louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01399164: Cobalamin Absorption From Fortified Food
Official title: Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B-12 Deficiency
Achlorhydria
Keywords: Vitamin B-12
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-07-21
Enrollment: 6
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

Detailed description: Cobalamin (vitamin B12) deficiency is highly prevalent in the US and worldwide. Deficiency is most common in the elderly, with an average prevalence ≈25% over age 60 y. About 40% of older persons with low serum cobalamin have food cobalamin malabsorption (F-CM), in which gastric atrophy/achlorhydria and/or dysfunction is implicated. Because of the prevalence of deficiency in those over age 60 y, it is generally recommended that the elderly consume a higher proportion of their cobalamin from fortified foods than what is recommended for younger people. However there is considerable debate about whether crystalline cobalamin is absorbed as well by the elderly with F-CM as it is by younger people, especially if it is added as a fortificant to food. The data to be collected in this study will provide information useful to on-going deliberations concerning the future fortification of wheat flour with vitamin B12 in the United States.

Eligibility criteria: Inclusion Criteria:

* good overall health
* normal absorptive capacity (controls) or with a serum B12 \<300 pg/mL and a pepsinogen I level \>100 μg/L (ACs).
* All subjects must be available to complete the protocol

Exclusion Criteria:

* Any chronic health disorder
* Anemia of any kind
* Renal insufficiency
* excessive alcohol consumption
* Prior GI surgery
* Use of OTC or prescription drugs that interfere with B-12 absorption or metabolism
* Use of vitamin supplements
* Pregnancy or lactation

Primary outcomes:
measure: B12 bioavailability
timeFrame: 8 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Western Human Nutrition Center, University of California Davis
state: California
Study officials:
affiliation: WHNRC, ARS, University of California Davis
name: Lindsay Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04666064: Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room
Official title: Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lung Ultrasound
Respiratory Complication
Keywords: Covid19
lung ultrasound
Respiratory Complication
triage
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to ER for suspicion of COVID-19 infection who has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound as part of the BLUE protocol

Brief summary: Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. The investigators demonstrated that the association of 4 signs in pulmonary ultrasound associated with a clinical sign (COVILUS score) could predict the occurrence of a positive RT-PCR in patients suspected of COVID-19 infection admitted to the emergency room. The investigators are going to conduct a new study to validate this COVILUS score in this type of patient. The main objective will be to validate the diagnostic performance of lung ultrasound in patients admitted to the emergency room with suspected COVID19 infection.


Eligibility criteria: Inclusion Criteria:

* patients admitted to ER for suspicion of COVID-19 infection who has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound as part of the BLUE protocol
* Age\> 18 years old

Exclusion Criteria:

* patients \< 18 years of age
* patients under guardianship or curators
* pregnancy
* poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.)
* patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ARDS))
* patients with chronic interstitial lung disease
* patients who will refuse to give their consent.

Primary outcomes:
measure: concordance between Covid19 RT-PCR results and lung ultrasound results
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: BAR
Study officials:
References:
Clinical trial NCT03308864: Strong Connections
Official title: Strong Connections-Interpersonal Psychotherapy for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two talking forms of therapy designed to help reduce depressive symptoms in teenagers: Interpersonal Psychotherapy for Adolescents and Treatment as Usual.

Detailed description: Interpersonal Psychotherapy for Adolescents (IPT-A) is a manualized short-term therapeutic intervention that has been shown to be efficacious in a number of randomized control trials for adolescent depression. The primary aim of the present study is to evaluate the feasibility of incorporating Interpersonal Psychotherapy for Adolescents (IPT-A) into routine psychotherapeutic treatment at Strong Behavioral Health: Child and Adolescent Outpatient. The second aim of the present investigation is to examine changes in adolescent symptomatology, interpersonal functioning, perceived stress, and social support throughout the course of treatment. The third aim of the present study is to compare the effectiveness of IPT-A versus treatment as usual (TAU) at reducing depressive symptoms among adolescents.

Eligibility criteria: Inclusion Criteria:

* age 12-18
* scoring in the clinically elevated range for depression using the Beck Depression Inventory for Youth

Exclusion Criteria:

* currently psychotic
* do not speak English
* currently participating in another form of mental health treatment
* considered to need inpatient hospitalization
* IQ less than 70

Primary outcomes:
measure: Change in Mean Beck Depression Inventory score
timeFrame: Baseline to 8 months
measure: Change in Mean Beck Depression Inventory score
timeFrame: Baseline to 5 months
Secondary outcomes:
measure: Change in the mean score in suicide ideation.
timeFrame: Baseline to 5 months
measure: Change in the mean score in suicide ideation.
timeFrame: Baseline to 8 months
measure: Change in mean perceived stress
timeFrame: Baseline to 5 months
measure: Change in mean perceived stress
timeFrame: Baseline to 8 months
measure: Change in mean social adjustment
timeFrame: Baseline to 5 months
measure: Change in mean social adjustment
timeFrame: Baseline to 8 months
measure: Mean change in social support
timeFrame: Baseline to 5 months
measure: Mean change in social support
timeFrame: Baseline to 8 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Pediatric Behavior Health and Wellness
state: New York
Study officials:
References:
Clinical trial NCT01643564: Cytokine Profiling Post-Heart Transplant
Official title: Cytokine Profiling of Cardiac Transplant Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Transplant
Keywords: Transplant
Cytokines
Graft Dysfunction
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology Clinic and inpatient service. Normal controls are volunteers from within the community.

Brief summary: Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.


Eligibility criteria: Inclusion Criteria:

Group 1

* 18 years and older
* Cardiac Transplant recipient with graft dysfunction of unknown etiology

Group 2

* 18 years or older
* No history of heart failure or cardiac transplantation Group 3
* 18 years or older
* Class II-IV heart failure Group 4
* 18 years or older
* Heart Transplant 6 months or greater prior to blood draw
* No graft dysfunction

Exclusion Criteria:

Group 1 Heart Transplant with Unexplained Graft Dysfunction

* Cellular or antibody-mediated cardiac allograft dysfunction

Group 2 Normal Control group

* Active infection within 1 month of blood draw
* Known Inflammatory Disease

Group 3 Heart Failure Group

* Active infection within 1 month of blood draw
* Known Inflammatory Disease

Group 4 Heart Transplant with Normal Graft Function Group

* Active infection within 1 month of blood draw
* Known graft dysfunction
* Known Inflammatory Disease

Primary outcomes:
measure: Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Peter M Eckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04723264: The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age
Official title: The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eating Behavior
Keywords: Body mass index
Dietary quality
Children
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-01-25
Enrollment: 400
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs).

At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the completion of questionnaires

Detailed description: This research study is a complex, long term investigation of the relationships between children's eating behaviors, and parent-child interaction during eating and their associations with BMI and dietary intake. It builds on earlier observational research which, like this research, had small experimental components used to classify children into different phenotypic groups based on different responses to the experimental conditions. The small activities and experiments of this follow up study constitute a trial as defined by NIH, registered here. The exploratory outcomes measured from these activities are not listed in this registration for reasons of scientific integrity. To be clear, the bigger structure of this research is essentially an observational follow up study with the same children who were previously studied as infants. The goal of the project is to identify potential future intervention targets.

Eligibility criteria: Inclusion Criteria for Children (ages 5-7.99) and their parents (18 and older):

* Prior participation in "The Development of Eating Behavior in Infancy" project
* Family lives within reasonable driving distance of the University of Michigan

Exclusion Criteria:

* Significant developmental delays that would impede child's ability to participate
* Foster child
* Child has developed significant health problems that affect appetite, eating, or growth.

Primary outcomes:
measure: Body Mass Index z - score (BMIz)
timeFrame: 1- 2 years
Secondary outcomes:
measure: Dietary Intake
timeFrame: 1- 2 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Lumeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01006564: Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer
Official title: Multifunctional MR for Radiotherapy Planning in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Magnetic Resonance Imaging
Prostate Cancer
Magnetic Resonance Spectroscopy
Radiotherapy planning
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2009-11-03
Enrollment: 30
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
* Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.

Exclusion Criteria:

* Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
* No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy \<10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).

Primary outcomes:
measure: Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP).
Secondary outcomes:
measure: Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy.
measure: Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues.
measure: Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate.
measure: Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution.
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: CRUK Clinical Magnetic Resonance Research Group
name: Dr Nandita deSouza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352364: Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic
Official title: Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Skills in Deaf Children
Deafness
Keywords: Physiotherapy.
Deafness.
Postural balance.
Motor skills.
Lead sponsor: University of the Sinos Valley
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. This study was quasi-experimental before and after, with 10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and post test KTK Coordination Body, and the activities were held once a week for six weeks in sessions of forty minutes. It was used for statistical analysis the Student t test dependent and independent (p ≤ 0.05).


Eligibility criteria: Inclusion Criteria:

* age 7 to 10 years of age.
* hearing disorders proven by presenting specific examination of Auditory Evoked Potential and Examination of the brainstem (Brainstem Evoked Response - Bera).
* consent of parents / guardians of children to participate in the study by signing Term of Informed Consent (IC).

Exclusion Criteria:

Primary outcomes:
measure: Balance
timeFrame: two months
Secondary outcomes:
measure: motor coordination
timeFrame: two months
Other outcomes:
Locations:
city: Caxias do Sul
country: Brazil
facility: Municipal School For Elementary School Helen Keller
state: RS
Study officials:
affiliation: University of the Sinos Valley
name: Fernanda Rombaldi Bernardi, Physiotherapist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05257421: The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain
Official title: The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 78
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. After signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group.

Hypothesis:

The hypothesis of this study states that:

o Research hypothesis: there will be a significant difference between the radial ESWT and back exercises in reducing LBP


Eligibility criteria: Inclusion Criteria:

* Only male patients will be included.
* Age 20-40 years old.
* Non-specific LBP for at least 3 months.
* At least one local tenderness or active trigger point in the anatomical region of the QL muscle.
* Pain intensity on numerical pain scale should be more than 4

Exclusion Criteria:

* LBP due to a pathology or trauma.
* Below 20 years of age.
* Previous lumbar surgeries.
* Malignancy.
* Patients under medications or painkillers.

Primary outcomes:
measure: pressure-pain threshold
timeFrame: 45 hour session
measure: The Oswestry Disability Index
timeFrame: 45 minutes session
measure: Numerical pain scale
timeFrame: 45 minutes session
Secondary outcomes:
measure: ROM of the back
timeFrame: 45 minutes session
Other outcomes:
Locations:
Study officials:
References:
citation: Epidemiological features of chronic low-back pain
citation: Joshi S, Sheth M. Effect of extracorporeal shockwave therapy on myofascial pain syndrome of upper trapezius: A systematic review. Int J Med Sci Public Health. 2020;9(10):1.
citation: Effect of Static Versus Dynamic Ultrasound on Pain in Subjects with Trigger Point in Quadratus Lumborum Having Non-Specific Chronic Low Back. 2020;10(December):263-9.
Clinical trial NCT04406064: Viral Specific T-cells for Treatment of COVID-19
Official title: Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Viral Infection
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Hoxworth Blood Center
First posted: 2020-05-28
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA).

COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.


Eligibility criteria: Inclusion Criteria:

1. Patients who have evidence of infection with SARS-CoV-2
2. Patients with symptomatic COVID-19 disease, as defined by at least one of the following

   1. Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection
   2. Requirement for supplemental oxygenation
   3. Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation
3. Age \>1 day
4. Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
5. Have failed at least one FDA-approved treatment for COVID-19 disease
6. Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or sub-investigator either in person or by phone)

Exclusion Criteria:

1. Uncontrolled bacterial or fungal infection
2. Uncontrolled relapse of malignancy
3. Unlikely to survive within 48 hours of VST infusion

Primary outcomes:
measure: Successful production of viral specific T-cells
timeFrame: Within 30 days post culture initiation
Secondary outcomes:
measure: Presence of viral-specific T-cells
timeFrame: At 30 days after infusion
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Adam Nelson, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References: