louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04845945: MISP 60528 Pneumococcal Vaccination
Official title: Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplant Infection Prevention
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-04-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are excluding infants and children as they are immunologically different from adults, respond to vaccinations differently, and guidelines for childhood vaccination are different from those for adult vaccination.

Brief summary: This study aims to use two different blood tests (ELISA and OPA) to study response to pneumococcal vaccination administered as per standard guidelines in patients who are undergoing workup for heart transplant (whether or not they have undergone LVAD implantation or have undergone heart transplant.

Detailed description: The patients will be receiving vaccination consistent with standard of care guidelines, regardless of study participation. The additional risk of study participation would be the risks associated with venipuncture (injury to vessel or nerve, syncope).

Patients will not accrue benefits personally. However, participation will help others by identifying whether current vaccination strategies in this population are adequate.

Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
* Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines

Exclusion Criteria:

* Infants and children under age 18
* Subjects without the capacity to consent
* Pregnancy
* Already up to date on pneumococcal vaccination or declining vaccination

Primary outcomes:
measure: Vaccine response
timeFrame: 12 weeks
Secondary outcomes:
measure: Serotype ELISA response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Infectious Diseases
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Vagish Hemmige, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06598345: Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility
Official title: Impact of Integrated Pet Care on Glycemic Control and Diabetes Responsibility
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes Mellitis
Keywords: type 1 diabetes
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with communication skills training works to improve glycemic control, blood glucose monitoring frequency and blood glucose review in early adolescents with suboptimal control of type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* age 10-13 years (inclusive)
* diagnosis of T1DM for at least one year
* fluency in English or Spanish, (d) recent HbA1c value 7.5% - 14%
* utilization of a CGM or glucometer that links with software to enable viewing and documentation in daily report including a section to enter "notes" (i.e. CGM/software, Dexcom/Clarity; Freestyle Libre/LibreView; AccuChek,OneTouch (glucometers)/MySugr)
* current pet fish at home or willingness to obtain a pet fish if randomized to that intervention.

Exclusion Criteria:

* clinical or laboratory characteristics suggestive of type 2 DM
* involvement in foster care
* dual-home living situation
* severe psychiatric disorders
* developmental delay or cognitive impairment that make it difficult to establish consistent diabetes and pet care behaviors
* current participation in another study that may impact glycemic control
* HbA1c \>14% (because these individuals may need a more intensive intervention than this is intended to provide)
* lack of a computer or compatible cell phone for uploading CGM or glucometer data.

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Fidelity to BGM (blood glucose monitoring) partnered with fish feeding
timeFrame: 3 months
measure: Fidelity to weekly reviews partnered with fish tank maintenance
timeFrame: 3 months
measure: Retention rate
timeFrame: 3 months
Secondary outcomes:
measure: Number of blood glucose (BG) readings receiving parental review
timeFrame: Baseline, during intervention and post-intervention (monthly intervals, up to 6 months)
measure: Time in Range (TIR)
timeFrame: Baseline, 3 months, 6 months
measure: Self Care Inventory (SCI) (modified)
timeFrame: Baseline, 3 months, 6 months
measure: Blood glucose monitoring (BGM) frequency
timeFrame: Baseline, 3 months, 6 months
measure: HbA1c (Hemoglobin A1C) level
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Olga Gupta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00727545: Effect of Rice Fortification With Iron on Anemia Among Children
Official title: Effect of Weekly Rice Fortification With Iron on Frequency of Anemia and Hemoglobin Concentration Among Children Attending Public Day Care Centers From Rio de Janeiro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Iron Deficiency Anemia
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 385
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a double-blind community-based trial, placebo controlled. During 16 weeks, children in the intervention group (GI, n=180) received iron fortified rice, and children in the control group (GC, n=174) received rice with placebo. Anemia was considered present when hemoglobin \< 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed by using Student's t-test. Hemoglobin concentration improved in both groups, with mean increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p \< 0.001), and 0.49 g/dL in GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p \< 0.001). Anemia decreased (p \< 0.01) in both groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them. Hemoglobin increase was significantly higher in children who received total amount of iron ≥ 53.76 mg from fortified rice, compared to those who received less than this cut-off value (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be useful in anemia control if fortified food intake is adequate.


Eligibility criteria: Inclusion Criteria:

* pre-school children attending public day care centers

Exclusion Criteria:

* sickle cell anemia, purpura

Primary outcomes:
measure: Hemoglobin in crease
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Public day care centers
Study officials:
References:
Clinical trial NCT01629745: Genetic Test in Detecting Minimal Residual Disease in Samples From Younger Patients Registered on the COG-AALL08B1 Trial
Official title: Feasibility of Minimal Residual Disease (MRD) Determination in Pediatric B-Lineage ALL Using Deep Sequencing of the Immunoglobulin Heavy Chain Locus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-28
Enrollment: 99
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients registered on the Children Oncology Group (COG - AALL08B1)

Brief summary: RATIONALE: Testing for minimal residual disease in blood samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment.

PURPOSE: This research trial studies a genetic test in detecting minimal residual disease in samples from younger patients registered on COG-AALL08B1 trial.

Detailed description: OBJECTIVES:

* Assess the feasibility of minimal residual disease (MRD) determination in pediatric B-lineage acute lymphoblastic leukemia (ALL) using deep sequencing of the immunoglobulin heavy chain locus.

OUTLINE: Archived blood and tumor tissue samples are analyzed for MDR using deep sequencing of immunoglobulin heavy chain locus. MDR quantification results are then compared with the flow cytometry reference methods used in COG studies.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Samples from patients registered on the Children Oncology Group (COG)-AALL08B1 protocol and stored in the Hematopathology Laboratory at the University of Washington

  * Pretreatment and after induction therapy samples

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Sensitivity of deep sequencing of the immunoglobulin heavy chain locus in determining MRD in B-lineage ALL
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Cancer Care Alliance
name: Brent Wood, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02499445: Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery
Official title: Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), and one day after surgery (postoperative).

Detailed description: To determine the difference of myocardial injury upon using different anesthesia regimens: remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.

Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration0.35-0.75 ng/ml) (Group-SS).

Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), 1 day after surgery (postoperative).

Eligibility criteria: Inclusion Criteria:

* patient undergoing OPCAB surgery
* patient signed written informed consent

Exclusion Criteria:

* patient with Intra-aortic balloon pump
* patient with renal replacement therapy
* patient wants to withdraw the participation to the study

Primary outcomes:
measure: troponin I
timeFrame: one day after surgery
Secondary outcomes:
measure: creatinin kinase-MB
timeFrame: one day after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References:
Clinical trial NCT00695045: Intrathecal Morphine in Knee Arthroplasty
Official title: Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Arthroplasty, Replacement, Knee
Keywords: Pain, Postoperative
Arthroplasty, Replacement, Knee
Morphine
Injections, Intrathecal
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.


Eligibility criteria: Inclusion Criteria:

* Patients for elective total knee arthroplasty

Exclusion Criteria:

* No contraindication to spinal
* No allergy to morphine, rescue analgesia or anti-emesis treatment.

Primary outcomes:
measure: pain
timeFrame: 24 hours
Secondary outcomes:
measure: nausea and vomiting
timeFrame: 24 hours
measure: pruritus
timeFrame: 24 hours
measure: sedation
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesia, UCHG
name: Patrick D Hassett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesia,UCHG
name: John Laffey, MD
role: STUDY_CHAIR
affiliation: Dept of Anaesthesia , UCHG
name: Brian Kinirons, MD
role: STUDY_DIRECTOR
References:
citation: Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
Clinical trial NCT02021045: Cerebral Microembolism During Hemodialysis
Official title: Quantity, Quality and Laterality of Cerebral Microembolism During Veno-Venous Hemodialysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Dialysis
Thrombus Due to Renal Dialysis Device, Implant, or Graft
Cerebral Embolism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population incloses patients who are in renal failure needing renal replacement therapy under intensive care conditions.

Brief summary: There is increasing evidence that renal replacement therapy (= continuous veno-venous hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler ultrasound.

The aim of this study is to monitor patients with transcranial Doppler under two conditions: during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic load is detected during 30 minutes).

The study hypothesis is that during hemodialysis the cerebral embolic load is significantly higher than in the hemodialysis-free interval.


Eligibility criteria: Inclusion Criteria:

* Renal replacement therapy (continuous veno-venous hemodilalysis) on the in-house intensive care unit
* Age \> 18yrs and \< 90yrs

Exclusion Criteria:

* Absent informed consent
* Preexistent neurological morbidity
* Neurocognitive disturbances
* Carotid artery stenosis \> 70%
* Patent foramen ovale
* Treatment with other extracorporeal devices
* Cardial pathology (valvular heart disease, prosthesis, endocarditis)
* Pregnancy, drug abuse
* Inclusion in an other clinical study
* Allergy against materials of the medical device used in the study (transcranial Doppler) or temporal skin/bone lesions

Primary outcomes:
measure: Quantity of cerebral embolic load
timeFrame: 30 minutes
Secondary outcomes:
measure: Quality and laterality of cerebral embolic load
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Gabor Erdoes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05014945: Combination Therapy With Atelocollagen in Epidural Nerve Block
Official title: Effect of Combination Therapy With Atelocollagen in Epidural Nerve Block in Patients With Chronic Low Back Pain From Degenerative Lumbar Spine: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spine Disease
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with chronic low back pain due to degenerative spinal disease for more than 6 months
Primary purpose: TREATMENT

Brief summary: "In this study, the investigators plan to evaluate muscle mass and pain relief 4 weeks after performing epidural nerve block and Type I porcine atelocollagen injection into multifidus muscle in patients with chronic low back pain due to degenerative spinal disease for more than 6 months.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for epidural nerve block for lower back pain
2. Patients over 21 years of age
3. Back pain lasting more than 6 months
4. Patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain
5. Patients with spinal stenosis or disc herniation at the lumbar 4-5 or lumbar 5-sacral 1 level on MRI, and the cross-sectional area of the multifidus muscle at the lesion site is less than 5 cm2 when measured by ultrasound.

Exclusion Criteria:

1. When the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter NRS)
2. If lower back pain has rapidly worsened within the last week
3. If you have other diseases that may cause low back pain: osteoarthritis of the hip joint, cancer, inflammatory arthritis, spondylitis, fibromyalgia, complex regional pain syndrome, herpes zoster, postherpetic neuralgia, etc.
4. When a diagnostic epidural nerve block is planned
5. In the case of receiving conservative treatment, procedure, or surgery other than oral drugs such as epidural nerve block or proliferation treatment for the treatment of lower back pain within 4 weeks of screening
6. When the low back pain assessed by NRS decreased by more than 50% after epidural nerve block in screening
7. If back surgery is planned within 3 months of the procedure
8. When NRS and ODI measurements cannot be made
9. When collagen injection is contraindicated (eg when allergic to swine)
10. Pregnant women
11. If you cannot read or agree to the consent form
12. If you are unable to sign the consent form yourself

Primary outcomes:
measure: cross-sectional area of the multifidus muscle
timeFrame: 28 days after atelocollagen injection
Secondary outcomes:
measure: numeric rating score
timeFrame: 28 days after atelocollagen injection
measure: oswestry disability index
timeFrame: 28 days after atelocollagen injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji Yeong Kim
Study officials:
References:
Clinical trial NCT05958745: Comparison of the Effects of Green Exercise Programs Including Resistance and Aerobic Exercises
Official title: Comparison of the Effects of Green Exercise Programs Including Resistance and Aerobic Exercises on Senior Fitness, Aerobic Capacity, Intrinsic Capacity at Nursing Homes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Keywords: Physical activity
Green exercise
Elderly
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to evaluate the effects of aerobic exercise and resistance exercises performed together with aerobic exercise, applied in the concept of green exercise with a multidisciplinary team (specialist doctors physiotherapists, nurses) on senior fitness, aerobic capacity and IC in individuals aged 65 and over.

Detailed description: The study is a multicenter, parallel three-group, randomized controlled study conducted to examine the effects of aerobic and resistance exercises applied within the framework of green exercise concept on physical fitness, aerobic capacity and intrinsic capacity. In this study, it was aimed to evaluate the effects of aerobic exercise and resistance exercises performed together with aerobic exercise, applied in the concept of green exercise with a multidisciplinary team (specialist doctors physiotherapists, nurses) on senior fitness, aerobic capacity and IC in individuals aged 65 and over.

Eligibility criteria: Inclusion Criteria:

* After the cardiology examination, it was decided that it was suitable for exercise,
* The Mini Mental Test score was above 24 points
* Had adequate communication skills

Exclusion Criteria:

* Individuals with uncontrollable arrhythmia and/or hypertension,
* neuromuscular disease,
* orthopedic injury that interferes with walking,
* severe sensory deficit, visual and/or hearing problems

Primary outcomes:
measure: Z Score of the Intrincic Capacity
timeFrame: 1 week
Secondary outcomes:
measure: V02max
timeFrame: 1 week
measure: Senior Fitness test
timeFrame: 1 week
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Elif Yıldırım Ayaz
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00332345: Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of glaucoma or ocular hypertension in both eyes
* Patient requires IOP-lowering in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Contraindication to beta-andrenoceptor antagonist or brimonidine therapy

Primary outcomes:
measure: IOP
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
Study officials:
References: