louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00131859: Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury
Official title: Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury, Fetus and Neonate
Keywords: Perinatal brain injury
Diffusion-tensor imaging
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
First posted: 2005-08-19
Enrollment: 5
Sex: ALL
Minimum age (years): 23
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates \< 1500 grams, with suspected brain injury, and with severe metabolic acidosis

Brief summary: The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.

Detailed description: Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight \< 1500 grams will be offered DTI, and infants \> 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.

Eligibility criteria: Inclusion Criteria:

* All infants born at our hospital at \< 1500 grams
* All infants born at our hospital at \> 1500 grams with brain injury or severe metabolic acidosis

Exclusion Criteria:

* Major congenital malformations
* Chromosomal abnormality

Primary outcomes:
measure: Diffusion-tensor imaging differences between brain injured cases and controls without brain injury
timeFrame: 2 years
Secondary outcomes:
measure: Umbilical cord gas results
timeFrame: 2 years
measure: Placental pathology
timeFrame: 2 years
measure: Electronic fetal monitoring
timeFrame: 2 years
measure: Nucleated red blood cells
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Univ; Dept. of Gyn-Ob
name: Ernest M Graham, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173459: Dynamic Profiles of Cytokine/Chemokine in Severe Acute Respiratory Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: Severe acute respiratory syndrome (SARS) is an emerging infectious disease caused by a novel coronavirus (SARS-CoV). The major clinical features of SARS include fever, dyspnea, lymphopenia, and a rapid progression of pulmonary infiltrates on chest radiologic images. The SARS-related deaths have resulted mainly from pulmonary complications, including progressive respiratory failure due to alveolar damage and acute respiratory distress syndrome (ARDS). Pathological changes in SARS suggest that SARS sequelae such as infiltration of PMN in lung tissue, multiple organ dysfunction and ARDS have been associated with cytokines and chemokine dysregulation. Some patients still manifested lung injury at a time when the viral load was falling also supports the immune nature of the lung damage. We therefore undertook an analysis of dynamic production of cytokine/chemokines in SARS patients with an initial normal chest radiograph in order to improve understanding of disease pathogenesis and improve patient management.


Eligibility criteria: Inclusion Criteria:

* SARS group: Patients with SARS

Exclusion Criteria:

* Hospital acquired pneumonia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NTUH
name: Jung-Yien Chien, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00584259: Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
Official title: Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Keywords: GERD
Gastro-Esophageal Disease
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.

Detailed description: Many patients with gastro-esophageal reflux disease (GERD) report that drinking coffee causes heartburn. The purpose of this study is to investigate the effects of coffee on gastro-esophageal acid reflux, and its relation to esophageal motility parameters in patients who are already scheduled to undergo 48 hour wireless pH testing as a result of having symptoms suggestive of GERD. The specific aims are to evaluate the effects of coffee on GERD during daily life and to elucidate the underlying pathogenic mechanism by which coffee induces reflux.

Eligibility criteria: Inclusion Criteria:

* persons undergoing wireless pH testing for diagnosis and treatment of GERD

Exclusion Criteria:

* those under the age of 18
* pregnant and lactating women
* those who do not meet the inclusion criteria

Primary outcomes:
measure: coffee leads to reflux events
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Peter Belafsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00465959: Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Official title: Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Alkermes, Inc.
First posted: 2007-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD


Eligibility criteria: Inclusion Criteria:

* Male or female COPD patients between the ages of 40 and 80 years
* Smoking history of at least 10 pack years
* Not currently using (or able to wash out of) any long acting bronchodilators

Exclusion Criteria:

* Candidate on a waiting list for surgery while on study
* Using long-term oxygen therapy
* Hospitalization for COPD exacerbation

Primary outcomes:
measure: Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
Secondary outcomes:
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: United States Investigational Site
state: South Carolina
Study officials:
References:
Clinical trial NCT03548259: Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial
Official title: Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Platelet-rich plasma
Surgery
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (Parallel Assignment)
Primary purpose: TREATMENT

Brief summary: The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as co-adjuvant in surgical treatment of CTS by open carpal tunnel release.

Design: Randomized Controlled Trial. Setting: Local Hospital.

Detailed description: Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of 125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population. CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and weakness of the median nerve distribution in patients.

The treatment of the CTS includes both, conservative and surgical treatment depending on the severity of the symptoms.

Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.

We propose a randomized clinical trial in patients in which the surgical treatment is indicated. Participants in the intervention group receive a PRP injection, and in the control group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is performed pretreatment as well as on the 6st week after treatment. Outcome measures include: hand grip strength (primary outcome), pain, sympton severity and functional status.

Eligibility criteria: Inclusion Criteria:

* Patients with Carpal Tunnel Syndrome (CTS)
* Conservative treatment failure

Exclusion Criteria:

* Previous CTS surgery on the same side
* Wrist fracture/trauma in history
* Polyneuropathy
* Diabetes mellitus
* Cervical neuropathy

Primary outcomes:
measure: Hand grip strength
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain
timeFrame: 6 weeks
measure: Sympton severity
timeFrame: 6 weeks
measure: Functional status
timeFrame: 6 weeks
measure: Wound healing
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad CEU Cardenal Herrera
Study officials:
affiliation: Cardenal Herrera University
name: Ignacio Pérez, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04345159: Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease
Official title: Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Sjogren's Syndrome
Psoriatic Arthritis
Keywords: Hydroxychloroquine
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-04-14
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at least one time at Rothschild Foundation with history of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome, Psoriatic Arthritis.

Brief summary: This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.


Eligibility criteria: Inclusion Criteria:

* History of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome or Psoriatic Arthritis.

Exclusion Criteria:

* beginning, or end, of an hydroxychloroquine treatment between Jan 1, 2020 and day of the phone call.
* Bad treatment compliance

Primary outcomes:
measure: Adjusted Odds Ratio
timeFrame: 4 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
Study officials:
affiliation: Fondation Adolphe de Rothschild
name: Guillaume DEBELLEMANIERE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillaume D, Magalie B, Sina E, Imene SM, Frederic V, Mathieu D, Aurore M, Yoni G, Emma E, Charlotte B, Laura F, Alain S, Steven N, Pierre Z, Jean-Luc F, Romain C, Alice GD, Adrien M, Wassim G, Pierre-Emmanuel R, Christophe P, Catherine C, Kevin B, Thomas S, Damien G. Antirheumatic Drug Intake Influence on Occurrence of COVID-19 Infection in Ambulatory Patients with Immune-Mediated Inflammatory Diseases: A Cohort Study. Rheumatol Ther. 2021 Dec;8(4):1887-1895. doi: 10.1007/s40744-021-00373-1. Epub 2021 Sep 16.
Clinical trial NCT01487759: Prebiotic Effect on Metabolites in Crohn's Disease
Official title: Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the influence of the prebiotic oligofructose enriched inulin on the metabolite pattern in Crohn's disease patients.


Eligibility criteria: Inclusion Criteria:

* crohn's disease

Exclusion Criteria:

* severe crohn's disease (harvey bradshaw index \>12)
* pregnancy
* history of colectomy
* use of antibiotics 4-wks before start of the study
* use of sulfapyridine
* use of commercially available prebiotics and probiotics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
Study officials:
References:
Clinical trial NCT06577259: Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
Official title: A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986435
MYK-224
Healthy participants
Single-dose
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.


Eligibility criteria: Inclusion Criteria:

* Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive.
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
* Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.

Exclusion Criteria:

* Any acute or chronic medical illness.
* History of heart disease.
* Prior exposure to BMS-986435.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 105 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 105 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to 105 days
Secondary outcomes:
measure: Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]
timeFrame: Up to 105 days
measure: Time of maximum observed concentration [Tmax]
timeFrame: Up to 105 days
measure: Apparent terminal half-life [T-HALF]
timeFrame: Up to 105 days
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 5 months
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to approximately 5 months
measure: Incidence of participants with vital sign abnormalities
timeFrame: Up to 105 days
measure: Incidence of participants with physical examinations abnormalities
timeFrame: Up to 105 days
measure: Incidence of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 105 days
measure: Incidence of participants with clinical laboratory abnormalities
timeFrame: Up to 105 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Local Institution - 0001
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05598359: TA-65 and Aging Associated Microvascular Dysfunction
Official title: TA-65 and Aging Associated Microvascular Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Telomere Shortening
Aging
Vascular Diseases
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: University of Louisville
name: Penn State University
First posted: 2022-10-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test whether activation of telomerase with a dietary supplement (TA-65) improves microvascular function.

Detailed description: The purpose of this clinical trial is to examine whether activation of autophagy with TA-65 which activates telomerase, improves microvascular function and blood pressure in an older population

Eligibility criteria: Inclusion Criteria:

* Healthy Adults 18 - 35 and 65+ years of age
* Subjects with clinical diagnosis of CAD

Exclusion criteria will include:

* 36-64 years of age without clinical diagnosis of CAD
* Self-reported habitual vigorous exercise (\>20 min, 3 times per week, 1 yr)
* Major Adverse Cardiovascular Event (MACE) in the last year (heart attack, stroke)
* Heart Failure
* Renal Impairment
* \>3 Pre-existing Cardiovascular Risk Factors (healthy groups only)
* Type 1 or type 2 diabetes
* Uncontrolled hypertension
* Current tobacco use or within last 6 months
* BMI \> 35
* Hyperlipidemia
* Hypercholesterolemia
* Use of anti-coagulant drugs
* Use of anti-platelet drugs
* Erectile dysfunction medication in the past 6 months
* Use of topical/non-topical steroids in last 6 months
* Hormone replacement therapy (Post-Menopause or Gender Reassignment)
* History of retinopathy
* Documented neuromuscular disorders
* Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
* Pregnancy (young female subjects)
* Allergy to lidocaine
* Current diagnosis of cancer with or without active anti-cancer treatment (pharmaceuticals) or treatment within last 12 months
* Active COVID-19 or within the past 3 months

Primary outcomes:
measure: Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis
timeFrame: 28 days
Secondary outcomes:
measure: Systemic Blood Pressure
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Andreas Beyer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165159: Influence of Type 1 Diabetes (T1DM) Treatment Type on Mental Workload
Official title: Influence du Type de Traitement du diabète de Type 1 (DT1) Sur la Charge Mentale Des Adolescents Avec un DT1 et Des Parents Ayant un Enfant Avec DT1.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes
Treatment
Keywords: Type 1 diabetes
Children
Adolescents
Parents
Pump
Multiple injections
Closed loop
Burden of treatment
Quality of life
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-12-11
Enrollment: 800
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the national network of the Association d'Aide aux Jeunes Diabetiques (AJD). The AJD federates local patient associations, which are regularly asked to distribute questionnaires to their members.

Brief summary: Influence of the type of treatment for type 1 diabetes (pump versus multiple injections versus closed loop) on the treatment burden of children and adolescents and their parents.

Detailed description: "The guidelines for the treatment of children and adolescents with type 1 diabetes emphasise an individualised approach to the child and provide target values (time in range, glycaemia and coefficient of variation). These recommendations aim to prevent long-term complications. It is rarely possible to achieve and maintain this level of control over the long term. Achieving these recommendations requires a great deal of investment from children and their families, which can significantly increase their psychological workload and reduce their quality of life.

The main aim of this study was to assess burden of treatment according to the treatment type (pump versus multiple injections versus closed loop) on a large scale."

Eligibility criteria: Inclusion Criteria:

* Children over the age of 8 whose type 1 diabetes has been diagnosed for at least 6 months
* Parents or people involved in the day-to-day life of children with type 1 diabetes who have been diagnosed for at least 6 months

Exclusion Criteria:

* Parents not involved in managing their child's type 1 diabetes (child in care)
* Have already completed the questionnaire (one questionnaire completed per child and their parents or family caregivers)

Primary outcomes:
measure: The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Emmanuelle LABARRE
Study officials:
affiliation: Angers University Hospital
name: Emmanuelle LABARRE
role: PRINCIPAL_INVESTIGATOR
References: