louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00742534: Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Official title: Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
Prematurity
Lung Disease
preterm infants
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Premature infants are at risk for developing bronchopulmonary dysplasia (BPD). L-citrulline may decrease that risk, but we do not know the safety or dose of this drug for use in premature babies. The purpose of this study is to determine the safety and optimal dose of intravenous L-citrulline in premature infants.

Detailed description: This is a prospective phase I study of the safety, pharmacokinetics, and optimal dose of intravenously administered L-citrulline in premature infants born at 24 to 29 weeks estimated gestational age (EGA) and who are at risk for bronchopulmonary dysplasia (BPD). This is a classic dose escalation using initial doses of 10 mg/kg of intravenous citrulline and advancing the dose by 10 mg/kg every 3 patients for a target peak plasma citrulline concentration of 100 umol/L. These infants will undergo intense hemodynamic monitoring and have intermittent blood sampling to determine levels of amino acids and nitric oxide metabolites. From this, we will determine citrulline pharmacokinetics including half life, clearance, and volume of distribution. Intravenous L-citrulline will be provided by Asklepion Pharmaceuticals and mixed by the Investigational Drug Service of the Vanderbilt Hospital Clinical Pharmacy. The study will be monitored closely by a data safety monitoring board (DSMB) consisting of clinicians not involved with this study.

Eligibility criteria: Inclusion Criteria:

* 24-29 Weeks Gestation
* Respiratory Distress requiring intubation and mechanical ventilation or positive pressure oxygen at 24 hours of life
* Parents willing and able to sign consent

Exclusion Criteria:

* Congenital malformation
* Suspected genetic or metabolic syndrome
* Surgical condition
* Life expectancy \< 24 hours
* Pre-existing, sustained hypotension
* Birth weight \< 500 grams
* Any condition which, in the opinion of the investigator, will interfere with the study objectives.

Primary outcomes:
measure: Pharmacokinetics and dose finding in preterm infants with BPD
timeFrame: Surrounding Dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Frederick E Barr, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02816034: Cerebellar Alterations in Individuals With a Cannabis Use Disorder
Official title: Alterations in Cerebellar-dependent Adaptation Due to Cannabis Use Measured With an Explicit-implicit Visuo-motor Learning Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis
Keywords: Learning
Cerebellum
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
First posted: 2016-06-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate if individuals with a cannabis use disorder have an impaired cerebellar function by assessing possible alterations to their implicit adaptation during a visuomotor rotation task.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a Cannabis use disorder following Diagnostic and Statistical Manual (DSM-V) criteria.
* Patients screen positive to cannabis in the urine analysis performed a week prior to assessment.
* Right-handed patients.
* Patients provide a signed consent.

Exclusion Criteria:

* Patients with another current substance use disorder (with the exception of tobacco).
* Patients with a visual impairment that has not been corrected.
* Patients with a cognitive impairment such as mental retardation.
* Patients with psychotic disorders.

Primary outcomes:
measure: Directional error of hand trajectories towards a target
timeFrame: 1 day (a single session)
Secondary outcomes:
measure: Reaction times
timeFrame: 1 day (a single session)
measure: Intrinsic Motivational Inventory
timeFrame: 1 day (a single session)
Other outcomes:
Locations:
Study officials:
References:
citation: Taylor JA, Klemfuss NM, Ivry RB. An explicit strategy prevails when the cerebellum fails to compute movement errors. Cerebellum. 2010 Dec;9(4):580-6. doi: 10.1007/s12311-010-0201-x.
citation: Mazzoni P, Krakauer JW. An implicit plan overrides an explicit strategy during visuomotor adaptation. J Neurosci. 2006 Apr 5;26(14):3642-5. doi: 10.1523/JNEUROSCI.5317-05.2006.
Clinical trial NCT04875234: Vision Improvement for Legally Blind Dry AMD Patients
Official title: Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dry Age-related Macular Degeneration
Vision Impairment and Blindness
Keywords: AMD, vision impairment, blindness
Lead sponsor: Optimal Acuity Corporation
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dry age-related macular degeneration an legal blindness in one or both eyes

Brief summary: This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.

Detailed description: This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.

Eligibility criteria: IInclusion Criteria:

* Male or Female
* Any race
* Patient is at least 50 years old.
* Patient must have dry AMD in the study eye.
* Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.
* Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).
* Patient is not a contact lens wearer.
* Patient is willing and able to comply with all examinations.
* Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

* Visually significant cataract in the study eye
* Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
* Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
* Previous corneal surgery in the study eye
* Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the study

Primary outcomes:
measure: Best spectacle-corrected distance visual acuity (BCDVA)
timeFrame: 12 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Optimal Acuity Corporation
name: Michael Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06203834: Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects
Official title: Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects: a Randomized, Double-blind, and Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: ITSWAY BIOTECH INC.
First posted: 2024-01-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.

Detailed description: This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.

Eligibility criteria: Inclusion Criteria:

* female
* aged 20-50 years old
* body mass index is greater than or equal to 27 kg/m2
* waist greater than or equal to 80 cm

Exclusion Criteria:

* Subjects diagnosed with cancer and on curative care.
* Subjects diagnosed with heart disease and on curative care.
* Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.
* Subjects with systemic infection requiring antibiotics.

Primary outcomes:
measure: Change from baseline body weight at week 12
timeFrame: Week 0, Week 12
measure: Change from baseline body fat at week 12
timeFrame: Week 0, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
affiliation: Chung Shan Medical University
name: Chin-Lin Hsu, Ph.D.
role: STUDY_CHAIR
affiliation: Chung Shan Medical University
name: Chin-Lin Hsu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Shiuan-Chih Chen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Hung-Hsuan Kuo, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Chun-Tse Tsai, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06781034: Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies
Official title: Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Hemorrhage
Acute Lobar Haematoma
Keywords: Cerebral haemorrhage
MRI
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute cerebral hematoma from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy; who underwent a follow-up cerebral CT scan in the event of worsening or for follow-up.

Brief summary: Cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment.

Arterial contrast ("spot sign") within the hematoma has been described in CT scans as a risk factor for further enlargement and poor prognosis.

An equivalent marker has also been described in gadolinium-enhanced MRI.

By studying the radiological appearance of gadolinium "spot signs" on MRI, which has better parenchymal resolution, the researchers propose to retrace the phenomenology of the acute phase of cerebral hemorrhage in order to better estimate the risk of radiological aggravation by subgroup, which could serve as a target population for future therapeutic trials.


Eligibility criteria: Inclusion Criteria:

* Patients with acute cerebral hematomas from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy managed at Nîmes University Hospital;
* Patients who have undergone a follow-up cerebral CT scan in the event of worsening or for follow-up.

Exclusion Criteria:

* Patient refusing to participate

Primary outcomes:
measure: Presence of spot sign on gadolinium MRI
timeFrame: baseline
measure: Morphologic description of gadolinium MRI spot sign
timeFrame: baseline
measure: Quantitative description of gadolinium MRI spot sign
timeFrame: baseline
Secondary outcomes:
measure: association of spot sign with hematoma expansion on follow-up CT
timeFrame: Baseline
measure: Association with the underlaying pathology
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT01926834: The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
Official title: The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: promoting angiogenesis in multiple targets
herbal medicine
traditional chinese medicine
random clinical trial
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction,test is made by random double-blind controlled.patients with acute cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function of promoting angiogenesis in multiple targets through this test.

Detailed description: OBJECTIVE:

To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction.

METHOD:

40 patients with acute cerebral infarction(in accordance with the inclusion criteria) were divided randomly into erigeron injection+aspirin group,aspirin group,and 20 health people. Erigeron injection+aspirin group and aspirin group drew peripheral blood on the prior treatment,the posttreatment 1th, 3th and 7th day,and tested the level of VEGF, MMP-9 and EPC.Tested the health people one time.

Eligibility criteria: Inclusion Criteria:

* patients aged no younger than 18yrs
* attack within 72 hours
* NIHSS score in the 2-25 points
* Ischemic Stroke occurred for the first time, or with a history of stroke disease but without sequelae
* Signed the informed consents

Exclusion Criteria:

* patients aged younger than 18yrs
* Patients with tumor, coronary heart disease, valvular heart disease, psoriasis, rheumatism, hematologic diseases, infertility, varieties of acute inflammation
* Patients with severe cognitive impairment
* Refused to cooperate or been unable to cooperation for neurological disorders
* Cerebral hemorrhage or hemorrhagic cerebral infarction
* Unstable vital signs dued to massive cerebral infarction
* Patients with serious heart, liver and renal insufficiency

Primary outcomes:
measure: the serum level of VEGF,MMP-9 and EPC
timeFrame: 0-7days
Secondary outcomes:
measure: National Institute of Health of stroke scale
timeFrame: 0-7days
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
name: Jianwen m Guo, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06350734: Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
Official title: Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women diagnosed with clinically localized bladder cancer

Brief summary: This study evaluates the effect of bladder cancer treatment on quality of life.

Detailed description: PRIMARY OBJECTIVES:

I. To compare general and disease-specific quality of life outcomes at 6, 12, 24, and 36 months after treatment for localized bladder cancer using the PROMIS-29 and the Bladder Cancer Index (BCI) respectively.

II. To identify patient level characteristics that may influence quality of life outcomes after treatment for localized bladder cancer.

OUTLINE: This is an observational study.

Patients complete surveys and also have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Have pathologically confirmed, clinically localized, bladder cancer
* Be willing to complete a survey in English before starting definitive treatment (surgery or radiation);
* Able to give consent.

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Change in quality of life outcomes - PROMIS-29
timeFrame: At baseline, 6, 12, 24, and 36 months
measure: Change in quality of life outcomes - Bladder Cancer Index
timeFrame: At baseline, 6, 12, 24, and 36 months
measure: Patient level characteristics
timeFrame: At baseline, 6, 12, 24, and 36 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark D. Tyson, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592734: Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
Official title: Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Faecal Impaction
Keywords: chronic constipation
faecal impaction
PEG-only laxative
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
First posted: 2012-05-07
Enrollment: 96
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation

Detailed description: Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.

Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.

It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.

Eligibility criteria: Inclusion Criteria:

* out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination

Exclusion Criteria:

* children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
* Children receiving medication influencing gastrointestinal motility;
* Children with suspected gastrointestinal obstruction or stenosis

Primary outcomes:
measure: Efficacy
timeFrame: 4 weeks of observation
measure: Efficacy
timeFrame: 7 days
Secondary outcomes:
measure: Clinical tolerability
timeFrame: 4 weeks of observation
measure: Acceptability
timeFrame: 4 weeks of observation
measure: Compliance
timeFrame: 4 weeks
measure: Efficacy
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.