louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04461106: A New Measure of Egg Consumption and the Effect of Social Marketing Eggs
Official title: A Two-Phase Study to Investigate Novel Biomarkers of Egg Consumption and Social Marketing Effectiveness of Egg Hubs for Malawian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Stunting
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Project Peanut Butter, Malawi
name: Kamuzu University of Health Sciences
First posted: 2020-07-08
Enrollment: 815
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be receive social marketing campaign to raise awareness about the benefits of eggs while the other 4 will not receive social marketing campaign. Children will provide a urine sample for analysis of metabolites to correlate with egg consumption.


Eligibility criteria: Inclusion Criteria:

* Health children between 6 and 24 months of age

Exclusion Criteria:

* acute malnutrition
* congenital abnormalities
* chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection

Primary outcomes:
measure: Amount of egg consumed daily
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Project Peanut Butter
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Perez I, Posma JM, Gibson R, Chambers ES, Hansen TH, Vestergaard H, Hansen T, Beckmann M, Pedersen O, Elliott P, Stamler J, Nicholson JK, Draper J, Mathers JC, Holmes E, Frost G. Objective assessment of dietary patterns by use of metabolic phenotyping: a randomised, controlled, crossover trial. Lancet Diabetes Endocrinol. 2017 Mar;5(3):184-195. doi: 10.1016/S2213-8587(16)30419-3. Epub 2017 Jan 13.
citation: S C Sri Harsha P, Abdul Wahab R, Cuparencu C, Dragsted LO, Brennan L. A Metabolomics Approach to the Identification of Urinary Biomarkers of Pea Intake. Nutrients. 2018 Dec 4;10(12):1911. doi: 10.3390/nu10121911.
citation: Koppmair S, Kassie M, Qaim M. Farm production, market access and dietary diversity in Malawi. Public Health Nutr. 2017 Feb;20(2):325-335. doi: 10.1017/S1368980016002135. Epub 2016 Sep 9.
citation: Eaton JC, Rothpletz-Puglia P, Dreker MR, Iannotti L, Lutter C, Kaganda J, Rayco-Solon P. Effectiveness of provision of animal-source foods for supporting optimal growth and development in children 6 to 59 months of age. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD012818. doi: 10.1002/14651858.CD012818.pub2.
Clinical trial NCT04757506: An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention
Official title: An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Attentional Bias Toward Social Cues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Esteem
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore the effects of endogenous opioids on self-esteem and attentional bias toward social cues. This is achieved by administering the drug naltrexone, which temporarily decreases endogenous opioid activity.


Eligibility criteria: Inclusion Criteria:

* good physical health,
* normal kidney and liver function results from within previous year

Exclusion Criteria:

* allergy to naltrexone
* kidney or liver injury or disorder
* bipolar, panic, or psychotic disorders
* epilepsy
* smoking more than 15 cigarettes per day
* pregnancy
* substance abuse
* use of opioid analgesics, cocaine, recreational drugs (e.g., marijuana, LSD, ecstasy, etc.), or prescription medication (except oral contraceptives) within the past 10 days
* use of over-the-counter drugs (e.g., analgesics, anti-inflammatories, sleeping aids, etc.) or alcohol within the past 24 hours
* current experience of pain (e.g., headache)
* use of anti-diarrheal medications in the 7 days prior to the study.

Primary outcomes:
measure: Self-esteem
timeFrame: Approximately 2 hours post placebo/drug administration
measure: Attentional bias scores for positive social cues on visual probe task
timeFrame: Approximately 2 hours post placebo/drug administration
Secondary outcomes:
measure: Attentional bias scores for negative social cues on visual probe task
timeFrame: Approximately 2 hours post placebo/drug administration
measure: Reaction times on neutral-neutral trials on visual probe task
timeFrame: Approximately 2 hours post placebo/drug administration
measure: Self-liking
timeFrame: Approximately 2 hours post placebo/drug administration
measure: Self-competence
timeFrame: Approximately 2 hours post placebo/drug administration
Other outcomes:
Locations:
Study officials:
affiliation: McGill University
name: Jennifer Bartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03743506: An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance
Official title: An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balancing Interference
Keywords: Wobble board
center of pressure
dynamic balance
force platform
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes

Detailed description: The wobble board is an unstable equilibrium platform, constant training on this platform generates an improvement in balance and strengthens the muscles, it is ideal for rehabilitation exercises and balance conditioning. However, these platforms do not provide quantitative data on exercises performed on it. And the force platform that provide this quantitative data is static, offering no difficulty in maintaining balance. In this way, a sensor board wobble board was developed using a conventional wobble board with a plate attached to it, between the plate and the platform are eight strain gauges sensors that are activated according to the position of the force applied on the platform, the values of the sensors are collected by software that demonstrates the point of greatest pressure on the disk and its displacement during the exercises, with this data it is possible to determine the stability of the user and observe their behavior during the exercises.

Eligibility criteria: Inclusion Criteria:

* Absence of musculoskeletal alteration in the lower limbs;
* consent form signed by the volunteer;
* with preserved cognitive

Exclusion Criteria:

* Present some impairment of the skeletal muscles of the lower limbs;
* Present cognitive deficit.

Primary outcomes:
measure: Pressure center displacement speed
timeFrame: 15 minutes
Secondary outcomes:
measure: Longest distance between points on X and Y axis
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Alessandro Pereira da Silva
state: São Paulo
Study officials:
affiliation: University of Mogi das Cruzes
name: Alessandro P Silva, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825006: The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
Official title: The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac resynchronization therapy
Anodal stimulation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal stimulation and triple site pacing compared with the usual dual site pacing by echocardiography and Tissue Doppler Imaging.

Detailed description: Thirty patients who underwent CRT and had evidence of anodal stimulation will be included in the study. All patients undergo a conventional echocardiography after 10 minutes of continuous triple site pacing and after 10 minutes of continuous dual site pacing (Customary biventricular pacing).Echocardiography studies will be performed to measure dP/dT using continuous flow Doppler velocity profiles of mitral regurgitation, LV volumes and Left ventricular ejection fraction. Left intraventricular desynchrony is assessed by using TDI.

Eligibility criteria: Inclusion Criteria:

* Patients with biventricular pacemakers who met currently accepted indications for CRT, including dilated cardiomyopathy with LV ejection fraction \< 35% (ischemic and nonischemic etiologies) with New York Heart Association class III to IV congestive heart failure and QRS duration \> 120 ms.

Exclusion Criteria:

* Patients with first generation CRT device
* Integrated bipolar defibrillator device
* Atrial fibrillation during the screening phase
* Patients who cannot tolerate triple site pacing for several minutes (i.e diaphragmatic pacing)
* Patients with epicardial LV leads
* Patients with LV leads located out of the lateral or posterolateral areas

Primary outcomes:
measure: Myocardial Performance Index, dP/dT
timeFrame: After 10 minutes of triple site pacing and 10 minutes of dual sute pacing
Secondary outcomes:
measure: Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF
timeFrame: After 10 minutes of triple site pacing and 10 minutes of dual site pacing
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Heart Institute, Sheba Medical Center
Study officials:
affiliation: Heart Institute, Sheba Medical Center
name: Michael Glikson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789906: Development of Population Norms of the Computerized Neuropsychological Assessment for Effectiveness of the Antipsychotic Treatment in Schizophrenia
Official title: Development of Population Norms of the Computerized Neuropsychological Assessment for Effectiveness of the Antipsychotic Treatment in Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: Computerized Neuropsychological Assessment
Development of Population Norms of the Computerized Neuropsychological Assessment
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2008-11-13
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 700 healthy adults (350 women and 350 men, aged from 18 to 89)

Brief summary: Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables a better understanding of antipsychotic effectiveness and the brain processes, underlying cognitive functioning in schizophrenia.

Neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the variance of functional outcome and is an important predictor of social reintegration (Peuskens et al, 2005) and independent living activitiy (Green et al, 2004). Impaired social functioning within schizophrenia population has been associated with increased health-care costs. Since social and occupational disability may generate the largest indirect costs of the illness, treatment of cognitive deficits has an enormous impact on the cost and disability associated with schizophrenia (McGurk and Mueser, 2004).

However, the gap between cognitive science and clinical practice limits the implementation of cognitive assessment in the routine evaluation of schizophrenia patients. Pharmaceutical industry initiated numerous large scale, multisite studies on the impact of novel antipsychotics on cognitive deficits in schizophrenia patients.

The aim of this research is to develop population norms of the computerized neuropsychological assessment for effectiveness of the antipsychotic treatment in schizophrenia.


Eligibility criteria: Inclusion Criteria:

* An IQ, which is within normal range.

Exclusion Criteria:

* Psychiatric co-morbidity.
* Physical disability or illness.
* A history of severe head injury.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Beer-Yaacov MHC
Study officials:
References:
Clinical trial NCT00762606: Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
Official title: A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 106
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)


Eligibility criteria: Inclusion Criteria:

* Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL);
* Pupil dilation ≧7 mm after mydrisis;
* Patient undergoing cataract surgery for the first eye;
* VA prognosis ≧6/12

Exclusion Criteria:

* Patients with history of ocular pathology or diabetic retinopathy;
* Patients with traumatic, subluxated and posterior polar cataract;
* Patients had ocular surgery in the past 6 months;
* Patients with significant intra-operative complications

Primary outcomes:
measure: Posterior Capsule Opacification Evaluation
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Corneal Astigmatism
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT04631406: A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)
Official title: A Phase 1/Phase 2a Safety and Tolerability Study of Intracerebral Transplantation of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS) and Early Evaluation of Potentially Useful Efficacy Parameters
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2020-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke.

Detailed description: Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke. The study will be a dose escalation using up to 4 cohorts each at a single dose level, of intracerebral administration of NR1 cells. Secondary objectives are to evaluate clinical and radiologic responses as well as utility of efficacy measurement tools.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 75 years
* History of ischemic subcortical stroke in the middle cerebral artery and/or lenticulostriate artery 6 to 60 months from time of stroke
* Ability of subject to understand and provide written Informed Consent
* Willing to take tacrolimus (Prograf) 2 days before and for 2 months after transplant

Exclusion Criteria:

* Stroke lesion less than 1 cubic centimeter or greater than 100 cubic centimeters measured by MRI
* Index stroke is lacunar infarct less than 1 year old
* History or presence of any major neurological disease
* History of active cancer other than basal or squamous cell skin cancers
* History of seizures
* Pregnant or breast-feeding

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 0-12 months
measure: Fugl Meyer (FM) motor score
timeFrame: 0-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Center
state: California
Study officials:
affiliation: Professor, Neurosurgery Department
name: Gary K Steinberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06420206: Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center
Official title: Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Gastrointestinal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.

Detailed description: Primary Objective:

To compare overall percentage of days spent in an acute care setting over the 30-day period from time of the index emergency department (ED), referred to as Acute Cancer Care Center (ACCC), visit for patients who receive the emergency department-based GOC intervention and those who do not.

Secondary Objective:

To obtain data on rates of admission to the ICU, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, and 30-day care costs for participants who receive the GOC intervention in the ACCC and those who do not.

Eligibility criteria: Inclusion Criteria:

1. Participant is at least 18 years old presenting to the triage area of the MDACC ACCC for treatment
2. Participant has advanced lung or GI cancer. Advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available.
3. Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status)
4. Participant has the ability to speak and write in English
5. Participant has the ability to provide consent OR is accompanied by a LAR able to provide consent

Exclusion Criteria:

1. Participant is already enrolled in hospice
2. Participant is comatose
3. Participant has severe intellectual disability
4. Participant has a history of dementia documented in the medical records
5. Participant has baseline communication barriers such as aphasia or deafness
6. Participant is new to MDACC, without established oncology care at our institution at time of ACCC arrival
7. Participant is 18 years or older, currently cared for by pediatrics service
8. Pregnant women
9. Prisoners

Primary outcomes:
measure: Quality Of Life Questionnaire
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ahmed Elsayem, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00480506: Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major
Official title: Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia Major
Keywords: chimerism
allogenic hematopoietic transplantation
assay
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
First posted: 2007-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thalassemia patients being treated at Shariati Hospital in Tehran.

Brief summary: The purpose of this study is to collect peripheral blood and bone marrow aspirate samples from thalassemia patients in Tehran, in a collaborative effort to develop an erythroid lineage specific chimerism assay applicable to patients with thalassemia. Development of such an assay would be useful both for identification of the exact mutation causing the disease, as well as for providing a direct method to measure and monitor the kinetics of donor erythropoiesis in this patient population following transplant.

Detailed description: * In the first phase of the study we will develop a panel of reagents designed to identify predominant thalassemia mutations in the Iranian population, as well as alternative highly variable erythroid specific polymorphisms. To determine how informative this panel is, these reagents will be applied to samples collected from patients homozygous for the disorder, and compared to patients with thalassemia trait and normal Iranian donors.
* In the second phase, we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant. Samples will be collected from participants before and at 1, 2, 3, 6 and 12 months following transplant and cryopreserved. Peripheral blood from the stem cell donor will also be collected and cryopreserved. Participants will undergo myeloablative or nonmyeloablative transplant.

Eligibility criteria: Inclusion Criteria:

* Thalassemia patients being treated at Shariati Hospital in Tehran.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Catherine Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: