louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01023282: Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients
Official title: Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Tolerability
Keywords: Parkinson's disease
Levodopa
Dyskinesia
ACR325
Lead sponsor: NeuroSearch A/S
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients and evaluate the effect on levodopa induced dyskinesias.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson"s disease according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
* Levodopa induced dyskinesia

Exclusion Criteria:

* Previous surgery for Parkinson's disease
* Any current or history of heart condition or increased pro-arrhythmic risk
* Severe or ongoing unstable medical condition

Primary outcomes:
measure: Safety and tolerability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Paracelsus-Elena-Klinik
state: Hessen
city: Marburg
country: Germany
facility: Klinik für Neurologie, Philipps-Universität Marburg
state: Hessen
Study officials:
References:
Clinical trial NCT05730582: Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening
Official title: Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Pre Diabetes
Keywords: Diagnostic Screening Program
Health System Intervention
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-02-16
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study team's central hypothesis is that the Parkland Diabetes Detection Program (PDDP) screening invitations targeted by race/ethnicity with culturally concordant messaging and tailored by glycemic risk (known PDM vs. unknown glycemic state) plus phone-based navigation of non-responders will be more effective at closing screening gaps than PDDP generic screening invitations and usual care, opportunistic screening alone.

Detailed description: The research team will conduct a pragmatic, split cluster randomized controlled trial (clinic=cluster; patient randomization) in 12 community-based primary care clinics in an integrated safety net health system serving a high-risk, racially/ethnically diverse population.

Eligibility criteria: Inclusion Criteria:

* Patient is alive at time of data extraction
* Age \>= 18 at time of data extraction and \<76
* Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit
* Patient NOT included in Parkland Diabetes Registry
* Preferred language is Spanish or English
* Ethnicity is Hispanic or Non-Hispanic
* Race is White or Black
* Patient is not pregnant in last 12 months

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group

* Last A1C value \<5.7 (normal)
* Last A1C value \>6.4 (diabetes)
* Last A1C value = blank (unchecked)
* Last A1C date occurred within last 12 months from date of export

Exclusion Criteria for Study Population 2: Score-Based Glycemic Risk Group

* Risk score \<9
* Last A1C date occurred in last 30 months from date of export
* Last A1C value was \>5.7 (PDM/DM)

Primary outcomes:
measure: Invitation efficacy
timeFrame: 60 days
measure: Program effectiveness
timeFrame: 12 months
measure: Direct costs
timeFrame: 12 months
measure: Cost effectiveness as measured by costs per patient screened
timeFrame: 12 months
measure: Cost effectiveness as measured by cost per case found
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Michael Bowen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391282: Internal Carotid Artery Blood Flow in Infants With Prone Position
Official title: A Study on Internal Carotid Artery Blood Flow Velocity Changes in Prone, Head Tilt and Trendelenberg Position in Infants: an Observational Study Using Transfontanel Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Lesion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 20
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric neurosurgical patients

Brief summary: Little is known about how implementation of prone position contributes to general anesthesia-induced decrease in cerebral blood flow in infants. The investigators investigated this question in participants undergoing untethering, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.


Eligibility criteria: Inclusion Criteria:

* pediatric neurosurgical patients receiving surgery under prone position

Exclusion Criteria:

* patients diagnosed as hydrocephalus
* premature closure of fontanelle
* patients diagnosed as patent ductus arteriosus or other congenital heart disease.

Primary outcomes:
measure: Changes of internal carotid artery blood flow velocity
timeFrame: from induction of anesthesia to end of operation, about 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT02363582: The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Official title: The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Formula Intolerance
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 65
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.

Detailed description: Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora as well as the intestinal immune systems. The purpose of this study is to investigate the stool characteristics（including intestinal microbiota） acceptability, and gastrointestinal tolerance in infants fed a starting infant formula supplemented with prebiotics and lactoferrin, and compared these data with infants on exclusively breast feeding.

Eligibility criteria: Inclusion Criteria:

* full-term with a birth weight ≥2,500 g
* be in good health
* without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment
* exclusively fed by breast milk or infant formula

Exclusion Criteria:

* preterm infant
* with known diseases or currently taking medication drugs
* mixed feeding
* with symptoms of diarrhea
* received antibiotics within 1 week

Primary outcomes:
measure: growth
timeFrame: 6 weeks
Secondary outcomes:
measure: Gastrointestinal tolerance and safety
timeFrame: 6 weeks
measure: intestinal microbiota
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital
state: Shanghai
Study officials:
affiliation: Xin Hua Hospital
name: Jiang Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097482: Triceps Surae Ultrasonographic Characteristics in Hemiparetic Stroke Survivors
Official title: Triceps Surae Muscle Characteristics in Hemiparetic Stroke Survivors: Clinical Implications From Ultrasonographic Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spastic Foot
Stroke
Keywords: post-stroke spasticity
muscle
ultrasound
Lead sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects already treated for focal post-stroke spasticity in our Unit

Brief summary: This study aims to evaluate, in hemiparetic patients, changes in muscle ultrasound structure about the focal treatment of spasticity with botulinum toxin type A. For this purpose, the analysis of the mean echo intensity will be carried out on ultrasound acquisitions, identifying the possible correlations between the muscle echogenicity, the variations in the pennation angle, and the length of the fascicles.

For image processing operations, ImageJ software was applied.


Eligibility criteria: Inclusion Criteria:

* unilateral ischaemic or haemorrhagic stroke (documented with clinical examination and neuroradiological findings)
* presence of spasticity at lower limb muscles, at least grade 1+ in the modified Ashworth Scale 3.
* age ≥ 18 years

Exclusion Criteria:

* inability to walk before stroke
* presence of severe cognitive impairment
* presence of other musculoskeletal, neurological or cardiopulmonary impairment which can interfere with clinical findings
* presence of skin lesions that can contraindicate BoNT-A treatment
* previous surgical myotendinous elongation

Primary outcomes:
measure: muscle structure variations
timeFrame: single measure through study completion (1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Maggiore della Carità University Hospital
Study officials:
References:
Clinical trial NCT00000282: Pemoline for Cocaine Abuse - 7
Official title: Pemoline for Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: pemoline
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Drug use
measure: Retention
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: J Psychoactive Drugs 28:301-304, 1996. Addictive Beh. 22, 1997. Am J Addiction 5, 275, 1996.
Clinical trial NCT02395380: Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track)
Official title: Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Postoperative Complication
Keywords: CRP
Postoperative complication
Length of stay
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP, procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and on the length of stay.


Eligibility criteria: Inclusion Criteria:

* Upper age to 18 years
* Planned hospital stay for a colonic resection with anastomosis without permanent or temporary digestive bypass
* Patient with pre-operative CRP lower or egal to 172 mg/L
* No opposition at the participation of the study
* Expected patient return home after surgery (or convalescent home or not medicalized institution)

Exclusion Criteria:

* Patient under guardianship
* Protected or private patient freedom
* Minor patient
* Colectomy surgery with digestive bypass or digestive anastomosis
* Complex combined surgery (significantly intestinal resection associated, another surgical procedure that can interfere with postoperative CRP)
* General inflammatory disease susceptive to modify dosage values
* Anti-inflammatory therapy (AINS/ corticosteroids/ immunosuppressive)
* Patient unable to understand the study

Primary outcomes:
measure: C-reactive protein rate
timeFrame: 3 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Vendee
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Centre Hospitalier Departemental Vendee
name: Emeric ABET
role: STUDY_DIRECTOR
References:
Clinical trial NCT03739580: DCB Compared Stenting in Popliteal Lesions
Official title: The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Popliteal Stenosis
Popliteal Artery Occlusion
Diabetes
Keywords: drug-coating balloon
stent
popliteal artery
atherosclerotic occlusion
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Symptomatic peripheral artery disease:
* Moderate or severe claudication (Rutherford category 2 or 3)
* Critical limb ischemia (Rutherford category 4 or 5)
* Atherosclerotic popliteal artery disease (stenosis \> 50%)
* Patients with signed informed consent

Exclusion Criteria:

* Acute critical limb ischemia
* Severe critical limb ischemia (Rutherford category 6)
* Involvement of SFA disease with stenosis
* Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
* Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
* Age \> 80 years
* Severe hepatic dysfunction (\> 3 times normal reference values)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* LVEF \< 40% or clinically overt congestive heart failure
* Pregnant women or women with potential childbearing
* Life expectancy \<1 year due to comorbidity
* Previous bypass surgery or stenting for the target popliteal artery
* Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Primary outcomes:
measure: Primary patency of claudicant patients
timeFrame: 12 months after the index procedure
measure: Salvage limb rate (for CLI patients)
timeFrame: 12 months after the index procedure
Secondary outcomes:
measure: Rutherford classification
timeFrame: 12 months
measure: ABI
timeFrame: 12 months
measure: TcpO2
timeFrame: 12 months
measure: Wagnar classification
timeFrame: 12 months
measure: Target vessel revascularization rate
timeFrame: 12 months
measure: Index Limb Ischemia at 12-month Follow up
timeFrame: 12 months
measure: Major Adverse Events at 12-month Post Procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gu Yong Quan
state: Beijing
Study officials:
affiliation: Xuanwu hospital CMU
name: Yongquan Gu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379180: Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN
Official title: Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent Pulmonary Hypertension of the Newborn
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
First posted: 2020-05-07
Enrollment: 500
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates suffered from persistent pulmonary hypertension

Brief summary: The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.


Eligibility criteria: Inclusion Criteria:

* Age: postnatal age ≤ 28 days;
* Patients have been diagnosed with PPHN;
* Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
* Parental written consent

Exclusion Criteria:

* Expected survival time less than the treatment cycle;
* Major congenital malformations;
* Undergoing surgery within the first week of life;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.

Primary outcomes:
measure: Oxygenation index
timeFrame: The first 72 hours of the initial treatment
measure: The change of hemodynamics
timeFrame: Through study completion, an average of 5 days
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: Within the first 28 days of patients' life
measure: Death
timeFrame: Within the first 28 days of patients' life
measure: Adverse events
timeFrame: Through study completion, an average of 5 days
measure: Sequelae of PPHN
timeFrame: Through study completion and a 6-month visit
measure: The need of extra support
timeFrame: Through study completion, an average of 5 days
measure: Pulse oxygen saturation
timeFrame: The first 72 hours of the initial treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT01660880: Validation of Receptor Occupancy Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dopamine Receptor Occupancy
Medication Satisfaction
Prolactin Level
Schizophrenia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia who is in the steady sate of antipsychotic treatment

Brief summary: * To estimate dopamine receptor occupancy by aripiprazole using computer simulation
* To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics
* To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of schizophrenia
* treated with aripiprazole or risperidone
* no change in dose of antipsychotics for at least 6 weeks
* total PANSS score should be below 80

Exclusion Criteria:

* Other psychiatric disorders rather than schizophrenia
* history of head trauma
* positive in urine hCG
* on antidepressant, anticholinergics or mood stabilizer

Primary outcomes:
measure: Dopamine receptor occupancy
timeFrame: 72 hrs after the last administration
Secondary outcomes:
measure: Hamilton rating scale for depression
timeFrame: Baseline and 72 hours after the last administration
measure: Barnes akathisia scale
timeFrame: Baseline and 72 hours after the last administration
measure: Abnormal involuntary movement scale
timeFrame: Baseline and 72 hours after the last administration
measure: Simpson-Angus scale
timeFrame: Baseline and 72 hours after the last administration
measure: Treatment satisfaction questionnaire for medication
timeFrame: Baseline and 72 hours after the last administration
measure: Medication satisfaction questionnaire
timeFrame: Baseline and 72 hours after the last administration
measure: N-back task
timeFrame: Baseline and 72 hours after the last administration
measure: Prolactin level
timeFrame: Baseline and 72 hours after the last administration
measure: Dopamine receptor occupancy
timeFrame: 3 hrs after the last administration
measure: Dopamine receptor occupancy
timeFrame: 24 hrs after the last administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jun Soo Kwon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: