for that week
* Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
* Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before Week 1 dosing.
Exclusion Criteria:
* Have not recovered to <= Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
* If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
* Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
* Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
* Known CNS metastasis, including leptomeningeal involvement
* Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
* Are currently receiving other medications intended for the treatment of their malignancy
* Women who are pregnant or breastfeeding
* Taking any of the following prohibited medications:
* Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
* Strong inhibitors (eg, gemfibrozil) or inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
* Strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication >=1 week before dosing and remain off that medication through the end of study treatment.
* An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg,digoxin, dabigatran) within 24 hours prior to start of dosing in the study
* Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
* Known allergic reaction or intolerance to study medication components
* Known allergic reaction or intolerance to contrast media
* Subjects who, in the Investigator's opinion, are not suitable for participation in this study
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
|
NCT04993040
|
{
"brief_title": "A PK Study of Oraxol in Breast Cancer Patients",
"conditions": [
"Breastcancer"
],
"interventions": [
"Drug: Oraxol"
],
"location_countries": [
"China"
],
"nct_id": "NCT04993040",
"official_title": "A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-09",
"study_completion_date(actual)": "2020-12-09",
"study_start_date(actual)": "2019-04-22"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-06",
"last_updated_that_met_qc_criteria": "2021-07-28",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-06",
"first_submitted": "2019-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study measures the effects of an Adapted Physical Activity on postural control of residents in nursing home. Half of participants will follow a program training 3 times a week during 8 weeks, while the other half will receive the usual accompaniment.
#Intervention
- OTHER : Adapted Physical Activity
- The sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training.
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to walk 20 meters with or without auxiliary help
* Able to stand 1 minute without help
* Health status considered stable
* Life expectancy greater than 6 months
* No major cognitive impairment preventing them from understanding a simple instruction
* No severe visual impairment
* No severe deafness
* Understanding french
* Able to discern
Exclusion Criteria:
* Unable to walk 20 meters with or without auxiliary help
* Unable to stand 1 minute without help
* Health status considered unstable
* Estimated life expectancy at less than 6 months
* Major cognitive impairment preventing them from understanding a simple instruction
* Severe visual impairment
* Severe deafness
* Not understanding french
* Inability to discern
Sex :
ALL
Ages :
- Minimum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03759977
|
{
"brief_title": "Effects of an Adapted Physical Activity on the Postural Control of Residents in Nursing Home.",
"conditions": [
"Postural Control"
],
"interventions": [
"Other: Adapted Physical Activity"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT03759977",
"official_title": "Effects of Adapted Physical Activity on the Static and Dynamic Postural Control of Residents in Nursing Home: an Exploratory Study of 8 Weeks in the Réseau Santé de la Glâne (Canton of Fribourg, Switzerland).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-22",
"study_completion_date(actual)": "2019-03-22",
"study_start_date(actual)": "2019-01-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-04-18",
"last_updated_that_met_qc_criteria": "2018-11-28",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-30",
"first_submitted": "2018-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether the study drug is effective in preventing the recurrence of atrial fibrillation (an abnormal heart rhythm).
#Intervention
- DRUG : SB-207266
- White, oval, biconvex tablets containing either 10mg, 25mg or 40mg
- OTHER : Placebo
- Placebo to match SB-207266
|
#Eligibility Criteria:
Inclusion Criteria:
* Symptomatic persistent atrial fibrillation requiring DC cardioversion.
* Duration of AF >48 hrs. <6 months
Exclusion Criteria:
* Concomitant Class I and/or III anti-arrhythmic drugs.
* Amiodarone treatment within 3 months of the study.
* Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
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
|
NCT00041496
|
{
"brief_title": "Prevention Of Recurrence Of Atrial Fibrillation",
"conditions": [
"Fibrillation, Atrial"
],
"interventions": [
"Other: Placebo",
"Drug: SB-207266"
],
"location_countries": null,
"nct_id": "NCT00041496",
"official_title": "A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of SB 207266 in Patients With Symptomatic Persistent Atrial Fibrillation (AF)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2003-12",
"study_completion_date(actual)": "2003-12",
"study_start_date(actual)": "2001-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-11",
"last_updated_that_met_qc_criteria": "2002-07-11",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-07-12",
"first_submitted": "2002-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).
Detailed Description
This study will enroll 3 age cohorts:
Adults: 18-49 years, Children: 3-17 years and 6-35 months of age.
#Intervention
- BIOLOGICAL : Influsplit Tetra™ vaccine produced by investigational process (IP)
- Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
- Other Names :
- Fluarix Tetra™, Fluarix Quadrivalent® (GSK2321138A)
- BIOLOGICAL : Influsplit Tetra™ vaccine produced by licensed process (LP)
- Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
- Other Names :
- Fluarix Tetra™, Fluarix Quadrivalent® (GSK2321138A)
|
#Eligibility Criteria:
Inclusion Criteria:
Adults 18 <= age <= 49 years cohort:
* A male or female between, and including, 18 and 49 years at the time of vaccination.
* Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
* Written informed assent obtained from the subject if/as required by local regulations.
* Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
* Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after vaccination.
Pediatric cohort:
United States:
* A male or female subject between, and including, the ages of 3 and 17 years in the United States.
Rest of the World:
* A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States.
All participating countries:
* Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
* Written informed assent obtained from the subject if/as required by local regulations.
* Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
* Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
Adults aged 18 <= age <= 49 years cohort:
* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
* Administration of an influenza vaccine during the 6 months preceding entry into the study.
* Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
* Any history of Guillain-Barré Syndrome.
* Acute disease and/or fever at the time of enrolment. Fever is defined as temperature >= 38.0ºC/100.4ºF.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of chronic alcohol consumption and/or drug abuse.
* Any contra-indication to intramuscular administration of influenza vaccines.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Pediatric cohort
* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
* Administration of an influenza vaccine during the 6 months preceding entry into the study.
* Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
* Any history of Guillain-Barré Syndrome.
* Acute disease and/or fever at the time of enrolment. Fever is defined as temperature >= 38.0ºC/100.4ºF.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of chronic alcohol consumption and/or drug abuse.
* Any contra-indication to intramuscular administration of influenza vaccines.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02207413
|
{
"brief_title": "A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children",
"conditions": [
"Influenza"
],
"interventions": [
"Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)",
"Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)"
],
"location_countries": [
"France",
"United States",
"Poland",
"Germany",
"Spain",
"Bangladesh",
"Czechia"
],
"nct_id": "NCT02207413",
"official_title": "Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04-18",
"study_completion_date(actual)": "2015-04-18",
"study_start_date(actual)": "2014-08-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-06",
"last_updated_that_met_qc_criteria": "2014-07-31",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-04",
"first_submitted": "2014-07-24",
"first_submitted_that_met_qc_criteria": "2016-05-12"
}
}
}
|
#Study Description
Brief Summary
The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula and duration after SND. The aims of this study are: 1. To assess the functional disabilities of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC post SND within 3months, \>3- 6months,\> 6months -1 year, more than 1 year as four different groups, 20 patient in each group.
Detailed Description
Lymph node metastasis is one the most important prognostic-factors in head and neck cancer(HNC). Radical neck dissection (RND) has been the standard surgical method for HNC with neck lymph nodes metastasis in past decades. This operation includes removal of the sternocleidomastoid muscle (SCM), internal jugular vein (IJV) all cervical lymph nodes on one side and spinal accessory nerve (SAN), leading to significant ipsilateral shoulder syndrome caused by SAN dysfunction and impact quality of life. Despite most clinics prefer to use the nerve-sparing selective neck dissection (SND) for patient with N0 or N1 nodal disease today, shoulder disability and pain were still reported from 31% to 40% after this procedure. However, most previous studies evaluated the shoulder disability only by functional evaluation, range of motion, and questionnaire. The short and long term adverse effect to soft tissue around shoulder girdle after SND has not been reported. The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula and duration after SND. The aims of this study are: 1. To assess the functional disabilities of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC post SND within 3months, \>3- 6months,\> 6months -1 year, more than 1 year as four different groups, 20 patient in each group. Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand (DASH) questionnaire. Statistical analysis will perform by SPSS software (SPSS V 20. International Business Machines. USA).
#Intervention
- OTHER : ultrasonography and elastography
- Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand
|
#Eligibility Criteria:
Inclusion Criteria:
head and neck cancer by Never-Sparing Selective Neck dissection, SND, the skin condition is stable, there is no wound, infection or inflammation metastasis.
Exclusion Criteria:
(1) in head and neck cancer before surgery and there had been other nerves, bones, muscles, tendons, resulting in lesions of the shoulder pain disorders or a history of activity. (2) severe cognitive function can not meet the examiner. (3) age less than 20 years or > 65 years.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02369276
|
{
"brief_title": "Safety Study of Musculoskeletal Ultrasonographic to Assess Disabilities Arm of Head and Neck Cancer Patient",
"conditions": [
"Head and Neck Cancer"
],
"interventions": [
"Other: ultrasonography and elastography"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT02369276",
"official_title": "Musculoskeletal Ultrasonographic Assessment for the Soft Tissue Injury of Ipsilateral Shoulder of Head and Neck Cancer Patient Following Selective Neck Dissection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-31",
"study_completion_date(actual)": "2017-12-31",
"study_start_date(actual)": "2015-04"
},
"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)": "2018-05-14",
"last_updated_that_met_qc_criteria": "2015-02-20",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-23",
"first_submitted": "2015-02-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another primary purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet. A secondary aim will be to test the reliability and validity of the Actical accelerometer, SenseWear Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated energy expenditure or posture allocation from the 3 devices is associated with weight change during and following a low calorie diet (LCD).
Detailed Description
The study will take place over a period of one year. Participants will spend 3 weeks completing Phase I, and eight weeks completing Phase II (the weight loss phase of the study). Then, participants will return to the center at months 6 and 12 for a follow-up visit. During these visits, body weight, blood pressure, and pulse will be recorded, and questionnaires about eating attitudes and habits will be collected and assessed.
#Intervention
- BEHAVIORAL : Digital Photography of Foods
- The digital photography of foods method was developed to unobtrusively measure energy intake in naturalistic settings (e.g., cafeterias). Participants will be provided with cell-phones with digital cameras and cellular network capability. Participants were trained to take pictures of their food selection and plate waste and to send these pictures to the researchers over the cellular network. The participant will collect data in free-living conditions and these data will be collected in near real time.
- Other Names :
- digital photography
- OTHER : doubly labeled water
- Doubly labeled water, considered the gold standard for measuring energy intake in humans, was used to measure total daily energy expenditure during free-living conditions. DLW is used to obtain an accurate measure of total daily energy expenditure, which is equal to energy intake during energy balance.
- Other Names :
- Doubly labeled water (DLW)
- DEVICE : IDEEA
- The Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
- Other Names :
- Intelligent Device for Energy Expenditure and Activity
- BEHAVIORAL : low-calorie diet
- Participants will be instructed to consume five packets of Health One per day, which provides 800 kcal and 125% of Recommended Daily Intake of vitamins and minerals. Additionally participants will be instructed to consume a meal consisting of 200 kcal to 350 kcal daily, which could consist of a portion-controlled meal replacement or a home-cooked meal. Participants will meet with a Registered Dietitian at weeks 0, 2, 4, and 6 and receive instructions on adhering to the meal plan.
- Other Names :
- LCD
- DEVICE : Actical
- The Actical will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
- DEVICE : Sensewear Armband
- The Sensewear armband will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 65 years
* Body Mass Index 25 <= age <= 40
* Willing to eat foods provided for two days.
* Willing to wear the IDEEA( Intelligent Device for Energy Expenditure and Activity), which is a device that attaches to the body and records movement and activity.
* Willing to wear an accelerometer, which is similar to a pager that attaches to belt or clothing and measures activity.
* Willing to use a cell phone equipped with a digital camera to take pictures of foods for one week.
* Willing to undergo an 8 week weight loss diet, consisting of supplement or powdered shakes, portion-controlled entrees, or home-cooked meals.
Exclusion Criteria:
* A diagnosis of diabetes, cardiovascular disease, or cancer.
* Females who are pregnant or planning to become pregnant during the trail.
* Medications that influence appetite or body weight (weight loss medications such as sibutramine, antipsychotic medications such as olanzapine, or herbal weight loss products) taken during the previous three months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01678885
|
{
"brief_title": "Assessment of Energy Balance",
"conditions": [
"Caloric Intake and Energy Metabolism"
],
"interventions": [
"Other: doubly labeled water",
"Device: Actical",
"Device: IDEEA",
"Behavioral: low-calorie diet",
"Behavioral: Digital Photography of Foods",
"Device: Sensewear Armband"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01678885",
"official_title": "Assessment of Energy Balance",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2007-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-31",
"last_updated_that_met_qc_criteria": "2012-08-31",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-05",
"first_submitted": "2012-08-31",
"first_submitted_that_met_qc_criteria": "2014-09-19"
}
}
}
|
#Study Description
Brief Summary
In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
Detailed Description
Investigational drug# Oral magnesium Study title# To explore the regulatory effect of magnesium on intestinal flora in healthy adults # A Single-center, Prospective, Self-controlled trial.
Principal Investigator# Professor Yu Chen, Department of Gastroenterology, The Seventh Affiliated Hospital, Southern Medical University.
Professor Peng Chen, Department of Pathophysiology, School of Basic Medical Sciences, Southern Medical University.
Study subjects# Healthy adult, Age 20-30 years Study phase# Investigator Initiated Trial(IIT) Study objectives# The objective of the study is to explore the regulatory effect of magnesium on intestinal flora in healthy adults Study design# A Single-center, Prospective, Self-controlled trial. Medication method# Subjects should avoid high magnesium diet for 1-3 weeks, and take magnesium supplement (food grade magnesium citrate: three capsules a day, after meals, 400mg magnesium) in 4-6 weeks. Peripheral blood and stool samples were collected from 60 subjects on day 0, day 21, and day 42 of the study period for routine blood tests, blood biochemical tests, and 16s rDNA sequencing analysis of gut microbiota.
Course#42days Sample size#60.
#Intervention
- DIETARY_SUPPLEMENT : Magnesium Citrate
- Each participant should receive a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults aged 20 <= age <= 30 years in the general community
* Without gender or ethnic requirements, who did not participate in other trials at the same time, volunteered to participate in this study
* No underlying diseases.
Exclusion Criteria:
* (1) Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation;
* (2) Those who have taken hormones within 3 months;
* (3) Those who have taken drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and those who have taken probiotics within 1 month;
* (4) smokers and drinkers;
* (5) Uncontrollable mental disorders (including hospitalization history of mental illness);
* (6) Currently attending a weight loss or weight management course;
* (7) prescribed diet for specific or other reasons (e.g. celiac disease);
* (8) pregnant or lactating women;
* (9) Patients with cardiac and renal insufficiency;
* (10) Long-term constipation.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05597150
|
{
"brief_title": "The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults",
"conditions": [
"Healthy State"
],
"interventions": [
"Dietary Supplement: Magnesium Citrate"
],
"location_countries": [
"China"
],
"nct_id": "NCT05597150",
"official_title": "To Explore the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults # A Single-center, Prospective, Self-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-30",
"study_completion_date(actual)": "2023-03-01",
"study_start_date(actual)": "2022-10-15"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-09",
"last_updated_that_met_qc_criteria": "2022-10-26",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-27",
"first_submitted": "2022-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to evaluate the effectiveness of a 12-month comprehensive weight management program on weight change in overweight/obese patients following treatment for endometrial cancer. During the study period, subjects will be monitored for recurrence during routine clinic visits A secondary exploratory purpose of this study will be to evaluate the gut microbiome in this intervention group and the changes that may occur while participating in a weight loss and weight management program.
Detailed Description
All enrolled subjects will participate in the Profile weight loss and weight management program for a period of 12 months. They will work with a Profile lifestyle coach weekly to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior as done with all Profile members. A comparison of similar retrospective chart reviews based on age, weight in pounds and stage of cancer will be conducted using the Electronic Medical Record (EMR). All enrolled subjects will collect and return a fecal specimen prior to beginning the weight management plan and again after 6 months of participation. The stool sample will be used to understand gut health.
#Intervention
- BEHAVIORAL : Profile by Sanford weight management plan
- The purpose of this study is to observe weight changes in patients who completed endometrial cancer treatment, are clinically overweight, and who participate in the Profile by Sanford weight management program. An exploratory purpose is to examine the bacterial content of the patient's gut by examining stool specimens before starting the Profile by Sanford weight management program and after 6 months of participation in the Profile by Sanford weight management program.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years and older with a diagnosis of endometrial cancer
* No known metastatic disease
* Has completed all treatment for their endometrial cancer at least 2 months prior to enrollment.
* Has a BMI (Body Mass Index) of 30 or higher
* Ability to understand the purpose of study and willingness to sign consent
* Willingness to collect fecal specimens at the required time points
* Capable of following the dietary guidelines and instructions for the Profile weight management plan
* Agrees to sharing information between Profile and Sanford Research study personnel
Exclusion Criteria:
* BMI (Body Mass Index) less than 30
* Known metastatic disease
* Receiving treatment or expected to receive treatment for endometrial cancer or any other cancer
* Any psychological, familial, sociological conditions that the physician feels will interfere with medical follow-up and compliance on the study
* Taking insulin for diabetes (oral medications for diabetes allowed)
* Use of corticosteroids for a chronic medical condition
* Known liver disease
* Bowel or stomach disorders that the physician feels would interfere with Profile participation.
* Any history of malabsorption syndrome or substantial amounts of small bowel or stomach surgery that impairs nutrient absorption
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
|
NCT03908996
|
{
"brief_title": "the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer",
"conditions": [
"Endometrial Cancer",
"Overweight"
],
"interventions": [
"Behavioral: Profile by Sanford weight management plan"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03908996",
"official_title": "Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-11",
"study_completion_date(actual)": "2021-01-11",
"study_start_date(actual)": "2019-02-11"
},
"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)": "2021-03-18",
"last_updated_that_met_qc_criteria": "2019-04-07",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-09",
"first_submitted": "2018-08-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.
#Intervention
- DEVICE : Deep brain stimulation
- Stimulating deep brain electrodes and pulse generator
- DEVICE : Sham stimulation
|
#Eligibility Criteria:
Inclusion Criteria:
* age below 71 years
* severe form of Parkinson's Disease with disease duration > 5 years
* presence of gait and/or balance disorders unresponsive to levodopa treatment,
* > 40% decrease in others motor symptoms with levodopa treatment
* health insurance
* give signed informed written consent
Exclusion Criteria:
* dementia (Mattis Dementia Rating Scale < 129, MDRS),
* ongoing psychiatric disturbances,
* surgical contraindications
* significant brain lesions detected on MRI.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 71 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02931097
|
{
"brief_title": "DBS of the MLR for Gait and Balance Disorders in PD Patients",
"conditions": [
"Parkinson's Disease"
],
"interventions": [
"Device: Sham stimulation",
"Device: Deep brain stimulation"
],
"location_countries": [
"France"
],
"nct_id": "NCT02931097",
"official_title": "Effects of Deep Brain Stimulation of the Mesencephalic Locomotor Region on Gait and Balance Disorders in Parkinson's Disease Patients : a Randomized, Double-blind, Cross-over Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10",
"study_completion_date(actual)": "2020-10",
"study_start_date(actual)": "2016-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-11",
"last_updated_that_met_qc_criteria": "2016-10-11",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-12",
"first_submitted": "2016-10-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study will examine the extent to which a group motivational intervention (ME) impacts retention, treatment compliance, and long-term outcomes in families with a history of, or high risk for, child maltreatment.
Detailed Description
The field of child abuse prevention faces not only the challenge of developing and disseminating effective treatments, but the problem of high attrition rates and treatment noncompliance. This study will compare the effects of a motivational intervention with a 'services as usual' orientation group on program retention, treatment compliance, and long-term outcomes in families with histories of child maltreatment.
#Intervention
- BEHAVIORAL : Motivational intervention, parent training
|
#Eligibility Criteria:
Inclusion Criteria:
* Families referred to service agency for child maltreatment prevention services
* Families with children between 2 <= age <= 1/2 and 12 years
Exclusion Criteria:
* Parents with cognitive, psychiatric, or social conditions that would limit their ability to provide voluntary consent or benefit from the intervention
* Parents who have sexually abused their children
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00153465
|
{
"brief_title": "University of Oklahoma Parenting Program Attrition",
"conditions": [
"Child Abuse"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00153465",
"official_title": "University of Oklahoma Health Sciences Center Parenting Program Attrition and Compliance Efficacy Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-09",
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-09-10",
"last_updated_that_met_qc_criteria": "2005-09-08",
"last_verified": "2007-09"
},
"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
Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles after each session
Detailed Description
Recruitment :
Relatively high level athletes will be recruited through social media and advertisements.
Each subject came twice to the Liege University Hospitals' Human Movement Analysis Laboratory.
After placing the different infrared emitters and placing and calibrating the surface EMG electrodes, subjects underwent 3 maximal squat jumps (without upper limb implication). They were then familiarized with the fatigue protocol (8 jumps at a 33 jumps per minute pace).
Then each subject received either bi-anodal tDCS of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, subjects underwent another warmup 3 maximal squat jumps, and then the fatigue protocol (comprised of 30 maximal jumps at a rate of 33 per minute).
#Intervention
- DEVICE : tDCS
- 20 minutes of anodal tDCS (C3 \& C4/FPZ) 2mA or sham
- Other Names :
- Non invasive brain stimulation
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 10 hours of sport a week
* Right handed and footed
Exclusion Criteria:
* One on the TSST (in high and relatively high risk sections)
* Previous neurological or orthopedic pathologies affecting limbs
Sex :
MALE
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
|
NCT03901222
|
{
"brief_title": "3D Analysis of the Effects of tDCS (Transcranial Direct Current Stimulation) on a Functional Task in High Level Athletes",
"conditions": [
"Healthy",
"Athlete"
],
"interventions": [
"Device: tDCS"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT03901222",
"official_title": "3D Analysis of the Effects of tDCS on a Functional Task in High Level Athletes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-31",
"study_completion_date(actual)": "2019-08-31",
"study_start_date(actual)": "2019-03-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-31",
"last_updated_that_met_qc_criteria": "2019-04-02",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-03",
"first_submitted": "2019-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.
#Intervention
- DRUG : AZD1656
- Single dose oral tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD or insulin
* Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal
Exclusion Criteria:
* Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
* Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.
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
|
NCT01069926
|
{
"brief_title": "To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients",
"conditions": [
"Glucose Lowering"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01069926",
"official_title": "A Phase I, Multi-center, Open-label, Single Dose Study, to Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients With or Without Renal Impairment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-12-09",
"last_updated_that_met_qc_criteria": "2010-02-16",
"last_verified": "2010-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-17",
"first_submitted": "2010-02-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
#Intervention
- DEVICE : Sepraspray
|
#Eligibility Criteria:
Inclusion Criteria:
* The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.
Exclusion Criteria:
* Pregnant/lactating women.
* The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
* The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
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:
No
|
NCT00624390
|
{
"brief_title": "Sepraspray™ Laparoscopic Myomectomy Study",
"conditions": [
"Laparoscopic Myomectomy"
],
"interventions": [
"Device: Sepraspray"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00624390",
"official_title": "A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2008-12",
"study_start_date(actual)": "2007-11"
},
"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)": "2016-12-14",
"last_updated_that_met_qc_criteria": "2008-02-15",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-27",
"first_submitted": "2008-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Purpose of the study:
1. To evaluate renal function maturation within the first month of life in very premature infants.
2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Detailed Description
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants.
Purpose of the study:
1. To evaluate renal function maturation within the first month of life in very premature infants.
2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Population:
At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.
#Intervention
- DRUG : Ibuprofen
|
#Eligibility Criteria:
Inclusion Criteria:
* Gestational Age = 27 to 31 weeks
* Postnatal age < 48 hours
* Parental Consent Obtained
Exclusion Criteria:
* Renal malformation
* Urinary tract infection
* Renal Failure
* Pulmonary Hypertension at echocardiography
Sex :
ALL
Ages :
- Minimum Age : 0 Years
- Maximum Age : 28 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00217191
|
{
"brief_title": "Ibuprofen and Renal Function in Premature Infants",
"conditions": [
"Premature Infants",
"Patent Ductus Arteriosus"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00217191",
"official_title": "Ibuprofen and Renal Function in Premature Infants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-09",
"study_start_date(actual)": "2004-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2006-09-19",
"last_updated_that_met_qc_criteria": "2005-09-19",
"last_verified": "2006-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-22",
"first_submitted": "2005-09-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.
#Intervention
- OTHER : Autologous Platelets Rich Plasma Treatment
- For PRP preparation 10 mL of the patient blood was collected. The blood was centrifuged at 2000 rpm for 5 min to obtain plasma. Then, this plasma was centrifuged at 3000 rpm for another 5 min to collect platelets. Platelets were diluted in 5 mL plasma to form PRP.
- OTHER : Conventional Saline dressing
- saline dressing of diabetic wounds will be done
|
#Eligibility Criteria:
Inclusion Criteria:
* Diabetic foot wound less than 5cm in greatest diameter Non healing duration greater than 3 months Non infected Palpable distal pulses
Exclusion Criteria:
* Infected wound Wound greater than 5 cm Patient having HBa1c greater than 8% Renal failure Wound with bone exposed or having osteomyelitis
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03716141
|
{
"brief_title": "Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer",
"conditions": [
"Diabetic Foot Ulcer"
],
"interventions": [
"Other: Autologous Platelets Rich Plasma Treatment",
"Other: Conventional Saline dressing"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT03716141",
"official_title": "Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-08-30",
"study_completion_date(actual)": "2018-08-30",
"study_start_date(actual)": "2018-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-23",
"last_updated_that_met_qc_criteria": "2018-10-21",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-23",
"first_submitted": "2018-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.
Detailed Description
Biocompatibles LC Bead (also known as DC Bead in Asia \& Europe) microspheres are preformed soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA. The fully polymerized microsphere is approximately 90% water and is compressible to approximately 30% by diameter. The microspheres can be delivered through conventional catheters (4-5Fr) or micro-catheters in the 2-3Fr range. These microspheres, like all agents used for arterial embolization, are mixed with radiographic contrast prior to administration in order to allow for fluoroscopic control of the embolization procedure.
#Intervention
- DEVICE : Bead Block microspheres
- Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
- OTHER : Bead + Dox Arm
- Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis; who is not a surgical resection candidate, or refuses surgery
* Patient must be 18 years or older
* Patient must be Okuda stage I or II
* Patient must have an ECOG performance status of 0 or 1
* No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all toxicities, if any, resolved to grade < than or = to 1
* Patient must have the following laboratory values confirmed within 14 days of registration:
* Creatinine <= than or = to 2.0 the institution ULN
* Platelets >= than or = to 50,000/mm3
* INR <= than or = to 2.0 for patients who are not on Coumadin
* aPTT < or = to twice control
* Bilirubin < 3 mg/dl
* WBC > 3000 cells/mm3
* ANC > 1500 cells/mm3
* Negative serum pregnancy test (Female of childbearing potential only)
Exclusion Criteria:
* Patient has another primary tumor, with the exception of conventional basal cell CA, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
* Women who are pregnant or lactating
* Patient previously treated with doxorubicin
* Contraindication to angiography/embolization including: patients who cannot receive contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on judgment of the investigator
* Patient has already undergone hepatic arterial embolization for the hepatocellular cancer for which they are currently being evaluated
* Patient has received prior radiotherapy for the hepatocellular cancer for which they are currently being evaluated
* Patient has had previous local-regional treatment of the current target tumor volume
* Patient who cannot have CT scan
* Patient at very high risk for post-embolization hepatic failure: 1. Child's C cirrhosis, 2. > 75% liver replaced by tumor
* Cardiac exclusion for: 1. Myocardial infarction within 90 days of study, 2. uncontrolled arrhythmia, 3. LVEF < 50% for patients randomized to receive LC Bead
* Patients with tumors exhibiting characteristics considered contra-indications to particle embolization, including: 1. collateral vessel pathways potentially endangering normal territories during embolization, 2. arteries supplying tumor not large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic venous shunts, 4. Presence of arterial to pulmonary vascular shunts
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
|
NCT00539643
|
{
"brief_title": "Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma",
"conditions": [
"Hepatocellular Carcinoma",
"Liver Cancer",
"Hepatoma"
],
"interventions": [
"Other: Bead + Dox Arm",
"Device: Bead Block microspheres"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00539643",
"official_title": "A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-17",
"study_completion_date(actual)": "2022-06-17",
"study_start_date(actual)": "2007-11"
},
"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)": "2023-08-18",
"last_updated_that_met_qc_criteria": "2007-10-03",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-04",
"first_submitted": "2007-10-03",
"first_submitted_that_met_qc_criteria": "2023-08-14"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether half-dose depot triptorelin are as effective as reduced-dose daily buserelin in the controlled ovarian stimulation for intracytoplasmic sperm injection and embryo transfer
Detailed Description
Significant doubts remain about which type of GnRH agonists \[GnRHa\] administration to be used in controlled ovarian stimulation \[COS\] cycles. The use of a single-dose depot long-acting GnRHa instead of a daily low dose preparation would be more comfortable for patients, however, inducing a profound pituitary desensitization, it increases the number of gonadotropin ampoules and the duration of the COS cycle without improving pregnancy rates or other clinical outcomes. Thus, some authors recommend a reduction of both dose and/or duration of GnRHa administration. Halving the dose of depot triptorelin, for instance, has been studied against its full dose administration since 1992 with rather similar clinical outcomes. Half-dose depot leuprolide acetate has also resulted in comparable clinical outcomes with standard daily injections in long GnRHa protocol. Reducing the daily doses of short acting GnRHa has been advocated to demonstrate equivalent results to standard doses. To our knowledge, however, the reduced daily doses have not been evaluated against half dose depot forms in long GnRHa protocols.
Thus, we originally compared a half-dose depot triptorelin with reduced daily doses of short-acting buserelin in a long protocol for intracytoplasmic sperm injection and embryo transfer \[ICSI/ET\] cycles.
#Intervention
- DRUG : Half-Dose Depot Triptorelin
- DRUG : Reduced-Dose Daily Buserelin
|
#Eligibility Criteria:
Inclusion Criteria:
* Candidate for ICSI/ET
* 35 years or younger
* Serum FSH less than 10 IU/l on day three of the previous menstrual cycle
* No more than two previous IVF/ICSI attempts
* No planned percutaneous epididymal sperm aspiration [PESA]
* No planned testicular sperm extraction [TESE]
* No known history or risk of severe hyperstimulation
* No evidence of hydrosalpinx
* No major systemic disease
* No uterine abnormality
* No previous ovarian surgery
Sex :
FEMALE
Ages :
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00461916
|
{
"brief_title": "Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin",
"conditions": [
"Infertility"
],
"interventions": null,
"location_countries": [
"Iran, Islamic Republic of"
],
"nct_id": "NCT00461916",
"official_title": "Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET",
"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)": "2005-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-04-18",
"last_updated_that_met_qc_criteria": "2007-04-17",
"last_verified": "2007-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-04-18",
"first_submitted": "2007-04-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.
#Intervention
- DRUG : sertraline/[S,S]-reboxetine
- Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg \[S,S\]-reboxetine for 5 and one half weeks.
- DRUG : sertraline/[S,S]-reboxetine
- Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg \[S,S\]-reboxetine for 5 and one half weeks.
- DRUG : sertraline
- Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
- DRUG : sertraline
- Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks
- DRUG : sertraline/[S,S]-reboxetine
- Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg \[S,S\]-reboxetine for 5 and one half weeks.
- DRUG : Placebo
- Tablets, orally once per day for 8 weeks
- DRUG : sertraline/[S,S]-reboxetine
- Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg \[S,S\]-reboxetine for 5 and one half weeks
- DRUG : [S,S]-reboxetine monotherapy
- Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
* HAM-D (17-item) >= 22 at Screening (Visit 1) and > 20 at Baseline (Visit 2).
* Minimum CGI-S >= 4 at Screening (Visit 1) and at Baseline (Visit 2).
Exclusion Criteria:
* Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
* Subjects with > 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
* Subjects with uncorrected hypothyroidism or hyperthyroidism.
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
|
NCT00636246
|
{
"brief_title": "A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.",
"conditions": [
"Depressive Disorder, Major"
],
"interventions": [
"Drug: [S,S]-reboxetine monotherapy",
"Drug: Placebo",
"Drug: sertraline",
"Drug: sertraline/[S,S]-reboxetine"
],
"location_countries": [
"Russian Federation",
"Estonia"
],
"nct_id": "NCT00636246",
"official_title": "Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-08",
"study_start_date(actual)": "2004-06"
},
"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)": "2021-01-28",
"last_updated_that_met_qc_criteria": "2008-03-07",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-14",
"first_submitted": "2008-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.
Detailed Description
Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).
#Intervention
- DRUG : Ritonavir
- DRUG : Nelfinavir mesylate
- DRUG : Saquinavir
- DRUG : Delavirdine mesylate
|
#Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV RNA >= 5000 copies/ml by Amplicor assay.
* Signed, informed consent from parent or legal guardian for patients less than 18 years.
Previous treatment with antiretrovirals.
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
|
NCT00002178
|
{
"brief_title": "A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002178",
"official_title": "A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-06-24",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "1997-08"
},
"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 purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.
Detailed Description
To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality
#Intervention
- OTHER : No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel
- No additional intervention than the intended major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) comparing with costs
|
#Eligibility Criteria:
Inclusion Criteria:
* Undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections)
Exclusion Criteria:
* Missing data of in-hospital costs
* Mortality
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00855387
|
{
"brief_title": "Severe Complications Triplicate the Costs of Major Surgical Procedures",
"conditions": [
"Major Surgical Procedures"
],
"interventions": [
"Other: No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT00855387",
"official_title": "Surgical Complications Dramatically Influence Overall Cost of Major Surgical Procedures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": "2009-11",
"study_start_date(actual)": "2009-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-11-26",
"last_updated_that_met_qc_criteria": "2009-03-03",
"last_verified": "2009-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-04",
"first_submitted": "2009-03-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Ectopic fat is the accumulation of adipose tissue in anatomical sites not classically associated with fat storage - for example, in the liver and skeletal muscles. Excessive fat accumulation in liver cells, often diagnosed as non-alcoholic fatty liver disease (NAFLD), is a precursor to a wide range of liver conditions and metabolic disorders. The usual standard of care for NAFLD is to advise weight loss through controlled diet and physical activity, but the outcome of weight management and treatment of NAFLD is highly variable.
Diet interventions - such as the Mediterranean, ketogenic, paleo, and high-protein-low-carbohydrate diets - have shown varied benefits in the management of NAFLD. However, food-based interventions must align with cultural and regional preferences in food to succeed in making the modifications part of the habitual diet. A recent diet intervention study (Della Pepa et al., 2020) highlighted that the components of a diet, rather than its caloric content, play a greater role in achieving healthier outcomes. In this study, a multifactorial diet intervention using locally sourced and produced meals will be implemented with the aim of reducing elevated liver fat content in healthy women diagnosed with NAFLD.
The study will also evaluate the effects of the proposed diet on the participants' metabolic health and describe potential changes in their gut microbiome signatures (via frequent stool samples). The dysregulation of the gut microbiota has been linked to the development of NAFLD and it is known that the composition of the gut microbiota could be modified by dietary intake. This study will investigate the association of gut microbiome signatures with elevated liver fat in Asian women and test whether the dietary intervention will modify their gut microbiota.
Finally, ectopic fat in the liver is a highly prevalent condition worldwide but the cut-off values for NAFLD has been largely derived from studies performed in Western populations. This study seeks to cross examine the diagnostic ranges in various clinical assessments of NAFLD that commonly involve ultrasound spectroscopy (Fibroscan), fatty liver indexes (FLI) and magnetic resonance spectroscopy (MRS). This effort seeks to derive appropriate cut-off values for NAFLD in Singaporean-Chinese women.
Detailed Description
The study will consist of a 12-week, parallel three-arm, single-centre, randomized controlled trial (RCT); 90 women of Chinese ethnicity matched for age and BMI will be randomized to one of 3 study arms in 1:1:1 ratio by Blockrand R software at Week -1 visit. The study arms are: (1) Lifestyle advice alone, (2) Lifestyle advice with calorie-restricted diet-intervention, and (3) Lifestyle advice with calorie-restricted diet-intervention inclusive of odd-chain fatty acids (OCFA)-containing food product.
In all 3 study arms, the lifestyle advice on maintaining a healthy diet and regular exercise (\~180 mins/ week) will be compatible with recommendations by Health Promotion Board. The participants in the control study arm (Lifestyle advice alone) will receive 1 session of diet advice from the study dietician at the start of the study only. The dietitian will provide dietary advice on the eating plans and instructions for completion of diet checklist.
In the 'Diet Intervention (calorie-restricted multifactorial diet)' study arm (arm 2), a moderate energy restriction (500-1000 kcal/day) will be prescribed to facilitate weight loss. To facilitate compliance, participants in the diet-intervention arms will receive individual diet consultations with the study dietitian during the study. Participants in both the meal-based diet-intervention arms (arm 2 and arm 3) will be supplied with 2 main meals per day as part of their daily diet, for 6 days a week. Additional food products may be supplied for breakfast and snacks. The diet will be designed to be nutritionally replete, feasible, and sustainable in the long-term. The diet will be based on whole grain-based products, vegetables, legumes, extra virgin olive oil, fruits, almonds, salmon, and plant-based meat analogues. Diet plans will be individualized and energy matched to enable any metabolic differences between arms to be attributed to the macronutrient profiles of the diets, without confounding by differences in weight loss between diet arms. Energy requirements will be calculated by indirect calorimetry (Quark CPET, COSMED) with an activity factor.
Participants in the 'OCFA meal-based diet-intervention' study arm (arm 3) will be provided with a daily OCFA-containing food product, in addition to the lunch and dinner meals. Both the participants in arm 2 and 3 will be receiving the same lunch and dinner meals. Participants in both the meal-based diet-intervention arms (arm 2 and arm 3) will be told to consume only low-fat dairy products (milk, yoghurt), avoid ruminant meat (beef, lamb), avoid cheese, butter and butter-containing food products. Both diet-intervention arms will be told to avoid sugar-sweetened beverages.
#Intervention
- OTHER : Lifestyle Advice
- Maintain a weekly healthy diet and regular exercise.
- OTHER : Diet Intervention
- Calorie-restricted meals (lunch and dinner)
- OTHER : OCFA Meal-Based Diet-Intervention
- OCFA-containing food product
|
#Eligibility Criteria:
Inclusion Criteria:
* Chinese ethnicity
* Females, Age 21 <= age <= 45 years
* Body mass index (BMI) 23 <= age <= 35 kg/m2
* Not planning to conceive within 6 months from enrolment
* Elevated liver fat content (FibroScan CAP score >=268 dB/m)
Exclusion Criteria:
* Do not intend to reside in Singapore for the next 6 months
* Delivered within the last 6 months
* Currently pregnant or breastfeeding
* Having more than 5% weight loss over the past 3 months
* Receiving antibiotics or suffering from diarrhoea over the last 3 months
* Not willing to adhere to lifestyle intervention required by study
* Following special diets or having intentional dietary restrictions (e.g. vegetarians/vegans/ketogenic diet)
* Having contraindications for MRI e.g. metallic implants such as cardiac pacemaker
* Having alcohol consumption on more than 4 days per week with 6 or more alcoholic drinks per week
* Current and/or history of diabetes mellitus, other than GDM (Gestational Diabetes Mellitus)
* Having chronic medical conditions such as cancer, severe gastrointestinal disorders, infectious diseases such as hepatitis and severe mental disorders
* Having uncontrolled hypertension (> 150/90 mmHg)
* Having any medication and/or supplements which may interfere with study results
* Having allergies or intolerances to any common food ingredients including eggs, fish, milk, sesame, mustard, sulphites, peanuts and tree nuts, shellfish, soy, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, food colourings or flavourings, etc.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05259475
|
{
"brief_title": "Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes (TANGO Study)",
"conditions": [
"Non-Alcoholic Fatty Liver Disease"
],
"interventions": [
"Other: OCFA Meal-Based Diet-Intervention",
"Other: Diet Intervention",
"Other: Lifestyle Advice"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT05259475",
"official_title": "Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-07-31",
"study_completion_date(actual)": "2022-07-31",
"study_start_date(actual)": "2021-08-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-25",
"last_updated_that_met_qc_criteria": "2022-02-25",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-28",
"first_submitted": "2022-01-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Comparison of the effect of Atomoxetine and psychoeducation with placebo and psychoeducation after 10 weeks of treatment
#Intervention
- DRUG : Atomoxetine
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Meet the criteria for ADHD of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) as well as severity criteria. Diagnosis is assessed by the investigator's clinical evaluation as well as administration of the K-SADS-PL structured interview.
* Meet a symptom severity threshold of 1.5 standard deviations above age and sex norms for their diagnostic subtype on the ADHDRS-IV-Parent: Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) This severity threshold must be met at Visit 1 and maintained at Visit 2.
* Be at least 7 years, but not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
* For female subjects of child-bearing potential only, test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control.
Exclusion Criteria:
* Weigh less than 20 kg at study entry
* Have a documented history of Bipolar Disorder or any history of psychosis or pervasive development disorder (autistic spectrum disorder).
* Are pregnant or breastfeeding.
* Are at serious suicidal risk as assessed by the investigator.
* Have been treated previously for ADHD with pyschostimulants such as Methylphenidate or Ritalin
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00191542
|
{
"brief_title": "Atomoxetine vs Placebo in the Treatment of ADHD in Swedish Children and Adolescents",
"conditions": [
"Attention Deficit Hyperactivity Disorder"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT00191542",
"official_title": "A Randomised, Double Blind Placebo Controlled Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Swedish Children and Adolescents",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2005-03"
},
"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)": "2006-10-11",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2006-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-19",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Although screening for pre-cancerous cervical lesions and human papilloma virus (HPV) vaccination are accepted and effective means to prevent cervical cancer, women in Mali have limited access to these interventions. In addition, cervical cancer prevention by HPV vaccination has been controversial in some settings. To reduce cervical cancer prevalence and increase HPV vaccine uptake, it is important to understand the level of knowledge about cervical cancer screening and practices related to vaccination in at-risk populations. In this study, the level of knowledge about HPV and cervical cancer and attitudes towards vaccination were assessed among 301 participants (male and female, adults and adolescents) in a house-to-house survey in two urban neighborhoods in Bamako, Mali. The survey was combined with a brief educational session on HPV. Prior to the education session, overall knowledge of HPV infection and cervical cancer was very low: only 8% knew that HPV is a sexually transmitted infection (STI). Less than 20% of women had ever consulted a gynecologist and less than 3% had ever had cervical cancer screening. After hearing a description of HPV vaccine, more than 80% would accept HPV vaccination; fathers and husbands were identified as primary decisions makers and local clinics or the home as preferred sites for vaccination. This study provides information on STI knowledge and vaccine acceptance in Bamako, Mali in 2012, prior to the introduction of HPV vaccination.
#Intervention
- BEHAVIORAL : HPV Vaccine Acceptance Survey
|
#Eligibility Criteria:
Inclusion Criteria:
* 12 <= age <= 17 years, with guardian consent
* >= 18 years
* Male or Female
* Living in Mèkin-Sikoro and Djikoroni
Exclusion Criteria:
* 12 <= age <= 17 years, without guardian consent
* <12 years
* Living outside Mèkin-Sikoro and Djikoroni
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05767138
|
{
"brief_title": "STI Knowledge and HPV Vaccine Acceptance in Bamako, Mali in 2012",
"conditions": [
"HPV",
"HPV-Related Cervical Carcinoma"
],
"interventions": [
"Behavioral: HPV Vaccine Acceptance Survey"
],
"location_countries": null,
"nct_id": "NCT05767138",
"official_title": "Knowledge, Attitudes, Practices and Willingness to Vaccinate in Preparation for the Introduction of HPV Vaccines in Bamako, Mali",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-05",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2011-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-14",
"last_updated_that_met_qc_criteria": "2023-03-01",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-03-14",
"first_submitted": "2022-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses.
Detailed Description
Low back pain occurs frequently and is one of the most costly health problems affecting industry and society. Prevention of low back pain is important both for the individual patient and from an economic perspective. Therefore, there are many measures available that claim to reduce low back pain and its recurrence. The most commonly used preventive strategies are fitness exercises, lumbar supports, education on back mechanics and lifting techniques, and ergonomic adjustments. However, their efficacy is still uncertain. The main objective of this study is to investigate the efficacy of two different design characteristics of lumbar support for low back pain prevention in hospital nurses. Investigators hope that those two types of lumbar support will reduce the incidence of low back pain and sick leave days. In addition, Investigators hypothesize that there are some differences on outcome measures between those two types of lumbar support. Enrolled subjects will be randomly assigned to one of the following three groups. The first group will wear an inelastic lumbar support for 6 months. The second group will wear an elastic lumbar support for 6 months. The third group will receive no intervention. After the completion of 6-month intervention, a further 6 months fellow-up will be added.
#Intervention
- DEVICE : QUIKDRAW Pro, Aspen Medical Products
- Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months
- Other Names :
- Lumbar belt, Lumbar orthoses, Lumbar brace
- DEVICE : MUELLER 4581, Mueller Sports Medicine
- Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months
- Other Names :
- Lumbar belt, Lumbar orthoses, Lumbar brace
|
#Eligibility Criteria:
Inclusion Criteria:
* Female between 20 and 25 years
* Subjects who have worked as a nurse less than two years and will continue working as a nurse no less than one year
* Job contents including moving and lifting patients, long-time standing and frequent bending
* Subjects who do not participate any other study concerning pain prevention currently and in the next year
Exclusion Criteria:
* Subjects who are experiencing low back pain symptoms at the time of inquiry, regardless of acute or chronic, and seeking medical care currently
* Subjects who have experienced 2 or more episodes (on 2 consecutive days) of low back pain symptoms in the 12 months before the inquiry
* Subjects who are suffering from any other chronic pain disorders symptomatically
* Subjects who have used a lumbar support during the last 6 months
* Subjects with specific low back pain (like infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis)
* Subjects who have had a spinal operation
* Subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically
* Subjects who are suffering from diseases that might be aggravated by increased intra-abdominal pressure, like hernia
* Subjects who are suffering from chronic gastrointestinal disorders symptomatically
* Subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery
* Subjects who are suffering from serious somatic disease and/or psychic disease
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01483222
|
{
"brief_title": "Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Device: MUELLER 4581, Mueller Sports Medicine",
"Device: QUIKDRAW Pro, Aspen Medical Products"
],
"location_countries": [
"China"
],
"nct_id": "NCT01483222",
"official_title": "Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses",
"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)": "2011-11"
},
"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)": "2014-10-15",
"last_updated_that_met_qc_criteria": "2011-11-29",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-01",
"first_submitted": "2011-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.
Detailed Description
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before \& after their first elective ICD replacement. For this purpose all consecutive ICD patients will be included in the study, whose first implanted device is replaced due to ICD battery depletion (i.e. arrival at battery indicator ERI). ICD replacements due to other reasons can be included if duration of first ICD implantation was \> 3 years. All patients included in the trial are regularly followed up until delivery of their first adequate ICD therapy. The collected data shall provide statistically valid information about the risk to patients who never have experienced adequate ICD therapy before the ICD replacement investigated in this study. In the future, these statistical risk data can give additional information to implanting physicians, such as whether an ICD replacement can eventually be omitted in those patients who are at very low risk for the occurrence of ICD therapies. All actually available GUIDANT ICDs with CE certificate can be implanted in this trial.
#Intervention
- DEVICE : ICD
- all models of Guidant/Bsc ICD's
- Other Names :
- implantable defibrillator
|
#Eligibility Criteria:
Inclusion Criteria:
* All elective ICD replacements due to battery depletion of the first ICD being implanted in the patient
Exclusion Criteria:
* Non-availability to regular follow-up
* Age < 18 years
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00180440
|
{
"brief_title": "INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement",
"conditions": [
"Ventricular Fibrillation"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT00180440",
"official_title": "INcidence Free SUrvival Before and After ICD Replacement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-11",
"study_completion_date(actual)": "2008-11",
"study_start_date(actual)": "2002-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-03-26",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2009-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-16",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.
Detailed Description
This study will evaluate the interval to relapse in patients with ulcerative colitis. The patients will be adults, who have been in remission for at least one month. They will have previously required corticosteroids to induce remission. Subjects will be instructed in a no-carrageenan diet and required to follow this diet for the duration of their participation in the clinical study. They will be randomized to receive either placebo capsules or capsules containing carrageenan 100 mg. In this way, the study will be a double blind study of no-carrageenan vs. carrageenan. Main study outcome is the interval to relapse. Since ulcerative colitis is associated with relapses, relapse is anticipated. Other outcome measures will include scores on questionnaires, including the SSCAI and the SIDBQ, and laboratory measurements of inflammation.
Subjects will participate for one year or until relapse, with study visits every three months and telephone contacts every two weeks. After three months, participants will increase to two capsules daily, of either placebo or carrageenan.
#Intervention
- DIETARY_SUPPLEMENT : carrageenan
- The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
- OTHER : dietary intervention with no-carrageenan diet
- The intervention will consist of the no-carrageenan diet.
|
#Eligibility Criteria:
Inclusion Criteria:
* Ulcerative colitis
* Adult
* In remission
* Required corticosteroids to induce remission
* Able to make food choices and follow diet
Exclusion Criteria:
* Not able to make food choices
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
|
NCT01065571
|
{
"brief_title": "Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity",
"conditions": [
"Ulcerative Colitis"
],
"interventions": [
"Other: dietary intervention with no-carrageenan diet",
"Dietary Supplement: carrageenan"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01065571",
"official_title": "Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2010-01"
},
"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)": "2019-11-26",
"last_updated_that_met_qc_criteria": "2010-02-08",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-09",
"first_submitted": "2010-02-04",
"first_submitted_that_met_qc_criteria": "2019-11-20"
}
}
}
|
#Study Description
Brief Summary
FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related parenting practices (e.g., number of drinks parents would permit their college student to consume). Theory and research suggests that correcting those common misperceptions can motivate parents to adjust their own behaviors (e.g., reducing the number of drinks they would permit), which, in turn, can impact college student drinking. Despite FITSTARTs success, the design of the program limits participation to only students who have parents who can attend on-campus orientation sessions during the summer months before the start of the Fall semester. To address this limitation and extend the previous work, the proposed randomized clinical trial (RCT) will evaluate the efficacy of an online adaptation of the FITSTART(+) PBI program. To examine the efficacy of the newly developed FITSTART+ PBI web app, the proposed RCT will use a longitudinal design to examine if students self-report drinking and related negative consequences during their first semester in college significantly differed between FITSTART+ PBI (intervention app) and a control version of the app. Self-reported drinking and consequences are expected to be lower amongst students with parents randomized to FITSTART+ PBI relative to those with parents randomized to the control app.
Detailed Description
Heavy episodic drinking (HED) rates remains at unacceptably high levels on college campuses. Researchers on parent-based interventions (PBIs) has revealed promising results. but studies have generally failed to reduce HED in college students. FITSTART was developed to address two limitations of traditional PBIs that may contribute to the lack of the aforementioned effects: (I) they are purely informational and (II) they typically lack a motivational component to capture parents' attention and increase motivation to proactively engage their students. Pilot work has revealed that parents display predictable normative misperceptions (e.g., overestimate how approving other parents are of drinking and underestimate how often other parents engage with their students about drinking). As predicted by social norms theory, these false beliefs are associated with parents displaying more approving attitudes themselves and communicating less frequently. Correcting these norms should motivate parents to proactively engage their child in risk-reducing directions. FITSTART combined a social norms feedback component with informational material ('tips') characteristic of a traditional PBI in an in-person interactive format and successfully reduced HED. While the effects on weekly drinking, HED, and non-drinker alcohol use initiation were robust 1-month into college (3-months post intervention). FITSTART's usefulness as a universal approach is limited because it was delivered to parent groups on-campus during pre-college orientation sessions and many colleges do not hold summer orientations and/or lack the resources to administer FITSTART. To address this limitation, a web-based platform (or app) was developed using a new cutting-edge modality that draws from the computer science literature on virtual co-presence to create an online environment that mimics the effects of a live group social norms session.
The current pilot study seeks to evaluate the efficacy of the FITSTART+ PBI in a randomized control trial (RCT) by evaluating changes in incoming first-year students' alcohol use and related negative consequences during the transition into college. The sample will consist of traditional first year students (17-20 years of age) from Loyola Marymount University who completed consent and the baseline survey, and whose parents downloaded and registered for the FITSTART+ intervention or control app. Parents will be invited to download the intervention/control app two weeks prior to their student's arrival on campus in the fall (beginning of August). To examine the short- and long-term effects of the intervention, students will complete a baseline survey at the end of July (pre- matriculation) and two follow-up surveys, approximately 1 month (October) and 6 months (April) after the students arrive on campus in the spring.
#Intervention
- BEHAVIORAL : FITSTART+ PBI
- Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice
- BEHAVIORAL : General Parenting Advice
- General parenting advice
|
#Eligibility Criteria:
Inclusion Criteria:
First-year incoming LMU student consented to participate in the study and their parent/guardian created a profile on the app
Exclusion Criteria:
Outside of the students age range
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Maximum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04549454
|
{
"brief_title": "Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study",
"conditions": [
"Alcohol Drinking",
"Alcohol Problem Drinking",
"Parenting"
],
"interventions": [
"Behavioral: FITSTART+ PBI",
"Behavioral: General Parenting Advice"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04549454",
"official_title": "Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-22",
"study_completion_date(actual)": "2022-03-22",
"study_start_date(actual)": "2021-07-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-01",
"last_updated_that_met_qc_criteria": "2020-09-08",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-16",
"first_submitted": "2020-09-08",
"first_submitted_that_met_qc_criteria": "2023-05-03"
}
}
}
|
#Study Description
Brief Summary
The COPD Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. The COPD Foundation is working with National Jewish Health in Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest confidentiality of participant information.
|
#Eligibility Criteria:
Inclusion Criteria:
*Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD.
Exclusion Criteria:
*Individuals under the age of 18
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
|
NCT01785706
|
{
"brief_title": "COPD Research Registry",
"conditions": [
"Chronic Obstructive Pulmonary Disease (COPD)"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01785706",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-06-12",
"last_updated_that_met_qc_criteria": "2013-02-05",
"last_verified": "2015-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-07",
"first_submitted": "2013-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is a randomised control trial (RCT) pilot study to determine the appropriate vitamin D dose for the main study. The pilot study includes three matched groups, which will form two vitamin D supplementation groups (at 25,000 IU and 50,000 IU every two months), and a third placebo supplementation group. The aim was to develop an appropriate supplementation regimen that was compatible with recruit training and maintained serum vitamin D (25OHD) status above 50 nmol/l during recruit training.
Detailed Description
Study Overview:
Aim: The dose-response to vitamin D3 supplementation in Royal Marine recruits undertaking military training. Part-A of this research project will provide a pilot study for the main study. Volunteer recruits will initially complete a healthy history, smoking habit and alcohol consumption questionnaire. Height, body mass (from which BMI will be calculated), and calf girth/skinfold will be measured. A 20 ml blood sample will be drawn in two parts: a 15 ml blood sample (gold top serum vacutainers) for determination of vitamin D status, calcium and albumin concentrations, PTH levels, serum collagen type I cross-linked C-telopeptide (CTx), carboxy-terminal propeptide of type I collagen (P1NP), ferritin (Fe) and antibody responses against S. aureus or other antigens; and a 5 ml blood sample (white top EDTA plasma vacutainers) will be drawn for determination of plasma cytokine levels. At one sample point only, DNA will be extracted from the cell pellet acquired following centrifuging of the whole blood to separate the plasma. This DNA will be analysed for the specific single nucleotide polymorphisms (SNPs) that have been shown to be associated with vitamin D metabolism. Permission will also be sought to collate the outcome of the week-1 and week-9 Royal Marine Fitness Assessment (RMFA). The pilot study recruit cohort will be randomised into one of three groups: (i) a vitamin-D3 supplementation providing 25,000 IU administered orally every two months (equivalent to \~400 IU.d-1); (ii) a vitamin-D3 supplementation providing 50,000 IU administered orally every two months (equivalent to \~800 IU.d-1); and (iii) a placebo (administered orally every two months) supplementation control group. The vitamin D and placebo supplements will be manufactured by Pharmaterials Ltd., Unit B, 5 Boulton Road, Reading, RG2 0NH, UK. Both the active and placebo supplements will be presented as identical (size and appearance) tablets, indiscernible from each other for either the volunteer or the study team in situ at CTC. All three groups will receive one tablet at each time point. Recruits will be randomly assigned to a study group, but the three groups will be matched for age, height, body mass and aerobic fitness. Randomisation of supplement/placebo administration to study volunteers will be undertaken by Statisticians from the University of Surrey. Study team staff will monitor supplement taking and will further confirm supplement taking through exit interviews. Further 20 ml blood samples will be drawn every two months (i.e. at weeks 8, 16 and 32 of RM training), and the smoking habit and alcohol consumption questionnaire will be readministered. The Food Frequency Questionnaire (FFQ)25,26 will be administered in week- 6 of training; this will allow the recruits' habitual RM training diet to be established following the civilian to military transition. Permission will be sought to collate the outcome of the week-1 and week-9 Royal Marine Fitness Assessment (RMFA). Permission will also be sought to prospectively collate data from the Defence Medical Information Capability Programme (DMICP) system describing the prevalence of injury and illness in study volunteers.
#Intervention
- DIETARY_SUPPLEMENT : 25,000 IU
- Vitamin-D3 supplementation providing 25,000 IU administered orally every two months (equivalent to \~400 IU/d);
- DIETARY_SUPPLEMENT : 50,000 IU
- Vitamin-D3 supplementation providing 50,000 IU administered orally every two months (equivalent to \~800 IU/d);
- DIETARY_SUPPLEMENT : Placebo
- A placebo (administered orally every two months) supplementation control group.
|
#Eligibility Criteria:
Inclusion Criteria:
* RM recruit troops commencing training during the winter and summer months,
* aged between 16 - 32 years at the Start of Training
* having successfully completed the physical and professional selection tests which comprise the Potential Royal Marine Course (PRMC)
* be deemed medically fit and healthy following medical screening at the AFCO and again at CTC if required
Exclusion Criteria:
* not participating in Recruit Syllabus (RS10) for RM recruit training
* deemed unsuitable by the IMO or the training team
Sex :
MALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 32 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04033796
|
{
"brief_title": "Vitamin D Supplementation D_SAF Pilot Study",
"conditions": [
"Vitamin D Deficiency"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: 50,000 IU",
"Dietary Supplement: 25,000 IU"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04033796",
"official_title": "Vitamin D Supplementation in the Armed Forces (D_SAF) PILOT STUDY",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-10",
"study_completion_date(actual)": "2016-06-10",
"study_start_date(actual)": "2014-12-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-26",
"last_updated_that_met_qc_criteria": "2019-07-25",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-26",
"first_submitted": "2019-07-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations
#Intervention
- DIETARY_SUPPLEMENT : Fortimel/Nutridrink Compact Protein
- Twice daily serving of the study product
|
#Eligibility Criteria:
Inclusion Criteria:
* Being diagnosed with cancer
* Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
* Age > 18 years
* Written informed consent
Exclusion Criteria:
* Taste and smell alterations not caused by the cancer or anti-cancer treatment
* Galactosaemia
* Use of thickener to be able to swallow safely
* Allergies to any of the product ingredients or any of the flavours
* Current prescription for ONS, enteral nutrition or parenteral nutrition
* Diabetes mellitus Type I or Type II
* Open sores or severe inflammation in the mouth or throat
* Undergoing dialysis
* Hepatic encephalopathy
* Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
* Known pregnancy or lactation
* Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women or drug abuse in opinion of the investigator
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
* Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
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
|
NCT05518825
|
{
"brief_title": "Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations",
"conditions": [
"Oncology",
"Taste, Altered"
],
"interventions": [
"Dietary Supplement: Fortimel/Nutridrink Compact Protein"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT05518825",
"official_title": "Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-28",
"study_completion_date(actual)": "2023-03-28",
"study_start_date(actual)": "2022-10-06"
},
"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)": "2023-08-24",
"last_updated_that_met_qc_criteria": "2022-08-24",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-29",
"first_submitted": "2022-08-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
#Intervention
- DRUG : LY3025876
- Given as a subcutaneous injection
- DRUG : Placebo
- Given as a subcutaneous injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be either a healthy male or a healthy female who cannot become pregnant
* Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2), inclusive, at screening
Exclusion Criteria:
* Are allergic to LY3025876 or related compounds
* Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication
* Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01528124
|
{
"brief_title": "A Study of LY3025876 in Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: Placebo",
"Drug: LY3025876"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT01528124",
"official_title": "A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3025876 in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-05",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-16",
"last_updated_that_met_qc_criteria": "2012-02-03",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-07",
"first_submitted": "2012-02-03",
"first_submitted_that_met_qc_criteria": "2017-09-27"
}
}
}
|
#Study Description
Brief Summary
Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest.
Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France.
All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months.
All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.
|
#Eligibility Criteria:
Inclusion Criteria:
* Followed in an addiction center.
* Confirmed positive for HCV ribonucleic acid (RNA).
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
|
NCT04366973
|
{
"brief_title": "A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers",
"conditions": [
"Hepatitis C Virus (HCV)"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04366973",
"official_title": "New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2020-05-26"
},
"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)": "2024-02-01",
"last_updated_that_met_qc_criteria": "2020-04-28",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-29",
"first_submitted": "2020-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.
After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).
Detailed Description
A Multi-center, Prospective, Observational Study
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female aged >= 15 years
* Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
* Patients who provided a signed written informed consent form
Exclusion Criteria:
* Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
* Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
* A female who is pregnant, may be pregnant, or is lactating
* Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04654702
|
{
"brief_title": "Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.",
"conditions": [
"Perennial Allergic Rhinitis",
"Asthma"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04654702",
"official_title": "A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-10",
"study_completion_date(actual)": "2020-07-20",
"study_start_date(actual)": "2017-11-17"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-26",
"last_updated_that_met_qc_criteria": "2020-12-03",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-12-04",
"first_submitted": "2020-11-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel groups of healthy male subjects.
#Intervention
- BIOLOGICAL : EG12014
- EG12014, single-dose IV infusion over 90 min at 6 mg/kg
- BIOLOGICAL : EU-sourced Herceptin
- EU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
- BIOLOGICAL : US-sourced Herceptin
- US-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
|
#Eligibility Criteria:
Inclusion Criteria:
* male Caucasian subject
* age between 18 and 55 years (inclusive)
* physically and mentally healthy as judged by means of medical and standard laboratory examinations
* non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of <=5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year ) and non-users of other nicotine containing products, confirmed by urine cotinine test
* BMI within the range (including the borders) of 18.5 to 30.0 kg/m2 and body weight not more than 105.0 kg
* Informed consent given in written form according to Section 5.4 of the protocol.
Exclusion Criteria:
* participation in another clinical trial at same time or within the preceding 3 months from the screening examination (calculated from the date of the final examination of the previous study)
* randomization into the present trial more than once
* blood donation or blood loss including plasmapheresis of >500 ml in the last 3 months before day 0 of the study
* history of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, opioids, phencyclidine within 1 year of screening
* alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
* regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
* positive drug screening and/or positive alcohol test at entry screening or on hospitalization day 0
* history of allergic diathesis or any clinically significant allergic disease (e.g. asthma or bronchial hyperreactivity, or allergic reactions to insect bites)
* any history of drug hypersensitivity (especially to the active and inactive ingredients of the trastuzumab preparation, or other monoclonal antibody or protein drugs) or intolerance to any sugar (e.g. fructose, glucose, or lactose)
* presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
* clinically significant illness within 4 weeks before day 0 of the study and during the study
* major surgery of the gastrointestinal tract except for appendectomy
* any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug
* positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
* administration of depot injectable solutions or medications with a half-life > 1 week (including study medications) within 6 months from day 0 of the study
* intake of enzyme-inducing, organotoxic or long half-life drugs, including prescription or OTC medications or herbal remedies (such as St. John's wort), within 4 weeks from day 0 of the study
* intake or administration of any systemic or topical medication within 2 weeks of day 0 of the study and during the study, except of up to a total dose of 1000 mg paracetamol or metamizole per day given in case of an adverse event (e.g. IRR's: pyrexia, headache) during the study
* intake of drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months
* previous exposure to a monoclonal antibody drug or current or expected use of other biological products.
* systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg at screening and on day 0
* heart rate outside the range of 50 to 90 beats/min at screening and on day 0
* axillary body temperature outside the interval of 35.5 to 37.1°C at screening and on day 0
* any clinically significant abnormality of the resting ECG (12-lead) (i.e. AV block, 2° to 3°, sinus bradycardia, sick sinus syndrome, SA block)
* laboratory values outside normal range with clinical relevance at screening examination and on day 0 of the study
* special diet due to any reason, e.g. vegetarians
* not fulfilling study specific restrictions given in Sections 9.4 Restrictions and 9.6 Diet of the protocol
* any planned surgery within 78 days after dosing on day 1
* subjects who are known or suspected: not to comply with the study directives or meet the required visit schedules; not to be reliable or trustworthy; not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed; to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
* left ventricular ejection fraction (LVEF) <55%, assessed by means of transthoracic echocardiography .
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03180242
|
{
"brief_title": "A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Biological: EU-sourced Herceptin",
"Biological: US-sourced Herceptin",
"Biological: EG12014"
],
"location_countries": null,
"nct_id": "NCT03180242",
"official_title": "Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Two-Stage, Comparative Pharmacokinetic Study of EirGenix' Trastuzumab and Herceptin® (Trastuzumab) Sourced From US and EU Administered to Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08-22",
"study_completion_date(actual)": "2016-08-22",
"study_start_date(actual)": "2016-03-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-08",
"last_updated_that_met_qc_criteria": "2017-06-06",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-08",
"first_submitted": "2017-05-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To examine the effects of oxygen therapy methods applied as indicated in COPD acute exacerbations on blood gas results and spirometric measurements.
Detailed Description
Patients requiring non-invasive ventilation will be divided into two groups: one group will receive NIMV in the form of Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP). The other group will receive EzPAP® (a non-invasive positive airway pressure device). For both groups, blood gas results and hand-held spirometer parameters, including Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), and Forced Expiratory Volume in one second (FEV1), will be evaluated before and after the application.It is aimed to evaluate the effect of COPD noninvasive treatment methods on hospitalization and mortality processes.
#Intervention
- DEVICE : EzPAP®
- EzPAP® is a portable, single-use respiratory exercise device that provides positive expiratory pressure during expiration while supporting respiration during inspiration. Its use has been increasing in recent years as an oxygenation device. It is portable, single-use, easy to use, well-tolerated, and cost-effective. EzPAP® helps increase functional capacity in the lungs and reduces atelectasis. With EzPAP®, an oxygen flow of 5-8 L/min reaches the patient as 35-42% fractionated oxygen, thus quadrupling the oxygen flow.
- DEVICE : Non-invasive mechanical ventilation (NIMV)
- NIMV provides respiratory support during both expiration and inspiration through continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP). Treatment success can be monitored within the first 2 hours by the improvement in oxygenation and reduction in pCO2 levels
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with acute exacerbation of COPD,
* Those without a history of trauma,
* Patients who have not undergone any lung surgery previously,
* Patients capable of providing written and verbal consent.
Exclusion Criteria:
* Patients without acute exacerbation of COPD,
* Pregnancy, suspected pregnancy,
* Those who have undergone any lung surgery previously,
* Patients with a history of trauma,
* Intubated patients and those not compliant with treatments,
* Patients unable to provide written and verbal 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:
Yes
|
NCT06561464
|
{
"brief_title": "Evaluation of Oxygen Delivery Methods in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)",
"conditions": [
"Chronic Obstructive Pulmonary Disease Exacerbation"
],
"interventions": [
"Device: Non-invasive mechanical ventilation (NIMV)",
"Device: EzPAP®"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06561464",
"official_title": "Reflections of Oxygen Delivery Methods Applied in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) on Blood Gas and Spirometer Measurements",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-30",
"study_completion_date(actual)": "2024-06-01",
"study_start_date(actual)": "2023-11-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-01",
"last_updated_that_met_qc_criteria": "2024-08-15",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-08-20",
"first_submitted": "2024-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.
Detailed Description
This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). This study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). The participant satisfaction will be evaluated at week 6 (or early discontinuation). Safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.
#Intervention
- DRUG : No intervention
- This is an observational study. Participants prescribed with paliperidone palmitate by the treating physician as per local labeling information in the hospital setting will be observed and data will be collected.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants diagnosed with schizophrenia
* Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity
* Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital
Exclusion Criteria:
* Participant has a known hypersensitivity to paliperidone or risperidone
* Participant has previously been treated with paliperidone palmitate
* Participant has a history of neuroleptic malignant syndrome
* Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01926912
|
{
"brief_title": "A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Drug: No intervention"
],
"location_countries": [
"Israel",
"Kazakhstan",
"Germany",
"Greece",
"Russian Federation",
"Bulgaria",
"Belgium",
"Denmark"
],
"nct_id": "NCT01926912",
"official_title": "HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2013-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-24",
"last_updated_that_met_qc_criteria": "2013-08-19",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-21",
"first_submitted": "2013-08-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive socioemotional development.
Detailed Description
Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy \[IPT\] for maternal depression and Child Parent Psychotherapy \[CPP\] for maternal-child relationship development and trauma treatment, and Parents As Teachers \[PAT\]. Families are provided a tiered complement of BHC services based upon risk and current need.
Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.
Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.
#Intervention
- BEHAVIORAL : Comprehensive preventive services
- Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
- Other Names :
- Parents as Teachers Home visitation, Child-Parent Psychotherapy, Interpersonal Psychotherapy, Outreach support
- BEHAVIORAL : Screening and referral
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
* residents of Monroe County,
* Temporary Assistance for Needy Families (TANF) eligible,
* are neither currently active nor have had an indicated CPS report,
* have a mother who is or was under 21 at the birth of her first child, and
* has a maximum of two children under the age of three.
Exclusion Criteria:
* Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
* Any children or mothers who are not able to complete the research protocol also will be excluded.
* Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
* Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.
Sex :
FEMALE
Ages :
- Minimum Age : 12 Years
- Maximum Age : 23 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01888809
|
{
"brief_title": "Building Healthy Children",
"conditions": [
"Teen Parenthood"
],
"interventions": [
"Behavioral: Screening and referral",
"Behavioral: Comprehensive preventive services"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01888809",
"official_title": "Building Health Children: Randomized Controlled Trial (RCT) Evaluation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-01",
"study_completion_date(actual)": "2019-08-01",
"study_start_date(actual)": "2007-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-19",
"last_updated_that_met_qc_criteria": "2013-06-25",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-28",
"first_submitted": "2013-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.
#Intervention
- DRUG : Cabozantinib
- Cabozantinib (40mg) will be taken by mouth daily for 8 weeks.
- Other Names :
- XL184
- DRUG : Nivolumab
- Nivolumab 240mg intravenously every 2 weeks (days 14, 28, 42, and 56 for a total of four doses), in combination with Cabozantinib 40mg by mouth daily for 8 weeks.
- Other Names :
- OPDIVO, BMS 936558, MDX-1106, ONO-4538
|
#Eligibility Criteria:
Inclusion Criteria:
* Must have locally advanced/borderline resectable hepatocellular carcinoma.
* Must have measurable disease.
* Age >=18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
* Patients must have adequate liver remnant and function.
* Antiviral therapy per local standard of care for hepatitis B.
* Woman of child bearing potential must have a negative pregnancy test.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Fibrolamellar carcinoma or mixed HCC.
* Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
* Concomitant Anticoagulation therapy.
* Any GI or pulmonary risks of bleeding.
* History of HIV Infection.
* Active co-infection with hepatitis B and hepatitis C.
* Active co-infection with hepatitis B and hepatitis D.
* Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
* History of any autoimmune disease requiring systemic treatment within the past 2 years. Any patient bearing an allograft is not eligible.
* Any additional malignancies with treatment or life-limiting cancers. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
* Uncontrolled intercurrent illness.
* Corrected QT interval calculated by the Fridericia formula.
* Uncontrolled high blood pressure.
* Are pregnant or breastfeeding.
* Any gastrointestinal (GI) disorders.
* Any certain study-specified heart conditions 6 months prior to enrollment.
* Major surgery within 2 months before enrollment.
* Have any evidence of moderate or severe ascites.
* Any untreated or incompletely treated varices with bleeding or high-risk bleeding.
* Inability to swallow intact tablets.
* Known or suspected hypersensitivity to study treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03299946
|
{
"brief_title": "Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)",
"conditions": [
"Locally Advanced Hepatocellular Carcinoma"
],
"interventions": [
"Drug: Nivolumab",
"Drug: Cabozantinib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03299946",
"official_title": "Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-09",
"study_completion_date(actual)": "2021-10-01",
"study_start_date(actual)": "2018-05-14"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-03",
"last_updated_that_met_qc_criteria": "2017-09-27",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-03",
"first_submitted": "2017-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare bipolar resection versus holmium laser enucleation for management of large BPH.
Detailed Description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 gm).
#Intervention
- PROCEDURE : holmium laser enucleation of the prostate
- cystoscopic transurethral enucleation of the prostate using Holmium laser (Versa pulse 100W; Lumenis; Germany)
- Other Names :
- HoLEP
- PROCEDURE : Bipolar resection of the prostate
- cystoscopic transurethral resection of the prostate using bipolar energy
- Other Names :
- BPRP
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from LUTS secondary to infravesical obstruction from BPH
* failed medical treatment
* International Prostate Symptom Score (IPSS) > 13
* a peak urinary flow rate (Qmax) < 15 ml/sec
* a prostate size >= 75 gm
Exclusion Criteria:
* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP
Sex :
MALE
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04143399
|
{
"brief_title": "HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial",
"conditions": [
"BPH With Urinary Obstruction",
"Male"
],
"interventions": [
"Procedure: Bipolar resection of the prostate",
"Procedure: holmium laser enucleation of the prostate"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04143399",
"official_title": "Holmium Laser Enucleation vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-01",
"study_completion_date(actual)": "2019-06-10",
"study_start_date(actual)": "2016-02-14"
},
"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)": "2019-10-29",
"last_updated_that_met_qc_criteria": "2019-10-26",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-29",
"first_submitted": "2019-10-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Urgency incontinence is a common and burdensome problem in women. Current treatments for this condition, while effective, are associated with potentially disabling side effects and high rates of discontinuation. There is an urgent need for alternate treatments for urgency incontinence that are both clinically effective and well-tolerated by women in the community.
RESPeRATE is a commercially available 'walkman-like' device that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the US Food and Drug Administration (FDA) for treatment of mild hypertension, and use of the device has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate. Because anxiety and stress are strongly associated with urgency incontinence, and common behavioral strategies for managing incontinence emphasize relaxation and slow breathing at the time of an urgency episode, paced respiration may also be useful in treating urgency incontinence and/or decreasing its burden on quality of life.
We propose to conduct a 6-week pilot randomized controlled trial of slow paced respiration using the RESPeRATE device among 30 women with urgency incontinence to assess the feasibility of recruiting and teaching women to use the RESPeRATE device as well as to gather preliminary data on the efficacy of slow paced respiration for treatment of urgency incontinence and related symptoms. Participants will complete a 7-day voiding diary and complete questionnaires to measure outcome.
#Intervention
- DEVICE : RESPeRATE
- RESPeRATE is a commercially available, 'walkman-like' device manufactured by Intercure, Ltd. that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the FDA for treatment of mild hypertension and has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate.
- OTHER : Urinary Incontinence Pamphlet
- The urinary incontinence pamphlet will provide information about classification, pathophysiology, and management of urinary incontinence, including management strategies such as timed urination and pelvic muscle exercises.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women aged >= 18 years who report urinary incontinence for greater than or equal to 3 months prior to screening
* Report that the majority of their incontinence episodes are associated with a sensation of urgency
* Record at least 7 urgency incontinence episodes per week on a screening 7-day voiding diary
* Able to walk to the toilet and use the toilet by themselves without difficulty
* Willing to refrain from initiating treatments that may affect their voiding pattern during the trial period
* Capable of understanding study procedures and giving informed consent
Exclusion Criteria:
* Current use of medical therapy for incontinence or use within the previous month (participants may be able to stop use of therapy and re-present for study)
* Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period (approximately 2 months)
* Current urinary tract infection (screening dipstick urinalysis with leukocyte estrace, nitrites or blood) or a history or 4 or more urinary tract infections in the preceding year
* Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, Parkinson's disease
* Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
* Report history of pulmonary disease including emphysema, chronic bronchitis, or chronic obstructive pulmonary disease
* Measured resting blood pressure (average of 2 measures) less than 100/60 at screening or baseline examination
* Report any history of prior anti-incontinence or urethral surgery, pelvic cancer, or pelvic irradiation for any reason
* Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
* Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) during the past 3 months
* Report conditions that, in the judgment of the clinical center Principal Investigator, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia
* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
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
|
NCT01048424
|
{
"brief_title": "Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)",
"conditions": [
"Urinary Incontinence, Urge"
],
"interventions": [
"Device: RESPeRATE",
"Other: Urinary Incontinence Pamphlet"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01048424",
"official_title": "Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)",
"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)": "2010-01"
},
"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)": "2013-11-21",
"last_updated_that_met_qc_criteria": "2010-01-11",
"last_verified": "2013-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-13",
"first_submitted": "2010-01-11",
"first_submitted_that_met_qc_criteria": "2013-10-29"
}
}
}
|
#Study Description
Brief Summary
A randomized, double-blind, placebo-controlled trial was conducted to assess the effect of magnesium glycinate on symptoms of moderate to severe depression in 90 patients. Patients were assessed at baseline, end of the 4 weeks, and end of the 8 weeks of treatment. Patients were randomized to receive either 200 mg elemental magnesium or 200 mg placebo tablet twice daily for 8 weeks. The primary outcome measure was depression severity score assessment using Depression Anxiety Stress Scale 21 items Bangla Version (DASS-21 BV) and the secondary outcome measure was serum magnesium level estimation and side effects assessment using a preformed checklist.
Detailed Description
Major depressive disorder (MDD), is a mood disorder affecting 300 million people worldwide with a prevalence of 6.7% in Bangladesh. Depression is the main contributor to suicidal deaths and is globally ranked as the single largest contributor to non-fatal health loss. Various psychological, genetic, environmental, and biochemical factors are presumed to be involved in the causation of MDD. About 30% to 50% of patients do not respond to initial antidepressant medication, and 15% of them continue to suffer from symptoms despite the completion of multiple antidepressants and more aggressive treatment regimens, in addition to facing untoward adverse drug reactions with increasing dose. Recent trials attempted to assess the effect of magnesium in reducing depressive symptoms in MDD patients. This study evaluates whether there was any role of magnesium in reducing depressive symptoms between those who did and did not receive magnesium in 8 weeks period. Patients attending the Outpatient Department of Psychiatry, BSMMU, and diagnosed with MDD were evaluated using the DASS-21 BV for assessment of severity. Those patients who were experiencing moderate to severe symptoms (scores of 14-27) were enrolled according to inclusion and exclusion criteria. Total enrolled 90 MDD patients who have received either 200 mg elemental magnesium twice daily in the form of magnesium glycinate tablet or 200 mg placebo tablet twice daily for 8 weeks. A baseline depression severity score assessment was done using DASS-21 items and again repeated at the end of the 4 weeks and 8 weeks of treatment. Initially, baseline serum magnesium level (mg/dL) was measured and repeated again at the end of the 8 weeks of treatment. DASS-21 is a validated set of three self-report scales to measure the state of depression, anxiety, and stress, where each of the three scales contains 7 items, and each item is rated from 0 to 3. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest, anhedonia, and inertia.
#Intervention
- DIETARY_SUPPLEMENT : Magnesium Glycinate tablet 200mg
- Magnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs
- DIETARY_SUPPLEMENT : Placebo tablet 200mg
- Placebo tablet 200mg twice daily orally for 8 weeks along with SSRIs
|
#Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed >= 18 years MDD patients of both gender according to DSM-5 at the Outpatient Department of Psychiatry, BSMMU
* Moderate to severe MDD according to DASS-21 (scores of 14 <= age <= 27)
* Patients prescribed only SSRIs
Exclusion Criteria:
* Patients having any other psychiatric disease, kidney disease, or gastrointestinal disease
* Taking dietary supplements in the last two months
* Taking fluoroquinolones, aminoglycosides, tetracyclines, calcium channel blockers, bisphosphonates, and skeletal muscle relaxants
* Pregnancy and lactation
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
|
NCT04880460
|
{
"brief_title": "Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients",
"conditions": [
"MDD"
],
"interventions": [
"Dietary Supplement: Magnesium Glycinate tablet 200mg",
"Dietary Supplement: Placebo tablet 200mg"
],
"location_countries": [
"Bangladesh"
],
"nct_id": "NCT04880460",
"official_title": "Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-21",
"study_completion_date(actual)": "2021-11-21",
"study_start_date(actual)": "2021-03-18"
},
"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)": "2022-03-21",
"last_updated_that_met_qc_criteria": "2021-05-07",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-10",
"first_submitted": "2021-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants. It has been previously shown that CRE result in transient brain hypoxia and hypoperfusion and may represent a possible risk factor for neurodevelopmental impairment and retinopathy of prematurity. The high cardio-respiratory instability typically seen in preterm infants during the first 72 hours of life may influence CRE occurrence, with possible clinical implications. This study aims to characterize CRE features in this transitional period and to evaluate whether specific neonatal and clinical characteristics are associated with different CRE types.
Newborn infants with gestational age (GA) \<32 weeks or birth weight (BW) \<1500 g are enrolled. Congenital malformations and mechanical ventilation are exclusion criteria. During the first 72 hours, heart rate (HR) and peripheral oxygen saturation (SpO2) are continuously monitored, and an echocardiogram is performed to assess the status of the ductus arteriosus. CRE are clustered into isolated desaturation (ID, SpO2\<85%), isolated bradycardia (IB, HR\<100 bpm or \<70% baseline), combined desaturation and bradycardia (DB, occurrence of the two events within a 60-sec window). According to their duration and SpO2 and/or HR nadir values, CRE are also classified as mild (SpO2 80-84% and HR 80-100 bpm and duration \<60 sec), moderate (SpO2 70-79% or HR 80-60 bpm or duration 61-120 sec) or severe (SpO2 \<70% or HR \<60 bpm or duration \>120 sec). A generalized estimating equation (GEE) will be used to examine the impact of relevant variables on CRE type and severity.
Detailed Description
Background Cardio-respiratory events (CRE), defined as intermittent hypoxic and/or bradycardic episodes, are very common among premature infants. The poor respiratory drive, together with the increased metabolic oxygen consumption and the reduced total blood oxygen carrying capacity of this population significantly enhance CRE frequency and severity.
Evidence from animal models has shown that CRE, either alone or combined to specific clinical factors (i.e., intrauterine growth restriction, support modality, need for supplemental oxygen etc.), can trigger oxidative stress, which may contribute to adverse neonatal outcomes. In particular, a significant association between CRE and the development of retinopathy of prematurity (ROP) has been largely established, with evidence of a positive correlation between ROP severity and CRE duration, depth of desaturation, and persistency after 3 to 5 weeks of age. A critical role for CRE on early brain development has also been suggested by several studies showing a relationship between the ensuing hypoxic burden and poor neurodevelopment from early infancy up to early school age. Eventually, a possible association between CRE severity and the development of bronchopulmonary dysplasia has been recently reported in very-low-birth-weight (VLBW) neonates.
Most of the available literature on CRE characteristics, physiological mechanisms and effects in the premature population, however, is based on infants aged 2-weeks or older, while data from the transitional period, defined as the first 72 hours after birth, are scarce.
The transitional period represents a critical phase of physiological adaptation and may affect several organ systems, most notably the heart and the lungs. In particular, the dynamic cardiovascular changes that characterize the transition from fetal to neonatal circulation may enhance preterm infants' cardiorespiratory instability, with possible effects on CRE characteristics. In turn, the hemodynamic and respiratory disturbances that characterize post-natal transition may exacerbate the clinical burden of CRE during this period, with possible clinical implications.
This study aims to characterize CRE during transitional periods in VLBW preterm infants, and to evaluate whether specific neonatal characteristics may have an influence on CRE type and severity.
Methods Infants born at S. Orsola-Malpighi Hospital are consecutively enrolled in this observational, prospective study if fulfilling the following eligibility criteria: gestational age (GA) \<32 weeks' gestation, birth weight \<1500 g, 0-12 hours of life, written informed consent obtained from the parents/legal guardians of each infant.
Peripheral oxygen saturation (SpO2) and heart rate (HR) are routinely monitored during hospital stay using a Masimo Radical 7 (Masimo Corporation, Irvine, CA, USA) pulse oximeter with a 1-Hz sampling frequency.
Isolated desaturations (ID) are defined as SpO2 \<85% and classified into mild (SpO2 80-84%), moderate (SpO2 70-79%) and severe (SpO2 \<70%).
Isolated bradycardias (IB) are defined as any HR drop \<100 bpm or \>30% from baseline values, calculated daily over the first 72 hours of life, and further stratified into mild (HR 80-100 bpm or any drop between 31-50% of the baseline), moderate (HR 60-79 bpm or any drop between 51-70% of baseline) or severe (HR \<60 bpm or any drop \>70% of baseline).
Desaturations and bradycardias occurring within a 60-sec time window are considered as combined events (DB).
Event duration is calculated as the period spent below the SpO2 and HR thresholds described for CRE definition. According to their duration, CRE are defined as mild (10-60 sec), moderate (61-120 sec), or severe (\>120 sec).
Neonatal clinical characteristics The following antenatal and neonatal data are tracked down on a specific case report form: GA, antenatal steroids (complete course vs. incomplete course or not given) evidence of reversed end-diastolic flow at antenatal umbilical Doppler (uREDF) (present vs. absent); ventilatory status over the first 72 hours of life (continuous positive airway pressure \[CPAP\] vs. nasal cannulas or self-ventilating in air \[SVIA\]).
A screening echocardiogram is routinely performed at the time of enrollment using an ultrasound scanner CX50 (Philips Healthcare) with a 12-MHz probe, and repeated 6-12 hourly in the presence of a patent ductus arteriosus (PDA) or 12-24 hourly if there is no evidence of PDA. Based on echocardiographic features, the ductal status is classified as follows: no evidence of PDA (noPDA), restrictive PDA (rPDA; restrictive shunt pattern and left atrium to aortic root ratio \[LA:Ao\] ratio \<1.5), hemodynamically significant PDA (hsPDA; pulsatile shunt pattern, LA:Ao ratio ≥1.5 or presence of reversed end-diastolic flow (REDF) either in the descending aorta or in the anterior cerebral artery).
Statistical analysis Generalized estimating equation (GEE) models will be used to analyze the effect of GA, uREDF, antenatal steroids, ductal and ventilatory status on CRE type (ID, IB, DB) and severity (mild, moderate and severe) and the relation of different neonatal characteristics and event types with event duration. Variations in the daily number of ID, IB and DB over the 3 days of life, adjusted for the effective hours of recording, will be analyzed using Repeated Measures ANOVA (RM-ANOVA). IBM SPSS, version 25.0, will be used for statistical analysis. The significance level is set at p\<0.05.
#Intervention
- DEVICE : pulse oximetry monitoring
- pulse oximetry monitoring as per routine clinical practice
|
#Eligibility Criteria:
Inclusion Criteria:
* gestational age <32 weeks and/or birth weight <1500 g
Exclusion Criteria:
* mechanical ventilation
* major congenital malformations
* genetic abnormalities
Sex :
ALL
Ages :
- Minimum Age : 1 Hour
- Maximum Age : 72 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04123691
|
{
"brief_title": "Cardio-respiratory Events in Preterm Infants During Transition",
"conditions": [
"Apnea of Prematurity",
"Apneic Spells of Newborn Nos",
"Patent Ductus Arteriosus",
"Premature Birth",
"Desaturation of Blood",
"Bradycardia Neonatal"
],
"interventions": null,
"location_countries": [
"Italy"
],
"nct_id": "NCT04123691",
"official_title": "Cardio-respiratory Events in VLBW Preterm Infants During the Transitional Period: Clinical Features and Impact of Neonatal Characteristics.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-31",
"study_completion_date(actual)": "2019-09-02",
"study_start_date(actual)": "2018-02-21"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-26",
"last_updated_that_met_qc_criteria": "2019-10-09",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-11",
"first_submitted": "2019-10-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.
Detailed Description
Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.
#Intervention
- DEVICE : CO2 removal with PRISMALUNG in ARDS
- Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.
|
#Eligibility Criteria:
Inclusion Criteria:
* Mechanical ventilation with expected duration of >24 hours
* Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O
Exclusion Criteria:
* Age <18 years
* Pregnancy
* Severe hypoxemia with PaO2/FiO2 <100 mmHg
* Body mass index > 40 kg/m2
* Decompensated heart insufficiency or acute coronary syndrome
* Severe Chronic obstructive pulmonary disease (COPD)
* Major respiratory acidosis with PaCO2 >60 mmHg
* Acute brain injury
* Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure
* Heparin-induced thrombocytopenia
* Contraindication for systemic anticoagulation
* Patient moribund, decision to limit therapeutic interventions
* Catheter access to femoral vein or jugular vein impossible
* Pneumothorax
* Platelet <50 G/L
* Lacking 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
|
NCT02606240
|
{
"brief_title": "Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG",
"conditions": [
"Acute Respiratory Distress Syndrome"
],
"interventions": [
"Device: CO2 removal with PRISMALUNG in ARDS"
],
"location_countries": [
"France"
],
"nct_id": "NCT02606240",
"official_title": "Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-06",
"study_start_date(actual)": "2016-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-08",
"last_updated_that_met_qc_criteria": "2015-11-13",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-17",
"first_submitted": "2015-11-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The broad objective of this project is to test the efficacy of a theory-based HIV risk-reduction intervention, which includes both an adolescent component and parental component, designed to reduce the adolescents' risk of sexually transmitted HIV.
Detailed Description
Sexually transmitted HIV infection among adolescents is a growing and significant problem in Mexico. Given the high mortality rate associated with AIDS, the lack of available treatment, and the social stigma associated with the disease, prevention is the key to reducing the threat of AIDS among this important subgroup in Mexico. The study has four specific aims including 1) to determine whether the HIV risk-reduction intervention causes a greater increase in adolescents' intentions to abstain from intercourse and/or avoid unprotected intercourse at post-intervention and decreased self-reported intercourse and unprotected intercourse at 3, 6, 12, and 48 month follow-ups, compared with the general health promotion control intervention; 2) to determine whether the effects of the intervention are moderated by individual, microsystem, and macrosystem variables; 3) to identify theory-based variables that mediate effects of the HIV intervention on adolescents' self-reported behavior; and 4) to determine whether the HIV risk-reduction intervention causes a greater increase in parents' comfort with, and quantity of communication (general and HIV specific) with adolescents at post-intervention, 3, 6, 12, and 48 month follow-up compared with the general health promotion control intervention.
#Intervention
- BEHAVIORAL : Adolescent Safer Sex Intervention
- Adolescents are randomly assigned to the HIV risk-reduction intervention condition. Adolescents receive a theory-based intervention designed to reduce HIV risk-associated behavior. The intervention consists of six 50-minute modules implemented over the course of two days. The intervention is highly interactive and includes games, videos, discussion, and role-plays.
- Other Names :
- Cuidate
- BEHAVIORAL : Parent Safer Sex Communication Intervention
- Parents are randomly assigned to the Safer Sex Communication Intervention. Parents learn about HIV and other consequences of unprotected sexual behavior. The intervention contains content that focuses on enhancing parent-adolescent communication.
- OTHER : Adolescent Health Promotion Control Condition
- Adolescents are randomly assigned to the Health Promotion control condition. Adolescents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Adolescents are taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use.
- OTHER : Parent Health Promotion Control Condition
- Parents are randomly assigned to the Health Promotion control condition. Parents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Parents will be taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use. The intervention also provides content that emphasizes the importance of families.
|
#Eligibility Criteria:
Inclusion Criteria:
* Families (adolescents [aged 14 <= age <= 17 of age] and one of their parents)
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01084395
|
{
"brief_title": "Reducing HIV Risk Among Mexican Youth",
"conditions": [
"HIV Infections",
"AIDS",
"Sexually Transmitted Diseases"
],
"interventions": [
"Other: Adolescent Health Promotion Control Condition",
"Behavioral: Adolescent Safer Sex Intervention",
"Behavioral: Parent Safer Sex Communication Intervention",
"Other: Parent Health Promotion Control Condition"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT01084395",
"official_title": "Reducing HIV Risk Among Mexican Youth",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-09",
"study_completion_date(actual)": "2006-09",
"study_start_date(actual)": "2002-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-03-19",
"last_updated_that_met_qc_criteria": "2010-03-09",
"last_verified": "2010-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-10",
"first_submitted": "2010-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome, changes in the peri-implant microflora and on the inflammatory response in the periimplant pocket at 12 months.
Detailed Description
This is a randomised controlled clinical trial. Recruiting 31 patient with periimplantitis at one or more implants in need for surgical treatment.
Randomisation to test group (EMD) with surgical treatment and additional application of enamel matrix derivative (Emdogain®) or surgical treatment alone in the control group (non-EMD).
Treatment of existing periodontitis performed before recruitment. Baseline examination including samples of microbiota and peri-implant fluid followed by surgical treatment. Access surgery to remove chronic inflammatory tissue and clean the implant surface from biofilm and implant stone with hand instrument and ultrasonic device with special tips for implants, followed by polishing the implant surface with a gauze, super floss and rinsing with saline. Allocation with a performed block randomisation at the stage of surgery, after cleaning of implant surface. Application of enamel matrix derivative (Emdogain®) or not, just before closure of flap. After surgery rinsing with chlorhexidine 0.2% twice a day in 6 weeks. No systemic antibiotic used in this study.
Supportive care program, including hygiene instructions and professional cleaning supragingival at implants and teeth at 2 weeks, 3, 6, 9 and 12 months after treatment.
Examination with measurements of pocket depth and bone levels at radiographs at baseline just before surgery and 12 months and prevalence of bleeding on probing, pus or recession as well as full mouth plaque score and full mouth bleeding score at 3, 6, 9 and 12 months.
Microbial sampling performed with endodontic paper points at baseline and 2 weeks after surgery as well 3, 6 and 12 months from implant site with at baseline the deepest pocket.
Sampling of the peri-implant fluid from the peri-implant pocket at baseline, 3, 6, and 12 months from implant site with at baseline the deepest pocket.
Removal of bridges performed to give accessibility at baseline examination/surgery and at 12 months.
#Intervention
- DEVICE : Emdogain®
- Surgery and Emdogain®
- Other Names :
- enamel matrix derivative, enamel matrix proteins
- DEVICE : Surgery alone
- Surgery alone
|
#Eligibility Criteria:
Inclusion Criteria:
* peri-implant angular bone loss >=3 mm, measured at radiographs
* deep pocket >=5 mm combined with bleeding and/or pus
Exclusion Criteria:
* individuals with uncontrolled diabetes (HbA1c > 7,0%)
* individuals where prophylaxis of antibiotic is indicated
* medication with prednisolon or other anti-inflammatory drug
* medication with gingival hyperplasia known as a side effect
* systemic antibiotic intake the last 3 months
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02500654
|
{
"brief_title": "Regenerative Surgical Treatment of Peri-implantitis",
"conditions": [
"Failure of Dental Implant Due to Infection",
"Infection",
"Inflammation",
"Peri-implantitis",
"Bacterial Infections",
"Bleeding of Subgingival Space",
"Molecular Sequence Variation",
"Periodontal Diseases",
"Mouth Diseases"
],
"interventions": [
"Device: Emdogain®",
"Device: Surgery alone"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT02500654",
"official_title": "Peri-implantitis - Regenerative Treatment With Enamel Matrix Derivative (EMD). Clinical Effects, Microbial Profiles and Molecular Mechanisms. A Randomised Controlled Pilot Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2008-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-01",
"last_updated_that_met_qc_criteria": "2015-07-15",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-16",
"first_submitted": "2015-07-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Post-operative monitoring of all patients after anaesthesia in the post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.
In addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring.
This research is going to investigate the influence of the continuation of goal directed haemodynamic optimization in the recovery room on the basis of non-invasive monitoring tools, i.e. ultrasound and the volume-clamp method, in regard of length of stay in the PACU and postoperative complications.
Detailed Description
Postoperative monitoring of all patients after surgery in post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.
In addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring. The time of transfer of patients from the PACU to the general ward is assessed on the basis of several parameters. There is consensus on the most important endpoints of transferability: awareness, quality of spontaneous breathing, circulatory situation, bleeding situation, body temperature, diuresis and satisfactory freedom from pain and absence of nausea, but the processes and contents and how they can be established as quickly and sustainable as possible are not yet defined.
This research will investigate the influence of continuing non-invasive, goal-directed haemodynamic optimization in the recovery room, after major traumatological, general and vascular surgery.
In a randomized controlled trial the investigators will include a population of 80 patients with a minimum age of 18 years in the study after clarification and approval.
The control group will be routinely treated with an appropriate protocol for goal-oriented haemodynamic optimization. The study group will receive targeted haemodynamic optimization using Vigileo FlowTrac-Analysis and transthoracic echocardiography in the operation room and finger-cuff based pulse analysis technology in the PACU. The observed parameters of targeted haemodynamic optimization will be stroke volume and cardiac output, volume response parameters and collapsability of the inferior vena cava for the volume status.
As primary endpoints the investigators considered the number of postoperative complications. As secondary endpoints, the investigators will compare the time spent in the recovery room, the time spent in hospital and 28-day mortality and morbidity.
The hypothesis is that, in patients classified ASA II and III, a continuation of a targeted haemodynamic optimization in the PACU with non-invasive monitoring methods can reduce postoperative complications after a variety of surgical procedures.
#Intervention
- OTHER : goal directed intraoperative haemodynamic optimization
- all interventions that were pre-specified to be administered as part of the protocol
- Other Names :
- crystalloids, transthoracic echocardiography, volume clamp method
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
* written consent
Exclusion Criteria:
* Age <18 years
* ASA classification IV or higher
* legal care relationship
* missing or faulty written 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
|
NCT04822116
|
{
"brief_title": "Continuation of Goal Directed Haemodynamic Optimization in the PACU",
"conditions": [
"Hemodynamic Instability",
"Postoperative Complications",
"Ultrasound Imaging"
],
"interventions": [
"Other: goal directed intraoperative haemodynamic optimization"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04822116",
"official_title": "Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31",
"study_completion_date(actual)": "2021-03-01",
"study_start_date(actual)": "2019-04-24"
},
"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)": "2021-03-30",
"last_updated_that_met_qc_criteria": "2021-03-25",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-30",
"first_submitted": "2019-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care
Detailed Description
Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study
|
#Eligibility Criteria:
Inclusion Criteria:
* An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
* At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
* 18 months of enrollment with medical and pharmacy records after index episode date
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
|
NCT01446692
|
{
"brief_title": "Badalona Major Depressive Disorder Database Study",
"conditions": [
"Major Depressive Disorder"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT01446692",
"official_title": "Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2011-11"
},
"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)": "2012-01-12",
"last_updated_that_met_qc_criteria": "2011-10-04",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-05",
"first_submitted": "2011-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Individuals with bipolar disorder (BD) experience extreme mood swings, or episodes of depression and (hypo)mania. These episodes are associated with poor functioning, worse course of illness, and high rates of suicidality. It is estimated that between 25 to 65% of individuals with BD attempt suicide and 4 to 19% of individuals with BD eventually die by suicide. Sleep disturbance has been identified as a primary prodromal as well as causal symptom of mood episodes and recently, has been found to be associated with higher rates of suicidal ideation and behavior. Given the role that sleep may have in mood stability and suicidality in BD, it seems imperative to further understand the association of sleep and suicide and how sleep interventions may be useful to reduce suicidality in BD. Thus, the primary aim of this study is to use an innovative home sleep monitoring device, or the Embla, to examine the association of sleep and suicidality in adult outpatients with BD. The Embla is unique in that it is a non-invasive device that can characterize sleep profiles by measuring the degree of sleep fragmentation and percentage of rapid eye movement (REM) sleep. The study duration is five to six weeks such that patients wear the Embla device for Week 1, participate in a brief sleep intervention for suicide during Weeks 2 and 3, and 4, and then wear the Embla device for one more week (Week 5). This intervention consists of three, 60-min sessions and utilizes cognitive-behavioral therapy strategies (e.g., psychoeducation, cognitive re-structuring, problem solving, behavioral activation) to improve sleep disturbance. The investigators expect that individuals at study entry with more sleep disturbance (as measured by the Embla) will report more suicidal ideation and behaviors. The investigators also hypothesize that from pre- to post-intervention, individuals will report less sleep disturbance as well as suicidal ideation and behaviors. Data from this research has immediate and practical implications for providers and their patients as it the first examination of sleep phenotypes and suicide in a high risk population as well as to explore the association of improvements in sleep with suicidality.
Detailed Description
Bipolar disorder is characterized by episodes of depression as well as episodes of mania (abnormally high mood). Individuals with bipolar disorder experience high rates of suicidal ideation and behavior, with risk of death due to suicide estimated to be 20 times greater than the general population. Moreover, some research suggests that among individuals treated for bipolar disorder, approximately 40% will report a past suicide attempt. Other studies suggest that between 25 and 65% of patients with bipolar disorder will attempt suicide and that between 4 and 19% of these individuals will be successful. Among the DSM-IV-TR Axis I disorders, suicide appears to be the highest in bipolar disorder. Individuals with bipolar disorder have a greater likelihood of both current and past suicidal ideation if they have an anxiety disorder, have an earlier age of onset, or a more severe course of illness. Nevertheless, there is a continued need for information on the epidemiology and risk factors for suicidal ideation and behavior in this population.
Several studies have shown that sleep difficulties (i.e., insomnia, hypersomnia, poor sleep quality, and nightmares) are significantly associated with suicidal ideation, even after controlling for depression. These disturbances are well documented during episodes of depression and mania, but sleep disturbances have also been shown to persist during periods of relative mood stability. A common symptom in bipolar patients experiencing manic episodes is a reduced need for sleep, and several studies using polysomnography have identified decreased REM sleep latency in manic episodes. Utilizing self-report measures, studies of bipolar patients in depressive episodes have identified variable rates of hypersomnia and insomnia as common factors. However, research conducted using laboratory-based polysomnography during depressive episodes have reported disparate findings.
This proposal involves a test of a novel measure of sleep architecture in patients with bipolar disorder, using a newly available home sleep monitoring device called Embla (www.embla.com). This device sticks to the skin on the chest with standard EKG-adhesive stickers and captures electrocardiogram (EKG) during sleep. The Embla device also measures movement, snoring, body position, and light levels. The on-board storage allows 2-3 weeks of nightly recording. By using an unobtrusive and potentially informative measure of sleep architecture, this protocol will allow longitudinal, objective information about sleep disturbance to be compared with corresponding mood states in patients with bipolar disorder.
Overall, this protocol is investigating the relationship between suicidality and sleep disturbance as well as assessing whether a brief CBT intervention for sleep disturbance is associated with reduced suicidal ideation and/or behavior. Since research suggests that CBT is an effective adjunct treatment for reducing suicidality in this population, and that treatment for insomnia can improve sleep in individuals with bipolar disorder, the present research has important implications for the prevention and intervention of suicide in this vulnerable population. To the investigators knowledge, no investigations have looked at the effectiveness of CBT on both sleep and suicidality in bipolar disorder. Furthermore, while past research has relied almost exclusively on subjective reports of sleep, this study captures both subjective and objective measures of sleep.
#Intervention
- BEHAVIORAL : Brief Sleep Intervention
- Participants will meet with a therapist for three sessions to try to improve sleep problems (hypersomnia or insomnia, depending on the problems the participant has).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 65.
* Have a primary diagnosis of bipolar I or bipolar II disorder
* Have a reported sleep disturbance
* Have reported suicide ideation (thoughts)
Exclusion Criteria:
* Any known or active sleep disorder (such as sleep apnea)
* Any history of significant cardiac, pulmonary, neurological, hepatic, or renal disease
* Any history of malignancy, chemotherapy, or radiation
* Any skin condition that would prevent wearing the device
* Pregnancy
* Current or suspected sleep apnea
* Current use of certain medications including beta blockers
* Known diagnosis of atrial fibrillation
* Acute major depressive or manic episode
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
|
NCT01764074
|
{
"brief_title": "Brief Sleep Intervention for Bipolar Disorder",
"conditions": [
"Bipolar Disorder",
"Sleep Problems",
"Suicidal Thoughts"
],
"interventions": [
"Behavioral: Brief Sleep Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01764074",
"official_title": "Brief Sleep Intervention for Suicide in Bipolar Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-15",
"study_completion_date(actual)": "2018-11-15",
"study_start_date(actual)": "2013-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-06",
"last_updated_that_met_qc_criteria": "2013-01-08",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-09",
"first_submitted": "2013-01-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram \[mcg\]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.
Detailed Description
The vaccine being tested in this study is called PIZV or TAK-426 adjuvanted with aluminum hydroxide. The Zika virus vaccine is being tested to provide safety and immunogenicity data to enable the vaccine to be further developed clinically.
The study will enroll approximately 240 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four groups-which will remain undisclosed to the study observer:
* Placebo
* PIZV: 2 microgram (mcg) Low Dose
* PIZV: 5 mcg Medium Dose
* PIZV: 10 mcg High Dose
All participants will be administered either placebo or PIZV by intramuscular (IM) injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4).
This multi-center trial will be conducted in the United States and Puerto Rico. The overall time to participate in this study is up to 25 months. Participants will make multiple visits to the clinic on Days 1, 8, 29, 36, 57, 211, 393 and will be contacted by telephone on Day 133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11) depending on the study arm, for a final follow-up assessment.
#Intervention
- DRUG : Placebo
- Placebo (normal saline (0.9% NaCl) IM injection.
- BIOLOGICAL : PIZV
- Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant IM injection.
- Other Names :
- TAK-426
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and eligibility screening tests (hematology, biochemistry and urinalysis) and clinical judgment of the investigator. Vital signs must be within normal limits (ie, below Grade 1 as specified in the Food and Drug Administration [FDA] Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers). Screening tests must be within normal limits or not be above Grade 1 as defined in the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers.
* Participants who can comply with trial procedures and are available for the duration of follow-up.
* All female participants must be willing to undergo serum beta human chorionic gonadotropin (B-hCG) pregnancy test and must test negative by urine pregnancy test prior to each study vaccination.
Exclusion Criteria:
* Participants and participants' partners with confirmed Zika virus (ZIKV) infection by self-report.
* Traveling to flavivirus endemic countries or flavivirus endemic regions of the United States (US) or US territories*, within 4 weeks prior to screening or planned travel through to Visit 6 (applicable only to participants to be enrolled into the flavivirus naïve cohort).
a. Centers for Disease Control and Prevention (CDC) website define the information about the flavivirus endemic countries and US regions and territories.
* Known hypersensitivity or allergy to any of the vaccine candidate components (including excipients of the investigational vaccine or placebo).
* Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
* Known or suspected impairment/alteration of immune function, including:
* Chronic use of oral steroids (equivalent to 20 milligram per day [mg/day] prednisone greater than or equal to [>=] 12 weeks / >= 2 milligram per kilogram [mg/kg] body weight / day prednisone >= 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
* Receipt of parenteral steroids (equivalent to 20 mg/day prednisone >= 12 weeks / >= 2 mg/kg body weight / day prednisone >= 2 weeks) within 60 days prior to Day 1.
* Receipt of immunostimulants within 60 days prior to Day 1.
* Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derived products within 3 months prior to Day 1 or planned during the full length of the trial. In addition, participants must be advised not to donate blood during the study period.
* Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
* Genetic immunodeficiency.
* Has known current or chronic hepatitis B and/or hepatitis C infections.
* Has abnormalities of spleen or thymic function.
* Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Individuals participating in any clinical trial with another investigational product, including ZIKV vaccine clinical trial within 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
* Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine/placebo administration.
* Female participants who are pregnant or breastfeeding, or are planning to become pregnant.
* Any positive or indeterminate pregnancy test.
* If female participant of childbearing potential, sexually active, and who has not used any of the 'acceptable contraceptive methods' for at least 2 months prior to trial entry:
* 'Of childbearing potential' is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years without any other alternative medical cause (as confirmed by a healthcare professional), status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
* Acceptable birth control methods are defined as one or more of the following:
* Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
* Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
* Intrauterine device.
* Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
* If female participant of childbearing potential and sexually active, refusal to use an 'acceptable contraceptive method' from trial entry through 2 months after the last dose of investigational vaccine/placebo. In addition female participants of childbearing potential must be advised not to donate ova during this period.
* To avoid sexual transmission of ZIKV from natural exposure: Refusal to use latex condoms correctly and consistently by sexually active participants even if other contraceptive measures are used from signing the informed consent form (ICF) through the end of the trial. Male participants must be advised not to donate sperm during this period.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03343626
|
{
"brief_title": "Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants",
"conditions": [
"Virus, Zika",
"Zika Virus Disease",
"Flavivirus Infections",
"Healthy Participants"
],
"interventions": [
"Drug: Placebo",
"Biological: PIZV"
],
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT03343626",
"official_title": "A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Safety, Immunogenicity, and Dose Ranging Study of Purified Inactivated Zika Virus Vaccine (PIZV) Candidate in Flavivirus Naïve and Primed Healthy Adults Aged 18 to 49 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-28",
"study_completion_date(actual)": "2020-11-24",
"study_start_date(actual)": "2017-11-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-11",
"last_updated_that_met_qc_criteria": "2017-11-13",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-17",
"first_submitted": "2017-11-13",
"first_submitted_that_met_qc_criteria": "2021-11-24"
}
}
}
|
#Study Description
Brief Summary
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.
#Intervention
- DRUG : prednisolone 0.5 mg/kg/day for three months
- period of treatment
- Other Names :
- prednisolone
- DRUG : prednisolone 0.5 mg/kg/day for six months
- period of therapy
- Other Names :
- prednisolone
|
#Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven chronic eosinophilic pneumonia
Exclusion Criteria:
* Patients who received oral glucocorticosteroid (more than 10 mg)
* Immunosuppressive drug
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00632554
|
{
"brief_title": "The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia",
"conditions": [
"Eosinophilic Pneumonia",
"Chronic Disease"
],
"interventions": [
"Drug: prednisolone 0.5 mg/kg/day for six months",
"Drug: prednisolone 0.5 mg/kg/day for three months"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT00632554",
"official_title": "Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2008-06"
},
"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)": "2014-09-19",
"last_updated_that_met_qc_criteria": "2008-02-28",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-10",
"first_submitted": "2008-02-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.The researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy.
Detailed Description
Chemotherapy-naive patients will be offered to participate in a two arms study. Following consent, patients will be randomized to one of two arms. Patients in both arms will be provided by booklet and audio-cassette that specify lifestyle recommendations (diet, physical activity and breathing exercises). Patients in one of the study arms will be provided in addition with frozen wheatgrass juice (recommended daily dosage of 55-110 CC daily). Patients in both arms will be asked to fill in a daily patient's diary monitoring the practice of the lifestyle recommendations.
Baseline assessment will include the following questionnaires: ESAS, MYCAW, FACIT- Fatigue. Evaluation will include weekly ESAS and FACIT-Fatigue questionnaire and subsequent evaluation (including ESAS, MYCAW, FACIT- Fatigue questionnaires) following 3 and 4 chemotherapy cycles of treatment. Follow-up evaluation will be performed at the completion of chemotherapy.
#Intervention
- DIETARY_SUPPLEMENT : Wheatgrass juice
- 110 CC daily od frozen wheatgrass juice in the intervention arm
- Other Names :
- Triticum aestivum
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of cancer with no sign of active disease
* First-time treatment with chemotherapy
Exclusion Criteria:
* Treatment with per os administration of chemotherapy
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
|
NCT01215448
|
{
"brief_title": "Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment",
"conditions": [
"Fatigue"
],
"interventions": [
"Dietary Supplement: Wheatgrass juice"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT01215448",
"official_title": "Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-08",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"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)": "2014-06-17",
"last_updated_that_met_qc_criteria": "2010-10-05",
"last_verified": "2014-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-06",
"first_submitted": "2010-09-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.
Adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.
ARTIX study (NCT01874587) entitled 'Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia' is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.
ARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
* Age >= 18 years and <= 75 years
* Performance status (WHO <= 2)
* Renal, hepatic and cardiovascular functions allowing systemic treatment administration
* Adapted stomatologic care
* Signed informed consent form
* Membership or beneficiary of a national insurance scheme
Exclusion Criteria:
* Both parotids totally included in the target volume
* Stages T1 or T2 with positive node disease N1
* Neoadjuvant chemotherapy
* Exereses of primitive tumor and/or nodes
* History of other cancer within 5 years (except for basocellular epithelioma and cervical)
* Previous neck radiotherapy
* Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy
* Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia) incompatible with study participation
* Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
* Patient already recruited in another biomedical research ( non interventional study is authorized)
* Pregnant or breast feeding patients
* Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
* Patient is deemed incapable of giving informed consent
* Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
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
|
NCT05025618
|
{
"brief_title": "Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)",
"conditions": [
"Oropharynx Cancer"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT05025618",
"official_title": "Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-10",
"study_completion_date(actual)": "2020-12-08",
"study_start_date(actual)": "2013-07-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-05",
"last_updated_that_met_qc_criteria": "2021-08-24",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-27",
"first_submitted": "2021-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.
#Intervention
- PROCEDURE : Renal Allograft Biopsy
- A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Recipient of renal transplant
* Positive for polyoma virus
* Haufen cells present in urine
* Positive for polyoma virus nephropathy
Exclusion Criteria:
* anyone who does not meet the inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01094691
|
{
"brief_title": "Haufen Diagnostic Biomarkers of BK Renal Disease",
"conditions": [
"Polyoma Virus Nephropathy"
],
"interventions": [
"Procedure: Renal Allograft Biopsy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01094691",
"official_title": "Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07",
"study_completion_date(actual)": "2019-07",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-12",
"last_updated_that_met_qc_criteria": "2010-03-25",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-29",
"first_submitted": "2010-03-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.
#Intervention
- BIOLOGICAL : Peginterferon alfa-2a
- Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
- Other Names :
- PEGASYS®, RO0258310
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients >= 18 years.
* Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
* Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but <= 10 x ULN according to local label.
Exclusion Criteria:
* Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
* Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
* Concomitant treatment with telbivudine.
* Pregnant or lactating women.
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
|
NCT01667432
|
{
"brief_title": "An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B",
"conditions": [
"Hepatitis B, Chronic"
],
"interventions": [
"Biological: Peginterferon alfa-2a"
],
"location_countries": [
"Bulgaria"
],
"nct_id": "NCT01667432",
"official_title": "A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08-12",
"study_completion_date(actual)": "2014-08-12",
"study_start_date(actual)": "2011-07-08"
},
"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)": "2017-04-10",
"last_updated_that_met_qc_criteria": "2012-08-15",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-17",
"first_submitted": "2012-08-15",
"first_submitted_that_met_qc_criteria": "2015-11-03"
}
}
}
|
#Study Description
Brief Summary
Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
#Intervention
- DRUG : desvenlafaxine succinate sustained release
- Titration 100 mg
- DRUG : desvenlafaxine succinate sustained release
- Titration 50 mg
- DRUG : desvenlafaxine succinate sustained release
- Titration 25 mg, 50mg
- DRUG : desvenlafaxine succinate sustained release
- Titration 25 mg
- DRUG : Placebo
- Tapering placebo
- DRUG : desvenlafaxine succinate sustained release
- Tapering 50 mg, placebo
- DRUG : desvenlafaxine succinate sustained release
- Tapering 50 mg, 25 mg
- DRUG : desvenlafaxine succinate sustained release
- Tapering 50 mg QOD
|
#Eligibility Criteria:
Inclusion Criteria:
* Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
* Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.
Exclusion Criteria:
* History of a seizure disorder other than a single childhood febrile seizure.
* History or presence of clinically important hepatic or renal disease or other medical disease.
* Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
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
|
NCT00401245
|
{
"brief_title": "The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms",
"conditions": [
"Vasomotor Symptoms"
],
"interventions": [
"Drug: Placebo",
"Drug: desvenlafaxine succinate sustained release"
],
"location_countries": [
"None",
"Canada",
"United States"
],
"nct_id": "NCT00401245",
"official_title": "The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-01",
"study_completion_date(actual)": "2008-01",
"study_start_date(actual)": "2006-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-10-26",
"last_updated_that_met_qc_criteria": "2006-11-17",
"last_verified": "2011-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-11-20",
"first_submitted": "2006-11-17",
"first_submitted_that_met_qc_criteria": "2011-09-06"
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
Detailed Description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of topiramate (400 milligrams/day) compared with placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder. In addition, a third group of patients will be treated with lithium (1500milligrams/day) as a comparator drug. The trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. Efficacy assessments include the change from baseline to Day 21 in the Young Mania Rating Scale (YMRS) score. Also included as efficacy assessments during the 12 week study are the Clinical Global Impressions (CGI) scale, Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), and health-related quality of life measures at specified time intervals. Safety assessments include evaluation of adverse events throughout the study, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) througout the study, as well as changes in clinical laboratory tests (hematology, chemistry, urinalysis), electrocardiograms (ECGs), and physical examinations at specified times. The study hypothesis is that the change from baseline in the total Young Mania Rating Scale (YMSR) score at Day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients. Topiramate oral capsule will be increased from once daily (50mg) to 3 times daily up to target total daily dose 400mg, maintained through Week 12. Lithium oral capsules will be increased from once daily (300mg) to 3 times daily up to target total daily dose of 1500mg, maintained through Week 12.
#Intervention
- DRUG : Topiramate
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
* )
* Currently in a manic or mixed episode and at least one previous manic or mixed episode
* meet minimum severity criteria (a Young Mania Rating Scale [YMRS] score of >=20 at screening and baseline visits) for the current acute manic or mixed episode
* Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test
Exclusion Criteria:
* DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
* DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
* Experienced a manic episode while taking an antidepressant or psychostimulant drug
* known hypersensitivity to topiramate or previously participated in a topiramate 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
|
NCT00035230
|
{
"brief_title": "A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder",
"conditions": [
"Bipolar Disorder"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00035230",
"official_title": "A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Topiramate in Patients With Acute Manic or Mixed Episodes of Bipolar I Disorder With an Optional Open-Label Extension",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2002-11",
"study_start_date(actual)": "2001-07"
},
"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)": "2011-06-08",
"last_updated_that_met_qc_criteria": "2002-05-02",
"last_verified": "2011-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-05-03",
"first_submitted": "2002-05-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.
Detailed Description
The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.
#Intervention
- DRUG : Ertugliflozin 5 mg
- Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104
- Other Names :
- MK-8835
- DRUG : Ertugliflozin 10 mg
- Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.
- Other Names :
- MK-8355
- DRUG : Glimerpiride
- Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose
- DRUG : Placebo to Ertugliflozin
- Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104
- DRUG : Placebo to Glimepiride
- Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.
- DRUG : Metformin
- Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.
- DRUG : Sitagliptin
- Open label, oral, once daily, rescue medication as required.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of T2DM in accordance to American Diabetes Association guidelines
* On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
* Body Mass Index (BMI) >=18.0 kg/m^2
* Male or female not of reproductive potential
* If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.
Exclusion Criteria:
* History or presence of type 1 diabetes mellitus or a history of ketoacidosis
* History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
* A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor
* Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
* Known hypersensitivity or intolerance to metformin or glimepiride
* On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months)
* History of bariatric surgery less than 12 months prior to study participation
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
* Active, obstructive uropathy or an indwelling urinary catheter
* A history of malignancy <=5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
* Known history of Human Immunodeficiency Virus (HIV)
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
* A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
* Any clinically significant malabsorption condition
* Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
* Previous randomization in a study with ertugliflozin
* Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
* A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
* A positive urine pregnancy test
* Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
* Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
* Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
* Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01999218
|
{
"brief_title": "Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Ertugliflozin 5 mg",
"Drug: Metformin",
"Drug: Placebo to Glimepiride",
"Drug: Sitagliptin",
"Drug: Placebo to Ertugliflozin",
"Drug: Glimerpiride",
"Drug: Ertugliflozin 10 mg"
],
"location_countries": null,
"nct_id": "NCT01999218",
"official_title": "A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-18",
"study_completion_date(actual)": "2017-04-18",
"study_start_date(actual)": "2013-12-16"
},
"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)": "2019-04-02",
"last_updated_that_met_qc_criteria": "2013-11-25",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-03",
"first_submitted": "2013-11-25",
"first_submitted_that_met_qc_criteria": "2018-04-10"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to compare the effectiveness of Ultrasound-Guided Percutaneous nephrolithotomyin different positions supine, prone positions and flank suspend supine position in renal stones treatment.
Detailed Description
Percutaneous nephrolithotomy (PCNL) has become the choice of modality for the treatment of large and complicated renal calculi. Initially, percutaneous access to the kidney was only performed in the prone position, as described sixty years ago.
#Intervention
- PROCEDURE : Flank suspended supine position percutaneous nephrolithotomy
- The patients will be placed in the supine position with the shoulder and the buttock will be raised by a 3-l bag of water suspending the flank of the affected side. The body contour will be aligned to the edge of the table. The operating table will be adjusted to the jack knife position, with the tip of the lower part of the table will be slightly lowered. The leg of the affected side of the patent will be straightened dorsally flexed and slightly inner rotated, with the knee of the other side will be flexed. The patients will be then immobilized at the chest and the pelvis with two adherent tapes which crossed each other at the abdomen to form a 'V' shape.
- PROCEDURE : Supine percutaneous nephrolithotomy group
- The patient will remain in the supine position, with the side of interest at the edge of the table, with a small cushion placed under the flank to elevate it 15-20°.
- PROCEDURE : Prone percutaneous nephrolithotomy group
- Prone percutaneous nephrolithotomy. The prone position (PRON) technique followed these classic steps: patients will be placed in a lithotomy position and a ureteral catheter will be inserted through a rigid cystoscope to perform a retrograde pyelogram. The ureteral catheter will be fixed to a Foley catheter, and then the patient will be repositioned to the prone position with pads under their shoulders.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients who underwent Percutaneous nephrolithotomy
* Patient's age from >18 - 70 years.
* Body mass index (30 <= age <= 40 kg/m2).
* Both sex
* Renal stones diameter >=2 cm
* Cardiac patients
Exclusion Criteria:
* Patient refusal.
* Pregnant women.
* Patients with renal anomalies.
* Transplanted kidney.
* Uncorrected coagulopathy, or active infection.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05855057
|
{
"brief_title": "Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment",
"conditions": [
"Percutaneous Nephrolithotomy",
"Renal Stones",
"Ultrasound Therapy; Complications"
],
"interventions": [
"Procedure: Supine percutaneous nephrolithotomy group",
"Procedure: Prone percutaneous nephrolithotomy group",
"Procedure: Flank suspended supine position percutaneous nephrolithotomy"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05855057",
"official_title": "A Retrospective Single Centered Cohort Study Comparing The Effectiveness of Ultrasound-Guided PCNL Different Positions in Renal Stones Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-20",
"study_completion_date(actual)": "2022-01-20",
"study_start_date(actual)": "2018-01-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-11",
"last_updated_that_met_qc_criteria": "2023-05-03",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-11",
"first_submitted": "2023-05-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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